CurrentNeighborhood Health Plan of Rhode IslandPolicy 1649-A

Bosentan

Policy governs coverage of bosentan (Tracleer and generics) for treatment of pulmonary arterial hypertension (WHO Group 1) including FDA-approved adult and pediatric indications; requires prescriber specialty and specific diagnostic confirmation. Other uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBosentan

Policy CodePolicy 1649-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for bosentan for PAH; authorization may be granted for 12 months when the listed diagnostic and prescriber specialty criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

1Covered Indication (WHO Group 1 PAH)

>=12 monthsAuthorization Duration

2Hemodynamic Thresholds (mPAP, PVR/PVRI)

Coverage Summary

Policy governs coverage of bosentan (Tracleer and generics) for treatment of pulmonary arterial hypertension (WHO Group 1). Coverage is limited to the FDA‑approved PAH indications: in adults to improve exercise ability and decrease clinical worsening, and in pediatric patients aged 3 years and older to improve pulmonary vascular resistance. Prior authorization is required and may be granted for 12 months when all diagnostic confirmation and prescriber specialty criteria are met. Bosentan must be prescribed by or in consultation with a pulmonologist or cardiologist. All other indications, including non‑Group 1 pulmonary hypertension and other non‑FDA‑approved or non‑compendial uses, are considered experimental/investigational and are not covered.

Initial Authorization Criteria

Initial Authorization for Pulmonary Arterial Hypertension (PAH)

Authorization of 12 months may be granted for treatment of PAH when ALL of the following criteria are met:

ALL of the following

Member has PAH defined as WHO Group 1 class of pulmonary hypertension (refer to Appendix).
ALL of the following
- Pretreatment right heart catheterization with all of the following results:
  - Mean pulmonary arterial pressure (mPAP) > 20 mmHg> 20 mmHg
  - Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg≤ 15 mmHg
  - Pulmonary vascular resistance (PVR) > 2 Wood units> 2 Wood units
    For pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units x m2 is also acceptable.
- For infants less than one year of age, PAH was confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.
Prescriber specialty requirement: Prescriber is a pulmonologist or cardiologist, or bosentan is prescribed in consultation with a pulmonologist or cardiologist.
Prescriber specialty requirement

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Continuation of Therapy Criteria

Continuation of Therapy

Authorization of 12 months may be granted for members currently receiving the requested medication and experiencing benefit.

ALL of the following

Member has an indication listed in the coverage criteria section and is currently receiving the requested medication through a paid pharmacy or medical benefit.
Clinical documentation of stability or improvement required: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.
Clinical documentation of stability or improvement required

Excluded / Not Covered Indications

Excluded/Not Covered Indications

All other indications not listed below are considered experimental/investigational and not medically necessary:

Indications other than WHO Group 1 PAH (as specified above), including non-PAH pulmonary hypertension groups (Groups 2-5) and all other uses not FDA-approved or compendial.

Provider Actions & Documentation Requirements

Prior Authorization

Authorization required

Prior authorization is required for bosentan (Tracleer) for treatment of pulmonary arterial hypertension (PAH). Authorization may be granted for up to 12 months when the diagnostic criteria (see hemodynamic confirmation and WHO Group 1 classification) and prescriber specialty requirements are met.

Authorization duration: 12 months

Documentation Required

Diagnostic confirmation required

Document pretreatment diagnostic confirmation of PAH. For most patients, provide right heart catheterization results including mean pulmonary arterial pressure (mPAP), pulmonary capillary wedge pressure (PCWP), and pulmonary vascular resistance (PVR). For infants under 1 year when catheterization cannot be performed, provide Doppler echocardiogram confirming PAH. Also document WHO Group 1 classification as applicable.

Mean pulmonary arterial pressure (mPAP) > 20 mmHg
Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
Pulmonary vascular resistance (PVR) > 2 Wood units (or PVRI > 3 Wood units·m2 for pediatrics)
Doppler echocardiogram confirmation for infants <1 year if catheterization cannot be performed

Documentation Required

Continuation documentation

For renewal of therapy, document that the member is currently receiving the medication through a paid pharmacy or medical benefit and provide clinical evidence that the member is benefiting from therapy, demonstrated by disease stability or improvement.

Documentation Required

Prescriber specialty documentation

Ensure the prescription is written by a pulmonologist or cardiologist, or is prescribed in consultation with a pulmonologist or cardiologist. When prescribed in consultation, document the consulting specialist and relevant consultation notes.

Document consulting pulmonologist or cardiologist when applicable

Background

Bosentan (Tracleer) is an endothelin receptor antagonist indicated for treatment of pulmonary arterial hypertension (WHO Group 1). In adults it is indicated to improve exercise ability and to decrease clinical worsening; in pediatric patients aged 3 years and older it is indicated to improve pulmonary vascular resistance. The policy references hemodynamic definitions and the WHO classification of pulmonary hypertension to define PAH and the diagnostic thresholds required for coverage.

Definitions

PAH: Pulmonary arterial hypertension, WHO Group 1 class of pulmonary hypertension.

mPAP: Mean pulmonary arterial pressure.

PCWP: Pulmonary capillary wedge pressure.

PVR: Pulmonary vascular resistance.

PVRI: Pulmonary vascular resistance index (pediatric measure).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBosentan

Policy CodePolicy 1649-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for bosentan for PAH; authorization may be granted for 12 months when the listed diagnostic and prescriber specialty criteria are met.

SourceLink

On This Page

OpenPayer

Bosentan

Coverage Summary

Initial Authorization Criteria

Continuation of Therapy Criteria

Excluded / Not Covered Indications

Provider Actions & Documentation Requirements

Applicable Codes

Clinical Evidence & References

Background

Definitions

Tracleer	Brand name bosentan (referenced along with generic bosentan and all dosage forms/strengths)
bosentan	Generic bosentan (all dosage forms and strengths)