RFP - Supply of erythropoietin

Medicines RFP Closed

PHARMAC invites proposals for the supply of erythropoietin 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 subsidised market for the pharmaceutical; and
  • Schedule 4 contains the RFP form in which you are to provide details of your proposal.

If you wish to submit a proposal, you must submit it to PHARMAC no later than 5.00 p.m. on 1 April 2014.

If you have any questions about this RFP, please contact Sue Anne Yee at PHARMAC by email sueanne.yee@pharmac.govt.nz.

We look forward to receiving your proposal.

Updated market information - 7 March 2014

We have received requests from potential suppliers for more information regarding patient numbers, namely:

  • use of funded erythropoietin alpha and beta by community based patients over the past few years; and
  • those likely to be treated with erythropoietin if access to funding were widened to include myelodysplasia.

Further information is provided, in response to these requests, in an update document below.

Full text of Request for Proposals - Supply of erythropoietin (includes all Schedules) [PDF, 159 KB]

Word version of Schedule 4: Proposal form [DOC, 85 KB]

Full text of Updated market information: Request for Proposals - Supply of erythropoietin - 7 March 2014 [PDF, 138 KB]

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

1.         Pharmaceutical

PHARMAC is interested in considering any proposal from suppliers of erythropoietin.  Proposals should be in relation to the supply of erythropoietin only and should not include any other pharmaceuticals.

2.         Background to RFP

The background to this RFP is as follows:

2.1   Current listing in the Pharmaceutical Schedule

The following erythropoietin products are currently fully subsidised subject to Special Authority restrictions in Section B of the Pharmaceutical Schedule (community listings) and are listed on the Hospital Medicines List (HML; Part II of Section H of the Pharmaceutical Schedule) with restrictions (see the following page for details of restrictions):

Erythropoietin alpha presentation Current list price*
(ex-manufacturer, excluding GST)		 Brand
(Supplier)

Inj 1,000 iu, prefilled syringe, 6 inj pack

$48.68

Eprex
(Janssen-CIlag)

Inj 2,000 iu, prefilled syringe, 6 inj pack

$120.18

Inj 3,000 iu, prefilled syringe, 6 inj pack

$166.87

Inj 4,000 iu, prefilled syringe, 6 inj pack

$193.13

Inj 5,000 iu, prefilled syringe, 6 inj pack

$243.26

Inj 6,000 iu, prefilled syringe, 6 inj pack

$291.92

Inj 10,000 iu, prefilled syringe, 6 inj pack

$395.18

*Prices subject to confidential rebate

Erythropoietin beta presentation Current list price*
(ex-manufacturer, excluding GST)		 Brand
(Supplier)

Inj 2,000 iu, prefilled syringe, 6 inj pack

$120.18

NeoRecormon
(Roche)

Inj 3,000 iu, prefilled syringe, 6 inj pack

$166.87

Inj 4,000 iu, prefilled syringe, 6 inj pack

$193.13

Inj 5,000 iu, prefilled syringe, 6 inj pack

$243.26

Inj 6,000 iu, prefilled syringe, 6 inj pack

$291.29

Inj 10,000 iu, prefilled syringe, 6 inj pack

$395.18

*Prices subject to confidential rebate

2.2   Current Special Authority criteria in Section B of the Pharmaceutical Schedule

The listing of erythropoietin in Section B of the Pharmaceutical Schedule is subject to the following Special Authority criteria:

Initial application only from a relevant specialist. Approvals valid for 2 years for applications meeting the following criteria:

  1. Both:
    1. patient in chronic renal failure; and
    2. Haemoglobin ≤ 100g/L; and
  2. Any of the following:
    1. Both:
      1. patient is not diabetic; and
      2. glomerular filtration rate ≤ 30ml/min; or
    2. Both:
      1. patient is diabetic; and
      2. glomerular filtration rate ≤ 45ml/min; or
    3. patient is on haemodialysis or peritoneal dialysis.

Renewal only from a relevant specialist. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.

Notes: Erythropoietin beta is indicated in the treatment of anaemia associated with chronic renal failure (CRF) where no cause for anaemia other than CRF is detected and there is adequate monitoring of iron stores and iron replacement therapy.

The Cockroft-Gault Formula may be used to estimate glomerular filtration rate (GFR) in persons 18 years and over:

GFR (ml/min) (male) = (140 - age) x Ideal Body Weight (kg) / 814 x serum creatinine (mmol/l)

GFR (ml/min) (female) = Estimated GFR (male) x 0.85

2.3    Current HML restrictions in Part II of Section H of the Pharmaceutical Schedule

The listing of erythropoietin in Part II of Section H of the Pharmaceutical Schedule subject to the following restrictions:

  1. Both:
    1. patient in chronic renal failure; and
    2. Haemoglobin ≤ 100g/L; and
  2. Any of the following:
    1. Both:
      1. patient is not diabetic; and
      2. glomerular filtration rate ≤ 30ml/min; or
    2. Both:
      1. patient is diabetic; and
      2. glomerular filtration rate ≤ 45ml/min; or
    3. patient is on haemodialysis or peritoneal dialysis.

2.4    PTAC recommendation to fund an erythropoietin for the treatment of anaemia associated with myelodysplasia.

Following review of a funding application for erythropoietin in myelodysplasia at its meetings in August 2012, November 2012 and February 2013, PTAC recommended that erythropoietin be funded for anaemia associated with myelodysplasia with a low priority. PTAC recommended that it be funded subject to the following Special Authority criteria: 

Initial application only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 2 months for applications meeting the following criteria:

  1. Patient has a confirmed diagnosis of myelodysplasia (MDS); and
  2. Has had symptomatic anaemia with haemoglobin <100g/L and is red cell transfusion-dependent*; and
  3. Patient has very low or low risk MDS based on the WHO classification based prognostic scoring system for myelodysplastic syndrome (WPSS) ; and
  4. Other causes of anaemia such as B12 and folate deficiency have been excluded; and
  5. Patient has a serum erythropoietin level of <500 IU/mL; and
  6. The minimum necessary dose of erythropoietin would be used and will not exceed 80,000 iu per week.

Renewal application only from a relevant specialist or medical practitioner on the recommendation of a relevant specialist. Approvals valid for 12 months for applications meeting the following criteria:

  1. The patient’s transfusion requirement continues to be reduced with erythropoietin treatment; and
  2. Transformation to acute myeloid leukaemia has not occurred; and
  3. The minimum necessary dose of erythropoietin would be used and will not exceed 80,000 iu per week.

*Transfusion dependence is defined as a transfusion requirement of at least 4 units of red cells per month over a period of 4 months.

Further details of PTAC’s recommendations can be found on the website.

We note that myelodysplasia is not a registered indication for the currently listed erythropoietin products.

2.5    PHARMAC now seeks proposals for the supply of erythropoietin in DHB hospitals and in the community.

3.       Types of proposals sought

3.1      PHARMAC is willing to consider the following types of proposals:

  1. Proposals for sole subsidised supply of a brand of erythropoietin in the community and DHB hospitals for a period up to, but no more than 3 years with the following conditions:
    1. If sole subsidised supply is awarded, there would be a transition period (with the length to be determined at PHARMAC’s discretion) where the successful supplier’s brand of erythropoietin would be available for sale or supply and subsidised or purchased but would not be the sole subsidised brand of erythropoietin, or brand of erythropoietin with hospital supply status; and
    2. If sole subsidised supply is awarded, PHARMAC expects to reserve the right to list an alternative brand of erythropoietin on the Pharmaceutical Schedule for up to 5% of the erythropoietin market, for patients that require treatment with a specific type of erythropoietin.
  2. Proposals involving, expenditure caps, rebates, or other expenditure risk sharing mechanisms (PHARMAC notes a DHB preference for effective prices being the list prices; however risk-sharing mechanisms will be considered);
  3. Proposals for current access and restrictions in Section B and Part II of Section H of the Pharmaceutical Schedule, respectively;
  4. Proposals that include widening of access to erythropoietin in Section B and Part II of Section H of the Pharmaceutical Schedule, for example widening access to patients with anaemia associated with myelodysplasia;
  5. Proposals that involve the listing of a different range of presentations to those currently subsidised must include, at a minimum, the same or a similar range of strengths as the currently funded strengths.

Please note: If you wish to submit a proposal for widened access as described in 3.1 (d) above, you must also submit a separate proposal for current access and restrictions as described in 3.1 (c) above.

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

  1. two part pricing arrangements, whereby PHARMAC may make an up-front payment (in addition to any on-going subsidy) in return for the listing of erythropoietin on specific terms; and
  2. proposals that include any pharmaceuticals other than erythropoietin.

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

Schedule 2: RFP process - in the full PDF [PDF, 159 KB]

Schedule 3: Current listing and market information - in the full PDF [PDF, 159 KB]

Schedule 4: Proposal form - in the full PDF [PDF, 159 KB] and separately as a MS Word document [DOC, 85 KB]

Updated market information: Request for Proposals - Supply of erythropoietin 7 March 2014 [PDF, 138 KB]