CurrentNeighborhood Health Plan of Rhode IslandPolicy 1647-A

Opsumit (macitentan) 1647-A SGM P2023

Defines coverage and authorization criteria for Opsumit (macitentan) for treatment of pulmonary arterial hypertension (PAH, WHO Group 1) including prescriber specialty requirements, diagnostic confirmation criteria, continuation criteria, and statement that non-FDA/compendial uses are investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpsumit (macitentan) 1647-A SGM P2023

Policy CodePolicy 1647-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Opsumit; authorization may be granted for 12 months when the PAH diagnosis and diagnostic criteria are met.

POLICY UPDATE CHANGES

No material change

1Covered Indications (WHO Group)

12 moAuthorization Duration

2Diagnostic confirmation pathways

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: This policy defines coverage and authorization criteria for Opsumit (macitentan) for treatment of pulmonary arterial hypertension (PAH, WHO Group 1). Authorization of 12 months may be granted when the specified diagnostic, prescriber specialty, and continuation criteria are met. Uses of Opsumit outside the FDA-approved/compendial indication for PAH (WHO Group 1) are considered investigational/not medically necessary.

Authorization & Diagnostic Criteria

Authorization duration12 months

Diagnostic confirmation pathways2 (right heart catheterization OR Doppler echocardiogram for infants <1 year)

Covered indicationFDA‑approved: Pulmonary arterial hypertension (PAH, WHO Group 1)

Required hemodynamic criteria (adults)mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units

Pediatric hemodynamic criterionPVRI ≥ 3 Wood units·m²

Initial Therapy Criteria — Indications (PAH)

Definitions and diagnostic confirmation: PAH is defined as World Health Organization Group 1 pulmonary hypertension (refer to the Appendix for subcategories). PAH must be confirmed by pretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics), or by Doppler echocardiogram for infants <1 year when catheterization cannot be performed. See the criteria group for threshold badges and exact numeric thresholds used for authorization.

Continuation Therapy Criteria

Documentation Required

Continuation documentation

For renewal, documentation must show the member is currently receiving Opsumit through a paid pharmacy or medical benefit and is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Provider Actions & Documentation Requirements

Prior Authorization

Authorization requirement and duration

Prior authorization is required for Opsumit; authorization may be granted for 12 months when the PAH diagnosis and diagnostic criteria are met.

Documentation Required

Diagnostic confirmation documentation

Providers must document pretreatment right heart catheterization results (mPAP, PCWP, PVR/PVRI) or for infants <1 year, Doppler echocardiogram if catheterization cannot be performed.

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 x m^2 (pediatrics)

Documentation Required

Prescriber specialty requirement

This medication must be prescribed by or in consultation with a pulmonologist or cardiologist; documentation of the consultation should be available.

Background & Clinical Evidence

Background: Opsumit (macitentan) is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to reduce the risks of disease progression and hospitalization. Effectiveness was established in a long-term study in PAH patients predominantly with WHO Functional Class II–III symptoms treated for an average of 2 years.

Evidence references:

Package insert — Opsumit [package insert], Actelion Pharmaceuticals, July 2022.

Definitions & Clinical Thresholds

Glossary:

PAH: Pulmonary arterial hypertension (World Health Organization Group 1).

mPAP: Mean pulmonary arterial pressure.

PCWP: Pulmonary capillary wedge pressure.

PVR: Pulmonary vascular resistance.

PVRI: Pulmonary vascular resistance index.

Hemodynamic Thresholds & Authorization

mPAP> 20 mmHg

PCWP≤ 15 mmHg

PVR (adults)≥ 3 Wood units

PVRI (pediatrics)≥ 3 Wood units x m²

Authorization duration12 months

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpsumit (macitentan) 1647-A SGM P2023

Policy CodePolicy 1647-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Opsumit; authorization may be granted for 12 months when the PAH diagnosis and diagnostic criteria are met.

On This Page

OpenPayer

Opsumit (macitentan) 1647-A SGM P2023

Coverage Summary

Initial Therapy Criteria — Indications (PAH)

Continuation Therapy Criteria

Covered Indications / Limitations

Provider Actions & Documentation Requirements

Applicable Codes

Background & Clinical Evidence

Definitions & Clinical Thresholds

Revision History