FIBROID DRUG THAT COULD OFFER WOMEN ALTERNATIVE TO FIBROID RELATED HYSTERECTOMIES IS APPROVED FOR USE IN WALES

18/05/2016

A once daily tablet that treats the moderate to severe symptoms of uterine fibroids has been approved for use across NHS Wales.

Ulipristal acetate (Esmya®) is an oral treatment that gives rapid control of heavy menstrual bleeding, reduces anaemia and shrinks the size of fibroids.[i],[ii] The drug has been recommended by the All Wales Medicines Strategy Group (AWMSG) to be taken on an intermittent basis, giving women in Wales the opportunity to choose the long term medical management of uterine fibroids and potentially avoid surgery.

Around 40 in every 100 women develop uterine fibroids at some time in their life.[iii] Surgery, including hysterectomies, is commonly used to treat fibroids and this can affect a woman’s fertility on a temporary or permanent basis. In 2014/15 there were 1,311 consultant episodes attributed to uterine fibroids in NHS Wales.[iv]

Richard Penketh, gynaecologist from Cardiff and Vale University Health Board said:  “This is an important step forward in the treatment of uterine fibroids, as many women in Wales will now be able to take Esmya® to shrink their fibroids and reduce their bleeding.  This will mean that surgery – either removal of the fibroid or the womb – can be avoided in some cases.”

A drug can only be routinely prescribed in Wales if it has been recommended for use by the AWMSG. The approval follows Esmya®’s manufacturer, Gedeon Richter, demonstrating to the AWMSG the benefits of the drug and that it represents value for money for NHS Wales.

The recommendation follows the marketing authorisation in May 2015 for Esmya® to be used on an intermittent basis, based on clinical studies which assessed the efficacy and safety of ulipristal acetate.

Commenting on the approval Kriszta Zolnay, UK Managing Director Gedeon Richter, said: “Gedeon Richter is committed to the development of treatments that improve the quality of life for women, offering them surgery-free options where possible.

“The AWMSG recommendation of Esmya® for use across NHS Wales is a significant development for both clinicians and patients in Wales. Many women with uterine fibroids who wish to avoid surgery can now have access to an effective treatment option.”