Adcirca™(tadalafil) FDA-APPROVED INDICATION Adcirca™ is indicated for the treatment of Pulmonary Arterial Hypertension (PAH) (World Health Organization group 1) to improve exercise ability. COVERAGE POLICY Adcirca™ is covered for members who meet the following criteria:
A. Patients with PAH diagnosed by a Pulmonologist or Cardiologist, and B. Belongs to WHO Group I, and C. Based on acute vasoreactivity testing result: a. For patients with positive testing result, documentation of a trial and failure with calcium
channel blocker therapy, unless it is contraindicated, such as those with right heart failure or hemodynamic instability.
OR b. For patients with negative testing result, Adcirca is covered as first line therapy.
* Per ACCP guideline, an acute response to acute vasodilator testing is defined as a decrease in mPAP (mean pulmonary artery pressure) by at least 10 mm Hg to an absolute level of less than 40 mg Hg without a decrease in cardiac output.
DOSE The recommended dose of Adcirca™ is 40 mg per day taken as a one time dose of two 20 mg tablets. This can be taken with or without food. Dividing the dose throughout the day is not recommended. Quantity limit: 2 tablets/day
AUTHORIZATION PERIOD Approval: 3 years Reason for Non-Coverage: 1. Use not approved by the FDA, and 2. The use is unapproved and not supported by the literature or evidence as an accepted off-label use. (see
Off-Label Use Policy for determining ‘accepted use’)
1. Adcirca (tadalafil) prescribing information. Eli Lilly and Company., May 2009.
2. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 Expert Consensus Document
on Pulmonary Hypertension. J. Am. Coll. Cardiol. 2009 Mar;53 [239 references]
3. Badesch DB, Abman SH, McLaughlin Vv, et. Al. Updated Medical Therapy For Pulmonary
Arterial Hypertension: ACCP Evidence-Based Clinical Practice Guidelines. Chest. June 2007; 131: 1917-1928.
Disclaimer: Coventry Health Care, Inc. (CHC) medical policies, technology assessments, and medical reviews (collectively “CHC Policies”) are developed by CHC to provide guidance in administering plan benefits and constitute neither offers of coverage nor medical advice. Access to CHC Policies is provided for general reference purposes only and does not infer guaranteed coverage. CHC does not provide health care services or supplies. Providers are expected to exercise their independent medical judgment in rendering the most appropriate care. State and federal law, as well as health plan policy terms and
conditions and CHC Policies in effect on the date that any service is rendered, including but not limited to definitions and specific inclusions/exclusions, take precedence over clinical policy and must be considered first in determining eligibility for coverage. Coverage may also differ for CHC Medicare and/or Medicaid members based on any applicable Centers for Medicare & Medicaid Services (CMS) coverage statements including National Coverage Determination (NCD), Local Medical Review Policies (LMRP) , and/or Local Coverage Determinations (LCD). As clinical technology is continually updated, CHC policies are subject to periodic updates. Do not rely on printed versions of CHC policies as they may be outdated. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or means without the written consent of CHC.
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