ModifiedmhnPolicy CP.PHAR.194

Macitentan (Opsumit) — Pulmonary Arterial Hypertension

Clinical policy governing prior authorization and coverage criteria for macitentan (Opsumit) for treatment of pulmonary arterial hypertension (WHO Group I) across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyMacitentan (Opsumit) — Pulmonary Arterial Hypertension

Policy CodePolicy CP.PHAR.194

Change TypeMaterial coverage and operational updates (step therapy bypass, duration extension, quantity confirmation)

Effective Date03.16

Next Review Date

Key ActionSubmit prior authorization with documentation confirming PAH diagnosis, specialist involvement, adherence to step therapy (unless IL HIM bypass applies), dose ≤10 mg/day and quantity within plan limits.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

Added requirement that request does not exceed health-plan approved quantity limit.

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

Updated dosing regimens and clarified drugs used for off-label indications in Appendix B.

10 mg/daymaximum recommended dose

12 monthsMedicaid & HIM initial approval

Commercial, HIM, Medicaidlines of business

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Coverage Criteria

Initial Therapy — PAH

Covered when ALL of the following are met:

Initial Approval - Pulmonary Arterial Hypertension: 1. Diagnosis of PAH; 2. Prescribed by or in consultation with a cardiologist or pulmonologist; 3. Failure of a calcium channel blocker (see Appendix B), unless member meets one of: (a) inadequate response or contraindication to acute vasodilator testing, or (b) contraindication or clinically significant adverse effects to calcium channel blockers; 4. Failure of generic ambrisentan or bosentan, unless clinically significant adverse effects are experienced or both are contraindicated; 5. Request does not exceed health-plan approved quantity limit; 6. Dose does not exceed both: (a) 10 mg per day; (b) 1 tablet per day.dose <= 10 mg/day AND tablets <=1/day

Illinois HIM requests exempt from step therapy per IL HB 5395

Continuation Therapy — PAH

Covered for continuation when ALL of the following are met:

Continued Therapy - Pulmonary Arterial Hypertension: 1. Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Request does not exceed health-plan approved quantity limit; 4. If request is for a dose increase, new dose does not exceed both: (a) 10 mg per day; (b) 1 tablet per day.dose <= 10 mg/day AND tablets <=1/day

Approval durations provided per line of business

Other Indications / Off-label routing

Other/Off-label uses:

Other indications or recent label changes: 1. If the drug has undergone a label change within the last 6 months not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the line of business (see policy references).N/A

See CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable

Off-label uses not listed under exclusions: 2. If the requested use is not specifically listed under the non-covered diagnoses/indications section and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (see policy references).N/A

See CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable

Coverage and Administration

Coverage conditions and administration details noted in this section include dosing and plan-level authorization durations/bypass rules.

Dosing: For the PAH indication, macitentan dosing is 10 mg orally once daily with a maximum dose of 10 mg/day.

tablet available as 10 mg

Product Availability: Macitentan is available as a 10 mg tablet.

Authorization Duration: Medicaid and HIM initial approval duration extended from 6 months to 12 months for this maintenance medication for a chronic condition.

Applies to Medicaid and HIM per 1Q 2026 review.

Step Therapy Bypass: Step therapy bypass added for IL HIM per IL HB 5395; applicable requests must document bypass eligibility.

Non–FDA-approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation demonstrating the efficacy and safety of the requested off‑label use in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid).

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements that apply to this clinical policy.

Coding and Dosing Summary

Maximum daily dose — 10 mg per day

Maximum daily dose10 mg per day

Dosing regimen (PAH)10 mg PO QD

Policy threshold noteDose must not exceed 10 mg/day for initial and continuation approvals

Tablet limit — 1 tablet per day

Tablet limit1 tablet per day

Tablet strength available10 mg tablet

Policy threshold noteRequests exceeding 1 tablet/day may be denied

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must confirm the indication (pulmonary arterial hypertension) and dosing (e.g., 10 mg PO QD) and submit documentation demonstrating the PAH diagnosis and that the prescriber is a cardiologist or pulmonologist or that the request was made in consultation with one.

Confirm diagnosis of PAH and intended dose (10 mg PO QD).
Prescribed by or in consultation with a cardiologist or pulmonologist.

Documentation Required

Provider must submit supporting documentation (office chart notes, lab results, prior medication trials, consultation notes, and other clinical information) that the member has met all approval criteria. Failure to provide required documentation may result in denial of the request.

Include office notes, labs, medication history, and specialist consultation documentation.

Background

Macitentan (Opsumit) is an endothelin receptor antagonist indicated to reduce the risk of disease progression and hospitalization in pulmonary arterial hypertension (WHO Group I). Effectiveness was established in long‑term studies of predominantly WHO functional class II–III patients treated over an average of two years, including idiopathic/heritable, connective tissue disease–associated, and congenital heart disease–related PAH. Prescribers should follow the policy’s PAH criteria, dosing limits, and documentation requirements when requesting coverage.

Definitions and References

Macitentan (Opsumit) — Endothelin receptor antagonist (key drug definition)

Drug classEndothelin receptor antagonist

Brand nameOpsumit (macitentan)

FDA indication summaryTreatment of pulmonary arterial hypertension (WHO Group I) to reduce risk of disease progression and hospitalization

References — Key references including prescribing information and guideline documents

Primary prescribing informationOpsumit Prescribing Information. Actelion Pharmaceuticals, Inc.; April 2025

Clinical pharmacology resourceClinical Pharmacology [database online]. Elsevier; 2024