CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Opsumit (macitentan) — Coverage Criteria for Pulmonary Arterial Hypertension (PAH)

Covers use of Opsumit (macitentan) for treatment of pulmonary arterial hypertension (WHO Group 1) when specified clinical and documentation criteria are met; applies to members of Neighborhood Health Plan of Rhode Island per this payer policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpsumit (macitentan) — Coverage Criteria for Pulmonary Arterial Hypertension (PAH)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document right heart catheterization results (mPAP, PCWP, PVR) and prescriber specialty (pulmonologist or cardiologist).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

WHO Group 1indication covered

>20 mmHgmPAP threshold

<15 mmHgPCWP threshold

≥3 WUPVR threshold

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Coverage Criteria for Opsumit (macitentan)

Initial therapy - PAH

Covered when ALL of the following are met:

Indication: Member has pulmonary arterial hypertension (WHO Group 1)

Includes idiopathic, heritable, drug/toxin‑induced, connective tissue disease–associated, HIV‑associated, portal hypertension–associated, schistosomiasis‑associated, congenital heart disease (repaired shunts), long‑term responders to calcium channel blockers, persistent pulmonary hypertension of the newborn, and PAH with overt features of PVOD/PCH involvement

Prescriber: Medication is prescribed by or in consultation with a pulmonologist or cardiologist

Hemodynamic confirmation: PAH confirmed by right heart catheterization showing mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) < 15 mmHg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units (or PVRI ≥ 3 Wood units·m2 in pediatric patients); for infants <1 year, Doppler echocardiogram acceptable if RHC cannot be performedmPAP > 20 mmHg; PCWP < 15 mmHg; PVR ≥ 3 WU

Provide pretreatment RHC results documenting mPAP, PCWP, and PVR

FDA‑approved use: Use is for FDA‑approved PAH indications (to reduce risk of disease progression and hospitalization) per product labeling

All other indications are considered experimental/investigational and not medically necessary

Continuation of therapy

Covered when ALL of the following are met:

Current therapy: Member is currently receiving the requested medication through a paid pharmacy or medical benefit

Clinical benefit: Member is experiencing benefit from therapy as evidenced by disease stability or improvement

Authorization may be granted for 12 months

All indications for Opsumit outside of the FDA‑approved pulmonary arterial hypertension (PAH, WHO Group 1) label and recognized compendial uses are considered experimental/investigational and not medically necessary.

Use of Opsumit (macitentan) for any indication other than FDA‑approved PAH (WHO Group 1) is not medically necessary and may be denied.

Coding and Hemodynamic Criteria

Referenced drugmixed

Opsumit

macitentan (brand name listed in document)

Hemodynamic thresholds for PAH

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)< 15 mmHg

Pulmonary vascular resistance (PVR)≥ 3 Wood units (adults)

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

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required; authorization may be granted for 12 months when all clinical criteria are met and for continuation therapy when criteria below are satisfied.

Authorization duration: up to 12 months

Documentation Required

Continuation Evidence

Continuation requests must include evidence of clinical benefit such as documentation of disease stability or improvement while on therapy (for members currently receiving the medication through a paid pharmacy or medical benefit). Authorization of 12 months may be granted for continuation when benefit is demonstrated.

Evidence of benefit: disease stability or improvement
Member must be currently receiving the requested medication through a paid pharmacy or medical benefit

Background

Pulmonary arterial hypertension (PAH, WHO Group 1) is a progressive condition targeted by Opsumit; the agent is an endothelin receptor antagonist indicated to reduce the risks of disease progression and hospitalization in PAH patients. Effectiveness was demonstrated in long‑term studies in patients with primarily WHO Functional Class II–III symptoms, including idiopathic, heritable, connective tissue disease–associated, and congenital heart disease–related PAH.

Definitions

Hemodynamic confirmation of PAH

Required diagnostic testRight heart catheterization demonstrating mean pulmonary arterial pressure (mPAP) > 20 mmHg

Supporting RHC criteriaPulmonary capillary wedge pressure (PCWP) < 15 mmHg on RHC

Resistance criterionPulmonary vascular resistance (PVR) ≥ 3 Wood units on RHC (or PVRI ≥ 3 Wood units·m2 in pediatric patients)

Pediatric exceptionFor infants <1 year, Doppler echocardiogram may confirm PAH if RHC cannot be performed

Opsumit (macitentan)

Drug classEndothelin receptor antagonist (ERA)

Indication (covered)

Documentation Required

Required Clinical Documentation

Prescriber specialty documentation: must be prescribed by or in consultation with a pulmonologist or cardiologist. Required documentation to support medical necessity includes confirmation of pulmonary arterial hypertension (PAH, WHO Group 1) with diagnostic data (for example, right heart catheterization showing mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR ≥ 3 Wood units in adults or PVRI ≥ 3 Wood units·m2 in pediatrics). For infants <1 year, Doppler echocardiogram may be used if right heart catheterization cannot be performed. Include relevant prior testing reports and consultation notes.

Prescriber: pulmonologist or cardiologist (or consultation note)
Diagnostic confirmation: right heart catheterization results OR, for infants <1 year, Doppler echocardiogram if catheterization not possible
Hemodynamics: mPAP > 20 mmHg; PCWP < 15 mmHg; PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)