National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 95 of 2010) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 95 of 2010
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) 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 subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated Twenty-Ninth October 2010
DAVID LEARMONTH
Deputy Secretary
Department of Health and Ageing
Amendment declaration and determination — drugs and medicinal preparations
1 Commencement
This instrument commences on 1 November 2010.
2 Amendment of PB 14 of 2010
Schedules 1 and 2 amend PB 14 of 2010.
Schedule 1 Amendments
[1]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;
“authorised optometrist” has the meaning given by subsection 84(1) of the Act;
[2]Paragraph 3, after definition of “palliative care patient”
insert
“participating dental practitioner” has the meaning given by subsection 84(1) of the Act;
[3]Paragraph 4
omit:
Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A and the circumstances (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a medical practitioner.
and substitute:
Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A, including where [NP] or [NP] [MW] is included in column 1 with the name of the drug or medicinal preparation, and the circumstances (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by a medical practitioner.
[4]After paragraph 4 as amended
insert
4AA. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 and, where “[MW]” is included in column 1 with the name of the drug or medicinal preparation, including where [NP] is also mentioned in column 1, the circumstances (if any) specified in column 3 of Schedule 1 opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by an authorised midwife, except where [MW] is also mentioned in column 3 of Schedule 1. The [MW] where included in column 1 does not form part of the name of the listed drug.
4AB. Where [MW] is included in column 1 of Schedule 1, and is also mentioned in column 3 of that Schedule with a form of a listed drug, Part VII of the Act applies for that form of the listed drug, and the circumstances (if any) specified in column 3 for that form apply, when prescribed by an authorised midwife or medical practitioner. The [MW] where included in column 3 does not constitute part of the form of the listed drug.
4AC. Part VII of the Act applies in relation to each of the drugs and medicinal preparations the name of which is specified in column 1 of Schedule 1 or 1A and, where “[NP]” is included in column 1 with the name of the drug or medicinal preparation, including where [MW] is also included in column 1 of Schedule 1, the circumstances (if any) specified in column 3 of Schedule 1 or column 2 of Schedule 1A opposite the name of that drug or medicinal preparation apply when the drug or medicinal preparation is prescribed by an authorised nurse practitioner, except where [NP] is also mentioned in column 3 of Schedule 1. The [NP] where included in column 1 of Schedule 1 or 1A does not form part of the name of the listed drug.
4AD. Where [NP] is included in column 1 of Schedule 1 and is also mentioned in column 3 of Schedule 1 with the circumstances for a listed drug, a form of a listed drug, or the circumstances for a form of a listed drug, Part VII of the Act applies in relation to the listed drug for those circumstances or for that form and the circumstances (if any) specified for that listed drug or for that form of the listed drug apply, when prescribed by an authorised nurse practitioner or medical practitioner. The [NP] when included with a circumstance, or form and strength of a listed drug does not constitute part of the circumstance or form and strength for the listed drug.
[5]Subparagraph 14(d)
omit:
where it is specified in column 3 of Schedule 1 or column 2 of Schedule 1A (in respect of medical practitioners), or in column 2 of Schedule 2A (in respect of authorised optometrists), that compliance with authority procedures set out in subparagraph 14(d) is required — that a medical practitioner or authorised optometrist has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:
and substitute:
where it is specified in column 3 of Schedule 1 or column 2 of Schedule 1A (in respect of medical practitioners); or in column 3 of Schedule 1 or column 2 of Schedule 1A where [NP] is included in column 1 with the name of the drug or medicinal preparation, and including where [MW] is also mentioned in column 1, (in respect of authorised nurse practitioners); or in column 2 of Schedule 2A (in respect of authorised optometrists); that compliance with authority procedures set out in subparagraph 14(d) is required — that a medical practitioner, authorised nurse practitioner or authorised optometrist has submitted to the Medicare Australia CEO a prescription for the supply of the pharmaceutical benefit:
[6]Subsubparagraph 14(d)(i), 14(d)(ii) and 14(d)(iii)
omit (wherever occurring):
the medical practitioner
and substitute:
the medical practitioner, authorised nurse practitioner
[7]Paragraph 14A
omit:
the medical practitioner
and substitute:
the medical practitioner, authorised nurse practitioner
[8]Subparagraph 15(a)
omit (wherever occurring):
the medical practitioner
and substitute:
the medical practitioner, authorised nurse practitioner
[9]Paragraph 15A
omit subparagraph (a) and substitute:
(a) the Medicare Australia CEO must tell the medical practitioner, orally or by electronic communication, the number that has been allotted to the authorised prescription; or in the case of an authorised nurse practitioner or authorised optometrist, must tell the authorised nurse practitioner or authorised optometrist orally the number that has been allotted to the authorised prescription; and
Subparagraph 15A(b)
omit:
the medical practitioner
and substitute:
the medical practitioner, authorised nurse practitioner
Paragraph 15B
omit (wherever occurring):
the medical practitioner
and substitute:
the medical practitioner, authorised nurse practitioner
Paragraph 15C
omit:
a medical practitioner
and substitute:
a medical practitioner or authorised nurse practitioner
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] |
Schedule 1A, all items in the column headed “Listed Drug” should display as “name of listed drug [NP]”
Schedule 2 Amendments
Schedule 1, item dealing with Adalimumab
insert in the column headed “Circumstances” following existing text:
| 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 14 (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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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 |
| Juvenile idiopathic arthritis — initial treatment 3 In compliance with authority procedures set out in subsubparagraph 14 (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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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 |
Schedule 1, item dealing with Albendazole
omit from the column headed “Circumstances”:
| In respect of the tablet 200 mg: |
and substitute:
| In respect of the tablet 200 mg [NP]: |
Schedule 1, item dealing with Alendronic Acid
after:
| In respect of the tablet 70 mg (as alendronate sodium): In compliance with authority procedures set out in subparagraph 14 (d): |
insert in the columns in the order indicated:
| 3070 | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated |
Schedule 1, item dealing with Alendronic acid with colecalciferol
after:
| In compliance with authority procedures set out in subparagraph 14 (d): |
insert in the columns in the order indicated:
| 3070 | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated |
Schedule 1, item dealing with Alendronic acid with colecalciferol and calcium
after:
| In compliance with authority procedures set out in subparagraph 14 (d): |
insert in the columns in the order indicated:
| 3070 | Treatment as the sole PBS-subsidised anti-resorptive agent for corticosteroid-induced osteoporosis in a patient currently on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy with a bone mineral density T-score of -1.5 or less, and where the duration and dose of corticosteroid therapy, and the date, site (femoral neck or lumbar spine) and score of the qualifying bone mineral density measurement, are documented in the patient's medical records when treatment is initiated |
Schedule 1, item dealing with Amino acid formula with vitamins and minerals without lysine and low in tryptophan
omit from the column headed “Circumstances”:
| In respect of the oral powder 500 g (XLYS, LOW TRY Maxamaid): A child aged less than 7 years with proven glutaric aciduria type 1 |
and substitute:
| In respect of the oral powder 500 g (XLYS, LOW TRY Maxamaid): A child aged less than 9 years with proven glutaric aciduria type 1 |
Schedule 1, after item dealing with Amlodipine with valsartan
insert in the columns in the order indicated:
| Amlodipine with valsartan and hydrochlorothiazide | Hypertension in a patient who is not adequately controlled with any two of the drugs in the combination |
Schedule 1, item dealing with Amoxycillin
omit from the column headed “Circumstances”:
| In respect of the capsule 250 mg (as trihydrate), capsule 500 mg (as trihydrate), sachet containing oral powder 3 g (as trihydrate), powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL, powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL, powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL and powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL: — |
and substitute:
| In respect of the capsule 250 mg (as trihydrate) [MW], capsule 500 mg (as trihydrate) [MW], sachet containing oral powder 3 g (as trihydrate), powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL, powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL, powder for oral suspension 250 mg (as trihydrate) per 5 mL, 100 mL and powder for oral suspension 500 mg (as trihydrate) per 5 mL, 100 mL: — |
Schedule 1, omit item dealing with Artemether with lumefantrine
and substitute:
| Artemether with lumefantrine | In respect of the tablet 20 mg-120 mg: In compliance with authority procedures set out in subparagraph 14 (d): |
| Treatment of suspected or confirmed malaria due to Plasmodium falciparum | |
| In respect of the tablet (dispersible) 20 mg-120 mg: In compliance with authority procedures set out in subparagraph 14 (d): | |
| Treatment of suspected or confirmed malaria due to Plasmodium falciparum in a patient unable to swallow a solid dosage form of artemether with lumefantrine |
Schedule 1, item dealing with Bromocriptine
omit from the column headed “Circumstances”:
| Prevention of the onset of lactation in the puerperium for medical reasons |
and substitute:
| Prevention of the onset of lactation in the puerperium for medical reasons [NP] |
Schedule 1, item dealing with Cabergoline
omit from the column headed “Circumstances”:
| Prevention of the onset of lactation in the puerperium for medical reasons |
and substitute:
| Prevention of the onset of lactation in the puerperium for medical reasons [NP] |
Schedule 1, item dealing with Carbomer
(a) omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the eye gel 2 mg per g, single dose units 0.6 mL, 30: |
and substitute:
| In respect of the eye gel 2 mg per g, single dose units 0.6 mL, 30 [NP]: |
Schedule 1, item dealing with Carmellose
(a) omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24, eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30, eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 and ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28: |
and substitute:
| In respect of the eye drops containing carmellose sodium 2.5 mg per mL, single dose units 0.6 mL, 24 [NP], eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30 [NP], eye drops containing carmellose sodium 10 mg per mL, single dose units 0.4 mL, 30 [NP] and ocular lubricating gel containing carmellose sodium 10 mg per mL, single dose units 0.6 mL, 28 [NP]: |
Schedule 1, item dealing with Carmellose with glycerin
(a) omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30: |
and substitute:
| In respect of the eye drops containing carmellose sodium 5 mg with glycerin 9 mg per mL, single dose units 0.4 mL, 30 [NP]: |
Schedule 1, item dealing with Desmopressin
(a) omit from the column headed “Circumstances”:
| Primary nocturnal enuresis in patients aged 6 years or older who are refractory to an enuresis alarm |
| Primary nocturnal enuresis in patients aged 6 years or older for whom an enuresis alarm is contraindicated, and where the reason for the contraindication is documented in the patient's medical records when treatment is initiated |
and substitute:
| Primary nocturnal enuresis in patients aged 6 years or older who are refractory to an enuresis alarm [NP] |
| Primary nocturnal enuresis in patients aged 6 years or older for whom an enuresis alarm is contraindicated, and where the reason for the contraindication is documented in the patient's medical records when treatment is initiated [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the wafer 120 micrograms (as acetate): |
and substitute:
| In respect of the wafer 120 micrograms (as acetate) [NP]: |
Schedule 1, item dealing with Diclofenac
omit from the column headed “Circumstances”:
| In respect of the suppository containing diclofenac sodium 100 mg: |
and substitute:
| In respect of the suppository containing diclofenac sodium 100 mg [MW]: |
Schedule 1, item dealing with Etanercept
(a) omit from the column headed “Circumstances”:
| Juvenile chronic arthritis — initial treatment 1 In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial treatment, for up to 4 months, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, and who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against the predetermined response criteria does not support continuation of PBS-subsidised treatment; and where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and where the following conditions apply: failure to achieve an adequate response is demonstrated by an elevated erythrocyte sedimentation rate greater than 25 mm per hour or a C-reactive protein level greater than 15 mg per L, and either an active joint count of at least 20 active (swollen and tender) joints or at least 4 active joints from the following list: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as 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); if the requirement to demonstrate an elevated erythrocyte sedimentation rate or C-reactive protein level cannot be met, the authority application includes the reasons why this criterion cannot be satisfied; the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; where the patient is exempted from demonstrating an inadequate response to the treatment regimens specified above, the authority application includes details of the contraindication or intolerance, including the degree of toxicity In compliance with authority procedures set out in subsubparagraph 14 (d) (i) or 14 (d) (ii): Initial treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 4 months, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 4 months of uninterrupted therapy |
(b) omit from the column headed “Circumstances”:
| Juvenile chronic arthritis — initial treatment 2 In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Initial PBS-subsidised supply for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who were receiving treatment with etanercept prior to 1 December 2002, who have signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if their response to treatment as assessed against predetermined response criteria does not support continuation of PBS-subsidised treatment, and who have demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with etanercept; and where the authority application includes sufficient information to determine the patient's eligibility for treatment and the date of assessment of the patient |
| Juvenile chronic arthritis — continuing treatment In compliance with authority procedures set out in subsubparagraph 14 (d) (i): Continuing PBS-subsidised treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of patients aged 18 years or older with a documented history of severe active polyarticular course juvenile chronic arthritis with onset prior to the age of 18 years, who, at the time of application, demonstrate an adequate response to treatment with etanercept as manifested by 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 an active joint count of fewer than 10 active (swollen and tender) joints or a reduction in the active (swollen and tender) joint count by at least 50% from baseline or a reduction in the number of the following active joints, from at least 4, by at least 50%: — elbow, wrist, knee or ankle (assessed as swollen and tender); — shoulder, cervical spine or hip (assessed as 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); and where the following conditions apply: the authority application includes sufficient information to determine the patient's response to treatment with etanercept according to the above criteria and the date of assessment of the patient; patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course |
Schedule 1, item dealing with Etanercept
insert in the column headed “Circumstances” following existing text:
| 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 14 (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 14 (d) (i) or 14 (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 14 (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 14 (d) (i) or 14 (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 |
| Juvenile idiopathic arthritis — continuing treatment In compliance with authority procedures set out in subsubparagraph 14 (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 14 (d) (i) or 14 (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 |
Schedule 1, item dealing with Fenofibrate
omit from the column headed “Circumstances”:
| For use in accordance with paragraph 16 |
and substitute:
| For use in accordance with paragraph 16 [NP]: |
Schedule 1, item dealing with Flucloxacillin
omit from the column headed “Circumstances”:
| In respect of the capsule 250 mg (as sodium), capsule 500 mg (as sodium), powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL: |
and substitute:
| In respect of the capsule 250 mg (as sodium) [MW], capsule 500 mg (as sodium) [MW], powder for oral liquid 125 mg (as sodium) per 5 mL, 100 mL and powder for oral liquid 250 mg (as sodium) per 5 mL, 100 mL: |
Schedule 1, item dealing with Fluvastatin
omit from the column headed “Circumstances”:
| For use in accordance with paragraph 16 |
and substitute:
| For use in accordance with paragraph 16 [NP]: |
Schedule 1, item dealing with Gemfibrozil
omit from the column headed “Circumstances”:
| For use in accordance with paragraph 16 |
and substitute:
| For use in accordance with paragraph 16 [NP]: |
Schedule 1, item dealing with Hypromellose
omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP]: |
Schedule 1, item dealing with Hypromellose with Carbomer 980
omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP]: |
Schedule 1, item dealing with Hypromellose with Dextran
(a) omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28: |
and substitute:
| In respect of the eye drops containing 3 mg hypromellose 2900 with 1 mg dextran 70 per mL, single dose units 0.4 mL, 28 [NP]: |
Schedule 1, omit item dealing with Lanthanum
and substitute:
| Lanthanum [NP] | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3546 | Maintenance therapy, following initiation and stabilisation of treatment with lanthanum carbonate, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy |
| 3547 | Maintenance therapy, following initiation and stabilisation of treatment with lanthanum carbonate, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy |
Schedule 1, item dealing with Levonorgestrel
omit from the column headed “Circumstances”:
| In respect of the tablets 30 micrograms, 28: |
and substitute:
| In respect of the tablets 30 micrograms, 28 [MW]: |
Schedule 1, item dealing with Medroxyprogesterone
omit from the column headed “Circumstances”:
| In respect of the tablet containing medroxyprogesterone acetate 5 mg, tablet containing medroxyprogesterone acetate 10 mg and injection containing medroxyprogesterone acetate 150 mg in 1 mL: — |
and substitute:
| In respect of the tablet containing medroxyprogesterone acetate 5 mg, tablet containing medroxyprogesterone acetate 10 mg and injection containing medroxyprogesterone acetate 150 mg in 1 mL: — [NP] |
Schedule 1, omit item dealing with Mexiletine
Schedule 1, item dealing with Morphine
omit from the column headed “Circumstances”:
| In respect of the injection containing morphine sulfate 10 mg in 1 mL, injection containing morphine tartrate 120 mg in 1.5 mL, injection containing morphine sulfate 15 mg in 1 mL and injection containing morphine sulfate 30 mg in 1 mL: |
and substitute:
| In respect of the injection containing morphine sulfate 10 mg in 1 mL [MW], injection containing morphine tartrate 120 mg in 1.5 mL, injection containing morphine sulfate 15 mg in 1 mL [MW] and injection containing morphine sulfate 30 mg in 1 mL: |
Schedule 1, after item dealing with Olmesartan
insert in the columns in the order indicated:
| Olmesartan with amlodipine | Hypertension in a patient who is not adequately controlled with either of the drugs in the combination |
Schedule 1, item dealing with Oxycodone
omit from the column headed “Circumstances”:
| Severe disabling pain not responding to non-narcotic analgesics |
and substitute:
| Severe disabling pain not responding to non-narcotic analgesics [NP] |
Schedule 1, after item dealing with Paliperidone
insert in the columns in the order indicated:
| Palonosetron | Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration |
Schedule 1, item dealing with Polyethylene glycol 400
(a) omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the eye drops 2.5 mg per mL, single dose units 0.4 mL, 20: |
and substitute:
| In respect of the eye drops 2.5 mg per mL, single dose units 0.4 mL, 20 [NP]: |
Schedule 1, item dealing with Polyethylene Glycol 400 with Propylene Glycol
(a) omit from the column headed “Circumstances”:
| Severe dry eye syndrome, including Sjogren's syndrome |
and substitute:
| Severe dry eye syndrome, including Sjogren's syndrome [NP] |
(b) omit from the column headed “Circumstances”:
| In respect of the eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28: |
and substitute:
| In respect of the eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 [NP]: |
Schedule 1, item dealing with Pravastatin
omit from the column headed “Circumstances”:
| For use in accordance with paragraph 16 |
and substitute:
| For use in accordance with paragraph 16 [NP]: |
Schedule 1, omit item dealing with Sevelamer
and substitute:
| Sevelamer [NP] | In compliance with authority procedures set out in subparagraph 14 (d): |
| 3548 | Maintenance therapy, following initiation and stabilisation of treatment with sevelamer hydrochloride, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where serum phosphate is greater than 1.6 mmol per L at the commencement of therapy |
| 3549 | Maintenance therapy, following initiation and stabilisation of treatment with sevelamer hydrochloride, of hyperphosphataemia in a patient with chronic kidney disease on dialysis whose serum phosphate is not controlled on calcium and where the serum calcium times phosphate product is greater than 4.0 at the commencement of therapy |
Schedule 1, item dealing with Simvastatin
omit from the column headed “Circumstances”:
| For use in accordance with paragraph 16 |
and substitute:
| For use in accordance with paragraph 16 [NP]: |
Schedule 1, item dealing with Tobramycin
(a) omit from the column headed “Circumstances”:
| In respect of the injection 80 mg (as sulfate) in 2 mL and injection 80 mg (as sulfate) in 2 mL (without preservative): |
and substitute:
| In respect of the injection 80 mg (as sulfate) in 2 mL and injection 80 mg (as sulfate) in 2 mL (without preservative) [NP]: |
(b) omit from the column headed “Circumstances”:
| In respect of the injection 500 mg (as sulfate) in 5 mL (without preservative): |
and substitute:
| In respect of the injection 500 mg (as sulfate) in 5 mL (without preservative) [NP]: |
Schedule 3, item dealing with Amlodipine
insert in the column headed “Allowable compounds” after “Amlodipine with Valsartan”:
Amlodipine with Valsartan and Hydrochlorothiazide
Olmesartan with Amlodipine
Schedule 3, item dealing with Hydrochlorothiazide
insert as first entry in the column headed “Allowable compounds”:
Amlodipine with Valsartan and Hydrochlorothiazide
Schedule 3, item dealing with Olmesartan
insert as first entry in the column headed “Allowable compounds”:
Olmesartan with Amlodipine
Schedule 3, item dealing with Valsartan
insert in the column headed “Allowable compounds” after “Amlodipine with Valsartan”:
Amlodipine with Valsartan and Hydrochlorothiazide
Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See
0
0
0