Subject: Acne Agents, Topical

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	Avita®  (tretinoin)				X
C	benzoyl peroxide/erythromycin gel
C	clindamycin soln
C	erythromycin/ benzoyl peroxide gel
C	erythromycin gel/oint/soln
C	sulfacetamide sodium lotion
C	tretinoin				X
NC	Aczone®  (dapsone)					X	X
NC	Akne-mycin®  (erythromycin)						X
NC	Atralin®  (tretinoin)				X		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	Duac®  (clindamycin/ benzoyl peroxide)						X
NC	Evoclin®  (clindamycin)						X
NC	Klaron®  (sulfacetamide sodium lotion)						X
NC	Panretin®gel  (alitretinoin)						X
NC	Retin-A®  (tretinoin)				X		X
NC	Retin-A Micro®  (tretinoin microsphere gel)				X		X
NC	Z-Clinz®  (clindamycin/benzoyl peroxide)						X
NC	Ziana®  (clindamycin/tretinoin gel)						X

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Atralin, Avita, Retin-A, Retin-A Micro and tretinoin are subject to precertification for members equal to or greater than 35 years of age.   If precertification requirements apply Aetna considers Atralin, Avita, Retin-A and tretinoin to be medically necessary for those members who meet any of the following precertification criteria:

A.  A documented diagnosis of acne vulgaris

OR

B.   A documented diagnosis of actinic keratoses

AND

• Lesions are on the face OR
• Lesions are not on the face and therapy includes the use of 5-fluorouracil in conjunction with tretinoin

OR

C.  A documented diagnosis of hypertrophic scars or keloids AND intralesional injection of corticosteroids is ineffective or not tolerated

OR

D.  A documented diagnosis of keratosis follicularis (Darier's disease, Darier-White disease)

OR

E.   A documented diagnosis of facial flat warts

OR

F.   A documented diagnosis of multiple flat warts
 

Note:  Topical tretinoin is not covered for treatment of basal cell carcinoma, lichen planus, or dysplastic nevi because its use in these conditions is not supported by the peer-reviewed medical literature.




2. 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.)


3. Medical Exception Criteria

Aczone, Akne-mycin, Atralin, Azelex, Benzaclin, Benzamycin, Cleocin-T, Differin, Duac, Evoclin, Klaron, Panretin, Retin-A, Retin-A Micro, Z-Clinz 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  Aczone, Akne-mycin, Atralin, Azelex, Benzaclin, Benzamycin, Cleocin-T, Differin, Duac, Evoclin, Klaron, Panretin, Retin-A, Retin-A Micro, Z-Clinz 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 covered alternatives indicated for the member's condition, one of which is erythromycin OR
• Intolerance to two covered alternatives indicated for the member's condition, one of which is erythromycin OR
• Allergy to two covered alternatives indicated for the member's condition, one of which is erythromycin OR
• Failure of an adequate trial of one month each of two covered alternatives indicated for the member's condition, one of which is erythromycin

For Benzaclin, Cleocin-T, Duac, Evoclin and Z-Clinz

A.  A documented:

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

For Azelex, Klaron and Panretin

A. A documented:

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

For Aczone

A. A documented:

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

For Atralin, Differin, Retin-A and Retin-A Micro (members under the age of 36-Atralin, Retin-A/Retin-A Micro  ONLY)

A.   A documented:

• Contraindication to one of the following covered alternatives-Avita or tretinoin OR,
• Intolerance to one of the following covered alternatives-Avita or tretinoin OR,
• Allergy to one of the following covered alternatives-Avita or tretinoin OR
• Failure of an adequate trial of one month of one of the following covered alternatives-Avita or tretinoin.

For Atralin, Retin-A and Retin-A Micro (members equal to or greater than 36 years of age)

A.   A documented diagnosis of acne vulgaris

OR

B.   A documented diagnosis of actinic keratoses

AND

• Lesions are on the face OR
• Lesions are not on the face and therapy includes the use of 5-fluorouracil in conjunction with tretinoin

OR

C.  A documented diagnosis of hypertrophic scars or keloids AND intralesional injection of corticosteroids is ineffective or not tolerated

OR

D.  A documented diagnosis of keratosis follicularis (Darier's disease, Darier-White disease)

OR

E.   A documented diagnosis of facial flat warts

OR

F.   A documented diagnosis of multiple flat warts
 

Note:  Topical tretinoin is not covered for treatment of basal cell carcinoma, lichen planus, or dysplastic nevi because its use in these conditions is not supported by the peer-reviewed medical literature.

AND

G.   A documented:

• Contraindication to one of the following covered alternatives-Avita or tretinoin OR,
• Intolerance to one of the following covered alternatives-Avita or tretinoin OR,
• Allergy to one of the following covered alternatives-Avita or tretinoin OR
• Failure of an adequate trial of one month of one of the following covered alternatives-Avita or tretinoin.

For Ziana

A.   A documented:

• Contraindication to two of the following covered alternatives-Avita, tretinoin or any covered alternative containing clindamycin OR,
• Intolerance to two of the following covered alternatives-Avita, tretinoin or any covered product containing clindamycin OR,
• Allergy to two of the following covered alternatives-Avita, tretinoin or any covered product containing clindamycin OR
• Failure of an adequate trial of one month each of two of the following covered alternatives-Avita, tretinoin or any covered product containing clindamycin
  

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, 2004.
2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
4. Retin-A Micro Package Insert. Ortho Dermatological, Skillman, NJ, May 2002
5. Leyden JJ, Berger RS, Dunlap NC, et al. Comparison of the efficacy and safety of a combination topical gel formulation of benzoyl peroxide and clindamycin with benzoyl peroxide, clindamycin and vehicle gel in the treatments of acne vulgaris. Am J Clin Dermatol 2001;2:33-9
6. Lesher JL, Jr. et al.  An evaluation of a 2 % erythromycin ointment in the topical therapy of acne vulgaris.  J Am Acad Dermatol 1985; 12(3): 526-531
7. Shrager D, Webster G. Azelaic acid 20% cream combined with benzoyl peroxide 4% gel compared to Benzamycin gel in the treatment of acne vulgaris. Poster presented at the 57th Annual Meeting of the American Academy of Dermatology, March 19-24, 1999. New Orleans, LA
8. Leyden JJ, Tanghetti EA, Miller B, et al. Once-daily tazarotene 0.1% gel versus once-daily tretinoin 0.1% microsponge gel for the treatment of facial acne vulgaris: a double-blind randomized trial. Cutis 2002;69(S2):12-9
9. Thiboutot D. Acne: 1991-2001.J Am Acad Dermatol. 2002;47:109-17
10. 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.
11. 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.

October 22, 2008