CurrentMass General Brigham Health PlanPolicy N/A

Adempas (riociguat) prior authorization for PAH and CTEPH

Prior authorization policy governing pharmacy benefit coverage of Adempas (riociguat) for Mass General Brigham Health Plan commercial/exchange members; defines clinical criteria for initial and continued coverage for PAH (WHO Group 1) and CTEPH (WHO Group 4).

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdempas (riociguat) prior authorization for PAH and CTEPH

Policy CodePolicy N/A

Change TypeOperational revision to custom criteria

Effective DateSep 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization for Adempas and submit documentation of WHO group, pretreatment right heart catheterization values (mPAP, PCWP, PVR), and imaging for CTEPH when applicable.

SourceLink

POLICY UPDATE CHANGES

Policy criteria were switched from CVS Standard to custom criteria effective 9/1/23.

CommercialPlan applicability

Prior AuthorizationProgram type

12 monthsApproval duration

90/30dQuantity limit

Coverage Criteria for Adempas (riociguat)

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Initial Therapy — PAH

Covered when ALL of the following are met

PAH initial authorization

Hemodynamics: Pretreatment right heart catheterization with all of the following results: mPAP > 20 mmHg AND PCWP ≤ 15 mmHg AND PVR ≥ 3 Wood unitsmPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units

Initial Therapy — CTEPH

Covered when ALL of the following are met

CTEPH initial authorization

CTEPH condition: Either recurrent/persistent CTEPH after pulmonary endarterectomy (PEA) OR inoperable CTEPH confirmed by imaging and pretreatment right heart catheterization
Inoperable CTEPH requires CT/MR angiography or pulmonary angiography AND pretreatment right heart catheterization with mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units

Continuation Therapy

Covered when ALL of the following are met

Continuation: Member is currently receiving Adempas through a paid pharmacy or medical benefit and is experiencing benefit from therapy

Authorization of 12 months may be granted for members with disease stability or disease improvement

Authorization exclusions: members new to the plan who are not currently receiving Adempas are not eligible for automatic coverage under this policy. The policy specifically excludes products obtained as samples or provided via a manufacturer's patient assistance program from being considered as existing paid therapy for the purposes of authorization.

For new members, prior authorization may be granted only if the member is already receiving Adempas through a paid benefit at the time of enrollment; members who obtained Adempas solely as samples or through the manufacturer's patient assistance program are not considered to be currently receiving therapy and do not qualify for authorization under this exception.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adempas (riociguat). This applies to Commercial/Exchange members under the pharmacy benefit and the program is operational as a Prior Authorization program.

Plan: Commercial/Exchange
Program Type: Prior Authorization
Benefit: Pharmacy Benefit

Step Therapy

No step therapy requirements specified for this medication in the policy.

Documentation Required

Required Clinical Documentation

For both PAH and CTEPH prior authorization requests, include clinical documentation confirming diagnosis and diagnostic testing, including pretreatment right heart catheterization reports when applicable.

For PAH: documentation confirming WHO Group 1 pulmonary hypertension and pretreatment right heart catheterization results showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units.
For CTEPH: documentation confirming WHO Group 4 pulmonary hypertension and either evidence of recurrent/persistent CTEPH after pulmonary endarterectomy (PEA) OR imaging (CT/MR angiography or pulmonary angiography) plus pretreatment right heart catheterization results showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units.

Denial Risk

Diagnostic Confirmation Required (Denial Risk)

Diagnostic confirmation with pretreatment right heart catheterization is required where specified. Denial risk exists if right heart catheterization is not documented or if hemodynamic thresholds are not met (mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units).

PAH: pretreatment right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, PVR ≥ 3 Wood units required.
CTEPH (inoperable cases): pretreatment right heart catheterization with mPAP > 20 mmHg, PCWP ≤ 15 mmHg, PVR ≥ 3 Wood units required; imaging confirmation (CT/MR angiography or pulmonary angiography) also required.

Definitions — Diagnostic Groups

PAH (WHO Group 1) — right heart catheterization thresholds and definition

Required diagnostic testRight heart catheterization confirming hemodynamics

mPAP thresholdmPAP > 20 mmHg

PCWP thresholdPCWP ≤ 15 mmHg

PVR thresholdPVR ≥ 3 Wood units

CTEPH (WHO Group 4) — definition and operability context

DefinitionChronic thromboembolic pulmonary hypertension (CTEPH), WHO Group 4; persistent or recurrent after pulmonary endarterectomy (PEA) or inoperable CTEPH

Operability context — post‑PEARecurrent or persistent CTEPH following pulmonary endarterectomy qualifies as one condition for treatment consideration

Operability context — inoperableInoperable CTEPH requires imaging confirmation (CT/MR angiography or pulmonary angiography) plus pretreatment right heart catheterization meeting hemodynamic thresholds (mPAP >20, PCWP ≤15, PVR ≥3)

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdempas (riociguat) prior authorization for PAH and CTEPH

Policy CodePolicy N/A

Change TypeOperational revision to custom criteria

Effective DateSep 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization for Adempas and submit documentation of WHO group, pretreatment right heart catheterization values (mPAP, PCWP, PVR), and imaging for CTEPH when applicable.

SourceLink

On This Page

OpenPayer

Adempas (riociguat) prior authorization for PAH and CTEPH

Coverage Criteria for Adempas (riociguat)

Coding and Hemodynamic Criteria

Provider Actions and Documentation Requirements

Definitions — Diagnostic Groups

Background

Revision History and Policy Changes