CurrentColorado Rocky Mountain Health PlansPolicy N/A

Intrarosa (prasterone) — Coverage Criteria and Prior Authorization

Criteria and prior authorization rules for coverage of Intrarosa (prasterone) vaginal insert for treatment of moderate to severe dyspareunia due to vulvar and vaginal atrophy in menopausal patients; applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs for the payer specified.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIntrarosa (prasterone) prior authorization — covered with criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionDocument diagnosis of moderate to severe dyspareunia, vulvar/vaginal atrophy due to menopause, and prior failure/contraindication/intolerance to two specified alternatives when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

2required prior therapies

4alternatives listed

9P&T approval years

Coverage Criteria

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

Covered when ALL of the following are met

Initial Authorization criteria: a. Diagnosis of moderate to severe dyspareunia

Initial Authorization criteria: b. Patient has vulvar and vaginal atrophy due to menopause

Initial Authorization criteria: c. History of failure, contraindication, or intolerance to two of the following: 1) Imvexxy (estradiol); 2) Osphena (ospemifene); 3) Premarin vaginal creamtwo required

Authorization will be issued for 12 months.

inv-02: Continuation Therapy / Reauthorization — Reauthorization covered when the following is met

Reauthorization covered when the following is met

Reauthorization criterion: Documentation of positive clinical response to therapy.documented positive response

Authorization will be issued for 12 months.

Coverage for Intrarosa (prasterone) is dependent on the member's benefit design. State mandates, federal regulatory requirements, and the member-specific benefit plan may affect whether the drug is covered. Other policies and utilization management programs may also apply; refer to the member's benefit plan for the final coverage determination.

Initial Therapy

inv-10: Initial therapy — Initial authorization criteria for Intrarosa

Initial authorization criteria for Intrarosa

Initial: Diagnosis of moderate to severe dyspareunia AND vulvar and vaginal atrophy due to menopause AND history of failure, contraindication, or intolerance to two of: Imvexxy (estradiol), Osphena (ospemifene), Premarin vaginal cream.all conditions required

Authorization will be issued for 12 months.

Continuation / Reauthorization

inv-11: Reauthorization — Reauthorization requirement

Reauthorization requirement

Reauth requirement: Documentation of positive clinical response to therapy.documented improvement

Authorization will be issued for 12 months.

Provider Actions

Prior Authorization

Initial authorization — Intrarosa

Initial authorization required for Intrarosa. Provider must document diagnosis and prior therapy history; authorization will be issued for 12 months when criteria are met.

Diagnosis: moderate to severe dyspareunia
Condition: vulvar and vaginal atrophy (VVA) due to menopause
Prior therapy: history of failure, contraindication, or intolerance to TWO of: Imvexxy (estradiol); Osphena (ospemifene); Premarin vaginal cream
Authorization duration: 12 months

Step Therapy

Step requirement

Step therapy requirement: patient must have tried and failed, or have documented contraindication or intolerance to, two specified alternatives prior to approval of Intrarosa.

Required failures/contraindications/intolerances: any two of Imvexxy (estradiol), Osphena (ospemifene), Premarin vaginal cream

Documentation Required

Reauthorization documentation

For reauthorization of Intrarosa, provider must document a positive clinical response to therapy. Reauthorizations will be issued for 12 months when this documentation is provided.

Documentation: positive clinical response to Intrarosa
Authorization duration: 12 months

Prior therapy requirement	Details
Required trial and failure/contraindication/intolerance to two specified alternatives
Member must have history of failure, contraindication, or intolerance to two of the following prior to Intrarosa: 1) Imvexxy (estradiol); 2) Osphena (ospemifene); 3) Premarin vaginal cream. Authorization is issued for 12 months.

Quantity Limits

Intrarosa (prasterone) — quantity / supply limits

Quantity limit statusMay be subject to supply limits per program rules.

Limit periodPer month (supply may be limited)

Program discretionSupply limits determined by UnitedHealthcare program/therapeutic class rules.

Notwithstanding criteriaAutomated approval/reauthorization processes and supply restrictions may apply regardless of coverage criteria.

Background

Intrarosa (prasterone) is one of several therapies indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. Comparable products referenced in this policy include Imvexxy (estradiol) vaginal insert, Osphena (ospemifene) oral tablet, and Premarin vaginal cream.

When considering Intrarosa for treatment, note that authorization rules require documentation of prior therapy outcomes and clinical response. Specifically, reauthorization requires documentation of a positive clinical response to therapy, and coverage decisions remain subject to applicable state mandates and the member's benefit design.

Definitions

Dyspareunia (in this policy)

DefinitionModerate to severe pain with sexual intercourse as a symptom of vulvar and vaginal atrophy due to menopause.

Context — related conditionsOccurs in association with vulvar and vaginal atrophy (VVA) due to menopause; VVA therapies include vaginal estrogen and non-estrogen options.

Related indicated productsImvexxy (estradiol) vaginal insert; Osphena (ospemifene) oral tablet; Premarin (conjugated estrogens) vaginal cream.

Clinical useServes as the primary symptom indication that must be documented for initiation of treatments like Intrarosa.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIntrarosa (prasterone) prior authorization — covered with criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2025

Next Review DateN/A

SourceLink

On This Page

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Intrarosa (prasterone) — Coverage Criteria and Prior Authorization

Coverage Criteria

Initial Therapy

Continuation / Reauthorization

Provider Actions

Step Therapy Requirements

Quantity Limits

Background

Definitions