Subject: Acne Agents, Oral

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
Oral Isotretinoins
C	Amnesteem™ (isotretinoin)		X
C	Claravis™ (isotretinoin)		X
C	isotretinoin		X
C	Sotret™ (isotretinoin)		X
NC	Accutane®  (isotretinoin)		X				X
Antibiotics
C	doxycycline				X
C	minocycline				X
C	minocycline er				X
NC	Minocin Pac Kit®  (minocycline cap w/acne care products)				X		X
NC	Solodyn®  (minocycline SR tablet)				X		X
Note: Criteria for doxycycline and minocycline is discussed in the Pharmacy Clinical Policy Bulletin: Tetracyclines

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open or closed formulary, Accutane, Amnesteem, Claravis, isotretinoin, minocycline, minocycline er, Minocin Pac Kit, Solodyn and Sotret are subject to precertification.  If precertification requirements apply Aetna considers Accutane, Amnesteem, Claravis, isotretinoin, minocycline, minocycline er, Minocin Pac Kit, Solodyn and Sotret to be medically necessary for those members who meet of the following precertification criteria:

For Accutane, Amnesteem, Claravis, isotretinoin and Sotret

A. Diagnosis of severe recalcitrant nodular or cystic acne

For minocycline, minocycline er, Minocin Pac Kit and Solodyn

Under some plans, including plans that use an open or closed formulary, minocycline, minocycline er, Minocin Pac Kit and Solodyn are subject to precertification for members less than or equal to 8 and 12 years of age, respectively.  Aetna considers minocycline, minocycline er, Minocin Pac Kit and Solodyn to be medically necessary for those members who meet the following precertification criteria:

A. Member's physician provides documentation from drug labeling OR CMS approved compendia for medical use of minocycline er and Solodyn in patients younger than 12 years old for acne  OR the medical use of minocycline and Minocin Pac Kit in pediatric patients younger than or equal to 8 years of old.


2. Medical Exception Criteria

Accutane, Minocin Pac Kit and Solodyn  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 Accutane, Minocin Pac Kit and Solodyn  to be medically necessary for those members who meet the following criteria:

For Accutane

A. A documented

• Contraindication to one preferred oral isotretinoin alternative OR
• Intolerance to one preferred oral isotretinoin alternative OR
• Allergy to one preferred oral isotretinoin alternative OR
• Failure of an adequate trial of one month of one preferred oral isotretinoin alternative

For Minocin Pac Kit and Solodyn

A.   A documented

• Contraindication to one preferred generic minocycline product OR
• Intolerance to one preferred generic minocycline product OR
• Allergy to one preferred generic minocycline product OR
• Failure of an adequate trial of one month of one preferred generic minocycline product

Special Notes:

Solodyn is an extended release, once-daily minocycline tablet that is indicated to treat only  inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years  of age or older.  The safety of Solodyn has not been established beyond 12 weeks of use.   Solodyn has not been evaluated in the treatment of infections.  The use of drugs in the  tetracycline class, the class Solodyn belongs too, may cause permanent teeth discoloration  (yellow-gray-brown) during tooth development (last half of pregnancy, infancy and childhood up to  the age of 8 years).

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. 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.
8. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
9. Haider A, Shaw JC. Treatment of acne vulgaris. JAMA. 2004;292(6):726-35.
10. Goldsmith LA, Bolognia JL, Callen JP, et al, American Academy of Dermatology. American Academy of Dermatology Consensus Conference on the safe and optimal use  of isotretinoin: summary and recommendations. J Am Acad Dermatol. 2004;50(6):900-6.
11. Garner SE, Eady EA, Popescu C, Newton J, Li WA. Minocycline for acne vulgaris: efficacy and safety. Cochrane Database Syst Rev. 2003;(1):CD002086

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.

August 28, 2009