Subject: Topical Antineoplastics

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	fluorouracil
C	Panretin®  (alitretinoin)
C	Solaraze®  (diclofenac sodium)
C	Targretin®  (bexarotene)
NC	Fluoroplex®  (fluorouracil)						X
NC	Efudex®  (fluorouracil)						X
NC	Carac®  (fluorouracil)						X
NC	Levulan Kerastick®  (aminolevulinic acid HCl)						X

Policy:

1. Medical Exception Criteria

Fluoroplex, Efudex, Carac and Levulan Kerastick are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.* Therefore, they are excluded from coverage for members enrolled in prescription drug benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Fluoroplex, Efudex, Carac and Levulan Kerastick to be medically necessary for those members who meet any of the following criteria:

A. A documented:

• Contraindication to one preferred alternative agent - fluorouracil - indicated for the member's condition OR
• Intolerance to one preferred alternative agent - fluorouracil - indicated for the member's condition OR
• Allergy to one preferred alternative agent - fluorouracil - indicated for the member's condition OR
• Failure of an adequate trial of one month of one preferred alternative agent - fluorouracil - indicated for the member's condition

OR

B. Member has a documented diagnosis of leukoplakia - for Levulan Kerastick ONLY.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2005.
2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
4. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
5. 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.
6. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
7. Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com (cited: April 14, 2005).
8. Levulan Kerastick [package insert]. Wilmington, WA: Dusa Pharm; December 1999.
9. Anon: 5-Aminolevulinic acid effective in actinic keratoses. Inpharma November 1 1997; 1111:8.
10. Jeffes EW, McCullough JL, Weinstein GD, et al: Photodynamic therapy of actinic keratosis with topical 5-aminolevulinic acid. Arch Dermatol 1997b; 133:727-732
11. Wang I, Bauer B, Andersson-Engles S, et al: Photodynamic therapy utilising topical delta-aminolevulinic acid in non-melanoma skin malignancies of the eyelid and the periocular skin. Acta Ophthalmol Scand 1999; 77:182-188.
12. Peng Q, Warloe T, Berg K, et al: 5-aminolevulinic acid-based photodynamic therapy: clinical research and future challenges. Cancer 1997c; 79:2282-2308.
13. Cairnduff F, Stringer MR, Hudson EJ, et al: Superficial photodynamic therapy with topical 5-aminolevulinic acid for superficial and secondary skin cancer. Br J Cancer 1994; 69:605-608.
14. Hurlimann AF, Hanggi G, & Panizzon RG: Photodynamic therapy of superficial basal cell carcinomas using topical 5-aminolevulinic acid in a nanocolloid lotion. Dermatology 1998; 197:248-254.
15. Fink-Puches R, Soyer HP, Hofer A, et al: Long-term follow-up and histological changes of superficial nonmelanoma skin cancers treated with topical 5-aminolevulinic acid photodynamic therapy. Arch Dermatol 1998; 134:821-826.
16. Kubler A, Haase T, Rheinwald M, et al: Treatment of oral leukoplakia by topical application of 5-aminolevulinic acid. In J Oral Maxillofac Surg 1998; 27:466-469.
17. Fan KFM, Hopper C, Speight PM, et al: Photodynamic therapy using 5-aminolevulinic acid for premalignant and malignant lesions of the oral cavity. Cancer 1996b; 78:1374-1383.
18. Anon: Drugs of choice for cancer. Treatment Guidelines from The Medical Letter 2003; 1(7):42-52.
19. Duvic M, Friedman-Kien AE, Looney DJ, et al: Topical treatment of cutaneous lesions of acquired immunodeficiency syndrome-related Kaposi sarcoma using alitretinoin gel: results of Phase 1 and 2 trials. Arch Dermatol 2000; 136:1461-1469.

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.

September 17, 2007