Subject: Acne Agents, Topical

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	Avita®  (tretinoin)
C	clindamycin soln
C	clindamycin/ benzoyl peroxide
C	erythromycin/ benzoyl peroxide gel
C	erythromycin gel/oint/soln
C	sulfacetamide sodium lotion
C	tretinoin
CS	Panretin gel®  (alitretinoin)
NC	Acanya™  (clindamycin phosphate-benzoyl peroxide gel)						X
NC	Aczone®  (dapsone)					X	X
NC	Akne-mycin®  (erythromycin)						X
NC	Atralin®  (tretinoin)						X
NC	Azelex®  (azelaic acid)						X
NC	Benzaclin®  (clindamycin/ benzoyl peroxide)						X
NC	Benzamycin®  (benzoyl peroxide/erythromycin)						X
NC	Cleocin-T®  (clindamycin)						X
NC	Differin®  (adapalene)						X
NC	Epiduo™  (adapalene-benzoyl peroxide gel)						X
NC	Evoclin®  (clindamycin)						X
NC	Klaron®  (sulfacetamide sodium lotion)						X
NC	Retin-A®  (tretinoin)						X
NC	Retin-A Micro®  (tretinoin microsphere gel)						X
NC	Ziana®  (clindamycin/tretinoin gel)						X

Policy:

1. Step Therapy Criteria

Under some plans, including plans that use an open or closed formulary, Aczone is subject to step-therapy.  Aetna considers Aczone to be medically necessary for those members who meet the following step-therapy criterion:

A documented trial of one month of one preferred alternative. 

If it is medically necessary for a member to be treated initially 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.)


2. Medical Exception Criteria

Acanya, Aczone, Akne-mycin, Atralin, Azelex, Benzaclin, Benzamycin, Cleocin-T, Differin, Epiduo, Evoclin, Klaron, Retin-A, Retin-A Micro, and Ziana 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 Acanya, Aczone, Akne-mycin, Atralin, Azelex, Benzaclin, Benzamycin, Cleocin-T, Differin, Epiduo, Evoclin, Klaron, Retin-A, Retin-A Micro, and Ziana to be medically necessary for those members who meet any of the following criteria:

For Akne-Mycin and Benzamycin

A. A documented

• Contraindication to two preferred alternatives indicated for the member's condition, one of which is erythromycin OR
• Intolerance to two preferred alternatives indicated for the member's condition, one of which is erythromycin OR
• Allergy to two preferred alternatives indicated for the member's condition, one of which is erythromycin OR
• Failure of an adequate trial of one month each of two preferred alternatives indicated for the member's condition, one of which is erythromycin

For Acanya, Benzaclin, Cleocin-T, Evoclin and Ziana

A.  A documented:

• Contraindication to two preferred alternatives indicated for the member's condition, one of which is clindamycin OR,
• Intolerance to two preferred alternatives indicated for the member's condition, one of which is clindamycin OR,
• Allergy to two preferred alternatives indicated for the member's condition, OR
• Failure of an adequate trial of one month each of two preferred alternatives indicated for the member's condition, one of which is clindamycin

For Aczone, Atralin, Differin, Epiduo, Klaron, Retin-A and Retin-A Micro

A. A documented:

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

 

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. 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.
7. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
8. Strauss, JS, Krowchuk DP, Leyden JJ, et al. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007;56:651-63.
9. Thiboutot DM, Weiss J, Bucko A, et al. Adapalene-benzoyl peroxide, a fixed-dose combination for the treatment of acne vulgaris: Results of a multicenter, randomized double-blind, controlled study. J Am Acad Dermatol 2007;57:791-9.
10. Loesche C, Pernin C, Poncet M. Adapalene 0.1% and benzoyl peroxide 2.5% as a fixed-dose combination gel is as well tolerated as the individual components alone in terms of cumulative irritancy. Eur J Dermatol. 2008;18(5):524-6.
11. Piette WW, Taylor S, Pariser D, et al. Hematologic safety of dapsone gel 5% for topical treatment of acne vulgaris. Arch Dermatol 2008;144(12):1564-70.
12. Raimer S, Maloney JM, Bourcier M, et al. Efficacy and safety of dapsone gel 5% for the treatment of acne vulgaris in adolescents. Cutis 2008;81(2):171-8.
13. Thiboutot D, Zaenglein A, Weiss J, et al. An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efficacy and safety in 2813 patients. J Am Acad Dermatol. 2008;59(5):792-800.

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.

October 09, 2009