CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1277-7

Osphena (ospemifene) prior authorization

Defines prior authorization criteria and reauthorization rules for Osphena (ospemifene) for treatment of moderate to severe dyspareunia or vaginal dryness due to menopausal vulvar and vaginal atrophy. Applies to members whose benefit plans use this UnitedHealthcare Pharmacy Clinical Pharmacy Program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOsphena (ospemifene) prior authorization

Policy CodePolicy 2025 P 1277-7

Change TypeAnnual reviewnon-material updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis of moderate to severe dyspareunia or vaginal dryness due to menopausal VVA.

SourceLink

POLICY UPDATE CHANGES

Annual review with updated references (3/2025).

Added mandate language (3/2023).

12 monthsauthorization duration

2025-06-01effective date

2019-2025policy approval history

2covered indications

Coverage Criteria for Osphena (ospemifene)

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Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Member has a diagnosis of either: (a) treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA) due to menopause; OR (b) treatment of moderate to severe vaginal dryness, a symptom of VVA due to menopause

Applies when the member's benefit design covers medications to treat sexual dysfunction; if the benefit design excludes medications to treat sexual dysfunction, see alternate criterion limiting approval to vaginal dryness only.

Reauthorization

Covered when the following is met:

Reauthorization: Documentation of positive clinical response to therapy

Authorization will be issued for 12 months; state mandates and member-specific benefit plans may affect coverage.

When a member's benefit plan expressly excludes medications to treat sexual dysfunction, approvals for Osphena (ospemifene) are limited. In those benefit designs authorization will be granted only for treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy (VVA) due to menopause. Requests for other sexual dysfunction indications (for example, dyspareunia) do not meet the allowed indication under these restricted benefit designs and are subject to denial.

Initial Therapy

Initial approval criteria

Indications: Diagnosis of either moderate to severe dyspareunia due to menopausal VVA OR moderate to severe vaginal dryness due to menopausal VVA (apply benefit-design distinctions as applicable)

If benefit design excludes medications to treat sexual dysfunction, approval is limited to the vaginal dryness indication only.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Osphena. Approval is contingent on a documented diagnosis of moderate to severe dyspareunia or moderate to severe vaginal dryness due to menopausal vulvar and vaginal atrophy (VVA).

Diagnosis must be documented in the medical record.
Authorization will be issued for 12 months; state mandates and member-specific benefit plans may affect coverage.

Denial Risk

Indication Requirement / Denial Risk

Requests lacking a documented diagnosis of moderate to severe dyspareunia or moderate to severe vaginal dryness due to menopausal VVA are at risk for denial.

For benefit designs that exclude medications to treat sexual dysfunction, Osphena may be approved only for treatment of moderate to severe vaginal dryness due to VVA.
Federal/regulatory requirements and plan-specific coverage may also impact denial risk.

Documentation Required

Reauthorization Documentation

Documentation of positive clinical response to Osphena therapy is required for reauthorization.

Reauthorization approvals require clinical notes or other documentation demonstrating symptomatic improvement.
Authorization durations are typically 12 months for approved reauthorizations.

Note

Supply Limits and Automated Approvals

Supply limits and automated approvals may apply. Initial or reauthorization may be approved based on prior claim/medication history, diagnosis codes, or claim logic per program rules.

Supply limits may be in place and vary by benefit design.
Automated approval processes vary by program and therapeutic class and may rely on claims history, ICD-10 diagnosis codes, or other claim logic.

Step	Requirement
1	Automated approval or re-approval may be granted based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Use of automated approval processes varies by program or therapeutic class.

Background

Ospemifene (Osphena) is covered under prior authorization when used for menopausal symptoms of vulvar and vaginal atrophy. For benefit designs that cover sexual dysfunction medications, Osphena may be approved for either moderate to severe dyspareunia or moderate to severe vaginal dryness, both recognized symptoms of VVA due to menopause. For benefit designs that exclude sexual dysfunction medications, approval is limited to the vaginal dryness indication only.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOsphena (ospemifene) prior authorization

Policy CodePolicy 2025 P 1277-7

Change TypeAnnual reviewnon-material updates

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documented diagnosis of moderate to severe dyspareunia or vaginal dryness due to menopausal VVA.

SourceLink

On This Page

OpenPayer

Osphena (ospemifene) prior authorization

Coverage Criteria for Osphena (ospemifene)

Initial Therapy

Reauthorization / Continuation Criteria

Coding and Authorization Duration

Provider Actions and Requirements

Step Therapy / Automated Approvals

Quantity Limits

Definitions

Background