NICE Approves First-Ever Daily Pill for Endometriosis Treatment

The National Institute for Health and Care Excellence (NICE) has approved relugolix combination therapy, which can be taken at home instead of requiring regular injections. Now available through the NHS in England and Wales, this first-ever daily pill for treating endometriosis symptoms, offers a new option for patients who have exhausted all other treatments. Around 1,000 women each year will have access to the treatment, which blocks specific hormones linked to endometriosis while providing necessary hormone replacement. The approval follows an initial rejection by NICE and adds to the available options for managing the condition, which affects 1.5 million women in the UK.

Endometriosis Treatment Innovation: A Milestone for Patients and the NHS

NICE has recommended the first daily oral pill on the NHS to treat endometriosis in its new final draft guidance. This follows its earlier decision not to recommend relugolix–estradiol–norethisterone (Ryeqo) for this use. Endometriosis causes debilitating symptoms such as severe period pain, heavy menstrual bleeding, and, in some cases, infertility. The newly approved treatment, Ryeqo (relugolix 40mg, estradiol 1mg, and norethisterone acetate 0.5mg), provides an alternative to traditional injectable treatments, allowing patients to manage their condition from home.

According to EndometriosisUK Endometriosis affects 1 in 10 women and those assigned female at birth of reproductive age in the UK, impacting 1.5 million people— a number similar to those living with diabetes. Globally, 10% of women, or approximately 176 million people, have endometriosis. Among those with infertility, prevalence can reach 30–50%. As a common gynecological condition in the UK, endometriosis takes an average of 8 years and 10 months from the first GP visit to receive a diagnosis. The condition costs the UK economy £8.2 billion annually in treatment, lost work, and healthcare expenses. Its cause remains unknown, and there is currently no definitive cure.

Helen Knight, Director of Medicines Evaluation at NICE, emphasized the pill’s benefits, highlighting that it not only eliminates the need for frequent clinic visits but also works more rapidly than injectable alternatives. “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. 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.”

Clinical Evidence and Cost Considerations: Ryeqo is Affordable with Significant Therapeutic Efficacy 

Clinical studies, including Phase III trials (SPIRIT 1 and 2), have demonstrated that Ryeqo significantly reduces endometriosis-related pain. In both trials, 75% of participants reported symptom improvement compared to just 27-30% of those on a placebo. It blocks specific hormones that contribute to the condition while supplying essential replacement hormones. NICE’s decision to approve the pill was based on these promising results and the treatment’s potential to offer higher efficacy than placebo, particularly in alleviating dysmenorrhoea (painful periods) and pelvic pain.

While this new pill provides hope for many, it will only be available on the NHS to patients who have already tried and failed other medical or surgical treatments. This includes treatments such as hormonal contraceptives and intrauterine devices. Approximately 1,000 women annually in England and Wales, who meet these criteria, will be eligible for this treatment.

At a cost of £72 ($93 USD) for a 28-day supply, the pill is expected to be a cost-effective solution, reducing reliance on hospital visits and potentially easing the burden on NHS services. Knight noted that putting control back into the hands of patients while ensuring value for the taxpayer is a crucial part of this treatment’s success.

A New Era for Endometriosis Management

This new treatment is a potential turning point in endometriosis care. While it will primarily benefit a smaller subset of women—those who have exhausted other treatment options—it provides a much-needed option for managing a condition that affects millions. Emma Cox, Chief Executive of Endometriosis UK, welcomed the approval but emphasized the need for continued research and investment into more comprehensive treatment options for the broader population.

In addition to the pill’s approval, NICE is also reviewing its guidelines for endometriosis diagnosis and management, focusing on improving imaging techniques and surgical interventions. The review will aim to address critical gaps in research, such as pain management and mental wellbeing, offering hope for further advancements in care.

Endometriosis Treatment Market Poised for Significant Growth

According to a report by Future Market Insights, the global market for endometriosis treatment is projected to experience substantial growth, with sales estimated to reach USD 3,727.4 million in 2025 and further expand to USD 6,297.2 million by 2035, reflecting a CAGR of 5.4%. The increasing prevalence of endometriosis, alongside rising awareness and advancements in diagnostic technologies, is driving the demand for more effective treatment options.

The market’s expansion is fueled by innovations in non-hormonal drugs, targeted biologics, and robotic-assisted surgeries, particularly in the USA. These advancements, coupled with improved accessibility to molecular therapies and non-invasive diagnostic tools, are enhancing patient outcomes. As a result, investments in research and development are growing, leading to the emergence of targeted and less invasive treatments for managing endometriosis.

Recognizing Endometriosis: Symptoms and Diagnosis

Many misunderstand endometriosis, often attributing symptoms solely to painful or heavy periods. However, the condition causes chronic pelvic pain, discomfort during sex, fatigue, and difficulty with bowel movements or urination. Some women also face fertility challenges. Endometriosis doesn’t just cause painful periods—it can trigger pain at any point in the cycle, impacting daily life, work, and relationships. Early diagnosis remains essential, but detecting the condition can be difficult. Ultrasounds and MRIs may not always reveal endometriosis, especially in milder or non-pelvic cases. Therefore, individuals experiencing persistent symptoms must seek specialized care.

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Author

Bernice Lottering