NICE includes Gedeon Richter’s uterine fibroids drug in national guidance

NICE is consulting on recommendations for Gedeon Richter’s Esmya (ulipristal acetate) in uterine fibroids in updated national guidance on heavy menstrual bleeding.

The guidance documents are separate from the technology appraisals that decide whether medicines are cost-effective – but could encourage prescription of drugs included on them as they are used as standard of care reference documents by health professionals.

Guidance recommends use of Esmya in line with its marketing authorisation, restricting it to no more than four courses and in women with heavy menstrual bleeding and fibroids of 3cm or more in diameter.

The draft recommendations say Esmya should be offered to women whose haemoglobin levels is 102g per litre or below, and considered if the haemoglobin level is above 102g per litre.

NICE’s proposals come shortly after the first of two pivotal trials needed for US approval of Esmya reported positive results.

A selective progesterone receptor modulator, ulipristal acetate exerts a direct effect on the endometrium by suppressing uterine bleeding and direct action on fibroid size by decreasing formation of new fibroid cells and promoting fibroid cell death.

Severe uterine fibroids can be treated with a hysterectomy – but Esmya offers women an alternative treatment that does not affect their fertility.

In a separate decision, NICE has also opted not to change recommendations on intrauterine insemination for people with unexplained infertility, mild endometriosis or ‘mild male factor infertility’, having regular unprotected sex.

Guidance still advises waiting for up two years before IVF is considered, and not to routinely offer intrauterine insemination, either with or without ovarian stimulation. Exceptional circumstances include when people have social, cultural or religious objections to IVF.

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