ModifiedHealth NetPolicy CP.PHAR.19

Bosentan (Tracleer) — Clinical Coverage Criteria for Pulmonary Arterial Hypertension

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Clinical coverage policy describing medical necessity criteria, contraindications, dosing, and authorization requirements for bosentan (Tracleer) for treatment of pulmonary arterial hypertension (PAH) for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyBosentan (Tracleer) — Clinical Coverage Criteria for PAH

Policy CodePolicy CP.PHAR.19

Change TypeScope clarification & approval duration revision

Effective DateFeb 25, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing PAH diagnosis, specialist involvement, and prior trial or contraindication to calcium channel blockers.

SourceLink

POLICY UPDATE CHANGES

Criteria also applies to brand Tracleer (in addition to generic bosentan).

Approval duration for Commercial line of business revised to 12 months or duration of request, whichever is less.

Appendix B was updated to remove commercially unavailable branded products and dosing regimens were updated per Clinical Pharmacology.

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ModifiedHealth NetPolicy CP.PHAR.19

Bosentan (Tracleer) — Clinical Coverage Criteria for Pulmonary Arterial Hypertension

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Policy Summary

PayerHealth Net

PolicyBosentan (Tracleer) — Clinical Coverage Criteria for PAH

Policy CodePolicy CP.PHAR.19

Change TypeScope clarification & approval duration revision

Effective DateFeb 25, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing PAH diagnosis, specialist involvement, and prior trial or contraindication to calcium channel blockers.

SourceLink

POLICY UPDATE CHANGES

Criteria also applies to brand Tracleer (in addition to generic bosentan).

Approval duration for Commercial line of business revised to 12 months or duration of request, whichever is less.

Appendix B was updated to remove commercially unavailable branded products and dosing regimens were updated per Clinical Pharmacology.

PAHIndication covered

250 mg/dayMax daily dose

12 moApproval duration (Commercial)

62.5/125 mgTablet strengths

Hepatotoxicity/Embryo-fetalSafety warnings

Includes TracleerScope clarification

Coverage Criteria for Bosentan (Tracleer)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial PAH criteria: Diagnosis of pulmonary arterial hypertension (PAH).

Prescriber requirement: Prescribed by or in consultation with a cardiologist or pulmonologist.

Acute vasodilator testing: Inadequate response to, or contraindication to, acute vasodilator testing.

Calcium channel blocker trial: Failure of a calcium channel blocker (see Appendix B) unless there is a contraindication or clinically significant adverse effects to calcium channel blockers.

Dose limits: Requested dose does not exceed 250 mg per day and does not exceed 2 tablets per day.250 mg/day

Brand/generic redirect: If the request is for brand Tracleer, the member must use generic bosentan unless contraindicated or clinically significant adverse effects are experienced.

Clarified in 1Q 2025 review

Continuation (Renewal) Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Current therapy or prior approval: Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria; or member is covered under applicable continuity of care provisions.

Clinical response: Member is responding positively to therapy.

Dose limits for increases: If the request is for a dose increase, the new dose does not exceed 250 mg per day and does not exceed 2 tablets per day.250 mg/day

Brand/generic redirect for continued therapy: If the request is for brand Tracleer, the member must use generic bosentan unless contraindicated or clinically significant adverse effects are experienced.

Policy Criteria and Dosing — Policy criteria and administrative provisions (as revised)

Policy criteria and administrative provisions (as revised):

Scope: Criteria apply to both generic bosentan and brand Tracleer.

Clarified in 1Q 2025 review

Approval duration: Commercial approval duration: 12 months or duration of request, whichever is less.12 months

Revised approval duration recorded in policy history

Dosing guidance: Adult dosing: initiate 62.5 mg orally twice daily for 4 weeks, then increase to 125 mg orally twice daily; maximum 250 mg per day.see dosing

Appendix dosing updated per Clinical Pharmacology

Non‑FDA approved indications that are not specifically addressed by this clinical policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy or evidence of coverage. For Commercial members follow CP.CPA.09, for Health Insurance Marketplace follow HIM.PA.154, and for Medicaid follow CP.PMN.53, or other applicable evidence of coverage documents.

Appendix updates removed commercially unavailable branded products from consideration; these products are no longer listed in Appendix B and are not considered for coverage. This change was applied during recent policy reviews and is documented in the policy history and appendix revisions.

The appendix removals and related reference updates were part of routine annual reviews (see prior review notes) and were implemented per Clinical Pharmacology recommendations.

Use of bosentan for non‑FDA approved indications without provision of adequate supporting documentation per the off‑label use policies is considered not authorized. Providers must submit clinical evidence (chart notes, lab results, or other pertinent information) demonstrating efficacy and safety in accordance with the referenced off‑label policies or evidence of coverage to support any such request.

Policy history documents operational changes including edits to generic redirection and step‑therapy language and a revision to the Commercial approval duration. Historical entries note retirement or revision of prior redirection requirements and adoption of explicit "must use" language for generic redirection where applicable.

The 1Q 2025 review clarified that the criteria apply to both generic bosentan and brand Tracleer and records that commercially unavailable branded products were removed from appendices and dosing regimens updated per Clinical Pharmacology; earlier revisions also revised the Commercial approval duration to 12 months or the duration of the request, whichever is less.

Dosing & Coding Details

No explicit codes providedmixed

No codes listed

Maximum adult daily dose

Maximum adult daily dose250 mg/day

Maximum tablets per day2 tablets per day

Applies toAdults with PAH (WHO Group 1)

PAH adult dosing escalation

Initial dosing62.5 mg orally twice daily for 4 weeks

Maintenance dosingIncrease to 125 mg orally twice daily after 4 weeks

Maximum daily doseTotal daily maximum 250 mg/day

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must document the diagnosis of pulmonary arterial hypertension (PAH) and that therapy is prescribed by or in consultation with a cardiologist or pulmonologist. Requests must include supporting documentation (e.g., chart notes, lab results) demonstrating the member meets all approval criteria.

Prior authorization is required before initiation or continuation of bosentan/Tracleer.
Prescriber requirement: cardiologist or pulmonologist involvement documented.

Documentation Required

Provider must submit documentation (such as chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to provide sufficient documentation may result in denial.

Documentation must support diagnosis, prior therapies tried, contraindications/intolerances, and response to therapy.

Background on Bosentan and Pulmonary Arterial Hypertension

Bosentan (brand name Tracleer) is an endothelin receptor antagonist indicated in adults to improve exercise capacity and to decrease clinical worsening in pulmonary arterial hypertension (WHO Group 1). Clinical trials supporting effectiveness included patients with WHO functional classes II–IV and a range of etiologies such as idiopathic/heritable PAH and connective tissue disease–associated PAH.

Recommended adult dosing per the policy and product labeling begins at 62.5 mg PO twice daily for 4 weeks then increases to 125 mg PO twice daily, with a maximum total daily dose of 250 mg/day. Tablet strengths available include 62.5 mg and 125 mg (a dispersible 32 mg formulation is also listed in the product information).

Definitions and Product Information

PAH (Pulmonary arterial hypertension) — definition & functional classification

WHO GroupPulmonary arterial hypertension (PAH) = WHO Group 1

Clinical intentCharacterized by elevated pulmonary arterial pressure; treated to improve exercise ability and decrease clinical worsening

Functional classificationSeverity often classified by WHO/NYHA Functional Class (FC I–IV); referenced in Appendix E

Pulmonary Hypertension WHO Classification (appendices)

Reference locationPulmonary Hypertension WHO Classification is provided in Appendix D

Related appendixWHO/NYHA Functional Classes are detailed in Appendix E

Policy Summary

PayerHealth Net

PolicyBosentan (Tracleer) — Clinical Coverage Criteria for PAH

Policy CodePolicy CP.PHAR.19

Change TypeScope clarification & approval duration revision

Effective DateFeb 25, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing PAH diagnosis, specialist involvement, and prior trial or contraindication to calcium channel blockers.

SourceLink

On This Page

Generic redirection also applies to continued therapy per prior revisions

Requests for continuation must document prior authorization or evidence of prior meeting initial criteria if applicable.

Step Therapy

Step Therapy Required

Step therapy applies: prior trial and inadequate response to or contraindication/intolerance of a calcium channel blocker is required unless an exception is documented. Appendix B lists acceptable calcium channel blocker alternatives (e.g., nifedipine, diltiazem, amlodipine).

Step therapy: trial and failure of a calcium channel blocker OR documented contraindication/intolerability.
See Appendix B for therapeutic alternatives and dosing guidance.

Denial Risk

Non‑FDA Indications Not Authorized Without Documentation

Requests for non‑FDA approved (off‑label) indications that are not addressed by this policy are not authorized unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies and evidence of coverage documents.

Off‑label use requires documentation of efficacy/safety per the referenced off‑label policies.
Coverage also depends on the member's Evidence of Coverage/Certificate of Coverage and applicable state rules.

Billing Rule

Brand vs Generic Requirement / Generic Redirection

If the request is for brand Tracleer, members must use generic bosentan unless there is a documented contraindication or clinically significant adverse effect to the generic formulation. Failure to follow updated generic redirection or to provide medical justification consistent with policy language may affect coverage decisions.

Brand Tracleer requests require documentation showing generic bosentan is contraindicated or not tolerated.
Generic redirection also applies to continued therapy requests; provide documentation if a brand is necessary.

Note

Policy History and Provider Implications

Policy history: prior step‑therapy and generic redirection edits were previously modified or retired and have been clarified in recent reviews. Providers should note that the current criteria explicitly apply to brand Tracleer and that the policy was revised to use mandatory language for generic redirection.

1Q 2022: retired prior policy WCG.CP.PHAR.191; changed redirection to generic bosentan and added generic redirection to continued therapy.
1Q 2025: clarified that criteria also apply to brand Tracleer and revised Appendix B; references reviewed and updated.

UseAppendices used for monitoring progression and treatment decisions

Bosentan product and dosing information

Tablet strengths62.5 mg and 125 mg tablets

Dispersible formulation32 mg dispersible tablet for oral suspension

Dosing referenceAdult dosing regimens (62.5 mg PO BID then 125 mg PO BID; max 250 mg/day) are listed in Dosage and Administration