CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pulmonary Arterial Hypertension (PAH) medication authorization criteria

Criteria and authorization rules for PAH medication coverage for Medicaid members, including initial and continuation approvals, quantity limits, and requirements specific to Winrevair (sotatercept). Applies to prescribers treating PAH patients.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPulmonary Arterial Hypertension (PAH) medication authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date9/2017

Next Review DateN/A

Key ActionSubmit prior authorization with WHO Group 1 PAH documentation and right heart catheterization results (mPAP, PCWP, PVR/PVRI).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

WHO Group 1PAH definition

PVR >2 WUhemodynamic threshold

add-on after ≥60dWinrevair requirement

limits listedquantity limits

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Coverage Criteria for PAH Medications

Initial Therapy

Authorization of 6 months may be granted for treatment of PAH when ALL of the following are met:

ALL of the following

Prescriber is either one of the following: (a) Prescriber is associated with an accredited Center of Comprehensive Care by the Pulmonary Hypertension Association for adult members; or (b) Prescriber is a cardiologist, pulmonologist or physician specializing in PAH for pediatric members.
Documentation that the member has PAH defined as WHO Group 1 class of pulmonary hypertension (refer to Appendix).
PAH confirmation
- Right heart catheterization with documentation of all of the following results: (i) Mean pulmonary arterial pressure (mPAP) > 20 mmHg; (ii) Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg; (iii) Pulmonary vascular resistance (PVR) > 2 Wood units in adult members or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units·m^2 in pediatric members.
- For infants less than one year of age for whom right heart catheterization cannot be performed: Doppler echocardiogram confirming PAH.
With the exception of members presenting in NYHA functional class IV, documentation that the member has undergone acute vasoreactivity testing and whether or not the results were positive.
Dose and dosing regimen prescribed as well as medication therapy regimen is within FDA‑approved guidelines and clinical guidelines.
If requesting Tracleer tablets for oral suspension, documentation of medical rationale must be submitted for the reason why the member is unable to trial bosentan tablets.
Winrevair specific
- If requesting Winrevair, member has WHO Functional Class II or III symptoms.
- Member has a platelet count ≥ 50,000/mm3.
- Member is currently receiving at least two other PAH therapies from two different pharmacological classes for ≥ 60 days: examples include (a) PDE5 inhibitors (e.g., sildenafil, tadalafil), (b) Endothelin receptor antagonists (e.g., ambrisentan, bosentan, Opsumit), (c) Soluble guanylate cyclase stimulators (e.g., Adempas), (d) Prostacyclins (e.g., Flolan, Remodulin, Tyvaso, Veletri, Uptravi).
- Winrevair will be used as add‑on therapy and current PAH background therapies will be continued unless not tolerated after addition of Winrevair.

Continuation Therapy

Authorization for 6 months may be granted for continuation when ALL of the following are met:

ALL of the following

Documentation of pulmonary arterial hypertension (PAH).
Documentation of improved outcomes with the requested therapy, such as sustained increase in six‑minute walk distance from baseline, improvement in PAH symptoms or functional class, or lack of clinical deterioration.

Medications, Hemodynamics, and Quantity Limits

Covered PAH medications (listed by name)mixed

Winrevair (sotatercept-csrk)	SC injection product listed for PAH
Orenitram (treprostinil) extended-release	oral PAH medication
Sildenafil (Revatio) - tablet	PDE5 inhibitor
Tadalafil (Adcirca, Alyq) - tablet	PDE5 inhibitor
Ambrisentan (Letairis) - tablet	endothelin receptor antagonist
Bosentan (Tracleer) - tablet	endothelin receptor antagonist
Opsumit (macitentan) - tablet	endothelin receptor antagonist
Epoprostenol (Flolan, Veletri) - injection	prostacyclin
Treprostinil (Remodulin) - injection IV/SC	prostacyclin
Ventavis (iloprost) - inhalation solution	inhaled prostacyclin

1–10 of 11

1/2

Hemodynamic thresholds

Mean pulmonary arterial pressure (mPAP)mPAP > 20 mmHg

Pulmonary capillary wedge pressure (PCWP)PCWP ≤ 15 mmHg

Pulmonary vascular resistance (PVR) — adultsPVR > 2 Wood units

Pulmonary vascular resistance index (PVRI) — pediatricsPVRI ≥ 3 Wood units·m2

Winrevair-specific PVR requirementFor Winrevair requests only, PVR ≥ 5 Wood units while stable on at least 2 PAH medications

Quantity limits — examples

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all pulmonary arterial hypertension (PAH) pharmacotherapies. Typical initial authorization duration is 6 months.

Applies to PAH medications including ERAs, PDE5i, sGC stimulators, prostacyclins, and Winrevair.
Authorization may be renewed per clinical criteria and documentation of response.

Step Therapy

Winrevair Step / Add‑on Requirement

Winrevair will be approved only when used as add‑on therapy to an adequate background regimen. The member must have been receiving at least two other PAH therapies from two different pharmacologic classes for ≥60 days prior to approval.

Required background classes (examples): PDE5 inhibitors (sildenafil, tadalafil); Endothelin receptor antagonists (ambrisentan, bosentan, Opsumit); Soluble guanylate cyclase stimulators (Adempas); Prostacyclins (Flolan, Orenitram, Remodulin, Tyvaso, Veletri, Ventavis, Uptravi).
Winrevair must be continued as add‑on and existing PAH background therapies should be continued unless not tolerated after addition of Winrevair.

Background

Pulmonary arterial hypertension (PAH) is the WHO Group 1 class of pulmonary hypertension diagnosed by hemodynamic criteria on right heart catheterization. Required catheterization measurements include mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units in adults (pediatric assessment uses PVRI ≥ 3 WU·m2). For infants under one year of age when catheterization is not feasible, Doppler echocardiogram may be used to confirm PAH. Acute vasoreactivity testing is generally required except in members presenting in NYHA functional class IV to inform vasoreactive therapy decisions.

Key Definitions

PAH (WHO Group 1) — definition and examples

WHO Group 1 — definitionPulmonary arterial hypertension (PAH): includes idiopathic, heritable, drug- and toxin-induced, and PAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis, PVOD/PCH, persistent pulmonary hypertension of the newborn, and long-term responders to calcium channel blockers

Idiopathic PAHPAH without identifiable cause (listed as 'Idiopathic')

Heritable PAHPAH with a heritable/genetic predisposition (listed as 'Heritable PAH')

Drug- and toxin-induced PAHPAH related to exposure to drugs or toxins (listed as 'Drug- and toxin-induced PAH')