Corifollitropin AlfaElonva
Controlled ovarian stimulation for the development of multiple follicles and pregnancy in women undergoing in-vitro fertilisation techniques, specifically in women undergoing a gonadotrophin releasing hormone antagonist cycle with an antral follicle count of 20 or less.
Decisions on record
- Meeting Mar 2014 Recommended Elonva® Merck Sharp and Dohme (Australia) Pty Ltd Assisted reproductive therapies To request removal of the maximum weight restriction wording from the PBS restriction of Elonva 100 microgram presentation.
- Meeting Jul 2011 Recommended Fertility drug
- Meeting Nov 2010 Not recommended Fertility drug
Access path
- TGA registered · Elonva
TGA label narrower than the PBS population
- Nov 2010Not recommended
uncertainty regarding comparative effectiveness in pregnancy rates (ENSURE trial underpowered for this outcome)…
- ↻ resubmittedJul 2011Recommended · restricted
Comparator changed: follitropin beta (Puregon®) → follitropin beta
- Mar 2013Not recommended
Comparator changed: follitropin beta → follitropin beta (recombinant FSH)
Cost-effectiveness
cost-minimisation analysis; no ICER calculated as non-inferiority claimed on effectiveness outcome
A cost-minimisation based on a non-inferiority claim for the effectiveness outcome of ongoing pregnancy rates, non-inferiority in terms of comparative safety in women aged 18 to 36, and superior comparative safety in women aged 35 to 42 (based on the rate of severe OHSS) was presented in the submission. PSD · 2013
Decision context
PopulationWomen undergoing assisted reproductive technologies (in-vitro fertilisation) with an antral follicle count of 20 or less, undergoing a gonadotrophin releasing hormone antagonist cycle.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2013 | Not recommended | follitropin beta (recombinant FSH) | — | RCT · Ongoing pregnancy rate |
| Jul 2011 | Recommended · restricted | follitropin beta | — | RCT |
| Nov 2010 | Not recommended | follitropin beta (Puregon®) | — | RCT · Ongoing pregnancy rate; Number of oocytes retrieved |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PURSUE | Ph 3 | 1,424 | Percentage of Participants With a Vital Pregnancy | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to antagonist cycles with antral follicle count ≤20; TGA label has no such restrictions.