National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10) (PB 95 of 2017) (Cth)
PB 95 of 2017
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Private Health Insurance and Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 28 November 2017
JULIANNE QUAINE
Assistant Secretary
Private Health Insurance and Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 10).
(2)This Instrument may also be cited as PB 95 of 2017.
Commencement
This Instrument commences on 1 December 2017.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Schedule 1, entry for Apomorphine
omit:
Injection containing apomorphine hydrochloride 10 mg in 1 mL Injection Apomine PF EMP C4833 C4860 360 5 D
Schedule 1, entry for Bosentan in the form Tablet 62.5 mg (as monohydrate)
omit:
APO-BOSENTAN GX EMP C4628 C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D
Schedule 1, entry for Bosentan in the form Tablet 125 mg (as monohydrate)
omit:
APO-BOSENTAN GX EMP C6089 C6710 C6734 C6748 C6764 C6776 See Note 1 See Note 2 D
Schedule 1, entry for Epoetin Lambda in all forms
(a)omit from the column headed “Listed Drug”: Epoetin Lambda substitute: Epoetin lambda
(b)omit from the column headed “Circumstances”: C6245 C6261 substitute: C6260 C6294
Schedule 1, omit entry for Foscarnet
Schedule 3, entry for Apomorphine
(a)omit from the column headed “Purposes Code” for Circumstances Code C4833:
P4833
(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4833:
Where the patient is receiving treatment at/from a public hospital
(c)omit from the column headed “Purposes Code” for Circumstances Code C4860:
P4860
(d)omit from the column headed “Circumstances and Purposes” for Circumstances Code C4860:
Where the patient is receiving treatment at/from a private hospital
(e)insert in numerical order after existing text:
C6813 Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.Compliance with Authority Required procedures - Streamlined Authority Code 6813
Schedule 3, entry for Epoetin Lambda
substitute:
Epoetin lambda C6260 Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.Compliance with Authority Required procedures C6294 Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist.Compliance with Authority Required procedures - Streamlined Authority Code 6294
Schedule 3, omit entry for Foscarnet
Schedule 3, entry for Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin
substitute:
Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin C6130 P6130 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 24 weeks.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.Compliance with Authority Required procedures C6131 P6131 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.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.Compliance with Authority Required procedures
Schedule 3, entry for Peginterferon alfa-2a
(a)insert in the column headed “Purposes Code” for Circumstances Code C5004:
P5004
(b)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5004:
Where the patient is receiving treatment at/from a public hospital
(c)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5004:
Population criteria:
(d)insert in the column headed “Purposes Code” for Circumstances Code C5010:
P5010
(e)omit:
C5016 Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored.
Chronic hepatitis B infection
Patient must not have cirrhosis, AND
Patient must not have previously received peginterferon alfa therapy for the treatment of hepatitis B, 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 confirmed elevated serum ALT or liver biopsy, AND
The treatment must be the sole PBS subsidised therapy for this condition.Compliance with Written and Telephone Authority Required procedures
substitute:
C5016 P5016 Chronic hepatitis C infection
Must be treated in an accredited treatment centre.
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age.
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
Patient must have a contraindication to ribavirin; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must be limited to a maximum duration of 48 weeks.
Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.Compliance with Authority Required procedures
(f)omit from the column headed “Circumstances and Purposes” for Circumstances Code C5067:
Where the patient is receiving treatment at/from a public hospital
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