Osphena — Medical Mutual

Initial criteria

• Patient is a post-menopausal woman with a diagnosis of moderate to severe dyspareunia due to vulvar and vaginal atrophy; AND
• Patient has tried and failed a low dose vaginal estrogen preparation (e.g. generic estradiol vaginal cream, generic estradiol vaginal insert, Yuvafem, Premarin vaginal cream, Estrace vaginal cream, Estring, Vagifem); AND
• Patient does NOT have any of the following contraindications to Osphena: undiagnosed abnormal genital bleeding; known or suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism, or a history of these conditions; active arterial thromboembolic disease; hypersensitivity to Osphena or any ingredient; known or suspected pregnancy; AND
• Osphena will NOT be used with estrogens, estrogen agonist/antagonists, fluconazole, or rifampin; AND
• The patient does not have hepatic impairment; AND
• Use of Osphena will be for the shortest duration consistent with treatment goals and risks; AND
• Patients will not exceed maximum recommended dose of 60 mg taken once daily with food

Reauthorization criteria

• The patient continues to meet all criteria for new starts; AND
• The patient has been evaluated and has seen improvement on Osphena, as determined by the prescriber

Approval duration

initial 60 days; reauth 1 year