DienogestDINASANE
Treatment of endometriosis, a chronic hormone-dependent gynaecological condition characterised by dysmenorrhea, pelvic pain, and dyspareunia.
Decision on record
- Meeting Jul 2024 Recommended Endometriosis
Access path
- TGA registered · DINASANE
TGA label narrower than the PBS population
- Jul 2024Recommended · restricted
vs norethisterone 5 mg, medroxyprogesterone 10 mg (PBS-listed…
- PBS listing · Restricted
From the public summary
The PBAC recommended the listing of dienogest on the PBS as an Authority Required (STREAMLINED) listing for the treatment of endometriosis on the basis that it would be cost effective with a price premium over medroxyprogesterone due to therapeutic advantages for some women.PSD · Jul 2024
The PBAC noted the public health benefit of PBS-subsidised access to effective treatment options for endometriosis. The PBAC considered that there was a clinical need for access to effective medicines to manage endometriosis, in particular for women who are not able to use estrogen-based treatment.PSD · Jul 2024
The submission did not provide an economic model for evaluation.PSD · Jul 2024
The submission described treatment with dienogest was superior in effectiveness compared to placebo in terms of the EAPP VAS and quality of life measures in patients with endometriosis pain. Dienogest has favourable safety and tolerability profile, with no impact to BMD over 24 weeks.PSD · Jul 2024
The clinical claim for effectiveness vs placebo may be supported by the evidence presented in the submission, however the claim of favourable safety may not be adequately supported, given treatment with dienogest was associated with higher incidence of AEs compared to placebo and evidence comparing longer-term treatment was limited.PSD · Jul 2024
The PBAC noted and welcomed comments from individuals with the health condition (15), parent or partner of an individual with the health condition (2), health professional (1) and organisations (2) via the Consumer Comments facility on the PBS website. Comments described the positive impacts of dienogest, particularly its effectiveness in reducing pain, but also in reducing other endometriosis-related symptoms.PSD · Jul 2024
The PBAC noted input stating that the addition of dienogest to the PBS will result in a better selection of progestogens available to consumers, which increases the likelihood of those with endometriosis having access to a suitable medication (given the variability of consumers response to differing progestogens), and that this will result in a reduction of repeated surgeries.PSD · Jul 2024
Cost-effectiveness
No economic model was provided; this was a cost-minimisation submission with pricing comparison only.
The PBAC considered that overall there was insufficient evidence provided to demonstrate superior effectiveness and safety compared to PBS listed oral progestogens that may be used for endometriosis. However, based on the clinical input received for this submission the PBAC considered the dienogest offered a therapeutic advantage for some patients. PBAC · 2024
Decision context
PopulationPatients with endometriosis, including those with contraindications to estrogens or long-acting progestogens, and those who do not tolerate other progestogens.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended · restricted | norethisterone 5 mg, medroxyprogesterone 10 mg (PBS-listed oral progestogens) | — | RCT · Endometriosis associated pelvic pain (assessed by Visual Analogue Scale) |
Consumer voice
Consumer input highlighted that dienogest effectively reduces endometriosis-related pain and symptoms, with comments emphasizing its suitability for long-term use, the importance of treatment choice variability, and the significant burden of current out-of-pocket costs as a barrier to access.
Comments described the positive impacts of dienogest, particularly its effectiveness in reducing pain, but also in reducing other endometriosis-related symptoms. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use and specific patient subgroups (estrogen contraindications, progestin intolerance); TGA label is unrestricted.