CurrentMass General Brigham Health PlanPolicy N/A

Adempas (riociguat) — Prior Authorization and Coverage Criteria

Defines prior authorization, quantity limits, and medical necessity criteria for Adempas (riociguat) for Mass General Brigham Health Plan members for FDA‑approved indications (PAH and CTEPH). Affects providers requesting coverage or continuation of Adempas therapy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdempas (riociguat) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeSwitched to custom criteria

Effective DateSep 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and submit diagnostic confirmation (right heart catheterization results and, for CTEPH, appropriate imaging) to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Policy was switched from CVS Standard to custom criteria as of 09/01/2023.

12 monthsInitial and reauthorization period

90 tabs/30dQuantity limit

2Approved indications

>20mPAP threshold

<15

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Coverage Criteria for Adempas (riociguat)

Pulmonary Arterial Hypertension (Initial or New to Plan)

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

PAH diagnosis: Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 pulmonary hypertension (refer to Appendix)

Hemodynamic confirmation by right heart catheterization

mPAP: Mean pulmonary artery pressure (mPAP) > 20 mmHgmPAP > 20 mmHg
PCWP: Pulmonary capillary wedge pressure (PCWP) < 15 mmHgPCWP < 15 mmHg
PVR: Pulmonary vascular resistance (PVR) as specified in policyPVR per policy
Policy text lists PVR (document contains typographic inconsistencies)

Additional requirements: All above criteria must be documented in the medical record prior to authorization.

Chronic Thromboembolic Pulmonary Hypertension (Initial or New to Plan)

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

CTEPH diagnosis: Member has chronic thromboembolic pulmonary hypertension (CTEPH) defined as WHO Group 4 pulmonary hypertension (refer to Appendix)

CTEPH subgroup criteria

Inoperable CTEPH
- Imaging confirmation: Computed tomography (CT) or magnetic resonance imaging (MRI) angiography or pulmonary angiography confirming CTEPH
- Pretreatment RHC results: Pretreatment right heart catheterization with mPAP > 20 mmHg; PCWP < 15 mmHg; PVR as specified in policymPAP > 20 mmHg; PCWP < 15 mmHg; PVR per policy

Continuation / Reauthorization

Authorization of 12 months may be granted for members currently receiving the medication who are experiencing benefit:

Current therapy: Member is currently receiving Adempas through a paid pharmacy or medical benefit, or is transitioning from another plan and prior supply was not obtained solely as samples or via manufacturer patient assistance programs.

Clinical benefit: Member is experiencing disease stability or improvement while on therapy, as documented in the medical record (e.g., clinical assessment indicating benefit).

Authorization period and limits: Authorization, if granted, will be for up to 12 months; quantity limit of 90 tablets per 30 days applies.12 months; 90 tablets/30 days

For members who are new to Mass General Brigham Health Plan, no authorization will be granted if prior therapy with Adempas was obtained solely as samples or through a manufacturer's patient assistance program. Providers should document that prior treatment was received via a paid pharmacy or medical benefit when requesting continuation or transition approvals.

Use of Adempas without the required diagnostic confirmation is not supported. For PAH (WHO Group 1), pretreatment right heart catheterization results must show mPAP > 20 mmHg and PCWP < 15 mmHg (and PVR as specified in the policy). For CTEPH (WHO Group 4), diagnosis must be confirmed by appropriate imaging (CT/MRI angiography or pulmonary angiography) AND pretreatment right heart catheterization demonstrating mPAP > 20 mmHg and PCWP < 15 mmHg (and PVR as specified). Requests lacking these diagnostic data do not meet medical necessity criteria.

Hemodynamic Criteria and Definitions

Hemodynamic criteria from right heart catheterization — RHC pretreatment results

Mean pulmonary artery pressure (mPAP)mPAP > 20 mmHg as measured on pretreatment right heart catheterization.

Pulmonary capillary wedge pressure (PCWP)PCWP < 15 mmHg as measured on pretreatment right heart catheterization.

Pulmonary vascular resistance (PVR)PVR threshold specified in policy; document shows PVR values (typographical inconsistencies noted) including 'PVR 23 Wood units' and 'PVR 2 3 Wood units'.

PAH (WHO Group 1) — definition and diagnostic requirement

WHO GroupPulmonary arterial hypertension (PAH) is WHO Group 1 pulmonary hypertension (see Appendix classifications).

Diagnostic confirmationDiagnosis requires confirmation by right heart catheterization with pretreatment results meeting hemodynamic criteria (mPAP > 20 mmHg; PCWP < 15 mmHg; elevated PVR as specified).

Provider Requirements, Limits, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adempas (riociguat). Initial approvals and reauthorizations are granted for up to 12 months. Quantity limit: 90 tablets per 30 days.

Prior authorization required
Initial and reauthorizations: 12 months
Quantity limit: 90 tablets / 30 days

Step Therapy

Step Therapy Note

Step therapy program type is listed for the Commercial/Exchange pharmacy benefit. No specific step requirements or preferred-agent sequencing are detailed in the source — verify whether step requirements apply at the plan level before denying for lack of prior step agents.

Program type: Step Therapy (Commercial/Exchange, Pharmacy Benefit)
No specific step-agent sequence documented in policy source

Background on Adempas (riociguat)

Adempas (riociguat) is an FDA‑approved therapy indicated to treat adults with pulmonary arterial hypertension (PAH, WHO Group 1) and to treat persistent/recurrent or inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4). The policy requires hemodynamic confirmation via right heart catheterization for diagnosis prior to authorization.

Policy Revision History

2023-09-01policy_source_changeLatest

Policy source changed from CVS Standard to custom criteria (custom criteria became effective).

2023-07-12review

Reviewed at July P&T; documented switch to custom criteria and set effective date of 2023-09-01.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdempas (riociguat) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeSwitched to custom criteria

Effective DateSep 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and submit diagnostic confirmation (right heart catheterization results and, for CTEPH, appropriate imaging) to support medical necessity.

SourceLink

On This Page

Recurrent or persistent CTEPH after PEA: Recurrent or persistent CTEPH following pulmonary endarterectomy (PEA)

Imaging and hemodynamic confirmation

mPAP: Mean pulmonary artery pressure (mPAP) > 20 mmHgmPAP > 20 mmHg
PCWP: Pulmonary capillary wedge pressure (PCWP) < 15 mmHgPCWP < 15 mmHg
PVR: Pulmonary vascular resistance (PVR) as specified in policyPVR per policy
Policy text lists PVR (document contains typographic inconsistencies)

Documentation requirement: All diagnostic imaging and pretreatment right heart catheterization results must be provided in the medical record for authorization review.

Scope of PAHIncludes idiopathic, heritable, toxin/drug‑induced, and associated forms listed in the Appendix (e.g., connective tissue disease, HIV, portal hypertension, congenital heart disease).

CTEPH (WHO Group 4) — definition, subgroups, and diagnostic requirements

WHO GroupChronic thromboembolic pulmonary hypertension (CTEPH) is WHO Group 4 pulmonary hypertension (chronic thromboembolic PH).

Clinical subgroupsIncludes persistent or recurrent CTEPH after pulmonary endarterectomy (PEA) and inoperable CTEPH (both are covered scenarios).

Diagnostic confirmationDiagnosis requires appropriate imaging (CT or MRI angiography or pulmonary angiography) AND pretreatment right heart catheterization with mPAP > 20 mmHg and PCWP < 15 mmHg (and PVR as specified).

Documentation Required

Required Documentation

Documentation must include diagnostic confirmation appropriate to the indication. For PAH: pretreatment right heart catheterization (RHC) results showing mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR ≥ 3 Wood units. For CTEPH: imaging confirming disease (CT/MR angiography or pulmonary angiography) and, when required, pretreatment RHC with mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR ≥ 3 Wood units.

PAH: RHC with mPAP > 20 mmHg; PCWP < 15 mmHg; PVR ≥ 3 Wood units
CTEPH: imaging (CT/MR angiography or pulmonary angiography) confirming disease; RHC with mPAP > 20 mmHg; PCWP < 15 mmHg; PVR ≥ 3 Wood units (when required)

Denial Risk

Denial Triggers

Authorizations may be denied if the member is not currently receiving Adempas during transitions of care (excluding samples or manufacturer patient assistance), or if required diagnostic confirmation (RHC and/or imaging) is not provided.

Denial triggers: not currently receiving Adempas for transition requests
Denial triggers: missing required diagnostic documentation (RHC, imaging)