By: 16 March 2016
Scottish Medicines Consortium approves uterine fibroid treatment that could reduce surgery needed

Scottish Medicines Consortium approves uterine fibroid treatment that could reduce surgery needed

The Scottish Medicines Consortium (SMC) has approved for use across NHS Scotland a uterine fibroid treatment that could enable some women to avoid hysterectomies.

Ulipristal acetate (Esmya®) is an oral treatment that gives rapid control of bleeding, reduces anaemia and shrinks the size of fibroids compared with baseline. Taken as a once daily tablet, it is used to treat women with moderate to severe uterine fibroids.[i],[ii]

The SMC has given approval for ulipristal acetate (Esmya®) to be taken on an intermittent basis, giving women the opportunity to choose the long term medical management of uterine fibroids and potentially avoid surgery.

The decision follows Esmya’s manufacturer, Gedeon Richter, demonstrating to the SMC the benefits of the drug and that it represents value for money for NHS Scotland.

Around 40 in every 100 women develop uterine fibroids at some time in their life.[iii] Some of the treatment options may affect fertility on a temporary or permanent basis and it is estimated that about 300,000 surgical procedures are performed annually in the EU for fibroids, including approximately 230,000 hysterectomies.[iv]

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 SMC’s approval of Esmya® is a significant development for both clinicians and patients in Scotland. Many women with uterine fibroids who wish to avoid surgery can now have access to an effective treatment option.”

A drug can only be routinely prescribed in Scotland if it has been approved for use by the SMC. The Consortium’s decision follows authorisation by the European Commission (EC) in May 2015 for Esmya® to be used on an intermittent basis, based on clinical studies (PEARL III and PEARL IV) which assessed the efficacy and safety of ulipristal acetate.

Ulipristal acetate was initially accepted in 2013 by the SMC for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, limited to one treatment of three months’ duration.


[i] Donnez J, Tatarchuk TF, Bouchard P, et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012;366(5):409-20.

[ii] Donnez J, Tomaszewski J, Vazquez F. et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012;366(5):421-32.

[iii] NHS Choices 1, Fibroids, at: (Accessed February 2016)

[iv] MedTech Insights Reports

Source: Gedeon Richer