CurrentCentenePolicy CP.PHAR.195

Riociguat (Adempas) (PDF)

Defines medical necessity criteria, quantity/dosing limits, approval durations, prescriber requirements, and exclusions for riociguat (Adempas) for commercial, HIM, and Medicaid lines of business within Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyRiociguat (Adempas) (PDF)

Policy CodePolicy CP.PHAR.195

Change TypeMaterial updates to quantity limits and approval durations

Effective Date2003-16

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added requirement that request does not exceed health-plan approved quantity limit.

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (prior change noted earlier).

Appendix B updated to remove commercially unavailable branded products and clarify dosing regimens and off-label drugs.

2FDA-approved indications (PAH, CTEPH)

7.5 mg/dayMaximum daily dose

3Maximum tablets per day

12 mo

Coverage Summary

This policy covers riociguat (Adempas) with a coverage stance of covered_with_criteria for adults with FDA-approved indications: pulmonary arterial hypertension (PAH, WHO Group 1) and chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) to improve exercise capacity and WHO functional class (and to delay clinical worsening for PAH). Authorization durations are specified at a high level as Medicaid/HIM: 12 months and Commercial: 12 months or duration of request, whichever is less.

Quick facts and thresholds

Maximum daily dose<= 7.5 mg/day

Maximum tablets per day<= 3 tablets/day

Authorization duration (Medicaid/HIM)12 months

Authorization duration (Commercial)12 months or duration of request, whichever is less

Other requirementRequest must not exceed health-plan approved quantity limit

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven Uses / Exclusions

III. Diagnoses/Indications NOT authorized

III. Diagnoses/Indications NOT authorized: Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies (CP.CPA.09; HIM.PA.154; CP.PMN.53) or evidence of coverage documents

Applicable Codes

Product availability (NDC not listed)mixed

tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg

Available riociguat tablet strengths

Provider Actions

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria for riociguat (Adempas).

Prior Authorization

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a cardiologist or pulmonologist as a condition of approval.

Clinical Evidence

Evidence sources include the Adempas Prescribing Information (Bayer) — Adempas PI, January 2023 — and guideline/review references such as the ESC/ERS and CHEST guidelines cited in the policy references. Per the policy background, efficacy has been demonstrated as monotherapy or in combination with endothelin receptor antagonists or prostanoids.

Background

Riociguat (Adempas) is a soluble guanylate cyclase stimulator indicated for adults with PAH (WHO Group 1) and CTEPH (WHO Group 4) to improve exercise capacity and WHO functional class (and to delay clinical worsening in PAH). The prescribing information and policy note that efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Dosing guidance includes titration to a maintenance regimen with a maximum total daily dose of 7.5 mg/day (e.g., up to 2.5 mg TID).

Definitions

PAHPulmonary arterial hypertension (WHO Group 1)

CTEPHChronic thromboembolic pulmonary hypertension (WHO Group 4)

Revision History

11.19.25 (P&T Approval Date: 02.26)addedLatest

Added requirement that request does not exceed health-plan approved quantity limit; extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

06.23.22 / 11.22revised

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

1Q 2024, 1Q 2025 (dates: 10.03.23; 11.08.24; P&T Approvals: 02.24; 02.25)clarified