CurrentMedical Mutual - OhioPolicy N/A

Intrarosa (prasterone) coverage

Defines Medical Mutual - Ohio's prior authorization recommendation and coverage criteria for the pharmacy benefit use of Intrarosa (prasterone) for treatment of moderate-to-severe dyspareunia due to vulvar and vaginal atrophy in postmenopausal women.

Policy Summary

PayerMedical Mutual - Ohio

PolicyIntrarosa (prasterone) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the stated coverage criteria and approval duration; for reauthorization, document clinical improvement on Intrarosa.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90Initial approval duration

365Extended approval duration

1Covered primary indication

3Explicit contraindications listed

Authorization Criteria for Intrarosa (prasterone)

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ALL of the following

Patient is a post-menopausal woman with a diagnosis of moderate-to-severe dyspareunia due to vulvar and vaginal atrophy
One of the following
- Patient has tried and failed a low dose estrogen preparation (examples: generic estradiol vaginal cream, generic estradiol vaginal insert, Yuvafem, Premarin vaginal cream, Estrace vaginal cream, Estring, Vagifem)
- Prescriber states the patient is at increased risk of endometrial cancer, stroke, and/or deep vein thrombosis (DVT)
No contraindications present
- No undiagnosed abnormal genital bleeding
- Not pregnant or breastfeeding
- No current or past history of breast cancer
Patient does not have renal or hepatic impairment
Use will be for the shortest duration consistent with treatment goals and risks; re-evaluate periodically to determine ongoing need

Recommended Authorization Criteria Continuation Therapy

Coverage for continuation is recommended when ALL of the following are met:

ALL of the following

Patient continues to meet all criteria for new starts (see Initial Therapy criteria)
Patient has been evaluated and shown improvement on Intrarosa as determined by the prescriber

Prescriber and Payer Actions

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Intrarosa; approvals are limited to patients who meet the policy's coverage criteria and to the specified initial or extended approval durations.

Initial approval duration: 90 days
Extended approval duration: 365 days
Applies to pharmacy benefit coverage

Documentation Required

Documentation may be requested to support medical necessity

The company may request additional documentation (patient records, test results, provider credentials) to support its coverage determination and may deny reimbursement when the drug or services are not medically necessary, investigational/experimental, not within member benefits, or part of inappropriate/excessive billing.

Documentation requested may include patient records, test results, and credentials of the provider ordering or performing the service

Note

Response required for reauthorization

For reauthorization/continuation of therapy, the prescriber must document that the patient has shown improvement on Intrarosa to support continuation or extended approval.

See Continuation Therapy criteria — patient must meet initial criteria and have shown improvement as determined by the prescriber

Defined Terms

Definitions

TermModerate-to-severe dyspareunia

DefinitionPainful sexual intercourse attributed to vulvar and vaginal atrophy in postmenopausal women; the policy does not provide a numeric severity scale.

ContextListed as the covered indication for Intrarosa (prasterone) treatment in postmenopausal women.

Related clinical notePolicy specifies patients must be post-menopausal and have dyspareunia due to vulvar and vaginal atrophy.

Policy implicationSeverity is defined descriptively only; no numeric severity scale is provided in the policy.