Proposal to award sole supply of bortezomib in DHB hospitals

Medicines

Consultation Closed

Following a Request for Proposals (RFP) for the supply of bortezomib, issued on 16 March 2016, PHARMAC is seeking feedback on a proposal to:

  • award Hospital Supply Status (the only available brand in DHB hospitals) to Janssen-Cilag Pty Ltd’s brand of bortezomib (Velcade) inj 3.5 mg vial from 1 July 2016 to 30 June 2019 subject to a 1% discretionary variance (DV) limit; and
  • delist the inj 1 mg vial presentation of bortezomib from 1 September 2016 in Part II of Section H, and from 1 December 2016 in Section B, of the Pharmaceutical Schedule.

As Velcade is currently the only funded brand of bortezomib, there would be no funded brand change resulting from this proposal.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm, Friday 3 June 2016 to:

Chloë Dimock
Procurement Manager
PHARMAC

Email: procurement@pharmac.govt.nz
Fax:     04 460 4995
Post:    PO Box 10 254, Wellington 6143

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

  • Velcade inj 3.5 mg vial would be awarded Hospital Supply Status from 1 July 2016 to 30 June 2019 with a 1% DV limit.
  • Velcade inj 3.5 mg vial, and bortezomib inj 1 mg for ECP, would remain listed in Part II of Section H (the Hospital Medicines List or HML) and/or Section B (as a PCT only - Specialist pharmaceutical) of the Pharmaceutical Schedule at the following price (ex-manufacturer and excluding GST):
    Chemical Presentation Brand Pack size Current/proposed Price
    bortezomib Inj 3.5 mg vial Velcade 1 $1,892.50
    bortezomib Inj 1 mg for ECP Baxter 1 mg $594.77
  • A confidential rebate would apply to Velcade inj 3.5 mg which would reduce its net price to the Funder.
  • Velcade inj 3.5 mg would remain listed subject to the current Special Authority criteria and hospital restrictions.
  • Velcade inj 1 mg vials would remain listed on the Pharmaceutical Schedule at the current price and subsidy until the following delisting dates:
    • 1 September 2016 in Part II of Section H of the Pharmaceutical Schedule
    • 1 December 2016 in Section B of the Pharmaceutical Schedule.

Background

Bortezomib inj 1 mg and inj 3.5 mg vials are currently listed in Section B and Part II of Section H (HML) of the Pharmaceutical Schedule with Special Authority restrictions for the treatment of multiple myeloma and systemic Amyloid Light-chain (AL) amyloidosis.

Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. Bortezomib is administered in hospital.

Request for proposals

In March 2016, PHARMAC ran an RFP process for the supply of bortezomib in DHB hospitals. This proposal to award Hospital Supply Status for bortezomib is the result of this process.

Should the proposal be approved, it would result in significant savings to DHBs. There would be no funded brand change or change in funded access criteria as a result of this proposal.

Clinical advice

PHARMAC has previously received advice from the Cancer Treatments Subcommittee of PTAC (CaTSoP) regarding a competitive process for bortezomib. The Subcommittee had no strong opposition to a sole supply being awarded for bortezomib but noted that continuity of supply was very important for this product.

The CaTSoP noted that bortezomib was currently supplied in a 3.5 mg and 1 mg vial and was approved for administration via intravenous (IV) or subcutaneous routes. Members considered it was essential that any generic could also be administered via IV or subcutaneous routes noting there was trend towards more patients receiving subcutaneous treatment.  Members considered it was not necessary to also have both the 1 mg and 3.5 mg vial strengths funded subject to PHARMAC confirming this was acceptable with an Oncology Pharmacist.

The full minute of the discussion can be found on PHARMAC’s website [PDF, 535 KB].

PHARMAC sought advice from an Oncology Pharmacist which has been taken into account in developing the proposal.