CurrentNeighborhood Health Plan of Rhode IslandPolicy 1647-A

macitentan (Opsumit) for pulmonary arterial hypertension — Coverage Criteria

Covers clinical criteria and authorization requirements for macitentan (Opsumit) to treat pulmonary arterial hypertension (WHO Group 1) when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policymacitentan (Opsumit) for pulmonary arterial hypertension — Coverage Criteria

Policy CodePolicy 1647-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionRequest prior authorization for up to 12 months when all coverage criteria are met and provide documentation of PAH diagnosis and pretreatment right heart catheterization results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

WHO Group 1indicated population

mPAP>20; PCWP≤15; PVR>2hemodynamic thresholds

Opsumitdrug referenced

Coverage Criteria

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Initial authorization requirements: Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1; PAH confirmation documented by either (1) pretreatment right heart catheterization showing mean pulmonary arterial pressure (mPAP) > 20 mmHg AND pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg AND pulmonary vascular resistance (PVR) > 2 Wood units (for pediatric members pulmonary vascular resistance index [PVRI] > 3 Wood units·m2 is acceptable), OR (2) for infants < 1 year of age, Doppler echocardiogram when right heart catheterization cannot be performed; indication aligns with the FDA‑approved use of macitentan (Opsumit) for PAH; and the medication is prescribed by or in consultation with a pulmonologist or cardiologist.

Authorization duration: 12 months.

inv-02: Continuation Therapy

Authorization of 12 months may be granted for continuation of therapy when ALL of the following are met:

Continuation of therapy: Member is currently receiving the requested medication through a paid pharmacy or medical benefit and is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Authorization duration: 12 months.

inv-03: Not Medically Necessary

Not medically necessary: Use of Opsumit (macitentan) for indications other than the FDA‑approved treatment of pulmonary arterial hypertension (PAH, WHO Group 1) and non‑compendial uses is considered experimental/investigational and not medically necessary.

Such uses are excluded from coverage.

Coding / Identifiers

Drug referencedNDC | mixed

macitentan

Opsumit (macitentan) — brand/generic name and all dosage forms/strengths referenced

Hemodynamic thresholds for PAH diagnosis

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Pediatric threshold (PVRI)> 3 Wood units·m2 (acceptable for pediatric members)

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization may be granted for 12 months when all coverage criteria are met; continuation requests also may be authorized for 12 months.

Authorization of 12 months for initial and continuation therapy when criteria met
Continuation: member currently receiving medication through paid benefit and demonstrating benefit (disease stability or improvement)

Step Therapy

No step therapy sequence specified in the document.

Documentation Required

Required Diagnostic Documentation

Documentation of PAH diagnosis and pretreatment right heart catheterization results is required. Required measurements: mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units (or PVRI > 3 Wood units·m2 for pediatric members). For infants <1 year when catheterization is not feasible, Doppler echocardiogram confirmation is acceptable.

Documentation Required

Prescriber Specialty Documentation

Documentation that the prescription is by or in consultation with a pulmonologist or cardiologist is required.

Denial Risk

Non‑FDA or Non‑Compendial Indications

Use of Opsumit for indications other than FDA‑approved pulmonary arterial hypertension (WHO Group 1) is considered experimental/investigational and not medically necessary.

Background

Pulmonary arterial hypertension (PAH; WHO Group 1) is a progressive disease for which endothelin receptor antagonists such as macitentan (Opsumit) have demonstrated benefit in reducing disease progression and hospitalization. The FDA‑approved indication for Opsumit is for treatment of PAH to reduce these risks based on long‑term studies in predominantly WHO Functional Class II–III patients. Use of Opsumit is limited to this FDA‑approved population; other indications are considered experimental/investigational and not medically necessary.

Definitions

Hemodynamic PAH confirmation

Required test for confirmationPretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units

Alternate for infants <1 yearDoppler echocardiogram if right heart catheterization cannot be performed

Documentation expectationReport all catheterization values (mPAP, PCWP, PVR) in the prior authorization submission

Indication covered

Covered indicationTreatment of pulmonary arterial hypertension (PAH, WHO Group 1) to reduce risks of disease progression and hospitalization

Drug referencedOpsumit (macitentan)

Evidence basisEffectiveness established in a long-term PAH study with predominantly WHO Functional Class II–III patients