Non-prescription (OTC) products available (NOT covered under standard benefit plans)
OTC
benzoyl peroxide (OTC)
OTC
benzoyl peroxide (OTC) and sulfur preparations (OTC)
Policy:
Precertification Criteria
Under some plans, including plans that use an open or closed formulary, 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 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.
Medical Exception Criteria
Akne-mycin, Azelex, Benzaclin, Benzagel, Benzamycin, Benziq, Binora, Brevoxyl, Brevoxyl-4/Brevoxyl-8, Cleocin-T, Clinac BPO, Differin, Duac, Evoclin, Inova, Inova 8/2 Acne Control, Klaron, Neobenz, Panretin, Retin-A, Retin-A Micro, Triaz3%, Triaz 6%, Triaz 9%, Z-Clinz, Ziana and Zoderm 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 Akne-mycin, Azelex, Benzaclin, Benzagel, Benzamycin, Benziq, Binora, Brevoxyl, Brevoxyl-4/Brevoxyl-8, Cleocin-T, Clinac BPO, Differin, Duac, Evoclin, Inova, Inova 8/2 Acne Control, Klaron, Neobenz, Panretin, Retin-A, Retin-A Micro, Triaz3%, Triaz 6%, Triaz 9%, Z-Clinz, Ziana and Zoderm 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
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 Differin, Retin-A and Retin-AMicro (members under the age of 36-Retin-A/Retin-A MicroONLY)
A. A documented:
Contraindication to one of the following covered alternatives-Avita, benzoyl peroxide (RX)or tretinoin OR,
Intolerance to one of the following covered alternatives-Avita, benzoyl peroxide (RX) or tretinoin OR,
Allergy to one of the following covered alternatives-Avita, benzoyl peroxide (RX)or tretinoin OR
Failure of an adequate trial of one month of one of the following covered alternatives-Avita, benzoyl peroxide (RX) or tretinoin.
For 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, benzoyl peroxide (RX)or tretinoin OR,
Intolerance to one of the following covered alternatives-Avita, benzoyl peroxide (RX) or tretinoin OR,
Allergy to one of the following covered alternatives-Avita, benzoyl peroxide (RX)or tretinoin OR
Failure of an adequate trial of one month of one of the following covered alternatives-Avita, benzoyl peroxide (RX) or tretinoin.
For Ziana
A. A documented:
Contraindication to two of the following covered alternatives-Avita, benzoyl peroxide (RX), tretinoin or any covered alternative containing clindamycin OR,
Intolerance to two of the following covered alternatives-Avita, benzoyl peroxide (RX) or tretinoin or any covered product containing clindamycin OR,
Allergy to two of the following covered alternatives-Avita, benzoyl peroxide (RX)or 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, benzoyl peroxide (RX) or tretinoin or any covered product containing clindamycin
Place of Service:
Outpatient
The above policy is based on the following references:
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional(online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
Retin-A Micro Package Insert. Ortho Dermatological, Skillman, NJ, May 2002
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
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
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
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
Thiboutot D. Acne: 1991-2001.J Am Acad Dermatol. 2002;47:109-17
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.
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.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.