CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pulmonary Arterial Hypertension (PAH) medication management — coverage criteria

Defines medical necessity, authorization, and quantity limits for PAH pharmacotherapies for members in the payer's Medicaid scope. Applies to prescribers requesting PAH drugs including add-on agents like Winrevair (sotatercept).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPulmonary Arterial Hypertension (PAH) medication management — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2017

Next Review DateJan 1, 2025

Key ActionSubmit prior authorization with documentation of WHO Group 1 PAH, right heart catheterization hemodynamics, prescriber specialty, and for Winrevair include platelet count and prior PAH therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization period

WHO Group 1required PAH classification

PVR > 2hemodynamic threshold

≥50kWinrevair platelet threshold

≥2 classes ≥60dWinrevair background therapy

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Coverage and Authorization Criteria

Initial Approval

Covered when ALL of the following are met for initial approval (authorization for 6 months):

Prescriber is a cardiologist, pulmonologist, or physician specializing in PAH for pediatric members; adult prescriber is associated with a Pulmonary Hypertension Association Center of Comprehensive Care.

Diagnosis: Documentation that the member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 pulmonary hypertension.

Refer to Appendix/WHO classification in policy.

Hemodynamics: Right heart catheterization confirming PAH by either: (1) mean pulmonary arterial pressure (mPAP) > 20 mmHg AND pulmonary vascular resistance (PVR) > 2 Wood units in adults (PVRI ≥ 3 Wood units·m2 in pediatrics) AND pulmonary capillary wedge pressure (PCWP) < 15 mmHg; OR (2) alternative pediatric pathway when RHC cannot be performed (see Appendix).mPAP > 20 mmHg; PVR > 2 Wood units (adults); PVRI ≥ 3 Wood units·m2 (pediatrics); PCWP < 15 mmHg

For infants < 1 year, Doppler echocardiogram may be acceptable if right heart catheterization cannot be performed.

Winrevair-specific hemodynamic threshold: For Winrevair requests ONLY, pulmonary vascular resistance (PVR) ≥ 5 Wood units while stable on at least 2 PAH medications.PVR ≥ 5 Wood units

Vasoreactivity testing: With the exception of members presenting in NYHA Functional Class IV, documentation of acute vasoreactivity testing and results; if positive, documentation that the member progressed despite maximal calcium channel blocker therapy.

Positive acute response defined in policy appendix.

Continuation Therapy

Continuation of therapy:

Duration: Authorization for 6 months may be granted for continuation when the member has documentation of improved outcomes or no clinical deterioration on the requested therapy.

Examples include sustained increase in six-minute walk distance from baseline or improvement in PAH symptoms/functional class.

Winrevair Add-on Criteria

Winrevair (sotatercept) specific criteria:

Platelets: Member has platelet count ≥ 50,000/mm3.≥ 50,000 /mm3

Functional class: Member has WHO Functional Class II or III symptoms.WHO FC II or III

Background therapy: Member is currently receiving at least two other PAH therapies from two different pharmacologic classes for ≥60 days (examples include endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, or prostacyclins).≥ 60 days on ≥2 classes

Winrevair is to be used as add-on therapy with continuation of background PAH therapies unless not tolerated.

If a request is for Tracleer oral suspension, include a clear medical rationale explaining why the member cannot tolerate or take bosentan tablets. The documentation should describe the specific reason (for example, inability to swallow tablets, documented intolerance, or other contraindication) and reference prior attempts or assessments that support using the suspension formulation instead of tablets.

Diagnostic Criteria and Key Clinical Values

Mean pulmonary arterial pressure (mPAP)

Diagnostic threshold (mPAP)> 20 mmHg

Source contextRight heart catheterization criterion for confirming PAH; listed under initial approval hemodynamics.

Usage noteRequired documentation of RHC demonstrating mPAP > 20 mmHg for initial authorization.

Pulmonary vascular resistance (PVR)

Adult PVR threshold> 2 Wood units

Pediatric PVRI thresholdPVRI ≥ 3 Wood units·m2

Winrevair-specific note

Authorization, Documentation, and Denial Risks — Actions for Providers

Prior Authorization

Prior Authorization Required

PAH therapies require prior authorization for a 6-month period. Submit authorization requests that include required diagnostics and supporting documentation to establish medical necessity before treatment initiation or continuation.

Authorization period: 6 months
Applies to initial and continuation therapy requests

Step Therapy

Winrevair Add‑on Therapy Requirement

For Winrevair (sotatercept) requests, the member must be on at least two other PAH therapies from different pharmacologic classes for ≥60 days prior to initiating Winrevair. Winrevair is intended as add‑on therapy and existing background PAH treatments (e.g., ERA, PDE5i, sGC stimulator, prostacyclin) should be continued unless not tolerated.

Background therapy requirement: ≥2 PAH agents from different classes for ≥60 days
Winrevair to be used as add‑on therapy to current PAH background regimens

Clinical Background

Pulmonary arterial hypertension (PAH; WHO Group 1) refers to the group of conditions characterized by pulmonary vascular disease causing elevated pulmonary arterial pressures and increased pulmonary vascular resistance. Diagnosis is based on hemodynamic assessment and clinical classification; management includes established PAH-targeted therapies and, for selected patients, newer add-on agents when background therapy is insufficient.

Key Definitions and Hemodynamic Criteria

PAH / WHO Group 1 — classification and examples

WHO Group 1 classification (PAH)Includes idiopathic, heritable, toxin-induced, and PAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, and other causes.

Examples: idiopathic and heritableIdiopathic PAH and heritable PAH are explicitly listed under WHO Group 1.

Associated conditionsPAH associated with connective tissue diseases, HIV, portal hypertension, congenital heart diseases, schistosomiasis, and other specified causes.

Clinical relevanceDocumentation that the member has WHO Group 1 PAH is required for coverage/authorization.

Hemodynamic diagnostic criteria — right heart catheterization thresholds

mPAP threshold