Does Anthem (Elevance Health) Cover Vyleesi (Bremelanotide)?

What Vyleesi is

Vyleesi is a prescription-only medicine that FDA approved under NDA 210557 on June 21, 2019; the application is held by Cosette Pharmaceuticals and was originally held by AMAG [1][2]. It is a 1.75 mg subcutaneous injection given with a prefilled autoinjector pen [1].

Approval sets the drug's legal status and its labeled use. It does not state what an insurer pays.

Who Vyleesi is approved for

Vyleesi is indicated for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug [1]. Acquired means the problem developed in a woman who previously had no trouble with sexual desire; generalized means it occurs regardless of the type of stimulation, situation or partner [1].

The label's limitations of use define the population the drug is for. Vyleesi is not indicated for HSDD in postmenopausal women or in men, and it is not indicated to enhance sexual performance [1]. It carries no boxed warning, and no risk evaluation and mitigation strategy appears in the label or in the 2019 approval letter [1][2].

How the label limits use

The label's dosing section directs 1.75 mg injected subcutaneously into the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity [1]. It says not to give more than one dose within 24 hours and states that more than 8 doses per month is not recommended; more frequent dosing increases the risk of focal hyperpigmentation and lengthens the time each month that blood pressure is raised [1]. The label also says to stop after 8 weeks if there has been no improvement in symptoms [1].

Compounded PT-141 is not Vyleesi

Vyleesi is the FDA-approved bremelanotide product. PT-141 sold as a compounded or research-use peptide is not Vyleesi and is not an FDA-approved drug; compounded drugs are not reviewed by FDA for safety, effectiveness or quality before marketing [1][3].