Enoxaparin sodium and plerixafor proposal
PHARMAC is seeking feedback on a proposal involving enoxaparin sodium and plerixafor, resulting from a provisional agreement with Sanofi-Aventis New Zealand Limited (Sanofi). The proposal includes price reductions for enoxaparin sodium and the listing of plerixafor for use in DHB hospitals.
In summary, this proposal would result in:
- price reductions for all funded strengths of enoxaparin sodium (Clexane), the first being effective 1 September 2016 and the second on 1 September 2017
- listing of plerixafor (Mozobil), a treatment used during mobilisation for autologous stem cell transplants, in Part II of Section H of the Pharmaceutical Schedule from 1 September 2016.
Feedback sought
PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 8 July 2016 to:
Andrew Park
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143
Email: andrew.park@pharmac.govt.nz
Fax: 04 460 4995
All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.
Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.
We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.
Details of the proposal
Enoxaparin sodium (Clexane)
- The price and subsidy for enoxaparin sodium (Clexane) injection syringes would be reduced in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 September 2016 and 1 September 2017 as follows (prices ex-manufacturer, excluding GST):
| Chemical | Formulation | Brand | Pack size | Current price and subsidy | Proposed price and subsidy from 1 September 2016 | Proposed price and subsidy from 1 September 2017 |
|---|---|---|---|---|---|---|
| Enoxaparin sodium | Inj 20 mg in 0.2 ml syringe | Clexane | 10 | $37.24 | $30.91 | $27.93 |
| Enoxaparin sodium | Inj 40 mg in 0.4 ml syringe | Clexane | 10 | $49.69 | $41.24 | $37.27 |
| Enoxaparin sodium | Inj 60 mg in 0.6 ml syringe | Clexane | 10 | $74.91 | $62.18 | $56.18 |
| Enoxaparin sodium | Inj 80 mg in 0.8 ml syringe | Clexane | 10 | $99.86 | $82.88 | $74.90 |
| Enoxaparin sodium | Inj 100 mg in 1 ml syringe | Clexane | 10 | $125.06 | $103.80 | $93.80 |
| Enoxaparin sodium | Inj 120 mg in 0.8 ml syringe | Clexane | 10 | $155.40 | $128.98 | $116.55 |
| Enoxaparin sodium | Inj 150 mg in 1 ml syringe | Clexane | 10 | $177.60 | $147.41 | $133.20 |
- Clexane would have subsidy and delisting protection until 30 August 2018.
- Enoxaparin sodium would remain listed in Section B, subject to unchanged Special Authority criteria for use during pregnancy and the treatment and/or prevention of venous thromboembolism, and would remain listed in Part II of Section H of the Pharmaceutical Schedule without restriction.
Plerixafor (Mozobil)
- Plerixafor (Mozobil) would be listed under a new Pharmaceutical Schedule subheading, named Drugs Used to Mobilise Stem Cells, in the Colony-Stimulating Factors, Blood and Blood Forming Organs therapeutic group, in Part II of Section H of the Pharmaceutical Schedule from 1 September 2016 as follows (ex-manufacturer, excluding GST):
| Chemical | Formulation | Brand | Pack size | Proposed price |
|---|---|---|---|---|
| Plerixafor | Inj 20 mg per ml, 1.2 ml vial | Mozobil | 1 | $8,740.00 |
- A confidential rebate would apply to Mozobil, reducing the net price.
- Mozobil would have price and delisting protection until 30 August 2019.
- Plerixafor would be listed in Section H of the Pharmaceutical Schedule subject to the following restriction:
Restricted
Initiation - autologous stem cell transplant
Haematologist
Limited to 3 days’ treatment
All of the following:
- Patient is undergoing stem cell transplantation; and
- Patient has not had a previous unsuccessful mobilisation attempt with plerixafor; and
- Any of the following:
- Patient is undergoing G-CSF mobilisation; and
- Either:
- Has a suboptimal peripheral blood CD34 count of ≤10 x 106/L on day 5 after 4 days of G-CSF treatment; or
- Efforts to collect >1×106 CD34 cells/kg have failed after one apheresis procedure; or
- Either:
- Patient is undergoing chemotherapy and G-CSF mobilisation; and
- Any of the following:
- Has rising white blood cell counts of >5 x 109/L and a suboptimal peripheral blood CD34 count of ≤10 x 106/L; or
- Efforts to collect >1×106 CD34 cells/kg have failed after one apheresis procedure; or
- The peripheral blood CD34 cell counts are decreasing before the target has been received; or
- Any of the following:
- A previous mobilisation attempt with G-CSF or G-CSF plus chemotherapy has failed.
- Patient is undergoing G-CSF mobilisation; and
Background
Enoxaparin sodium
Enoxaparin sodium is a low molecular weight heparin anticoagulant which is administered by subcutaneous injection. It is used for the prevention and treatment of deep-vein thrombosis in surgical and medical patients, treatment of unstable angina and myocardial infarction and for the prevention of thrombus formation in haemodialysis. It is also used for treatment of venous thromboembolism in pregnancy and the prevention of thrombus formation in cardioversion for atrial fibrillation (unapproved indications). There are no restrictions on the use of enoxaparin sodium in DHB hospitals.
There would be no change to the funding of enoxaparin as a result of this proposal, only the price and the subsidy and delisting protection period would change.
Plerixafor
Plerixafor is approved for use in combination with granulocyte-colony stimulating factors (G-CSFs) during autologous stem cell transplantations for the treatment of lymphoma and multiple myeloma. Plerixafor enhances the release of haematopoietic stem cells into the peripheral circulation, increasing the likelihood of successful mobilisation.
Currently, stem cells are mobilised using G-CSF (filgrastim or pegfilgrastim), either alone or in combination with chemotherapy. G-CSFs stimulate the production of excess haematopoietic stem cells within the bone marrow, some of which are released into the peripheral circulation. Circulating stem cells in the peripheral blood are then collected using a process called apheresis, and are then stored for later reinfusion following conditioning therapy.
Clinical advice
PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) considered plerixafor at its meeting in May 2015. The Committee recommended that plerixafor be listed with a high priority subject to restriction criteria developed by PTAC and the Cancer Treatments Subcommittee of PTAC (CaTSoP). Advisory committee minutes relevant to plerixafor are available via the application tracker on our website(external link).