Approximately 4500 women with uterine fibroids will be eligible to receive the drug

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In a final draft of new guidance, NICE has recommended relugolix-estradiol-norethisterone acetate (Ryeqo; Gedeon Ritcher UK) for the treatment of moderate-to-severe symptoms of uterine fibroids in women of reproductive age.

Following the decision by NICE, around 4500 women with uterine fibroids will be eligible to receive the drug. Sold under the brand name Ryeqo, the drug will be accessible to patients 3 months after the final guidance is issued.

The Minister for Women’s Health, Maria Caulfield, said: ‘This is another ground-breaking step forward to not only improve women’s quality of life and reduce symptoms, but to give them greater choice in the medication available and options for alternative, less invasive treatment.’

Burden of uterine fibroids and treatment options

Uterine fibroids are a common condition affecting one in three women aged 16–50 years. Although their exact cause is unknown, oestrogen is believed to play a role in their development. Fibroids are often accompanied by symptoms such as prolonged heavy menstrual bleeding, pelvic pain and pressure, and fertility problems. Current symptomatic treatment options are limited, and include hormonal contraceptives and non-steroidal anti-inflammatory drugs.

In women with moderate-to-severe symptoms, injectable gonadotrophin-releasing hormone (GnRH) agonists are often used before considering surgical options such as myomectomy and hysterectomy. Relugolix-estradiol-norethisterone is an effective alternative to surgery and injectable GnRH agonists, which acts by reducing the production of oestrogen and progesterone in the ovaries.

Helen Knight, interim Director of Medicines Evaluation in the NICE Centre for Health Technology Evaluation, said: ‘This treatment has the potential to improve quality of life. As well as effectively reducing symptoms, it can be taken at home and is, therefore, more convenient than the injectable treatment given in a hospital setting.’

Evidence from trials

Evidence considered by NICE in its evaluation shows relugolix-estradiol-norethisterone acetate to be more effective than placebo for decreasing heavy menstrual bleeding. An indirect comparison of relugolix-estradiol-norethisterone acetate with injectable GnRH agonists suggests a similar efficacy for both, but the findings are uncertain.

NICE has considered the cost-effectiveness of relugolix-estradiol-norethisterone acetate to be acceptable for routine use within the NHS.

This article was originally published on Medscape, part of the Medscape Professional Network.

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