CurrentNeighborhood Health Plan of Rhode IslandPolicy 1641-A

Riociguat (Adempas) — Authorization Criteria for Pulmonary Hypertension

Covers clinical authorization criteria for riociguat (Adempas) for adults with pulmonary arterial hypertension (PAH, WHO Group 1) and chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRiociguat (Adempas) — Authorization Criteria for Pulmonary Hypertension

Policy CodePolicy 1641-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months when all coverage criteria for PAH or CTEPH are met and document pretreatment right heart catheterization hemodynamics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

WHO Group 1PAH group

WHO Group 4CTEPH group

mPAP >20hemodynamic thresholds

Pulmonologist/Cardiologyprescriber

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Coverage Criteria for Riociguat (Adempas)

Initial therapy — PAH

Covered when ALL of the following are met:

PAH initial authorization

Hemodynamic confirmation: PAH confirmed by right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood unitsmPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units
Prescriber requirement: Must be prescribed by or in consultation with a pulmonologist or cardiologist

Clinical context: Indication consistent with Adempas regulatory labeling to improve exercise capacity and WHO functional class (typically WHO FC II–III); efficacy demonstrated as monotherapy or in combination with endothelin receptor antagonists or prostanoids

Initial therapy — CTEPH

Covered when ALL of the following are met:

CTEPH initial authorization: Member has CTEPH defined as WHO Group 4

CTEPH disease state: Member has either recurrent/persistent CTEPH after pulmonary endarterectomy (PEA) OR inoperable CTEPH with imaging confirmation and hemodynamic criteria

For inoperable CTEPH, diagnosis must be confirmed by CT/MR angiography or pulmonary angiography AND pretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units.

Continuation therapy

Covered when ALL of the following are met:

Continuation of therapy: Member is currently receiving riociguat through a paid benefit and is experiencing benefit from therapy as evidenced by disease stability or improvement

Authorization may be granted for 12 months.

All indications for riociguat (Adempas) beyond pulmonary arterial hypertension (PAH, WHO Group 1) and chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) are considered experimental/investigational and therefore not covered under this policy. Requests for use in conditions other than the listed indications should be denied as they lack established coverage within this policy.

Use of riociguat (Adempas) for indications not explicitly listed in the coverage criteria (i.e., indications other than PAH — WHO Group 1 or CTEPH — WHO Group 4) is not medically necessary. Prior authorization for non‑listed indications will not be approved.

Hemodynamic and Diagnostic Coding / Thresholds

Hemodynamic thresholds for right heart catheterization

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Hemodynamic definitions for pulmonary hypertension

Diagnostic requirementPulmonary hypertension diagnosis for coverage requires right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units.

PAH classification (WHO Group 1)Includes idiopathic, heritable, long‑term responders to calcium channel blockers, drug/toxin‑associated, and PAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, schistosomiasis, PVOD/PCH features, and persistent PH of the newborn.

Prescriber and Authorization Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required. Initial and continuation authorizations may be granted for up to 12 months when all clinical criteria are met for the requested indication.

Authorization duration: 12 months
Prior authorization required for both PAH and CTEPH indications

Step Therapy

Step therapy is not specified in the source policy. Prescribers should follow the coverage criteria for initial and continuation therapy rather than a step-therapy pathway.

Documentation Required

Background and Indication Summary

Riociguat (Adempas) is indicated to improve exercise capacity and WHO functional class in adults with persistent/recurrent or inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) and, separately, for pulmonary arterial hypertension (PAH, WHO Group 1). The policy limits coverage to these approved indications; all other uses are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRiociguat (Adempas) — Authorization Criteria for Pulmonary Hypertension

Policy CodePolicy 1641-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months when all coverage criteria for PAH or CTEPH are met and document pretreatment right heart catheterization hemodynamics.

SourceLink

On This Page

CTEPH classification (WHO Group 4)Includes chronic thromboembolic PH and other pulmonary artery obstructions (e.g., sarcomas, other malignant and non‑malignant tumors, arteritis, congenital pulmonary artery stenoses, hydatidosis).

Required Diagnostic Documentation

Documentation of diagnostic testing confirming the diagnosis is required prior to authorization. For PAH: right heart catheterization pretreatment results must include mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units. For CTEPH: diagnosis must be supported by CT/MRI angiography or pulmonary angiography and pretreatment right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units.

PAH: right heart catheterization with mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units
CTEPH: imaging with CT/MRI angiography or pulmonary angiography plus right heart catheterization with the same hemodynamic criteria

Note

Prescriber Specialty

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

Denial Risk

Non‑covered Indications

Use is limited to the FDA‑approved/covered indications. Adempas is indicated for PAH (WHO Group 1) and for treatment of adults with persistent/recurrent or inoperable CTEPH (WHO Group 4) after surgical treatment or when inoperable. All other indications are considered experimental/investigational and not medically necessary.