CurrentmhnPolicy CP.PHAR.446

Clinical Policy: Flibanserin (Addyi)

Defines medical necessity, prior authorization, and coverage criteria for flibanserin (Addyi) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) for Centene-affiliated health plans (Commercial and Medicaid).

Policy Summary

Payermhn

PolicyFlibanserin (Addyi) coverage

Policy CodePolicy CP.PHAR.446

Change TypeNo material change

Effective DateMar 1, 2020

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating the member meets all approval criteria, including age ≥18, ≥6 months of HSDD symptoms, and a 3-month trial of bupropion unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 mg/dayMaximum daily dose

3 monthsInitial approval

12 monthsContinuation approval

≥18Minimum age

6 monthsMin symptom duration

Excluded

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Coverage Criteria

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial HSDD criteria: 1. Diagnosis of hypoactive sexual desire disorder (HSDD) in premenopausal women; 2. Age ≥ 18 years; 3. Failure of a 3-month trial of bupropion at up to maximally studied effective doses unless contraindicated or intolerant; 4. HSDD symptoms have persisted for a minimum of 6 months; 5. HSDD is not attributed to any of the following: (a) a co-existing medical or psychiatric condition; (b) problems within the relationship; (c) effects of a medication or other drug/substance; 6. Flibanserin (Addyi) is not prescribed concurrently with Vyleesi®; 7. Dose does not exceed 100 mg (1 tablet) per day.see individual nodes

Approval duration: 3 months

inv-02: Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met:

Continuation HSDD criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or member has previously met initial approval criteria; or (b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If 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

Non‑FDA approved indications are not authorized for coverage under this policy unless there is sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (see CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid) or unless coverage is specified in the member's evidence of coverage document.

Hypoactive sexual desire disorder (HSDD) is excluded from coverage for the HIM line of business; requests for flibanserin (Addyi) for members in the HIM line of business may be denied on that basis.

Flibanserin (Addyi) is not indicated for the treatment of HSDD in postmenopausal women or in men and therefore such uses are not covered. In addition, Addyi is not indicated to enhance sexual performance and requests for that purpose are not supported by the prescribing information.

Initial Therapy

inv-21: Initial Therapy — Initial approval requirements

Initial approval requirements

Initial: Diagnosis of HSDD in premenopausal women; age ≥ 18 years; failure of a 3-month trial of bupropion at up to maximally studied effective doses unless contraindicated or intolerant (see Appendix B for dosing); HSDD symptoms persisted ≥ 6 months; HSDD not due to co-existing medical/psychiatric condition, relationship problems, or effects of a medication/substance; not prescribed with Vyleesi®; dose ≤ 100 mg/day.

inv-22: Initial Therapy — Initial criteria updates noted in policy history

Initial criteria updates noted in policy history

Initial therapy considerations: Initial criteria were updated to require HSDD symptom persistence of 6 months per DSM-5 (added 4Q2021) and to specify that HSDD is not due to co-existing medical or psychiatric conditions, relationship problems, or medication/substance effects (added 4Q2022).

Continuation / Continued Therapy

inv-23: Continuation — Criteria for continuation of therapy

Criteria for continuation of therapy

Continuation: Member meets prior therapy requirements (currently receiving via benefit, previously met initial approval criteria, or continuity of care per state/product); member is responding positively to therapy; any requested dose increase does not exceed 100 mg/day.

inv-24: Continued Therapy — Continued therapy approval duration for Commercial line of business was revised

Continued therapy approval duration for Commercial line of business was revised

Commercial continued therapy duration: Continued therapy approval duration for Commercial line of business limited to 12 months or duration of request, whichever is less (revised 4Q2023).

Step Therapy Requirements

Step	Requirement	Notes
1	Trial of bupropion for 3 months at up to maximally studied effective doses	Required prior to approval unless contraindicated or clinically significant adverse effects; see Appendix B for dosing and alternatives

Step	Requirement	Policy history / rationale
1	Evaluation to exclude other causes of low sexual desire per prescribing information (medical/psychiatric conditions, relationship problems, medication/substance effects)	Added to initial criteria in 4Q2022 per policy history; symptom persistence criterion (≥6 months) added 4Q2021; Appendix D lists examples

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Provider must demonstrate all approval criteria for HSDD in premenopausal women are met. Submit supporting documentation such as office chart notes, lab results, or other clinical information to verify diagnosis, symptom duration, prior therapies, contraindications, and dosing.

Applies to requests for flibanserin (Addyi).
Approval duration: 3 months.
Dose limit: ≤ 100 mg (1 tablet) per day.

Step Therapy

Step Therapy Requirement

Step therapy requirement: A documented failure of a 3-month trial of bupropion at up to maximally studied effective doses is required unless there is a contraindication or clinically significant adverse effect. Providers should include medication history with doses and dates, or documentation of intolerance/contraindication to bupropion.

See Appendix B for bupropion maximally studied effective doses (Immediate-release: 450 mg/day; Sustained-release: 400 mg/day; Extended-release HCl: 450 mg/day; Extended-release HBr: 522 mg/day).

Coding and Key Values

Minimum symptom duration

Minimum symptom duration>= 6 months

ContextHSDD symptoms must have persisted for a minimum of 6 months as part of initial approval criteria.

Source standardAligned with DSM-5 duration guidance added in 4Q2021.

Required prior therapy duration

Required prior therapy duration3 months trial of bupropion at up to maximally studied effective doses

ExceptionsUnless contraindicated or clinically significant adverse effects are experienced.

Documentation

Definitions

HSDD — definition

DefinitionHypoactive sexual desire disorder (HSDD): deficiency or absence of sexual fantasies and desire causing marked distress or interpersonal difficulty

ScopeIndicated for acquired, generalized HSDD in premenopausal women per FDA labeling.

ExclusionsNot due to a co-existing medical or psychiatric condition, relationship problems, or effects of a medication or other drug substance.

HSDD symptom duration

Symptom persistence requirementSymptom persistence of at least 6 months per DSM-5

Policy updateAdded to policy in 4Q2021 to align with DSM-5 diagnostic criteria.

Background

Flibanserin is a serotonin receptor modulator with activity as a 5‑HT1A receptor agonist and 5‑HT2A antagonist. It is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by a deficiency or absence of sexual fantasies and desire that causes marked distress or interpersonal difficulty and is not better explained by another psychiatric disorder, medical condition, relationship problems, or effects of a substance/medication. The prescribing information and policy note that HSDD symptoms should typically persist for at least 6 months, and treatment should be discontinued if there is no improvement after an appropriate trial period.

Quantity Limits

Flibanserin (Addyi) — quantity limit / dispense details

Quantity limit1 tablet per day

Maximum daily dose100 mg/day (100 mg PO once daily at bedtime)

Approval duration contextInitial approval duration is 3 months; continued therapy subject to continuation criteria and limits.

Revision History

2021-08-15policy_update

Added requirement that HSDD symptoms persist for at least 6 months per DSM-5 diagnostic criteria (4Q2021).

2022-08-11policy_update

Added to initial criteria that HSDD must not be due to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication/substance; Appendix D updated with examples (4Q2022).

2023-06-30policy_update

Policy Summary

Payermhn

PolicyFlibanserin (Addyi) coverage

Policy CodePolicy CP.PHAR.446

Change TypeNo material change

Effective DateMar 1, 2020

Next Review Date

SourceLink

On This Page

If bupropion is contraindicated or not tolerated, submit rationale and supporting clinical documentation.

Documentation Required

Required Documentation

Required Documentation — Providers must submit documentation supporting that the member meets all approval criteria, including: confirmation of HSDD diagnosis in a premenopausal woman, age ≥ 18 years, symptom persistence ≥ 6 months, exclusion of co-existing medical/psychiatric conditions, relationship problems, or medication/substance effects as the primary cause, prior bupropion trial details or contraindication, and assurance that flibanserin is not being used concurrently with Vyleesi.

Office chart notes, standardized assessment results, and medication administration records.
Relevant lab results or consult notes to exclude other medical causes.
Documentation of contraindications (e.g., hepatic impairment, concomitant moderate/strong CYP3A4 inhibitors) and hypersensitivity, as applicable.

Denial Risk

Denial Risk — Requests may be denied if criteria are not met. Common triggers for denial include: insufficient documentation of HSDD diagnosis or symptom duration, lack of or inadequate trial of bupropion, concurrent prescription with excluded agents (e.g., Vyleesi), contraindications noted in product labeling, dosing above the 100 mg/day limit, or coverage exclusions for the line of business (e.g., HIM).

Ensure documentation demonstrates symptoms persisted ≥ 6 months and are not due to other causes.
Verify line of business coverage; HSDD may be excluded for certain lines (HIM).

Note

Assessment Requirements

Assessment Requirements — Policy history additions require assessment to exclude co-existing medical or psychiatric conditions, relationship issues, and medication or substance effects as causes of low sexual desire. Providers should document evaluations or referrals performed to rule out these alternative causes.

Appendix D examples (per policy history) may guide assessment of conditions and medications associated with low sexual desire.
Document any specialist evaluations (e.g., psychiatry, endocrinology) or pertinent lab work.

See Appendix B for maximally studied bupropion doses to support prior therapy documentation.

HSDD symptom duration

HSDD symptom duration (DSM-5)>= 6 months

Policy historyCriterion for symptom persistence of 6 months was added in the 4Q2021 annual review.

Clinical rationaleDSM-5 recommended minimum duration to distinguish transient from persistent sexual dysfunction.

Helps distinguish transient sexual difficulties from persistent disorder for diagnosis and coverage decisions.

HSDD attribution

Attribution ruleHSDD must not be attributable to a co-existing medical or psychiatric condition, relationship problems, or the effects of a medication or other drug substance

Policy additionsClarified in 4Q2022 that initial criteria must exclude these causes per prescribing information.

Examples to considerSee policy appendices for examples of medical/psychiatric conditions and medications associated with low sexual desire.

For Commercial line of business, revised continued therapy approval duration to 12 months or duration of request, whichever is less (4Q2023).

2024-07-31annual_review

Annual review with no significant clinical changes; references reviewed and updated (4Q2024).

2025-02-04policy_update

Removed HIM line of business because HSDD is excluded from coverage (entry dated 02.04.25).

2025-08-04annual_reviewLatest

Annual review with no significant clinical changes; references reviewed and updated (4Q2025).