Ospemifen (1) – Senshio®

moderate to severe symptomatic vulvovaginal atrophy (VVA) in post-menopausal women for whom local vaginal oestrogen therapy is not an option

• For postmenopausal women with moderate to severe symptomatic vulvovaginal atrophy (VVA) for whom local vaginal oestrogen therapy is not an option, additional benefit is not proven compared with the appropriate comparator therapy.
• The studies submitted are not suitable for drawing conclusions regarding the additional benefit of ospemifene compared with the appropriate comparator therapy.
• The G-BA takes a critical view, primarily of the questionable or insufficiently demonstrated generalisability of the study population to the target population for ospemifene.
• Symptomatic VVA (classified as moderate to severe within the authorised therapeutic indication) was not a prerequisite for the inclusion of patients in Study 718.
• The pharmaceutical manufacturer provides no information as to whether, and if so how many, patients in the study suffered from moderate to severe VVA.
• Although the two further randomised, controlled studies 310 and 821 investigated patients with moderate to severe VVA, they did not take into account the criterion ‘for whom local vaginal oestrogen therapy is not an option’.
• In studies 310 and 821, a history of breast cancer within the last 10 years was an exclusion criterion.
• In summary, studies 310 and 821 did not include a relevant number of patients to whom any of the stated reasons for unsuitability for local hormone therapy applied.
• The studies presented are also unsuitable for an assessment of additional benefit due to the implementation of the appropriate comparator therapy (ZVT) in studies 310, 821 and 718.
• Specifically, in studies 310 and 821, patients were provided with a specified lubricant as required; in study 718, the free use of a lubricant and the use of moisturising creams were permitted after week 12.
• It is questionable to what extent lubricant was the sole best possible and individually optimised treatment for patients in studies 310 and 821, and why the use of vaginal moisturisers was not permitted.
• In summary, the appropriate comparator therapy (ZVT) was not correctly implemented in the therapeutic indication of VVA.
• Conclusion
  • For the reasons outlined above, none of the studies submitted by the pharmaceutical manufacturer can be used to determine the additional benefit.
  • Accordingly, the additional benefit of ospemifene compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.