Subject: Metabolic Modifiers

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	Cystadane®  (betaine)
C	Hectorol®  (doxercalciferol)
C	levocarnitine
CS	Aldurazyme®  (laronidase)
CS	Buphenyl®  (sodium phenylbutyrate)
CS	Fabrazyme®  (agalsidase beta)
CS	Kuvan®  (sapropterin dihydrochloride)		X
CS	Naglazyme®  (galsulfase)
CS	Orfadin®  (nitisinone)		X
NC	Carnitor®  (levocarnitine)						X

Policy:

1. Precertification Criteria

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

For Kuvan

A.   A documented diagnosis of hyperphenylalaninemia caused by tetrahydrobiopterin-(BH4-) responsive phenylketonuria

AND

B.   Medication is being dosed within the range of 5 to 20 mg/kg/day


For Orfadin

A. Member has documented diagnosis of hereditary tyrosinemia type 1 (HT-1)


2. Medical Exception Criteria

Carnitor 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 benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Carnitor to be medically necessary for those members who meet the criteria specified below:

A. A documented

• Failure of an adequate trial of one month of the preferred generic alternative, levocarnitine OR
• Intolerance to the preferred generic alternative, levocarnitine
  
  

 

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. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
8. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.

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