CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Winrevair Prior Authorization Policy

Prior authorization coverage policy for Winrevair (sotatercept-csrk) for treatment of pulmonary arterial hypertension (WHO Group 1) in adults, including initiation and continuation criteria, documentation requirements, prescriber specialty requirement, duration of approval, and non-covered uses.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Winrevair Prior Authorization Policy

Policy CodePolicy N/A

Change TypeEarly Annual Revision (functional class and documentation updates)

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation of right heart catheterization, background PAH therapies, and specialist prescribing as required for approval.

POLICY UPDATE CHANGES

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

Documentation examples 'prescription claims records and prescription receipts' were added as acceptable documentation.

Added 'Documentation required' language to criteria regarding patients receiving at least two other PAH therapies or receiving at least one other PAH therapy and intolerant to combination therapy.

1Covered Indication (WHO Group 1 PAH)

3Functional Classes Covered (II, III, IV)

6 moInitial approval duration

Renewal duration for current users

Coverage Summary

Scope: This policy is a prior authorization coverage policy for Winrevair (sotatercept-csrk) for treatment of pulmonary arterial hypertension (WHO Group 1) in adults, addressing initiation and continuation criteria, documentation requirements, prescriber specialty requirement, approval durations (initial and renewal), and non-covered uses.

Background: Winrevair is an activin signaling inhibitor indicated to treat WHO Group 1 pulmonary arterial hypertension (PAH) in adults to increase exercise capacity, improve WHO functional class, and reduce risk of clinical worsening.

Key evidence: Clinical trials referenced include STELLAR (enrolled WHO FC II–III) and ZENITH (enrolled WHO FC III–IV), which support use in the indicated functional classes. The policy references the Merck Winrevair prescribing information (March 2024).

Guideline context: Expert guidance (WSPH, ESC/ERS, CHEST) supports individualized risk-based therapy and notes Winrevair may be considered as add-on therapy for patients at intermediate-low, intermediate-high, and high risk.

Coverage stance: Winrevair is covered with criteria (prior authorization required) with specified initiation and continuation criteria, documentation requirements, prescriber specialty requirement, and defined approval durations.

Quick Facts and Thresholds

Age> 18 years

Background therapy duration> 60 days

Initial approval duration6 months

Renewal duration1 year

Functional Classes CoveredII, III, IV

Covered indications count1 covered indication

Functional classes count3 functional classes covered

Recommended Authorization Criteria

FDA-Approved Indication

Winrevair is covered as medically necessary for PAH (WHO Group 1) when ONE of the following is met:

A) Initial Therapy (approve for 6 months)

ALL of the following
- Right heart catheterization confirmation
  - Patient is > 18 years of age> 18 years
  - The patient has had a right heart catheterization
    [documentation required]
  - Results of the right heart catheterization confirmed the diagnosis of WHO Group 1 PAH

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Winrevair. Approvals are provided for specified durations: 6 months for new starts (initial therapy) and 1 year for patients currently receiving Winrevair.

Documentation Required

Right heart catheterization documentation

Documentation of a prior right heart catheterization and the catheterization results confirming WHO Group 1 PAH are required for both initiation and continuation of therapy. Acceptable documentation examples include chart notes, catheterization laboratory reports, prescription claims records, and prescription receipts.

Coding

Drug (NDC)NDC

No codes listed

Background & Evidence

Mechanism and indication: Winrevair (sotatercept-csrk) is an activin signaling inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) [WHO Group 1] in adults to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening.

Key trials: The agent was previously evaluated in the STELLAR trial (eligible patients had WHO FC II or III) and was more recently evaluated in the ZENITH trial (enrolled WHO FC III or IV), with the ZENITH data supporting use in patients with more severe functional classes.

Guideline recommendation context: The 2024 World Symposium on Pulmonary Hypertension treatment algorithm and other guideline documents (ESC/ERS, CHEST) emphasize individualized risk assessment and list Winrevair as a potential add-on therapy for patients at intermediate-low, intermediate-high, or high risk of decompensation.

Prescribing information: Referenced prescribing information is Merck Winrevair prescribing information; March 2024 for full product labeling and indications.

Prior authorization and documentation: Per policy, prior authorization is recommended; approvals require prescription by or in consultation with a cardiologist or pulmonologist and documentation (e.g., chart notes, catheterization lab reports, prescription claims records, prescription receipts) as specified in the criteria.

Source	Notes
Key trial (ZENITH)	ZENITH enrolled patients with WHO Functional Class III or IV PAH and supports use in these functional classes.
Prescribing information (Merck Winrevair; March 2024)	Winrevair indicated for WHO Group 1 PAH in adults to increase exercise capacity, improve WHO functional class, and reduce risk of clinical worsening (prescribing information March 2024).

WHO Group 1 PAH diagnostic hemodynamics: PAH is defined by right heart catheterization with mean pulmonary artery pressure (mPAP) > 20 mmHg at rest, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units.

Documentation examples: Acceptable documentation to confirm diagnosis and meet policy requirements may include catheterization laboratory reports, chart notes, and medication evidence such as prescription claims records or prescription receipts.

Revision History

2025-06-04revisedLatest

Early Annual Revision: Functional Class IV was added to the required functional class list (previously only II and III).

2025-01-15revised

Early Annual Revision: 'Documentation required' was added to the criteria regarding patients receiving at least two other PAH therapies or receiving at least one other PAH therapy and intolerant to combination therapy.

2024-04-10clarified

Early Annual Revision: Documentation examples 'prescription claims records and prescription receipts' were added as acceptable documentation.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Winrevair Prior Authorization Policy

Policy CodePolicy N/A

Change TypeEarly Annual Revision (functional class and documentation updates)

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide documentation of right heart catheterization, background PAH therapies, and specialist prescribing as required for approval.

On This Page

Background PAH therapy requirement

Patient is in Functional Class II, III, or IV
Patient is currently receiving at least two other PAH therapies from different pharmacologic categories each for > 60 days> 60 days
[documentation required]; permissible categories: phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCs), and prostacyclins
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
[documentation required]

Medication is prescribed by or in consultation with a cardiologist or a pulmonologist

B) Patient is Currently Receiving Winrevair (approve for 1 year)

ALL of the following
- Patient has had a right heart catheterization
- Results of the right heart catheterization confirmed the diagnosis of WHO Group 1 PAH
Medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Conditions Not Covered

Winrevair is considered not medically necessary for any other uses not listed in the Recommended Authorization Criteria.

Any use not explicitly listed in the Recommended Authorization Criteria is not covered

Documentation Required

Background therapy documentation

Documentation is required to show background PAH therapy before initiation: either the patient is currently receiving at least two other PAH therapies from different pharmacologic categories each for more than 60 days, OR the patient is currently receiving at least one other PAH therapy for more than 60 days and is intolerant to combination therapy. Note: permissible pharmacologic categories include phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCs), and prostacyclins.

Documentation Required

Specialist prescriber requirement

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

Clinical context for functional class: The policy permits use in patients with WHO Functional Class II, III, or IV, consistent with trial enrollment and guideline-supported populations.