CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Treprostinil Remodulin 1644 A Sgm P2023

Defines coverage criteria for Remodulin (treprostinil injection) for treatment of pulmonary arterial hypertension (WHO Group 1) including FDA-approved indications, prescriber specialty requirements, diagnostic confirmation criteria, and continuation criteria; all other indications considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTreprostinil Remodulin 1644 A Sgm P2023

Policy CodePolicy N/A

Change TypeClarified/formatting

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 clinical/coverage changes; document references and formatting updated to include Remodulin (treprostinil injection) with reference number 1644-A.

1Primary Covered Indication (WHO Group)

3Hemodynamic thresholds required

0Non-covered indications listed (explicitly experimental)

0.86Confidence score

Scope: This policy defines coverage criteria for Remodulin (treprostinil injection) for treatment of pulmonary arterial hypertension (WHO Group 1) including FDA-approved indications to diminish symptoms associated with exercise and for transition from epoprostenol. Coverage is covered_with_criteria and aligns to FDA-approved indications, requiring hemodynamic confirmation of PAH, prescriber specialty, and evidence of benefit for continuation. Background: Remodulin is indicated for PAH (WHO Group 1) to diminish exercise-associated symptoms and for transition from epoprostenol; the policy requires pretreatment right heart catheterization results (mPAP, PCWP, and PVR/PVRI thresholds) or Doppler echo confirmation in infants <1 year, medication prescribed by or in consultation with a pulmonologist or cardiologist, and documentation of benefit for ongoing authorization.

Quick thresholds & requirements

mPAP (mean pulmonary arterial pressure)> 20 mmHg

PCWP (pulmonary capillary wedge pressure)≤ 15 mmHg

PVR (adult)≥ 3 Wood units

PVRI (pediatric)≥ 3 Wood units x m^2

Age threshold for echo-only confirmationInfants < 1 year if right heart catheterization cannot be performed

Prescriber specialty requirementMust be prescribed by or in consultation with a pulmonologist or cardiologist

Continuation requirementCurrent receipt via paid benefit and evidence of disease stability or improvement for indefinite authorization

Initial Therapy — Indications & Authorization Criteria

Indications - Covered

The following FDA-approved indications and compendial uses are covered when all approval criteria are met and member has no exclusions:

ALL of the following

Treatment of pulmonary arterial hypertension (PAH; World Health Organization [WHO] Group 1) to diminish symptoms associated with exercise; includes patients with NYHA Functional Class II-IV and etiologies of idiopathic or heritable PAH, PAH associated with congenital systemic-to-pulmonary shunts, or PAH associated with connective tissue diseases.
Patients with PAH requiring transition from epoprostenol to treprostinil to diminish the rate of clinical deterioration; risks and benefits should be considered prior to transition.
Prescriber specialty requirement: Medication must be prescribed by or in consultation with a pulmonologist or cardiologist.

Pulmonary Arterial Hypertension (PAH) - Authorization Criteria

Indefinite authorization may be granted when ALL of the following are met:

ALL of the following

Confirmation of PAH
- Pretreatment right heart catheterization
  - mPAP: Mean pulmonary arterial pressure (mPAP) > 20 mmHg> 20 mmHg
  - PCWP: Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg≤ 15 mmHg
  - PVR or PVRI: Pulmonary vascular resistance (PVR) ≥ 3 Wood units in adult patients OR pulmonary vascular resistance index (PVRI) ≥ 3 Wood units x m^2 in pediatric patientsPVR ≥ 3 WU (adult) or PVRI ≥ 3 WU·m^2 (pediatric)

Continuation of Therapy

Indefinite authorization may be granted for members currently receiving the medication who are experiencing benefit.

ALL of the following

Current receipt: Member currently receiving requested medication through a paid pharmacy or medical benefit.
Evidence of benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.
Indication present: Member has an indication listed in Section III (PAH indications).

Documentation Required

Continuation documentation

For continuation requests, document current receipt of the medication through a paid pharmacy or medical benefit and provide evidence the member is experiencing benefit from therapy as demonstrated by disease stability or disease improvement.

Proof of active paid benefit (pharmacy or medical)
Clinical notes or objective measures showing disease stability or improvement

Not Covered / Experimental

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

Not covered: Any indication for treprostinil not listed in the FDA-approved indications above or compendial uses described is not medically necessary.

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 pretreatment right heart catheterization results showing mPAP, PCWP, and PVR (or PVRI for pediatrics) or, for infants <1 year when catheterization cannot be performed, Doppler echocardiogram confirming PAH.

Mean pulmonary arterial pressure (mPAP) > 20 mmHg
Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
Pulmonary vascular resistance (PVR) ≥ 3 Wood units (adult) or pulmonary vascular resistance index (PVRI) ≥ 3 Wood units x m^2 (pediatric)
For infants < 1 year, Doppler echocardiogram if right heart catheterization cannot be performed

Background & Definitions

Background: Remodulin (treprostinil) is indicated for PAH (WHO Group 1) to diminish symptoms associated with exercise and for transition from epoprostenol. The policy requires hemodynamic confirmation of PAH (pretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units in adults or PVRI ≥ 3 Wood units·m2 in pediatrics; Doppler echocardiogram may be used for infants <1 year if catheterization cannot be performed) and that the medication be prescribed by or in consultation with a pulmonologist or cardiologist. Continuation requires documentation of current receipt through a paid benefit and evidence of disease stability or improvement.

Term	Definition
PAH
Pulmonary arterial hypertension, WHO Group 1 pulmonary hypertension.
PVR
Pulmonary vascular resistance (Wood units).
PVRI
Pulmonary vascular resistance index (Wood units x m^2).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTreprostinil Remodulin 1644 A Sgm P2023

Policy CodePolicy N/A

Change TypeClarified/formatting

Effective Date

Next Review Date

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

SourceLink

On This Page

OpenPayer

Treprostinil Remodulin 1644 A Sgm P2023

Coverage Summary

Initial Therapy — Indications & Authorization Criteria

Continuation of Therapy

Not Covered / Experimental

Provider Actions & Documentation Requirements

Applicable Codes & Reference

Clinical Evidence & References

Background & Definitions

Revision History