CurrentMass General Brigham Health PlanPolicy N/A

Pulmonary Arterial Hypertension Agents — Remodulin (treprostinil) (Medical Benefit)

Medical-benefit prior authorization policy for Remodulin (treprostinil injection) for treatment of pulmonary arterial hypertension (WHO Group 1) for MassHealth members; applies to medical benefit requests (Remodulin is also available via pharmacy benefit).

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyRemodulin (treprostinil) — Medical-benefit prior authorization for PAH

Policy CodePolicy N/A

Change TypeClarified clinical sequencingconfirmed dual-benefit management

Effective DateAug 11, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of PAH diagnosis and either pulmonologist/cardiologist prescriber or consult notes, plus evidence of inadequate response/intolerance to epoprostenol or one of the specified inability reasons.

SourceLink

POLICY UPDATE CHANGES

Further clarified reasons as to why a member cannot use epoprostenol.

Remodulin will continue to be managed as a dual benefit with prior authorization under the medical benefit.

MassHealthapplicable plan

Prior Authprogram type

12 moapproval duration

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Pulmonologist/Cardiologist

prescriber requirement

Coverage Criteria for Remodulin (treprostinil)

Initial Authorization Criteria

Authorization may be granted when ALL of the following are met:

Primary authorization requirements: 1. Diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1)

Prescriber requirement: 2. Prescriber is a pulmonologist or cardiologist, or consult notes from a pulmonologist or cardiologist are provided

Clinical sequencing or intolerance to epoprostenol

Inadequate response or contraindication to epoprostenol: a. Inadequate response, adverse reaction, or contraindication to epoprostenol (Veletri) or Flolan
Inability to use epoprostenol for patient-specific reasons: b. Member is unable to use epoprostenol due to ONE of the following: i. Cognitive or physical issues affecting ability to manage intravenous therapy; ii. Need for fluid restriction; iii. Low health literacy; iv. Risk of infection; v. History of intravenous drug use
These are alternative qualifying reasons; documentation is required.

Continuation of Therapy

Reauthorization requirements

Reauthorization: Prescriber reauthorization (attestation) that infers a positive clinical response to therapy

Initial approvals and reauthorizations will be granted for 12 months.

Remodulin (treprostinil injection) is managed as a dual-benefit product: it is available under the medical benefit with prior authorization and is also available on the pharmacy benefit. Other pulmonary arterial hypertension agents have been removed from medical-benefit management and are deferred to the MassHealth Drug List (MHDL); see the MHDL for coverage and criteria for those agents.

Requests may be reviewed on a case-by-case basis when a member is new to the plan and currently receiving the requested medication; however, authorization will not be considered for products obtained solely as samples or through the manufacturer's patient assistance programs. Requests that do not include documentation establishing the member meets the policy criteria — including the PAH diagnosis, required prescriber specialty or consult, and evidence of sequencing/intolerance to epoprostenol or one of the specified reasons the member cannot use epoprostenol — may be considered not medically necessary or denied.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior authorization required for Remodulin (medical benefit)

Prior authorization is required for Remodulin (treprostinil injection) when billed under the medical benefit for MassHealth members; requests are reviewed case-by-case and must meet the clinical criteria with supporting documentation.

Step Therapy

Step/sequencing requirement versus epoprostenol

Authorization requires either documented inadequate response, adverse reaction, or contraindication to epoprostenol (Veletri or Flolan), or documentation that the member is unable to use epoprostenol for one of the specified patient-centered reasons.

Inadequate response, adverse reaction, or contraindication to epoprostenol (Veletri) or Flolan
Member unable to use epoprostenol due to: cognitive/physical issues managing IV therapy; need for fluid restriction; low health literacy; infection risk; or history of IV drug use

Definitions

Pulmonary arterial hypertension (PAH) — key definitions

DefinitionPulmonary arterial hypertension (PAH) — WHO Group 1 pulmonary hypertension characterized by elevated pulmonary arterial pressure; Remodulin (treprostinil injection) is indicated for treatment of PAH (WHO Group 1) to diminish symptoms associated with exercise and, for patients transitioning from epoprostenol, to reduce clinical deterioration.

AbbreviationPAH = Pulmonary arterial hypertension (WHO Group 1).

Indication contextRemodulin is indicated specifically for WHO Group 1 PAH to diminish exercise-associated symptoms and to lessen clinical deterioration when transitioning from epoprostenol.

Related therapy notePolicy requires documentation of PAH diagnosis for authorization of Remodulin under the medical benefit; other PAH agents may be managed through the pharmacy benefit per MassHealth formularies.

Prescriber expectationAuthorization criteria require that the prescriber is a pulmonologist or cardiologist, or that consult notes from one are provided to confirm the PAH diagnosis and treatment plan.

Background

Remodulin (treprostinil) is indicated for treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to reduce exercise-associated symptoms and, for patients transitioning from epoprostenol, to reduce clinical deterioration. Under this policy, Remodulin is subject to prior authorization when billed under the medical benefit for MassHealth members; initial and reauthorization approvals are granted for 12 months when clinical criteria are met.

Revision History and Policy Changes

2025-08-11policy_effective_dateLatest

Policy effective date updated to 08/11/2025; Remodulin managed as prior authorization under the medical benefit (dual-benefit with pharmacy availability).

2025-07-09clarification

Reviewed and updated for P&T; further clarified patient-specific reasons that make epoprostenol unsuitable (e.g., cognitive/physical issues, fluid restriction, low health literacy, infection risk, history of IV drug use).

2024-09-11

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyRemodulin (treprostinil) — Medical-benefit prior authorization for PAH

Policy CodePolicy N/A

Change TypeClarified clinical sequencingconfirmed dual-benefit management

Effective DateAug 11, 2025

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Required clinical documentation for authorization

Provide documentation that the member has a diagnosis of pulmonary arterial hypertension (PAH) and that the prescriber is a pulmonologist or cardiologist (or supply consult notes); include evidence supporting the required sequencing/intolerance to epoprostenol or one of the specified reasons the member cannot use epoprostenol.

Diagnosis of PAH
Prescriber specialty (pulmonologist or cardiologist) or consult notes from a pulmonologist or cardiologist
Documentation of inadequate response, adverse reaction, or contraindication to epoprostenol OR one of the specified inability reasons

Denial Risk

Denial risk for insufficient documentation

Authorization may be denied if documentation does not establish that the member meets the criteria — for example, if the member is receiving the drug only as a sample or via manufacturer assistance and no other qualifying documentation is provided, or if required diagnosis, prescriber/consult, or qualifying sequencing/intolerance reasons are missing.

Absence of documentation that member currently receives the requested medication other than as a sample or through manufacturer's patient assistance
Missing documentation of PAH diagnosis
Missing prescriber specialty or consult notes from a pulmonologist/cardiologist
No documentation of inadequate response/intolerance/contraindication to epoprostenol or of one of the specified inability reasons

coverage_scope_change

Removed other PAH agents from medical benefit management and deferred them to the MassHealth Drug List; Remodulin retained as dual-benefit with prior authorization under the medical benefit. (Effective 10/01/2024).

2023-06-14administrative_update

Administrative clarification that Veletri (epoprostenol) is available through both pharmacy and medical benefits.

2023-05-10criteria_update

Reviewed and updated for P&T: added agents requiring PA, updated reauthorization criteria and approval durations, and updated specific drug-related criteria and references. (Effective 06/05/2023).

2023-04-01original_creation

Policy reviewed and created for P&T to match MassHealth UPPL criteria and comply with MassHealth unified formulary requirements (Effective 04/01/2023).