This is the text extract for Request for Proposals - Supply of insulin pumps and consumables, browse documents here.

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8 August 2012

Dear Supplier REQUEST FOR PROPOSALS – SUPPLY OF INSULIN PUMP AND CONSUMABLES PHARMAC invites proposals for the supply of insulin pumps and consumables in New Zealand. This request for proposals (RFP) letter incorporates the following schedules:  Schedule 1 specifies the products 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 products; and Schedule 4 contains the RFP form in which you are to provide details of your proposal.

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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 Friday the 7th of September 2012. If you have any questions about this RFP, please contact Natalie Davis at PHARMAC at natalie.davis@pharmac.govt.nz or 04 916 7562 at PHARMAC. We look forward to receiving your proposal. Yours sincerely

Steffan Crausaz Chief Executive

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Schedule 1: Products, background to RFP and types of proposals sought 1. Pharmaceutical PHARMAC is interested in considering any proposal from suppliers of insulin pumps and consumables. 2. Background to RFP The background to this RFP is as follows: A dual supply proposal to fund Animas 2020 insulin pumps and its associated consumables through an agreement with NZMS was approved in June 2012. This proposal resulted from an RFP released on 26 August 2011 supply of diabetes management products (http://pharmac.govt.nz/2011/08/26). Animas 2020 insulin pumps and consumables will be fully funded from 1 September 2012 and Special Authority criteria will apply (see www.pharmac.govt.nz/diabetes for the notification letter for insulin pumps and consumables for the Special Authority criteria). The following changes to Section B of the Pharmaceutical Schedule will take effect from 1 September 2012:   A new therapeutic subgroup will be added to the Alimentary Tract and Metabolism therapeutic group, ‘Insulin Pumps and Consumables’. The following restriction will apply to the dispensing of insulin pumps: a) Only on a prescription b) Maximum of 1 insulin pump per prescription c) Maximum of 1 insulin pump per patient each four year period  The following restriction applies to the prescribing of insulin pump infusion sets: a) Maximum of 3 packs per prescription, b) Maximum of 1 prescription per 90 days, c) Only on a prescription Note: One additional pack of infusion sets will be funded per year (Maximum of 13 packs per annum)  The following restriction applies to the prescribing of insulin pump reservoir packs: a) Maximum of 3 packs per prescription, b) Maximum of 1 prescription per 90 days. c) Only on a prescription Note: One additional pack of infusion sets will be funded per year (Maximum of 13 packs per annum)  Animas 2020 Battery Cap (battery cap) will be listed subject to the following restrictions: a) Maximum of 1 cap per prescription, b) Maximum of 1 prescription per 180 days c) Only on a prescription

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We now seek another supplier of insulin pumps and consumables for listing in a dual supply arrangement with NZMS, the supplier of Animas 2020 insulin pumps and consumables. 3. 3.1 Types of proposals sought PHARMAC is willing to consider the following types of proposals:  Proposals for Dual Subsidised Supply in the community (provided that the Dual Subsidised Supply period does not extend beyond 1 July 2015) that may involve reference pricing, subsidy and/or delisting protection for a period not extending beyond 1 July 2015, of insulin pumps and consumables. Caps or rebates, (note caps/rebates may be for more than 3 years). Proposals involving caps and rebates must specify price arrangements, and any other terms, applicable at the end of the supply protection period and/or cap period. Note: Any supplier that is awarded Dual Subsidised Supply shall be responsible for ongoing educational and operational support to patients and clinicians and the details of relevant service specifications should be submitted with any proposal for insulin pumps and consumables. 3.2 Proposals must include the following information:  proposals for an insulin pump device must include a proposal for appropriate consumables; the proposed prices of the insulin pump(s) and consumables included in the proposal; information about the supplier’s ability to ensure reliability and continuity of supply of diabetes management products (including replacement/repair policies, battery/device replacement services and customer services where applicable); length of the warranty for insulin pumps; which insulin pumps the consumables are compatible with; information regarding the supplier’s ability to provide clinical and technical support for insulin pumps and consumables (including 0800 line information and clinician and patient training); details of packaging and pack size; the supplier’s rationale as to why PHARMAC should accept their proposal; and any other information in support of your proposal contemplated by Schedule 4.

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PHARMAC is not willing to consider the following types of proposals:   Proposals for insulin pump devices only. Proposals for insulin pump consumables only.

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Proposals including the widening of funded access to other products currently listed on the Pharmaceutical Schedule. Proposals for part-funding of diabetes management products. Proposals which involve cross-deal or bundling arrangements which involve any product or pharmaceutical other than insulin pumps and consumables. 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 or diabetes management product(s) on specific terms.

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3.4

PHARMAC may request samples of any product included in a proposal and such samples must be provided within 10 working days of such a request.

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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 Friday 7 September 2012. Late proposals will only be considered in exceptional circumstances and at PHARMAC’s discretion. You cannot withdraw your proposal, once submitted, while the RFP process is continuing. All proposals must be submitted electronically by email to Natalie Davis at PHARMAC (natalie.davis@pharmac.govt.nz ).

(b)

(c)

(d)

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 the Diabetes Subcommittee; the ability of the supplier to ensure reliability and continuity of supply of diabetes management products including: o o (iv) device replacement and/or repair policies including warrantee customer and clinician support and training services where applicable

(b)

(ii) (iii)

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).

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

(d)

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3.

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)

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(d)

(e)

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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: (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;

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

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.

(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 insulin pumps and consumables 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. PHARMAC will consider your proposal and information exchanged between us in any negotiations relating to your proposal, excluding information already in the

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(c)

(d)

(e) (f)

(g)

(h)

(i)

(j)

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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 September 2012; negotiating with submitter(s) of one or more preferred proposals in October 2012; consulting on a provisional agreement in November 2012; PHARMAC’s Board or Chief Executive considering this provisional agreement in or after November 2012;

(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, the earliest that changes to the Pharmaceutical Schedule could be implemented is 1 December 2012;

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Schedule 3: Market information The following information relates to the estimated subsidised market size of insulin pumps and consumables. 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 insulin pumps and consumables 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. It is estimated that long term, there would be approximately 1,000 patients on funded insulin pumps and consumables. Based on figures provided by DHBs we estimate there are approximately 450 patients using insulin pumps who have already been initiated by DHBs; of these about 270 are presently funded by DHBs. It is expected that most existing DHB funded patients would move to PHARMAC funding within the first year of listing. The capacity for each multidisciplinary team to assess and train patients may limit the rate of new patients beginning insulin pump therapy.

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Schedule 4: Proposal form An electronic version of this form is available from Natalie Davis. You should expand the boxes as necessary. Date: By email: natalie.davis@pharmac .govt.nz

Dear Natalie Proposal for the supply of insulin pumps and consumables In response to your request for proposals (RFP) dated xx August 2012 we put forward the following proposal in respect of insulin pumps and consumables. 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: Product name Form (eg. Insulin pump, infusion set) Materials of construction/size of needle or cannula etc. Brand name Pack size Functions (eg. flow rates, bolus size)

(c)

Key features of our proposal:

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(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 sole supply, reference price protection, risk sharing mechanisms, etc.):

(e)

Evidence of market approval and any other required consents: Date of Notification to WAND database Evidence of any other approval required or otherwise obtained in relation to supply of the pharmaceutical including CE and or FDA approval. Date of market approval (as applicable please attach copy of Medsafe Gazette notice)

(f)

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

(g)

Information about our previous supply performance and relevant expertise:

(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:

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(i)

Reasons why PHARMAC should accept our proposal:

(j)

Additional information that PHARMAC should consider when evaluating our proposal:

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