December 2019

Vyleesi™ approved to treat HSDD in premenopausal women

Vyleesi (bremelanotide) is considered a sexual dysfunction drug and is the first specialty drug in this category. It is the second drug approved by the U.S. Food and Drug Administration (FDA) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Vyleesi is an injectable drug with a dose limit of one dose within 24 hours and no more than eight doses per month. The average cost of Vyleesi for a cash-paying customer is $237 per dose.1 The average cost per year would vary depending on use, but could exceed $22,000.1

When coverage of sexual dysfunction drugs either are available through plan design or elected coverage (lifestyle benefit), Vyleesi will require prior authorization to confirm that the use is consistent with the FDA-approved indication and available clinical evidence.

Vyleesi will also be subject to quantity limitations (eight doses per month) consistent with the FDA-recommended dosing. When covered, the formulary tier for Vyleesi depends on the client’s plan design. If the Cigna formulary used by the client does not have a specialty tier, Vyleesi is placed on the Non-Preferred Brand Drug tier. If, however, the Cigna formulary used by the client offers a specialty drug tier, then Vyleesi is placed on the Specialty Drug tier.

  1. Vyleesi Prices, Coupons and Patient Assistance Programs. (Accessed October 22, 2019). Retrieved from https://www.drugs.com/price-guide/vyleesi.

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