National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 11) (No. PB 94 of 2014) (Cth)

PB 94 of 2014

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 11)

National Health Act 1953

___________________________________________________________________________

I, Kim Bessell, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated  27 November 2014

KIM BESSELL

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor  

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________

1              Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No.11).

(2)This Instrument may also be cited as PB 94 of 2014.

2             Commencement

This Instrument commences on 1 December 2014.

3              Amendments to PB 79 of 2011

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1                   Amendments

1. After section 34

insert:

34A Modified application of paragraph 92A(1)(f) conditions of approval

a)Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of an infusion, once prepared as a final product ready for infusion to a person, when the infusion has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.

b)For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.

1. Schedule 1, Part 1 after the entry for Bortezomib:

insert:

Brentuximab Vedotin Powder for I.V. Infusion 50 mg Injection Adcetris TK MP C4675 C4719 D

1. Schedule 1 Part 1 entry for ‘Rituximab’ in each of the forms ‘Solution for I.V. injection 100 mg in 10 mL’ and ‘Solution for I.V. injection 500 mg in 50 mL’ with manner of administration Injection:

omit from the column headed ‘Circumstances’ (all instances):

C1744 C1745 C2068 C2386 C3908 C3909 C3912 C3915 C3931 C3932

insert in the column headed ‘Circumstances’ (all instances) :

C4671 C4674 C4677 C4678 C4679 C4686 C4687 C4701 C4706 C4726 C4727 C4728 C4752 C4765

1. Schedule 1, Part 2 after the entry for Bortezomib;

insert:

Brentuximab Vedotin		P4675	200	11
P4719	200	3

1. Schedule 1, Part 2 entry for Rituximab;

omit:

Rituximab	P2068	800	7
P2386
P3912
P3915
P1744	800	3
P1745
P3908
P3909
P3931	1100	5
P3932

insert:

Rituximab	P4686	800	7
P4687
P4701
P4726 P4727 P4728
P4677	800	3
P4678
P4752
P4765
P4671	1100	5
P4701
P4674	800	11
P4679

1. Schedule 3, Responsible Person codes, after entry for SZ:

insert:

TK Takeda Pharmaceuticals Australia Pty Ltd  71 095 610 870

1. Schedule 4, after the entry for Bortezomib;

insert:

Brentuximab vedotin	C4675	P4675	CD30 positive systemic anaplastic large cell lymphoma. Treatment Phase: Continuing treatment Patient must not have progressive disease, and must have previously been issued with an authority prescription for this drug. The treatment must not exceed a lifetime total of 16 cycles.	Compliance with Authority Required procedures
C4719	P4719	CD30 positive systemic anaplastic large cell lymphoma. Treatment Phase: Initial treatment The treatment must be for curative intent. Patient must have undergone appropriate prior front-line curative intent chemotherapy, and 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 from a biopsy subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy or other agents; (ii) The date of initial diagnosis of systemic anaplastic large cell lymphoma; (iii) Dates of commencement and completion of front-line curative intent chemotherapy; (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; (v) a declaration of whether the patient has had, or is planned to have, a transplant 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

1. Schedule 4, entry for Rituximab ;

omit:

Rituximab	C1744	P1744	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory low‑grade B‑cell non‑Hodgkin's lymphoma	Compliance with Authority Required procedures
C1745	P1745	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Relapsed or refractory follicular B‑cell non‑Hodgkin's lymphoma	Compliance with Authority Required procedures
C2068	P2068	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Treatment of previously untreated, CD20 positive, diffuse large B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy	Compliance with Authority Required procedures
C2386	P2386	Where the patient is receiving treatment in the community setting or at/from a Private Hospital Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B‑cell non‑Hodgkin's lymphoma in combination with chemotherapy	Compliance with Authority Required procedures
C3908	P3908	Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory low‑grade B‑cell non‑Hodgkin's lymphoma	Compliance with Authority Required procedures ‑ Streamlined Authority Code 3908
C3909	P3909	Where the patient is receiving treatment at/from a Public Hospital Relapsed or refractory follicular B‑cell non‑Hodgkin's lymphoma	Compliance with Authority Required procedures ‑ Streamlined Authority Code 3909
C3912	P3912	Where the patient is receiving treatment at/from a Public Hospital Treatment of previously untreated, CD20 positive, diffuse large B‑cell non‑Hodgkin's lymphoma, in combination with chemotherapy	Compliance with Authority Required procedures ‑ Streamlined Authority Code 3912
C3915	P3915	Where the patient is receiving treatment at/from a Public Hospital Treatment of symptomatic patients with previously untreated, CD20 positive, Stage III or IV, follicular, B‑cell non‑Hodgkin's lymphoma in combination with chemotherapy	Compliance with Authority Required procedures ‑ Streamlined Authority Code 3915
C3931	P3931	Where the patient is receiving treatment in the community setting or at/from a Private Hospital CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide	Compliance with Authority Required procedures
C3932	P3932	Where the patient is receiving treatment at/from a Public Hospital CD20 positive, chronic lymphocytic leukaemia, in combination with fludarabine and cyclophosphamide	Compliance with Authority Required procedures ‑ Streamlined Authority Code 3932

insert:

Rituximab	C4671	P4671	Chronic lymphocytic leukaemia (CLL). The condition must be CD20 positive chronic lymphocytic leukaemia (CLL), and treatment must be in combination with chemotherapy.	Compliance with Authority Required procedures
C4674	P4674	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma.  Treatment Phase: Maintenance therapy. Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application. The treatment must be maintenance therapy, and patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 4674
C4677	P4677	Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment The treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 4677
C4678	P4678	Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment The treatment must be for re-induction treatment purposes only, and the condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 4678
C4679	P4679	Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy Patient must have demonstrated a partial or complete response to the induction phase of treatment for previously untreated follicular B-cell Non-Hodgkin's lymphoma, received immediately prior to this current Authority application. Treatment must be maintenance therapy, and Patient must not receive more than 12 doses or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures
C4686	P4686	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy The treatment must be maintenance therapy. Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application, and patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 4686
C4687	P4687	Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment Treatment must be in combination with chemotherapy. The condition must be previously untreated, and must be symptomatic. The treatment must be for induction treatment purposes only, and patient must not receive more than 8 doses under this restriction.	Compliance with Authority Required procedures
C4701	P4701	Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. The treatment must be in combination with chemotherapy.  The condition must be previously untreated, and must be symptomatic. The treatment must be for induction treatment purposes only, and patient must not receive more than 8 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 4701
C4706	P4706	Chronic lymphocytic leukaemia (CLL). The condition must be CD20 positive chronic lymphocytic leukaemia (CLL), and treatment must be in combination with chemotherapy.	Compliance with Authority Required procedures - Streamlined Authority Code 4706
C4726	P4726	Previously untreated Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment. The treatment must be in combination with chemotherapy.  The condition must be previously untreated, and must be symptomatic.  The treatment must be for induction treatment purposes only, and patient must not receive more than 8 doses under this restriction.	Compliance with Authority Required procedures - Streamlined Authority Code 4726
C4727	P4727	Previously untreated CD20 positive diffuse large B-cell non-Hodgkin's lymphoma. Treatment Phase: Induction treatment.  Treatment must be in combination with chemotherapy. The condition must be previously untreated, and must be symptomatic, The treatment must be for induction treatment purposes only, and patient must not receive more than 8 doses under this restriction.	Compliance with Authority Required procedures
C4728	P4728	Relapsed or refractory Stage III or IV CD20 positive follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Maintenance therapy. The treatment must be maintenance therapy. Patient must have demonstrated a partial or complete response to re-induction treatment received immediately prior to this current Authority application, and patient must not receive more than 8 cycles or 2 years duration of treatment, whichever comes first, under this restriction.	Compliance with Authority Required procedures
C4752	P4752	Relapsed or refractory follicular B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment The treatment must be for re-induction treatment purposes only. The condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.	Compliance with Authority Required procedures
C4765	P4765	Relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Treatment Phase: Re-induction treatment The treatment must be for re-induction treatment purposes only.  The condition must have relapsed or be refractory to treatment. Patient must not receive more than 4 doses under this restriction.	Compliance with Authority Required procedures

1. Schedule 5, entry for the listed drug ‘Bleomycin’:

omit from the column headed ‘Claimed Ex-manufacturer Price’ (all instances): $65.24

insert in the column headed ‘Claimed Ex-manufacturer Price’ (all instances): $40.28