CurrentNeighborhood Health Plan of Rhode IslandPolicy 1647-A

macitentan (Opsumit) — coverage and medical necessity criteria for pulmonary arterial hypertension (PAH)

Coverage and medical necessity criteria for macitentan (Opsumit) to treat pulmonary arterial hypertension (WHO Group 1) for members of Neighborhood Health Plan of Rhode Island when prescriber and clinical criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policymacitentan (Opsumit) for pulmonary arterial hypertension (PAH)

Policy CodePolicy 1647-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide pretreatment right heart catheterization results confirming PAH (mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units) or required documentation for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

WHO Group 1disease group

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

2024references

Coverage Criteria for macitentan (Opsumit)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policymacitentan (Opsumit) for pulmonary arterial hypertension (PAH)

Policy CodePolicy 1647-A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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PAH indication: Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 pulmonary hypertension.

See WHO Group 1 definitions; Opsumit indication is for WHO Group 1 PAH

PAH confirmation: PAH was confirmed by either: (1) pretreatment right heart catheterization showing mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units (PVRI > 3 Wood units·m2 acceptable for pediatric members); OR (2) for infants < 1 year when catheterization cannot be performed, Doppler echocardiogram confirming PAH.

Hemodynamic thresholds required for catheterization confirmation

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

Prescriber specialty requirement may be enforced

Continuation therapy

Continuation of therapy

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

Documentation of prior paid benefit required for continuation requests

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

Authorization of 12 months may be granted when criteria are met

Provider Requirements, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy. Initial and continuation authorizations may be granted for up to 12 months when the coverage criteria are met.

Authorization duration: up to 12 months
Prior authorization required for initial and continuation requests

Documentation Required

Required Diagnostic Documentation

Documentation of pretreatment confirmatory testing is required for initial requests. Acceptable documentation includes right heart catheterization results showing mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units (or pulmonary vascular resistance index [PVRI] > 3 Wood units·m2 for pediatric members). For infants under one year where right heart catheterization cannot be performed, a Doppler echocardiogram confirming PAH is acceptable.

Required: pretreatment right heart catheterization report with mPAP, PCWP, and PVR (or PVRI for pediatrics)
Alternative for infants <1 year: Doppler echocardiogram if catheterization not possible

Documentation Required

Continuation Authorization Documentation

For continuation requests, provide documentation of a prior paid benefit for the requested medication and objective evidence of ongoing benefit, such as documentation of disease stability or improvement while on therapy.

Must document prior paid pharmacy or medical benefit for the requested medication
Provide clinical evidence of disease stability or improvement on therapy

Note

Calcium Channel Blocker Consideration

Patients with heritable PAH or PAH associated with drugs and toxins may be long-term responders to calcium channel blockers; this should be considered when evaluating therapy and documenting prior treatment history.

Note long-term responders to calcium channel blockers in heritable PAH or drug/toxin-associated PAH

Denial Risk

Indication Limitation

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

Only FDA‑approved indication (PAH, WHO Group 1) is covered; other uses are not covered

Denial Risk

Prescriber Specialty Requirement

This medication must be prescribed by or in consultation with a pulmonologist or cardiologist; requests lacking appropriate specialty involvement may be denied.

Prescriber must be a pulmonologist or cardiologist, or have documented consultation

Background on Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH, WHO Group 1) is the FDA-approved indication for macitentan (Opsumit). Opsumit is an endothelin receptor antagonist indicated to reduce the risks of disease progression and hospitalization in PAH; effectiveness was demonstrated in a long-term study of predominantly WHO Functional Class II–III patients treated for an average of 2 years. Covered PAH populations in those studies included idiopathic and heritable PAH, PAH associated with connective tissue disease, and PAH caused by congenital heart disease with repaired shunts.

Definitions and Hemodynamic Confirmation

PAH (WHO Group 1)

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

ScopeWHO Group 1 designates the pulmonary hypertension subgroup targeted by this policy and by FDA‑approved Opsumit indication.

Clinical noteLong‑term responders to calcium channel blockers are included in Group 1 but step therapy is not mandated by this policy.

Hemodynamic confirmation of PAH

Required diagnostic testPretreatment right heart catheterization

mPAP thresholdmPAP > 20 mmHg

PCWP thresholdPCWP ≤ 15 mmHg

PVR thresholdPVR > 2 Wood units (PVRI > 3 Wood units·m2 acceptable for pediatric members)

OpenPayer

macitentan (Opsumit) — coverage and medical necessity criteria for pulmonary arterial hypertension (PAH)

Coverage Criteria for macitentan (Opsumit)

Key Diagnostic and Hemodynamic Thresholds

Provider Requirements, Documentation, and Prior Authorization

Background on Pulmonary Arterial Hypertension

Definitions and Hemodynamic Confirmation