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