Decision relating to enoxaparin sodium and plerixafor

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with Sanofi-Aventis New Zealand Limited (Sanofi) for the listing of plerixafor for use in DHB hospitals, along with price reductions for enoxaparin sodium.

The funding of plerixafor means that a new pharmaceutical used to mobilise stem cells for autologous stem cell transplants will be funded for use in DHB hospitals from 1 September 2016. Plerixafor increases the likelihood of a successful mobilisation, reducing the delay to transplant for certain presentations of multiple myeloma, Hodgkin's lymphoma, and non-Hodgkin's lymphoma.

This was the subject of a consultation letter dated 24 June 2016. The proposal was approved as consulted on except for non-material changes to the plerixafor hospital restriction criteria.

In summary, the effect of the decision is that:

From 1 September 2016:

  • the price and subsidy for all strengths of enoxaparin sodium (Clexane) will be reduced.
  • plerixafor (Mozobil) will be listed in Part II of Section H of the Pharmaceutical Schedule.

And from 1 September 2017:

  • the price and subsidy for all strengths of enoxaparin sodium (Clexane) will be further reduced.

Details of the decision

Enoxaparin sodium (Clexane)

  • The price and subsidy for enoxaparin sodium injection syringes will 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 New price and subsidy from 1 September 2016 New 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 will have subsidy and delisting protection until 30 August 2018.
  • Enoxaparin sodium will 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 will remain listed in Part II of Section H of the Pharmaceutical Schedule without restriction. 

Plerixafor (Mozobil)

  • Plerixafor will be listed under a new Pharmaceutical Schedule subheading, 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 will apply to Mozobil, reducing the net price.
  • Mozobil will have price and delisting protection until 30 August 2019.
  • Plerixafor will be listed in Part II of 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:

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 8 July 2016 were considered in their entirety in making a decision on the proposed changes. All responses were supportive of the proposal:

Theme Comment
A responder recommended a minor change to the plerixafor restriction criteria being “Patient is undergoing to undergo stem cell transplantation” on the basis that the harvest happens before the transplant. The restriction criteria for plerixafor has been amended as suggested.
A responder, although supportive of the proposal, considered the Special Authority criteria that applies to enoxaparin sodium in the community should be removed for small quantities.  The responder, noted that Special Authorities may not always have been applied for when a patient is discharged from hospital, which may cause supply issues for a medicine with an urgent clinical need. At its March 2015 meeting, the Haematology Subcommittee of PTAC considered that Special Authority access to enoxaparin sodium could be widened, however members considered this could lead to both clinical risk and increased expenditure without strong evidence of clinical benefit. Members expressed concern that widened access may result in the use of funded enoxaparin sodium for prophylaxis of deep-vein thrombosis during travel or in elderly patients in residential care.No changes will be made to the Special Authority  for enoxaparin sodium as a result of this proposal, but this does not prevent widening of access to enoxaparin sodium in the community from being considered at a later stage.
A responder requested that enoxaparin sodium be funded in original packs (OP rule), as dispensing volumes of enoxaparin sodium are generally low, intermittent and spread across multiple strengths. All strengths of enoxaparin sodium are currently supplied in packs of ten injections.PHARMAC considers it would be a very rare occurrence that a pack containing ten injections would need to be divided by a pharmacy, as each pack only contains five or ten days supply depending on the dose frequency. For this reason, PHARMAC consider that it is unnecessary to apply the original pack (OP) rule to enoxaparin sodium. PHARMAC staff note that enoxaparin sodium is not a new listing and does not currently have OP applied.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz