CurrentHealth NetPolicy CP PMN.99

Prasterone (Intrarosa) Coverage

Defines medical necessity and prior authorization criteria for prasterone (Intrarosa) for treatment of moderate to severe dyspareunia due to menopause for Health Net lines of business (Commercial, HIM, Medicaid). Applies to providers requesting coverage under the payer policies noted.

Policy Summary

PayerHealth Net

PolicyPrasterone (Intrarosa) Coverage

Policy CodePolicy CP PMN.99

Change TypeNo material change

Effective DateDec 20, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis and that all approval criteria, including required prior therapy trials, are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6.5 mgproduct strength

1 insert/daymax dosing

12 monthsapproval duration

4-week estrogen trialstep therapy

fail 2 lubricantsstep therapy

1Q 2021

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Coverage Criteria for Prasterone (Intrarosa)

Initial Therapy

Covered when ALL of the following are met

Initial Approval for Dyspareunia due to menopause: 1) Diagnosis of dyspareunia due to menopause; 2) Patient meets the dyspareunia-specific requirements: age >= 18 years; 3) Failure of a 4-week trial of one vaginal estrogen (e.g., estradiol vaginal cream, estradiol vaginal insert, conjugated estrogens vaginal cream) unless clinically significant adverse effects occur or all are contraindicated; 4) Failure of two vaginal lubricants or vaginal moisturizers unless clinically significant adverse effects occur or all are contraindicated; 5) Dose does not exceed one vaginal insert daily.age >= 18; 4-week trial of vaginal estrogen; failure of two lubricants/moisturizers

For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Continuation Therapy

Covered for continuation when ALL of the following are met

Continuation of Therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria (including continuity of care situations where applicable); 2) Member is responding positively to therapy (e.g., reduction in dyspareunia symptoms); 3) If dose increase is requested, the new dose does not exceed one vaginal insert daily.response to therapy

Approval duration per benefit/PA process (see provider authorization guidance)

Requests for uses of prasterone (Intrarosa) for non‑FDA approved indications that are not specifically addressed in this clinical policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy. See CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid for requirements and acceptable evidence for off‑label requests.

Prasterone (Intrarosa) is contraindicated in members with undiagnosed abnormal genital bleeding. Such bleeding must be evaluated and diagnosed before initiating therapy; do not authorize treatment until the cause has been determined and appropriate management completed.

Coverage determinations for prasterone (Intrarosa) are subject to the member's specific benefit documents, including the evidence of coverage, certificate of coverage, policy or contract terms, and any state or federal requirements. When state Medicaid provisions conflict with this clinical policy, the state Medicaid requirements take precedence. Providers should verify member eligibility and benefits and follow any plan‑level administrative policies when requesting authorization.

Requests for off‑label use of prasterone (Intrarosa) that do not include adequate supporting evidence as required by the applicable off‑label use policy are considered not authorized / not medically necessary. Providers must follow the referenced off‑label policies (Commercial: CP.CPA.09, HIM: HIM.PA.154, Medicaid: CP.PMN.53) to determine what documentation and evidence are required for consideration.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization and submit documentation (e.g., office chart notes, lab results, or other clinical information) confirming the diagnosis of dyspareunia due to menopause and that the member meets all initial approval criteria prior to benefit coverage.

Affected drug: prasterone (Intrarosa)
Documentation: chart notes, labs, prior treatment records

Step Therapy

Step Therapy Requirements

Step therapy requirements apply: prior to approval, documentation must show failure of a 4‑week trial of one vaginal estrogen (e.g., estradiol vaginal cream, estradiol vaginal insert, Premarin vaginal cream), unless clinically significant adverse effects are experienced or all are contraindicated. Also required is failure of two vaginal lubricants or moisturizers unless contraindicated. Lack of documented prior trials may result in denial.

4‑week trial of one vaginal estrogen required (unless contraindicated)

Coding

Coding (none listed)mixed

N/A	No procedure or HCPCS/CPT/NDC codes explicitly listed in this part of the document

Background

Prasterone (Intrarosa) is an inactive endogenous steroid that is converted in local tissues to active androgens and/or estrogens and is FDA‑approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. The product is supplied as a vaginal insert containing 6.5 mg prasterone and is administered once daily at bedtime. Authorization requires documentation of the diagnosis and fulfillment of the policy's initial approval criteria, including step‑therapy requirements and dose limits (no more than one insert per day).

Definitions

Definition — Moderate to severe pain with sexual intercourse associated with vulvar and vaginal atrophy related to menopause (dyspareunia)

TermModerate to severe pain with sexual intercourse associated with vulvar and vaginal atrophy related to menopause

SynonymDyspareunia due to menopause

FDA‑approved useIntrarosa (prasterone) indicated for treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause

AdministrationVaginal insert, 6.5 mg, given once daily at bedtime

Patient populationPostmenopausal women with vulvar and vaginal atrophy causing moderate to severe dyspareunia

Medical necessity definition