'Transformational' pill for endometriosis gets NHS nod
Around 1,000 women in England a year with endometriosis will soon have access to the first daily oral therapy after Gedeon Richter's Ryeqo was cleared for NHS use.
This morning, NICE recommended Ryeqo (relugolix/estradiol/norethisterone) for routine NHS commissioning after initially turning down the drug in earlier draft guidance.
The health technology assessment (HTA) agency said that Ryeqo "could transform how this painful condition is managed" as it starts working more quickly than current injectable therapies – which can also make symptoms worse initially – and can be dosed at home, rather than at a clinic.
Affecting up to 10% of women of reproductive age, endometriosis is a painful condition caused by tissue normally found lining the uterus instead growing outside the uterus. This tissue thickens, breaks down, and bleeds during menstruation, but becomes trapped, potentially leading to cysts and scarring.
There is no cure, and current treatment relies on pain relief and hormonal treatment, with injectable gonadotropin-releasing hormone (GnRH) agonists and surgery generally used as second-line options. Ryeqo will be available via the NHS to treat endometriosis patients for whom medical or surgical treatment has failed.
NICE's change of heart follows patient expert testimony that highlighted the importance of having additional treatment options that can be taken at home, giving people more autonomy in managing their condition, as well as additional data on efficacy and cost-effectiveness from the manufacturer. The list price for the treatment is £72 for a 28-day supply.
The new guidance – which should be finalised on 16th April – has been welcomed by patient organisation Endometriosis UK, which said it hoped that the other nations within the UK would follow suit and back coverage of Ryeqo. The Scottish Medicines Consortium (SMC) backed the use of the drug for endometriosis in January.
"For those with a history of previous medical or surgical treatment for their endometriosis, [it] is an alternative option if treatments such as tranexamic acid, hormonal contraceptives, and intrauterine delivery systems have not worked or are unsuitable," said the charity in a statement.
Gedeon Richter's drug is the only licensed GnRH antagonist option and, unlike GnRH agonists like Takeda's Prostap (leuprorelin acetate) and AstraZeneca's Zoladex (goserelin acetate) – which are only licensed for up to six months – can be taken up until menopause.
"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," said Helen Knight, director of medicines evaluation at NICE.
"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," she added.
"This convenience not only benefits patients, but reduces pressure on NHS services."
