CurrentCentenePolicy CP PHAR.446

Flibanserin (Addyi) Coverage

This policy governs prior authorization and coverage criteria for flibanserin (Addyi) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) under Centene lines of business (Commercial, Medicaid). It specifies initial and continuation approval requirements, dosing limits, contraindications, and duration of approval.

Policy Summary

PayerCentene

PolicyFlibanserin (Addyi) Coverage

Policy CodePolicy CP PHAR.446

Change TypeNo material change

Effective DateMar 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing trial of bupropion and clinical notes supporting HSDD criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 mg/daymaximum daily dose

3 monthsinitial approval duration

12 monthscontinued therapy duration

Premenopausalindicated population

Coverage Criteria

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Initial Approval - HSDD in premenopausal women: 1) Diagnosis of hypoactive sexual desire disorder (HSDD) in a premenopausal woman; 2) Age >= 18 years; 3) HSDD symptoms have persisted for a minimum of 6 months; 4) Failure of a 3-month trial of bupropion at up to maximally studied effective doses unless contraindicated or clinically significant adverse effects occur; 5) HSDD is not primarily attributed to problems within the relationship, the effects of a medication or other substance, or a co-existing medical or psychiatric condition; 6) Not prescribed concurrently with Vyleesi; 7) Dose does not exceed 100 mg (1 tablet) per day.duration >= 6 months

Approval duration: 3 months

inv-02: Continuation Therapy — Continuation/renewal criteria (Covered when)

Continuation/renewal criteria (Covered when):

Continued Therapy for members already receiving medication: 1) Member is currently receiving medication via the Centene benefit and previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care; 2) Member is responding positively to therapy; 3) If the request is for a dose increase, the new dose does not exceed 100 mg (1 tablet) per day.

Approval duration: Medicaid 12 months; Commercial 12 months or duration of request, whichever is less

Addyi (flibanserin) is indicated for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and is not indicated for treatment of HSDD in postmenopausal women or in men. Non‑FDA approved indications or uses not described in this policy are not authorized unless there is sufficient supporting documentation of efficacy and safety in accordance with applicable off‑label use policies.

Requests for Addyi for indications not described in this policy (non‑FDA approved uses) require submission of sufficient clinical documentation to demonstrate efficacy and safety consistent with the plan's off‑label use policy. Acceptable supporting documentation includes office chart notes, relevant laboratory or diagnostic testing, and other clinical information that substantiates the requested off‑label use.

Initial Therapy Requirements

inv-17: Initial Therapy — Initial authorization criteria

Initial authorization criteria

Initial therapy nodes: Diagnosis of HSDD in premenopausal women; age >= 18 years; symptoms have persisted for a minimum of 6 months; failure of a 3-month trial of bupropion at up to maximally studied effective doses unless contraindicated; HSDD is not due to relationship problems, medication/substance effects, or explained by a co-existing medical or psychiatric condition; Addyi is not prescribed concurrently with Vyleesi; dose does not exceed 100 mg/day.

inv-18: Initial therapy — policy history notes about initial criteria additions

Policy history notes regarding initial criteria additions

Initial therapy policy history notes: Policy history: added Medicaid line of business; added 3-month trial and failure of bupropion; clarified bupropion trial language to 'up to maximally studied effective doses'; added requirement that symptoms persist for at least 6 months; added criterion that HSDD is not due to co-existing medical or psychiatric conditions, relationship problems, or effects of medications/substances; added that Addyi is not to be prescribed concurrently with Vyleesi.

Continuation / Renewal Requirements

inv-19: Continuation Therapy — continuation therapy requirements

Continuation therapy requirements

Continued therapy nodes: Member currently receiving medication with prior approval or under continuity of care; member is responding positively to therapy; if request is for dose increase, new dose does not exceed 100 mg (1 tablet) per day.

Approval duration: Medicaid 12 months; Commercial 12 months or duration of request, whichever is less

inv-20: Continued therapy — policy history references to changes in continued therapy approval durations

Policy history references to continued therapy approval duration changes

continued_therapy_duration: Policy history: revised Medicaid continued therapy approval duration from length of benefit to 12 months; Commercial continued therapy duration documented as 12 months or duration of request in the policy history.

See policy history for dates and line-of-business details.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Addyi (flibanserin) is medically necessary only when the policy criteria are met and prior authorization has been obtained.

Prior authorization required for Addyi (flibanserin).
Medication approved only when ALL policy criteria are satisfied.

Documentation Required

Required Documentation / Missing Documentation

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests that lack sufficient supporting documentation to demonstrate that the member meets all approval criteria may be denied or pended for additional information.

Include office visit notes, diagnostic assessments, medication trials and dates, and relevant laboratory results.
If documentation is incomplete, the request may be returned or denied.

Step Therapy

Step Therapy / Therapeutic Alternative

A 3-month trial and failure of bupropion at maximally studied effective doses is required prior to approval, unless contraindicated or not tolerated. See Appendix B for bupropion dosing details.

Failure of a 3-month trial of bupropion at up to maximally studied effective doses is required unless contraindicated or clinically significant adverse effects are experienced.
Appendix B lists bupropion formulations and maximum studied doses (e.g., IR 450 mg/day, SR 400 mg/day, ER (HCl) 450 mg/day, ER (HBr) 522 mg/day).

Note

Policy History and Administrative Notes

Policy history: a required 3-month trial and failure of bupropion was added historically; HIM line of business was later removed because HSDD is excluded from coverage for that line of business.

11/19/2019 — Added 3-month trial and failure of bupropion; added Vyleesi non‑concurrent use.
02/04/2025 — Removed HIM line of business as HSDD is excluded from coverage.

Step Therapy Requirements

Step	Requirement	Notes
1	Trial of bupropion at up to maximally studied effective doses	Duration: 3 months; use maximally studied effective doses per Appendix B (see dosing limits in Appendix B).

Historical Step	Historical Requirement	Historical Notes
1	Prior trial of bupropion required before flibanserin approval	Policy history documents that a 3-month trial and failure of bupropion was added historically; exact dose/duration details referenced in Appendix B and clarified to 'maximally studied effective doses'.

Definitions

HSDD definition

Core definitionHSDD is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity causing marked distress or interpersonal difficulty

Exclusion from definitionNot better accounted for by another psychiatric disorder

Substance/medical exclusionNot due exclusively to direct physiological effects of a substance or another medical condition

Fluctuation noteDoes not include normal (e.g., daily or weekly) fluctuations in levels of desire

HSDD (policy context)

Policy-context exclusionsHSDD must not be primarily attributable to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication/substance

Policy history — step therapyA required 3-month trial and failure of bupropion was added historically (clarified to 'up to maximally studied effective doses')

Policy history — continuity and lines of businessMedicaid and Commercial continued therapy approval durations were revised historically; HIM line of business later removed as HSDD excluded from coverage

Background

Hypoactive sexual desire disorder (HSDD) is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty and is not better accounted for by another psychiatric disorder, substance use, or medical condition. Addyi (flibanserin) is approved specifically for premenopausal women with acquired, generalized HSDD; the policy clarifies that HSDD should not be primarily attributable to relationship problems, the effects of a medication or substance, or a co‑existing medical or psychiatric condition.