RFP - Supply of bortezomib

Medicines

RFP Closed

PHARMAC invites proposals for the supply of bortezomib in New Zealand.

Answers to questions will be provided through the Government Electronic Tenders Service (GETS). PHARMAC will also post any addenda through GETS. We encourage interested suppliers to register with GETS and subscribe to this RFP to be kept up to date.

This request for proposals (RFP) letter incorporates the following schedules:

  • Schedule 1 specifies the pharmaceutical for which PHARMAC is requesting proposals and sets out the background to the RFP and the types of proposals sought;
  • Schedule 2 describes the process that PHARMAC expects to follow in relation to the RFP;
  • Schedule 3 sets out information about the estimated size of the current subsidised market for the pharmaceutical; and
  • Schedule 4 contains the RFP form in which you are to provide details of your proposal.

Full text of Request for Proposals - supply of bortezomib [PDF, 203 KB]

If you wish to submit a proposal, you must submit it to PHARMAC via the Government Electronic Tenders Services (GETS) no later than 5.00 p.m. on 13 April 2016.

If you have any questions about this RFP, please post these on the Government Electronic Tenders Service (www.gets.govt.nz(external link)) or alternatively contact Chloë Dimock at PHARMAC by email procurement@pharmac.govt.nz.

Schedule 1: Pharmaceutical, background to RFP and types of proposals sought

Pharmaceutical

PHARMAC is interested in considering any proposals from suppliers of bortezomib. Bortezomib is a Pharmaceutical Cancer Treatment (PCT) pharmaceutical.

Background to RFP

The background to this RFP is outlined below.

    Subsidy/Price Per Fully Subsidised Brand or Generic Manufacturer
BORTEZOMIB – PCT only – Specialist – Special Authority see SA1576 below
Inj 1 mg …………………………… $540.70 * 1 Yes Velcade
Inj 3.5 mg …………………………… $1,892.50 * 1 Yes Velcade
Inj 1 mg for ECP …………………………… $594.77 * 1 Yes Baxter
 *a confidential rebate currently exists

SA1576 Special Authority for Subsidy [Restricted in Part II of Section H]

Initial application — (Treatment naive multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

Both:

Note: Indications marked with * are Unapproved Indications.

Initial application—(Relapsed/refractory multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

All of the following:

Note: Indications marked with * are Unapproved Indications.

Renewal — (Relapsed/refractory multiple myeloma/amyloidosis) only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 8 months for applications meeting the following criteria:

Both:

  1. The patient’s disease obtained at least a partial response from treatment with bortezomib at the completion of cycle 4; and
  2. Maximum of 4 further treatment cycles (making a total maximum of 8 consecutive treatment cycles).

Notes: Responding relapsed/refractory multiple myeloma patients should receive no more than 2 additional cycles of treatment beyond the cycle at which a confirmed complete response was first achieved. A line of therapy is considered to comprise either:

a) a known therapeutic chemotherapy regimen and supportive treatments; or

b) a transplant induction chemotherapy regimen, stem cell transplantation and supportive treatments.

Refer to datasheet for recommended dosage and number of doses of bortezomib per treatment cycle.

    2. Reasons for running the RFP

    2.1 Contractual restrictions on delisting and subsidy reduction for the Velcade brand of bortezomib ended on 1 December 2013.
    2.2 PHARMAC is aware of other brands of bortezomib which are currently in the process of seeking regulatory approval, meaning that competition in this market is now imminent.
    2.3 PHARMAC had included bortezomib inj 1 mg and inj 3.5 mg in its 2014/15 Invitation to Tender issued 6 November 2014. The tender for the inj 1 mg presentation was declined in February 2015 and the outstanding tender for bortezomib inj 3.5 mg was declined in February 2016 due to the length of time that had passed since the tender had been issued

    3. Expected outcome of the RFP

    3.1 As a result of this RFP, we expect to secure future supply of bortezomib in the community and DHB hospitals at competitive prices.

    4. Relevant advisory committee 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 to this product.

    The Subcommittee considered that in the event of a brand switch to a generic product being implemented in this market it would be important to provide prescribers with pharmacokinetic/pharmacodynamic data for the generic product to provide reassurance of its bioequivalence with Velcade.

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

      Subject to the above, PHARMAC is open to considering any other types of proposals you may wish to put forward.

      Access by PHARMAC to price and volume data

      1. In submitting a proposal you acknowledge that PHARMAC and its agents may require access to price and volume data held by you and DHB Hospitals in respect of the Pharmaceutical and will assist with providing this information to assist PHARMAC to carry out its statutory function in relation to managing the purchasing of hospital pharmaceuticals on behalf of DHBs should PHARMAC enter into an agreement with you.

      Consents not yet held

      1. Consents means all consents, permits, licences and authorisations, whether statutory or otherwise, required for the supply of your brand of bortezomib in New Zealand (including Ministry of Health market approval);
      2. PHARMAC would consider proposals for a brand of bortezomib that is yet to obtain all necessary Consents. In those circumstances, you may be required to demonstrate your ability to obtain those Consents within a time frame acceptable to PHARMAC.

      Stability data

      1. Any supplier proposing HSS for its product would be expected to provide stability data for its product. PHARMAC has a preference for products where stability data is greater than 24 hours post compounding. PHARMAC requests product stability data is submitted with proposals or, if the data is unavailable at the time of submission, within 10 business days of any request from PHARMAC.

      Training, education and support

      1. Any supplier awarded HSS would be expected to provide initial associated services including training, education and product support where applicable.

      Schedule 2:  RFP process

      PHARMAC expects to follow the process set out below in the sequence indicated.

      Submission

      1. You may submit more than one proposal. Each proposal will be considered as a separate proposal.
      2. All proposals must be submitted to PHARMAC via the Government Electronic Tenders Service (GETS) no later than 5.00 p.m. (New Zealand time) on 13 April 2016. Late proposals will only be considered at PHARMAC’s discretion, taking into account the need for fairness to other suppliers and integrity of the RFP process.
      3. You cannot withdraw your proposal, once submitted, while the RFP process is continuing.
      4. If you have any enquiries about this RFP you should contact Chloë Dimock (procurement@pharmac.govt.nz) or submit questions through GETS (www.gets.govt.nz(external link)).

      Evaluation

      PHARMAC may request further information

      Negotiation

      1. PHARMAC may negotiate with the submitter(s) of one or more preferred proposals, in the latter case whether or not the acceptance of either supplier’s proposal would exclude acceptance of the other proposal.
      2. Negotiations will proceed on the basis that PHARMAC’s standard terms and conditions for supply of pharmaceuticals, which will be made available on GETS and on our website, will apply.
      3. Given that PHARMAC expects your proposal to be the best you can offer, PHARMAC does not intend to initiate negotiation with you on price. However, PHARMAC does not exclude the possibility that the final price agreed will be different from the price put forward in your proposal, as a result of the impact that other negotiated terms may have on price.
      4. PHARMAC may negotiate and enter into a provisional agreement with a preferred supplier(s) on whatever special terms, in addition to PHARMAC’s standard terms and conditions, PHARMAC considers appropriate.
      5. If PHARMAC and the supplier(s) are unable to reach a provisional agreement within what PHARMAC considers to be a reasonable time, PHARMAC may terminate those negotiations and negotiate with a different supplier(s).

      Consultation and approval

      Miscellaneous

      PHARMAC may consult with you before deciding whether to disclose Confidential Information for the purposes described in sub-clauses (i) to (iv) above. You acknowledge, however, that it is for PHARMAC to decide, in its absolute discretion, whether it is necessary or appropriate to disclose information for any of the above purposes, provided that PHARMAC shall act in good faith in disclosing any Confidential Information.

      Anticipated timetable

      Schedule 3:  Current listing and market information

      The following information relates to the estimated subsidised market size of bortezomib. The information is approximate and indicative only. PHARMAC makes no representation as to the accuracy of this information or as to the level of sales or likely sales of bortezomib and, while PHARMAC has taken all reasonable care in preparing the information set out below, it accepts no liability for any errors or omissions in the information. PHARMAC is not obliged to notify you in the event of any change to the figures below.

      Table One - Amount claimed per milligram for currently listed bortezomib presentations

      2013

      2014

      2015

      Bortezomib

      Inj 1 mg

      41

      59

      9

      Bortezomib

      Inj 3.5 mg

      9,595

      8,109

      5,657

      Bortezomib

      Inj 1 mg for ECP

      15,136

      16,289

      16,609

      Schedule 4: Proposal form

      If you wish to submit a proposal, you must submit it to PHARMAC via the Government Electronic Tenders Services (GETS) no later than 5.00 p.m. on 13 April 2016.

      If you have any questions about this RFP, please post these on the Government Electronic Tenders Service (www.gets.govt.nz(external link)) or alternatively contact Chloë Dimock at PHARMAC by email procurement@pharmac.govt.nz.