ESMYA: Insufficient clinical benefit to justify reimbursement for the treatment of uterine fibroids (February 2019)

Summary

This document was drafted on the basis of the Transparency Committee opinion, French National Authority for Health, dated 27 February 2019.

It found insufficient clinical benefit of ESMYA* for the treatment of uterine fibroids to justify reimbursement. They conclude:

• The actual clinical benefit of ESMYA is insufficient to justify its reimbursement by public funding in its two indications.
• Not approved for non-hospital pharmacy reimbursement or for hospital treatment.

*ESMYA - (ulipristal acetate), progesterone receptor modulator.