National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 8) (PB 78 of 2020) (Cth)
PB 78 of 2020
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 8)
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 26 August 2020
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 2020 (No. 8).
(2)This Instrument may also be cited as PB 78 of 2020.
Commencement
This Instrument commences on 1 September 2020.
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, after entry for Abiraterone in the form Tablet containing abiraterone acetate 500 mg
insert:
| Acalabrutinib | Capsule 100 mg | Oral | Calquence | AP | MP | C10652 C10668 C10669 | 56 | 5 | 56 |
Schedule 1, entry for Adefovir
(a)omit from the column headed “Schedule Equivalent” for the brand “APO-Adefovir”: a
(b)omit:
| a | Hepsera | GI | MP NP | C4490 C4510 | 60 | 5 | 30 | D(100) |
Schedule 1, entry for Amitriptyline in each of the forms: Tablet containing amitriptyline hydrochloride 10 mg; Tablet containing amitriptyline hydrochloride 25 mg; and Tablet containing amitriptyline hydrochloride 50 mg
(a)omit:
| a | Chem mart Amitriptyline | CH | MP NP | 50 | 2 | 50 |
(b)omit:
| a | Terry White Chemists Amitriptyline | TW | MP NP | 50 | 2 | 50 |
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)
(a)omit:
| a | Moxiclav Duo 500/125 | LN | MP NP | C5832 C5893 C10405 | P5832 P5893 | 10 | 0 | 10 |
| MW | C5832 C5893 | 10 | 0 | 10 | ||||
| PDP | C5833 C5894 | 10 | 0 | 10 |
(b)omit:
| a | Moxiclav Duo 500/125 | LN | MP NP | C5832 C5893 C10405 | P10405 | 20 | 0 | 10 |
Schedule 1, entry for Amoxicillin with clavulanic acid in the form Tablet containing 875 mg amoxicillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
(a)omit:
| a | Moxiclav Duo Forte 875/125 | LN | MP NP | C5832 C5893 C10413 | P5832 P5893 | 10 | 0 | 10 |
| PDP | C5833 C5894 | 10 | 0 | 10 |
(b)omit:
| a | Moxiclav Duo Forte 875/125 | LN | MP NP | C5832 C5893 C10413 | P10413 | 20 | 0 | 10 |
Schedule 1, entry for Atenolol in the form Tablet 50 mg
(a)omit:
| a | Chem mart Atenolol | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Atenolol | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Atorvastatin in each of the forms: Tablet 10 mg (as calcium);Tablet 20 mg (as calcium); Tablet 40 mg (as calcium);and Tablet 80 mg (as calcium)
(a)omit:
| a | Terry White Chemists Atorvastatin | TW | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Atorvastatin | TW | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U.
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Bleomycin Sulfate
Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide
200 micrograms with formoterol fumarate dihydrate 6 micrograms per dose, 120 doses
omit from the column headed “Responsible Person” for the brand “DuoResp Spiromax” (all instances): TB substitute: AF
Schedule 1, entry for Budesonide with formoterol in the form Powder for oral inhalation in breath actuated device containing budesonide
400 micrograms with formoterol fumarate dihydrate 12 micrograms per dose, 60 doses, 2
omit from the column headed “Responsible Person” for the brand “DuoResp Spiromax”: TB substitute: AF
Schedule 1, entry for Calcitriol
omit from the column headed “Responsible Person” for the brand “Rocaltrol”: RO substitute: IX
Schedule 1, entry for Carboplatin in each of the forms: Solution for I.V. injection 150 mg in 15 mL; and Solution for I.V. injection 450 mg in
45 mL
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Carboplatin
Schedule 1, entry for Cefalotin
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Cephalothin
Schedule 1, entry for Cefazolin
substitute:
| Cefazolin | Powder for injection 500 mg (as sodium) | Injection | Cefazolin-AFT | AE | MP NP | C5826 C5867 C5881 C5890 | 10 | 0 | 5 |
| Powder for injection 1 g (as sodium) | Injection | Cefazolin-AFT | AE | MP NP | C5861 C5882 C5883 C5891 | 10 | 0 | 5 | |
| Powder for injection 2 g (as sodium) | Injection | Cephazolin Alphapharm | AF | MP NP | C5826 C5867 C5881 C5890 | 10 | 0 | 1 | |
| MP NP | C5826 C5867 C5881 C5890 | 10 | 0 | 10 |
Schedule 1, entry for Cefotaxime in each of the forms: Powder for injection 1 g (as sodium); and Powder for injection 2 g (as sodium)
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Cefotaxime
Schedule 1, entry for Ceftriaxone
substitute:
| Ceftriaxone | Powder for injection 500 mg (as sodium) | Injection | Ceftriaxone-AFT | AE | MP NP | C5826 C5855 C5881 C5890 | P5855 | 1 | 0 | 1 |
| MP NP | C5826 C5855 C5881 C5890 | P5826 P5881 P5890 | 5 | 0 | 1 | |||||
| Powder for injection 1 g (as sodium) | Injection | a | Ceftriaxone-AFT | AE | MP NP | C5830 C5862 C5868 | 5 | 0 | 1 | |
| a | Ceftriaxone Alphapharm | AF | MP NP | C5830 C5862 C5868 | 5 | 0 | 5 | |||
| MP NP | C5830 C5862 C5868 | 5 | 0 | 10 | ||||||
| Powder for injection 2 g (as sodium) | Injection | a | Ceftriaxone-AFT | AE | MP NP | C5826 C5881 C5890 | 5 | 0 | 1 | |
| a | Ceftriaxone Alphapharm | AF | MP NP | C5826 C5881 C5890 | 5 | 0 | 5 | |||
| MP NP | C5826 C5881 C5890 | 5 | 0 | 10 |
Schedule 1, entry for Ciprofloxacin in the form Tablet 500 mg (as hydrochloride)
omit:
| a | Ciproxin 500 | BN | MP NP | C5614 C5615 C5687 C5688 C5689 C5722 C5780 | 14 | 0 | 14 |
Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
(a)omit:
| a | Chem mart Citalopram | CH | MP NP | C4755 | 28 | 5 | 28 |
(b)omit:
| a | Terry White Chemists Citalopram | TW | MP NP | C4755 | 28 | 5 | 28 |
Schedule 1, entry for Clindamycin
(a)omit:
| a | Chem mart Clindamycin | CH | PDP | C5487 | 24 | 0 | 24 |
(b)omit:
| a | Terry White Chemists Clindamycin | TW | PDP | C5487 | 24 | 0 | 24 |
(c)omit:
| a | Chem mart Clindamycin | CH | MP NP MW | C5470 | 48 | 1 | 24 |
(d)omit:
| a | Terry White Chemists Clindamycin | TW | MP NP MW | C5470 | 48 | 1 | 24 |
Schedule 1, entry for Crizotinib in each of the forms: Capsule 200 mg; and Capsule 250 mg
(a)omit from the column headed “Circumstances”: C6994
(b)omit from the column headed “Circumstances”: C10595
(c)insert in numerical order in the column headed “Circumstances”: C10650 C10665
Schedule 1, entry for Deferiprone in each of the forms: Oral solution 100 mg per mL, 250 mL; Tablet 500 mg; and Tablet 1000 mg
omit from the column headed “Responsible Person”: TX substitute: EU
Schedule 1, entry for Desferrioxamine in each of the forms: Powder for injection containing desferrioxamine mesilate 500 mg; and Powder for injection containing desferrioxamine mesilate 2 g
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Desferrioxamine Mesilate
Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg; and Tablet containing donepezil hydrochloride 10 mg
(a)omit:
| a | Chem mart Donepezil | CH | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 |
(b)omit:
| a | Terry White Chemists Donepezil | TW | MP | C10099 C10100 C10107 C10108 C10110 | P10107 P10110 | 28 | 1 | 28 |
(c)omit:
| a | Chem mart Donepezil | CH | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 |
| NP | C10108 | 28 | 5 | 28 |
(d)omit:
| a | Terry White Chemists Donepezil | TW | MP | C10099 C10100 C10107 C10108 C10110 | P10099 P10100 P10108 | 28 | 5 | 28 |
| NP | C10108 | 28 | 5 | 28 |
Schedule 1, entry for Entrectinib
(a)omit from the column headed “Circumstances”: C10597 C10614
(b)insert in numerical order in the column headed “Circumstances”: C10658 C10672
Schedule 1, entry for Escitalopram in each of the forms: Tablet 10 mg (as oxalate); and Tablet 20 mg (as oxalate)
(a)omit:
| a | Chem mart Escitalopram | CH | MP NP | C4755 | 28 | 5 | 28 |
(b)omit:
| a | Terry White Chemists Escitalopram | TW | MP NP | C4755 | 28 | 5 | 28 |
Schedule 1, entry for Heparin in the form Injection 5,000 units (as sodium) in 0.2 mL
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Heparin Sodium
Schedule 1, entry for Ibrutinib [Maximum Quantity: 90; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7871
(b)insert in numerical order in the column headed “Circumstances”: C10647
(c)omit from the column headed “Purposes”: P7871
(d)insert in numerical order in the column headed “Purposes”: P10647
Schedule 1, entry for Ibrutinib [Maximum Quantity: 120; Number of Repeats: 5]
(a)omit from the column headed “Circumstances”: C7871
(b)insert in numerical order in the column headed “Circumstances”: C10647
Schedule 1, after entry for Imipramine in the form Tablet containing imipramine hydrochloride 25 mg
insert:
| Tablet containing imipramine hydrochloride 25 mg USP | Oral | Imipramine (Leading) | QY | MP NP | 50 | 2 | 100 |
Schedule 1, entry for Lurasidone in each of the forms: Tablet containing lurasidone hydrochloride 40 mg; and Tablet containing lurasidone hydrochloride 80 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Ardix Lurasidone | RX | MP NP | C4246 | 30 | 5 | 30 |
Schedule 1, entry for Meloxicam in the form Tablet 7.5 mg
(a)omit:
| Chem mart Meloxicam 7.5 mg | CH | MP NP | C4907 C4962 | 30 | 3 | 30 |
(b)omit:
| Terry White Chemists Meloxicam 7.5 mg | TW | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, entry for Meloxicam in the form Tablet 15 mg
(a)omit:
| Chem mart Meloxicam 15 mg | CH | MP NP | C4907 C4962 | 30 | 3 | 30 |
(b)omit:
| Terry White Chemists Meloxicam 15 mg | TW | MP NP | C4907 C4962 | 30 | 3 | 30 |
Schedule 1, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg
omit from the column headed “Brand”: Diabex XR substitute: Diabex XR 500
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 500 mg
(a)omit:
| a | Chem mart Metformin | CH | MP NP | 100 | 5 | 100 |
(b)omit:
| a | Terry White Chemists Metformin | TW | MP NP | 100 | 5 | 100 |
Schedule 1, entry for Metformin in the form Tablet containing metformin hydrochloride 1 g
(a)omit:
| a | Chem mart Metformin 1000 | CH | MP NP | 90 | 5 | 90 |
(b)omit:
| a | Terry White Chemists Metformin 1000 | TW | MP NP | 90 | 5 | 90 |
Schedule 1, entry for Methotrexate in the form Injection 5 mg in 2 mL vial
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Methotrexate
Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial
omit from the column headed “Brand” (all instances): Hospira Pty Limited substitute: DBL Methotrexate
Schedule 1, entry for Methotrexate in each of the forms: Solution concentrate for I.V. infusion 500 mg in 20 mL vial; and Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Methotrexate
Schedule 1, after entry for Methylphenidate in the form Capsule containing methylphenidate hydrochloride 40 mg (modified release)
insert:
| Capsule containing methylphenidate hydrochloride 60 mg (modified release) | Oral | Ritalin LA | NV | MP NP | C6298 | 30 | 5 | 30 |
Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 50 mg
(a)omit:
| b | Chem mart Metoprolol | CH | MP NP | 100 | 5 | 100 |
(b)omit:
| b | Terry White Chemists Metoprolol | TW | MP NP | 100 | 5 | 100 |
Schedule 1, entry for Metoprolol in the form Tablet containing metoprolol tartrate 100 mg
(a)omit:
| b | Chem mart Metoprolol | CH | MP NP | 60 | 5 | 60 |
(b)omit:
| b | Terry White Chemists Metoprolol | TW | MP NP | 60 | 5 | 60 |
Schedule 1, entry for Mirtazapine in the form Tablet 30 mg
(a)omit:
| a | Chem mart Mirtazapine | CH | MP NP | C5650 | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Mirtazapine | TW | MP NP | C5650 | 30 | 5 | 30 |
Schedule 1, entry for Mirtazapine in the form Tablet 45 mg
(a)omit:
| a | Chem mart Mirtazapine | CH | MP NP | C5650 | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Mirtazapine | TW | MP NP | C5650 | 30 | 5 | 30 |
Schedule 1, entry for Morphine in each of the forms: Injection containing morphine sulfate pentahydrate 10 mg in 1 mL; and Injection containing morphine sulfate pentahydrate 15 mg in 1 mL
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Morphine Pentahydrate
Schedule 1, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 30 mg in 1 mL
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Morphine Pentahydrate
Schedule 1, entry for Nebivolol in the form Tablet 1.25 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Nebivolol Sandoz | SZ | MP NP | C5324 | 56 | 5 | 28 |
Schedule 1, entry for Nebivolol in each of the forms: Tablet 5 mg (as hydrochloride); and Tablet 10 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| a | Nebivolol Sandoz | SZ | MP NP | C5324 | 28 | 5 | 28 |
Schedule 1, entry for Nifedipine in the form Tablet 30 mg (controlled release)
omit:
| a | Adalat Oros 30 | BN | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Nifedipine in the form Tablet 60 mg (controlled release)
omit:
| a | Adalat Oros 60 | BN | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Osimertinib in the form Tablet 40 mg
omit from the column headed “Circumstances”: C8537 substitute: C10666
Schedule 1, entry for Osimertinib in the form Tablet 80 mg
omit from the column headed “Circumstances”: C8524 C8537 substitute: C10663 C10666
Schedule 1, entry for Paroxetine
(a)omit:
| a | Chem mart Paroxetine | CH | MP NP | C4755 C6277 C6636 | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Paroxetine | TW | MP NP | C4755 C6277 C6636 | 30 | 5 | 30 |
Schedule 1, entry for Pembrolizumab
(a)omit from the column headed “Circumstances”: C9868
(b)omit from the column headed “Circumstances”: C9924
(c)omit from the column headed “Circumstances”: C10088 C10142 C10159 C10181
(d)insert in numerical order in the column headed “Circumstances”: C10675 C10676 C10678 C10679 C10681 C10682 C10683 C10685 C10687 C10688 C10689 C10693 C10695 C10696 C10697 C10701 C10702 C10704 C10705
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
(a)omit:
| Chem mart Perindopril | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| Terry White Chemists Perindopril | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
(a)omit:
| Chem mart Perindopril | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| Terry White Chemists Perindopril | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
(a)omit:
| Chem mart Perindopril | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| Terry White Chemists Perindopril | TW | MP NP | 30 | 5 | 30 |
Schedule 1, entry for Phenoxymethylpenicillin in the form Oral suspension 150 mg (as benzathine) per 5 mL, 100 mL
omit from the column headed “Responsible Person”: AS substitute: AF
Schedule 1, entry for Promethazine
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Promethazine Hydrochloride
Schedule 1, entry for Quetiapine in the form Tablet 25 mg (as fumarate)
(a)omit:
| a | Chem mart Quetiapine | CH | MP NP | C7893 C7916 C7927 | 60 | 0 | 60 |
(b)omit:
| a | Terry White Chemists Quetiapine | TW | MP NP | C7893 C7916 C7927 | 60 | 0 | 60 |
Schedule 1, entry for Quetiapine in the form Tablet 100 mg (as fumarate)
(a)omit:
| a | Chem mart Quetiapine | CH | MP NP | C4246 C5611 C5639 | 90 | 5 | 90 |
(b)omit:
| a | Terry White Chemists Quetiapine | TW | MP NP | C4246 C5611 C5639 | 90 | 5 | 90 |
Schedule 1, entry for Quetiapine in the form Tablet 200 mg (as fumarate)
(a)omit:
| a | Chem mart Quetiapine | CH | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
(b)omit:
| a | Terry White Chemists Quetiapine | TW | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, entry for Quetiapine in the form Tablet 300 mg (as fumarate)
(a)omit:
| a | Chem mart Quetiapine | CH | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
(b)omit:
| a | Terry White Chemists Quetiapine | TW | MP NP | C4246 C5611 C5639 | 60 | 5 | 60 |
Schedule 1, entry for Rosuvastatin in each of the forms: Tablet 5 mg (as calcium); Tablet 10 mg (as calcium); Tablet 20 mg (as calcium); and Tablet 40 mg (as calcium)
(a)omit:
| a | Chem mart Rosuvastatin | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Rosuvastatin | TW | MP NP | 30 | 5 | 30 |
(c)omit:
| a | Chem mart Rosuvastatin | CH | MP | P7598 | 30 | 11 | 30 |
(d)omit:
| a | Terry White Chemists Rosuvastatin | TW | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Roxithromycin in the form Tablet 150 mg
(a)omit:
| a | Chem mart Roxithromycin | CH | MP NP PDP | 10 | 0 | 10 |
(b)omit:
| a | Terry White Chemists Roxithromycin | TW | MP NP PDP | 10 | 0 | 10 |
(c)omit:
| a | Chem mart Roxithromycin | CH | MP NP | P10404 | 20 CN10404 | 0 CN10404 | 10 |
(d)omit:
| a | Terry White Chemists Roxithromycin | TW | MP NP | P10404 | 20 CN10404 | 0 CN10404 | 10 |
Schedule 1, entry for Roxithromycin in the form Tablet 300 mg
(a)omit:
| a | Chem mart Roxithromycin | CH | MP NP PDP | 5 | 0 | 5 |
(b)omit:
| a | Terry White Chemists Roxithromycin | TW | MP NP PDP | 5 | 0 | 5 |
(c)omit:
| a | Chem mart Roxithromycin | CH | MP NP | P10404 | 10 CN10404 | 0 CN10404 | 5 |
(d)omit:
| a | Terry White Chemists Roxithromycin | TW | MP NP | P10404 | 10 CN10404 | 0 CN10404 | 5 |
Schedule 1, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation)
(a)omit from the column headed “Brand”: Ventolin substitute: Ventolin CFC-Free with dose counter
(b)omit from the column headed “Brand”: Zempreon substitute: Zempreon CFC-Free with dose counter
Schedule 1, entry for Simvastatin in each of the forms: Tablet 10 mg; Tablet 20 mg; Tablet 40 mg; and Tablet 80 mg
(a)omit:
| a | Chem mart Simvastatin | CH | MP NP | 30 | 5 | 30 |
(b)omit:
| a | Terry White Chemists Simvastatin | TW | MP NP | 30 | 5 | 30 |
(c)omit:
| a | Chem mart Simvastatin | CH | MP | P7598 | 30 | 11 | 30 |
(d)omit:
| a | Terry White Chemists Simvastatin | TW | MP | P7598 | 30 | 11 | 30 |
Schedule 1, entry for Tiotropium in the form Capsule containing powder for oral inhalation 13 micrograms (as bromide) (for use in Zonda device)
omit from the column headed “Responsible Person”: TB substitute: AF
Schedule 1, entry for Tobramycin in the form Injection 80 mg in 2 mL
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Tobramycin
Schedule 1, entry for Tramadol in the form Capsule containing tramadol hydrochloride 50 mg
(a)omit:
| a | Chem mart Tramadol | CH | MP NP | C10442 C10444 | P10442 | 10 | 0 | 20 |
| PDP | C10442 C10446 | P10442 | 10 | 0 | 20 | |||
| a | Terry White Chemists Tramadol | TW | MP NP | C10442 C10444 | P10442 | 10 | 0 | 20 |
| PDP | C10442 C10446 | P10442 | 10 | 0 | 20 |
(b)omit:
| a | Chem mart Tramadol | CH | MP NP | C10442 C10444 | P10444 | 20 | 0 | 20 |
| PDP | C10442 C10446 | P10446 | 20 | 0 | 20 | |||
| a | Terry White Chemists Tramadol | TW | MP NP | C10442 C10444 | P10444 | 20 | 0 | 20 |
| PDP | C10442 C10446 | P10446 | 20 | 0 | 20 |
Schedule 1, entry for Tramadol in each of the forms: Tablet (sustained release) containing tramadol hydrochloride 100 mg; Tablet (sustained release) containing tramadol hydrochloride 150 mg; and Tablet (sustained release) containing tramadol hydrochloride 200 mg
omit:
| a | Chem mart Tramadol SR | CH | MP NP | C10445 | 20 | 0 | 20 |
| a | Terry White Chemists Tramadol SR | TW | MP NP | C10445 | 20 | 0 | 20 |
Schedule 1, entry for Vancomycin in the form Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)
omit from the column headed “Brand” (all instances): Hospira Pty Limited substitute: DBL Vancomycin Hydrochloride
Schedule 1, entry for Vinblastine
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Vinblastine
Schedule 1, entry for Vincristine
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Vincristine Sulfate
Schedule 3, details relevant to Responsible Person code EU
omit from the column headed “Responsible Person” for the Code “EU”: Emerge Health Pty Ltd substitute: Chiesi Australia Pty Ltd
Schedule 4, Part 1, after entry for Abiraterone
insert:
| Acalabrutinib | C10652 | Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Continuing treatment of relapsed or refractory CLL/SLL The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
| C10668 | Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 1 or less; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL. A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following: a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles; b) Age is 70 years or older; c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen; d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia; e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medical Benefits Schedule listed test. | Compliance with Authority Required procedures | |
| C10669 | Relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Grandfather treatment (initial treatment in a patient commenced on non-PBS-subsidised treatment) Patient must have previously received non-PBS-subsidised treatment with this drug for relapsed or refractory CLL/SLL prior to 1 September 2020; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND Patient must have been considered unsuitable for treatment or retreatment with a purine analogue prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must be considered unsuitable for treatment or retreatment with a purine analogue; AND Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease) prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following being met prior to commencing non-PBS-subsidised treatment with this drug for this condition: a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles; b) Age is 70 years or older; c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen; d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia; e) Evidence of one or more 17p chromosomal deletions demonstrated by a Medical Benefits Schedule listed test. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Crizotinib
(a)omit:
| C6994 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed ALK-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ALK gene rearrangement in tumour material by FISH testing. | Compliance with Written Authority Required procedures |
(b)omit:
| C10595 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material. | Compliance with Written Authority Required procedures |
(c)insert in numerical order after existing text:
| C10650 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form. | Compliance with Written Authority Required procedures |
| C10665 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less. Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Entrectinib
(a)omit:
| C10597 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material. | Compliance with Written Authority Required procedures |
| C10614 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND The treatment must be as monotherapy; AND Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed ROS1-Positive Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form, which includes details of ROS1 gene rearrangement in tumour material. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures |
(b)insert in numerical order after existing text:
| C10658 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form. | Compliance with Written Authority Required procedures |
| C10672 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2020; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND The treatment must be as monotherapy; AND Patient must have had a WHO performance status of 2 or less prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing prior to initiating non-PBS subsidised treatment with this drug for this condition. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures |
Schedule 4, Part 1, entry for Ibrutinib
(a)omit:
| C7871 | P7871 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be considered unsuitable for treatment or retreatment with a purine analogue. A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following: a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles; b) Age is 70 years or older; c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen; d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia; e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). | Compliance with Authority Required procedures |
(b)insert in numerical order after existing text:
| C10647 | P10647 | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have received treatment with another Bruton's tyrosine kinase (BTK) inhibitor for any line of treatment of CLL/SLL (untreated or relapsed/refractory disease); OR Patient must have developed intolerance to another Bruton's tyrosine kinase (BTK) inhibitor of a severity necessitating permanent treatment withdrawal when being treated for relapsed or refractory CLL/SLL; AND Patient must be considered unsuitable for treatment or retreatment with a purine analogue. A patient is considered unsuitable for treatment or retreatment with a purine analogue as demonstrated by at least one of the following: a) Failure to respond (stable disease or disease progression on treatment), or a progression-free interval of less than 3 years from treatment with a purine analogue-based therapy and anti-CD20-containing chemoimmunotherapy regimen after at least two cycles; b) Age is 70 years or older; c) Age is 65 years or older and the presence of comorbidities (Cumulative Illness Rating Scale of 6 or greater, or creatinine clearance of less than 70 mL/min) that might place the patient at an unacceptable risk for treatment-related toxicity with purine analogue-based therapy, provided they have received one or more prior treatment including at least two cycles of an alkylating agent-based (or purine analogue-based) anti-CD20 antibody-containing chemoimmunotherapy regimen; d) History of purine analogue-associated autoimmune anaemia or autoimmune thrombocytopenia; e) Evidence of one or more 17p chromosomal deletions demonstrated by fluorescence in situ hybridisation (FISH). | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Osimertinib
substitute:
| Osimertinib | C10663 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be as monotherapy; AND Patient must have a WHO performance status of 2 or less; AND The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment. Authority applications for initial treatment must be made in writing and must include: (a) a completed authority prescription form; (b) a completed Non-Small-Cell Lung Cancer Authority Application - Supporting Information Form; (c) details of the pathology report from an Approved Pathology Authority confirming evidence of EGFR T790M mutation in tumour material while on or after first line EGFR TKI treatment; and (d) date of commencement of first line EGFR TKI treatment and date of progression whilst on or after first line EGFR TKI treatment. | Compliance with Written Authority Required procedures |
| C10666 | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be as monotherapy; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. | Compliance with Authority Required procedures |
Schedule 4, Part 1, entry for Pembrolizumab
(a)omit:
| C9868 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 9868 |
(b)omit:
| C9924 | Unresectable Stage III or Stage IV malignant melanoma Continuing treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 9924 |
(c)omit:
| C10088 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment 2 - 3 weekly treatment regimen The condition must be negative for a BRAF V600 mutation; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10088 |
| C10142 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10142 |
| C10159 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment 1 - 3 weekly treatment regimen The condition must be positive for a BRAF V600 mutation; AND The condition must have progressed following treatment with a BRAF inhibitor (with or without a MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; OR Patient must have experienced disease recurrence whilst receiving a BRAF inhibitor with MEK inhibitor as an adjuvant treatment for resected Stage IIIB, IIIC or IIID melanoma; OR Patient must have experienced disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment; AND Patient must not have been treated with an adjuvant programmed cell death-1 (PD-1) inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma; OR Patient must have experienced disease recurrence after at least 6 months from completion of an adjuvant PD-1 inhibitor for resected Stage IIIB, IIIC, IIID or IV melanoma, followed by disease progression after treatment with a BRAF inhibitor (with or without MEK inhibitor) in the unresectable or metastatic setting unless contraindicated or not tolerated according to the TGA approved Product Information; AND Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10159 |
| C10181 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment Patient must not have previously been treated for this condition in the metastatic setting; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10181 |
(d)insert in numerical order after existing text:
| C10675 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Grandfather treatment - 6 weekly treatment regimen Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND Patient must not have evidence of recurrence; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior PBS-subsidised treatment for this condition; AND Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
| C10676 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Continuing treatment - 6 weekly treatment regimen Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND Patient must not have experienced disease recurrence; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10678 | Relapsed or refractory primary mediastinal B-cell lymphoma Grandfather treatment (initial treatment of a patient commenced on non-PBS-subsidised treatment) Patient must have received treatment with this drug for this condition prior to 1 September 2020; AND The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND Patient must have been treated with rituximab-based chemotherapy prior to initiating treatment with this drug for this condition; AND Patient must have been experiencing relapsed/refractory disease prior to initiating treatment with this drug for this condition; AND Patient must have been autologous stem cell transplant (ASCT) ineligible following a single line of treatment prior to initiating treatment with this drug for this condition; OR Patient must have undergone an autologous stem cell transplant (ASCT) prior to initiating treatment with this drug for this condition; OR Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must have included rituximab-based chemotherapy, prior to initiating treatment with this drug for this condition; AND Patient must not have received treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must not exceed a total of 35 cycles in a lifetime; AND The treatment must not exceed a total of 7 doses under this restriction. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; (b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application for Grandfathered patients, which includes: (i) confirmation that histology results and PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records; (ii) details of prior treatments for this condition | Compliance with Written Authority Required procedures |
| C10679 | Relapsed or refractory primary mediastinal B-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of 35 cycles in a lifetime. | Compliance with Authority Required procedures |
| C10681 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10681 |
| C10682 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10682 |
| C10683 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment - 6 weekly treatment regimen Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10683 |
| C10685 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Grandfather treatment - 3 weekly treatment regimen Patient must have previously received non-PBS-subsidised drug for adjuvant treatment following complete surgical resection prior to 1 May 2020; AND Patient must have a WHO performance status of 1 or less prior to starting non-PBS treatment with this drug; AND Patient must not have evidence of recurrence; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior PBS-subsidised treatment for this condition; AND Patient must have commenced non-PBS-subsidised treatment within 12 weeks of complete surgical resection; AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Authority Required procedures |
| C10687 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Initial treatment - 3 weekly treatment regimen The treatment must be adjuvant to complete surgical resection; AND Patient must have a WHO performance status of 1 or less; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior PBS-subsidised treatment for this condition; AND The treatment must commence within 12 weeks of complete resection; AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10688 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Initial treatment - 6 weekly treatment regimen The treatment must be adjuvant to complete surgical resection; AND Patient must have a WHO performance status of 1 or less; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior PBS-subsidised treatment for this condition; AND The treatment must commence within 12 weeks of complete resection; AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10689 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment - 6 weekly treatment regimen Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 3 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10689 |
| C10693 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 6 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10693 |
| C10695 | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Continuing treatment - 3 weekly treatment regimen Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND Patient must not have experienced disease recurrence; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10696 | Unresectable Stage III or Stage IV malignant melanoma Initial treatment - 3 weekly treatment regimen Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 6 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10696 |
| C10697 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment - 3 weekly treatment regimen Patient must have previously received non-PBS subsidised treatment with this drug for this condition prior to 1 December 2019; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must not have had been treated for this condition in the metastatic setting prior to initiating non-PBS subsidised treatment with this drug for this condition; AND Patient must have stable or responding disease; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10697 |
| C10701 | Unresectable Stage III or Stage IV malignant melanoma Continuing treatment - 6 weekly treatment regimen The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10701 |
| C10702 | Relapsed or refractory primary mediastinal B-cell lymphoma Initial treatment The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of: (i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan, with the results retained in the patient's medical records; AND Patient must have been treated with rituximab-based chemotherapy for this condition; AND Patient must be experiencing relapsed/refractory disease; AND Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; OR Patient must have undergone an autologous stem cell transplant (ASCT); OR Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a total of 7 doses under this restriction. Applications for authorisation of initial treatment must be in writing and must include: (a) a completed authority prescription form; (b) a completed primary mediastinal B-cell lymphoma pembrolizumab PBS Authority Application, which includes: (i) confirmation that histology results with PET/CT scans support a diagnosis of primary mediastinal B-cell lymphoma and are retained on the patient's medical records; (ii) details of prior treatments for this condition. | Compliance with Written Authority Required procedures |
| C10704 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 6 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 4 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 10704 |
| C10705 | Unresectable Stage III or Stage IV malignant melanoma Continuing treatment - 3 weekly treatment regimen The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must have stable or responding disease. | Compliance with Authority Required procedures - Streamlined Authority Code 10705 |
Schedule 4, Part 1, entry for Venetoclax
omit entry for Circumstances Code “C8579” and substitute:
| C8579 | Chronic lymphocytic leukaemia (CLL) Grandfathered treatment Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 March 2019; AND Patient must have been considered unsuitable for treatment or retreatment with a purine analogue prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment with this drug for this condition, whichever comes first. A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria. | Compliance with Authority Required procedures |
Schedule 5, after entry for Imatinib in the form Tablet 400 mg (as mesilate) [GRP-21080]
insert:
| Imipramine | GRP-24222 | Tablet containing imipramine hydrochloride 25 mg | Oral | Tofranil 25 |
| Tablet containing imipramine hydrochloride 25 mg USP | Oral | Imipramine (Leading) |
Schedule 5, entry for Meloxicam in the form Tablet 15 mg [GRP-15468]
(a)omit from the column headed “Brand”: Chem mart Meloxicam 15 mg
(b)omit from the column headed “Brand”: Terry White Chemists Meloxicam 15 mg
Schedule 5, entry for Meloxicam in the form Tablet 7.5 mg [GRP-15658]
(a)omit from the column headed “Brand”: Chem mart Meloxicam 7.5 mg
(b)omit from the column headed “Brand”: Terry White Chemists Meloxicam 7.5 mg
Schedule 5, entry for Metformin in the form Tablet (extended release) containing metformin hydrochloride 500 mg [GRP-24200]
omit from the column headed “Brand”: Diabex XR substitute: Diabex XR 500
Schedule 5, entry for Morphine in the form Injection containing morphine sulfate pentahydrate 10 mg in 1 mL [GRP-20890]
omit from the column headed “Brand”: Hospira Pty Limited substitute: DBL Morphine Pentahydrate
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg [GRP-15442]
(a)omit from the column headed “Brand”: Chem mart Perindopril
(b)omit from the column headed “Brand”: Terry White Chemists Perindopril
Schedule 5, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg [GRP-15525]
(a)omit from the column headed “Brand”: Chem mart Perindopril
(b)omit from the column headed “Brand”: Terry White Chemists Perindopril
Schedule 5, entry for Perindoprilin the form Tablet containing perindopril erbumine 2 mg [GRP-15965]
(a)omit from the column headed “Brand”: Chem mart Perindopril
(b)omit from the column headed “Brand”: Terry White Chemists Perindopril
Schedule 5, entry for Salbutamol in the form Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) [GRP-24211]
(a)omit from the column headed “Brand”: Ventolin substitute: Ventolin CFC-Free with dose counter
(b)omit from the column headed “Brand”: Zempreon substitute: Zempreon CFC-Free with dose counter
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