National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 7) (PB 68 of 2018) (Cth)
PB 68 of 2018
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 7)
National Health Act 1953
___________________________________________________________________________
I, JULIANNE QUAINE, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.
Dated 30 JULY 2018
JULIANNE QUAINE
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 7).
(2)This Instrument may also be cited as PB 68 of 2018.
Commencement
This Instrument commences on 1 August 2018.
Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Schedule 1 Amendments
Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL
(a)insert in numerical order in the column headed “Circumstances”: C6996
(b)omit from the column headed “Circumstances”: C7567
(c)insert in numerical order in the column headed “Circumstances”: C7787 C7802 C7864
Schedule 1, Part 1, entry for Pembrolizumab in each of the forms: Powder for injection 50 mg; and Solution concentrate for I.V. infusion 100 mg in 4 mL
insert in numerical order in the column headed “Circumstances”: C7773
Schedule 1, Part 1, entry for Vinblastine
omit:
Vinblastine Teva DZ MP D
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 8]
(a)insert in numerical order in the column headed “Purposes”: P6996
(b)omit from the column headed “Purposes”: P7567
(c)insert in numerical order in the column headed “Purposes”: P7864
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 11]
insert in numerical order in the column headed “Purposes”: P7787 P7802
Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]
insert in numerical order in the column headed “Purposes”: P7773
Schedule 4, entry for Nivolumab
(a)insert in numerical order for the column headed “Circumstances Code”:
C6996 P6996 Locally advanced or metastatic non-small cell lung cancer
Initial treatment
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.Compliance with Authority Required procedures - Streamlined Authority Code 6996
(b)omit:
C7567 P7567 Locally advanced or metastatic non-small cell lung cancer
Initial treatment
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
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.Compliance with Authority Required procedures - Streamlined Authority Code 7567
(c)insert in numerical order after existing text:
C7787 P7787 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be the sole PBS-subsidised therapy for this condition.Compliance with Authority Required procedures - Streamlined Authority Code 7787 C7802 P7802 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Grandfather treatment
Patient must have received non-PBS subsidised treatment with this drug for this condition prior to 1 August 2018; AND
Patient must have had a WHO performance status of 0 or 1; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy, prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
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 - Streamlined Authority Code 7802 C7864 P7864 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.Compliance with Authority Required procedures - Streamlined Authority Code 7864
Schedule 4, entry for Pembrolizumab
insert in numerical order after existing text:
C7773 P7773 Relapsed or Refractory Hodgkin lymphoma
Initial treatment - Grandfathered patients
Patient must have previously received non-PBS-subsidised treatment with a programmed cell death 1 (PD-1) inhibitor for this condition prior to 1 May 2018; AND
Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT prior to receiving treatment with a PD-1 inhibitor for this condition; OR
Patient must not have been suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition prior to receiving treatment with a PD-1 inhibitor for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug 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 35 cycles in a lifetime.
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.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form;
(b) a completed Hodgkin lymphoma pembrolizumab PBS Authority Application for Grandfathered patients.Compliance with Written Authority Required procedures
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