CurrentCentenePolicy CP.PHAR.19

Bosentan (Tracleer)

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, brand/generic redirection, approval durations, contraindications and monitoring for bosentan (Tracleer) for PAH across Commercial, HIM and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyBosentan (Tracleer)

Policy CodePolicy CP.PHAR.19

Change TypeClarified / Revised / Removed

Effective Date03.16

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

In Policy/Criteria clarified criteria also applies to brand Tracleer.

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

Removed commercially unavailable branded products from Appendix B.

1Covered Indication (PAH)

3Lines of Business covered

250Max daily dose (mg)

2Max tablets/day

Coverage Summary

Coverage stance: covered_with_criteria for bosentan (Tracleer) for the treatment of pulmonary arterial hypertension (PAH). This policy applies across lines of business: Commercial, HIM, and Medicaid. Approval durations: for Commercial the approval duration is 12 months or the duration of request, whichever is less; for HIM and Medicaid the approval duration is 6 months (initial) and continued therapy durations align with policy (Commercial: 12 months or duration of request; Medicaid/HIM: 12 months). Scope summary: defines medical necessity criteria for initial and continuation approval, dosing limits (maximum 250 mg per day and maximum 2 tablets per day), specialist prescribing requirement, brand-to-generic redirection, contraindications and monitoring for bosentan (Tracleer) for PAH.

Quick facts & thresholds

Maximum daily dose250 mg per day

Maximum tablets per day2 tablets per day

Lines of Business coveredCommercial, HIM (marketplace), Medicaid

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Failure of a calcium channel blocker
- Failure of a calcium channel blocker (see Appendix B)
- Contraindication to calcium channel blockers
- Clinically significant adverse effects to calcium channel blockers
Dose limits
- Dose does not exceed 250 mg per day
  Maximum total daily dose
- Dose does not exceed 2 tablets per day
  Tablet-based limit
Prescribed by or in consultation with a cardiologist or pulmonologist
Specialist prescribing requirement
If request is for brand Tracleer, member must use generic bosentan unless contraindicated or clinically significant adverse effects are experienced
Brand-to-generic redirection
Non‑FDA/off‑label uses require referral per off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP.PMN.53 (Medicaid).
Policy referral requirement

Prior Authorization

Specialist prescribing requirement

Bosentan must be prescribed by or in consultation with a cardiologist or pulmonologist.

Billing Rule

Brand to generic redirection

If the request is for brand Tracleer, the member must use generic bosentan unless there is a documented contraindication or clinically significant adverse effects to the generic.

Continuation Therapy Criteria

Continued Therapy

Coverage for continuation is authorized when ONE of the following and ALL of the continued-therapy specific criteria are met:

ANY of the following

Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria
Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums)

ALL of the following

Member is responding positively to therapy
Demonstration of response required for continuation
If request is for dose increase
- New dose does not exceed 250 mg per day250 mg per day
  Maximum daily dose for dose increase
- New dose does not exceed 2 tablets per day2 tablets per day
  Maximum tablets per day for dose increase
If request is for brand Tracleer, member must use generic bosentan unless contraindicated or clinically significant adverse effects are experienced
Generic redirection applies to brand Tracleer for continued therapy

Documentation Required

Demonstration of response for continuation

For continuation of therapy, document that the member is responding positively to therapy, or that the member previously met the initial criteria, or that continuity-of-care regulations apply.

Other Diagnoses / Off‑label and Formulary Handling

Other diagnoses/indications (formulary/non-formulary/off-label handling)

When indication is not standard PAH or the drug's formulary status differs, one of the following must be followed:

ANY of the following

For drugs on the formulary (commercial, marketplace) or PDL (Medicaid): follow the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid)
For drugs NOT on the formulary/PDL: follow the non-formulary policy for the relevant line of business (CP.CPA.190 commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid)
If requested use is not specifically listed under section III and initial criteria do not apply: refer to off-label use policy for relevant line of business (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid)

Diagnoses/Indications NOT authorized

Not authorized: Non-FDA approved indications that are not addressed in this policy (unless sufficient documentation of efficacy/safety per off-label use policies or evidence of coverage documents)

Refer to off-label use policies CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Denial Risk

Non‑FDA/off‑label uses require policy referrals

Requests for non‑FDA or off‑label indications that are not addressed in this policy will not be authorized unless sufficient documentation of efficacy and safety is provided per the applicable off‑label or non‑formulary policies; refer to the CP.* policies listed in the policy (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53 and the non‑formulary/no‑coverage policies cited).

Provider Actions

Documentation Required

Submission of supporting documentation

Provider must submit chart notes, lab results, or other clinical information supporting that the member meets all approval criteria when requesting bosentan (Tracleer).

Prior Authorization

Specialist prescribing requirement

Bosentan (Tracleer) must be prescribed by or in consultation with a cardiologist or pulmonologist.

Billing Rule

Brand to generic redirection

If the request is for brand Tracleer, the member must use generic bosentan unless a contraindication or clinically significant adverse effects to the generic are documented.

Clinical Evidence & References

Evidence sources include the Tracleer Prescribing Information (February 2024) as the primary source and major guideline references cited in the policy: ESC/ERS 2022, ACCF/AHA 2009, and the AHA/ATS pediatric pulmonary hypertension 2015 guideline. Background evidence summarized: Tracleer is an endothelin receptor antagonist indicated for PAH (WHO Group 1) with demonstrated benefit in improving exercise ability and decreasing clinical worsening; pediatric indications are supported for patients 3 years and older for certain forms of PAH.

Background

Bosentan (Tracleer) is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (WHO Group 1). It is indicated in adults to improve exercise ability and to decrease clinical worsening; pediatric indications exist for patients 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance. The policy references the FDA label (Tracleer Prescribing Information) and major guidelines when establishing coverage criteria.

Definitions

PAHPulmonary arterial hypertension (WHO Group 1)

PDLPreferred Drug List

Revision History

02.25.2025clarifiedLatest

In Policy/Criteria clarified criteria also applies to brand Tracleer (explicitly stating brand requests must follow same criteria as generic bosentan).

02.24.2024updated_appendix

Appendix B therapeutic alternatives updated per Clinical Pharmacology; removed commercially unavailable branded products and updated dosing regimens.

06.23.2022revised

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

01.01.2022applied_previous_update_note

Applied previously in 1Q2022 updates: added generic redirection language requiring use of generic bosentan (‘‘must use’’) for brand Tracleer and added generic redirection to continued therapy.

2003-03-16policy_effective

Policy effective date recorded (Effective Date: 03.16); defines coverage criteria, dosing limits (maximum 250 mg/day and 2 tablets/day), specialist prescribing requirement, and approval durations by line of business.

02.25.2025documented_changes_logLatest

Revision log documents template changes and references reviewed/updated across annual reviews; includes repeated notes of no significant clinical statement changes in several 1Q reviews but records the specific administrative and Appendix B updates noted above.