CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

treprostinil (Remodulin) — coverage criteria for pulmonary arterial hypertension (PAH)

Policy governs coverage criteria for treprostinil (Remodulin) for treatment of pulmonary arterial hypertension (WHO Group 1) including initiation and continuation authorizations and prescriber specialty requirements for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policytreprostinil (Remodulin) — coverage criteria for pulmonary arterial hypertension (PAH)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of pretreatment right heart catheterization confirming PAH hemodynamics (mPAP >20 mmHg, PVR >2 WU, PCWP <15 mmHg) and ensure prescriber is or consults a pulmonologist or cardiologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

WHO Group 1Indication group covered

NYHA II-IVSymptom classes included in efficacy studies

>20mPAP threshold

>2PVR threshold

<15

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Coverage and Medical Necessity Criteria

Initial therapy

Indefinite authorization may be granted for treatment of pulmonary arterial hypertension (PAH) when ALL of the following criteria are met:

ALL of the following

Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 pulmonary hypertension (refer to Appendix).
ALL of the following
- Mean pulmonary arterial pressure (mPAP) > 20 mmHg.
- Pulmonary vascular resistance (PVR) > 2 Wood units. For pediatric members, pulmonary vascular resistance index (PVRI) > 3 Wood units × m^2 is also acceptable.
- Pulmonary capillary wedge pressure (PCWP) < 15 mmHg.
For infants less than one year of age, PAH may be confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.
When applicable, documentation that the requested therapy is for treatment of PAH to diminish symptoms associated with exercise or for transition from epoprostenol to diminish the rate of clinical deterioration; consider the risks and benefits of transition prior to approval.

Continuation therapy

Indefinite authorization may be granted for members with an indication listed in the coverage criteria section who are currently receiving the requested medication through a paid pharmacy or medical benefit; and who are experiencing benefit from therapy as evidenced by disease stability or disease improvement.

ALL of the following

Member is currently receiving the requested PAH medication through a paid pharmacy or medical benefit.
Member is experiencing clinical benefit from therapy as evidenced by disease stability or disease improvement, as documented by the provider (examples: stable or improved NYHA/WHO functional class, exercise tolerance, hemodynamics, or relevant clinical markers).

Drug and Hemodynamic Coding / Thresholds

Referenced drugNDC | mixed

treprostinil

Remodulin (treprostinil) injection solution — drug referenced (brand and generic, all dosage forms and strengths unless stated)

Hemodynamic thresholds — diagnostic criteria

Mean pulmonary arterial pressure (mPAP)mPAP > 20 mmHg

Pulmonary vascular resistance (PVR)PVR > 2 Wood units

Pulmonary vascular resistance index (PVRI) — pediatricsPVRI > 3 Wood units·m2 (acceptable for pediatric members)

Pulmonary capillary wedge pressure (PCWP)PCWP < 15 mmHg

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for initiation and continuation of therapy for pulmonary arterial hypertension (PAH). Initial approvals are granted when the member meets the required diagnostic hemodynamics and documentation (see documentation callout). Indefinite authorization may be granted for continuation when the member is currently receiving the medication through a paid benefit and is experiencing clinical benefit (disease stability or improvement).

A PAH diagnosis consistent with WHO Group 1 is required.
Initial approval requires pretreatment right heart catheterization (RHC) results confirming PAH (see documentation).
Continuation requests require evidence of ongoing benefit (stability or improvement) and a history of paid benefit receipt.

Step Therapy

Therapy sequencing / Transition from Epoprostenol

Therapy sequencing note. There is no required step therapy; however, when transitioning from IV epoprostenol to the requested therapy, clinicians should carefully consider risks and benefits. Transition from epoprostenol is an FDA‑recognized circumstance for use and may be covered when clinically appropriate.

Definitions

PAH (WHO Group 1) — definition and associated conditions

WHO GroupPulmonary arterial hypertension (PAH) — WHO Group 1

Included subtypesIdiopathic and heritable PAH

Drug/toxin-associatedPAH associated with drugs and toxins

Associated conditionsConnective tissue disease, HIV infection, portal hypertension, congenital heart disease, schistosomiasis

Other included groupsLong-term responders to calcium channel blockers; PAH with PVOD/PCH features; persistent pulmonary hypertension of the newborn

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 right heart strain. Treprostinil (Remodulin) is a prostacyclin analogue FDA‑approved for PAH to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce clinical deterioration. Hemodynamic confirmation with right heart catheterization is required by the coverage criteria to document PAH.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policytreprostinil (Remodulin) — coverage criteria for pulmonary arterial hypertension (PAH)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Required clinical documentation. Provide pretreatment right heart catheterization (RHC) report including all required hemodynamic values. For infants <1 year old, Doppler echocardiogram is acceptable if RHC cannot be performed.

Documented WHO Group 1 PAH diagnosis.
RHC values showing either mean pulmonary arterial pressure (mPAP) > 20 mmHg OR pulmonary vascular resistance (PVR) > 2 Wood units (for pediatric members, pulmonary vascular resistance index [PVRI] > 3 Wood units × m2 is acceptable).
Pulmonary capillary wedge pressure (PCWP) < 15 mmHg.
If member is an infant <1 year and RHC is not feasible, provide Doppler echocardiogram confirming PAH.
For continuation: documentation of clinical benefit (disease stability or improvement) and evidence the member is currently receiving the medication through a paid pharmacy or medical benefit.

Denial Risk

Missing Hemodynamic Confirmation

Missing hemodynamic confirmation — denial risk. Requests lacking the required pretreatment RHC results (or acceptable infant echocardiographic substitute) will be at high risk for denial. Ensure complete hemodynamic data are submitted with the prior authorization to avoid delay or denial.

Absence of mPAP, PVR (or PVRI for pediatrics), or PCWP values on the submitted RHC report may lead to denial.
If transitioning from epoprostenol, clearly document prior therapy and rationale for transition.