National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 6) (PB 57 of 2017) (Cth)
PB 57 of 2017
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 6)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health and Minister for Sport, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 25 July 2017
Julianne Quaine
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
Part 1 Preliminary
1 Name of Instrument
(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 6).
(2)This instrument may also be cited as PB 57 of 2017.
2 Commencement
This instrument commences on 1 August 2017.
3 Amendment
The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule – Amendments
Schedule
National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1, entry for Azacitidine
Substitute:
Azacitidine Powder for injection 100 mg Injection Azacitidine Accord OC EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D Azadine RZ EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D Celazadine JU EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D Vidaza CJ EMP C6132 C6143 C6144 C6177 C6186 C6199 See Note 1 See Note 2 D
Schedule 1, entry for Bosentan
Substitute:
Bosentan Tablet 62.5 mg (as monohydrate) Oral APO-BOSENTAN GX EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan APOTEX TX EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan Mylan AF EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan RBX RA EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan Sandoz SZ EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D BOSENTAN-DRLA RZ EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D BOSLEER RW EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Tracleer AT EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Tablet 125 mg (as monohydrate) Oral APO-BOSENTAN GX EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan APOTEX TX EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan GH GQ EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan Mylan AF EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan RBX RA EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Bosentan Sandoz SZ EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D BOSENTAN-DRLA RZ EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D BOSLEER RW EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D Tracleer AT EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D
Schedule 1, entry for Desferrioxamine in the form ‘Powder for injection containing desferrioxamine mesylate 500 mg’
Omit second entry for brand: Hospira Pty Limited
Schedule 1, entry for Epoprostenol
Substitute:
Epoprostenol Powder for I.V. infusion 500 micrograms (as sodium) Injection Veletri AT EMP C6123 C6734 C6748 C6945 C6955 See Note 1 See Note 2 D Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL Injection Flolan GK EMP C6123 C6734 C6748 C6945 C6955 See Note 1 See Note 2 D Powder for I.V. infusion 1.5 mg (as sodium) Injection Veletri AT EMP C6123 C6734 C6748 C6945 C6955 See Note 1 See Note 2 D Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL Injection Flolan GK EMP C6123 C6734 C6748 C6945 C6955 See Note 1 See Note 2 D
Schedule 1, entry for Etanercept in the form ‘Injection 50mg in 1 mL single use auto-injector, 4’
Omit from the column titled ‘Brand’: PF
Insert into the column titled ‘Brand’: Enbrel
Schedule 1, entry for Infliximab
Substitute:
Infliximab Powder for I.V. infusion 100 mg Injection Inflectra PF EMP C3691 C3693 C3819 C3820 C4524 C4535 C4626 C4627 C4705 C4718 C4846 C4854 C5077 C5078 C5084 C5097 C5103 C5109 C5110 C5118 C5440 C5484 C5485 C6379 C6400 C6414 C6441 C6446 C6461 C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791 C6901 C6909 C6928 C6943 See Note 1 See Note 2 D Remicade JC EMP C3691 C3693 C3819 C3820 C4524 C4535 C4626 C4627 C4705 C4718 C4846 C4854 C5077 C5078 C5084 C5097 C5103 C5109 C5110 C5118 C5440 C5484 C5485 C6379 C6400 C6414 C6441 C6446 C6461 C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791 C6901 C6909 C6928 C6943 See Note 1 See Note 2 D Renflexis MK EMP C3691 C3693 C3819 C3820 C4524 C4535 C4626 C4627 C4705 C4718 C4846 C4854 C5077 C5078 C5084 C5097 C5103 C5109 C5110 C5118 C5440 C5484 C5485 C6379 C6400 C6414 C6441 C6446 C6461 C6712 C6729 C6741 C6757 C6767 C6768 C6780 C6791 C6901 C6909 C6928 C6943 See Note 1 See Note 2 D
Schedule 1, entry for Omalizumab
Substitute:
Omalizumab
Injection 75 mg in 0.5 mL single dose pre-filled syringe Injection Xolair NV EMP C4875 C4879 C6627 C6689 C6563 C6596 C6603 C6788 See Note 1 See Note 2 D Injection 150 mg in 1 mL single dose pre-filled syringe Injection Xolair NV EMP C4875 C4879 C6627 C6689 C6563 C6596 C6603 C6788 See Note 1 See Note 2 D
Schedule 1, entry for Sirolimus in the form ‘Oral solution 1 mg per mL, 60 mL’
Omit from the column titled ‘Maximum Quantity’: 200
Insert into the column titled ‘Maximum Quantity’: 2
Schedule 1, after the entry for Sofosbuvir
Insert:
Sofosbuvir with velpatasvir Tablet containing 400 mg sofosbuvir with 100 mg velpatasvir Oral Epclusa GI EMP C5969 28 2 D
Schedule 1, entry for Tenofovir
Substitute:
Tenofovir Tablet containing tenofovir disoproxil fumarate 300 mg Oral Viread GI EMP C6980 C6982 C6983 C6984 C6992 C6998 60 5 D Tablet containing tenofovir disoproxil maleate 300 mg Oral Tenofovir Disoproxil Mylan AF EMP C6980 C6982 C6983 C6984 C6992 C6998 60 5 D Tablet containing tenofovir disoproxil phosphate 291 mg Oral Tenofovir GH GQ EMP C6980 C6982 C6983 C6984 C6992 C6998 60 5 D
Schedule 1, entry for Tenofovir with emtricitabine
Substitute:
Tenofovir with emtricitabine Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg Oral Truvada GI EMP C6985 C6986 60 5 D Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg Oral Tenofovir Disoproxil Emtricitabine Mylan 300/200 AF EMP C6985 C6986 60 5 D Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg Oral Tenofovir EMT GH GQ EMP C6985 C6986 60 5 D
Schedule 1, second entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
Omit:
Tenofovir with emtricitabine, elvitegravir and cobicistat Tablet containing elvitegravir 150 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg Oral Genvoya GI EMP C4470 C4522 60 5 D Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg
Oral
Stribild
GI
EMP
C4470 C4522
60
5
D
Schedule 1, entry for Valganciclovir in the form ‘Tablet 450 mg (as hydrochloride)’
Insert in alphabetical order:
Valganciclovir AN EA EMP C4980 C4989 C5031 120 5 D Valganciclovir Mylan AF EMP C4980 C4989 C5031 120 5 D Valganciclovir Sandoz SZ EMP C4980 C4989 C5031 120 5 D
Schedule 3, entry for Epoprostenol
Omit entries for: C6762 C6763
Schedule 3, after entry for Sofosbuvir
Insert:
Sofosbuvir with velpatasvir C5969 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
Compliance with Authority Required procedures
Schedule 3, entry for Tenofovir
Omit entries for: C4454 C4476 C4489 C4490 C4510 C4512
Insert:
Tenofovir C6980 Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naive; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
Compliance with Authority Required procedures - Streamlined Authority Code 6980 C6982
HIV infection
Continuing
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents.
Compliance with Authority Required procedures - Streamlined Authority Code 6982
C6983
Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA.
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
Compliance with Authority Required procedures - Streamlined Authority Code 6983
C6984
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.
Compliance with Authority Required procedures - Streamlined Authority Code 6984
C6992
Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naive; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Compliance with Authority Required procedures - Streamlined Authority Code 6992
C6998
HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents.
Compliance with Authority Required procedures - Streamlined Authority Code 6998
Schedule , entry for Tenofovir with emtricitabine
Omit entries for: C4454 C4512
Insert:
Tenofovir with emtricitabine
C6985
HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents.
Compliance with Authority Required procedures - Streamlined Authority Code 6985
C6986
HIV infection
Continuing
Patient must have previously received PBS-subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents.
Compliance with Authority Required procedures - Streamlined Authority Code 6986
0
0
0