Decision to award sole supply of progestogen-only long-acting intra-uterine system (LIUS) in the community and DHB hospitals

Medicines

Decision

PHARMAC is pleased to announce the approval of a sole supply agreement with Bayer New Zealand Limited for Mirena, the currently funded brand of progestogen-only long-acting intrauterine system (LIUS).

In summary, the effect of the decision is that:

  • Mirena will continue to be subsidised in the community for the treatment of heavy menstrual bleeding subject to Special Authority criteria.
  • Mirena will be listed on the Hospital Medicines List (HML) subject to hospital restrictions for the treatment of heavy menstrual bleeding and endometriosis.
  • Mirena would be the only subsidised progestogen-only LIUS in the community; and Mirena will have Hospital Supply Status with a 1% Discretionary Variance (DV) limit in DHB hospitals[1], from 1 August 2016 until 30 June 2019.
  • A confidential rebate will apply which reduces the net price of Mirena (used in both the community and hospital setting) to the Funder.
[1] Discretionary variance (DV) limit in DHB hospitals relates to the discretion for DHB hospitals to purchase and use a limited amount of a pharmaceutical that does not have Hospital Supply Status (HSS) but is used or can be used in place of one that does have HSS.  Usually this means it is the same chemical entity, at the same strength, and in the same presentation or form, as the relevant pharmaceutical that has HSS.  Where this is not the case, a note will be included with the listing of the relevant pharmaceutical.

Please note that this decision does not preclude PHARMAC from considering widening access to LIUS for contraception or other indications in the future or during the sole supply period. LIUS for contraception remains under consideration, and updated advice from the Pharmacology and Therapeutics Advisory Committee (PTAC) and/or its Subcommittees will be sought in light of the consultation feedback.

We will also be seeking funding applications from individual submitters who have requested widened access to LIUS for contraception in their consultation response, in particular, widened access for specific patient groups (eg high body mass index (BMI) and those contraindicated to other contraceptives). A funding application with supporting evidence will allow PTAC and/or its Subcommittees to more easily identify any unmet health need and/or additional health benefit to be gained from widening access to LIUS for contraception. 

Details of the decision

  • The Mirena brand of LIUS will 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

Intra-uterine system, 20 mcg per day

Mirena

1

$269.50

  • The Mirena brand of LIUS will 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 will apply which reduces the net price of Mirena (used in both the community and hospital setting).
  • Mirena will 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) from 1 August 2016.
  • Mirena will continue to be subsidised in the community for the treatment of heavy menstrual bleeding subject to Special Authority criteria.
  • Mirena will be listed on the Hospital Medicines List (HML) subject to hospital restrictions for the treatment of heavy menstrual bleeding and endometriosis.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. We received feedback from 11 different submitters. All consultation responses received by 5 pm, 11 July 2016 were considered in their entirety in making a decision on the proposed changes.

Feedback regarding widening access to LIUS for contraception

The majority of consultation feedback did not support the proposal as it did not propose to widen access to LIUS for contraception. Submitters provided a number of reasons why PHARMAC should consider widening access for LIUS for contraception, including:

  • reduction in costs (social and health) associated with unwanted pregnancies;
  • provides greater choice and equitable access to LIUS as another effective long acting contraceptive option;
  • increased suitability of LIUS as a contraceptive for certain patient groups (eg high BMI, contraindicated for other contraceptives) and additional benefits of a LIUS (eg prevention of endometrial hyperplasia);
  • issues with access and the cost of other hospital interventions (eg surgical);
  • popularity of LIUS as a contraceptive in other countries with a high level of continuation; and
  • current access criteria for LIUS for heavy menstrual bleeding considered to be too restrictive.

We consider that providing another option for long acting contraception is desirable. This is why PHARMAC sought proposals for supply of LIUS for both current access and widened access for contraception. It was noted that widened access for contraception would be assessed on cost comparison to other currently funded contraceptives, with the expectation that access would be widened if pricing proposals received were cost-neutral.

The clinical advice we have received to date indicates that the health need for a long acting reversible contraceptive (LARC) is met with the currently funded range of contraceptives including other LARC presentations (eg levonorgestrel subdermal implant and copper IUD) and based on review of the evidence are considered to be as effective as Mirena, in relation to contraception. Further information regarding consideration of LIUS for contraception including links to the relevant clinical advice is available on our website(external link).

As discussed above, this decision does not preclude PHARMAC from considering widening of access to LIUS for contraception or other indications in the future or during the sole supply period. We will be actively seeking updated advice from PTAC and/or its Subcommittees in light of the consultation feedback, and will also seek funding applications from submitters who consider access should be widened to LIUS for contraception and other indications.

Guidance on submitting funding applications to PHARMAC can be found on our website

Other consultation feedback

The following other issues were raised in relation to specific aspects of the proposal:

Theme

Comment

Questioned whether PHARMAC would consider widening access to Mirena for the treatment of endometrial hyperplasia without atypia.

This decision does not preclude PHARMAC considering funding applications for widening of access to Mirena for new indications not considered by PTAC. We welcome funding applications for widened access to LIUS.

Questioned whether PHARMAC is aware of generic competition in this market.

PHARMAC is aware of generic competition in this market which was one of the main reasons for running an open competitive process by issuing a request for proposals.

Supported the proposed sole subsidised brand (Mirena) as the alternative brands may be more difficult to insert.

Noted.

Considers that progressing with sole subsidised supply agreement for Mirena for the next three years will prevent PHARMAC considering the option of funding cheaper generic presentations for three years and/or widening access.

PHARMAC ran an open competitive process for the LIUS market and invited proposals from both the innovator and generic suppliers for current access and widened access (for the indication of contraception). Generic suppliers who have not yet obtained regulatory approval or consents had the opportunity to submit proposals to PHARMAC as part of this competitive process. As noted above, this decision does not preclude PHARMAC from considering widening of access to LIUS in the future or during the sole supply period.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz.