A daily pill has been approved by NICE for treating some women with endometriosis after initially being rejected.
It is estimated around 1,000 patients a year will be able to access the treatment called relugolix–estradiol–norethisterone (also known as relugolix combination therapy or Ryeqo).
The turnaround from NICE came after the company provided new evidence on the effectiveness and value for money of the treatment.
This included a broader systematic review of comparison treatments and long-term efficacy data collated by makers Gideon Richter.
Clinical evidence shows that it reduces pain compared with placebo but it has not been directly compared in trials with usual treatment, the committee noted.
Indirect comparisons presented to NICE suggest that it is likely to reduce pelvic pain almost as well as GnRH agonists, but it is unclear it compares to surgery.
The ruling published as a final draft means the drug will be an option for treating symptoms of endometriosis in adults of reproductive age who have had medical – gonadotropin-releasing hormone (GnRH) agonists – or surgical treatment for the condition that has not worked.
It is the first long-term daily pill licensed to treat endometriosis symptoms and in eligible patients will eliminate the need for multiple medications and regular trips to clinics for injections, NICE said.
Committee members also agreed that compared with current injectable treatments, which can initially worsen symptoms, the daily pill starts working more quickly, combines all the hormones needed in one medicine and hormone levels return to normal more quickly when it is stopped.
A clinical expert advised the committee that the treatment would be ‘a step-change in the management of endometriosis’.
Having an all-in-one daily tablet that includes hormone replacement therapy, also means the patient does not have to remember to take add-back therapy separately
Endometriosis affecting an estimated 1.5 million women in the UK. Updated guidelines on diagnosis and management of the condition were published by NICE in November.
Helen Knight, director of medicines evaluation at NICE, said: ‘This new treatment marks a potential step-change in how we manage endometriosis, putting control back in patients’ hands while ensuring value for the taxpayer.
‘Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects. This convenience not only benefits patients but reduces pressure on NHS services.’
A spokesperson for Endometriosis UK welcomed the decision saying women and those assigned female at birth in the UK should be able to choose the right treatment and management options for them.
‘We recommend that treatment decisions are always made in partnership with the individual and their medical practitioner.
‘There are far too few options available due to the historic lack of research into endometriosis.’
