Subject: Dermatological - Rosacea Agents
| P |
doxycycline
|
|
|
X
|
|
|
| P |
metronidazole cream/lotion
|
|
|
|
|
|
| P |
Metrogel® 1%
(metronidazole)
|
|
|
|
|
|
| FE |
Finacea®
(azelaic acid)
|
|
|
|
|
X
|
| FE |
Metrocream®
(metronidazole)
|
|
|
|
|
X
|
| FE |
Metrolotion®
(metronidazole)
|
|
|
|
|
X
|
| FE |
Noritate®
(metronidazole)
|
|
|
|
|
X
|
| FE |
Oracea®
(doxycycline)
|
X
|
X
|
X
|
|
X
|
| FE |
Rozex® emulsion
(metronidazole)
|
|
|
|
|
X
|
| Note: Note: Criteria for doxycycline are also discussed in the Pharmacy Clinical Policy Bulletin: Tetracyclines /products/rxnonmedicare/data/ID/tetracyclines_20007.html |
Policy:
- Precertification Criteria
Under some plans, including plans that use an open or closed formulary Oracea is subject to precertification. If precertification requirements apply Aetna considers Oracea to be medically necessary for those members who meet the following precertification criterion:
For Oracea- (A and B and C) and D
A. A documented diagnosis of Rosacea
AND
B. Age > 8yrs old
AND
C. A documented:
-
Contraindication to the preferred alternative topical metronidazole OR generic doxycycline OR,
-
Intolerance to the preferred alternative topical metronidazole OR generic doxycycline OR,
-
Allergy to the preferred alternative topical metronidazole OR generic doxycycline OR,
-
History of failure of an adequate trial of three days of the preferred alternative topical metronidazole OR generic doxycycline.
AND
According to the manufacturer, Oracea can be dosed up to a maximum daily dose at the interval(s) indicated in the table below. A quantity of Oracea will be considered medically necessary as indicated in the table below, if member fulfills criteria (A and B and C) above.
| Oracea |
40 mg/ Once daily |
40 mg |
Up to 30 capsules in 30 days |
For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit. Additional quantities will be considered medically necessary for those members who meet ANY of the following criteria:
- Medical Exception Criteria
Finacea, Noritate, Oracea, Metrocream, Metrolotion, and Rozex are currently listed on the Aetna Formulary Exclusions List.* Therefore, Finacea, Noritate and Oracea, Metrocream and Metrolotion and Rozex 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 Finacea, Noritate and Oracea, Metrocream, Metrolotion and Rozex to be medically necessary for those members who meet any of the following criteria:
For Finacea, Noritate, Metrocream, Metrolotion, and Rozex
A. A documented
-
Contraindication to one preferred alternative indicated for the member's condition OR
-
Intolerance to one preferred alternative indicated for the member's condition OR
-
Allergy to one preferred alternative agent indicated for the member's condition OR
-
Failure of an adequate trial of one month of one preferred alternative indicated for the member's condition
For Oracea- (A and B and C)
A. A documented diagnosis of Rosacea
AND
B. Age > 8yrs old
AND
C. A documented:
-
Contraindication to the preferred alternative topical metronidazole OR generic doxycycline OR,
-
Intolerance to the preferred alternative topical metronidazole OR generic doxycycline OR,
-
Allergy to the preferred alternative topical metronidazole OR generic doxycycline OR,
-
History of failure of an adequate trial of three days of the preferred alternative topical metronidazole OR generic doxycycline.
Place of Service:
Outpatient
The above policy is based on the following references:
- Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
- USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006.
- AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
- DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
- PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
- Oracea product information internet site; accessed 7-11-06 at http://oracea.com/
- van Zuuren EJ, Graber MA, Hollis S, et al. Interventions for rosacea. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003262.
- Margolis DJ. Evidence-based dermatology. Cutis. 2005;75(3 Suppl):8-12; discussion 33-6.
- Liu RH, Smith MK, Basta SA, Farmer ER. Azelaic acid in the treatment of papulopustular rosacea: a systematic review of randomized controlled trials. Arch Dermatol. 2006 Aug;142(8):1047-52.
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, 2007
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