WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR OSPHENA?: CADTH recommends that Osphena should be reimbursed by public drug plans for the treatment of postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause, if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Osphena should only be covered for patients who share the same characteristics as patients who are eligible for vaginal estrogen products that are currently reimbursed by public drug plans for the treatment of postmenopausal VVA. WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Osphena should only be reimbursed if it is not used with other estrogen therapies and if treatment with Osphena does not cost more than treatment with the least costly vaginal estrogen product currently reimbursed for postmenopausal VVA. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from 5 clinical trials demonstrated that Osphena improves dyspareunia (painful sex) and vaginal dryness, restores vaginal tissues, and improves vaginal pH levels better than placebo. Osphena provides a treatment option for patients who prefer an oral treatment over a local vaginal therapy. There is no evidence to show Osphena is more effective than other reimbursed therapies used to treat postmenopausal VVA. Osphena will cost the public drug plans an additional $4,294,925 over 3 years.

ADDITIONAL INFORMATION

WHAT ARE DYSPAREUNIA AND VAGINAL DRYNESS? Dyspareunia (painful sex) and vaginal dryness are symptoms of VVA, which is when the lining of the vagina thins due to the loss of estrogen after menopause. Approximately 34% of postmenopausal individuals are living with dyspareunia and/or vaginal dryness associated with VVA. UNMET NEEDS FOR DYSPAREUNIA AND VAGINAL DRYNESS: Currently available vaginal estrogen therapies are typically effective in providing symptom relief for most patients. Patients with mobility issues may find local vaginal therapies difficult to use. Some patients also may find these therapies very painful to use. HOW MUCH DOES OSPHENA COST? Treatment with Osphena is expected to cost approximately $567 per patient per year.