Does Humana Cover Vyleesi (Bremelanotide)? Coverage, Prior Auth, and Appeals Explained

How to check a Humana plan's drug list for Vyleesi

A formulary is the list of drugs a plan covers. Humana sells many separate plans, each with its own formulary and utilization-management rules, so the plan's own formulary document is the place to search for both Vyleesi and bremelanotide.

A formulary entry shows a tier and any restriction attached to the drug, such as prior authorization, a quantity limit or step therapy through another drug first.

Vyleesi itself is a 1.75 mg subcutaneous autoinjector, prescription only, given as needed at least 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours; more than 8 doses per month is not recommended [1].

What the FDA label says about who the drug is for

Vyleesi is indicated for premenopausal women with acquired, generalized HSDD: low sexual desire causing marked distress or interpersonal difficulty that is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug [1]. Acquired means it developed in a woman who previously had no problem with sexual desire; generalized means it occurs regardless 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].

Contraindications and blood pressure on the label

The label lists uncontrolled hypertension or known cardiovascular disease as contraindications and does not recommend Vyleesi for people at high risk for cardiovascular disease; it directs assessment of cardiovascular risk and confirmation that blood pressure is well controlled before starting and periodically during treatment [1].

Each dose raises blood pressure transiently. In clinical studies the maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 hours after the dose, with a heart rate reduction of up to 5 beats per minute; values usually returned to baseline within 12 hours [1]. In a separate ambulatory study of 127 premenopausal women dosed once daily for 8 days, the mean daytime increase was 1.9 mmHg systolic (95% CI 1.0 to 2.7) and 1.7 mmHg diastolic (95% CI 0.9 to 2.4) [1].

What the pivotal trials showed

In the two RECONNECT trials, 1,267 premenopausal women with HSDD were randomized to bremelanotide 1.75 mg as needed or placebo for 24 weeks, with 1,202 in the efficacy analysis. Versus placebo, the Female Sexual Function Index desire domain improved by 0.30 points in study 301, 0.42 in study 302 and 0.35 across both, all P<0.001 [3].

Compounded PT-141 is not Vyleesi

Products sold as PT-141, whether compounded preparations or research-use peptides, are not Vyleesi and are not FDA-approved drugs; compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [1][2].