Proposal to fully-subsidise oestradiol transdermal patches without restriction through the Invitation to Tender

Medicines

Consultation Closed

As part of PHARMAC’s annual tender process, PHARMAC is proposing to widen access to fully-funded oestradiol transdermal patches.

A tender decision has not been made, so the brand name, pricing and timing for these changes is still to be determined; however, PHARMAC is seeking your feedback on the proposed new investment.

In summary, PHARMAC is seeking feedback on a proposal to:

  • Amend the listing for oestradiol transdermal patches in Section B of the Pharmaceutical Schedule, to make them fully-subsidised without restriction.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Wednesday, 25 May 2016 to:

Oestradiol transdermal patches consultation
c/- Andrew Park
PHARMAC
PO Box 10 254
Wellington 6143

Email: andrew.park@pharmac.govt.nz

Fax: 04 460 4995

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

PHARMAC is seeking feedback on a proposal to, following the award of tender bids, amend the listing for oestradiol transdermal patches in Section B of the Pharmaceutical Schedule, to make them fully-subsidised without restriction.

Any brand listed through the award of tender bids would have sole supply status until either 30 June 2018 or 30 June 2019, as applicable.

Background

In PHARMAC’s 2015/16 annual Invitation to Tender, bids were sought for the supply of a number of medicines including oestradiol transdermal patches. As the amendment to the current listing would be through the tender, the brands to be listed, the pricing and subsidy, and the dates of listing are still to be confirmed.

Oestradiol transdermal patches are a form of Hormone Replacement Therapy (HRT) used for the treatment of adverse effects associated with menopause and post-menopause, including signs and symptoms of oestrogen deficiency and prevention of postmenopausal osteoporosis.

Oestradiol transdermal patches provide an alternate delivery mechanism that avoids the first-pass metabolism that occurs following oral administration, providing an additional benefit in patients with certain cardiovascular diseases, obese patients, and adolescents who require pubertal induction. Transdermal patches may also provide an adherence advantage over tablets which are taken each day.

Oestradiol transdermal patches have been listed partly-subsidied in the Hormone Preparations therapeutic group of Section B of the Pharmaceutical Schedule since 1996, with an additional subsidy via Special Authority. The additional subsidy (which results in fully-funded patches) is currently available for patients meeting the following Special Authority criteria:

Hormone Replacement Therapy - Systemic

Initial application- from any relevant practitioner. Approvals valid for 5 years for applications meeting the following criteria:

Any of the following:

  1. acute or significant liver disease - where oral oestrogens are contraindicated as determined by a gastroenterologist or general physician. The applicant must keep written confirmation from such a specialist with the patient's record diagnosed by skin prick testing; or
  2. oestrogen induced hypertension requiring antihypertensive therapy - documented evidence must be kept on file that raised blood pressure levels or inability to control blood pressure adequately occurred post oral oestrogens; or
  3. hypertriglyceridaemia - documented evidence must be kept on file that triglyceride levels increased to at least 2 × normal triglyceride levels post oral oestrogens; or
  4. somatropin co-therapy - patient is being prescribed somatropin with subsidy provided under a valid approval issued under Special Authority.

Note: Prescriptions with a valid Special Authority (CHEM) number will be reimbursed at the level of the lowest priced TDDS product within the specified dose group.

In June 2014, the Endocrinology Subcommittee of PTAC recommended that an oestradiol patch be fully subsidised in the Pharmaceutical Schedule without restriction.