CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2343-2

Winrevair™ (sotatercept-csrk) - Prior Authorizatin/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines UnitedHealthcare commercial prior authorization and medical necessity criteria for initial authorization and reauthorization of Winrevair (sotatercept-csrk) for adults with pulmonary arterial hypertension (PAH). Includes prescriber requirements, concomitant therapy criteria, documentation expectations, authorization duration, and note about automated approvals and supply limits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWinrevair™ (sotatercept-csrk) - Prior Authorizatin/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2343-2

Change TypeAnnual review — no coverage changes

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit documentation meeting the listed initial or reauthorization criteria (including right heart catheterization when applicable, prescriber attestation, concomitant therapy or evidence of current Winrevair use) to obtain a 12-month authorization.

SourceLink

POLICY UPDATE CHANGES

Annual review completed 6/2025 with no changes to coverage criteria.

12 monthsAuthorization Duration

2P&T approvals (6/2024, 6/2025)

Coverage Summary

UnitedHealthcare covers Winrevair (sotatercept-csrk) for adults with pulmonary arterial hypertension (PAH, WHO Group 1) with criteria. Initial authorization requires meeting the detailed clinical criteria and will be issued for 12 months. The policy is implemented as part of UnitedHealthcare’s commercial prior authorization and medical necessity programs; automated approvals based on prior claims/medication history, diagnosis codes, and claim logic may occur and plan-specific supply limitations may apply.

Unproven / Exclusions

Coverage is limited when required criteria are not met: examples include lack of diagnostic confirmation by right heart catheterization (when that pathway is applicable), absence of prescriber attestation excluding other types of pulmonary hypertension, failure to document symptomatic PAH, failure to show required concomitant oral therapies (or evidence of current Winrevair therapy), or lack of specialist prescribing/consultation. For reauthorization, failure to document a positive clinical response (e.g., improvement in symptoms, exercise tolerance, 6MWD, or oximetry) may result in non‑coverage.

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required

Winrevair initial authorization requires meeting the detailed criteria in the policy. Authorization will be issued for 12 months.

Documentation Required

Document diagnostic confirmation and prior therapy

For initial approval document confirmation of PAH by right heart catheterization (when applicable), prescriber attestation that other types of pulmonary hypertension are excluded, that PAH is symptomatic, and documentation of current use of qualifying oral therapies or evidence of current Winrevair therapy (claims or medical records including date and duration).

Documentation Required

Demonstrate clinical response for reauthorization

For reauthorization provide documentation of a positive clinical response to Winrevair such as improvement in symptoms of right heart failure, exercise tolerance, six-minute walk distance (6MWD), or resting and ambulatory oximetry.

Documentation Required

Specialist involvement required

Prescriber must be the treating or consulting cardiologist, pulmonologist, or rheumatologist for both initial authorization and reauthorization.

Billing Rule

Automated approval possibility

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; automated approval and re-approval processes vary by program and therapeutic class.

Billing Rule

Supply limitations

Supply limitations may be in place and can be plan-specific.

Background

Winrevair (sotatercept-csrk) is an activin signaling inhibitor indicated for treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. This policy defines UnitedHealthcare prior authorization and medical necessity criteria for initial authorization and reauthorization, including prescriber requirements, concomitant therapy criteria, documentation expectations, and an authorization duration of 12 months.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWinrevair™ (sotatercept-csrk) - Prior Authorizatin/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2343-2

Change TypeAnnual review — no coverage changes

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Winrevair™ (sotatercept-csrk) - Prior Authorizatin/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions & Authorization Workflow

Clinical Evidence & References

Background

Revision History