CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Letairis (ambrisentan) for pulmonary arterial hypertension

Policy governs coverage and authorization criteria for ambrisentan (Letairis) for treatment of pulmonary arterial hypertension (WHO Group 1) including combination therapy with tadalafil, prescriber specialty requirements, diagnostic confirmation and continuation/renewal criteria. Non‑FDA or non‑compendial uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLetairis (ambrisentan) for pulmonary arterial hypertension

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of PAH confirmation (hemodynamics or echocardiogram for infants) and ensure prescribing by or in consultation with a pulmonologist or cardiologist; approvals may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria.

1Covered Indications (WHO Group 1 PAH)

12Authorization Duration (months)

3Hemodynamic Threshold (PVR/PVRI)

Coverage Summary

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Scope: This policy governs coverage and authorization criteria for Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension (WHO Group 1). Coverage is available for FDA‑approved uses to improve exercise ability and delay clinical worsening and for use in combination with tadalafil to reduce disease progression and hospitalization and improve exercise ability. Authorization of 12 months may be granted when the specified diagnostic, prescriber, and other criteria are met. Coverage stance: covered_with_criteria.

Thresholds / Quick Facts

Covered IndicationsPulmonary arterial hypertension (WHO Group 1); indicated to improve exercise ability and delay clinical worsening; in combination with tadalafil to reduce disease progression and hospitalization

Authorization Duration12 months (initial and renewal when criteria/met and patient benefiting)

Hemodynamic Threshold (PVR/PVRI)PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)< 15 mmHg

NotesPrescriber must be a pulmonologist or cardiologist; for infants <1 year, Doppler echocardiogram may confirm PAH if RHC not feasible

Not Covered / Experimental or Investigational

All other indications (other than FDA‑approved and compendial uses listed) are considered experimental/investigational and not medically necessary

Denial Risk

Non‑covered indications will be denied

Requests for uses outside FDA-approved indications and listed compendial uses will be considered experimental/investigational and not medically necessary, risking denial.

Non‑covered indications will be denied: Requests for uses outside FDA‑approved indications and listed compendial uses will be considered experimental/investigational and not medically necessary, risking denial.

Provider Actions

Prior Authorization

Authorization required for Letairis

Authorization of up to 12 months may be granted only when criteria are met (WHO Group 1 PAH diagnosis, diagnostic confirmation as specified, prescriber specialty) and for continuation when member shows benefit; prior authorization documentation should include diagnostic hemodynamics or echocardiogram for infants.

Documentation Required

Diagnostic evidence required

Provide documentation of PAH confirmation: pretreatment hemodynamic assessment is required. For diagnostic confirmation, document mean pulmonary arterial pressure (mPAP) > 20 mmHg and pretreatment right heart catheterization results showing pulmonary capillary wedge pressure (PCWP) < 15 mmHg and pulmonary vascular resistance (PVR) ≥ 3 Wood units in adults (or pulmonary vascular resistance index [PVRI] ≥ 3 Wood units·m2 in pediatric patients). For infants less than one year of age, PAH may be confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.

mPAP > 20 mmHg
PCWP < 15 mmHg
PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)
Infants < 1 year: Doppler echocardiogram acceptable if catheterization not feasible

Documentation Required

Prescriber specialty

Prescription must be from or in consultation with a pulmonologist or cardiologist; include consult notes if applicable.

Denial Risk

Non‑covered indications will be denied

Requests for uses outside FDA‑approved indications and listed compendial uses will be considered experimental/investigational and not medically necessary, risking denial.

Clinical Evidence

Evidence and background: Primary sources include the Letairis and ambrisentan package inserts and multiple guideline and consensus documents (ACC/AHA, CHEST, AHA/ATS pediatric guidelines, and World Symposium reports). Clinical trials establishing effectiveness predominantly enrolled patients with WHO Functional Class II‑III symptoms and etiologies including idiopathic, heritable, and connective tissue disease‑associated PAH. Diagnostic and hemodynamic thresholds used in the policy are aligned with guideline references and package insert data.

Background

Background: Letairis (ambrisentan) is FDA‑approved to improve exercise ability and delay clinical worsening in pulmonary arterial hypertension (WHO Group 1). It is also approved in combination with tadalafil to reduce the risks of disease progression and hospitalization and to improve exercise ability. Trials predominantly included patients with WHO Functional Class II‑III symptoms and etiologies such as idiopathic, heritable, and connective tissue disease‑associated PAH. Authorization and continuation criteria include documentation of diagnostic hemodynamics and prescriber specialty, and approvals may be granted for up to 12 months when criteria are met and the member is benefiting from therapy.

Definitions

PAHPulmonary arterial hypertension defined as WHO Group 1 pulmonary hypertension

mPAPMean pulmonary arterial pressure

PCWPPulmonary capillary wedge pressure

PVRPulmonary vascular resistance

PVRIPulmonary vascular resistance index