Supply of gonadotropin-releasing hormone analogues - extension to deadline

Medicines

RFP Closed

PHARMAC invites proposals for the supply of gonadotropin-releasing hormone analogues 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 approximate market size  of the pharmaceutical in the community and in DHB hospitals; and
  • Schedule 4 contains the RFP form in which you are to provide details of your proposal.
Gonadotropin-releasing hormone analogues RFP document in .pdf [PDF, 162 KB]

If you wish to submit a proposal, you must submit it to PHARMAC via the Government Electronic Tender Service (GETS) no later than 5 pm, Thursday 21 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 proposals from suppliers of gonadotropin-releasing hormone analogues (hereinafter referred to as “GnRH analogues”). For the purposes of this RFP “GnRH analogues” refers to the chemicals goserelin (goserelin acetate) and leuprorelin (leuprorelin acetate).

Background to RFP

The background to this RFP is as follows:

1.  Two GnRH analogues (goserelin and leuprorelin) are currently listed and fully subsidised by PHARMAC without any restrictions.   There are two presentations of goserelin and seven presentations of leuprorelin currently listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

    Subsidy/Price Per Fully Subsidised Brand or Generic Manufacturer
GOSERELIN          
Inj 3.6 mg, depot implant ……………… 166.20 1 Yes Zoladex
Inj 10.8 mg, depot implant ……………… 443.76 1 Yes Zoladex
LEUPRORELIN          
Inj 3.75 mg prefilled syringe ……………… 221.60* 1 Yes Lucrin Depot PDS
Inj 7.5 mg ……………… 166.20 1 Yes Eligard
Inj 11.25 mg prefilled syringe ……………… 591.68* 1 Yes Lucrin Depot PDS
Inj 22.5 mg ……………… 443.76 1 Yes Eligard
Inj 30 mg ……………… 591.68 1 Yes Eligard
Inj 30 mg prefilled syringe ……………… 1,109.40* 1 Yes Lucrin Depot PDS
Inj 45 mg ……………… 832.05 1 Yes Eligard
*A rebate exists

2.  The currently funded GnRH analogues represent significant expenditure to the Combined Pharmaceutical Budget (CPB). For the 2015 calendar year, the approximate expenditure on leuprorelin and goserelin was as follows:

Chemical Approximate net expenditure for community market Approximate net expenditure for DHB hospital market*
Leuprorelin $5.3 million* $90,000*
Goserelin $4.2 million $150,000
Total $9.5 million* $230,000*
*a rebate exists for three presentations of leuprorelin [PDF, 66 KB]

3.  PHARMAC previously received advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) that goserelin and leuprorelin were in the same therapeutic sub-group, and had the same or similar therapeutic effect. As such reference pricing has been applied to this subgroup. The currently listed GnRH analogue presentations have the same net price for all listed brands with the same dose formulations, i.e. monthly, 3 monthly and 6 monthly  (previous notifications relating to goserelin [PDF, 130 KB] and leuprorelin [PDF, 66 KB] pricing can be found on our website).

4.  In September 2015, PHARMAC received advice from the Cancer Treatments Subcommittee (CatSoP) of PTAC. The Subcommittee considered that it would be clinically reasonable to reference price goserelin to leuprorelin (or vice versa), or to run a competitive process that would result in only one of goserelin or leuprorelin being funded. The relevant minutes can be found on the PHARMAC website: CaTSoP minute [PDF, 83 KB].

5.  PHARMAC recently received advice from the Endocrinology Subcommittee of PTAC that on the basis that leuprorelin and goserelin can be expected to provide the same or similar therapeutic effect in the endocrinology indications, it would be clinically reasonable to apply reference pricing of leuprorelin to goserelin (or vice versa), or to run a competitive process that would result in only one of leuprorelin or goserelin being funded. The relevant minutes can be found on the PHARMAC website: Endocrinology Subcommittee minute [PDF, 1.2 MB].

6.  PHARMAC is now seeking proposals for the funding of a single GnRH analogue with an opportunity to reduce the expenditure on GnRH analogues and improve health outcomes for New Zealanders. PHARMAC may also consider the possibility of the continued funding of two GnRH analogues (both goserelin and leuprorelin), depending on pricing and types of proposals received. 

7.  PHARMAC would follow its usual processes, including consulting with interested parties where appropriate, prior to a decision to make any change in this market as a result of this RFP.

Types of proposals sought

1. PHARMAC is willing to consider the following types of proposals:

1.1  proposals that involve a period of sole subsidised supply in the community and hospital supply status with a discretionary variance (DV) limit of 1% in DHB hospitals (hereinafter referred to as “Sole Supply”) for a period of up to, but no more than, 3 years provided that the Sole Supply period does not extend beyond 30 June 2019;

Note: Suppliers who are not familiar with hospital supply status arrangements (including DV limits) should consult Part I of Section H of the Pharmaceutical Schedule.

Specifically, PHARMAC will consider:

1.2  proposals for Sole Supply at the chemical level where both goserelin and leuprorelin would remain listed in the Pharmaceutical Schedule. Proposals could include a range of dose formulations (monthly and 3-monthly and could include 6 monthly administered presentations, but not 4 monthly or 12 monthly administered presentations) of goserelin or leuprorelin. For example:

  Subsidy/Price Per Fully Subsidised Brand or Generic Manufacturer
GOSERELIN          
Inj XX mg, monthly implant ………………… $XX.XX 1 Yes BrandX
Inj XX mg, 3 monthly implant ………………… $XX.XX 1 Yes BrandX
LEUPRORELIN          
Inj XX mg, monthly injection ………………… $XX.XX 1 Yes BrandY
Inj XX mg, 3 monthly injection ………………… $XX.XX 1 Yes BrandY
Inj XX mg, 6 monthly injection ………………… $XX.XX 1 Yes BrandY

1.3  proposals for Sole Supply at the therapeutic sub-group level (i.e. sole supply of a GnRH analogue) where either goserelin or leuprorelin would be listed (but not both). Proposals could include a range of dose formulations (monthly and 3-monthly and could include 6 monthly administered presentations, but not 4 monthly or 12 monthly administered presentations) of goserelin or leuprorelin. For the avoidance of doubt if a proposal for goserelin monthly and 3 monthly was selected the 6 monthly leuprorelin presentation could not be listed under this scenario. For example:

 

  Subsidy/Price Per Fully Subsidised Brand or Generic Manufacturer
GOSERELIN          
Inj XX mg, monthly implant ………………… $XX.XX 1 Yes BrandX
Inj XX mg, 3 monthly implant ………………… $XX.XX 1 Yes BrandX

Note: under this scenario the alternative chemical would be listed in Part II of Section H of the Pharmaceutical Schedule as a DV Pharmaceutical. Using the above example, leuprorelin presentations would remain listed in Part II of Section H as DV Pharmaceuticals.

1.4  Suppliers that wish to submit proposals for Sole Supply at the chemical level and/or at the GnRH therapeutic sub-group level as outlined in clause 3 (a)(iii) or 3 (a)(iv) above must also submit separate proposals for the individual dose formulations that are able to be accepted individually.  For example if a proposal is submitted for both a monthly and 3 monthly formulation of a chemical, a supplier needs to also submit individual proposals for both formulations able to be accepted independently of one another.

1.5  proposals that include a period of subsidy protection in the community and price protection in DHB hospitals and/or protection from delisting for a period of up to, but no more than, 3 years provided that the protection period does not extend beyond 30 June 2019;

1.6  proposals that include expenditure caps, rebates or other risk-sharing arrangements;

1.7  for the avoidance of doubt, PHARMAC is willing to consider all different presentation types of goserelin and leuprorelin, for example, prefilled syringes, depot injections and depot implants. However, there may be a preference for some patient populations (specifically children) for non-implant presentations. Suppliers with implant presentations may wish to consider an allowance for a non-implantable presentation to be accessed for children.

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

1.1  proposals that include products other than goserelin or leuprorelin.;

1.2  proposals that involve listing goserelin or leuprorelin with a partial subsidy;

1.3  proposals that involve an end date for expenditure caps, rebates or other risk-sharing arrangements; and

1.4  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.

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

Consents not yet held

  1. Consents means all consents, permits, licences and authorisations, whether statutory or otherwise, required for the supply of the Tender Item in New Zealand (including Ministry of Health market approval);
  2. PHARMAC would consider proposals where your product/s are 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. 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.

Training, education and support

  1. Any supplier awarded Sole Supply would be expected to provide initial and ongoing health professional education, training and product support services throughout the term of the contract. Suppliers would be expected to provide support to aid any transition from another brand or chemical that would occur as a result of acceptance of its proposal.

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 5.00 p.m. (New Zealand time) on 7 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 submit them on GETS or alternatively contact Chloë Dimock, 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 

Anticipated timetable 

Schedule 3:  Current listing and market information

The following information relates to the approximate subsidised market size of goserelin and leuprorelin in both the community and 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 goserelin and leuprorelin 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.

In addition, PHARMAC notes that market dynamics, and therefore the volumes reflected below, may be subject to change with the absence or inclusion of other GnRH analogue presentations that may be listed in the Pharmaceutical Schedule. 

Community usage

Table One below indicates the approximate numbers of units (injections or implants) of the GnRH analogue presentations subsidised by PHARMAC, and claimed for by community pharmacies for the calendar years 2013, 2014 and 2015.

Table One: community usage of GnRH analogue presentation

Dose formulation

Chemical

Brand

Presentation

List Price

Units

2013

2014

2015

1 monthly

Goserelin

Zoladex

Inj 3.6 mg, syringe, depot implant

$166.20

3,100

3,200

4,000

Leuprorelin 

Eligard

Inj 7.5 mg, prefilled syringes

$166.20

40

30

50

Leuprorelin 

Lucrin Depot 1- Month Injection

Inj 3.75 mg, dual chamber syringe

221.60*

1,400

1,700

1,400

Leuprorelin 

Lucrin Depot 1- Month Suspension

Inj 3.75 mg, vial

Not currently listed

100

10

0

3 monthly

Goserelin

Zoladex

Inj 10.8 mg, syringe, depot implant

$443.76

7,900

7,700

7,900

Leuprorelin 

Eligard

Inj 22.5 mg , prefilled syringes

$443.76

250

300

400

Leuprorelin

Lucrin Depot 3- Month Injection

Inj 11.25 mg, dual chamber syringe

$591.68*

4,100

5,100

5,600

Leuprorelin

Lucrin Depot 3- Month Suspension

Inj 11.25 mg, vial

Not currently listed

560

370

0

4 monthly

Leuprorelin 

Eligard

Inj 30 mg, prefilled syringes

$591.68

<5

<5

<5

6 monthly

Leuprorelin 

Eligard

Inj 45 mg, prefilled syringes

$832.05

1,100

1,100

1,200

Leuprorelin

Lucrin Depot 6- Month Injection

Inj 30 mg, dual chamber syringe

$1,109.40*

1,400

1,500

1,700

*A rebate exists 

Hospital Usage

Table Two below indicates the approximate use GnRH analogues in DHB hospital as a percentage of the community dose formulation market for goserelin and leuprorelin:

Table Two Hospital Usage Data as a percentage of Community Usage (in number of injections) 

Dose formulations

Chemical

Community market

Hospital Market Usage( % of community market use)

2013

2014

2015

2013

2014

2015

1 month

Goserelin

3,100

3,200

4,000

4%

4%

4%

Leuprorelin

1,500

1,700

1,400

11%

14%

7%

3 month

Goserelin

7,900

7,700

7,900

4%

4%

3%

Leuprorelin

4,900

5,500

6,000

1%

2%

2%

6 month

Leuprorelin

2,500

2,600

2,900

1%

1%

1%

Patient Demographic Usage

Table Three below indicates the approximate numbers of units (injections or implants) of goserelin and leuprorelin dose formulations subsidised by PHARMAC, and claimed for by community pharmacies for the years 2013, 2014 and 2015 for patients under 20 years old. 

Table Three:  approximate number of injections used by patients under 20 years old 

Dose formulation

Chemical

Number of injections used in patients 12 and under and patients between 12 -19
by calendar year

2013

2014

2015

00 to 12

13 to 19

00 to 12

13 to 19

00 to 12

13 to 19

1 month

Goserelin

10

130

15

70

<5

70

Leuprorelin

510

115

600

165

410

115

3 month

Goserelin

<5

10

10

15

<5

15

Leuprorelin

310

165

395

240

550

400

6 month

Leuprorelin

-

-

<5

<5

<5

<5

Schedule 4: Proposal form

Proposal form (Word document) [DOCX, 24 KB]