CurrentNeighborhood Health Plan of Rhode IslandPolicy 1644-A

treprostinil (Remodulin) for pulmonary arterial hypertension

Covers use of treprostinil (Remodulin) for treatment of pulmonary arterial hypertension (WHO Group 1) when specified clinical and administrative criteria are met; applies to prescribers and members under Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policytreprostinil (Remodulin) for pulmonary arterial hypertension

Policy CodePolicy 1644-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization documenting WHO Group 1 PAH and confirmatory hemodynamics (mPAP > 20 mmHg, PCWP ≤ 15 mmHg, PVR > 2 WU) or echocardiographic confirmation for infants.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

WHO Group 1Indication covered

NYHA II-IVSymptom classes

mPAP>20; PCWP≤15; PVR>2Hemodynamic thresholds

Pulmonologist/CardiologistPrescriber requirement

Coverage Criteria for Treprostinil (Remodulin)

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Initial and ongoing authorization for PAH

Indefinite authorization may be granted for treatment of PAH when ALL of the following criteria are met:

PAH indication: Member has PAH defined as WHO Group 1 class of pulmonary hypertension

refer to WHO classification appendix

Diagnostic confirmation: PAH confirmed by either: (1) pretreatment right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units (PVRI > 3 WU·m2 acceptable in pediatrics); OR (2) for infants <1 year, Doppler echocardiogram if catheterization cannot be performed

Prescriber requirement: Medication must be prescribed by or in consultation with a pulmonologist or cardiologist

Continuation criteria

Indefinite authorization may be granted for members currently receiving the medication who meet 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

All indications for this therapy outside the FDA‑approved indications and recognized compendial uses are considered experimental/investigational and are not covered. The FDA‑approved uses include treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms with exertion (studied in NYHA Functional Class II–IV) and transition from epoprostenol to reduce clinical deterioration; uses beyond these specified indications will be considered investigational and may be denied.

Use of this medication for indications not listed among the FDA‑approved indications or accepted compendial uses is considered not medically necessary and will not be covered. Providers seeking coverage should ensure the requested use matches the policy’s FDA‑approved indications for PAH or documented compendial recommendations to avoid denial.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for PAH; confirmatory hemodynamics required

Prior authorization is required. Authorization may be granted when ALL of the following are documented: the member has pulmonary arterial hypertension (WHO Group 1), and PAH confirmation by pretreatment right heart catheterization meeting hemodynamic criteria or, for infants <1 year when catheterization cannot be performed, by Doppler echocardiography. Hemodynamic criteria: mean pulmonary arterial pressure (mPAP) > 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units (or pulmonary vascular resistance index [PVRI] > 3 Wood units·m2 for pediatric members).

PAH must be WHO Group 1 (see Appendix).
Right heart catheterization results required pre-treatment unless infant <1 year and catheterization not feasible.
Hemodynamics: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units (PVRI > 3 Wood units·m2 acceptable for pediatrics).

Documentation Required

Continuation of therapy — documentation of benefit required

Documentation of ongoing benefit is required for continuation of therapy. Indefinite authorization may be granted when the member is currently receiving the requested medication through a paid pharmacy or medical benefit and is experiencing benefit from therapy, demonstrated by disease stability or improvement.

Applicable when member has an indication listed in the coverage criteria and is currently on therapy through a paid benefit.
Provider must document clinical benefit (stability or improvement) for continuation requests.

Denial Risk

Not covered uses — experimental/investigational

Use of the medication for indications other than FDA‑approved PAH indications or accepted compendial uses is considered experimental/investigational and not medically necessary.

Covered FDA‑approved PAH indications include treatment of WHO Group 1 PAH to diminish exercise‑associated symptoms (studies included NYHA Class II–IV) and for transition from epoprostenol to diminish clinical deterioration where appropriate.
All other indications are not covered.

Background

Pulmonary arterial hypertension (PAH; WHO Group 1) is a progressive disorder of the pulmonary vasculature characterized by elevated pulmonary arterial pressures and increased pulmonary vascular resistance leading to exertional symptoms. The FDA‑approved indication for treprostinil includes treatment of PAH to diminish symptoms associated with exercise; clinical trials establishing effectiveness enrolled patients with NYHA Functional Class II–IV symptoms and etiologies such as idiopathic or heritable PAH, PAH related to congenital systemic‑to‑pulmonary shunts, or connective tissue disease–associated PAH. Treprostinil is also indicated for patients who require transition from epoprostenol to diminish the rate of clinical deterioration, with appropriate consideration of risks and benefits.