National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 11) (PB 92 of 2019) (Cth)
PB 92 of 2019
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 11)
National Health Act 1953
________________________________________________________________________
I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access 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 27th November 2019
THEA DANIEL
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
Name of Instrument
(1)This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 11).
(2)This Instrument may also be cited as PB 92 of 2019.
Commencement
This Instrument commences on 1 December 2019.
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
Schedule 1, entry for Aciclovir
omit:
| Eye ointment 30 mg per g, 4.5 g | Application to the eye | Zovirax | GK | MP NP | C5965 | 1 | 0 | 1 |
| AO | C5964 | 1 | 0 | 1 |
Schedule 1, entry for Aciclovir in the form Tablet 200 mg
omit:
| a | Acyclo-V 200 | AF | MP NP | C5942 | 90 | 5 | 90 |
Schedule 1, after entry for Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid in the form Sachets containing oral powder 12.5 g, 30 (PKU Anamix First Spoon)
insert:
| Sachets containing oral powder 12.5 g, 30 (PKU Explore 5) | Oral | PKU Explore 5 | VF | MP NP | C4295 | 8 | 5 | 1 |
| Sachets containing oral powder 25 g, 30 (PKU Explore 10) | Oral | PKU Explore 10 | VF | MP NP | C4295 | 4 | 5 | 1 |
Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Amoxycillin/Clavulanic Acid 500/125 APOTEX | TY | PDP | C5833 C5894 | 10 | 0 | 10 |
Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 500 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) [Maximum Quantity: 10; Number of Repeats: 1]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Amoxycillin/Clavulanic Acid 500/125 APOTEX | TY | MP NP MW | C5832 C5893 | 10 | 1 | 10 |
Schedule 1, entry for Blinatumomab
(a)omit from the column headed “Circumstances”: C9373
(b)omit from the column headed “Circumstances”: C9551
(c)insert in numerical order in the column headed “Circumstances”: C9878 C9911 C9936 C9937
Schedule 1, after entry for Carmellose in the form Eye drops containing carmellose sodium 5 mg per mL, single dose units 0.4 mL, 30
insert:
| Eye drops containing carmellose sodium 5 mg per mL, 10 mL | Application to the eye | Evolve Carmellose | CX | MP NP AO | C6172 | 1 | 5 | 1 |
Schedule 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex
substitute:
| Clostridium botulinum type A toxin - haemagglutinin complex | Lyophilised powder for I.M. injection 300 units | Injection | Dysport | IS | MP | C5359 C5405 C5406 C8822 C9334 C9463 C9547 C9871 | P5359 P5405 P5406 P8822 P9463 P9547 | 4 | 0 | 1 | D(100) |
| MP | C5359 C5405 C5406 C8822 C9334 C9463 C9547 C9871 | P9334 P9871 | 5 | 0 | 1 | D(100) | |||||
| Lyophilised powder for I.M. injection 500 units | Injection | Dysport | IS | MP | C5359 C5405 C5406 C8822 C9334 C9463 C9547 C9871 | P5359 P5405 P5406 P8822 P9463 P9547 | 2 | 0 | 1 | D(100) | |
| MP | C5359 C5405 C5406 C8822 C9334 C9463 C9547 C9871 | P9334 P9871 | 3 | 0 | 1 | D(100) |
Schedule 1, entry for Dolutegravir with abacavir and lamivudine
omit from the column headed “Circumstances”: C4480 C4495 substitute: C9934 C9981
Schedule 1, after entry for Dolutegravir with abacavir and lamivudine
insert:
| Dolutegravir with lamivudine | Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg | Oral | Dovato | VI | MP | C9909 C9934 C9987 | 60 | 5 | 30 | D(100) |
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”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
(d)omit from the column headed “Purposes”: P8850
(e)omit from the column headed “Purposes”: P8980
(f)insert in numerical order in the column headed “Purposes”: P9874 P9905
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”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
(d)omit from the column headed “Purposes”: P8850
(e)omit from the column headed “Purposes”: P8980
(f)insert in numerical order in the column headed “Purposes”: P9874 P9905
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
(d)omit from the column headed “Purposes”: P8850
(e)omit from the column headed “Purposes”: P8980
(f)insert in numerical order in the column headed “Purposes”: P9874 P9905
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
(d)omit from the column headed “Purposes”: P8850
(e)omit from the column headed “Purposes”: P8980
(f)insert in numerical order in the column headed “Purposes”: P9874 P9905
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
(d)omit from the column headed “Purposes”: P8850
(e)omit from the column headed “Purposes”: P8980
(f)insert in numerical order in the column headed “Purposes”: P9874 P9905
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Brenzys; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Brand: Enbrel; Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8850
(b)omit from the column headed “Circumstances”: C8980
(c)insert in numerical order in the column headed “Circumstances”: C9874 C9905
Schedule 1, entry for Fenofibrate in the form Tablet 48 mg [Maximum Quantity: 60; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Fenofibrate | TX | MP NP | 60 | 5 | 60 |
Schedule 1, entry for Fenofibrate in the form Tablet 48 mg [Maximum Quantity: 60; Number of Repeats: 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Fenofibrate | TX | MP | P7640 | 60 | 11 | 60 |
Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Fenofibrate | TX | MP NP | 30 | 5 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Blooms the Chemist Fenofibrate | IB | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Fenofibrate in the form Tablet 145 mg [Maximum Quantity: 30; Number of Repeats: 11]
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | APO-Fenofibrate | TX | MP | P7640 | 30 | 11 | 30 |
(b)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Blooms the Chemist Fenofibrate | IB | MP | P7640 | 30 | 11 | 30 |
Schedule 1, entry for Fluconazole in the form Solution for I.V. infusion 200 mg in 100 mL
(a)omit from the column headed “Schedule Equivalent” for the brand “Fluconazole Alphapharm”: a
(b)omit:
| a | Fluconazole Sandoz | SZ | MP NP | C6956 C6965 C6969 C6974 C6978 C7897 | 7 | 0 | 1 |
Schedule 1, entry for Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine
insert as first entry:
| Oral liquid 250 mL, 18 (PKU GMPro LQ) | Oral | PKU GMPro LQ | SB | MP NP | C5012 | 10 | 5 | 1 |
Schedule 1, entry for Guselkumab
(a)omit from the column headed “Circumstances”: C8795 C8840
(b)insert in numerical order in the column headed “Circumstances”: C9903 C9996
Schedule 1, entry for Hypromellose
insert as first entry:
| 0.3% w/v eye drops, 10 mL (preservative free) | Application to the eye | Evolve Hypromellose | CX | MP NP AO | C6172 | 1 | 5 | 1 |
Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8811
(b)omit from the column headed “Circumstances”: C8836
(c)insert in numerical order in the column headed “Circumstances”: C9901 C9983
Schedule 1, entry for Ixekizumab in the form Injection 80 mg in 1 mL single dose pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)omit from the column headed “Circumstances”: C8811
(b)omit from the column headed “Circumstances”: C8836
(c)insert in numerical order in the column headed “Circumstances”: C9901 C9983
(d)omit from the column headed “Purposes”: P8811 P8836
(e)insert in numerical order in the column headed “Purposes”: P9901 P9983
Schedule 1, entry for Leflunomide in each of the forms: Tablet 10 mg; and Tablet 20 mg
omit:
| a | Leflunomide GH | GQ | MP | C5681 | 30 | 5 | 30 |
Schedule 1, entry for Letrozole
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Letrozole APOTEX | GX | MP NP | C5464 | 30 | 5 | 30 |
(b)omit:
| a | Letrozole generichealth | GQ | MP NP | C5464 | 30 | 5 | 30 |
Schedule 1, entry for Lumacaftor with ivacaftor
insert as first entry:
| Sachet containing granules, lumacaftor 100 mg and ivacaftor 125 mg | Oral | Orkambi | VR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 56 | D(100) |
| Sachet containing granules, lumacaftor 150 mg and ivacaftor 188 mg | Oral | Orkambi | VR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 56 | D(100) |
Schedule 1, entry for Mesalazine in the form Tablet 800 mg (enteric coated)
omit from the column headed “Circumstances”: C9510 substitute: C9444
Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 150; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Mycophenolate APOTEX | GX | MP | 150 | 5 | 50 |
Schedule 1, entry for Mycophenolic acid in the form Tablet containing mycophenolate mofetil 500 mg [Maximum Quantity: 300; Number of Repeats: 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Mycophenolate APOTEX | GX | MP | P5554 P5795 P9691 P9693 | 300 CN5554 CN5795 CN9691 CN9693 | 5 CN5554 CN5795 CN9691 CN9693 | 50 | C(100) |
Schedule 1, entry for Octreotide in each of the forms: Injection 50 micrograms (as acetate) in 1 mL; Injection 100 micrograms (as acetate) in 1 mL; and Injection 500 micrograms (as acetate) in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Octreotide GH | HQ | MP | C6369 C6390 C8165 C9232 C9233 C9289 | 90 | 11 | 5 | D(100) |
Schedule 1, entry for Olanzapine in the form Tablet 7.5 mg
insert in the column headed “Schedule Equivalent” (all instances): a
Schedule 1, entry for Olanzapine
omit:
| Tablet 7.5 mg (as benzoate) | Oral | Olanzapine generichealth 7.5 | GQ | MP NP | C5856 C5869 | 28 | 5 | 28 |
Schedule 1, entry for Pantoprazole in the form Tablet (enteric coated) 40 mg (as sodium sesquihydrate)
(a)omit:
| a | Pantoprazole GH | GQ | MP NP | C8774 C8775 C8776 C8780 C8866 | P8774 P8775 | 30 | 1 | 30 |
(b)omit:
| a | Pantoprazole GH | GQ | MP NP | C8774 C8775 C8776 C8780 C8866 | P8776 P8780 P8866 | 30 | 5 | 30 |
Schedule 1, entry for Pembrolizumab
omit from the column headed “Circumstances”: C7606 C7610 C7773 C8122 C8123 C8124 C8542 C8543 C8563 C9044 C9127 C9843 substitute: C9863 C9864 C9868 C9869 C9894 C9895 C9897 C9921 C9924 C9926 C9966 C9974
Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Quetiapine APOTEX | GX | MP NP | C7893 C7916 C7927 | 60 | 0 | 60 |
Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Quetiapine APOTEX | GX | MP NP | C4246 C5611 C5639 | 90 | 5 | 90 |
Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Quetiapine APOTEX | GX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Quetiapine APOTEX | GX | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, after entry for Riociguat in the form Tablet 2.5 mg
insert:
| Risankizumab | Injection 75 mg in 0.83 mL pre-filled syringe | Injection | Skyrizi | VE | MP | C9932 C9933 C9952 C9953 C9955 C9970 C9978 C9979 C9980 C9984 C9986 C10001 | P9933 P9955 P9986 | 2 | 1 | 2 |
| MP | C9932 C9933 C9952 C9953 C9955 C9970 C9978 C9979 C9980 C9984 C9986 C10001 | P9932 P9952 P9953 P9970 P9978 P9979 P9980 P9984 P10001 | 2 | 2 | 2 |
Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Rizatriptan ODT APOTEX | GX | MP NP | C5708 | 4 | 5 | 2 |
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8836
(b)omit from the column headed “Circumstances”: C8990
(c)insert in numerical order in the column headed “Circumstances”: C9872 C9901
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 1; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8836
(b)omit from the column headed “Circumstances”: C8990
(c)insert in numerical order in the column headed “Circumstances”: C9872 C9901
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8836
(b)omit from the column headed “Circumstances”: C8990
(c)insert in numerical order in the column headed “Circumstances”: C9872 C9901
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C8836
(b)omit from the column headed “Circumstances”: C8990
(c)insert in numerical order in the column headed “Circumstances”: C9872 C9901
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 4; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8836
(b)omit from the column headed “Circumstances”: C8990
(c)insert in numerical order in the column headed “Circumstances”: C9872 C9901
Schedule 1, entry for Secukinumab in the form Injection 150 mg in 1 mL pre-filled pen [Maximum Quantity: 8; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8836
(b)omit from the column headed “Circumstances”: C8990
(c)insert in numerical order in the column headed “Circumstances”: C9872 C9901
(d)omit from the column headed “Purposes”: P8836
(e)omit from the column headed “Purposes”: P8990
(f)insert in numerical order in the column headed “Purposes”: P9872 P9901
Schedule 1, entry for Sertraline in each of the forms: Tablet 50 mg (as hydrochloride); and Tablet 100 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | NOUMED SERTRALINE | VO | MP NP | C4755 C6277 C6289 | 30 | 5 | 30 |
Schedule 1, entry for Sevelamer
insert as first entry:
| Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Apotex | TX | MP NP | C5491 | 180 | 5 | 180 |
| MP | C5530 C9762 | 360 | 5 | 180 | C(100) |
Schedule 1, entry for Sirolimus in the form Oral solution 1 mg per mL, 60 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P9693
(b)insert in numerical order in the column headed “Purposes”: P9914
(c)omit from the column headed “Maximum Quantity”: CN9693
(d)insert in numerical order in the column headed “Maximum Quantity”: CN9914
(e)omit from the column headed “Number of Repeats”: CN9693
(f)insert in numerical order in the column headed “Number of Repeats”: CN9914
Schedule 1, entry for Sirolimus in the form Tablet 0.5 mg [Maximum Quantity: 200; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P9693
(b)insert in numerical order in the column headed “Purposes”: P9914
(c)omit from the column headed “Maximum Quantity”: CN9693
(d)insert in numerical order in the column headed “Maximum Quantity”: CN9914
(e)omit from the column headed “Number of Repeats”: CN9693
(f)insert in numerical order in the column headed “Number of Repeats”: CN9914
Schedule 1, entry for Sirolimus in the form Tablet 1 mg [Maximum Quantity: 200; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P9693
(b)insert in numerical order in the column headed “Purposes”: P9914
(c)omit from the column headed “Maximum Quantity”: CN9693
(d)insert in numerical order in the column headed “Maximum Quantity”: CN9914
(e)omit from the column headed “Number of Repeats”: CN9693
(f)insert in numerical order in the column headed “Number of Repeats”: CN9914
Schedule 1, entry for Sirolimus in the form Tablet 2 mg [Maximum Quantity: 200; Number of Repeats: 5]
(a)omit from the column headed “Purposes”: P9693
(b)insert in numerical order in the column headed “Purposes”: P9914
(c)omit from the column headed “Maximum Quantity”: CN9693
(d)insert in numerical order in the column headed “Maximum Quantity”: CN9914
(e)omit from the column headed “Number of Repeats”: CN9693
(f)insert in numerical order in the column headed “Number of Repeats”: CN9914
Schedule 1, after entry for Sodium bicarbonate
insert:
| Sodium phenylbutyrate | Granules 483 mg per g, 174 g | Oral | Pheburane | OH | MP NP | C9888 C9919 C9993 | 3 | 5 | 1 |
Schedule 1, after entry for Tetracosactide
insert:
| Tezacaftor with ivacaftor and ivacaftor | Pack containing 28 tablets tezacaftor 100 mg with ivacaftor 150 mg and 28 tablets ivacaftor 150 mg | Oral | Symdeko | VR | MP | See Note 3 | See Note 3 | See Note 3 | See Note 3 | 1 | D(100) |
Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C8870 C8871
(b)insert in numerical order in the column headed “Circumstances”: C9947 C9997
Schedule 1, entry for Tildrakizumab in the form Injection 100 mg in 1 mL single dose pre-filled syringe [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8870 C8871
(b)insert in numerical order in the column headed “Circumstances”: C9947 C9997
(c)omit from the column headed “Purposes”: P8870 P8871
(d)insert in numerical order in the column headed “Purposes”: P9947 P9997
Schedule 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Kanjinti | AN | MP | C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628 | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, after entry for Trastuzumab in the form Powder for I.V. infusion 150 mg
insert:
| Powder for I.V. infusion 420 mg | Injection | Kanjinti | AN | MP | C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628 | See Note 3 | See Note 3 | 1 | PB(100) |
Schedule 1, entry for Triamcinolone with neomycin, gramicidin and nystatin
omit from the column headed “Form”: Ear drops containing triamcinolone acetonide 1 mg with neomycin 2.5 mg (as sulfate), gramicidin 250 micrograms and nystatin 100,000 units per g, 7.5 mL substitute: Ear drops containing triamcinolone acetonide 0.9 mg with neomycin 2.25 mg (as sulfate), gramicidin 225 micrograms and nystatin 90,000 units per mL, 7.5 mL
Schedule 1, entry for Trimethoprim with sulfamethoxazole in the form Tablet 160 mg-800 mg
(a)omit:
| a | Bactrim DS | RO | PDP | 10 | 0 | 10 |
(b)omit:
| a | Bactrim DS | RO | MP NP | 10 | 1 | 10 |
(c)omit:
| a | Bactrim DS | RO | MP | P6201 | 30 CN6201 | 2 CN6201 | 10 |
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 1]
(a)omit from the column headed “Circumstances”: C8854 C8890
(b)insert in numerical order in the column headed “Circumstances”: C9875 C9930
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 1; Number of Repeats: 2]
(a)omit from the column headed “Circumstances”: C8854 C8890
(b)insert in numerical order in the column headed “Circumstances”: C9875 C9930
(c)omit from the column headed “Purposes”: P8854 P8890
(d)insert in numerical order in the column headed “Purposes”: P9875 P9930
Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL [Maximum Quantity: 2; Number of Repeats: 0]
(a)omit from the column headed “Circumstances”: C8854 C8890
(b)insert in numerical order in the column headed “Circumstances”: C9875 C9930
Schedule 1, entry for Valsartan in the form Tablet 40 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dilart | AF | MP NP | 28 | 0 | 28 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Diovan”: a
Schedule 1, entry for Valsartan in the form Tablet 80 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dilart | AF | MP NP | 28 | 5 | 28 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Diovan”: a
Schedule 1, entry for Valsartan in the form Tablet 160 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dilart | AF | MP NP | 28 | 5 | 28 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Diovan”: a
Schedule 1, entry for Valsartan in the form Tablet 320 mg
(a)insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Dilart | AF | MP NP | 28 | 5 | 28 |
(b)insert in the column headed “Schedule Equivalent” for the brand “Diovan”: a
Schedule 3, after details relevant to Responsible Person code CS
insert:
| CX | Contact Lens Centre Australia Limited | 42 092 190 040 |
Schedule 3, details relevant to Responsible Person code SG
omit from the column headed “Responsible Person”: Merck Serono Australia Pty Ltd substitute: Merck Healthcare Pty Ltd
Schedule 4, Part 1, entry for Blinatumomab
(a)omit:
| C9373 | Acute lymphoblastic leukaemia Grandfather treatment Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND Patient must not have received more than 1 line of salvage therapy; AND Patient must have a documented history of more than 5% blasts in bone marrow; AND Patient must have received treatment with this drug for this condition prior to 1 October 2019; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug. An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. A patient may qualify for PBS-subsidised treatment under this restriction once only. Treatment with this drug for this condition must not exceed 5 treatment cycles in a lifetime. Patients who have received up to 2 treatment cycles as induction therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug. Patients who have received at least 1 treatment cycle as consolidation therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug. Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 2 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment with this agent. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and (3) date of the most recent blinatumomab dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of induction or consolidation therapy; and (4) date of most recent chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and (5) a copy of the most recent bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab. | Compliance with Written Authority Required procedures |
(b)omit:
| C9551 | Acute lymphoblastic leukaemia Induction treatment The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND The condition must not be present in the central nervous system or testis; AND Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND Patient must not have received more than 1 line of salvage therapy; AND The condition must have more than 5% blasts in bone marrow; AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended. An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment - balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The authority application must be made in writing and must include: (1) a completed authority prescription form; (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and (4) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C9878 | Acute lymphoblastic leukaemia Grandfather treatment Patient must have a documented history of relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND Patient must have a documented history of receiving intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND Patient must not have received more than 1 line of salvage therapy; AND Patient must have a documented history of more than 5% blasts in bone marrow; AND Patient must have received treatment with this drug for this condition prior to 1 October 2019; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug. An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained through a request for an increased maximum amount, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. A patient may qualify for PBS-subsidised treatment under this restriction once only. Treatment with this drug for this condition must not exceed 5 treatment cycles in a lifetime. Patients who have received up to 2 treatment cycles as induction therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug. Patients who have received at least 1 treatment cycle as consolidation therapy with this drug for this condition prior to 1 October 2019 must have achieved a complete remission or a complete remission with partial haematological recovery in order to continue with PBS-subsidised treatment with this drug. Patients who fail to demonstrate a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) after 2 cycles of PBS-subsidised treatment with this agent must cease PBS-subsidised treatment with this agent. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and (3) date of the most recent blinatumomab dose, if this was for induction or consolidation therapy, and how many treatment cycle(s) of PBS-subsidised blinatumomab will be required for completion of induction or consolidation therapy; and (4) date of most recent chemotherapy prior to receiving non-PBS subsidised blinatumomab, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and (5) a copy of the most recent bone marrow biopsy report prior to receiving non-PBS subsidised blinatumomab. | Compliance with Written Authority Required procedures |
| C9911 | Acute lymphoblastic leukaemia Induction treatment | Compliance with Written Authority Required procedures |
| C9936 | Minimal residual disease of precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL) Continuing treatment of previously detectable minimal residual disease of Pre-B-cell ALL Must be treated by a physician experienced in the treatment of haematological malignancies. Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND Patient must have achieved a complete remission; AND Patient must be minimal residual disease negative, defined as either undetectable using the same method used to determine original eligibility or less than 10-4(0.01%) blasts based on measurement in bone marrow; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended. An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent. | Compliance with Written Authority Required procedures |
| C9937 | Minimal residual disease of precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL) Initial treatment of minimal residual disease of Pre-B-cell ALL Must be treated by a physician experienced in the treatment of haematological malignancies. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND The condition must not be present in the central nervous system or testis; AND Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL) or for subsequent salvage therapy; AND Patient must have minimal residual disease defined as at least 10-4(0.01%) blasts based on measurement in bone marrow, documented after an interval of at least 2 weeks from the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL or as subsequent salvage therapy, whichever was the later, and measured using polymerase chain reaction or flow cytometry; AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended. An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Minimal residual disease positive Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and (4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Clostridium botulinum type A toxin - haemagglutinin complex
(a)insert in the column headed “Purposes Code” for Circumstances Code “C5359”: P5359
(b)insert in the column headed “Purposes Code” for Circumstances Code “C5405”: P5405
(c)insert in the column headed “Purposes Code” for Circumstances Code “C5406”: P5406
(d)insert in the column headed “Purposes Code” for Circumstances Code “C8822”: P8822
(e)insert after entry for Circumstances Code “C8822”:
| C9334 | P9334 | Moderate to severe spasticity of the lower limb following an acute event Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. The condition must be moderate to severe spasticity of the lower limb/s following stroke or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND Patient must not have established severe contracture in the limb to be treated; AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter. Patient must be aged 18 years or older. Standard management includes physiotherapy and/or oral spasticity agents. | Compliance with Authority Required procedures - Streamlined Authority Code 9334 |
(f)insert in the column headed “Purposes Code” for Circumstances Code “C9463”: P9463
(g)insert in the column headed “Purposes Code” for Circumstances Code “C9547”: P9547
(h)insert in numerical order after existing text:
| C9871 | P9871 | Moderate to severe spasticity of the lower limb following an acute event Grandfather treatment Must be treated by a neurologist; OR Must be treated by an orthopaedic surgeon; OR Must be treated by a rehabilitation specialist; OR Must be treated by a plastic surgeon; OR Must be treated by a geriatrician. Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND The condition must have been moderate to severe spasticity of the lower limb/s following stroke, or other acute neurological event, defined as a Modified Ashworth Scale rating of 3 or more prior to commencing non-PBS subsidised treatment; AND The treatment must only be used as second line therapy when standard management has failed; OR The treatment must only be used as an adjunct to physical therapy; AND The treatment must not continue if the patient does not respond (defined as not having had a decrease in spasticity rating of at least 1, using the Modified Ashworth Scale, in at least one joint) after two treatment periods (with any botulinum toxin type A); AND Patient must not have established severe contracture in the limb to be treated; AND The treatment must not exceed a maximum of 4 treatment periods (with any botulinum toxin type A) per lower limb in the the first year of treatment, and 2 treatment periods (with any botulinum toxin type A) per lower limb each year thereafter. Patient must be aged 18 years or older. Standard management includes physiotherapy and/or oral spasticity agents. | Compliance with Authority Required procedures - Streamlined Authority Code 9871 |
Schedule 4, Part 1, entry for Dolutegravir with abacavir and lamivudine
substitute:
| Dolutegravir with abacavir and lamivudine | C9934 | HIV infection Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9934 |
| C9981 | HIV infection Initial treatment Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures - Streamlined Authority Code 9981 |
Schedule 4, Part 1, after entry for Dolutegravir with abacavir and lamivudine
insert:
| Dolutegravir with lamivudine | C9909 | HIV infection Grandfathered treatment Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must have been antiretroviral treatment naive prior to initiating this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9909 |
| C9934 | HIV infection Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 9934 | |
| C9987 | HIV infection Initial treatment Patient must be antiretroviral treatment naive; AND Patient must not have suspected resistance to either antiretroviral component. | Compliance with Authority Required procedures - Streamlined Authority Code 9987 |
Schedule 4, Part 1, entry for Etanercept
(a)omit:
| C8850 | P8850 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
(b)omit:
| C8980 | P8980 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C9874 | P9874 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9905 | P9905 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine
insert in numerical order after existing text:
| C5012 | Phenylketonuria |
Schedule 4, Part 1, entry for Guselkumab
(a)omit:
| C8795 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8840 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C9903 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9996 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Hypromellose
insert in numerical order after existing text:
| C6172 | Severe dry eye syndrome Patient must be sensitive to preservatives in multi-dose eye drops. | Compliance with Authority Required procedures - Streamlined Authority Code 6172 |
Schedule 4, Part 1, entry for Ixekizumab
(a)omit:
| C8811 | P8811 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C9947 | P9947 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
| C9997 | P9997 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Ustekinumab
(a)omit:
| C8854 | P8854 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8890 | P8890 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised therapy with this drug for this condition in the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C9875 | P9875 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing: (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9930 | P9930 | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 18 years or older. Must be treated by a dermatologist. An adequate response to treatment is defined as: A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include: (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following: (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Schedule 5, omit entry for Aciclovir
Schedule 5, entry for Olanzapine
omit:
| GRP-15884 | Tablet 7.5 mg | Oral | APO-Olanzapine Olanzapine AN Olanzapine APOTEX Olanzapine RBX Olanzapine Sandoz Olanzapine-DRLA Ozin 7.5 PRYZEX Zypine Zyprexa |
| Tablet 7.5 mg (as benzoate) | Oral | Olanzapine generichealth 7.5 |
Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) [GRP-17623]
insert in alphabetical order in the column headed “Brand”: Rizatriptan ODT APOTEX
Schedule 5, after entry for Salbutamol
insert:
| Sevelamer | GRP-23578 | Tablet containing sevelamer carbonate 800 mg | Oral | Sevelamer Apotex |
| Tablet containing sevelamer hydrochloride 800 mg | Oral | Renagel |
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