National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 3) (PB 26 of 2015) (Cth)
PB 26 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 3)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 23 March 2015
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
1 Name of Instrument
(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015 (No. 3).
(2) This Instrument may also be cited as PB 26 of 2015.
2 Commencement
This Instrument commences on 1 April 2015.
3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
Section 4
insert after the definition of “electronic communication”:
electronic prescription has the meaning given by the Regulations;
Section 4
insert after the definition of “palliative care patient”:
paper-based prescription has the meaning given by the Regulations;
Section 4
insert after the definition of “Regulations”:
residential care service has the meaning given by the Regulations;
After subsection 11(2)
insert:
(3) In all circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit, except those which include a Streamlined Authority Code, a medication chart prescription for a person receiving treatment in a residential care service may not be authorised under the authority required procedures in sections 11 to 15.
Subsection 12(1)
substitute:
(1) A prescription is submitted in accordance with this subsection if:
(a) the authorised prescriber submits to the Chief Executive Medicare:
(i) the prescription itself; or
(ii) for a medication chart prescription that is not an electronic prescription — the medication chart by which the prescription was written, or a copy of so much of that chart as would indicate that subregulation 19AA(2) of the Regulations has been complied with; or
(b) the authorised prescriber submits details of the prescription by telephone to the Chief Executive Medicare; or
(c) the authorised prescriber submits the prescription in accordance with the instructions in an emergency telephone message provided to the authorised prescriber by the Chief Executive Medicare; or
(d) the authorised prescriber submits details of the prescription to the Chief Executive Medicare, by means of electronic communication of a kind approved in writing by the Chief Executive Medicare.
Subsection 13(1)
substitute:
(1) A paper-based prescription (other than a prescription submitted in accordance with paragraph 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the prescription, and:
(a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — returning it to the authorised prescriber for alteration before the authorised prescriber gives it to the person in respect of whom it was prepared; or
(b) by returning it to the authorised prescriber; or
(c) if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.
After subsection 13(1)
insert:
(1A) A medication chart prescription (other than an electronic prescription, or a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the medication chart prescription, or a copy of the medication chart prescription, and:
(a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— indicating this on the medication chart prescription or copy; and
(b) returning the medication chart or copy to the authorised prescriber for alteration.
(1B) An electronic prescription (other than a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare writing his or her authorisation on the electronic prescription, and:
(a) if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— by returning it, including by means of an electronic communication, to the authorised prescriber for alteration; or
(b) by returning it, including by means of electronic communication to the authorised prescriber; or
(c) if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.
Paragraph 13(4)(a)
omit: given by the CEO to the prescription
substitute: that has been allotted to the authorised prescription
Subparagraph 13(4)(b)(ii)
insert after “copy of the prescription”: showing the number marked in accordance with subparagraph (i)
Subsection 14(2)
omit: authorised prescriber has:
substitute: authorised prescriber has written the Streamlined Authority Code on the prescription.
Omit paragraphs 14(2)(a) and 14(2)(b)
Schedule 1, entry for Adalimumab in all forms
omit from the column headed “Authorised Prescriber” (wherever occurring): See Note 1
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
(d)omit from the column headed “Purposes”: P3486 P3749
(e)insert in numerical order”: P4826 P4840 P4851
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
(d)omit from the column headed “Purposes”: P3750
(e)insert in numerical order”: P4845 P4864
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
(d)omit from the column headed “Purposes”: P3486 P3749
(e)insert in numerical order”: P4826 P4840 P4851
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C3486
(b)omit from the column headed “Circumstances”: C3749 C3750
(c)insert in numerical order”: C4826 C4840 C4845 C4851 C4864
(d)omit from the column headed “Purposes”: P3750
(e)insert in numerical order”: P4845 P4864
Schedule 1, after entry for Albendazole in the form Tablet 400 mg
insert:
| Alemtuzumab | Solution concentrate for I.V. infusion 12 mg in 1.2 mL | Injection | Lemtrada | GZ | MP | C4829 C4834 C4838 C4850 | P4829 P4850 | 3 | 0 | 1 | D(100) |
| MP | C4829 C4834 C4838 C4850 | P4834 P4838 | 5 | 0 | 1 | D(100) |
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Alendronate D3 70 mg/70 microgram | UA | MP NP | C4070 C4087 C4110 | 4 | 5 | 4 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Alendronate Plus D3 70 mg/70 mcg | TX | MP NP | C4070 C4087 C4110 | 4 | 5 | 4 |
Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Alendronate D3 70 mg/140 microgram | UA | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Alendronate Plus D3 70 mg/140 mcg | TX | MP NP | C4122 C4123 C4133 | 4 | 5 | 4 |
Schedule 1, entry for Alendronic acid with colecalciferol and calcium
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Alendronate Plus D3 and Calcium Sandoz | SZ | MP NP | C4122 C4123 C4133 | 1 | 5 | 1 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Alendronate Plus D3 Calcium Actavis | UA | MP NP | C4122 C4123 C4133 | 1 | 5 | 1 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| ReddyMax Plus D-Cal | RZ | MP NP | C4122 C4123 C4133 | 1 | 5 | 1 |
Schedule 1, entry for Allopurinol in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Allopurinol | TX | MP NP | 200 | 2 | 200 |
Schedule 1, entry for Allopurinol in the form Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Allopurinol | TX | MP NP | 60 | 2 | 60 |
Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Amiodarone Actavis | GN | MP NP | C1350 | 30 | 5 | 30 |
Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amitriptyline 10 | TX | MP NP | 50 | 2 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Chem mart Amitriptyline | CH | MP NP | 50 | 2 | 50 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Amitriptyline | TW | MP NP | 50 | 2 | 50 |
Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amitriptyline 25 | TX | MP NP | 50 | 2 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Chem mart Amitriptyline | CH | MP NP | 50 | 2 | 50 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Amitriptyline | TW | MP NP | 50 | 2 | 50 |
Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amitriptyline 50 | TX | MP NP | 50 | 2 | 50 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Chem mart Amitriptyline | CH | MP NP | 50 | 2 | 50 |
(c)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Amitriptyline | TW | MP NP | 50 | 2 | 50 |
Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Amlodipine AN | EA | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Brand” (twice occurring): Amoxiclav AN 500/125 substitute: Amoxyclav AN 500/125
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Brand” (twice occurring): Amoxiclav AN 875/125 substitute: Amoxyclav AN 875/125
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amoxycillin and Clavulanic Acid 125/31.25 | TX | PDP | C1836 C1837 | 1 | 0 | 1 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amoxycillin and Clavulanic Acid 125/31.25 | TX | MP NP | C1836 C1837 | 1 | 1 | 1 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amoxycillin and Clavulanic Acid 400/57 | TX | PDP | C1836 C1837 | 1 | 0 | 1 |
Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| APO-Amoxycillin and Clavulanic Acid 400/57 | TX | MP NP | C1836 C1837 | 1 | 1 | 1 |
Schedule 1, entry for Apomorphine
insert as first item in the columns in the order indicated:
| Injection containing apomorphine hydrochloride 10 mg in 1 mL | Injection | Apomine | HH | MP | C4833 C4860 | 360 | 5 | 5 | D(100) |
Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL
(a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Circumstances”: C1256 C3314 substitute C4833 C4860
Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL
(a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Circumstances”: C1256 C3314 substitute C4833 C4860
Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg
in 10 mL pre-filled syringe(a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Circumstances”: C1256 C3314 substitute C4833 C4860
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Blooms the Chemist Atorvastatin | IB | MP | C1540 C3047 | P1540 | 30 | 5 | 30 |
| NP | C1540 | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Blooms the Chemist Atorvastatin | IB | MP | C1540 C3047 | P3047 | 30 | 11 | 30 |
Schedule 1, entry for Baclofen in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Terry White Chemists Baclofen | TW | MP NP | 100 | 5 | 100 |
Schedule 1, entry for Captopril in each of the forms: Tablet 12.5 mg; Tablet 25 mg; and Tablet 50 mg
omit:
| APO-Captopril | TX | MP NP | 90 | 5 | 90 |
Schedule 1, entry for Certolizumab pegol
insert in numerical order in the column headed “Circumstances”: C4830 C4831 C4839 C4842 C4843 C4853 C4863
Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Citalopram Actavis | VN | MP NP | C1211 | 28 | 5 | 28 |
Schedule 1, entry for Cyclophosphamide in the form Tablet 50 mg
omit from the column headed “Responsible Person”: PF substitute: ZX
Schedule 1, entry for Dapagliflozin
omit from the column headed “Circumstances”: C4736 substitute: C4825 C4844
Schedule 1, entry for Desvenlafaxine in the form Tablet (extended release) 50 mg (as succinate)
omit from the column headed “Circumstances”: C1211 substitute: C4855
Schedule 1, after entry for Desvenlafaxine in the form Tablet (extended release) 50 mg (as succinate)
insert in the columns in the order indicated:
| Tablet (modified release) 50 mg | Oral | Desfax | AF | MP NP | C4855 | 28 | 5 | 28 |
| Desvenlafaxine Actavis | GN | MP NP | C4855 | 28 | 5 | 28 | ||
| Tablet (modified release) 50 mg (as benzoate) | Oral | Desvenlafaxine GH XR | GQ | MP NP | C4855 | 28 | 5 | 28 |
Schedule 1, entry for Desvenlafaxine in the form Tablet (extended release) 100 mg (as succinate)
omit from the column headed “Circumstances”: C1211 substitute: C4855
Schedule 1, after entry for Desvenlafaxine in the form Tablet (extended release) 100 mg (as succinate)
insert in the columns in the order indicated:
| Tablet (modified release) 100 mg | Oral | Desfax | AF | MP NP | C4855 | 28 | 5 | 28 |
| Desvenlafaxine Actavis | GN | MP NP | C4855 | 28 | 5 | 28 | ||
| Tablet (modified release) 100 mg (as benzoate) | Oral | Desvenlafaxine GH XR | GQ | MP NP | C4855 | 28 | 5 | 28 |
Schedule 1, entry for Diazepam in the form Tablet 5 mg
(a)omit:
| Diazepam‑GA | GN | MP NP PDP | 50 | 0 | 50 |
| MP NP | P3656 | 50 CN3656 | 0 | 50 |
(b)omit:
| Diazepam‑GA | GN | MP NP | P3655 | 50 CN3655 | 3 CN3655 | 50 |
Schedule 1, after entry for Diphtheria and tetanus vaccine, adsorbed, diluted for adult use in the form Injection 0.5 mL in pre-filled syringe
insert in the columns in the order indicated:
| Injection 0.5 mL | Injection | MassBiologics tetanus and diphtheria toxoids adsorbed | CS | MP NP | 10 | 0 | 10 | PB(MP) PB(NP) |
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Dotax | RZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL
omit:
| Docetaxel Sandoz | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Dotax | RZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, after entry for Dolutegravir
insert:
| Dolutegravir with abacavir and lamivudine | Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg | Oral | Triumeq | VI | MP | C4472 C4480 C4495 C4523 | 60 | 5 | 30 | D(100) |
Schedule 1, entry for Dorzolamide
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Trusamide | QA | MP AO | 1 | 5 | 1 |
Schedule 1, entry for Doxorubicin in each of the forms: Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial; and Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
omit:
| Doxorubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
omit:
| Doxorubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Empagliflozin in each of the forms: Tablet 10 mg; and Tablet 25 mg
omit from the column headed “Circumstances”: C4770 substitute: C4848
Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL; Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL; Solution for injection containing epirubicin hydrochloride 100 mg in
50 mL; and Solution for injection containing epirubicin hydrochloride 200 mg in 100 mLomit:
| Epirubicin Ebewe | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate)
(a)omit:
| Esomeprazole Actavis | GN | MP NP | C1337 C1629 C2273 C3429 | P2273 | 30 | 1 | 30 |
(b)omit:
| Esomeprazole Actavis | GN | MP NP | C1337 C1629 C2273 C3429 | P1337 P1629 P3429 | 30 | 5 | 30 |
Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate)
(a)omit:
| Esomeprazole Actavis | GN | MP NP | C1337 C1628 C3429 | P1628 | 30 | 1 | 30 |
(b)omit:
| Esomeprazole Actavis | GN | MP NP | C1337 C1628 C3429 | P1337 P3429 | 30 | 5 | 30 |
Schedule 1, entry for Etanercept in all forms
omit from the column headed “Authorised Prescriber” (wherever occurring): See Note 1
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C3489 C3776 C3777
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3489 P3776
(d)insert in numerical order: P4826 P4840 P4851
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C3489 C3776 C3777
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3777
(d)insert in numerical order: P4845 P4864
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C3489 C3776 C3777
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3489 P3776
(d)insert in numerical order: P4826 P4840 P4851
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C3489 C3776 C3777
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3777
(d)insert in numerical order: P4845 P4864
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3](a)omit from the column headed “Circumstances”: C3489 C3776 C3777
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3489 P3776
(d)insert in numerical order: P4826 P4840 P4851
Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5](a)omit from the column headed “Circumstances”: C3489 C3776 C3777
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3777
(d)insert in numerical order: P4845 P4864
Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C4837 C4861
(b)insert in numerical order in the column headed “Purposes”: P4861
Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in numerical order in the column headed “Circumstances”: C4837 C4861
(b)insert in numerical order in the column headed “Purposes”: P4837
Schedule 1, entry for Everolimus in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)insert in numerical order in the column headed “Circumstances”: C4837 C4861
(b)insert in numerical order in the column headed “Purposes”: P4861
Schedule 1, entry for Everolimus in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats 5]
(a)omit from the column headed “Circumstances”: C4557
(b)insert in numerical order: C4812 C4837 C4861
(c)omit from the column headed “Purposes”: P4557
(d)insert in numerical order: P4812 P4837
Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses; and
Injection solution 10 micrograms per dose in pre-filled pen, 60 dosesomit from the column headed “Circumstances”: C4392 C4405 substitute: C4856 C4857
Schedule 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL
omit:
| Fluorouracil Ebewe | SZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 5 | D(100) |
Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL
omit:
| Calcium Folinate Ebewe | SZ | MP See Note 1 | 10 | 2 | 5 |
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C3495 C3497 C3784 C3785
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3495 P3784
(d)insert in numerical order: P4826 P4840 P4851
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C3495 C3497 C3784 C3785
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3497 P3785
(d)insert in numerical order: P4845 P4864
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3](a)omit from the column headed “Circumstances”: C3495 C3497 C3784 C3785
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3495 P3784
(d)insert in numerical order: P4826 P4840 P4851
Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5](a)omit from the column headed “Circumstances”: C3495 C3497 C3784 C3785
(b)insert in numerical order: C4826 C4840 C4845 C4851 C4864
(c)omit from the column headed “Purposes”: P3497 P3785
(d)insert in numerical order: P4845 P4864
Schedule 1, after entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12 [Brand: APO-Imiquimod]
insert in the columns in the order indicated:
| IncobotulinumtoxinA | Lyophilised powder for injection 100 units | Injection | Xeomin | EZ | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Iron Polymaltose Complex
substitute:
| Iron Polymaltose Complex | Injection 100 mg (iron) in 2 mL | Injection | Ferrosig | SI | MP NP | 5 | 0 | 5 |
| MP NP | P4302 | 5 CN4302 | 5 CN4302 | 5 | ||||
| Ferrum H | AS | MP NP | 5 | 0 | 5 | |||
| MP NP | P4302 | 5 CN4302 | 5 CN4302 | 5 |
Schedule 1, entry for Iron Sucrose
substitute:
| Iron sucrose | Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL | Injection | Venofer | AS | MP NP | 5 | 0 | 5 |
| MP NP | P4302 | 5 CN4302 | 5 CN4302 | 5 |
Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 90;
Number of Repeats: 5]omit from the column headed “Circumstances”: C3546 C3547 substitute: C4827
Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 180;
Number of Repeats: 5](a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Circumstances”: C3103 C3104 C3390 C3391 substitute: C4832 C4847
Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 90;
Number of Repeats: 5]omit from the column headed “Circumstances”: C3546 C3547 substitute: C4827
Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 180;
Number of Repeats: 5](a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Circumstances”: C3103 C3104 C3390 C3391 substitute: C4832 C4847
Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 90;
Number of Repeats: 5]omit from the column headed “Circumstances”: C3546 C3547 substitute: C4827
Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 180;
Number of Repeats: 5](a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Circumstances”: C3103 C3104 C3390 C3391 substitute: C4832 C4847
Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 17 g, 30
omit from the column headed “Brand”: MediHealth substitute: Herron
Schedule 1, after entry for Mesalazine in the form Sachet containing prolonged release granules, 2 g per sachet
insert in the columns in the order indicated:
| Sachet containing prolonged release granules, 4 g per sachet | Oral | Pentasa | FP | MP NP | C4824 | 30 | 5 | 30 |
Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
omit:
| Methotrexate Ebewe | SZ | MP | See Note 3 | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, omit entry for Mifepristone
Schedule 1, omit entry for Misoprostol
Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 60 mg (controlled release)
omit from the column headed “Brand”: APOTEX-MORPHINE MR substitute: MORPHINE MR APOTEX
Schedule 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ikotab | QA | MP NP | 1 | 5 | 1 |
Schedule 1, after entry for Oestriol in the form Vaginal cream 1 mg per g, 15 g
insert:
| Ofatumumab | Solution concentrate for I.V. infusion 100 mg in 5 mL | Injection | Arzerra | GK | MP | C4828 | See Note 3 | See Note 3 | 3 | D(100) |
| Solution concentrate for I.V. infusion 1000 mg in 50 mL | Injection | Arzerra | GK | MP | C4828 C4858 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit:
| Oxaliplatin Ebewe | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit:
| Oxaliplatin Ebewe | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg
insert:
| Oxytocin | Injection 10 I.U. in 1 mL | Injection | Oxytocin Sandoz | SZ | See Note 4 | See Note 4 | See Note 4 | See Note 4 | See Note 4 | 5 | D(MP) |
Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
omit:
| Paclitaxel Ebewe | SZ | MP | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Blooms the Chemist Perindopril | IB | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Blooms the Chemist Perindopril | IB | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Blooms the Chemist Perindopril | IB | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Polyvinyl Alcohol
omit:
| Eye drops 30 mg per mL, 15 mL | Application to the eye | Liquifilm Forte | AG | MP | C1362 C3036 | P1362 | 1 | 5 | 1 |
| NP AO | C1362 | 1 | 5 | 1 | |||||
| PVA Forte | PE | MP | C1362 C3036 | P1362 | 1 | 5 | 1 | ||
| NP AO | C1362 | 1 | 5 | 1 | |||||
| Liquifilm Forte | AG | MP | C1362 C3036 | P3036 | 1 | 11 | 1 | ||
| PVA Forte | PE | MP | C1362 C3036 | P3036 | 1 | 11 | 1 |
Schedule 1, entry for Raloxifene
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Raloxifene AN | EA | MP NP | C4071 | 28 | 5 | 28 |
Schedule 1, entry for Ramipril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ramipril Winthrop | WA | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ranitidine GH | GQ | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Salcatonin
omit:
| Injection 50 I.U. in 1 mL ampoule | Injection | Miacalcic 50 | NV | MP NP | C1412 C3256 | 30 | 5 | 5 |
Schedule 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Maximum Quantity: 180;
Number of Repeats: 5]omit from the column headed “Circumstances”: C3548 C3549 substitute: C4827
Schedule 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Maximum Quantity: 360;
Number of Repeats: 5](a)omit from the column headed “Authorised Prescriber”: See Note 1
(b)omit from the column headed “Brand”: Renagel
(c)omit from the column headed “Responsible Person”: GZ
(d)omit from the column headed “Circumstances”: C3103 C3104 C3390 C3391 substitute: C4832 C4847
Schedule 1, entry for Sildenafil
(a)omit from the column headed “Authorised Prescriber” (wherever occurring): See Note 1
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Sildenafil AN PHT 20 | EA | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 90 | D(100) |
Schedule 1, entry for Sorafenib
substitute:
| Sorafenib | Tablet 200 mg (as tosylate) | Oral | Nexavar | BN | MP | C4230 C4234 C4820 C4841 | P4230 P4234 P4841 | 120 | 2 | 60 |
| C4230 C4234 C4820 C4841 | P4820 | 120 | 5 | 60 |
Schedule 1, after entry for Sucralfate
insert:
| Sucroferric oxyhydroxide | Tablet, chewable, 2.5 g (equivalent to 500 mg iron) | Oral | Velphoro | FN | MP NP | C4827 | 90 | 5 | 90 |
| MP | C4832 C4847 | 180 | 5 | 90 | C(100) |
Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats 5; Pack Quantity: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Iptam | AL | MP NP | C4558 | 4 | 5 | 2 |
Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats 5; Pack Quantity: 4]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Iptam | AL | MP NP | C4558 | 4 | 5 | 4 |
Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Circumstances”: C4341 C4354 substitute: C4837 C4862
Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4341 C4354substitute: C4837 C4862
(b)omit from the column headed “Purposes”: P4354 substitute: P4862
Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]
omit from the column headed “Circumstances”: C4341 C4354 substitute: C4837 C4862
Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4341 C4354substitute: C4837 C4862
(b)omit from the column headed “Purposes”: P4341 substitute: P4837
Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Circumstances”: C4341 C4354 substitute: C4837 C4862
Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4341 C4354substitute: C4837 C4862
(b)omit from the column headed “Purposes”: P4354 substitute: P4862
Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]
omit from the column headed “Circumstances”: C4341 C4354 substitute: C4837 C4862
Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4341 C4354substitute: C4837 C4862
(b)omit from the column headed “Purposes”: P4341 substitute: P4837
Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Circumstances”: C4341 C4354 substitute: C4837 C4862
Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4341 C4354substitute: C4837 C4862
(b)omit from the column headed “Purposes”: P4354 substitute: P4862
Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]
omit from the column headed “Circumstances”: C4341 C4354 substitute: C4837 C4862
Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C4341 C4354substitute: C4837 C4862
(b)omit from the column headed “Purposes”: P4341 substitute: P4837
Schedule 1, entry for Tacrolimus in all forms
omit from the column headed “Authorised Prescriber” (wherever occurring): See Note 1
Schedule 1, entry for Tacrolimus in each of the forms: Capsule 0.5 mg; Capsule 1 mg; and Capsule 5 mg
omit from the column headed “Responsible Person” for the brand “Prograf” (all instances): JC substitute: LL
Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)
(a)omit from the column headed “Responsible Person” for the brand “Prograf XL” (first instance): JC substitute: LL
(b)omit from the column headed “Brand” (second instance): Prograf XL
(c)omit from the column headed “Responsible Person” (second instance): JC
Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release)
(a)omit from the column headed “Responsible Person” for the brand “Prograf XL” (first instance): JC substitute: LL
(b)omit from the column headed “Brand” (second instance): Prograf XL
(c)omit from the column headed “Responsible Person” (second instance): JC
Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release)
(a)omit from the column headed “Responsible Person” for the brand “Prograf XL” (first instance): JC substitute: LL
(b)omit from the column headed “Brand” (second instance): Prograf XL
(c)omit from the column headed “Responsible Person” (second instance): JC
Schedule 1, entry for Testosterone in each of the forms: Capsule containing testosterone undecanoate 40 mg; Injection containing testosterone enanthate 250 mg in 1 mL; I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL; Transdermal gel 50 mg
in 5 g sachet, 30; Transdermal patches 12.2 mg, 60; Transdermal patches 24.3 mg, 30; and Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 dosesomit from the column headed “Circumstances”: C4815 C4816 C4817 C4818 C4819substitute:C4866 C4867 C4868 C4869 C4870
Schedule 1, entry for Ursodeoxycholic Acid
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Ursosan | BZ | MP NP | C1700 | 200 | 2 | 100 |
Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 56; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C4647
(b)insert in numerical order: C4835
(c)omit from the column headed “Purposes”: P4647
(d)substitute: P4835
Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 112; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C4647
(b)insert in numerical order: C4835
Schedule 3, after details relevant to Responsible Person code EU
insert:
| EZ | Merz Australia Pty Ltd | 62 151 073 559 |
Schedule 3, after details relevant to Responsible Person code FM
insert:
| FN | Fresenius Medical Care Australia Pty Ltd | 80 067 557 877 |
Schedule 3, after details relevant to Responsible Person code ZP
insert:
| ZX | Zenex Pharmaceuticals Pty Ltd | 51 603 281 509 |
Schedule 4, Part 1, entry for Adalimumab
(a)omit:
| C3486 | P3486 | Psoriatic arthritis — initial treatment 1 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); and/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 is made in writing and 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 | Compliance with Written Authority Required procedures |
| Continuation of a course of initial treatment with adalimumab 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 | Compliance with Written or Telephone Authority Required procedures |
(b)omit:
| C3749 | P3749 | Psoriatic arthritis — initial treatment 2 Initial treatment, or recommencement of treatment, with adalimumab 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 adalimumab 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 is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form; where a patient has received PBS‑subsidised treatment with adalimumab 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 adalimumab treatment; the response assessment included in the application is provided to the Chief Executive Medicare 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 course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment | Compliance with Written Authority Required procedures |
| Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab 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 | Compliance with Written or Telephone Authority Required procedures | ||
| C3750 | P3750 | Psoriatic arthritis — continuing treatment Continuing treatment with adalimumab 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 adalimumab; and (3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; 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 adalimumab 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); and/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 is made in writing and 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 adalimumab; the response assessment included in the application is provided to the Chief Executive Medicare 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 Chief Executive Medicare 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 | Compliance with Written Authority Required procedures |
| Continuation of a course of continuing treatment with adalimumab 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 | Compliance with Written or Telephone Authority Required procedures |
(c)insert in numerical order after existing text:
| C4826 | P4826 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C4840 | P4840 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab The authority application must be made in writing and must include: Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
| C4845 | P4845 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4851 | P4851 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4864 | P4864 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab An adequate response to treatment is defined as: The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, after entry for Albendazole
insert:
| Alemtuzumab | C4829 | P4829 | Multiple sclerosis Continuing Patient must have previously been issued with an authority prescription for this drug; AND Must be treated by a neurologist | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4829 |
| C4834 | P4834 | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR; Must be treated by a neurologist Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4834 | |
| C4838 | P4838 | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR Must be treated by a neurologist Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application | Compliance with Written or Telephone Authority Required procedures | |
| C4850 | P4850 | Multiple sclerosis Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Must be treated by a neurologist | Compliance with Written and Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Apomorphine
substitute:
| Apomorphine | C4833 | Parkinson disease Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4833 |
| C4860 | Parkinson disease Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy | Compliance with Written or Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Certolizumab pegol
insert in numerical order after existing text:
| C4830 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 18 to 20 weeks treatment; OR Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4831 | Severe psoriatic arthritis Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4839 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C4842 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab The authority application must be made in writing and must include: Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
| C4843 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab An adequate response to treatment is defined as: The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C4853 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4863 | Severe psoriatic arthritis Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR The authority application must be made in writing and must include: A patient may qualify for PBS-subsidised treatment under this restriction once only | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Dapagliflozin
substitute:
| Dapagliflozin | C4825 | Diabetes mellitus type 2 The treatment must be in combination with insulin; AND The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4825 |
| C4844 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug | Compliance with Authority Required procedures - Streamlined Authority Code 4844 |
Schedule 4, Part 1, entry for Everolimus
insert in numerical order after existing text:
| C4837 | P4837 | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug | Compliance with Authority Required procedures |
| C4861 | P4861 | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Initial treatment Patient must be symptomatic (despite somatostatin analogues); OR Disease progression must be documented in the patient's medical records Patients who have developed progressive disease on sunitinib are not eligible to receive PBS-subsidised everolimus Patients who have developed intolerance to sunitinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Exenatide
substitute:
| Exenatide | C4856 | Diabetes mellitus type 2 The treatment must be in combination with metformin; OR The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4856 |
| C4857 | Diabetes mellitus type 2 The treatment must be in combination with metformin; AND The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances: The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records | Compliance with Authority Required procedures - Streamlined Authority Code 4857 |
Schedule 4, Part 1, entry for Golimumab
(a)omit:
| C3495 | P3495 | Psoriatic arthritis — initial treatment 1 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); and/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 is made in writing and 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 | Compliance with Written Authority Required procedures |
| Continuation of a course of initial treatment with golimumab 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 | Compliance with Written or Telephone Authority Required procedures | ||
| C3497 | P3497 | Psoriatic arthritis — initial treatment 3 Commencement of a Biological Treatment Cycle, with an initial PBS‑subsidised course of golimumab for continuing treatment, 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) were receiving treatment with golimumab prior to 1 March 2010; and (3) have demonstrated a response to golimumab treatment as specified in the criteria for continuing PBS‑subsidised treatment with golimumab; and (4) are receiving treatment with golimumab at the time of application; 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: the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgment; the course of treatment is limited to a maximum of 24 weeks of treatment; patients are eligible for PBS‑subsidised treatment under the above criteria once only | Compliance with Written Authority Required procedures |
| Continuation of a course of initial PBS‑subsidised treatment with golimumab commencing a 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 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 | Compliance with Written or Telephone Authority Required procedures | ||
| C3784 | P3784 | Psoriatic arthritis — initial treatment 2 Initial treatment, or recommencement of treatment, with golimumab 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 golimumab 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 is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form; where a patient has received PBS‑subsidised treatment with golimumab 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 golimumab treatment; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised golimumab 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 | Compliance with Written Authority Required procedures |
| Continuation of a course of initial treatment, or of a course which recommences treatment, with golimumab 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 | Compliance with Written or Telephone Authority Required procedures | ||
| C3785 | P3785 | Psoriatic arthritis — continuing treatment Continuing treatment with golimumab 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 golimumab; and (3) who, at the time of application, demonstrate an adequate response to treatment with golimumab; 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 golimumab 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); and/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 is made in writing and 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 golimumab; the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course; if the most recent course of golimumab 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 Chief Executive Medicare 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 | Compliance with Written Authority Required procedures |
| Continuation of a course of continuing treatment with golimumab 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 | Compliance with Written or Telephone Authority Required procedures |
(b)insert in numerical order after existing text:
| C4826 | P4826 | Severe psoriatic arthritis Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) Patient must have severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application: If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
| C4840 | P4840 | Severe psoriatic arthritis Initial treatment – Initial 2 (change or recommencement of treatment) Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab The authority application must be made in writing and must include: Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment An adequate response to treatment is defined as: | Compliance with Written Authority Required procedures |
| C4845 | P4845 | Severe psoriatic arthritis Continuing treatment - balance of supply Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4851 | P4851 | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR Must be treated by a rheumatologist; OR | Compliance with Written or Telephone Authority Required procedures |
| C4864 | P4864 | Severe psoriatic arthritis Continuing treatment Patient must have a documented history of severe active psoriatic arthritis; AND Patient must be an adult Must be treated by a rheumatologist; OR For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab An adequate response to treatment is defined as: The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug The authority application must be made in writing and must include: | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Iron Polymaltose Complex
insert in the column headed “Conditions Code”: CN4302
Schedule 4, Part 1, entry for Iron Sucrose
substitute:
| Iron sucrose | P4302 | CN4302 | Iron deficiency anaemia Patient must be undergoing chronic haemodialysis | Compliance with Authority Required procedures - Streamlined Authority Code 4302 |
Schedule 4, Part 1, entry for Lanthanum
substitute:
| Lanthanum | C4827 | Hyperphosphataemia Maintenance following initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Authority Required procedures - Streamlined Authority Code 4827 |
| C4832 | Where the patient is receiving treatment at/from a public hospital Hyperphosphataemia Initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832 | |
| C4847 | Where the patient is receiving treatment at/from a private hospital Hyperphosphataemia Initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Written and Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Mesalazine
insert in numerical order in the columns in the order indicated:
| C4824 | Ulcerative colitis Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR | Compliance with Authority Required procedures - Streamlined Authority Code 4824 |
Schedule 4, Part 1, omit entry for Mifepristone
Schedule 4, Part 1, omit entry for Misoprostol
Schedule 4, Part 1, after entry for Octreotide
insert:
| Ofatumumab | C4828 | Chronic lymphocytic leukaemia (CLL) Initial treatment The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND | Compliance with Authority Required procedures - Streamlined Authority Code 4828 |
| C4858 | Chronic lymphocytic leukaemia (CLL) Continuing treatment The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND | Compliance with Authority Required procedures - Streamlined Authority Code 4858 |
Schedule 4, Part 1, entry for Sevelamer
substitute:
| Sevelamer | C4827 | Hyperphosphataemia Maintenance following initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Authority Required procedures - Streamlined Authority Code 4827 |
| C4832 | Where the patient is receiving treatment at/from a public hospital Hyperphosphataemia Initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4832 | |
| C4847 | Where the patient is receiving treatment at/from a private hospital Hyperphosphataemia Initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Written or Telephone Authority Required procedures |
Sorafenib
(a)insert in numerical order in the column headed “Purposes Code” for Circumstances Code C4230: P4230
(b)insert in numerical order in the column headed “Purposes Code” for Circumstances Code C4234: P4234
(c)insert in numerical order after existing text:
| C4820 | P4820 | Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment beyond 3 months Patient must have previously been issued with an authority prescription for this drug for this condition; AND A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug | Compliance with Authority Required procedures |
| C4841 | P4841 | Stage IV clear cell variant renal cell carcinoma (RCC) Initial treatment Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug | Compliance with Authority Required procedures |
Schedule 4, Part 1, after entry for Strontium
insert:
| Sucroferric oxyhydroxide | C4827 | Hyperphosphataemia Maintenance following initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Authority Required procedures - Streamlined Authority Code 4827 |
| C4832 | Where the patient is receiving treatment at/from a public hospital Hyperphosphataemia Initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832 | |
| C4847 | Where the patient is receiving treatment at/from a private hospital Hyperphosphataemia Initiation and stabilisation The condition must not be adequately controlled by calcium; AND Patient must be undergoing dialysis for chronic kidney disease | Compliance with Written and Telephone Authority Required procedures |
Schedule 4, Part 1, entry for Sunitinib
omit:
| C4341 | P4341 | Metastatic or unresectable, well‑differentiated malignant pancreatic neuroendocrine tumour (pNET) Continuing treatment Patient must have previously been issued with an authority prescription for sunitinib; | Compliance with Authority Required procedures |
| C4354 | P4354 | Metastatic or unresectable, well‑differentiated malignant pancreatic neuroendocrine tumour (pNET) Initial treatment Patient must be symptomatic (despite somatostatin analogues); OR Disease progression must be documented in the patient’s medical records | Compliance with Authority Required procedures |
substitute:
| C4837 | P4837 | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Continuing treatment Patient must have previously been issued with an authority prescription for this drug; AND Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug | Compliance with Authority Required procedures |
| C4862 | P4862 | Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Initial treatment Patient must be symptomatic (despite somatostatin analogues); OR Disease progression must be documented in the patient's medical records Patients who have developed progressive disease on everolimus are not eligible to receive PBS-subsidised sunitinib for this condition Patients who have developed intolerance to everolimus of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Testosterone
substitute:
| Testosterone | C4866 | Androgen deficiency Patient must not have an established pituitary or testicular disorder; AND Patient must be male; AND Must be treated by a specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists Androgen deficiency is defined as: Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated The name of the specialist must be included in the authority application | Compliance with Authority Required procedures |
| C4867 | Micropenis Patient must be male; AND Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists The name of the specialist must be included in the authority application | Compliance with Authority Required procedures | |
| C4868 | Androgen deficiency Patient must have an established pituitary or testicular disorder Patient must be male Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists The name of the specialist must be included in the authority application | Compliance with Authority Required procedures | |
| C4869 | Pubertal induction Patient must be male; AND Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures | |
| C4870 | Constitutional delay of growth or puberty Patient must be male; AND Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists The name of the specialist must be included in the authority application | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Varenicline
(a)omit:
| C4647 | P4647 | Nicotine dependence Completion of a short-term (24 weeks) course of treatment The treatment must be as an aid to achieving abstinence from smoking; AND Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C4835 | P4835 | Nicotine dependence Completion of a short-term (24 weeks) course of treatment The treatment must be as an aid to achieving abstinence from smoking; AND Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program | Compliance with Authority Required procedures |
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