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27 November 2007

Dear Supplier REQUEST FOR PROPOSALS – SUPPLY OF RECOMBINANT FACTOR VIII PHARMAC invites proposals for the supply of Recombinant Factor VIII in New Zealand (to DHB Hospitals). 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 funded market for the pharmaceutical; and Schedule 4 contains the RFP form in which you are to provide details of your proposal.

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·

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If you wish to submit a proposal, you must submit it to PHARMAC no later than 5.00 p.m. on Thursday, 31 January 2008. If you have any questions about this RFP, please contact Matthew Perkins (Email: matthew.perkins@pharmac.govt.nz; Ph: +64 4 9167 507) at PHARMAC. We look forward to receiving your proposals. Yours sincerely

Matthew Brougham Acting Chief Executive

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Schedule 1: Pharmaceutical, background to RFP and types of proposals sought 1. Pharmaceutical PHARMAC is interested in considering any proposal from suppliers of Recombinant Factor VIII. 2. Background to RFP The background to this RFP is as follows: · PHARMAC first contracted for the national supply of Recombinant Factor VIII in 2005 – prior to this DHBs contracted for their own purchases. National contracts are currently in place with three suppliers of Recombinant Factor VIII – the per unit list prices in Section H of the Pharmaceutical Schedule are as follows: Brand Kogenate FS ReFacto Recombinate Price per IU $0.80 $0.86 $0.98

·

Note that some prices may be subject to additional discounts beyond the prices itemised above. · Kogenate FS was awarded Preferred Supply Status with the following criteria:

(a) Subject to paragraphs (b) and (c) below: (i) (ii) (iii) (iv) (v) patients receiving Kogenate FS prior to 1 July 2005; patients commencing treatment with Recombinant Factor VIII after receiving plasma derived Factor VIII; new patients commencing treatment with Recombinant Factor VIII; patients undergoing tolerisation with Recombinant Factor VIII; or patients requiring prophylaxis for surgical procedures or in emergency situations and being treated with Recombinant Factor VIII;

are required to use Kogenate FS from 1 July 2005. (b) (c) Patients receiving, prior to 1 July 2005, an alternate brand of Recombinant Factor VIII may continue to receive that brand if they continue to tolerate it. Patients whose clinician, for clinical reasons, recommends that the patient receive an alternate brand of Recombinant Factor VIII listed in the Pharmaceutical Schedule may receive that brand.

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PHARMAC is looking to again secure the supply of Recombinant Factor VIII for a period of 2-3 years to ensure those in the haemophilia community are able to access appropriate, timely treatment.

3.

Types of proposals sought PHARMAC is willing to consider the following types of proposals:

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·

proposals for dual supply (in that you would be one of two contracted suppliers of recombinant Factor VIII to DHBs) for a period of up to three years, provided that you also submit a proposal to be one of three contracted suppliers; proposals for Preferred Supply Status (under the criteria listed above or with proposed amendments) for a period of up to three years; proposals containing rebates, discounts on invoice, foreign exchange pricing or other risk-sharing mechanisms; proposals combining the supply of Recombinant Factor VIII and other recombinant blood products (suppliers offering to combine the supply of Recombinant Factor VIII with other recombinant products must also submit a proposal for the supply of Recombinant Factor VIII alone); and proposals including clinical education and support to DHB staff and patients.

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PHARMAC is not willing to consider the following types of proposals: · proposals for the sole supply of Recombinant Factor VIII (i.e. “Hospital Supply Status”); and proposals including non-recombinant related products.

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

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Schedule 2: RFP process PHARMAC expects to follow the process set out below in the sequence indicated. 1. Submission (a) You may submit more than one proposal. Each proposal will be considered as a separate proposal. Proposals must be submitted no later than 5.00 p.m. (New Zealand time) on Thursday, 31 January 2008. Late proposals will only be considered at PHARMAC’s discretion. You cannot withdraw your proposal, once submitted, while the RFP process is continuing. All proposals must be submitted to PHARMAC at Level 14 Cigna House 40 Mercer St PO Box 10-254 Wellington 6143 New Zealand to the attention of Matthew Perkins, either by hand delivery, by courier or by post (and not by facsimile or email). 2. Evaluation (a) Following the deadline for submitting proposals an Evaluation Committee comprising PHARMAC staff will evaluate each proposal to select its preferred proposal(s). The basis on which the Evaluation Committee will evaluate proposals, and the weight to be given to the criteria and other matters that it considers, are to be determined by the Evaluation Committee at its sole discretion. The matters to be taken into account by the Evaluation Committee will, however, include: (i) the decision criteria set out in PHARMAC’s then current Operating Policies and Procedures (OPPs), as published on PHARMAC’s website (www.pharmac.govt.nz), to the extent applicable; any clinical advice from PTAC or its relevant sub-committee; any clinical or commercial advice from New Zealand Blood Service, DHB personnel and the Ministry of Health; any other matters that the Evaluation Committee considers to be relevant (provided that PHARMAC will notify such matters and allow an opportunity for submitters of proposals to address them).

(b)

(c)

(d)

(b)

(ii) (iii)

(iv)

(c)

Each proposal will be evaluated on the basis that the price offered, the expenditure entailed, and any other terms included in the proposal, are the best that the supplier is able to offer. If you do not put forward your best terms you risk having your proposal excluded at the evaluation stage.

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(d) 3.

PHARMAC is not bound to select the lowest priced proposal or any proposal.

Negotiation (a) 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. Negotiations will proceed on the basis that PHARMAC’s standard terms and conditions for supply of pharmaceuticals, which are available on request from PHARMAC, will apply. 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. 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. 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).

(b)

(c)

(d)

(e)

4.

Consultation and approval (a) Any provisional agreement will be conditional on consultation with suppliers and other interested parties, to the extent PHARMAC considers consultation to be necessary or appropriate, and on Board approval (or approval by PHARMAC's Chief Executive under delegated authority). PHARMAC will not consider any counter-offers received during consultation. The provisional agreement and responses to consultation will be considered by PHARMAC's Board (or by PHARMAC’s Chief Executive under delegated authority) in accordance with the decision criteria in PHARMAC’s then current OPPs. If the Board or the Chief Executive does not approve the provisional agreement, then PHARMAC may initiate negotiations for a provisional agreement with any other supplier(s). The RFP process will be complete once PHARMAC has notified suppliers of either: (i) the Board's or its Chief Executive's decision to accept a negotiated agreement; or the termination of the RFP process.

(b) (c)

(d)

(e)

(ii) 5.

Miscellaneous (a) PHARMAC reserves the right:

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(i)

to make such adjustments to the above RFP process as it considers appropriate, at any time during the process, provided that it notifies suppliers affected by those changes; not to accept any proposal; to seek clarification of any proposal; to meet with any supplier in relation to its proposal; to enter into an agreement or arrangement that differs in material respects from that envisaged in this RFP letter; to suspend this RFP process. For example, if during the RFP process (and before a provisional agreement is entered into) it becomes apparent to PHARMAC that further consultation is appropriate or required we may suspend the RFP process in order to consult. In this situation we may ask you to adapt and resubmit your proposal in light of consultation, or alternatively we may request that new proposals be submitted; to terminate this RFP process at any time, by notifying suppliers who submitted proposals, and, following termination, to negotiate with any supplier(s) on whatever terms PHARMAC thinks fit; to readvertise for proposals.

(ii) (iii) (iv) (v)

(vi)

(vii)

(viii) (b)

PHARMAC may consult or seek clinical advice from PTAC or its relevant subcommittee at any stage of the RFP process. PHARMAC will notify you if the clinical advice results in any changes to the terms of the RFP. You must not initiate or engage in any communication with other suppliers in relation to the RFP, whether before or after submitting their proposal(s), until such time as a provisional agreement is accepted by PHARMAC’s Board or Chief Executive. You must not at any time initiate any communication with PHARMAC’s directors or officers, the Ministry of Health, the Minister of Health or District Health Boards, with a view to influencing the outcome of this RFP process. You must pay your own costs for preparing and submitting your proposal. Proposals are submitted in reliance on your own knowledge, skill, and independent advice, and not in reliance on any representations made by PHARMAC. Your submission of a proposal will be taken as acceptance of the terms contained in this RFP letter. PHARMAC may exclude your proposal if you do not comply with any of the terms contained in this RFP letter. This is an RFP and not a tender. Your proposal is not an offer capable of being converted into a contract for the supply of Recombinant Factor VIII by PHARMAC's apparent acceptance and instead a separate agreement needs to be negotiated. PHARMAC is not liable in any way whatsoever for any direct or indirect loss (including loss of profit), damage or cost of any kind incurred by you or any other person in relation to this RFP.

(c)

(d)

(e) (f)

(g)

(h)

(i)

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(j)

PHARMAC will consider your proposal and information exchanged between us in any negotiations relating to your proposal, excluding information already in the public domain, to be confidential to us and our employees, legal advisors and other consultants, the Ministry of Health and DHBs (Confidential Information). However, you acknowledge that it may be necessary or appropriate for PHARMAC to release Confidential Information: (i) (ii) pursuant to the Official Information Act 1982; or in the course of consultation on a provisional agreement entered into with a supplier; or in publicly notifying any approval by the PHARMAC Board of that agreement; or otherwise pursuant to PHARMAC’s public law or any other legal obligations.

(iii)

(iv)

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. 6. Anticipated timetable (a) Following receipt of proposals, PHARMAC anticipates: (i) (ii) the Evaluation Committee evaluating proposals in February 2008; negotiating with submitter(s) of one or more preferred proposals in FebruaryMarch 2008; consulting on a provisional agreement in March-April 2008; PHARMAC’s Board or Chief Executive considering this provisional agreement in or after April 2008,

(iii) (iv)

provided that the above time frames are only approximate and may be extended, without notice being required from PHARMAC, if any stages of the RFP process take longer than anticipated. (b) Under this indicative timetable and current contractual obligations, the earliest that changes to the Pharmaceutical Schedule could be implemented is July 2008. Please note that if a proposal involving a significant number of patients switching brands is accepted, the date of implementation may be later to allow for an orderly transition to any such arrangements.

(c)

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Schedule 3: Current listing and market information The following information relates to the estimated funded market size of Recombinant Factor VIII. 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 Recombinant Factor VIII 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.

Total IU’s purchased by DHB Hospitals 1,183,750 998,500 1,715,000 748,000 1,411,000 998,250 1,240,750 1,420,250 1,184,500 1,308,500 963,750 1,153,750

Month October 2006 November 2006 December 2006 January 2007 February 2007 March 2007 April 2007 May 2007 June 2007 July 2007 August 2007 September 2007

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Schedule 4: Proposal form

An electronic version of this form is available on PHARMAC’s website at www.pharmac.govt.nz. You should expand the boxes as necessary.

[Supplier to insert date] Chief Executive C/- Matthew Perkins PHARMAC PO Box 10-254 (or for courier delivery: Level 14, Cigna House 40 Mercer Street) Wellington New Zealand Dear Sir/Madam Proposal for the supply of Recombinant Factor VIII In response to your request for proposals (RFP) dated 27 November 2007, we put forward the following proposal in respect of Recombinant Factor VIII. Set out below is further information in support of our proposal. (a) Our contact details: Name of supplier Contact person Address Phone Facsimile Email address

(b)

Details of pharmaceutical presentation: Chemical name Strength (e.g. 500 IU) Form (e.g. vial for reconstitution) Brand name Pack size (e.g. 1 vial) Packaging type

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(c)

Key features of our proposal:

(d)

Information relating to pricing ($NZ, GST exclusive), including any related conditions or proposed terms affecting cost for PHARMAC (e.g. price in return for dual supply, preferred supply status, risk sharing mechanisms, etc.):

(e)

Evidence of market approval and any other required consents: Date of market approval (please attach copy of Medsafe Gazette notice) OR Date of submission of dossier (please attach confirmation from Medsafe that dossier has been submitted) OR Expected date of dossier submission to Medsafe Insert any other consents required for pharmaceutical

(f)

Information about our ability to ensure the continuity of supply of the pharmaceutical:

(g)

Information about our previous supply performance and relevant expertise:

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(h)

Proposals/suggestions (e.g. pricing, risk sharing arrangements, etc) regarding the pharmaceutical not expressly identified in this RFP that we would like PHARMAC to consider as part of our proposal:

(i)

Reasons why PHARMAC should accept our proposal:

(j)

Additional information that PHARMAC should consider when evaluating our proposal:

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