CurrentCignaPolicy IP0645

Pulmonary Arterial Hypertension Winrevair

Cigna coverage policy defining prior authorization requirements, clinical criteria, documentation, and approval durations for Winrevair (sotatercept-csrk) subcutaneous injection for treatment of WHO Group 1 pulmonary arterial hypertension (PAH) in adults.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension Winrevair

Policy CodePolicy IP0645

Change TypeNew policy; annual revision adding FC IV and documentation requirements

Effective Date

Next Review Date

Key ActionPrior Authorization is required for Winrevair; obtain and submit right heart catheterization documentation and specialist (cardiologist or pulmonologist) prescription/consultation to support approval.

POLICY UPDATE CHANGES

New policy created 08/15/2024.

Functional Class IV was added to the required Functional Class list (previously only II and III).

Annual revision dated 8/1/2025 noted.

IndicationFDA indication: PAH (WHO Group 1)

6 moInitial approval: 6 months

1 yrContinuation approval: 1 year

>18Age requirement: >18

Coverage Summary

Scope summary: Winrevair (sotatercept) is covered_with_criteria by this Cigna policy (Policy ID: IP0645) for the FDA‑approved indication of Pulmonary Arterial Hypertension (WHO Group 1) in adults. The policy requires patients be aged > 18 years and documents that approvals are granted for an initial duration of 6 months for new starts and continuation approvals of 1 year for patients currently receiving Winrevair. Coverage is contingent on diagnostic confirmation by right heart catheterization and prescribing by or in consultation with a cardiologist or pulmonologist, consistent with the policy’s prior authorization and documentation requirements.

Initial Therapy Criteria

FDA-Approved Indication - Approve when ONE of A or B is met

A) Initial Therapy - Approve for 6 months

Age requirement: Patient is > 18 years of age
Right heart catheterization documentation and confirmation
- Right heart catheterization performed: The patient has had a right heart catheterization
- Hemodynamic confirmation: Results of the right heart catheterization confirmed the diagnosis of WHO Group 1 PAH
Functional class: Patient is in Functional Class II, III, or IV
Concomitant therapy requirement (ONE of)
- Two other PAH therapies: Patient is currently receiving at least two other PAH therapies from different pharmacologic categories each for > 60 days> 60 days
  Allowed pharmacologic categories: phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulator (sGCs), and prostacyclins
- One other PAH therapy and intolerance to combination: Patient is currently receiving at least one other PAH therapy for > 60 days and is intolerant to combination therapy with a PDE5i, ERA, sGC, or prostacyclin> 60 days
Specialist prescribing requirement: The medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Continuation Therapy Criteria

FDA-Approved Indication - Approve when ONE of A or B is met

B) Patient is Currently Receiving Winrevair - Approve for 1 year

Prior diagnostic confirmation
- Right heart catheterization performed: Patient has had a right heart catheterization
- Hemodynamic confirmation: Results of the right heart catheterization confirmed the diagnosis of WHO Group 1 PAH
Specialist prescribing requirement: The medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Winrevair. Approvals are provided for specified durations: initial therapy approvals are for 6 months; continuing therapy approvals are for 1 year.

Documentation Required

Right heart catheterization documentation

Documentation of a right heart catheterization and the results confirming WHO Group 1 PAH is required for initiation and continuing therapy. Acceptable documentation may include chart notes, catheterization laboratory reports, and prescription records/claims.

Chart notes
Catheterization laboratory reports
Prescription records / prescription claims

Documentation Required

Concomitant therapy documentation

When initial therapy criteria require prior use of other PAH therapies, documentation is required that the patient received the specified prior therapies for > 60 days as stated in the criteria (either at least two different PAH pharmacologic categories each for > 60 days, or at least one therapy for > 60 days with intolerance to combination therapy).

At least two other PAH therapies from different pharmacologic categories each for > 60 days, OR
At least one other PAH therapy for > 60 days with documented intolerance to combination therapy

Documentation Required

Specialist prescribing requirement

The medication must be prescribed by or in consultation with a cardiologist or a pulmonologist; this specialist prescribing requirement applies to both initiation and continuation of therapy.

Billing Rule

Sample product not acceptable

Receipt of sample product does not satisfy any criteria requirements for coverage and therefore is not acceptable documentation for meeting policy criteria.

Background & Definitions

Background: Winrevair is an activin signaling inhibitor indicated to increase exercise capacity, improve WHO functional class, and reduce clinical worsening in adults with WHO Group 1 PAH. The policy aligns use as an add‑on therapy per guideline recommendations, requires diagnostic confirmation by right heart catheterization (mPAP, PAWP, PVR criteria defined by cardiac catheterization), and mandates that the medication be prescribed by or in consultation with a cardiologist or pulmonologist. This Cigna policy defines prior authorization criteria, required documentation (including catheterization reports and prior PAH therapy use), and approves initial therapy for 6 months or continuation therapy for 1 year, with Functional Class II, III, or IV included in the eligibility criteria.

Definitions

WHO Group 1 PAH definitionMean pulmonary artery pressure (mPAP) > 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units measured by cardiac catheterization

PDE5i (example agents)Phosphodiesterase type 5 inhibitors — examples include sildenafil and tadalafil

ERA (example agents)Endothelin receptor antagonists — examples include bosentan, ambrisentan, and macitentan (Opsumit)

sGCs (example agent)Soluble guanylate cyclase stimulator — example: riociguat (Adempas)

Prostacyclins (example agents)Prostacyclin therapies — examples include treprostinil (Tyvaso, Orenitram, treprostinil injection), iloprost (Ventavis), selexipag (Uptravi), and epoprostenol injection

Revision History

08/15/2024policy_created

New policy created 08/15/2024. (is_material: true)

08/01/2025documentation_change

Functional Class IV added to required Functional Class list (previously only II and III) and documentation requirements aligned with ESI policy. (is_material: true)

08/01/2025annual_revisionLatest

Annual revision dated 8/1/2025 noted. (is_material: true)

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension Winrevair

Policy CodePolicy IP0645

Change TypeNew policy; annual revision adding FC IV and documentation requirements

Effective Date

Next Review Date

On This Page

OpenPayer

Pulmonary Arterial Hypertension Winrevair

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Applicable Codes

Provider Actions

Clinical Evidence

Background & Definitions

Revision History