The Scottish Medicines Consortium (SMC) has recommended Theramex’s Yselty®▼ for the treatment of moderate to severe symptoms of uterine fibroids (UFs) aligned to the product indication in adult women of reproductive age.1,2
UFs occur in approximately 70% of women of reproductive age, with black women two to three times more likely to develop UFs compared to white women. Approximately 25% of women will experience symptoms severe enough to require treatment.3
UFs are the most prevalent tumors in the uterus, with symptoms including pelvic pressure, back or abdominal pain, fullness, sexual dysfunction, dysmenorrhea, urinary frequency, constipation and heavy and prolonged bleeding.4
The symptoms of UFs can also have a negative impact on emotional wellbeing, with many women feeling embarrassed, worried, anxious, sad or depressed. Longer, heavier, and surprise bleeding compared to ‘normal’ menstrual bleeding can result in excessive costs to women for feminine products, replacing or cleaning soiled clothing, and medications. These costs, in addition to symptoms, can have a major impact on a woman’s quality of life. 5
This decision by SMC means that Yselty® will be available for eligible women across Scotland through the NHS.
The SMC decision is based on evidence from the two PRIMROSE studies (of replicate design) investigating the efficacy and safety of Yselty® in women who have uterine fibroids with heavy menstrual bleeding (HMB).1,2
Dr Sigi Joseph, Co-Founder of The Doctor Explains, GP and National Lead for Women’s Health Plan said: “The SMC’s approval of Yselty is a significant milestone for women’s health in Scotland. As both a GP and advocate for women’s healthcare, I am delighted to see more treatment options becoming available for women and their health needs. The recommendation is a step towards closing the gender health gap and ensuring that women have access to a wider range of evidence-based treatments. Having more approved medications gives us greater flexibility in tailoring care to individual needs.”
Tina Backhouse, UK General Manager at Theramex said: “Women should not have to endure painful gynaecological conditions – and uterine fibroids are just one of many issues in women’s health that needs immediate improvement. We are committed to working closely with SMC and NHS Scotland to ensure that eligible women in Scotland will now have access to Yselty® – diversifying their treatment options. As a dedicated women’s health company committed to reducing the gender health gap, improving access to treatments and diversifying choice is paramount to our goal of meeting the health needs of all women, at every life stage.”
References:
1. Yselty® 100mg MHRA SmPC
2. Yselty® 200mg MHRA SmPC
3. Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017 Sep;124(10):1501-1512
4. Giuliani E, As-Sanie S, Marsh EE. Epidemiology and management of uterine fibroids. Int J Gynecol Obstet. 2020;149(1):3–9
5. Hunsche E, Rakov V, Scippa K, Witherspoon B, McKain L. The Burden of Uterine Fibroids from the Perspective of US Women Participating in Open-Ended Interviews. Womens Health Rep. 2022 Mar 4;3(1):286–96
