CurrentNeighborhood Health Plan of Rhode IslandPolicy 1644-A

Treprostinil

Covers treprostinil (Remodulin) injection solution for FDA‑approved indications (PAH/WHO Group 1) and compendial uses when all approval criteria are met; defines prescriber specialty requirement, diagnostic confirmation criteria, and continuation criteria. All other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTreprostinil

Policy CodePolicy 1644-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionMedication must be prescribed by or in consultation with a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material changes: has_material_change=false

1Primary Covered Indication (WHO Group)

3Hemodynamic thresholds required

2Prescriber specialties required

Coverage Summary

Covers treprostinil (Remodulin) injection solution for FDA‑approved indications — treatment of pulmonary arterial hypertension (PAH; World Health Organization [WHO] Group 1) to diminish symptoms associated with exercise and for transition from epoprostenol to diminish the rate of clinical deterioration — and for compendial uses when all approval criteria are met; covered_with_criteria. Requires prescriber specialty (pulmonologist or cardiologist), documentation of diagnostic confirmation (pretreatment right heart catheterization results or, for infants <1 year when catheterization cannot be performed, Doppler echocardiogram), and demonstration of benefit for continuation. All other indications not listed are considered experimental/investigational and not medically necessary.

Hemodynamic thresholds and summary stats

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Pulmonary vascular resistance index (PVRI) - pediatric> 3 Wood units x m2

Primary Covered Indication (WHO Group)1

Hemodynamic thresholds required3

Prescriber specialties required2 (pulmonologist or cardiologist)

Continuation Therapy Criteria

Continuation of Therapy

Indefinite authorization may be granted for members currently receiving therapy who demonstrate benefit

ALL of the following

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

Documentation Required

Continuation documentation

For continuation (renewal) requests, document that the member is currently receiving treprostinil through a paid pharmacy or medical benefit and is experiencing benefit from therapy as evidenced by disease stability or improvement.

FDA-Approved Indications

Covered when ALL approval criteria above are met and no exclusions to prescribed therapy exist:

ALL of the following

Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise in patients with NYHA Functional Class II-IV, including idiopathic, heritable PAH, PAH associated with congenital systemic-to-pulmonary shunts, or PAH associated with connective tissue diseases.
In patients with PAH requiring transition from epoprostenol, to diminish the rate of clinical deterioration. Consider risks and benefits prior to transition.

Unproven / Not Medically Necessary

Denial Risk

Non-covered indications

All indications other than the listed FDA‑approved indications and compendial uses (treatment of PAH/WHO Group 1 and transition from epoprostenol as specified) are considered experimental/investigational and will be not medically necessary and may be denied.

Provider Actions & Documentation Requirements

Prior Authorization

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a pulmonologist or cardiologist.

Documentation Required

Diagnostic confirmation documentation

Provide documentation of pretreatment right heart catheterization results including mean pulmonary arterial pressure (mPAP), pulmonary capillary wedge pressure (PCWP), and pulmonary vascular resistance (PVR). For infants less than one year of age, when right heart catheterization cannot be performed, provide Doppler echocardiogram confirming PAH.

Clinical Evidence & References

Primary sources: Remodulin and treprostinil package inserts (October 2023; April 2023) and contemporary guideline/classification references cited (2019–2024). Note: PAH diagnosis requires hemodynamic confirmation via right heart catheterization except in select infants where Doppler echocardiogram is acceptable.

Background

Treprostinil (Remodulin) is indicated for treatment of pulmonary arterial hypertension (WHO Group 1) to diminish exercise-associated symptoms and for transition from epoprostenol to reduce the rate of clinical deterioration. PAH must be confirmed hemodynamically by pretreatment right heart catheterization demonstrating mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units (or for pediatric members PVRI > 3 Wood units x m2); for infants <1 year when catheterization cannot be performed, diagnosis may be confirmed by Doppler echocardiogram. See Appendix and referenced guidance for WHO Group definitions and further details.

Definitions: PAH = pulmonary arterial hypertension (WHO Group 1); PVR = pulmonary vascular resistance (Wood units); PVRI = pulmonary vascular resistance index (Wood units × m2) for pediatric patients.