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.
[2] 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
[3] 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
[4] Schedule 1, Part 2 after the entry for Bortezomib;
insert:
Brentuximab Vedotin
P4675
200
11
P4719
200
3
[5] 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
[6] Schedule 3, Responsible Person codes, after entry for SZ:
insert:
TK
Takeda Pharmaceuticals Australia Pty Ltd
71 095 610 870
[7] 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
[8] 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
[9] 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
