Subject: Acne Agents, Oral
| P |
Amnesteem™ (isotretinoin)
|
X
|
|
|
|
|
| P |
Claravis™ (isotretinoin)
|
X
|
|
|
|
|
| P |
doxycycline
|
|
|
X
|
|
|
| P |
isotretinoin
|
X
|
|
|
|
|
| P |
minocycline
|
|
|
X
|
|
|
| P |
Sotret™ (isotretinoin)
|
X
|
|
|
|
|
| Note:
|
Policy:
- Precertification Criteria
Under some plans, including plans that use an open or closed formulary, amnesteem, claravis, isotretinoin, and sotret are subject to precertification. If precertification requirements apply Aetna considers amnesteem, claravis, isotretinoin, and sotret to be medically necessary for those members who meet ALL of the following precertification criteria:
A. Diagnosis of severe recalcitrant nodular or cystic acne
AND
B. Documented one of the following:
Member already has evidence of scarring OR
Contraindication to brand or generic systemic antibiotics minocycline OR doxycycline OR
Intolerance to brand or generic systemic antibiotics minocycline OR doxycycline OR
Failure of an adequate trial of one month of brand or generic systemic antibiotics minocycline OR doxycycline--generics are preferred.
AND
C. If female, member is enrolled in the FDA iPLEDGE program
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. Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris-10 years later: a safe and successful treatment. Br J Dermatol. 1993;129:282-96.
8. McLane J. Supplement: Isotretinoin – A State-of-the-Art Conference. Analysis of common side effects of isotretinoin. J Am Acad Dermatol. 2001;45:S188-94.
9. Jick SS, Kremers HM, Vasilakis-Scaramozza C. Isotretinoin use and risk of depression, psychotic symptoms, suicide, and attempted suicide. Arch Dermatol. 2000 Oct;136(10):1231-6.
10. Haider A, Shaw JC. Treatment of acne vulgaris. JAMA. 2004 Aug 11;292(6):726-35.
11. American Academy of Dermatology Consensus Conference on the safe and optimal useof isotretinoin: summary and recommendations. J Am Acad Dermatol. 2004 Jun;50(6):900-6.
12. Larsen TH, Jemec GB. Acne: comparing hormonal approaches to antibiotics and isotretinoin. Expert Opin Pharmacother. 2003 Jul;4(7):1097-103.
13. Cheetham TC, Wagner RA, Chiu G, Day JM, Yoshinaga MA, Wong L. A risk management program aimed at preventing fetal exposure to isotretinoin: retrospective cohort study. J Am Acad Dermatol. 2006 Sep;55(3):442-8. Epub 2006 Jul 13.
14. FDA Accutane information (accessed October 2005) : http://www.fda.gov/cder/drug/infopage/accutane/default.htm
15. Zaenglein AL, Thiboutot D. Expert committee recommedations for acne management. Pediatrics 2006:118;1188-99.
16. Del Russo JQ, Kim G. Optimizing the use of oral antibiotics for acne vulgaris. Dermatol Clini 2009;27:33-42.
17. Thiboutot D, Gollnick H, Bettoli V et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne Group. J Am Acad Derm 2009;60(5 Suppl): S1-50.
Copyright 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, 2010
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