Subject: Acne Agents, Oral

Status	Drug	PR	PR-QL	PR-AL	ST	M EX‡
P	Amnesteem™ (isotretinoin)	X	X
P	Claravis™ (isotretinoin)	X	X
P	doxycycline			X
P	isotretinoin	X	X
P	minocycline			X
P	Sotret™ (isotretinoin)	X	X
NP	Accutane®  (isotretinoin)	X	X		X	X
Note: Note: Criteria for doxycycline  and minocycline are discussed in the Pharmacy Clinical Policy Bulletin: Tetracyclines /products/rxnonmedicare/data/ID/tetracyclines_20007.html

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Accutane, amnesteem, claravis, isotretinoin, and sotret are subject to precertification.  If precertification requirements apply Aetna considers Accutane, 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, in accordance with FDA iPLEDGE program that requires completing an informed consent form, obtaining counseling about the risks and requirements for safe use of isotretinoin, and, for women of childbearing potential (non-hysterctomized), complying with required pregnancy testing and use of contraception , patient is not pregnant (report of negative pregnancy test obtained within the last 7 days**) and has been counseled about the use of reliable contraception 1 month before, during, and 1 month after isotretinoin therapy. 

AND


Due to patient safety, and in accordance with  the FDA prescribing requirements for Accutane, amnesteem, claravis, isotretinoin, and sotret, a maximum of a 30-day supply will be allowed per prescription for all strengths of Accutane, amnesteem, claravis, isotretinoin, and sotret if member fulfills criteria (A and B and C)above.

For coverage of additional quantities, a member's treating physician must request prior authorization through the Pharmacy Management Precertification Unit. Additional quantities of Accutane, amnesteem, claravis, isotretinoin, and sotret will be considered medically necessary for those members who meet the following criterion:

• Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.
  
2. Step Therapy Criteria

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

A documented trial of one month of one preferred generic isotretinoin alternative on the Preferred Drug List.

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

Accutane is currently listed on the Aetna Step-Therapy List.* If it is medically necessary for a member to be treated initially with Accutane, Aetna considers Accutane to be medically necessary for those members who meet the criteria specified below:

 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, in accordance with FDA iPLEDGE program that requires completing an informed consent form, obtaining counseling about the risks and requirements for safe use of isotretinoin, and, for women of childbearing potential (non-hysterctomized), complying with required pregnancy testing and use of contraception , patient is not pregnant (report of negative pregnancy test obtained within the last 7 days**) and has been counseled about the use of reliable contraception 1 month before, during, and 1 month after isotretinoin therapy.

AND

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

Special Notes:

** The 7 day negative pregnancy test time frame starts on the date that the urine or blood sample is taken for the pregnancy test. This date is counted as Day 1.

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. Saurat JH. Systemic Retinoids; what's new? Dermatol Clin. 1998;16:331-40.
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. Goulden V, Layton AM, Cunliffe WJ. Current indications forisotretinoin as a treatment for acne vulgaris. Dermatology. 1995;190:284-7.
9. 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.
10. 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.
11. Haider A, Shaw JC. Treatment of acne vulgaris. JAMA. 2004 Aug 11;292(6):726-35.
12. 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.
13. Larsen TH, Jemec GB. Acne: comparing hormonal approaches to antibiotics and isotretinoin. Expert Opin Pharmacother. 2003 Jul;4(7):1097-103.
14. 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.
15.  FDA Accutane information (accessed October 2005) : http://www.fda.gov/cder/drug/infopage/accutane/default.htm

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.

July 23, 2009