Decision to fund testosterone gel and to award Principal Supply Status to Testogel
We are pleased to announce a decision to fund a testosterone gel product, Testogel, supplied by Pharmaco.
Testogel will be listed on the Pharmaceutical Schedule without funding restrictions from 1 April 2024 and will have Principal Supply Status from 1 July 2024 to 30 June 2027. This means that Testogel will be the main funded brand of testosterone gel in the community and Te Whatu Ora hospitals.
What we’re doing
From 1 April, Testogel will be fully funded without restriction. This means Testogel will be funded when prescribed for any relevant clinical use.
There are no changes to the other presentations of testosterone currently listed on the Pharmaceutical Schedule. Pharmaco’s Testogel product will provide another funded formulation of testosterone and be listed alongside the currently funded options.
Any changes to the original proposal?
This decision was subject to a consultation letter dated 8 November 2023.
This consultation included information about the new listing of testosterone gel and sought feedback about implementation activities and support that would be required to assist health care professionals and people using testosterone gel with this listing. We’re really grateful to everyone who took the time to share their support and provide us with feedback.
Most of the responses received were supportive of the proposal, highlighting the suitability and equity benefits of funding testosterone gel. There have been no changes to the original proposal following consultation. All consultation feedback received, and our responses have been summarised at the end of this page.
Implementation support
A number of respondents provided feedback about the activities that would be required to support people using testosterone gel and health care professionals with the use of testosterone gel, and how we can ensure people are aware of and able to access this product. We are grateful for the feedback provided and intend to use this to support the implementation of testosterone gel.
We will work with the supplier to support the listing of testosterone gel. This will include educational resources for health care professionals such as prescriber guidance and training, and educational resources to support people with the use of testosterone gel.
Who we think will be most 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
Detail about this decision
Testosterone gel, brand name Testogel, will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 April 2024 as follows:
|
Chemical and presentation |
Formulation |
Brand |
Pack Size |
Price and Subsidy |
|---|---|---|---|---|
|
Testosterone |
Gel (transdermal) 16.2 mg per g |
Testogel |
88 g OP |
$52.00 |
Testogel will be listed alongside the current presentations of testosterone. There have been no changes to the listings of other testosterone products on the Pharmaceutical Schedule.
Testogel will have Principal Supply Status from 1 July 2024 to 30 June 2027.
Our response to what you told us
We’re grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback and our responses to the feedback received are available below.
|
Theme |
Pharmac Comment |
|---|---|
|
Listing of testosterone gel |
|
|
A number of responses were supportive of the proposal. |
We are pleased to be funding an alternative formulation of testosterone without restrictions as an alternative testosterone option for people to enable them to choose a product suitable for their circumstances.
|
|
Some respondents highlighted difficulties with the currently funded testosterone formulations, including needle phobia for injections and skin reactions to the patches. |
We are pleased to be funding an alternative formulation of testosterone without restrictions as an alternative testosterone option for people to enable them to choose a product suitable for their circumstances. |
|
Some respondents noted that the proposal to fund testosterone gel without restrictions would have positive equity implications for Māori and Pacific people requiring testosterone treatment, as well as people requiring gender affirming therapy. |
We are pleased to be funding an alternative formulation of testosterone without restrictions as an alternative testosterone option for people to enable them to choose a product suitable for their circumstances. |
|
Some respondents noted women with Hypoactive Sexual Desire Disorder would benefit from a testosterone product being available, however noted a lower strength product would be easier to administer and that approved indications should be expanded to include hypoactive sexual desire disorder for postmenopausal woman. |
Medsafe is the authority responsible for the regulation of therapeutic products in New Zealand.(external link) Testogel is Medsafe approved for adults as testosterone replacement therapy for male hypogonadism.(external link) There is not currently a testosterone gel or cream product Medsafe approved for use in hypoactive sexual desire disorder. There are no funding restrictions on Testogel, this means it can be prescribed for any indication that is clinically appropriate. Information on the unapproved use of medicines is on the Medsafe website.(external link) Listing Testogel would not prohibit Pharmac from considering funding a lower strength testosterone gel or cream product. |
|
A respondent requested that an oral formulation of testosterone remains available for all. The respondent noted a preference for a Medsafe approved product. |
There are no changes to the currently funded formulations of testosterone as a result of this decision. Unfortunately, we were unable to secure a Medsafe approved testosterone capsule product from this procurement process. We will continue to explore options that could address an unmet health need for people requiring testosterone. |
|
Some respondents highlighted the unmet health need across a range of conditions and requested Pharmac consider funding medicines for these conditions rather than testosterone gel for gender affirming therapy.
|
We acknowledge there remains a clinical need across other disease areas. Funding testosterone gel is expected to be cost saving to the Pharmaceutical Budget and health sector. Any savings realised would support investment in other medicines. Pharmac currently funds several testosterone formulations. Funding a gel formulation may provide a more suitable option for people with different clinical needs. We understand the majority of its use would be for male hypogonadism. |
|
Some respondents considered that testosterone gel should not be funded or used. |
Pharmac currently funds several testosterone formulations. Funding testosterone gel is expected to be cost saving to the Pharmaceutical Budget and health sector and ensures a suitable option is available for individuals with different clinical needs. Individuals should discuss with their prescriber what treatment options are available and most appropriate for their clinical circumstances. |
|
Some respondents considered that treatment with testosterone may not be the most appropriate treatment option for people considering or undergoing gender affirming therapy. |
Individuals should discuss with their prescriber what treatment options are available and most appropriate for their clinical circumstances. |
|
Implementation support activities |
|
|
A number of respondents provided feedback in relation to information and activities to support the implementation of testosterone gel, including suggestions for prescriber guidance and training, resources to support people using testosterone gel, and how we can best communicate this information. |
We would like to thank the respondents for providing this information. We intend to use this to guide implementation of the listing of testosterone gel. |
If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.