CurrentCignaPolicy N/A

Adempas (riociguat) prior authorization for PAH and CTEPH

This policy governs prior authorization and medical necessity criteria for coverage of Adempas (riociguat) for adults with pulmonary arterial hypertension (WHO Group 1) and chronic thromboembolic pulmonary hypertension (CTEPH) for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyAdempas (riociguat) prior authorization for PAH and CTEPH

Policy CodePolicy N/A

Change TypeClarification and administrative review

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionObtain and submit right heart catheterization (RHC) documentation confirming WHO Group 1 PAH (a prior RHC before starting PAH therapy satisfies this requirement).

SourceLink

POLICY UPDATE CHANGES

For a patient currently receiving Adempas, added a Note to indicate that requirement of a right heart catheterization (RHC) refers to a RHC prior to starting therapy with a medication for WHO Group 1 PAH.

Annual revision entries noting review dates with no criteria changes for 10/11/2023 and 10/08/2025.

2FDA-approved indications covered

1 yearTypical approval duration

40%Inoperable CTEPH (approx.)

WHO Group 1PAH group referenced

Coverage and Medical Necessity Criteria

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Covered when ALL of the following are met

CTEPH coverage: Patient has a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH).

Medication is prescribed by or in consultation with a pulmonologist or cardiologist; approve for 1 year. Applies to persistent/recurrent disease after surgical treatment or inoperable CTEPH per FDA indication.

Pulmonary Arterial Hypertension (PAH) - Initial or Ongoing Therapy

Approve for 1 year if the patient meets ONE of the following (A or B)

PAH approval pathways: Patient meets either A (Initial Therapy) OR B (Currently Receiving Adempas).

See detailed A and B criteria below.

Policy Summary

PayerCigna

PolicyAdempas (riociguat) prior authorization for PAH and CTEPH

Policy CodePolicy N/A

Change TypeClarification and administrative review

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionObtain and submit right heart catheterization (RHC) documentation confirming WHO Group 1 PAH (a prior RHC before starting PAH therapy satisfies this requirement).

SourceLink

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A - Initial Therapy (i):

Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH).

A - Initial Therapy (ii): Both: a) patient has had a right heart catheterization [documentation required]; and b) results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH.

Documentation may include chart notes and catheterization laboratory reports; prior provision of RHC documentation for a different WHO Group 1 PAH medication satisfies this requirement.

A - Initial Therapy (iii): Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.

Approve for 1 year.

B - Currently Receiving Adempas (i): Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH).

B - Currently Receiving Adempas (ii): Both: a) patient has had a right heart catheterization (note: refers to an RHC performed prior to starting therapy with a medication for WHO Group 1 PAH); and b) results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH.

This clarification applies to patients already receiving Adempas.

B - Currently Receiving Adempas (iii): Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.

Approve for 1 year.

Concurrent administration of Adempas (riociguat) with phosphodiesterase type 5 (PDE5) inhibitors used for pulmonary hypertension or with other soluble guanylate cyclase (sGC) stimulators is a contraindication and is considered not medically necessary. The policy explicitly lists this combination as a condition not covered and warns against using Adempas with agents such as Revatio, Adcirca, Alyq, Tadliq (examples of PDE5 inhibitors) or with an sGC stimulator example Verquvo (vericiguat).

Any use of Adempas that is not an FDA‑approved indication or not supported by evidence in this policy is considered not medically necessary. This specifically includes concurrent use with phosphodiesterase inhibitors for pulmonary hypertension or with other soluble guanylate cyclase stimulators, which the policy identifies as contraindicated.

Coding and Diagnostic Thresholds

Drugs contraindicated with Adempas (examples)mixedNot Covered

Revatio, Adcirca, Alyq, Tadliq (examples)	Examples of phosphodiesterase inhibitors used for pulmonary hypertension listed as contraindicated in combination with Adempas
Verquvo (vericiguat)	Example of another soluble guanylate cyclase stimulator listed as contraindicated in combination with Adempas

PAH Hemodynamic Thresholds

Mean pulmonary artery pressure (mPAP)> 20 mmHg (at rest)

Pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Prescriber, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Prescriber Requirement

Prior Authorization is recommended for prescription benefit coverage of Adempas. Approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (pulmonologist or cardiologist). Approvals are provided for the durations specified in the clinical criteria (typically 1 year).

Prior authorization recommended; approvals require pulmonologist or cardiologist involvement.
Approvals granted for specified duration (commonly 1 year).

Step Therapy

No step therapy (fail-first) requirements are specified for Adempas in this policy.

Documentation Required

Required Documentation

Documentation is required for initiation of therapy where noted in the criteria. Acceptable documentation may include, but is not limited to, patient-specific chart notes and catheterization laboratory reports. Right heart catheterization (RHC) reports are required to confirm WHO Group 1 PAH when indicated. If an RHC was previously provided as part of prior authorization review for a different medication indicated for WHO Group 1 PAH, that documentation is considered to meet the RHC requirement for this policy.

Documentation must include patient-specific identifying information.
RHC report and results confirming WHO Group 1 PAH required for initial therapy and for patients not previously documented; prior RHC provided for another WHO Group 1 PAH medication satisfies requirement.
Documentation examples: chart notes, catheterization lab reports.

Denial Risk

Triggers for Denial

Claims submitted without covered diagnosis or procedure codes, or for uses listed as not medically necessary, will be denied. Concurrent use with phosphodiesterase (PDE5) inhibitors or other soluble guanylate cyclase stimulators is contraindicated and will trigger denial.

Denial triggers include submission without covered diagnosis/procedure codes.
Use for indications listed under 'Conditions Not Covered' will be denied.
Concurrent use with PDE5 inhibitors (e.g., sildenafil, tadalafil products) or other soluble guanylate cyclase stimulators is contraindicated and will be denied.

Clinical Background

Pulmonary arterial hypertension (PAH) is a progressive condition affecting the small pulmonary arteries and leading to increased pulmonary vascular resistance and right‑heart strain. For patients with PAH or chronic thromboembolic pulmonary hypertension (CTEPH), targeted therapies such as Adempas (riociguat) are used under specific clinical criteria; however, certain combinations—most notably with PDE5 inhibitors or other sGC stimulators—are contraindicated because of safety concerns, and therefore are not covered by this policy.

Definitions and Contraindicated Concomitant Therapy

PAH Diagnostic Hemodynamics

Mean pulmonary artery pressure (mPAP)> 20 mmHg at rest

Pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units (measured by cardiac catheterization)

Contraindicated Concomitant Therapy

Contraindicated concomitant therapyConcurrent use of Adempas with phosphodiesterase inhibitors used for pulmonary hypertension is a contraindication.

Examples of PDE5 inhibitors listedRevatio (sildenafil), Adcirca (tadalafil), Alyq (tadalafil), Tadliq (tadalafil suspension)

Other sGC stimulatorsConcurrent use with other soluble guanylate cyclase stimulators (e.g., Verquvo/vericiguat) is contraindicated.