National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 4) (PB 33 of 2018) (Cth)
PB 33 of 2018
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 4)
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 Instrument under subsection 100(2) of the National Health Act 1953.
Dated 27 April 2018
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 (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 4).
(2)This Instrument may also be cited as PB 33 of 2018.
Commencement
This Instrument commences on 1 May 2018.
Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
This Instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).
Schedule 1— Amendments
Schedule 1, Part 1, entry for Bleomycin
omit from the column headed “Responsible Person” for the brand “Bleo 15K”: EA substitute: JU
Schedule 1, Part 1, entry for Brentuximab vedotin
omit from the column headed “Circumstances”: C7244 substitute: C7616
Schedule 1, Part 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL; Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL; and Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit from the column headed “Responsible Person” for the brand “Epirubicin ACT”: EA substitute: JU
Schedule 1, Part 1, entry for Fludarabine in the form Powder for I.V. injection containing fludarabine phosphate 50 mg
omit from the column headed “Responsible Person” for the brand “Fludarabine ACT”: EA substitute: JU
Schedule 1, Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
omit from the column headed “Responsible Person” for the brand “IRINOTECAN ACT”: ED substitute: JU
Schedule 1, Part 1, entry for Paclitaxel in each of the forms: Solution concentrate for I.V. infusion 30 mg in 5 mL; Solution concentrate for I.V. infusion 100 mg in 16.7 mL; Solution concentrate for I.V. infusion 150 mg in 25 mL; and Solution concentrate for I.V. infusion 300 mg in 50 mL
omit from the column headed “Responsible Person” for the brand “Paclitaxel ACT”: EF substitute: JU
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”: C7606 C7610
Schedule 1, Part 2, entry for Brentuximab vedotin [Maximum Amount: 200; Number of Repeats: 3]
omit from the column headed “Purposes”: P7244 substitute: P7616
Schedule 1, Part 2, entry for Pembrolizumab
substitute:
Pembrolizumab P7606 P7610 200 6 P6806 P6817 240 5 P6801 240 7
Schedule 3
omit:
ED Amneal Pharmaceuticals Pty Ltd 11 163 167 851 EF Amneal Pharmaceuticals Pty Ltd 11 163 167 851
Schedule 4, entry for Brentuximab vedotin
insert in numerical order after existing text:
C7616
P7616
CD30 positive systemic anaplastic large cell lymphoma
Initial treatment
The treatment must be for curative intent; AND
Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy-refractory disease.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Systemic anaplastic large cell lymphoma Brentuximab PBS Authority Application - Supporting Information Form which includes the following:
(i) a histology report including evidence of the tumour's CD30 positivity;
(ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma;
(iii) Dates of commencement and completion of front-line curative intent chemotherapy; and
(iv) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.
A maximum quantity and number of repeats to provide for an initial course of brentuximab vedotin of 4 cycles will be authorised as part of the initiating restriction.Compliance with Written Authority Required procedures
Schedule 4, entry for Pembrolizumab
insert in numerical order after existing text:
C7606 P7606 Relapsed or Refractory Hodgkin 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.
The treatment must not exceed a total of 35 cycles in a lifetime.Compliance with Authority Required procedures C7610 P7610 Relapsed or Refractory Hodgkin lymphoma
Initial treatment
Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; OR
Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND
Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
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.Compliance with Written Authority Required procedures
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