Vyleesi — Medical Mutual

Initial criteria

• Patient is a premenopausal woman age ≥ 18 years; AND
• Patient has acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty; AND
• Patient has had normal sexual desire in the past, prior to the diagnosis of HSDD; AND
• Condition is NOT due to a co-existing medical or psychiatric condition; AND
• Condition is NOT due to problems with the relationship; AND
• Condition is NOT due to the effects of a medication or drug substance; AND
• Prescribing physician has determined the average pre-treatment number of satisfying sexual events for the patient over a specific time frame in order to evaluate treatment efficacy after initiation; AND
• Patient does NOT have uncontrolled hypertension or known cardiovascular disease; AND
• Patient will not be using more than 8 doses per month or more than one dose within a 24-hour time-frame

Reauthorization criteria

• Patient continues to meet all criteria for new starts; AND
• Prescribing physician confirms that since initiating Vyleesi therapy, the patient reports an increase in the number of satisfying sexual events as compared to pre-treatment

Approval duration

initial 2 months; reauth 6 months