Proposal to fund testosterone gel and to award Principal Supply Status to Testogel
Te Pātaka Whaioranga - Pharmac is seeking feedback on a proposal to fund a testosterone gel product, Testogel.
What we’re proposing
We are seeking feedback on a proposal to fund a testosterone gel product, Testogel, supplied by Pharmaco.
This proposal is a result of a Request for Proposals (RFP) for the supply of non-injectable testosterone. Further details on this proposal can be found below.
We are particularly interested in hearing feedback on the following areas:
- What implementation activities would be required to support the funding of testosterone gel.
- What support would be needed to assist health care professionals when prescribing testosterone gel.
- How we could ensure people using testosterone gel and their whānau are able to access this product, particularly Māori, Pacific peoples, those using testosterone gel as part of gender affirming hormone therapy and other populations experiencing health disparities.
- What information pharmacists would require to support the dispensing and patient counselling of this product (eg its side effect profile, misuse information, and correct storage conditions).
We welcome your feedback on this proposal.
Consultation closes at 5pm Wednesday 22 November 2023 and feedback can be emailed to firstname.lastname@example.org.
What would the effect be?
This proposal would result in testosterone gel being fully funded without restriction. This would mean that the Testogel brand would be funded when prescribed for any relevant use.
Testogel would have Principal Supply Status from 1 July 2024 to 30 June 2027. This means that Testogel would be the main brand funded in the community and bought by Te Whatu Ora hospitals. An alternative brand allowance would enable up to 5% of the market to be supplied by another brand. We are not proposing funding an alternative brand at this time.
We are aiming to provide greater availability of choice for people who are prescribed testosterone. As a result of this RFP, there are no changes proposed to the other forms of testosterone (ie capsules, patches and injections) currently listed on the Pharmaceutical Schedule.
Who we think will be interested
- People who use (or may use) medicines containing testosterone, their family, whānau and caregivers
- Endocrinologists, primary care prescribers and health care professionals who support people using testosterone
- Te Whatu Ora – Health New Zealand hospitals and other organisations who deliver services and support for people who may use testosterone
- Pharmacies and pharmaceutical wholesalers
- Pharmaceutical suppliers
About testosterone gel
Testosterone gel is used to increase testosterone levels in your body, this is sometimes called testosterone replacement therapy. Testosterone is part of a group of medicines called androgen medicines.
Currently, testosterone is approved in Aotearoa New Zealand for:
- Replacement of testosterone for people with primary and secondary hypogonadal disorders
- Testosterone-based gender affirming hormone therapy
Testosterone is currently funded in three presentation types:
- injections (three different strengths available)
- capsules (one strength available)
- patch (one strength available)
Why we’re proposing this
We understand that testosterone supports many New Zealanders to live longer, healthier lives. Different people may prefer to use different presentations of testosterone. We have heard from healthcare professionals and people using testosterone that the injections are not suitable for everyone. We want to ensure people have appropriate and suitable funded options to choose from.
An RFP invites suppliers to submit commercial proposals for supply of a product.
From this RFP, Pharmac has entered into an agreement with Pharmaco New Zealand Limited for the Principal Supply of testosterone gel (Testogel). Testogel would be listed without restrictions. This agreement is provisional on consultation and a final decision from the Pharmac Board (or its delegate).
The RFP also included testosterone patches and capsules. We are not proposing to make any changes to the funded testosterone patches or capsule products from this RFP.
Enabling clinician and individual choice
Advice from our expert advisors was supportive of funding a testosterone gel product:
- The Pharmacology and Therapeutics Advisory Committee (PTAC) recommended testosterone gel be funded with a high priority.
- Members of the Endocrinology and Reproductive and Sexual Health Advisory Committees told us that people using testosterone have different healthcare journeys. Therefore, funding a wide range of products would support people in finding a medicine that is suitable for them.
We are proposing to award Pharmaco’s Testogel product as another funded option. This would be funded alongside other testosterone presentations such as capsules, patches and injections.
We hope this proposal to list testosterone gel would allow health practitioners and people needing testosterone to choose the form of testosterone that meets the individual’s circumstances.
Details about our proposal
Testosterone gel, brand name Testogel, would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2024 as follows:
Chemical and presentation
Testosterone Transdermal Gel
16.2 mg per g gel
88 g OP
Testogel would be listed alongside the current presentations of testosterone. This proposal does not affect the listing of other testosterone products listed on the Pharmaceutical Schedule.
Support for people who would use testosterone gel and health care professionals
We would want to support equitable access and use of funded testosterone gel. In particular, we are interested to know what we could do to support Māori, Pacific peoples, disabled people, as well as people using testosterone gel as part of gender affirming hormone therapy. We have included some proposed activities below and want to hear your feedback and suggestions.
This includes giving effect to the principles of te Tiriti o Waitangi and to take all necessary actions to achieve equity.
The interim Government Policy Statement (iGPS) identifies communities that have been historically underserved by the health system including Māori, Pacific peoples, disabled peoples including tāngata whaikaha Māori, and LGBTQI+ communities.(external link)
Therefore, in helping to achieve equity of access to testosterone gel we are particularly interested in understanding what implementation activities would support the groups identified in the iGPS, and those using testosterone gel as part of gender affirming hormone therapy.
We would work alongside the supplier (Pharmaco NZ Limited), advocacy and support groups for people using testosterone, and health care professionals to provide information on the new product.
Support for people using testosterone gel
We want everyone to have the information they would need about the new product, so people are confident about what using testosterone gel would mean for them. We would work with Pharmaco NZ Limited to provide specific information for people prescribed the proposed testosterone gel product (Testogel), including education and support resources with information about the product.
This information would be provided to health care professionals and consumer groups to share with people who would be using this medicine, as well as hosted on a website for people using the product. The website would include product information and guidelines. Education material would be available to download as a PDF in a range of languages including English, Māori, Samoan, Tongan and Mandarin. We would also have a dedicated page on the Pharmac website with information for individuals as well as health care professionals.
We would also explore working with other educational providers such as Healthify to update their patient resources to include information about testosterone gel (Testogel).
Support for health care professionals
We understand health care professionals would need information about this so they can support people using this medicine. This would include:
- Access to patient education resources outlined above to provide to individuals using testosterone gel
- Product training from supplier representatives
- Online learning resources including clinical and practical information about the prescribing and use of testosterone gel
- Training resource for pharmacists that includes training on correct storage, side effects, and misuse information
To provide feedback
Please send us an email: email@example.com by 5pm Wednesday 22 November 2023.
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.
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