CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2026 P 2074-13

Addyi™ (flibanserin) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization and medical necessity criteria for Addyi (flibanserin) for UnitedHealthcare Commercial Plans, including initial authorization, reauthorization, clinical rules, and restrictions (age, sex at birth, hepatic function, and CYP3A4 inhibitor contraindications).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyAddyi™ (flibanserin) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 2074-13

Change TypeFDA age-label updateprior material updates

Effective DateMay 1, 2026

Next Review Date

Key ActionInitial and reauthorization require meeting the specified medical necessity criteria; reauthorization will be issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated based on new FDA approval for women ages 65 and less.

Changed criteria to require patient was female at birth.

Removed REMS and alcohol abstinence requirements due to updated labeling.

Changed reauthorization period from 6 to 12 months.

2Authorized Diagnoses (examples)

12 monthsReauthorization duration

65Age upper limit per 2026 update

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Coverage Summary

Coverage stance: covered_with_criteria for Addyi (flibanserin).

Scope: Defines prior authorization and medical necessity criteria for UnitedHealthcare Commercial Plans, including initial authorization and reauthorization rules, clinical exclusions, and restrictions on age, sex at birth, hepatic function, and concomitant CYP3A4 inhibitor use.

Subject: Addyi (flibanserin) prior authorization / medical necessity.

Indication (brief): Addyi is indicated for treatment of acquired, generalized hypoactive sexual desire disorder in women ≤ 65 years (per 2026 update), characterized by low desire causing marked distress or interpersonal difficulty and not due to medical/psychiatric conditions, relationship problems, or effects of medications/substances; not indicated for men or to enhance sexual performance.

Initial Therapy Criteria

Initial Authorization

Addyi will be approved based on all of the following criteria:

ALL of the following

Diagnosis (ONE of)
- Acquired, generalized hypoactive sexual desire disorder (HSDD)
- Female sexual interest/arousal disorder
Symptoms of HSDD or female sexual interest/arousal disorder have persisted for at least 6 months>= 6 months
duration requirement
Low sexual desire is NOT due to a co-existing medical or psychiatric condition
exclusion
Low sexual desire is NOT due to problems within the relationship
exclusion
Low sexual desire is NOT due to the effects of a medication or other drug substance
exclusion
Patient was female at birth
sex-at-birth requirement
Patient does not have hepatic impairment (e.g., a Child-Pugh score of 6 points or greater)>= 6 points
excludes hepatic impairment; example threshold provided
Patient is not concomitantly on moderate or strong CYP3A4 inhibitors (e.g., ciprofloxacin, clarithromycin, diltiazem, fluconazole, itraconazole, ketoconazole, ritonavir, verapamil)
drug-drug interaction exclusion

Continuation / Reauthorization Criteria

Reauthorization

Addyi will be approved for reauthorization based on all of the following criteria:

ALL of the following

Documentation of positive clinical response to Addyi therapy
Patient does not have hepatic impairment (e.g., a Child-Pugh score of 6 points or greater)>= 6 points
excludes hepatic impairment; example threshold provided
Patient is not concomitantly on moderate or strong CYP3A4 inhibitors (e.g., ciprofloxacin, clarithromycin, diltiazem, fluconazole, itraconazole, ketoconazole, ritonavir, verapamil)
include examples

Unproven / Exclusions

Exclusion Criteria (Disqualifying Conditions)

Exclusion / Not-covered conditions

Patient is male or was not female at birth (policy requires patient was female at birth)
historical change noted: criteria requires patient was female at birth
Patient has hepatic impairment (e.g., Child-Pugh score of 6 points or greater)>= 6 points
hepatic impairment exclusion
Patient is concomitantly on moderate or strong CYP3A4 inhibitors (e.g., ciprofloxacin, clarithromycin, diltiazem, fluconazole, itraconazole, ketoconazole, ritonavir, verapamil)
drug-drug interaction exclusion; examples listed

Applicable Codes

Relevant diagnosis examples citedICD-10

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Initial and reauthorization require meeting the specified medical necessity criteria; reauthorization will be issued for 12 months.

Initial and reauthorization require meeting the specified medical necessity criteria; prior auth required

Documentation Required

Documentation of diagnosis and duration

Provide documentation that diagnosis is acquired, generalized HSDD or female sexual interest/arousal disorder and that symptoms have persisted at least 6 months; for reauthorization, document positive clinical response.

Document diagnosis (acquired, generalized HSDD or female sexual interest/arousal disorder)
Document symptoms persisted >= 6 months

Clinical Evidence & Rationale

Evidence summary: The policy includes P&T review history with approvals and updates from 9/2015 through 2/2026, and the program effective date is 5/1/2026.

The package insert cited is dated December 2025 and is listed as the primary manufacturer reference.

Clinical evidence cited includes multiple randomized trials and meta-analyses (for example DAISY, BEGONIA, VIOLET trials and a JAMA Internal Medicine systematic review/meta-analysis) informing safety and efficacy.

Background & Definitions

Addyi is indicated for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in women ≤ 65 years of age. The disorder is 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, or the effects of a medication or other drug substance. Addyi is not indicated for men and is not indicated to enhance sexual performance.

Initial authorization criteria include diagnosis of acquired, generalized HSDD or female sexual interest/arousal disorder and symptom persistence for at least 6 months, among other exclusions (see clinical rules).

Reauthorization requires documentation of a positive clinical response to Addyi and continued absence of hepatic impairment and contraindicated CYP3A4 inhibitors; reauthorizations are issued for 12 months.

Definitions:

Acquired HSDD: HSDD that develops in a patient who previously had no problems with sexual desire.

Generalized HSDD: HSDD that occurs regardless of the type of stimulation, situation or partner.

Revision History

2/2026revisedLatest

Updated based on new FDA approval for women ages 65 and less.

12/2019added

Changed criteria to require patient was female at birth.

8/2021removed

Removed REMS and alcohol abstinence requirements due to updated labeling.