National Health Act 1953 Amendment determinations under sections 85, 85A and 88 pharmaceutical benefits (No. PB 96 of 2010) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 96 of 2010
Amendment determinations under sections 85, 85A and 88 of the National Health Act 1953
I, DAVID LEARMONTH, Deputy Secretary, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under sections 85, 85A and 88 of the National Health Act 1953.
Dated Twenty-Ninth October 2010
DAVID LEARMONTH
Deputy Secretary
Department of Health and Ageing
Amendment determination — pharmaceutical benefits
1 Commencement
This instrument commences on 1 November 2010.
2 Amendment of PB 68 of 2010
Schedules 1 and 2 amend PB 68 of 2010.
Schedule 1 Amendments
Paragraph 3, after definition of “Act”
insert
“authorised midwife” has the meaning given by subsection 84(1) of the Act;
“authorised nurse practitioner” has the meaning given by subsection 84(1) of the Act;
Paragraph 3, after definition of “palliative care patient”
insert
“participating dental practitioner” has the meaning given by subsection 84(1) of the Act;
After paragraph 5B
insert:
Authorised midwives
5C. For the purposes of subsection 88(1D) of the Act, the pharmaceutical benefits identified in Part 1 of Schedule 1 by “[MW]” in the column headed “Listed Drug”, including where “[NP]” is also mentioned in that column, are the pharmaceutical benefits for the supply of which an authorised midwife is authorised to write a prescription, except where [MW] is also included in the column headed “Form (strength, type, size, etc)”. Where [MW] is also included in the column headed “Form (strength, type, size, etc)”, the pharmaceutical benefits mentioned for that form or forms of the listed drug, are the pharmaceutical benefits for the supply of which an authorised midwife is authorised to write a prescription. The [MW] when included in the column headed “Listed Drug” does not constitute part of the name of the listed drug; nor does [MW], when included with the form of a listed drug, constitute part of the form of the pharmaceutical item or pharmaceutical benefit.
Authorised nurse practitioners
5D. For the purposes of subsection 88(1E) of the Act, the pharmaceutical benefits identified in Schedule 1 or Schedule 2 by “NP” in the column headed “Listed Drug”, including where [MW] is also mentioned in that column, are the pharmaceutical benefits for the supply of which an authorised nurse practitioner is authorised to write a prescription, except where [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”. Where [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats” the pharmaceutical benefits mentioned for that form or forms of the listed drug or for that number of repeats for that form of the listed drug, are the pharmaceutical benefits for the supply of which an authorised nurse practitioner is authorised to write a prescription. The identifier [NP], when included in the columns headed “Listed Drug”, “Form” or “Maximum number of repeats”, does not form part of the name of the listed drug; form, or number of repeats for the pharmaceutical item or pharmaceutical benefit.
After paragraph 7
insert
7A. For the purposes of subsection 85A(2) of the Act, the quantities and numbers of repeats in Part 2 of Schedule 1 or of Schedule 2 for a pharmaceutical item or pharmaceutical benefit where [NP] is included in the column headed “Listed Drug”, except where [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, are the maximum quantities and number of repeats that an authorised nurse practitioner may prescribe or direct on one occasion for the purposes mentioned in the pharmaceutical item or pharmaceutical benefit and not for other purposes. Where [NP] is also included in the column headed “Form (strength, type, size, etc)”, the quantities and numbers of repeats that apply for prescribing by an authorised nurse practitioner are the maximum quantities and number of repeats specified for that form of the listed drug. Where [NP] is also included in the column headed “Maximum number of repeats” the numbers of repeats that apply for prescribing by an authorised nurse practitioner are the maximum number of repeats specified for the form of the listed drug.
After subparagraph 8(a)
insert
(aa) Schedule 1, for a pharmaceutical item or pharmaceutical benefit where [MW] is included in the column headed “Listed Drug”, including where [NP] is also mentioned in that column, or [MW] is also included in the column headed “Form (strength, type, size, etc)”, is the only manner in which an authorised midwife may, in a prescription, direct the pharmaceutical benefit to be administered;
(ab) Schedule 1, or if not mentioned in Schedule 1, in Schedule 2, for a pharmaceutical item or pharmaceutical benefit where [NP] is included in the column headed “Listed Drug”, including where [MW] is also mentioned in that column, or [NP] is also included in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, is the only manner in which an authorised nurse practitioner may, in a prescription, direct the pharmaceutical benefit to be administered;
After paragraph 10
insert
10A. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit mentioned in Part 1 of Schedule 1 where [MW] is included in the column headed “Listed Drug”, including where [NP] is also mentioned in that column, or where [MW] is also in the column headed “Form (strength, type, size, etc)”, may, in one prescription, be directed by an authorised midwife to be repeated is the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit.
10B. For the purposes of subsection 85A(2) of the Act, the maximum number of occasions, if any, on which the supply of a pharmaceutical benefit in Schedule 1 or Schedule 2 where [NP] is included in the column headed “Listed Drug”, including where [MW] is mentioned in that column, or where [NP] is also in the column headed “Form (strength, type, size, etc)” or “Maximum number of repeats”, may, in one prescription, be directed by an authorised nurse practitioner to be repeated is, where the pharmaceutical benefit is mentioned:
(a) in Part 1 of Schedule 1 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(b) in Part 2 of Schedule 1 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(c) in Part 1 of Schedule 2 — the quantity or number, if any, specified in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit; or
(d) in Part 2 of Schedule 2 and the pharmaceutical benefit is prescribed in accordance with the provisions of the column headed “Purposes” — the quantity or number, if any, in that Part of the Schedule in the column headed “Maximum number of repeats” in relation to the pharmaceutical benefit.
Subparagraph 11(d)
(a) omit:
a medical practitioner
and substitute:
a medical practitioner or an authorised nurse practitioner
(b) omit (wherever occurring):
the medical practitioner
and substitute:
the medical practitioner or authorised nurse practitioner
Paragraph 11A
omit:
medical practitioner
and substitute:
medical practitioner or authorised nurse practitioner
Paragraph 12
omit (wherever occurring):
medical practitioner
and substitute:
medical practitioner or authorised nurse practitioner
Subparagraph 12A(a)
omit:
medical practitioner, orally or by electronic communication
and substitute:
medical practitioner, orally or by electronic communication, or an authorised nurse practitioner, orally
Subparagraph 12A(b)
omit:
medical practitioner
and substitute:
medical practitioner or authorised nurse practitioner
Paragraph 12B
omit (wherever occurring):
medical practitioner
and substitute:
medical practitioner or authorised nurse practitioner
Paragraph 12BA
a medical practitioner
and substitute:
a medical practitioner or an authorised nurse practitioner
Part 1 of Schedule 1, items listed below should display as indicated in the column headed “Listed Drug”
| Acamprosate [NP] |
| Acarbose [NP] |
| Acetazolamide [NP] |
| Aciclovir [NP] |
| Adrenaline [NP] |
| Albendazole [NP] |
| Alendronic Acid [NP] |
| Alendronic acid with colecalciferol [NP] |
| Alendronic acid with colecalciferol and calcium [NP] |
| Alginic acid with calcium carbonate and sodium bicarbonate [NP] |
| Allopurinol [NP] |
| Alprazolam [NP] |
| Aluminium Hydroxide with Magnesium Hydroxide [NP] |
| Aluminium Hydroxide with Magnesium Trisilicate and Magnesium Hydroxide [NP] |
| Amantadine [NP] |
| Amiloride [NP] |
| Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid [NP] |
| Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid [NP] |
| Amino acid formula without phenylalanine [NP] |
| Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine [NP] |
| Amino acid formula with vitamins and minerals without lysine and low in tryptophan [NP] |
| Amino acid formula with vitamins and minerals without methionine [NP] |
| Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine [NP] |
| Amino acid formula with vitamins and minerals without phenylalanine [NP] |
| Amino acid formula with vitamins and minerals without phenylalanine and tyrosine [NP] |
| Amino acid formula with vitamins and minerals without valine, leucine and isoleucine [NP] |
| Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid [NP] |
| Amino acids — synthetic, formula [NP] |
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids [NP] |
| Amiodarone [NP] |
| Amisulpride [NP] |
| Amitriptyline [NP] |
| Amlodipine [NP] |
| Amlodipine with Atorvastatin [NP] |
| Amlodipine with valsartan [NP] |
| Amoxycillin [NP] [MW] |
| Amoxycillin with Clavulanic Acid [NP] [MW] |
| Amphotericin [NP] |
| Ampicillin [NP] |
| Amylopectin, modified long chain [NP] |
| Anastrozole [NP] |
| Aprepitant [NP] |
| Arginine with carbohydrate [NP] |
| Aripiprazole [NP] |
| Aspirin [NP] |
| Atenolol [NP] |
| Atorvastatin [NP] |
| Atovaquone [NP] |
| Atovaquone with proguanil [NP] |
| Atropine [NP] |
| Auranofin [NP] |
| Aurothiomalate [NP] |
| Azathioprine [NP] |
| Azithromycin [NP] |
| Baclofen [NP] |
| Balsalazide[NP] |
| Beclomethasone [NP] |
| Benzathine benzylpenicillin [NP] |
| Benzhexol [NP] |
| Benztropine [NP] |
| Benzydamine [NP] |
| Benzylpenicillin [NP] [MW] |
| Betamethasone [NP] |
| Bethanechol [NP] |
| Bicalutamide [NP] |
| Biperiden [NP] |
| Bisacodyl [NP] |
| Bisoprolol [NP] |
| Bromocriptine [NP] |
| Budesonide [NP] |
| Budesonide with Eformoterol [NP] |
| Buprenorphine [NP] |
| Bupropion [NP] |
| Cabergoline [NP] |
| Calcipotriol [NP] |
| Calcipotriol with betamethasone [NP] |
| Calcitriol [NP] |
| Calcium [NP] |
| Candesartan [NP] |
| Candesartan with Hydrochlorothiazide [NP] |
| Captopril [NP] |
| Carbamazepine [NP] |
| Carbimazole [NP] |
| Carbohydrate, fat, vitamins, minerals and trace elements [NP] |
| Carbomer [NP] |
| Carbomer 974 [NP] |
| Carmellose [NP] |
| Carmellose with glycerin [NP] |
| Carvedilol [NP] |
| Cefalotin [NP] |
| Cefepime [NP] |
| Cefotaxime [NP] |
| Ceftriaxone [NP] |
| Celecoxib [NP] |
| Cephalexin [NP] [MW] |
| Cephazolin [NP] |
| Chloramphenicol [NP] [MW] |
| Chlorpromazine [NP] |
| Chlorthalidone [NP] |
| Cholestyramine [NP] |
| Ciclesonide [NP] |
| Cimetidine [NP] |
| Cinacalcet [NP] |
| Ciprofloxacin [NP] |
| Citalopram [NP] |
| Clarithromycin [NP] |
| Clindamycin [NP] [MW] |
| Clodronic Acid [NP] |
| Clomipramine [NP] |
| Clonazepam [NP] |
| Clonidine [NP] |
| Clopidogrel [NP] |
| Clopidogrel with aspirin [NP] |
| Clotrimazole [NP] |
| Coal Tar – Prepared [NP] |
| Codeine with Paracetamol [NP] |
| Colchicine [NP] |
| Colestipol [NP] |
| Copper Sulfate [NP] |
| Cortisone [NP] |
| Cromoglycic Acid [NP] |
| Cyproheptadine [NP] |
| Cystine with carbohydrate [NP] |
| Dabigatran etexilate [NP] |
| Dalteparin [NP] |
| Dantrolene [NP] |
| Dapsone [NP] |
| Desmopressin [NP] |
| Desvenlafaxine [NP] |
| Dexamethasone [NP] |
| Dexamethasone with Framycetin and Gramicidin [NP] |
| Dexamphetamine [NP] |
| Diazepam [NP] |
| Diclofenac [NP] [MW] |
| Dicloxacillin [NP] [MW] |
| Digoxin [NP] |
| Dihydroergotamine [NP] |
| Diltiazem [NP] |
| Diphenoxylate with Atropine [NP] |
| Diphtheria and tetanus vaccine, adsorbed, diluted for adult use [NP] |
| Dipyridamole [NP] |
| Dipyridamole with Aspirin [NP] |
| Disopyramide [NP] |
| Dolasetron [NP] |
| Domperidone [NP] |
| Donepezil [NP] |
| Dothiepin [NP] |
| Doxepin [NP] |
| Doxycycline [NP] |
| Duloxetine [NP] |
| Dydrogesterone [NP] |
| Eformoterol [NP] |
| Electrolyte Replacement, Oral [NP] |
| Electrolyte Replacement, Solution [NP] |
| Eletriptan [NP] |
| Enalapril [NP] |
| Enalapril with Hydrochlorothiazide [NP] |
| Enoxaparin [NP] |
| Entacapone [NP] |
| Eplerenone [NP] |
| Eprosartan [NP] |
| Eprosartan with Hydrochlorothiazide [NP] |
| Erythromycin [NP] |
| Escitalopram [NP] |
| Esomeprazole [NP] |
| Esomeprazole and Clarithromycin and Amoxycillin [NP] |
| Essential amino acids formula [NP] |
| Essential amino acids formula with minerals and vitamin C [NP] |
| Essential amino acids formula with vitamins and minerals [NP] |
| Ethacrynic Acid [NP] |
| Ethosuximide [NP] |
| Etidronic Acid [NP] |
| Etidronic Acid and Calcium [NP] |
| Etonogestrel [NP] |
| Exemestane [NP] |
| Exenatide [NP] |
| Ezetimibe [NP] |
| Ezetimibe with Simvastatin [NP] |
| Famciclovir [NP] |
| Famotidine [NP] |
| Felodipine [NP] |
| Fenofibrate [NP] |
| Fentanyl [NP] |
| Ferrous Fumarate with Folic Acid [NP] |
| Ferrous Sulfate [NP] |
| Flecainide [NP] |
| Flucloxacillin [NP] [MW] |
| Fluconazole [NP] |
| Fludrocortisone [NP] |
| Fluorometholone [NP] |
| Fluoxetine [NP] |
| Flupenthixol Decanoate [NP] |
| Fluphenazine Decanoate [NP] |
| Flurbiprofen [NP] |
| Flutamide [NP] |
| Fluticasone [NP] |
| Fluticasone with Salmeterol [NP] |
| Fluvastatin [NP] |
| Fluvoxamine [NP] |
| Folic Acid [NP] |
| Folinic acid [NP] |
| Fondaparinux [NP] |
| Fosinopril [NP] |
| Fosinopril with Hydrochlorothiazide [NP] |
| Framycetin [NP] [MW] |
| Frusemide[NP] |
| Gabapentin [NP] |
| Galantamine [NP] |
| Gelatin – Succinylated [NP] |
| Gemfibrozil [NP] |
| Gentamicin [NP] |
| Glibenclamide [NP] |
| Gliclazide [NP] |
| Glimepiride [NP] |
| Glipizide [NP] |
| Glucagon [NP] |
| Glucose [NP] |
| Glucose and Ketone Indicator—Urine [NP] |
| Glucose Indicator—Blood [NP] |
| Glucose Indicator—Urine [NP] |
| Glycerol [NP] |
| Glyceryl Trinitrate [NP] |
| Granisetron [NP] |
| Griseofulvin [NP] |
| Haloperidol [NP] |
| Haloperidol Decanoate [NP] |
| Heparin [NP] |
| Hexamine [NP] |
| High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate [NP] |
| Homatropine [NP] |
| Hydralazine [NP] |
| Hydrochlorothiazide [NP] |
| Hydrochlorothiazide with Amiloride [NP] |
| Hydrochlorothiazide with Triamterene [NP] |
| Hydrocortisone [NP] |
| Hydromorphone [NP] |
| Hydroxocobalamin [NP] |
| Hydroxychloroquine [NP] |
| Hydroxyethyl starch 130/0.4 [NP] |
| Hypromellose [NP] |
| Hypromellose with Carbomer 980 [NP] |
| Hypromellose with Dextran [NP] |
| Ibandronic acid [NP] |
| Ibuprofen [NP] [MW] |
| Imipramine [NP] |
| Indapamide [NP] |
| Indomethacin [NP] |
| Insulin Aspart [NP] |
| Insulin Aspart with Insulin Aspart Protamine Suspension [NP] |
| Insulin Detemir [NP] |
| Insulin Glargine [NP] |
| Insulin Glulisine [NP] |
| Insulin Isophane [NP] |
| Insulin Lispro [NP] |
| Insulin Lispro with Insulin Lispro Protamine Suspension [NP] |
| Insulin Neutral [NP] |
| Insulin Neutral with Insulin Isophane [NP] |
| Ipratropium [NP] |
| Irbesartan [NP] |
| Irbesartan with Hydrochlorothiazide [NP] |
| Iron Polymaltose Complex [NP] |
| Iron Sucrose [NP] |
| Isoleucine with carbohydrate [NP] |
| Isoniazid [NP] |
| Isosorbide Dinitrate [NP] |
| Isosorbide Mononitrate [NP] |
| Itraconazole [NP] |
| Ivermectin [NP] |
| Ketoconazole [NP] |
| Ketoprofen [NP] |
| Labetalol [NP] |
| Lacosamide [NP] |
| Lactulose [NP] |
| Lamotrigine [NP] |
| Lansoprazole [NP] |
| Lanthanum [NP] |
| Lercanidipine [NP] |
| Lercanidipine with enalapril [NP] |
| Letrozole [NP] |
| Levetiracetam [NP] |
| Levodopa with Benserazide [NP] |
| Levodopa with Carbidopa [NP] |
| Levodopa with Carbidopa and Entacapone [NP] |
| Levonorgestrel [NP] [MW] |
| Levonorgestrel with Ethinyloestradiol [NP] |
| Lignocaine [NP] |
| Lincomycin [NP] [MW] |
| Liothyronine [NP] |
| Lisinopril [NP] |
| Lithium [NP] |
| Loperamide [NP] |
| Macrogol 3350 [NP] |
| Medroxyprogesterone [NP] |
| Mefenamic Acid [NP] |
| Meloxicam [NP] |
| Memantine [NP] |
| Mesalazine [NP] |
| Metformin [NP] |
| Metformin with Glibenclamide [NP] |
| Methadone [NP] |
| Methyldopa [NP] |
| Methylphenidate [NP] |
| Methylprednisolone [NP] |
| Methysergide [NP] |
| Metoclopramide [NP] [MW] |
| Metoprolol [NP] |
| Metoprolol succinate [NP] |
| Metronidazole [NP] |
| Mianserin [NP] |
| Miconazole [NP] |
| Milk powder — lactose free formula [NP] |
| Milk powder — lactose modified [NP] |
| Milk powder — synthetic [NP] |
| Milk protein and fat formula with vitamins and minerals — carbohydrate free [NP] |
| Minocycline [NP] |
| Minoxidil [NP] |
| Mirtazapine [NP] |
| Moclobemide [NP] |
| Mometasone [NP] |
| Montelukast [NP] |
| Morphine [NP] [MW] |
| Moxonidine [NP] |
| Mupirocin [NP] |
| Naloxone [NP] |
| Naltrexone [NP] |
| Naproxen [NP] |
| Naratriptan [NP] |
| Nebivolol [NP] |
| Nedocromil [NP] |
| Neomycin [NP] |
| Neomycin with Bacitracin [NP] |
| Nicorandil [NP] |
| Nicotine [NP] |
| Nifedipine [NP] |
| Nilutamide [NP] |
| Nitrazepam [NP] |
| Nitrofurantoin [NP] [MW] |
| Nizatidine [NP] |
| Norethisterone [NP] |
| Norethisterone with Ethinyloestradiol [NP] |
| Norethisterone with Mestranol [NP] |
| Norfloxacin [NP] |
| Nortriptyline [NP] |
| Nystatin [NP] |
| Oestradiol [NP] |
| Oestradiol and Oestradiol with Dydrogesterone [NP] |
| Oestradiol and Oestradiol with Norethisterone [NP] |
| Oestradiol with Norethisterone [NP] |
| Oestriol [NP] |
| Olanzapine [NP] |
| Olmesartan [NP] |
| Olmesartan with Hydrochlorothiazide [NP] |
| Olsalazine [NP] |
| Omeprazole [NP] |
| Omeprazole and Clarithromycin and Amoxycillin [NP] |
| Ondansetron [NP] |
| Oxazepam [NP] |
| Oxcarbazepine [NP] |
| Oxprenolol [NP] |
| Oxybutynin [NP] |
| Oxycodone [NP] |
| Paliperidone [NP] |
| Pamidronic Acid [NP] |
| Pancreatic Extract [NP] |
| Pancrelipase [NP] |
| Pantoprazole [NP] |
| Paracetamol [NP] |
| Paraffin [NP] |
| Paroxetine [NP] |
| Penicillamine [NP] |
| Pergolide [NP] |
| Perhexiline [NP] |
| Pericyazine [NP] |
| Perindopril [NP] |
| Perindopril with amlodipine [NP] |
| Perindopril with Indapamide [NP] |
| Permethrin [NP] |
| Phenobarbitone [NP] |
| Phenoxybenzamine [NP] |
| Phenoxymethylpenicillin [NP] |
| Phenylalanine with carbohydrate [NP] |
| Phenytoin [NP] |
| Pindolol [NP] |
| Pioglitazone [NP] |
| Piroxicam[NP] |
| Pizotifen [NP] |
| Pneumococcal Vaccine – Polyvalent [NP] |
| Polyethylene glycol 400 [NP] |
| Polyethylene Glycol 400 with Propylene Glycol [NP] |
| Polygeline [NP] |
| Polyvinyl Alcohol [NP] |
| Posaconazole [NP] |
| Potassium Chloride [NP] |
| Potassium Chloride with Potassium Bicarbonate [NP] |
| Pramipexole [NP] |
| Prasugrel [NP] |
| Pravastatin [NP] |
| Praziquantel [NP] |
| Prazosin [NP] |
| Prednisolone [NP] |
| Prednisolone with Phenylephrine [NP] |
| Prednisone [NP] |
| Primidone [NP] |
| Probenecid [NP] |
| Procaine Penicillin [NP] |
| Prochlorperazine [NP] |
| Promethazine [NP] |
| Propantheline [NP] |
| Propranolol [NP] |
| Propylthiouracil [NP] |
| Protein hydrolysate formula with medium chain triglycerides [NP] |
| Pyrantel [NP] |
| Pyrimethamine [NP] |
| Quetiapine [NP] |
| Quinapril [NP] |
| Quinapril with Hydrochlorothiazide [NP] |
| Quinine [NP] |
| Rabeprazole [NP] |
| Raloxifene [NP] |
| Ramipril [NP] |
| Ramipril with Felodipine [NP] |
| Ranitidine [NP] [MW] |
| Reboxetine [NP] |
| Reteplase [NP] |
| Rifampicin [NP] |
| Riluzole [NP] |
| Risedronic Acid [NP] |
| Risedronic Acid and Calcium [NP] |
| Risedronic acid and calcium with colecalciferol [NP] |
| Risperidone [NP] |
| Rivaroxaban [NP] |
| Rivastigmine [NP] |
| Rizatriptan [NP] |
| Rosiglitazone [NP] |
| Rosiglitazone with Metformin [NP] |
| Rosuvastatin [NP] |
| Roxithromycin [NP] |
| Salbutamol [NP] |
| Salcatonin [NP] |
| Salmeterol [NP] |
| Selegiline [NP] |
| Sertraline [NP] |
| Sevelamer [NP] |
| Silver sulfadiazine [NP] |
| Simvastatin [NP] |
| Sitagliptin [NP] |
| Sitagliptin with metformin [NP] |
| Sodium Acid Phosphate [NP] |
| Sodium bicarbonate [NP] |
| Sodium Chloride [NP] |
| Sodium Chloride Compound [NP] |
| Sodium Chloride with Glucose [NP] |
| Sodium Lactate Compound [NP] |
| Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate [NP] |
| Sotalol [NP] |
| Soy lecithin [NP] |
| Soy protein and fat formula with vitamins and minerals — carbohydrate free [NP] |
| Spironolactone [NP] |
| Sterculia with Frangula Bark [NP] |
| Strontium [NP] |
| Sucralfate [NP] |
| Sulfacetamide [NP] |
| Sulfasalazine [NP] |
| Sulindac [NP] |
| Sulthiame [NP] |
| Sumatriptan [NP] |
| Tamoxifen [NP] |
| Telmisartan [NP] |
| Telmisartan with Hydrochlorothiazide [NP] |
| Temazepam [NP] |
| Tenecteplase [NP] |
| Terbinafine [NP] |
| Terbutaline [NP] |
| Tetrabenazine [NP] |
| Theophylline [NP] |
| Thiamine [NP] |
| Thyroxine [NP] |
| Tiagabine [NP] |
| Tiaprofenic Acid [NP] |
| Ticarcillin with Clavulanic Acid [NP] |
| Ticlopidine [NP] |
| Tiludronic Acid [NP] |
| Tinidazole [NP] |
| Tiotropium [NP] |
| Tirofiban [NP] |
| Tobramycin [NP] |
| Topiramate [NP] |
| Tramadol [NP] |
| Trandolapril [NP] |
| Trandolapril with Verapamil [NP] |
| Tranexamic Acid [NP] |
| Triamcinolone [NP] |
| Triamcinolone with Neomycin, Gramicidin and Nystatin [NP] |
| Trifluoperazine [NP] |
| Triglycerides, long chain with glucose polymer [NP] |
| Triglycerides, medium chain [NP] |
| Triglycerides, medium chain and long chain with glucose polymer [NP] |
| Triglycerides — medium chain, formula [NP] |
| Trimethoprim [NP] |
| Trimethoprim with Sulfamethoxazole [NP] |
| Tropisetron [NP] |
| Tyrosine with carbohydrate [NP] |
| Ursodeoxycholic Acid [NP] |
| Valaciclovir [NP] |
| Valine with carbohydrate [NP] |
| Valproic Acid [NP] |
| Valsartan [NP] |
| Valsartan with hydrochlorothiazide [NP] |
| Varenicline [NP] |
| Venlafaxine [NP] |
| Verapamil [NP] |
| Vigabatrin [NP] |
| Vitamins, minerals and trace elements with carbohydrate [NP] |
| Voriconazole [NP] |
| Warfarin [NP] |
| Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose [NP] |
| Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose [NP] |
| Ziprasidone [NP] |
| Zolmitriptan [NP] |
| Zuclopenthixol Decanoate [NP] |
Part 2 of Schedule 1, items listed below should display as indicated in the column headed “Listed Drug”
| Aciclovir [NP] |
| Albendazole [NP] |
| Amino acids — synthetic, formula [NP] |
| Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids [NP] |
| Amoxycillin [NP] |
| Azithromycin [NP] |
| Buprenorphine [NP] |
| Bupropion [NP] |
| Ceftriaxone [NP] |
| Clopidogrel [NP] |
| Codeine with Paracetamol [NP] |
| Dabigatran etexilate [NP] |
| Dalteparin [NP] |
| Diazepam [NP] |
| Doxycycline [NP] |
| Enoxaparin [NP] |
| Eprosartan [NP] |
| Escitalopram [NP] |
| Esomeprazole [NP] |
| Famciclovir [NP] |
| Fentanyl [NP] |
| Granisetron [NP] |
| Hydrocortisone [NP] |
| Hydromorphone [NP] |
| Ibuprofen [NP] |
| Ketoconazole [NP] |
| Lansoprazole [NP] |
| Lercanidipine [NP] |
| Methadone [NP] |
| Metronidazole [NP] |
| Milk powder — lactose free formula [NP] |
| Milk powder — lactose modified [NP] |
| Morphine [NP] |
| Naratriptan [NP] |
| Nifedipine [NP] |
| Nitrazepam [NP] |
| Omeprazole [NP] |
| Ondansetron [NP] |
| Oxazepam [NP] |
| Oxycodone [NP] |
| Pantoprazole [NP] |
| Paracetamol [NP] |
| Phenoxymethylpenicillin [NP] |
| Pramipexole [NP] |
| Rabeprazole [NP] |
| Ranitidine [NP] |
| Rifampicin [NP] |
| Risperidone [NP] |
| Rivaroxaban [NP] |
| Sertraline [NP] |
| Temazepam [NP] |
| Terbinafine [NP] |
| Tramadol [NP] |
| Valaciclovir [NP] |
| Zolmitriptan [NP] |
Part 1 of Schedule 2, all items in the column headed “Listed Drug” should display as “name of listed drug [NP]”
Part 2 of Schedule 2, all items in the column headed “Listed Drug” should display as “name of listed drug [NP]”
Schedule 2 Amendments
Part 1 of Schedule 1, item dealing with Aciclovir in the form Tablet 800 mg
omit from the column headed “Brand”: Lovir
Part 1 of Schedule 1, item dealing with Albendazole
omit from the column headed “Form (strength, type, size, etc.)”:
Tablet 200 mg
and substitute:
Tablet 200 mg [NP]
Part 1 of Schedule 1, after item dealing with Amlodipine with valsartan
insert in the columns in the order indicated:
| Amlodipine with valsartan and hydrochlorothiazide | Tablet 5 mg (as besylate)-160 mg-12.5 mg | Oral | 28 | 5 | Exforge HCT 5/160/12.5 |
| Tablet 5 mg (as besylate)-160 mg-25 mg | Oral | 28 | 5 | Exforge HCT 5/160/25 | |
| Tablet 10 mg (as besylate)-160 mg-12.5 mg | Oral | 28 | 5 | Exforge HCT 10/160/12.5 | |
| Tablet 10 mg (as besylate)-160 mg-25 mg | Oral | 28 | 5 | Exforge HCT 10/160/25 | |
| Tablet 10 mg (as besylate)-320 mg-25 mg | Oral | 28 | 5 | Exforge HCT 10/320/25 |
Part 1 of Schedule 1, item dealing with Amoxycillin
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Capsule 250 mg (as trihydrate)
and substitute:
Capsule 250 mg (as trihydrate) [MW]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Capsule 500 mg (as trihydrate)
and substitute:
Capsule 500 mg (as trihydrate) [MW]
Part 1 of Schedule 1, item dealing with Amoxycillin with Clavulanic Acid
omit from the column headed “Form (strength, type, size, etc.)”:
Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
and substitute:
Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [MW]
Part 1 of Schedule 1, item dealing with Artemether with lumefantrine
insert as next entry in the columns in the order indicated:
| Tablet (dispersible) 20 mg-120 mg | Oral | 18 | .. | Riamet 20mg/120mg Dispersible |
Part 1 of Schedule 1, item dealing with Benzylpenicillin
omit from the column headed “Form (strength, type, size, etc.)”:
Powder for injection 600 mg (as sodium)
and substitute:
Powder for injection 600 mg (as sodium) [MW]
Part 1 of Schedule 1, item dealing with Brimonidine
insert as first entry in the columns in the order indicated:
| Eye drops containing brimonidine tartrate 1.5 mg per mL, 5 mL | Application to the eye | 1 | 5 | Alphagan P 1.5 |
Part 1 of Schedule 1, item dealing with Bromocriptine
omit from the column headed “Form (strength, type, size, etc.)”:
Tablet 2.5 mg (as mesylate)
and substitute:
Tablet 2.5 mg (as mesylate) [NP]
Part 1 of Schedule 1, item dealing with Cephalexin
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Capsule 250 mg (anhydrous)
and substitute:
Capsule 250 mg (anhydrous) [MW]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Capsule 500 mg (anhydrous)
and substitute:
Capsule 500 mg (anhydrous) [MW]
Part 1 of Schedule 1, item dealing with Chloramphenicol
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Eye drops 5 mg per mL, 10 mL
and substitute:
Eye drops 5 mg per mL, 10 mL [MW]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Eye ointment 10 mg per g, 4 mg
and substitute:
Eye ointment 10 mg per g, 4 mg [MW]
Part 1 of Schedule 1, item dealing with Desmopressin
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Tablet containing desmopressin acetate 200 micrograms
and substitute:
Tablet containing desmopressin acetate 200 micrograms [NP]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Wafer 120 micrograms (as acetate)
and substitute:
Wafer 120 micrograms (as acetate) [NP]
(c) omit from the column headed “Form (strength, type, size, etc.)”:
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL
and substitute:
Nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 60 actuations, 6 mL [NP]
Part 1 of Schedule 1, item dealing with Diclofenac
omit from the column headed “Form (strength, type, size, etc.)”:
Suppository containing diclofenac sodium 100 mg
and substitute:
Suppository containing diclofenac sodium 100 mg [MW]
Part 1 of Schedule 1, item dealing with Enalapril in the forms Tablet containing enalapril maleate 5 mg, Tablet containing enalapril maleate 10 mg and Tablet containing enalapril maleate 20 mg
insert in alphabetical order in the column headed “Brand”: Enalapril Sandoz
Part 1 of Schedule 1, item dealing with Famotidine in the form Tablet 20 mg
insert in alphabetical order in the column headed “Brand”: Famotidine Sandoz
Part 1 of Schedule 1, item dealing with Flucloxacillin
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Capsule 250 mg (as sodium)
and substitute:
Capsule 250 mg (as sodium) [MW]
(b)omit from the column headed “Form (strength, type, size, etc.)”:
Capsule 500 mg (as sodium)
and substitute:
Capsule 500 mg (as sodium) [MW]
Part 1 of Schedule 1, item dealing with Fluconazole in the forms Solution for I.V. infusion 100 mg in 50 mL and Solution for I.V. infusion
200 mg in 100 mL
insert in alphabetical order in the column headed “Brand”: Fluconazole-Claris
Part 1 of Schedule 1, item dealing with Gentamicin
omit from the column headed “Form (strength, type, size, etc.)”:
Injection 80 mg (as sulfate) in 2 mL
and substitute:
Injection 80 mg (as sulfate) in 2 mL [NP]
Part 1 of Schedule 1, item dealing with Hydromorphone in the forms Tablet (modified release) containing hydromorphone hydrochloride
4 mg, Tablet (modified release) containing hydromorphone hydrochloride 8 mg, Tablet (modified release) containing hydromorphone hydrochloride 16 mg, Tablet (modified release) containing hydromorphone hydrochloride 32 mg and Tablet (modified release) containing hydromorphone hydrochloride 64 mg
omit from the column headed “Maximum quantity”: 10 and substitute: 14
Part 1 of Schedule 1, item dealing with Lamotrigine in the form Tablet 25 mg
insert in alphabetical order in the column headed “Brand”: APO-Lamotrigine
Part 1 of Schedule 1, item dealing with Levonorgestrel
omit from the column headed “Form (strength, type, size, etc.)”:
Tablets 30 micrograms, 28
and substitute:
Tablets 30 micrograms, 28 [MW]
Part 1 of Schedule 1, item dealing with Medroxyprogesterone
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Tablet containing medroxyprogesterone acetate 5 mg
and substitute:
Tablet containing medroxyprogesterone acetate 5 mg [NP]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Tablet containing medroxyprogesterone acetate 10 mg
and substitute:
Tablet containing medroxyprogesterone acetate 10 mg [NP]
(c) omit from the column headed “Form (strength, type, size, etc.)”:
Injection containing medroxyprogesterone acetate 150 mg in 1 mL
and substitute:
Injection containing medroxyprogesterone acetate 150 mg in 1 mL [NP]
Part 1 of Schedule 1, omit item dealing with Mexiletine
Part 1 of Schedule 1, item dealing with Moclobemide in the form Tablet 300 mg
omit from the column headed “Brand”: Maosig
Part 1 of Schedule 1, item dealing with Morphine
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Injection containing morphine sulfate 10 mg in 1 mL
and substitute:
Injection containing morphine sulfate 10 mg in 1 mL [MW]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Injection containing morphine sulfate 15 mg in 1 mL
and substitute:
Injection containing morphine sulfate 15 mg in 1 mL [MW]
Part 1 of Schedule 1, after item dealing with Olmesartan
insert in the columns in the order indicated:
| Olmesartan with amlodipine | Tablet containing olmesartan medoxomil 20 mg with amlodipine 5 mg (as besylate) | Oral | 30 | 5 | Sevikar 20/5 |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 5 mg (as besylate) | Oral | 30 | 5 | Sevikar 40/5 | |
| Tablet containing olmesartan medoxomil 40 mg with amlodipine 10 mg (as besylate) | Oral | 30 | 5 | Sevikar 40/10 |
Part 1 of Schedule 1, after item dealing with Paliperidone
insert in the columns in the order indicated:
| Palonosetron | Injection 250 micrograms (as hydrochloride) in 5 mL | Injection | 1 | .. | Aloxi |
Part 1 of Schedule 1, item dealing with Perindopril in the form Tablet containing perindopril erbumine 2 mg
insert in alphabetical order in the column headed “Brand”: APO-Perindopril
Part 1 of Schedule 1, item dealing with Ranitidine
omit from the column headed “Form (strength, type, size, etc.)”:
Tablet 150 mg (as hydrochloride)
and substitute:
Tablet 150 mg (as hydrochloride) [MW]
Part 1 of Schedule 1, after item dealing with Tacrolimus in the form Capsule 5 mg
insert in the columns in the order indicated:
| Capsule 0.5 mg (once daily prolonged release) | Oral | 30 | 3 | Prograf XL |
| Capsule 1 mg (once daily prolonged release) | Oral | 60 | 3 | Prograf XL |
| Capsule 5 mg (once daily prolonged release) | Oral | 30 | 3 | Prograf XL |
Part 1 of Schedule 1, item dealing with Tobramycin
(a) omit from the column headed “Form (strength, type, size, etc.)”:
Injection 80 mg (as sulphate) in 2 mL
and substitute:
Injection 80 mg (as sulphate) in 2 mL [NP]
(b) omit from the column headed “Form (strength, type, size, etc.)”:
Injection 80 mg (as sulphate) in 2 mL (without preservative)
and substitute:
Injection 80 mg (as sulphate) in 2 mL (without preservative) [NP]
(c) omit from the column headed “Form (strength, type, size, etc.)”:
Injection 500 mg (as sulphate) in 5 mL (without preservative)
and substitute:
Injection 500 mg (as sulphate) in 5 mL (without preservative) [NP]
Part 1 of Schedule 1, item dealing with Triptorelin
insert as next entry in the columns in the order indicated:
| Powder for I.M. injection (prolonged release) 22.5 mg (as embonate) with solvent, syringe and needles | Injection | 1 | .. | Diphereline |
Part 2 of Schedule 1, item dealing with Aciclovir in the form Tablet 800 mg
omit from the column headed “Brand”: Lovir
Part 2 of Schedule 1, item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe
insert after existing entries and immediately before the entries for the form “Injection 40 mg in 0.8 mL pre-filled pen” in the columns in the order indicated:
Injection 40 mg in 0.8 mL pre-filled syringe
Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg per day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Injection
2
3
Humira
Injection 40 mg in 0.8 mL pre-filled syringe
Juvenile idiopathic arthritis — initial treatment 3
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) was receiving treatment with adalimumab prior to 1 March 2010; and
(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(d) is receiving treatment with adalimumab at the time of application; and
where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Juvenile idiopathic arthritis — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Injection
2
5
Humira
Part 2 of Schedule 1, item dealing with Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen
insert after existing entries in the columns in the order indicated:
Injection 40 mg in 0.8 mL pre-filled pen
Juvenile idiopathic arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg per day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of adalimumab provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle;
a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Juvenile idiopathic arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Initial PBS-subsidised treatment, or recommencement of treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and
(c) has not failed PBS-subsidised therapy with adalimumab for this condition more than once in the current treatment cycle; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with adalimumab in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised adalimumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised adalimumab treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with adalimumab for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Injection
2
3
Humira
Injection 40 mg in 0.8 mL pre-filled pen
Juvenile idiopathic arthritis — initial treatment 3
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Commencement of a treatment cycle with an initial PBS-subsidised course of adalimumab for continuing treatment, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who:
(a) has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) was receiving treatment with adalimumab prior to 1 March 2010; and
(c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with adalimumab; and
(d) is receiving treatment with adalimumab at the time of application; and
where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
the course of treatment is limited to a maximum of 24 weeks of treatment;
a patient is eligible for PBS-subsidised treatment under the above criteria once only
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of initial PBS-subsidised treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who was receiving non-PBS-subsidised treatment with adalimumab prior to 1 March 2010 and at the time of the initial application for PBS-subsidised therapy, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial PBS-subsidised treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Juvenile idiopathic arthritis — continuing treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i):
Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older:
(a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and
(b) who has demonstrated an adequate response to treatment with adalimumab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with adalimumab; and
where bDMARD means adalimumab or etanercept; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) an active joint count of fewer than 10 active (swollen and tender) joints; or
(ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle;
a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment
In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii):
Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with adalimumab for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Injection
2
5
Humira
Part 2 of Schedule 1, omit item dealing with Etanercept
and substitute in the columns in the order indicated:
| Etanercept | Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL | Rheumatoid arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 12 months) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: (a) have severe active rheumatoid arthritis; and (b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and (c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include: (i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: — hydroxychloroquine at a dose of at least 200 mg daily; or — leflunomide at a dose of at least 10 mg daily; or — sulfasalazine at a dose of at least 2 g daily; or (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs: — hydroxychloroquine at a dose of at least 200 mg daily; and/or — leflunomide at a dose of at least 10 mg daily; and/or — sulfasalazine at a dose of at least 2 g daily; or (iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: — azathioprine at a dose of at least 1 mg/kg per day; and/or — cyclosporin at a dose of at least 2 mg/kg/day; and/or — sodium aurothiomalate at a dose of 50 mg weekly; and where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and where the following conditions apply: if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable; the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances; the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs; if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD; failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following: (a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either: (i) a total active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list of major joints: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application; if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied; the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement; a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with etanercept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; a course of initial treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with severe active rheumatoid arthritis who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Rheumatoid arthritis — initial treatment 2 (change or recommencement after a break of less than 12 months) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who: (a) have a documented history of severe active rheumatoid arthritis; and (b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and (c) have not failed previous PBS-subsidised treatment with etanercept for this condition; and where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and where the following conditions apply: patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with etanercept are not eligible to commence treatment with etanercept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion; the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; where a patient has received PBS-subsidised treatment with etanercept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy; a course of initial treatment is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Injection | 2 | 3 | Enbrel |
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL | Psoriatic arthritis — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis; and (2) have received no prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and where biological agent means adalimumab, etanercept, golimumab or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following: (a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either: (i) an active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list of major joints: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgment; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment with etanercept in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Psoriatic arthritis — initial treatment 2 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis; and (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and (3) have not failed treatment with etanercept during the current Treatment Cycle; and where biological agent means adalimumab, etanercept, golimumab or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; where a patient has received PBS-subsidised treatment with etanercept within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy; a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Injection | 2 | 3 | Enbrel | |
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL | Ankylosing spondylitis — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment with etanercept commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: (a) who has not received any PBS-subsidised treatment with a tumour necrosis factor (TNF)-alfa antagonist, or, where the patient has previously received PBS-subsidised TNF-alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and (b) who has at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; and (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is demonstrated by: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; both ESR and CRP measurements are included in the authority application and are no more than 1 month old; if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; the application for authorisation includes: (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a completed BASDAI Assessment Form; and (iii) a signed patient acknowledgment form; and (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment with etanercept in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Ankylosing spondylitis — initial treatment 2 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist treatment for this condition and is eligible to receive further TNF-alfa antagonist therapy, and has not failed PBS-subsidised therapy with etanercept in the current treatment cycle; and where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: a patient is eligible to receive further therapy with a TNF-alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists within this treatment cycle; the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form; an assessment of response to the patient's most recent course of PBS-subsidised TNF-alfa antagonist treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; where the most recent course of TNF-antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Injection | 2 | 3 |
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL | Chronic plaque psoriasis (whole body) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; the most recent PASI assessment is no more than 1 month old at the time of application; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Chronic plaque psoriasis (face, hand, foot) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; the most recent PASI assessment is no more than 1 month old at the time of application; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 2 | 5 | Enbrel |
| Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL | Juvenile idiopathic arthritis — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older: (a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) who has demonstrated an adequate response to treatment with etanercept; and (c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with etanercept; and where bDMARD means adalimumab or etanercept; and where the following conditions apply: an adequate response to treatment is defined as: (a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) an active joint count of fewer than 10 active (swollen and tender) joints; or (ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course; if the most recent course of etanercept therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 2 | 5 | Enbrel |
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Rheumatoid arthritis — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults: (a) who have a documented history of severe active rheumatoid arthritis; and (b) who have demonstrated an adequate response to treatment with etanercept; and (c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with etanercept; and where bDMARD means abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and where the following conditions apply: an adequate response to treatment is defined as: (a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course; if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of continuing treatment is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of continuing treatment with etanercept, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults with a documented history of severe active rheumatoid arthritis, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 | Enbrel |
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Psoriatic arthritis — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have severe active psoriatic arthritis; and (2) have received no prior PBS-subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS-subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS-subsidised therapy with a biological agent for this condition was approved; and (3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and where biological agent means adalimumab, etanercept, golimumab or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following: (a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either: (i) an active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list of major joints: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication; if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgment; a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment with etanercept in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Psoriatic arthritis — initial treatment 2 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who: (1) have a documented history of severe active psoriatic arthritis; and (2) have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and (3) have not failed treatment with etanercept during the current Treatment Cycle; and where biological agent means adalimumab, etanercept, golimumab or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form; where a patient has received PBS-subsidised treatment with etanercept within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy; a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Injection | 1 | 3 | |
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Psoriatic arthritis — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults: (1) who have a documented history of severe active psoriatic arthritis; and (2) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and (3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and where biological agent means adalimumab, etanercept, golimumab or infliximab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to treatment with etanercept is defined as: (a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); or — shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course; if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of continuing treatment with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 | Enbrel |
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Ankylosing spondylitis — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment with etanercept commencing a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and: (a) who has not received any PBS-subsidised treatment with a tumour necrosis factor (TNF)-alfa antagonist, or, where the patient has previously received PBS-subsidised TNF-alfa antagonist treatment for this condition, has received no such treatment for a period of 5 years or more starting from the date the last course of PBS-subsidised treatment was approved; and (b) who has at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; or (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); or (iii) limitation of chest expansion relative to normal values for age and gender; and (c) who has failed to achieve an adequate response following treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of at least 3 months, unless the patient has had a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years duration, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months; and where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: failure to achieve an adequate response is demonstrated by: (a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0-10 scale, where the BASDAI score is determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment, and is no more than 1 month old at the time of application; and (b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 10 mg per L; both ESR and CRP measurements are included in the authority application and are no more than 1 month old; if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reason why this criterion cannot be satisfied; the authority application includes details of the NSAIDs trialled, their doses and duration of treatment; if the NSAID dose is less than the maximum recommended dose in the relevant Therapeutic Goods Administration (TGA)-approved Product Information, the authority application includes the reason why a higher dose cannot be used; if treatment with NSAIDs is contraindicated according to the relevant TGA-approved Product Information, the authority application includes details of the contraindication; if intolerance to NSAID treatment develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the nature and severity of this intolerance; an appropriate minimum exercise program includes stretch and range of motion exercises at least 5 times per week, and either aerobic exercise of at least 20 minutes duration at least 3 times per week or a group exercise class at least once per week; if a patient is unable to complete the minimum exercise program, the authority application includes the clinical reasons for this and details what, if any, exercise program has been followed; the application for authorisation includes: (a) a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following: (i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and (ii) a completed BASDAI Assessment Form; and (iii) a signed patient acknowledgment form; and (iv) a completed Exercise Program Self Certification Form detailing the program followed and the dates over which it was followed, and including confirmation by the prescribing doctor that, to the best of their knowledge, the patient has followed the exercise program detailed; a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment with etanercept in a treatment cycle, by a rheumatologist, of an adult with active ankylosing spondylitis who has radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis, and who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Ankylosing spondylitis — initial treatment 2 In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, in this treatment cycle, has received prior PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist treatment for this condition and is eligible to receive further TNF-alfa antagonist therapy, and has not failed PBS-subsidised therapy with etanercept in the current treatment cycle; and where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: a patient is eligible to receive further therapy with a TNF-alfa antagonist within this treatment cycle provided they have not already failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists within this treatment cycle; the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form; an assessment of response to the patient's most recent course of PBS-subsidised TNF-alfa antagonist treatment is provided to the Medicare Australia CEO no later than 4 weeks from the date that course was ceased; where the most recent course of TNF-antagonist treatment is an initial treatment course, the assessment of response is made following a minimum of 12 weeks of treatment; if the response assessment to the previous course of TNF-alfa antagonist treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Injection | 1 | 3 | Enbrel |
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Ankylosing spondylitis — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline; all measurements provided are no more than 1 month old at the time of application; where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS-subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications; the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course; if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 | Enbrel |
| Injections 50 mg in 1 mL single use pre-filled syringes, 4 | Chronic plaque psoriasis (whole body) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; the most recent PASI assessment is no more than 1 month old at the time of application; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Chronic plaque psoriasis (face, hand, foot) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; the most recent PASI assessment is no more than 1 month old at the time of application; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 |
| Injection 50 mg in 1 mL single use auto-injector, 4 | Ankylosing spondylitis — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who has demonstrated an adequate response to treatment with etanercept, and whose most recent course of PBS-subsidised therapy in this treatment cycle was with etanercept; and where TNF-alfa antagonist means adalimumab, etanercept, golimumab or infliximab; and where a treatment cycle is a period of treatment with successive TNF-alfa antagonists which commences when an eligible patient (one who has not received PBS-subsidised treatment with a TNF-alfa antagonist for ankylosing spondylitis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 TNF-alfa antagonist, and which continues until the patient has tried and either failed, or ceased to respond to, PBS-subsidised treatment with 3 TNF-alfa antagonists, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response is defined as an improvement from baseline of at least 2 in the patient's Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and 1 of the following: (a) an erythrocyte sedimentation rate (ESR) measurement no greater than 25 mm per hour; or (b) a C-reactive protein (CRP) measurement no greater than 10 mg per L; or (c) an ESR or CRP measurement reduced by at least 20% from baseline; all measurements provided are no more than 1 month old at the time of application; where only 1 acute phase reactant measurement is supplied to establish baseline in the first application for PBS-subsidised treatment, that same marker is measured and supplied in all subsequent continuing treatment applications; the authority application includes a completed copy of the appropriate Ankylosing Spondylitis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course; if the most recent course of etanercept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of continuing treatment with etanercept within an ongoing treatment cycle, by a rheumatologist, of an adult with a documented history of active ankylosing spondylitis who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 | Enbrel |
| Injection 50 mg in 1 mL single use auto-injector, 4 | Chronic plaque psoriasis (whole body) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre-biological treatment baseline value for this Treatment Cycle; the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition; the most recent PASI assessment is no more than 1 month old at the time of application; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total Chronic plaque psoriasis (face, hand, foot) — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over: (a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and (b) whose most recent course of PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle was with etanercept; and (c) who have demonstrated an adequate response to their most recent course of treatment with etanercept; and where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and where the following conditions apply: an adequate response to etanercept treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value; the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value; the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 16-week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24-week treatment course, and is submitted to the Medicare Australia CEO no later than 1 month from the date of completion of the course of treatment; where an assessment of the patient's response to a course of PBS-subsidised treatment is not undertaken and submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with etanercept; the application for authorisation includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition; the most recent PASI assessment is no more than 1 month old at the time of application; a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 | Enbrel |
| Injection 50 mg in 1 mL single use auto-injector, 4 | Juvenile idiopathic arthritis — initial treatment 1 (new patient or patient recommencing after a break of more than 12 months) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who: (a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) has received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 12 months; and (c) has failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include: (i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: — hydroxychloroquine at a dose of at least 200 mg daily; or — leflunomide at a dose of at least 10 mg daily; or — sulfasalazine at a dose of at least 2 g daily; or (ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs: — hydroxychloroquine at a dose of at least 200 mg daily; and/or — leflunomide at a dose of at least 10 mg daily; and/or — sulfasalazine at a dose of at least 2 g daily; or (iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: — azathioprine at a dose of at least 1 mg/kg per day; and/or — cyclosporin at a dose of at least 2 mg/kg per day; and/or — sodium aurothiomalate at a dose of 50 mg weekly; and where bDMARD means adalimumab or etanercept; and where the following conditions apply: if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable; the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances; the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs; if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD; failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following: (a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and (b) either: (i) an active joint count of at least 20 active (swollen and tender) joints; or (ii) at least 4 active joints from the following list: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application; if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application states the reason this criterion cannot be satisfied; the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement; a patient whose previous treatment cycle was ceased due to their failure to respond to bDMARD treatment 3 times (twice with one agent and once with the other) is eligible to commence a new treatment cycle with an initial course of etanercept provided a minimum of 5 years have elapsed between the date of the last approval for PBS-subsidised bDMARD therapy in their previous treatment cycle and the date of the first application under the new treatment cycle; a course of initial treatment commencing a treatment cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment commencing a treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total Juvenile idiopathic arthritis — initial treatment 2 (change or recommencement after a break of less than 12 months) In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Initial PBS-subsidised treatment, or recommencement of treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older who: (a) has a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) in this treatment cycle, has received prior PBS-subsidised treatment with adalimumab or etanercept for this condition; and (c) has not failed PBS-subsidised therapy with etanercept for this condition more than once in the current treatment cycle; and where the following conditions apply: the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form; where a patient has received PBS-subsidised treatment with etanercept in this treatment cycle and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised etanercept treatment; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised etanercept treatment is a 16 week initial treatment course, is made following a minimum of 12 weeks of therapy; a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle; a course of initial treatment within an ongoing treatment cycle is limited to a maximum of 16 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for initial treatment or recommencement of treatment with etanercept for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total | Injection | 1 | 3 | Enbrel |
| Injection 50 mg in 1 mL single use auto-injector, 4 | Juvenile idiopathic arthritis — continuing treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i): Continuing PBS-subsidised treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older: (a) who has a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; and (b) who has demonstrated an adequate response to treatment with etanercept; and (c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with etanercept; and where bDMARD means adalimumab or etanercept; and where the following conditions apply: an adequate response to treatment is defined as: (a) an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and (b) either of the following: (i) an active joint count of fewer than 10 active (swollen and tender) joints; or (ii) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (iii) a reduction in the number of the following joints which are active, from at least 4, by at least 50%: — elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or — shoulder, cervical spine and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment; the authority application is made in writing and includes a completed copy of the appropriate Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept; the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course; if the most recent course of etanercept therapy is a 16 week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course; if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment; a patient who has failed to respond to treatment with adalimumab and etanercept 3 times (twice with one agent and once with the other) is not eligible to receive further PBS-subsidised therapy in this treatment cycle; a course of continuing treatment within an ongoing treatment cycle is limited to a maximum of 24 weeks of treatment In compliance with authority procedures set out in subsubparagraph 11 (d) (i) or 11 (d) (ii): Continuation of a course of continuing treatment within an ongoing treatment cycle, by a rheumatologist or clinical immunologist with expertise in the management of rheumatoid arthritis, of a patient aged 18 years or older with a documented history of juvenile idiopathic arthritis with onset prior to the age of 18 years who, qualifying under the criteria specified above, has previously been issued with an authority prescription for continuing treatment with etanercept for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total | Injection | 1 | 5 | Enbrel |
Part 2 of Schedule 1, item dealing with Hydromorphone in the forms Tablet (modified release) containing hydromorphone hydrochloride
4 mg, Tablet (modified release) containing hydromorphone hydrochloride 8 mg, Tablet (modified release) containing hydromorphone hydrochloride 16 mg, Tablet (modified release) containing hydromorphone hydrochloride 32 mg and Tablet (modified release) containing hydromorphone hydrochloride 64 mg
omit from the column headed “Maximum quantity”: 20 and substitute: 28
Part 1 of Schedule 3, item dealing with Hydromorphone in the forms Tablet (modified release) containing hydromorphone hydrochloride
4 mg, Tablet (modified release) containing hydromorphone hydrochloride 8 mg, Tablet (modified release) containing hydromorphone hydrochloride 16 mg, Tablet (modified release) containing hydromorphone hydrochloride 32 mg and Tablet (modified release) containing hydromorphone hydrochloride 64 mg
omit from the column headed “Maximum quantity”: 10 and substitute: 14
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
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