NICE backs Gedeon Richter's Esmya, which it says could save the NHS 'millions'

The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has issued an updated guideline recommending the use of Esmya (ulipristal acetate 5mg), up to four courses, as first-line treatment for patients presenting with heavy menstrual bleeding and uterine fibroids 3cm or more in diameter.

The UK marketing authorization for Esmya is held by Hungary’s largest drugmaker Gedeon Richter (RICHT: HB), and gained marketing authorization from the European Commission in early 2014 to extend the drug’s use as up to two courses of three-month treatment of for uterine fibroids. The company gained a non-exclusive UK and rest of the world license for the product from HRA Pharma.

Clinical data has shown that four courses of Esmya resulted in 73% of eligible patients achieving “normal” (controlled) bleeding, and a 72% fibroid volume reduction from baseline. Current treatment options include major surgery, such as hysterectomy, which can significantly affect a woman’s ability to have children and are costly to the National Health Service; surgical treatment for uterine fibroids cost NHS England £119 million ($156 million) in 2015 alone.