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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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
05/27/2016: Policy number L.5.01.443 added. Investigative definition updated in Policy Guidelines section.
08/24/2016: Policy statement criteria for initial therapy updated for clarity purposes: "Confirmed diagnosis of severe cystic acne" changed to "Confirmed diagnosis of acne vulgaris variants, acne fulminans and acne conglobata."
11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
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.