CurrentCentenePolicy CP.PHAR.194

Macitentan (Opsumit) — Coverage Criteria for Pulmonary Arterial Hypertension

Covers medical necessity and authorization criteria for macitentan (Opsumit) to treat pulmonary arterial hypertension (WHO Group I) for Centene lines of business (Commercial, HIM, Medicaid). Affects prescribers and providers requesting coverage.

Policy Summary

PayerCentene

PolicyMacitentan (Opsumit) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy CP.PHAR.194

Change TypeAnnual review updates; template clarifications

Effective Date03.16

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

In 1Q 2025 annual review: in Appendix B per Clinical Pharmacology, removed commercially unavailable branded products, updated dosing regimens, clarified use for off-label indications, and clarified drug classes of recommended redirections; references reviewed and updated.

Per September SDC, added HIM and Commercial line of business to policy (CP PCH.31 retired); template changes applied to other diagnoses/indications and continued therapy sections.

10 mg/daymaximum approved macitentan dose for PAH

Commercial, HIM, Medicaidlines of business covered

Embryo-fetal toxicityboxed warning / REMS requirement

WHO Group I (PAH)

FDA approved indication

Tablet: 10 mgproduct availability

Coverage Criteria for Macitentan (Opsumit)

Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Initial Approval: 1. Diagnosis of pulmonary arterial hypertension (PAH).

Initial Approval: 2. Prescription is by or in consultation with a cardiologist or pulmonologist.

Initial Approval: 2a. Inadequate response to or contraindication for acute vasodilator testing.

Initial Approval: 3. Failure of a calcium channel blocker unless there is a contraindication or clinically significant adverse effects.

Initial Approval: 4. Failure of generic ambrisentan or bosentan unless both are contraindicated or not tolerated due to clinically significant adverse effects.

Initial Approval: 5. Requested dose does not exceed 10 mg per day.10 mg/day

Continuation — Continued therapy covered when ALL of the following are met:

Continued therapy covered when ALL of the following are met:

Continued Therapy: 1. Member meets one of the following: a) currently receiving the medication via the Centene benefit; or b) member previously met initial approval criteria; OR member is receiving medication and enrolled in a state/product with continuity of care regulations (as applicable).

Continued Therapy: 2. Member is responding positively to therapy.

Continued Therapy: 3. If the request is for a dose increase, the new dose does not exceed 10 mg per day (typically 1 tablet per day).10 mg/day

Non‑FDA (off‑label) uses of macitentan are not authorized under this policy unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy. For Commercial members follow CP.CPA.09, for Health Insurance Marketplace follow HIM.PA.154, and for Medicaid follow CP.PMN.53, or provide evidence of coverage documents that support the requested indication.

For members covered by Medicaid, any state Medicaid coverage provisions that conflict with this clinical policy take precedence. Providers should consult the applicable state Medicaid manual for specific coverage rules and requirements that supersede this policy.

Product and Dosing Information

Macitentan dosing

Typical dosing10 mg once daily (QD)

Maximum approved dose10 mg per day

Dosage form notedTablet: 10 mg

Provider Actions, Prior Authorization, and Documentation

Note

Use of policy for coverage decisions

Use of policy for coverage decisions: This clinical policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits; it does not constitute a contract or guarantee of payment. Coverage decisions and benefit administration remain subject to all terms, conditions, exclusions, and limitations in the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance) and to applicable state and federal requirements. For Medicaid members, state Medicaid provisions take precedence where they conflict with this clinical policy; refer to the applicable state Medicaid manual for specific provisions.

Policy is a guide to medical necessity and not a payment guarantee
Coverage subject to coverage documents, state/federal requirements, and Health Plan administrative policies
Medicaid state provisions override policy when conflicts exist

Documentation Required

Documentation and governance

Background on Macitentan and Pulmonary Arterial Hypertension

Macitentan is an endothelin receptor antagonist indicated for treatment of WHO Group I pulmonary arterial hypertension (PAH) to reduce risk of disease progression and hospitalization. The prescription is typically for a maximum dose of 10 mg once daily, consistent with labeled dosing for PAH and the dosing listed in this policy.

Definitions, REMS, and Guideline References

PAH (pulmonary arterial hypertension)

WHO classificationWHO Group I (pulmonary arterial hypertension, PAH)

Functional classes referencedWHO/NYHA functional classes (predominantly FC II–III in trials)

Targeted therapy classesEndothelin receptor antagonists, prostacyclin pathway agents, phosphodiesterase-5 (PDE5) inhibitors, calcium channel blockers (when vasoreactive)

REMS / boxed warning

Boxed warningEmbryo-fetal toxicity (boxed warning)

REMS requirementAssociated with a REMS program for embryo-fetal toxicity

Policy Summary

PayerCentene

PolicyMacitentan (Opsumit) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy CP.PHAR.194

Change TypeAnnual review updates; template clarifications

Effective Date03.16

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing member meets all approval criteria.

SourceLink

On This Page

Documentation and governance: Providers must exercise professional judgment and are responsible for the medical care of members. This policy was developed by qualified professionals using current standards and evidence but does not replace clinical judgment. The Health Plan may change, amend, or withdraw this policy at any time. Providers are independent contractors and not agents of the Health Plan.

Policy developed by licensed healthcare professionals using peer-reviewed literature and guidelines
Providers remain responsible for diagnosis and treatment decisions
Health Plan may revise or withdraw the policy; effective date on posting may differ from plan-determined effective date

Denial Risk

Documentation-based denials

Documentation-based denials: Provider must submit supporting documentation (e.g., office chart notes, diagnostic test results, labs, and other clinical information) demonstrating the member meets all applicable approval criteria. Requests lacking sufficient documentation to verify criteria or seeking coverage for non‑FDA indications without adequate off‑label justification (per CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable) may be denied.

Submit office notes, lab results, and other relevant clinical records with the prior authorization request
Insufficient documentation may result in denial of the request
Non‑FDA indications require sufficient off‑label evidence per applicable off‑label use policies

Prior Authorization

Coverage conditions

Coverage conditions: Coverage is provided only when the member meets the clinical criteria within this policy and all other applicable benefit terms and plan-level rules. Approval durations vary by line of business (e.g., HIM/Medicaid: 6 months; Commercial: up to 12 months or duration of request, whichever is less). Prior authorization is required where indicated and approvals are subject to periodic review.

Coverage contingent on meeting policy clinical criteria and benefit document terms
Approval durations: HIM/Medicaid = 6 months; Commercial = 12 months or duration requested, whichever is less
Prior authorization required; approval durations vary by line of business

ContraindicationContraindicated in pregnancy

Pulmonary hypertension guidelines

Primary guideline referencesESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension (2015 and 2022)

Additional guideline literatureHaemodynamic definitions and updated clinical classification of pulmonary hypertension (Eur Respir J 2019)

Supporting clinical reviewsClinical updates and reviews on pulmonary hypertension (various citations included in policy references)