Proposal for sole subsidised supply of progestogen-only long-acting intra-uterine system (LIUS) (Mirena)

Medicines

Consultation Closed

Following a Request for Proposals for the supply of LIUS issued on 11 September 2015, PHARMAC is seeking feedback on a proposal for a sole supply arrangement for the currently funded brand of progestogen-only LIUS (Mirena) through a provisional agreement with Bayer New Zealand Limited.

In summary, if this proposal is approved:

  • Mirena would continue to be listed in the Pharmaceutical Schedule for the currently funded indications, which are:
    • heavy menstrual bleeding in both the community and hospital settings; and
    • only in the hospital setting, for endometriosis confirmed by laparoscopy.
  • Mirena would be the only subsidised progestogen-only LIUS in the community, and Mirena would have Hospital Supply Status with a 1% Discretionary Variance (DV) limit in DHB hospitals, from 1 August 2016 date until 30 June 2019.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5 pm, Monday 11 July 2016 to:

Marcus Kim
Procurement Manager/Team Leader
PHARMAC

Email: marcus.kim@pharmac.govt.nz
Post:     PO Box 10 254, Wellington 6143

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Details of the proposal

  • The Mirena brand of LIUS would continue to be listed in Section B of the Pharmaceutical Schedule from 1 August 2016 at the current price and subsidy (ex-manufacturer and ex-GST) as follows:

Chemical

Presentation

Brand

Pack size

Current and proposed price and subsidy

Levonorgestrel

Levonorgestrel – releasing intrauterine system 20 mcg/24 hr

Mirena

1

$269.50

  • The Mirena brand of LIUS would be listed in Part II of Section H of the Pharmaceutical Schedule from 1 August 2016 at the following price (ex-manufacturer and ex-GST):
Chemical Presentation Brand Pack size Proposed price
Levonorgestrel Intra-uterine system,20 mcg per 24/hr Mirena 1 $269.50
  • A confidential rebate would apply which would reduce the net price of Mirena (used in both the community and hospital setting) to the Funder.
  • Mirena would be awarded Sole Subsidised Supply Status (the only funded brand in the community) and Hospital Supply Status (the only available brand in DHB hospitals, subject to a 1% Discretionary Variance Limit).
  • Mirena would continue to be subsidised in the community for the treatment of heavy menstrual bleeding subject to Special Authority criteria.
  • Mirena would continue to be listed on the Hospital Medicines List (HML) subject to hospital restrictions for the treatment of heavy menstrual bleeding and endometriosis. 

Background information

Product information and current funding

Mirena is a progestogen-only LIUS registered for use up to 5 years following insertion. Mirena is a small T-shaped intrauterine system containing a total amount of 52 mg levonorgestrel which after insertion releases 20 microgram every 24 hours.

Mirena is registered for the indications of contraception, treatment of idiopathic menorrhagia (provided there is no underlying pathology) and for the prevention of endometrial hyperplasia during oestrogen replacement therapy.

The Mirena brand is funded in the community but no specific brand is currently listed on the Hospital Medicines List (Mirena is listed as an example brand).

Competitive process

PHARMAC issued a Request for Proposals (RFP) for the sole subsidised supply of progestogen-only LIUS on 11 September 2015. Following evaluation of bids received in response to the RFP, PHARMAC and Bayer New Zealand Limited have entered into a provisional agreement relating to sole supply of a progestogen-only LIUS for the currently funded indications.

Widening access to contraception

The RFP sought a number of different types of proposals, including proposals for widening of funded access to include the indication of contraception, noting that widened access for contraception would be assessed on cost comparison to other currently funded contraceptives.

The proposal being consulted on does not include widening of funded access to include contraception. Our assessment indicates that this would result in a significant cost.

Other currently funded contraceptives include (note, some may carry a manufacturer’s surcharge):