Ospemifene Medicine 07 December 2021 Extended indication Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Ospemifene Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women Current proprietary name Already available biosimilars / generics Proprietary name Senshio Manufacturer Shionogi Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks The active substance in Senshio, ospemifene, is a selective oestrogen receptor modulator (SERM). This means that it acts in the same way as oestrogen in some tissues in the body such as the vagina and so helps to reduce symptoms of vulvovaginal atrophy. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2021 Expected Registration February 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie ontvangen in januari 2022. Therapeutic value Current treatment options Vaginaal oestrogeen (estriol of estradiol). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Ospemifene is een SERM − selectieve oestrogeen receptor modulator − die in de vagina agonistisch werkt en antagonistisch op het endometrium en op de mammae. Het geneesmiddel lijkt veelbelovend te zijn. Er wordt verwacht dat dit geneesmiddel te gebruiken is naast oestradiol en oestriol bij vooral vrouwen na of tijdens borstkanker. Duration of treatment Frequency of administration 1 times a day Dosage per administration 60 mg References NCT01586364; NCT00276094; NCT00276094 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Gipdatabank (1); Expertopinie (2); Additional remarks Er wordt verwacht dat dit geneesmiddel te gebruiken is naast oestradiol en oestriol bij vooral vrouwen na of tijdens borstkanker. De gebruikersaantallen voor deze twee oestrogenen lag in 2021 op 146.866 gebruikers in totaal (1). Het is niet bekend hoe vaak ospemifene naast oestradiol en oestriol ingezet zal worden (2). Expected cost per patient per year Cost € 605.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References NHS Commissioning Statement Additional remarks De jaarlijkse kosten in het Verenigd Koninkrijk zijn door de NHS berekend als £514.68 per jaar. Omgerekend zou dit €604,58 per patiënt per jaar betekenen. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks