CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Adempas Drug Quantity Management Policy - Per Rx

Defines retail and home delivery maximum quantities per prescription for all strengths of Adempas (riociguat) and the quantity management rule for smokers. Applies to Cigna-administered health benefit plans unless superseded by specific plan documents.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Adempas Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeAnnual Revision — No criteria changes

Effective Date

Next Review Date

Key ActionIf the Drug Quantity Management rule is not met at point of service, determine coverage by the policy criteria; approvals are provided for 1 year.

POLICY UPDATE CHANGES

Annual Revision noted 'No criteria changes.'

90Retail max tablets per Rx

270Home delivery max tablets per Rx

1Approval duration (years)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines retail and home delivery maximum quantities per prescription for all strengths of Adempas (riociguat) and the quantity management rule for smokers; applies to Cigna-administered health benefit plans. Effective/Last review: Last review 08/27/2024 (no effective date provided).

Drug Quantity Limits / Coverage Criteria

Adempas product(s) are covered as medically necessary when the following criterion is met. Any other exception is considered not medically necessary.

ALL of the following

Applies to all strengths
- Adempas tablets (all strengths) — retail maximum quantity per Rx = 90 tablets
- Adempas tablets (all strengths) — home delivery maximum quantity per Rx = 270 tablets
If the patient is a smoker, approve a quantity sufficient for a 30-day supply at retail and a 90-day supply at home delivery.
Document the patient's smoker status to justify approval of a 30-day retail supply or 90-day home delivery supply when patient is a smoker.

Provider Actions & Billing Rules

Prior Authorization

Quantity management enforcement at point of sale

If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the policy criteria. Approvals are provided for 1 year in duration.

Documentation Required

Smoking status documentation

Document the patient's smoker status to justify approval of a 30-day retail supply or a 90-day home delivery supply when the patient is a smoker.

Billing Rule

Maximum quantities per prescription

Do not exceed a retail maximum of 90 tablets per prescription or a home delivery maximum of 270 tablets per prescription for any Adempas strength. Exceptions to these limits may be approved only per the policy criteria (for example, smokers may be approved for a 30-day retail or 90-day home delivery supply per criteria).

Background

Background: Adempas (riociguat) is indicated for CTEPH and pulmonary arterial hypertension (PAH). It is a soluble guanylate cyclase stimulator. Recommended dosing initiates at 1 mg three times daily (TID), with consideration of a 0.5 mg TID start for patients who may not tolerate hypotension, and titration by 0.5 mg TID increments no more frequently than every 2 weeks to a maximum of 2.5 mg TID (with re-titration after interruptions ≥ 3 days and consideration for higher titration in patients who smoke due to reduced plasma concentrations). Adempas is available in 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg tablets supplied in bottles of 9 or 90 tablets. The Drug Quantity Management program is intended to promote safe, effective, and economic use of Adempas, with specific quantity limits per prescription and rules for smokers.