Isotretinoin Agents

generic isotretinoin, Claravis, Amnesteem, Myorisan, Zenatane, Accutane, Absorica, Absorica LD

Self-Administration - oral capsules

 

Diagnosis considered for coverage:

 

  • Severe recalcitrant nodular acne: Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. 
    • Limitations of Use: If a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy. 

 

Coverage Criteria:

 

For diagnosis of acne:

  • Documentation of severe recalcitrant nodular acne; AND 
  • Dose does not exceed 0.5 to 1 mg/kg/day (0.4 to 0.8 mg/kg/day of Absorica LD). Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of isotretinoin (1.6 mg/kg/day of Absorica LD); AND
  • For Absorica®/Absorica LD® only: medical records document the patient has a medical need to consume a very low-fat or fasting diet.

 

Coverage Duration:
  • One Year

 

Dosing:

 

Acne (12 years and older):

  • The recommended dosing of isotretinoin capsules is 0.5 to 1 mg/kg/day (0.4 to 0.8 mg/kg/day of Absorica LD) given in two divided doses with or without meals for 15 to 20 weeks. 
  • Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of isotretinoin capsules (1.6 mg/kg/day of Absorica LD) in divided doses.

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Policy Updates:
  • 10/10/2020 – Policy reviewed.
  • 02/08/2023 – Updated coverage duration. Update qualifications for Absorica/Absorica LD.

 

References:

Last review date: February 15, 2023

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