Does Kaiser Permanente Cover Vyleesi (Bremelanotide)?

What to check about Kaiser coverage

The open questions are plan-specific: whether Vyleesi sits on a plan's formulary, whether a prior authorization is required, and whether the plan asks for a trial of another HSDD drug first. Those rules are written by each plan and are not part of the FDA label.

Kaiser member services can confirm formulary status for a specific product, and the plan's published drug list or prior-authorization criteria is where the answer sits.

What the FDA approval covers

Vyleesi is a 1.75 mg injection given with a prefilled autoinjector into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity [1]. The label says not to use more than one dose in 24 hours and does not recommend more than eight doses per month, and says to stop after 8 weeks if symptoms have not improved [1]. It is prescription only, and FDA approved it on June 21, 2019 under NDA 210557; the current holder is Cosette Pharmaceuticals [1][2].

The approved population is defined precisely: premenopausal women with acquired, generalized hypoactive sexual desire disorder, meaning desire low enough to cause marked distress or interpersonal difficulty and not explained by a coexisting medical or psychiatric condition, relationship problems, or a medication or drug. Acquired means the problem developed in a woman who previously had none; 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].

The label carries no boxed warning and no risk evaluation and mitigation strategy [1][2]. It lists two contraindications, uncontrolled hypertension and known cardiovascular disease; it says to weigh cardiovascular risk and confirm blood pressure is well controlled before starting and periodically during treatment, and does not recommend the drug for patients at high cardiovascular risk [1]. Each dose causes a transient rise in blood pressure and a fall in heart rate, with maximal increases of 6 mmHg systolic and 3 mmHg diastolic peaking 2 to 4 hours after dosing and a heart rate reduction of up to 5 beats per minute, usually back to baseline within 12 hours [1].

If the prescription is compounded PT-141

Vyleesi is the FDA-approved bremelanotide product [1]. Products sold as compounded or research-use PT-141 are not Vyleesi and are not FDA-approved drugs, and compounded drugs are not reviewed by FDA for safety, effectiveness or quality before they are marketed [3][1].