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Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older. Nodules are inflammatory lesions with a diameter of 5mm or more. The nodules may become suppurative or hemorrhagic. “Severe”, by definition, means “many” as opposed to “few or several” nodules.
Dosage and Administration
Black Box Warning
POLICYPrior authorization is required.
Isotretinoin will be approved based on all of the following criteria:
Initial authorization will be issued for 5 months of therapy.
Isotretinoin will be approved for continuation of therapy based on one of the following criteria:
Continuation of therapy will only be approved for a 5 month period. A max of two courses (initial and continuation) will be approved.
Absorica® is a branded medication, and will be excluded from coverage.
POLICY EXCEPTIONSPrior authorization of isotretinoin is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY09/01/2013: New policy added.
11/18/2013: Policy statement updated to clarify the history of failure following adequate trial: "6 weeks" was changed to "60 days." Also, the statement "on two oral antibiotics" was changed to "on oral antibiotics."
06/25/2014: Policy statement on Initial Therapy revised with the following changes: 1) Removed "In cases when oral antibiotics are not indicated and patient has documented failure of an adequate trial (> 6 weeks) of benzoyl peroxide and topical antibiotic" from the criteria. 2) Added "Confirmed diagnosis of severe cystic acne."
08/31/2015: Medical policy revised to add ICD-10 codes.
SOURCE(S)1. Product information, Claravis. Teva Pharmaceuticals Inc, Revised 02/2013
2. Product information, Amnesteem. Mylan Pharmaceuticals Inc, Revised 05/2012
3. Product information, Sotret. Ranbaxy Laboratories Inc, Revised 11/2006
4. Facts and Comparisons, 2013 Wolters Kluwer Health
5. FDA.gov, Isotretinoin Capsule Information, Accessed May 2013
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.