Prior Authorization Criteria — Winrevair (sotatercept-csrk)
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This document sets prior authorization criteria for Winrevair (sotatercept-csrk) for adults with WHO Group 1 pulmonary arterial hypertension (PAH) under West Virginia Bureau for Medical Services. It defines initial and continuation approval requirements and prescriber qualifications.
No material clinical or coverage changes in this revision.
Coverage Criteria for Winrevair (sotatercept-csrk)
Initial Approval Criteria
Covered when ALL of the following are met:
Initial approvals may be authorized for 90 days.
Continuation of Therapy Criteria
Covered when ALL of the following are met:
After continuation criteria are met, approvals may be granted for up to 1 year.
This policy does not list any specific exclusions for Winrevair (sotatercept-csrk). The document’s approval logic instead defines explicit inclusion and continuation criteria that must be met for authorization (e.g., hemodynamic confirmation of WHO Group 1 PAH, symptomatic WHO Functional Class II–IV, prescriber specialty/consultation, and background therapy requirements). Because no exclusions are stated, denial or noncoverage is determined by failure to meet those stated criteria rather than by reference to a separate exclusion list.
If the patient does not meet the policy’s specified initial or continuation criteria, therapy is not approvable under this policy. The criteria that must be satisfied include documented right heart catheterization confirming WHO Group 1 PAH, symptomatic status of WHO Functional Class II–IV, appropriate age per the FDA label, prescribing by or consultation with an M.D./D.O. cardiologist or pulmonologist, and being on at least two other PAH therapies from different pharmacologic classes each for >60 days.
Provider Actions, Documentation & Authorization
Prior authorization required; initial 90‑day approval, renewals up to 1 year
Prior authorization is required for Winrevair (sotatercept-csrk). Initial approvals may be authorized for 90 days; further approvals may be granted for up to 1 year after continuation criteria are met.
Require ≥2 background PAH therapies from different classes (each >60 days)
Patient must be currently receiving at least TWO other PAH therapies from different pharmacologic categories, with each agent used for >60 days prior to approval.
- Acceptable classes: PDE5 inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCs), or prostacyclins.
- Each background therapy must be from a different pharmacologic category and used for greater than 60 days.
Document RHC results and clinical details to confirm WHO Group 1 PAH
Include chart notes and catheterization laboratory reports documenting right heart catheterization results that confirm a diagnosis of WHO Group 1 PAH; also document WHO functional class, patient age per FDA label, and prescriber specialty or consultation.
- Right heart catheterization results must be in the chart and/or catheterization lab report confirming WHO Group 1 PAH.
- Document WHO Functional Class (II, III, or IV), patient age per FDA label, and that the prescriber is an M.D./D.O. cardiologist or pulmonologist (or consulted with one).
- Records showing at least two other PAH therapies from different classes each used >60 days should be included.
Denial risk: missing RHC confirmation, non‑symptomatic FC, or insufficient background therapy
Requests will be denied if documentation does not confirm right heart catheterization–proven WHO Group 1 PAH, if the patient is not symptomatic (WHO FC II–IV), or if the background therapy requirement is not met.
- No documented right heart catheterization confirming WHO Group 1 PAH (chart notes/catheterization lab report).
- Patient not classified as WHO Functional Class II, III, or IV.
- Patient not currently receiving at least two other PAH therapies from different pharmacologic categories each for >60 days.
Background on Winrevair (sotatercept-csrk)
Winrevair (sotatercept-csrk) is used for adults with WHO Group 1 pulmonary arterial hypertension (PAH). Appropriate candidates must have hemodynamic confirmation of WHO Group 1 PAH documented by chart notes and catheterization laboratory reports from a right heart catheterization, and be symptomatic with WHO Functional Class II, III, or IV. Prescribing must be by, or in consultation with, an M.D./D.O. cardiologist or pulmonologist. For initial authorization, patients must also be currently receiving at least two other PAH therapies from different pharmacologic categories (phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, or prostacyclins) each for >60 days. Initial approvals may be authorized for 90 days, with subsequent approvals possible for up to 1 year after continuation criteria are met.
Definitions
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