RFP - Supply of anti-vascular endothelial growth factor agents

Medicines

RFP Closed

PHARMAC invites proposals for the supply of anti-vascular endothelial growth factor agents in New Zealand.

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 market for the pharmaceutical in DHB hospitals; and
  • Schedule 4 contains the RFP form in which you are to provide details of your proposal.

Anti-vascular endothelial growth factor agents RFP document in .pdf [PDF, 103 KB]

If you wish to submit a proposal, you must submit it to PHARMAC via the Government Electronic Tender Service (GETS) (www.gets.govt.nz(external link)) no later than 4.00 p.m. on Thursday 23 June 2016. If you have any questions about this RFP, please post these on GETS or alternatively contact Jeremy Price at PHARMAC by email procurement@pharmac.govt.nz.

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.

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

PHARMAC is interested in considering proposals from suppliers of anti-vascular endothelial growth factor agents (hereinafter referred to as “anti-VEGF agents”) primarily for the treatment of wet-age related macular degeneration (wAMD).

Background to RFP

The background to this RFP is as follows:

PHARMAC currently lists two anti-VEGF agents for intravitreal use, bevacizumab and ranibizumab in Part II of Section H of the Pharmaceutical Schedule under the following restriction criteria:

Bevacizumab:

Either:

  1. Ocular neovascularisation; or
  2. Exudative ocular angiopathy.

Ranibizumab:

Initiation: Re-assessment required after 3 doses

Continuation

Both:

  1. Documented benefit after three doses must be demonstrated to continue; and
  2. In the case of but previous non-response to bevacizumab, a retrial of bevacizumab is required to confirm non-response before continuing with ranibizumab.

Bevacizumab and ranibizumab were listed in section II of Section H of the Pharmaceutical Schedule from 1 July 2013 as a result of the formation HML (Hospital Medicines List). It should be noted that no anti-VEGF agents are listed in Section B (community use) of the Pharmaceutical Schedule.

The Ophthalmology Subcommittee of PTAC reviewed aflibercept at its October 2014 meeting.  Here are the relevant minutes. [PDF, 135 KB] The Subcommittee also considered that ranibizumab was the preferred treatment for patients of child bearing potential and those who had recently had a stroke.

PTAC subsequently reviewed aflibercept in February 2015 for the indication of wAMD and recommended PHARMAC run a competitive process for a second line agent in wAMD. Here are the relevant minutes. [PDF, 498 KB]

Types of proposals sought

Suppliers must submit a proposal for anti-VEGF agents used in first line treatment.

Suppliers must submit proposals anti-VEGF agents for use in second treatment.

Suppliers must submit proposals anti-VEGF agents for use in third line treatment.

PHARMAC is willing to consider the following types of proposals for anti-VEGF agents:

Initiation:

Re-assessment required after 3 doses

Both

Continuation

Re-assessment required at 6 months, 12 months and 24 months from initiation of treatment, then 2 yearly thereafter.

Both:

Note suppliers who are not familiar with HSS arrangements should consult Part I of Section H of the Pharmaceutical schedule which can be found here.

For the avoidance of doubt, PHARMAC is willing to consider all different presentation types of anti-VEGF agents, for example, prefilled syringes, vials with filter needles, etc.

Proposals which would require a brand switch must include an option that permits the incumbent second line agent, ranibizumab, to continue to be used for patients who have had a myocardial infarction or stroke within the last three months or if the patient is of child-bearing potential and has not completed a family.

Proposals in respect of product/s where Consents not yet held. PHARMAC would consider proposals where your product/s are yet to obtain all necessary Consents (where Consents means all consents, permits, licences and authorisations, whether statutory or otherwise, required for the supply of the pharmaceutical in New Zealand (including Ministry of Health market approval). In those circumstances, you may be required to demonstrate your ability to obtain those Consents within a time frame acceptable to PHARMAC. For example, you may be required to demonstrate that you have the dossier for your product/s ready to submit to Medsafe within one month of such a request being made by PHARMAC.

PHARMAC is not willing to consider the following types of proposals:

  1. Proposals involving pharmaceuticals or related products not specified in Schedule 1.
  2. Proposals that involve an end date for expenditure caps (other than described for a hard cap in sub-clause (d) iii. above), rebates or other risk-sharing arrangements.
  3. Two-part pricing arrangements, whereby PHARMAC may make an up-front payment (in addition to any ongoing subsidy) in return for the listing of a pharmaceutical on specific terms. 

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

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. Proposals must be submitted to PHARMAC via the Government Electronic Tenders Service (GETS no later than 4.00 p.m. (New Zealand time) on Thursday 9 June 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 submit them on GETS or alternatively contact Jeremy Price, Procurement Manager, by email at procurement@pharmac.govt.nz.

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 market size of bevacizumab and ranibizumab in DHB hospitals.

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 bevacizumab and ranibizumab 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.

Hospital Usage

The table below indicates the approximate use of anti-VEGF agents in DHB hospitals (in mg)

  Units Purchased (mg)
Year (FYR) Bevacizumab (includes all indications) Ranibizumab
2013 72,064 230
2014 94,884 427
2015 105,956 1,629
2016 125,747 3,257
*2016 financial year figures are best estimates from current usage data.

It should be noted that due to inconsistencies in the reporting of hospital data, the figures above may not accurately represent DHB usage. We are unable to separate the purchasing data by indication, however bevacizumab is almost exclusively for ocular indications and some limited use in oncology through NPPA.

Third Line patient numbers

There is some uncertainty around the number of units or patient numbers requiring a third line agent. Specialist advice received by PHARMAC noted that there could be up to 400 patients per year requiring a third line agent for wAMD.