CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Adempas (riociguat) — coverage criteria for pulmonary hypertension

Covers clinical criteria, authorization, quantity limits, and continuation requirements for Adempas (riociguat) when used to treat pulmonary arterial hypertension (PAH, WHO Group 1) and chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) for Medicaid members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdempas (riociguat) — coverage criteria for pulmonary hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, pretreatment right heart catheterization hemodynamics, and prescriber specialty or accredited center affiliation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

12 monthsContinuation authorization duration

3 tabs/dayQuantity limit

mPAP>20; PCWP≤15; PVR>2Hemodynamic thresholds required

Specialist/centerPrescriber requirement

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdempas (riociguat) — coverage criteria for pulmonary hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, pretreatment right heart catheterization hemodynamics, and prescriber specialty or accredited center affiliation.

SourceLink

On This Page

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Coverage Criteria for Adempas (riociguat)

Initial and continuation therapy criteria

Covered when ALL of the following are met for the relevant diagnosis:

PAH Initial Approval

Prescriber is either (a) associated with an accredited Center of Comprehensive Care by the Pulmonary Hypertension Association for adult members OR (b) a cardiologist, pulmonologist, or physician specializing in PAH for pediatric members
See prescriber requirement
Diagnosis: Documentation that the member has PAH defined as WHO Group 1 class of pulmonary hypertension
Refer to Appendix
Hemodynamics: PAH confirmed by right heart catheterization with pretreatment results: mPAP > 20 mmHg AND PCWP ≤ 15 mmHg AND PVR > 2 Wood unitsmPAP>20; PCWP<=15; PVR>2
Required hemodynamics
Vasoreactivity testing: Except for members presenting in NYHA/WHO functional class IV, documentation that acute vasoreactivity testing was performed; if test positive (fall in mPAP ≥ 10 mmHg to < 40 mmHg with increased/unchanged cardiac output), must document progression despite maximal medical treatment with a calcium channel blocker
Applies to responders
Dosing: Dose and dosing regimen prescribed and medication therapy regimen are within FDA-approved guidelines and clinical guidelines
Compliance with labeling/guidelines

CTEPH Initial Approval

Diagnosis: Documentation that the member has CTEPH defined as WHO Group 4 class of pulmonary hypertension
Refer to Appendix
CTEPH subcriteria: Member meets either (i) recurrent/persistent CTEPH after pulmonary endarterectomy (PEA) OR (ii) inoperable CTEPH with diagnosis confirmed by BOTH CT/MR angiography or pulmonary angiography AND pretreatment right heart catheterization meeting hemodynamic thresholds
Either post‑PEA or inoperable with imaging + RHC
Hemodynamics for inoperable CTEPH: Pretreatment right heart catheterization with mPAP > 20 mmHg AND PCWP ≤ 15 mmHg AND PVR > 2 Wood unitsmPAP>20; PCWP<=15; PVR>2
Required when claiming inoperable CTEPH
Dosing:

Continuation of Therapy: Authorization of 12 months may be granted for members currently receiving the medication with documentation of an indication listed in Section II and documented benefit evidenced by disease stability or improvement

Continuation requires evidence of benefit

All indications other than the FDA‑approved indications listed for Adempas (riociguat) — Pulmonary Arterial Hypertension (PAH; WHO Group 1) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH; WHO Group 4) — are considered experimental/investigational and are not a covered benefit.

Hemodynamic Criteria and Definitions

Hemodynamic thresholds on right heart catheterization

Mean pulmonary arterial pressure (mPAP)mPAP > 20 mmHg

Pulmonary capillary wedge pressure (PCWP)PCWP ≤ 15 mmHg

Pulmonary vascular resistance (PVR)PVR > 2 Wood units

PAH (WHO Group 1) definition

Confirmation methodConfirmed by right heart catheterization with pretreatment results documenting mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units

WHO classificationDefined as WHO Group 1 pulmonary hypertension (PAH)

Vasoreactivity testing noteExcept for NYHA/WHO functional class IV, acute vasoreactivity testing should be performed; responders must show progression despite maximal calcium channel blocker therapy before riociguat

Inoperable CTEPH — diagnostic confirmation

Imaging confirmationDiagnosis of inoperable CTEPH must be confirmed by CT/MR angiography or pulmonary angiography

Hemodynamic confirmationPretreatment right heart catheterization documenting mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR > 2 Wood units

Inoperability context'Inoperable' applied when PEA is not an option; member may alternatively have recurrent/persistent CTEPH after PEA

Prescriber Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Prescribers must document specialty or center affiliation, diagnostic confirmation, and pretreatment right heart catheterization results when applicable. Authorization may be granted for up to 6 months when criteria are met.

Prior authorization required for initial therapy — request must include prescriber specialty/Center affiliation.
Include diagnostic confirmation of WHO Group (PAH = Group 1; CTEPH = Group 4) per policy appendix.
Attach pretreatment right heart catheterization (RHC) results showing mPAP, PCWP, and PVR when applicable.

Step Therapy

Step Therapy After Positive Vasoreactivity

For members with PAH who are vasoreactive responders on acute vasoreactivity testing, prior authorization for therapy beyond a calcium channel blocker requires documentation that PAH has progressed despite maximally tolerated CCB therapy.

Document acute vasoreactivity testing result (positive response defined as fall in mPAP ≥ 10 mmHg to < 40 mmHg with increased/unchanged cardiac output).
If vasoreactive and initially treated with a calcium channel blocker, provide documentation of disease progression despite maximal medical treatment with a CCB before approving alternative PAH therapies.

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request.

Diagnosis and WHO Group classification (PAH = Group 1; CTEPH = Group 4).
Pretreatment RHC results with: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg; pulmonary vascular resistance (PVR) > 2 Wood units.
For PAH: acute vasoreactivity testing result and, if positive, documentation of trial and progression despite maximal CCB therapy.
For CTEPH: imaging confirming inoperable disease (CT/MR angiography or pulmonary angiography) when applicable, or documentation of recurrent/persistent disease after pulmonary endarterectomy (PEA).
Dose and dosing regimen consistent with FDA-approved and clinical guidelines.

Denial Risk

Non‑approved Indications — Denial Risk

Use of therapy for indications other than PAH (WHO Group 1) or CTEPH (WHO Group 4) is considered experimental or investigational and may be denied.

Non‑approved indications are not covered and subject to denial.
Ensure all approval criteria and absence of exclusions are met for covered benefit determination.

Background on Adempas (riociguat)

Adempas (riociguat) is indicated to improve exercise capacity and WHO functional class in adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1) and to improve exercise capacity and WHO functional class in adults with persistent/recurrent or inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH, WHO Group 4). For CTEPH the indication applies after surgical treatment or when the disease is determined to be inoperable. Use is intended to provide clinical benefit by improving functional status and delaying clinical worsening in the approved populations.