CurrentNeighborhood Health Plan of Rhode IslandPolicy 1645-A

Selexipag (Uptravi) for pulmonary arterial hypertension — Coverage Criteria

Covers clinical authorization criteria for Uptravi (selexipag) for treatment of pulmonary arterial hypertension (WHO Group 1) for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySelexipag (Uptravi) for pulmonary arterial hypertension — Coverage Criteria

Policy CodePolicy 1645-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of PAH and hemodynamic confirmation (right heart catheterization results) and ensure prescription is by or in consultation with a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

WHO Group 1indication limited to

>20mPAP threshold

≤15PCWP threshold

Coverage Criteria for Selexipag (Uptravi)

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Initial Authorization for PAH (WHO Group 1)

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

Population: Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 pulmonary hypertension.

Refer to WHO classification appendix.

Hemodynamic confirmation

Right heart catheterization: Pretreatment right heart catheterization demonstrating all of: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg; and pulmonary vascular resistance (PVR) > 2 Wood units (for pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units·m2 is acceptable).mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units
Infants <1 year: For infants less than one year of age, confirmation by Doppler echocardiogram is acceptable if right heart catheterization cannot be performed.

Indication is the FDA‑approved indication for Uptravi: pulmonary arterial hypertension (WHO Group 1).

All other indications are considered experimental/investigational and not medically necessary.

Continuation of Therapy

Authorization of 12 months may be granted for members currently receiving the medication and meeting the following:

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

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

Use of Uptravi (selexipag) for any indication other than the FDA‑approved treatment of pulmonary arterial hypertension (PAH, WHO Group I) is considered experimental/investigational and not medically necessary. The FDA indication specifies use to delay disease progression and reduce the risk of hospitalization in PAH patients (WHO Functional Class II–III) and effectiveness was established in a long‑term study including idiopathic, heritable, connective tissue disease‑associated, and congenital heart disease with repaired shunts.

Hemodynamic & Diagnostic Coding/Values

inv-05: Mean pulmonary arterial pressure (mPAP) — > 20 mmHg

Threshold> 20 mmHg

Measurement contextMeasured on pretreatment right heart catheterization

Use in infants <1 yearIf catheterization cannot be performed, Doppler echocardiogram may be used instead

inv-06: Pulmonary capillary wedge pressure (PCWP) — ≤ 15 mmHg

Threshold≤ 15 mmHg

Measurement contextMeasured on pretreatment right heart catheterization

Role in diagnosisRequired along with mPAP > 20 mmHg and PVR > 2 Wood units to confirm PAH

inv-07: Pulmonary vascular resistance (PVR) — > 2 Wood units (PVRI > 3 Wood units·m2 for pediatrics)

Threshold> 2 Wood units

Pediatric alternativePulmonary vascular resistance index (PVRI) > 3 Wood units·m2 acceptable for pediatric members

Measurement contextMeasured on pretreatment right heart catheterization as part of hemodynamic confirmation

Prescriber & Authorization Actions

Prior Authorization

Prior authorization and renewal

Prior authorization may be granted for up to 12 months when all coverage criteria are met. Continuation/renewal requests require evidence that the member is currently receiving the medication through a paid benefit and is experiencing benefit from therapy (disease stability or improvement).

Authorization duration: 12 months
Continuation requires evidence of benefit (disease stability or improvement)

Step Therapy

Step therapy

No step-therapy or fail-first requirements are specified for this medication in the source document.

Documentation Required

Required diagnostic documentation

Documentation of diagnosis and hemodynamic confirmation is required prior to authorization. Acceptable documentation includes a pretreatment right heart catheterization showing mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units. For pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units·m2 is acceptable. For infants <1 year old, a Doppler echocardiogram may be used if right heart catheterization cannot be performed.

Right heart catheterization: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units
Pediatric alternative: PVRI > 3 Wood units·m2
Infants <1 year: Doppler echocardiogram if RHC not possible

Note

Prescriber specialty

Prescription must be written by or in consultation with a pulmonologist or cardiologist.

Prescriber specialty: pulmonologist or cardiologist

Denial Risk

Experimental/Investigational — Not Medically Necessary

Use of Uptravi for indications other than the FDA‑approved indication for pulmonary arterial hypertension (PAH, WHO Group I) is considered experimental/investigational and not medically necessary.

Background

Pulmonary arterial hypertension (PAH, WHO Group I) is the FDA‑labeled indication for Uptravi. The drug is approved to delay disease progression and reduce PAH‑related hospitalizations in patients with WHO Functional Class II–III symptoms; the pivotal long‑term study demonstrating effectiveness included patients with idiopathic and heritable PAH, PAH associated with connective tissue disease, and PAH associated with congenital heart disease with repaired shunts. Hemodynamic confirmation and clinical documentation consistent with PAH are required for coverage under the approved indication.

Definitions

inv-14: Hemodynamic confirmation of PAH — Either pretreatment right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units (PVRI > 3 Wood units·m2 acceptable for pediatrics)

Required hemodynamic criteriaPretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units

Pediatric optionPVRI > 3 Wood units·m2 is acceptable for pediatric members

Infant exceptionFor infants <1 year, Doppler echocardiogram may be used if catheterization cannot be performed

inv-15: WHO Group 1 (PAH) — Includes idiopathic, heritable, drug/toxin-associated, connective tissue disease-associated, HIV-associated, portal hypertension-associated ...

Included conditionsIdiopathic PAH

Associated conditionsPAH associated with drugs/toxins, connective tissue disease, HIV infection, portal hypertension

Other examplesHeritable PAH; congenital heart disease; PAH with PVOD/PCH features; persistent pulmonary hypertension of the newborn