CurrentNeighborhood Health Plan of Rhode IslandPolicy 961-A

Ospemifene (Osphena) prior authorization

Criteria governing prior authorization for ospemifene (Osphena) for treatment of moderate to severe dyspareunia or vaginal dryness due to menopause for members of Neighborhood Health Plan of Rhode Island under this payer policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOspemifene (Osphena) prior authorization

Policy CodePolicy 961-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization requests only for patients with moderate to severe dyspareunia or vaginal dryness due to menopause and document clinical response for continued approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDuration of approval (DOA)

2FDA‑approved indications listed

Initial PARequest type

Coverage Criteria for Ospemifene (Osphena)

Moderate to Severe Dyspareunia Due to Menopause

Covered when ALL of the following are met for dyspareunia:

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Dyspareunia criteria: 1) Ospemifene is prescribed for moderate to severe dyspareunia (pain during sexual intercourse) due to menopause; 2) The patient has achieved or maintained a positive clinical response to ospemifene; 3) The patient has been re-evaluated periodically to determine if treatment is still necessary.

Authorization may be granted when all criteria are met.

Moderate to Severe Vaginal Dryness Due to Menopause

Covered when ALL of the following are met for vaginal dryness:

Vaginal dryness criteria: 1) Ospemifene is prescribed for moderate to severe vaginal dryness due to menopause; 2) The patient has achieved or maintained a positive clinical response to ospemifene; 3) The patient has been re-evaluated periodically to determine if treatment is still necessary.

Authorization may be granted when all criteria are met.

Use of ospemifene (Osphena) is limited to the FDA‑approved indications. Specifically, authorization applies only when prescribed for moderate to severe dyspareunia or moderate to severe vaginal dryness, each a symptom of vulvar and vaginal atrophy due to menopause. Requests for ospemifene for any other indications are not within the listed FDA‑approved uses and are therefore outside the scope of coverage under this policy.

Provider Actions and Authorization Requirements

Prior Authorization

Moderate to Severe Dyspareunia Due to Menopause

Prior authorization may be granted when ospemifene is prescribed for moderate to severe dyspareunia (pain during sexual intercourse) due to menopause.

Prior Authorization

Moderate to Severe Vaginal Dryness Due to Menopause

Prior authorization may be granted when ospemifene is prescribed for moderate to severe vaginal dryness due to menopause.

Documentation Required

Continuation Criteria / Required Clinical Response Documentation

Ongoing therapy requires documentation that the patient has achieved or maintained a positive clinical response to ospemifene and periodic reassessment to determine if continued treatment is necessary.

Documentation of positive clinical response is required
Periodic re-evaluation to confirm ongoing need for therapy is required

Denial Risk

Indication Mismatch — Not Covered

Requests for ospemifene for indications other than moderate to severe dyspareunia or moderate to severe vaginal dryness due to menopause are not within the coverage criteria and are subject to denial.

Documentation Required

Provider Documentation and Submission Requirements

Providers must submit clinical documentation supporting the initial indication and, for continuation, evidence of positive clinical response and periodic reassessment.

Initial request: documentation of diagnosis (dyspareunia or vaginal dryness due to menopause) and severity (moderate to severe)
Continuation request: documentation of positive clinical response and dates/notes of periodic re-evaluation

Key Definitions

Moderate to severe dyspareunia

DefinitionPain during sexual intercourse as a symptom of vulvar and vaginal atrophy due to menopause.

Clinical contextSpecifically referenced as an FDA‑approved indication for ospemifene (Osphena).

Policy relevanceAuthorization may be granted when ospemifene is prescribed for this indication and continuation requires documented clinical response and periodic re‑evaluation.

Moderate to severe vaginal dryness

DefinitionVaginal dryness as a symptom of vulvar and vaginal atrophy due to menopause.

Clinical contextListed as an FDA‑approved indication for treatment with ospemifene (Osphena).

Policy relevancePrior authorization may be granted when ospemifene is prescribed for this indication; continued approval requires documented benefit and periodic re‑evaluation.