CurrentColorado Rocky Mountain Health PlansPolicy Program Number 2025 P 2343-2

Winrevair (sotatercept-csrk) prior authorization / medical necessity for pulmonary arterial hypertension

Defines initial authorization and reauthorization clinical criteria and prescriber requirements for Winrevair (sotatercept-csrk) for adults with pulmonary arterial hypertension (PAH, WHO Group 1). Applies to prior authorization decisions within the payer's pharmacy clinical programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWinrevair (sotatercept-csrk) prior authorization / medical necessity for pulmonary arterial hypertension

Policy CodePolicy Program Number 2025 P 2343-2

Change TypeAnnual review — no coverage changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document required criteria (diagnostic confirmation by right heart catheterization or existing therapy evidence, prescriber specialty, comorbidity and concomitant oral therapy requirements) to support approval.

SourceLink

POLICY UPDATE CHANGES

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

12Initial authorization duration

12Reauthorization duration

AdultsIndicated population

SpecialistRequired prescriber specialty

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Authorization Criteria for Winrevair (sotatercept-csrk)

Initial Authorization

Winrevair will be approved based on all of the following criteria:

ALL of the following

Diagnosis pathways
- New diagnosis confirmed by hemodynamics
  - Diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1)
  - PAH has been confirmed by right heart catheterization
  - Prescriber attestation that other types of pulmonary hypertension (PH) are excluded as a diagnosis
  - Pulmonary arterial hypertension is symptomatic
- Existing Winrevair therapy
  - Diagnosis of pulmonary arterial hypertension
  - Patient is currently on Winrevair therapy as documented by claims history or submission of medical records (document date and duration of therapy)
Concomitant therapy and comorbidity pathway
- If patient has cardiopulmonary comorbidity
  - Patient has a cardiopulmonary comorbidity (e.g., obesity, hypertension, diabetes mellitus, coronary heart disease)
  - Patient is currently taking at least one of the following oral therapies: Endothelin receptor antagonist (ERA) (e.g., ambrisentan, bosentan, macitentan) OR Phosphodiesterase-5 inhibitor (PDE5i) (e.g., sildenafil, tadalafil)
- If patient does NOT have cardiopulmonary comorbidity
  - Patient does not have a cardiopulmonary comorbidity (e.g., obesity, hypertension, diabetes mellitus, coronary heart disease)
  - Patient is currently taking oral combination therapy with both: an Endothelin receptor antagonist (ERA) (e.g., ambrisentan, bosentan, macitentan) AND one of: a Phosphodiesterase-5 inhibitor (PDE5i) (e.g., sildenafil, tadalafil) OR a soluble guanylate cyclase stimulator (sGC) (e.g., riociguat)
ALL of the following
- Prescribed by, or in consultation with, a cardiologist, pulmonologist, or rheumatologist

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Reauthorization

Winrevair will be approved for reauthorization when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to Winrevair therapy (examples: improvement in symptoms of right heart failure, exercise tolerance, six-minute walk distance (6MWD), resting and ambulatory oximetry)
Prescribed by, or in consultation with, a cardiologist, pulmonologist, or rheumatologist

Key Authorization Details

Authorization duration12 months

Initial authorization duration12 months

Reauthorization duration12 months

Indicated populationAdults with PAH (WHO Group 1)

Prescriber specialty requirementPrescribed by, or in consultation with, a cardiologist, pulmonologist, or rheumatologist

Relevant Codes

ICD-10 (diagnosis)ICD-10

I27.0

Primary pulmonary hypertension / pulmonary arterial hypertension (example - document lists PAH diagnosis requirement; specific ICD-10 not provided in text)

What Providers Must Do

Prior Authorization

Prior authorization requirement

Winrevair requires prior authorization and will be approved only when the documented clinical criteria (initial or reauthorization) are met.

Documentation Required

Diagnostic confirmation and attestation

For new starts, document right heart catheterization confirming PAH, an attestation that other types of pulmonary hypertension are excluded, that pulmonary arterial hypertension is symptomatic, and current PAH medications or claims history if already on therapy.

Right heart catheterization confirming PAH
Attestation that other types of pulmonary hypertension (PH) are excluded
Documentation that PAH is symptomatic
Current PAH medications or claims history (document date and duration of therapy)

Clinical Background

Winrevair (sotatercept-csrk) is an activin signaling inhibitor indicated for adults with pulmonary arterial hypertension (PAH, WHO Group 1) with the clinical goals to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. Authorization is managed through prior authorization with documentation requirements to confirm PAH diagnosis and ensure appropriate specialist involvement for treatment decisions.

Defined Terms

Definitions

PAHPulmonary arterial hypertension (WHO Group 1).

Right heart catheterizationInvasive hemodynamic test required to confirm diagnosis of PAH for initial authorization.

Policy Changes

2025-06reviewLatest

Annual review performed 6/2025; document notes the 6/2025 review resulted in no changes to coverage criteria (brief detail: Document notes P&T approval dates and that the 6/2025 review resulted in no coverage changes; type: clarified).

2024-06approval

P&T approval of the prior authorization/medical necessity program for Winrevair noted 6/2024.