Does Aetna (CVS Health) Cover Vyleesi (Bremelanotide)?

The approved use is narrow, and that shapes any coverage request

Bremelanotide is FDA-approved as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder: low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, relationship problems, or a medication or drug [1]. Two of the label's definitions do most of the work here. Acquired means the problem developed in a woman who previously had none, and generalized means it occurs regardless of the type of stimulation, situation or partner [1].

The label states that Vyleesi is not indicated for HSDD in postmenopausal women or in men, and not to enhance sexual performance [1]. A request written outside that population is asking a plan to pay for a use the label does not cover.

Dosing and quantity limits on the label

The dose is 1.75 mg injected subcutaneously into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity [1]. The label says not to give more than one dose within 24 hours and that more than 8 doses per month is not recommended [1].

Contraindications on the label

The label contraindicates Vyleesi in people with uncontrolled hypertension or known cardiovascular disease, and says it is not recommended in patients at high risk for cardiovascular disease [1]. The drug has no boxed warning, and no REMS appears in the label or in the 2019 approval letter for NDA 210557 [1][2].

What to ask Aetna

The member services number on the Aetna ID card reaches the people who can answer these questions about bremelanotide (brand name Vyleesi):

• Is bremelanotide on my plan's drug list?
• Does the plan require prior authorization, and what documentation does it ask for?
• Does the plan require step therapy before it will pay?
• Is there a quantity limit, a separate specialty deductible, or a separate specialty pharmacy requirement?

Vyleesi requires a prescription [1]. Ask which benefit under your plan processes the claim.

Compounded PT-141 is not Vyleesi

Peptide products sold as PT-141, whether compounded or labeled for research use, are not Vyleesi and are not FDA-approved drugs; compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [3]. The FDA-approved bremelanotide product is Vyleesi, a 1.75 mg subcutaneous autoinjector [1].