Absorica
Restricted Product(s):
- Absorica LD™ (isotretinoin)
FDA Approved Use:
- For the treatment of severe recalcitrant nodular acne in patients 12 years of age and older
Criteria for Approval of Restricted Product(s):
- The patient is 12 years of age or older; AND
- The patient has a diagnosis of severe recalcitrant nodular acne; AND
- The patient has “many” (opposed to “few or several”) lesions measuring 5 mm or greater; AND
- The patient has not completed a previous course of isotretinoin therapy within the past 8 weeks; AND
- The patient was unresponsive to systemic antibiotics; AND
- The patient was unresponsive to the following products: Absorica, Amnesteem, Claravis, Myorisan, and Zenatane; AND
- The therapeutic failure was due to the patient’s inability to take the isotretinoin product with fat containing meals for the course of therapy; AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 24 weeks
References:
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation / Update Information:
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.
June 2022: Criteria update: Removed Brand Absorica from policy. Updated policy name to Absorica LD.
May 2021: Criteria update: Removed generic Absorica from the policy
May 2021: Criteria update: Added new Absorica generic to the policy
Jan 2020: Criteria update: Added new to market Absorica LD to the policy
Aug 2018: Criteria point regarding the inability to take generic isotretinoins with a meal has been clarified as a sub bullet of failing therapy with a generic isotretinoin.
Jul 2018: Original utilization management criteria issued
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