Subject: Antilipidemic Agents - Caduet

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
NC	Caduet®  (atorvastatin/ amlodipine)			X		X	X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Caduet is subject to precertification.  If precertification requirements apply Aetna considers Caduet to be medically necessary for those members who meet the following precertification criteria:

A.  Quantity limits:  According to the manufacturer, Caduet can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below.


Drug	Maximum Daily Dose/ Dosing Interval	Dosage Strength	Quantity Limits
Caduet	Once daily	2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80	Up to 30 tablets in 30 days





For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit.  Additional quantities of Caduet will be considered medically necessary for those members who meet ANY of the following criteria:

• Member's dose is being titrated by physician (3-month limit) OR
• Member has had intolerance to drug administered as a single daily dose and requires twice daily dosing to achieve the same cumulative dose OR
• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  



2. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Caduet is subject to step-therapy.  Aetna considers Caduet to be medically necessary for those members who meet the step-therapy criteria as specified below:

A documented trial of one month of concurrent use of both amlodipine and one of the following:  Lipitor, Crestor, simvastatin (at a dose of 40mg/day or higher) OR Vytorin (any dose)  -


If it is medically necessary for a member to be initially treated with a medication subject to step-therapy, the member's treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception at 1-800-414-2386. (See criteria under section III below.)


3. Medical Exception Criteria

Caduet is currently a Not Covered Part D drug under the Aetna Medicare Prescription Drug Plan.*  Therefore, it is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Caduet to be medically necessary for those members who meet ANY of the following criteria:

A. Member is already receiving amlodipine AND atorvastatin/Lipitor for antihypertensive and antilipidemic therapy.

OR

B. Member is documented to be currently on Caduet

OR

C. Member is receiving amlodipine and has a documented:

• Contraindication to Crestor OR simvastatin
• Intolerance to Crestor OR simvastatin
• Allergy to Crestor OR simvastatin
• Failure of an adequate trial of one month of a preferred alternative, Crestor OR simvastatin (at a dose of 40mg/day or higher)
  

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. McKeage K, Siddiqui MA. Amlodipine/atorvastatin fixed-dose combination: a review of its use in the prevention of cardiovascular disease and in the treatment of hypertension and dyslipidemia. Am J Cardiovasc Drugs. 2008;8(1):51-67.
8. Flack JM, Victor R, Watson K, et al. Improved attainment of blood pressure and cholesterol goals using single-pill amlodipine/atorvastatin in African Americans: the CAPABLE trial. Mayo Clin Proc. 2008;83(1):35-45.
9. Cowie MR. Simultaneous treatment of hypertension and dyslipidaemia may help to reduce overall cardiovascular risk: focus on amlodipine/atorvastatin single-pill therapy. Int J Clin Pract. 2005;59(7):839-46.

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 01, 2009