Ulipristal AcetateEllaOne
Acute management of moderate to severe symptomatic uterine fibroids prior to planned surgery in patients eligible for and planning surgery.
Decisions on record
- Meeting Mar 2017 Not recommended Ulipristal is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
- Meeting Jul 2016 Not recommended Moderate to severe symptoms of uterine fibroids
Access path
- TGA registered · EllaOne
TGA label narrower than the PBS population
- Jul 2016Not recommended
vs goserelin (a gonadotrophin releasing hormone analogue)…
- Mar 2017Not recommended
Comparator changed: goserelin (a gonadotrophin releasing hormone analogue), either alone…
From the public summary
7.1 The PBAC did not recommend the listing of ulipristal on the PBS for the treatment of 21PSD · Mar 2017
7.2 The PBAC considered the proposed restriction did not clearly identify the patients likely to benefit from treatment with ulipristal and agreed with DUSC that it is unclear how clinician and patient preference might change if ulipristal was subsidised.PSD · Mar 2017
6.24 The resubmission presented an economic model to evaluate the cost-effectiveness of ulipristal followed by surgery versus conservative management followed by surgery.PSD · Mar 2017
6.25 The summary of model structure and rationale is presented in Table 7. Regarding the model structure, the ESC considered the health states used within the model were treatment outcomes rather than health outcomes, and it was considered complicated given the available data. The ESC noted costs associated with conservative management for the treatment of symptoms were not included in the model.PSD · Mar 2017
6.21 The resubmission described ulipristal as superior in terms of comparative effectiveness to placebo as a proxy for an equivalent period of conservative management, with an acceptable and comparable safety and tolerability profile. This claim was adequately supported in relation to effectiveness for controlling abnormal uterine bleeding and reducing both fibroid and uterine volume in pre- menopausal women eligible for surgery.PSD · Mar 2017
6.22 The PBAC considered the claim of superior comparative effectiveness of ulipristal over placebo was reasonable for the outcomes of controlling abnormal uterine bleeding and reducing both fibroid and uterine volume. The PBAC considered the claim of superior effectiveness was not adequately supported for the surgical or quality of life outcomes.PSD · Mar 2017
6.2 The PBAC noted and welcomed the input from health care professionals (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with ulipristal including fewer side effects compared to GnRH analogues, avoidance of surgery and significant improvements with menstrual symptoms.PSD · Jul 2016
6.45 Due to the uncertainty surrounding the financial estimates and in line with the advice from the PBAC for the July 2016 submission (Ulipristal PSD, July 2016, paragraph 6.45) the resubmission proposed a Risk Share Arrangement (RSA).PSD · Mar 2017
Cost-effectiveness
ICER stated as 'less than $15,000 per QALY' in the resubmission cost-utility analysis.
Decision context
PopulationAdult women of reproductive age eligible for and planning surgery for uterine fibroids with moderate to severe symptoms, including at least 1 fibroid ≥3 cm in diameter or multiple fibroids confirmed by ultrasound, and significant menstrual bleeding negatively affecting quality of life or confirmed anaemia (haemoglobin ≤120 g/L).
Risk sharingA Risk Share Arrangement was proposed to account for residual uncertainty surrounding cost to the government.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2017 | Not recommended | placebo (no treatment prior to planned surgery) | $15k | RCT · PFS |
| Jul 2016 | Not recommended | goserelin (a gonadotrophin releasing hormone analogue), either alone or in conjunction with hormonal add-back therapy wi | — | RCT |
Consumer voice
Healthcare professionals reported that ulipristal acetate offers fewer side effects compared to GnRH analogues, helps avoid surgery, and provides significant improvements in menstrual symptoms for patients with uterine fibroids.
fewer side effects compared to GnRH analogues Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to acute pre-surgical use with specific imaging/lab criteria; TGA label permits broader intermittent treatment regardless of surgical intent.