CurrentNeighborhood Health Plan of Rhode IslandPolicy 1646-A

Ambrisentan (Letairis) — Coverage Criteria for Pulmonary Arterial Hypertension

Covers clinical authorization criteria for ambrisentan (Letairis) for treatment of pulmonary arterial hypertension (WHO Group 1) in adults and select pediatric compendial use; applies to Neighborhood Health Plan of Rhode Island members under the payer products referencing this document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAmbrisentan (Letairis) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy 1646-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months when PAH diagnosis and hemodynamic confirmation criteria are documented.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

WHO Group 1indication group covered

Pulmonologist/Cardiologistprescriber requirement

RHC requiredhemodynamic criteria

Coverage Criteria for ambrisentan (Letairis)

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Initial therapy — PAH

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

PAH authorization criteria: Member has pulmonary arterial hypertension (WHO Group 1).

Refer to WHO Group 1 definitions in policy Appendix.

Hemodynamic confirmation: PAH confirmed by either: a) pretreatment right heart catheterization showing all of: mean pulmonary arterial pressure (mPAP) > 20 mmHg AND pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg AND pulmonary vascular resistance (PVR) > 2 Wood units (for pediatric members, PVRI > 3 Wood units·m2 is acceptable); OR b) for infants <1 year of age, Doppler echocardiogram when right heart catheterization cannot be performed.mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 WU (PVRI > 3 WU·m2 pediatric)

Documentation of right heart catheterization results (or echocardiogram for infants <1 year) must be provided.

Prescriber requirement: Prescription is provided by or in consultation with a pulmonologist or cardiologist.

Authorization duration: 12 months.

Continuation Therapy

Authorization of 12 months may be granted for continuation when ALL of the following are met:

Current therapy: Member is currently receiving the requested medication through a paid pharmacy or medical benefit.

Provide evidence of prior paid benefit.

Clinical benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Documentation of clinical status (stability or improvement) should be submitted.

Prescriber requirement: Prescription must be from or in consultation with a pulmonologist or cardiologist.

Prescriber specialty requirement applies to continuation requests.

All indications for ambrisentan not explicitly listed in the coverage criteria (that is, indications outside the FDA‑approved adult PAH indications and the specified pediatric compendial use) are considered experimental/investigational and not medically necessary and therefore are not covered.

Use of ambrisentan for indications other than the FDA‑approved adult pulmonary arterial hypertension (PAH, WHO Group 1) indications and the listed pediatric compendial use is considered not medically necessary (experimental/investigational) and is not covered.

Prescriber Requirements and Documentation

Prior Authorization

Prior Authorization and Combination Therapy

Prior authorization for up to 12 months is required and may be granted when PAH diagnosis and hemodynamic confirmation criteria are met. Combination therapy with tadalafil is noted in FDA‑approved indications; no step-therapy requirement is specified for use with tadalafil.

Prior authorization required — up to 12 months
Combination therapy with tadalafil noted (no step-therapy requirement stated)

Denial Risk

Hemodynamic Confirmation Required

Hemodynamic confirmation of pulmonary arterial hypertension (PAH) is required. Denial is likely if pretreatment right heart catheterization documentation is not provided demonstrating all of the following: mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units (PVRI > 3 WU·m2 acceptable for pediatric members). For infants <1 year, Doppler echocardiogram confirmation is acceptable if right heart catheterization cannot be performed.

Required: pretreatment right heart catheterization results with mPAP, PCWP, and PVR (or PVRI for pediatrics)
Exception: infants <1 year — Doppler echocardiogram if catheterization not possible

Documentation Required

Prescriber Specialty and Continuation Documentation

Prescriptions must be written by or in consultation with a pulmonologist or cardiologist. For continuation requests, documentation must show the member is currently receiving the medication through a paid benefit and is experiencing benefit from therapy (disease stability or improvement).

Prescriber specialty: pulmonologist or cardiologist
Continuation: current paid benefit plus evidence of benefit (stability or improvement)

Clinical Background

Pulmonary arterial hypertension (PAH; World Health Organization Group 1) is a progressive vasculopathy characterized by elevated pulmonary arterial pressure and increased pulmonary vascular resistance leading to reduced exercise capacity and risk of clinical worsening. Diagnosis requires hemodynamic confirmation—typically pretreatment right heart catheterization demonstrating mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units (with pediatric PVRI thresholds noted separately)—and management aims to improve functional capacity and delay disease progression.

Key Definitions

Hemodynamic confirmation of PAH

Required testPretreatment right heart catheterization

mPAP thresholdmPAP > 20 mmHg

PCWP thresholdPCWP ≤ 15 mmHg

PVR thresholdPVR > 2 Wood units (PVRI > 3 Wood units·m2 acceptable for pediatrics)

Infants alternativeFor infants <1 year, Doppler echocardiogram if catheterization cannot be performed

WHO Group 1 (PAH)

Included conditionsIdiopathic PAH

Heritable and drug/toxin-associatedHeritable PAH; PAH associated with drugs and toxins

Associated diseasesPAH associated with connective tissue disease, HIV infection, portal hypertension, congenital heart disease, schistosomiasis

Other formsLong-term responders to calcium channel blockers; PAH with PVOD/PCH features; persistent pulmonary hypertension of the newborn

OpenPayer

Ambrisentan (Letairis) — Coverage Criteria for Pulmonary Arterial Hypertension

Coverage Criteria for ambrisentan (Letairis)

Hemodynamic and Diagnostic Thresholds

Prescriber Requirements and Documentation

Clinical Background

Key Definitions