Currentmedical mutual - ohioPolicy N/A

Addyi (flibanserin)

Defines recommended prior-authorization criteria, initial and continuation approval requirements, approval durations, and conditions not recommended for approval for Addyi (flibanserin) under the pharmacy benefit.

Policy Summary

Payermedical mutual - ohio

PolicyAddyi (flibanserin)

Policy CodePolicy N/A

Change TypeAnnual review; references updated

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approve only patients who meet the listed criteria and document counseling on alcohol interaction.

POLICY UPDATE CHANGES

Annual review and last revised date listed as 01/15/2026.

60 daysInitial approval length

180 daysExtended approval length

2Approval Durations (initial/extended)

1Primary covered indication (premenopausal HSDD/FSIAD)

Coverage Summary

Coverage is covered with criteria for Addyi (flibanserin) for the treatment of acquired, generalized HSDD/FSIAD in premenopausal women. The policy defines prior-authorization criteria for initial and continuation approval, requires documentation of response for reauthorization, specifies approval durations (initial 60 days; extended 180 days), and lists conditions not recommended for approval under the pharmacy benefit.

Initial Therapy - Acquired, Generalized HSDD/FSIAD

Covered when ALL of the following are met:

ALL of the following

The patient is an adult woman younger than 65 years of age
The patient has a diagnosis of acquired, generalized hypoactive sexual desire disorder (HSDD)/female sexual interest/arousal disorder (FSIAD) consistent with the current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)
The patient has had normal sexual desire in the past, prior to the diagnosis of HSDD/FSIAD
Low sexual desire is NOT caused by any of the following
- Co-existing medical or psychiatric condition
- Problems within the relationship
- The effects of medication (e.g. antidepressants) or other drug substances
- Drug abuse
The prescriber has counseled the patient regarding the interaction of Addyi with alcohol and the increased risk of hypotension and syncope
Patient does not have hepatic impairment
Patient will not use Addyi concurrently with CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin)
Patient will not exceed maximum recommended dose of 100 mg taken once daily at bedtimemax dose 100 mg once daily
Patient is not currently pregnant or breastfeeding

Continuation of Therapy - Acquired, Generalized HSDD/FSIAD

Continued coverage when ALL of the following are met:

ALL of the following

The patient continues to meet all criteria for new starts (all initial therapy criteria)
Patient has been evaluated and has seen improvement on Addyi defined by an increase in satisfying sexual events, and/or improvement in sexual desire, as determined by the prescriber
The patient has not reported any serious or concerning adverse events (e.g. hypotension, syncope, dizziness) while using Addyi

Provider Actions / Utilization Management

Prior Authorization

Prior authorization required

Prior authorization is recommended for pharmacy benefit coverage of Addyi; approval is recommended only for patients meeting the listed criteria.

Documentation Required

Counseling on alcohol interaction

Prescriber must counsel the patient regarding the interaction of Addyi with alcohol and the increased risk of hypotension and syncope. Documentation of this counseling may be requested by the company.

Documentation of counseling may be requested

Documentation Required

Continuation response assessment

For reauthorization, the prescriber must document that the patient has had improvement on Addyi (e.g., increase in satisfying sexual events and/or improvement in sexual desire) and that no serious or concerning adverse events (such as hypotension, syncope, or dizziness) have been reported while using Addyi.

Documented improvement (increase in satisfying sexual events and/or improvement in sexual desire)
Documented absence of serious adverse events (e.g., hypotension, syncope, dizziness)

Documentation Required

Medical necessity documentation

The company may request additional documentation (patient records, test results, provider credentials) to support medical necessity and may deny reimbursement if documentation is not provided or if the drug/services are deemed not medically necessary, investigational, or outside the scope of benefits.

Patient records may be requested
Test results may be requested
Provider credentials may be requested
Reimbursement may be denied if medical necessity is not supported

Denial Risk

Contraindications / exclusion risk

Requests will be denied or not recommended for approval if the patient has hepatic impairment, is pregnant or breastfeeding, will use CYP3A4 inhibitors concurrently, or if low sexual desire is due to medical or psychiatric conditions, relationship problems, medications, or drug abuse.

Hepatic impairment
Pregnancy or breastfeeding
Concurrent use of CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
Low sexual desire caused by medical/psychiatric conditions, relationship problems, medications, or drug abuse

Unapproved Uses, Contraindications, and Safety Requirements

Patients with hepatic impairment, those who are pregnant or breastfeeding, and patients who will use concurrent CYP3A4 inhibitors (for example ketoconazole or clarithromycin) are excluded from use. The prescriber must counsel the patient regarding the interaction of Addyi with alcohol and the increased risk of hypotension and syncope; patients should also be counseled about dizziness and related safety concerns. The policy also indicates the maximum recommended dose is 100 mg once daily at bedtime.

Dose, Prescribing Info, Key Trials

Maximum dose100 mg once daily at bedtime

Prescribing information dateDecember 2025

Key trials from evidenceSNOWDROP, PLUMERIA

Background & Definitions

Addyi (flibanserin) is indicated for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, medications or drug abuse. The policy requires prescriber counseling about the alcohol interaction and excludes use in patients with hepatic impairment, those taking CYP3A4 inhibitors concurrently, and patients who are pregnant or breastfeeding.

HSDD/FSIAD: hypoactive sexual desire disorder / female sexual interest/arousal disorder as defined by the current Diagnostic and Statistical Manual of Mental Disorders (DSM).

OpenPayer

Addyi (flibanserin)

Coverage Summary

Provider Actions / Utilization Management

Applicable Codes

Unapproved Uses, Contraindications, and Safety Requirements

Clinical Evidence & References

Background & Definitions

Revision History