CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Uptravi (selexipag) coverage and authorization criteria for pulmonary arterial hypertension (PAH)

Defines coverage and authorization criteria for Uptravi (selexipag) for treatment of pulmonary arterial hypertension (WHO Group 1) when prescribed by or in consultation with a pulmonologist or cardiologist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUptravi (selexipag) coverage and authorization criteria for pulmonary arterial hypertension (PAH)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of WHO Group 1 PAH and hemodynamic confirmation (right heart catheterization results or Doppler echo for infants <1 year) and ensure prescriber is or consults a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12authorization duration

1covered disease group (WHO Group)

>20mPAP threshold (mmHg)

≤15PCWP threshold (mmHg)

≥3PVR threshold (adult, Wood units)

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Authorization criteria for Uptravi (selexipag)

Initial authorization — Pulmonary arterial hypertension (PAH, WHO Group 1)

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 pulmonary arterial hypertension (PAH) defined as World Health Organization (WHO) Group 1 pulmonary hypertension.
Prescriber is a pulmonologist or cardiologist, or the prescription is in consultation with a pulmonologist or cardiologist.
PAH confirmation
- Right heart catheterization (preferred) (adult patients)
  - Pretreatment right heart catheterization performed
  - Mean pulmonary arterial pressure (mPAP) > 20 mmHgmPAP > 20 mmHg
  - Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHgPCWP ≤ 15 mmHg
  - Pulmonary vascular resistance (PVR) ≥ 3 Wood units (adult) or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units·m2 (pediatric)PVR ≥ 3 Wood units or PVRI ≥ 3 Wood units·m2
- Infants < 1 year (when RHC cannot be performed)
  - Member is an infant less than one year of age
  - PAH confirmed by Doppler echocardiogram because right heart catheterization cannot be performed

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Continuation of therapy

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

ALL of the following

Member is currently receiving Uptravi through a paid pharmacy or medical benefit.
Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Indications not covered

Non-FDA-approved and non-compendial indications are not covered

ANY of the following

Any indication for Uptravi that is not an FDA-approved indication or compendial use
Considered experimental/investigational and not medically necessary

Relevant diagnostic classification references

Relevant diagnostic / classification references (WHO groups)informational

WHO Group 1	Pulmonary arterial hypertension (PAH) — idiopathic, heritable, drug/toxin-induced, associated conditions
WHO Group 2	PH due to left heart disease
WHO Group 3	PH due to lung diseases and/or hypoxia
WHO Group 4	PH due to pulmonary artery obstructions (including CTEPH)
WHO Group 5	PH with unclear and/or multifactorial mechanisms

Actions required of prescribers and documentation

Prior Authorization

Prior authorization required with clinical documentation

Authorization requires documentation that the member has pulmonary arterial hypertension (WHO Group 1) and hemodynamic confirmation by right heart catheterization, or Doppler echocardiogram evidence for infants <1 year when RHC cannot be performed. The prescriber must be a pulmonologist or cardiologist, or the prescription must be in consultation with a pulmonologist or cardiologist.

Documentation Required

Hemodynamic documentation required

Provide pretreatment right heart catheterization results including mean pulmonary arterial pressure (mPAP), pulmonary capillary wedge pressure (PCWP), and pulmonary vascular resistance (PVR) — or pulmonary vascular resistance index (PVRI) for pediatric patients. For infants less than one year of age, submit Doppler echocardiogram confirmation if RHC cannot be performed.

Clinical context

Uptravi (selexipag) is a prostacyclin receptor (IP) agonist indicated for the treatment of pulmonary arterial hypertension (PAH, World Health Organization Group 1) to delay disease progression and reduce the risk of hospitalization for PAH. The medication’s efficacy was established in a long-term study of PAH patients with WHO Functional Class II–III symptoms, including idiopathic and heritable PAH as well as PAH associated with connective tissue disease and repaired congenital heart disease.

Use of Uptravi for PAH is contingent upon appropriate specialist involvement and diagnostic confirmation. Prescriptions must be written by or in consultation with a pulmonologist or cardiologist, and initiation of therapy requires hemodynamic confirmation of PAH (typically via right heart catheterization) consistent with WHO Group 1 disease.

Key term definitions

Definitions

PAHPulmonary arterial hypertension (WHO Group 1) — a group of conditions characterized by elevated pulmonary arterial pressure and vascular resistance leading to right heart strain.

Right heart catheterization (RHC)Invasive hemodynamic test measuring mPAP, PCWP and PVR to confirm pulmonary hypertension and classify type.

Wood unitUnit of pulmonary vascular resistance (mmHg·min/L). PVR in Wood units = (mPAP − PCWP) / cardiac output.

Clinical thresholds used for eligibility

Hemodynamic thresholds for PAH diagnosis

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR) — adult≥ 3 Wood units

Pulmonary vascular resistance index (PVRI) — pediatric≥ 3 Wood units·m2