CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Winrevair Prior Authorization Policy

Defines Cigna's prior authorization requirements, documentation, and coverage criteria for Winrevair (sotaterept-csrk) for treatment of WHO Group 1 pulmonary arterial hypertension in adults; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Winrevair Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial updates (risk stratification and step therapy added)documentation clarified

Effective DateApr 10, 2024

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation including right heart catheterization results; for low/intermediate-low risk patients document ≥60 days trial/current use of specified PAH agents.

SourceLink

POLICY UPDATE CHANGES

Functional Class IV was added to the listed eligible WHO Functional Classes in the policy.

Requirement that prescriber assess and state patient risk category (intermediate-high/high vs low/intermediate-low) was added, with additional requirements for low/intermediate-low patients to have tried or be receiving at least one agent from specified PAH drug classes for ≥ 60 days.

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

FDA-approvedIndication

6 monthsInitial approval

1 year

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Continuation approval

RHCDiagnostic requirement

≥60 daysPrior therapies

Coverage Criteria for Winrevair (sotatercept)

FDA-Approved Indication (Initial and Continuation)

Covered when the conditions below are met for WHO Group 1 PAH in adults:

A or B

A Initial Therapy
- Age and hemodynamic confirmation: Patient is >18 years AND right heart catheterization documented with results confirming WHO Group 1 PAH
  Documentation required
- Risk/status and prior therapy: Either prescriber states patient is intermediate-high/high risk OR prescriber states patient is low-risk/intermediate-low risk AND documentation of ≥60 days trial/current use of agents from specified classes≥60 days when applicable
  Classes: Phosphodiesterase type 5 (PDE5) inhibitors; Endothelin receptor antagonists (ERAs); Adempas (riociguat); prostacyclin analogs/mimetics
- Prescriber specialty: Medication prescribed by or in consultation with a cardiologist or pulmonologist
B Current User: Patient currently receiving Winrevair; prior right heart catheterization confirming WHO Group 1 PAH; medication prescribed by or in consultation with a cardiologist or pulmonologist; approve for 1 year
Right heart catheterization refers to test prior to starting therapy

Requests for Winrevair™ (sotaterept-csrk) for uses other than those specifically described in this policy are not medically necessary and will be denied. The policy’s coverage criteria define the approved indication(s); any indication not listed in those criteria is excluded from coverage and may be revisited if new clinical evidence becomes available.

Any use of Winrevair outside of WHO Group 1 pulmonary arterial hypertension (PAH) as defined in this policy is considered not medically necessary. Requests for treatment of conditions not meeting the WHO Group 1 PAH indication will be denied.

Billing and Coding

Covered drug billingNDCCovered

NDC	Winrevair (sotaterept-csrk subcutaneous injection - Merck) product billing as NDC

Prior therapy duration — requirement for low/intermediate‑low risk patients

RequirementFor patients judged by the prescriber to be low‑risk or intermediate‑low risk, documentation of trial or current use for ≥ 60 days of one or more agents from specified PAH drug classes is required before approval.

Applicable drug classesPhosphodiesterase type 5 (PDE5) inhibitors; Endothelin receptor antagonists (ERAs); Adempas (riociguat); Prostacyclin analogs/mimetics.

Duration definition≥ 60 days on at least one agent (either alone or in combination) from the listed classes.

DocumentationDocumentation of the ≥ 60‑day trial or current use is required (e.g., chart notes, prescription claims).

When it appliesApplies only to patients the prescriber states are low‑risk or intermediate‑low risk as part of Initial Therapy criteria; does not apply if prescriber states patient is intermediate‑high or high risk.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are for 6 months; approvals for patients currently receiving therapy are for 1 year. Prescriptions must be written by or in consultation with a cardiologist or pulmonologist. Documentation is required with the prior authorization request and may include chart notes, prescription claims records, prescription receipts, and right heart catheterization reports. If right heart catheterization documentation was previously provided for a different WHO Group 1 PAH medication prior authorization, that documentation will be accepted to meet the requirement for this policy.

Initial approval duration: 6 months
Continuation (current user) approval duration: 1 year
Prescriber: cardiologist or pulmonologist (or in consultation)
Acceptable documentation: chart notes; prescription claims records; prescription receipts; catheterization laboratory reports

Step Therapy

Step/Adjunct Therapy Requirement for Low/Intermediate‑Low Risk

Key Definitions

PAH diagnostic hemodynamics (right heart catheterization)

Mean pulmonary artery pressure (mPAP)> 20 mmHg at rest as measured by right heart catheterization.

Pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg.

Pulmonary vascular resistance (PVR)> 2 Wood units.

Winrevair — Indication summary

IndicationTreatment of pulmonary arterial hypertension (PAH) WHO Group 1 in adults.

Clinical benefitsTo increase exercise capacity, improve WHO functional class, and reduce risk of clinical worsening events (including hospitalization for PAH, lung transplantation, and death).

Background and Rationale

Pulmonary arterial hypertension (PAH, WHO Group 1) is a progressive, uncommon disorder characterized by elevated pulmonary arterial pressures and increased pulmonary vascular resistance, which can lead to right heart failure. Diagnosis requires hemodynamic confirmation by right heart catheterization. Winrevair (sotaterept-csrk) is indicated for treatment of adults with WHO Group 1 PAH to improve exercise capacity, functional class, and reduce risk of clinical worsening; coverage under this policy is limited to that FDA‑approved population and to the documentation and prior‑therapy requirements described in the criteria.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Winrevair Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial updates (risk stratification and step therapy added)documentation clarified

Effective DateApr 10, 2024

Next Review DateN/A

SourceLink

On This Page

For patients assessed by the prescriber as low-risk or intermediate-low risk, the prescriber must document a trial of (or current use ≥ 60 days of) one or more agents from different PAH therapy categories prior to approval: PDE5 inhibitors; endothelin receptor antagonists (ERAs); riociguat (Adempas); or prostacyclin analogs/mimetics. Examples of agents in these categories include sildenafil, tadalafil (PDE5 inhibitors); bosentan, ambrisentan, macitentan (ERAs); and prostacyclin therapies such as inhaled or parenteral treprostinil, epoprostenol, selexipag, and Yutrepia. Documentation of the trial (e.g., prescriptions, chart notes) is required with the prior authorization request.

Required trial/current use duration: ≥ 60 days
Acceptable agent categories: PDE5 inhibitors, ERAs, Adempas (riociguat), prostacyclin analogs/mimetics
Examples: sildenafil, tadalafil, bosentan, ambrisentan, macitentan, treprostinil, epoprostenol, selexipag, Yutrepia

Documentation Required

Required Documentation to Submit with Prior Authorization

Documentation must be submitted to support the criteria selected on the prior authorization. Examples of acceptable documentation include chart notes, prescription claims records, prescription receipts, and right heart catheterization laboratory reports. All documentation must include patient-specific identifying information. If qualifying right heart catheterization documentation has been previously provided for another WHO Group 1 PAH medication prior authorization, it will satisfy this policy's catheterization documentation requirement.

Right heart catheterization report: required for initial therapy and for current users (unless previously supplied for another WHO Group 1 PAH prior auth)
Prescription claims/receipts or chart notes to document ≥ 60-day trials of other PAH agents when applicable
All documentation must include patient identifiers

Activin signaling inhibitor (Winrevair, sotaterept-csrk).