Approval of reimbursement for “controlled ovarian stimulation to induce the development of multiple follicles in women undergoing Assistive Reproductive Technologies (ART) such as an in vitro fertilisation (IVF) or IVF with intracytoplasmic sperm injection (ICSI) cycle.”
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of REKOVELLE (follitropin delta), solution for injection, is substantial in the marketing authorisation indication.
Clinical Added Value
no clinical added value
In view of:
the new data submitted, in response to the Committee’s request issued in its initial opinion of 5 April 2017, namely the post-trial follow-up findings in order to assess the cryopreserved cycles initiated in the year following the date of randomisation for patients included in ESTHER-1, and in the year following the start of controlled ovarian stimulation of the final cycle in ESTHER-2,
the fact that the pregnancy follow-up data collected from the cryopreserved cycles from the ESTHER-1 and ESTHER-2 studies do not suggest a difference in terms of risk of pregnancy loss when patients undergo controlled ovarian stimulation with REKOVELLE (follitropin delta) compared with GONAL F (follitropin alfa),
the fact that, hence, the data do not demonstrate a particular signal,
the fact that these follow-up findings do not demonstrate any data liable to modify the Committee’s previous assessment,
the Committee deems that REKOVELLE (follitropin delta), solution for injection provides no clinical added value (CAV V) compared with GONAL-F (follitropin alfa).
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