ORTIKOS (budesonide ER)

ORTIKOS (budesonide ER)

Self-Administration – oral

Diagnosis considered for coverage:

• Treatment of Mild to Moderate Active Crohn's Disease
  • Indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older
• Maintenance of Clinical Remission of Mild to Moderate Crohn's Disease
  • Indicated for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults

Coverage Criteria:

For diagnosis of treatment of active Crohn's Disease:

• Dose does not exceed the maximum FDA approved dose for age
  • Adults: 9 mg once daily for up to 8 weeks
  • Pediatric patients 8 to 17 years who weigh more than 25 kg: 9 mg once daily for up to 8 weeks, followed by 6 mg once daily for 2 weeks; AND
• Patient is 8 years of age and older; AND
• Chart notes document a medical reason why generic budesonide delayed-release 3 mg capsules cannot be used

For diagnosis of maintenance of remission of Crohn's Disease:

• Dose does not exceed 6 mg once daily; AND
• Patient is 18 years of age and older; AND
• Patient has completed an 8-week course of Ortikos 9mg once daily for Crohn’s disease and is currently in remission

Reauthorization Criteria:

For diagnosis of treatment of active Crohn's Disease:

• Dose does not exceed 9 mg once daily for up to 8 weeks; AND
• Patient is 18 years of age and older; AND
• Medical records confirm patient had a recurring episode of active disease

Coverage Duration: 

For diagnosis of treatment of active Crohn's Disease:

• Initial:
  • Adults: 8 weeks
  • Pediatric patients:10 weeks
• Reauthorization:
  • 8 weeks

For diagnosis of maintenance of remission of Crohn's Disease:

• 3 months

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.

Additional Information: 

• Recommended Dose for Treatment of Mild to Moderate Active Crohn's Disease:
  • Adults: 9 mg orally once daily for up to 8 weeks. Repeated 8 week courses of Ortikos can be given for recurring episodes of active disease
  • Pediatric patients 8 to 17 years who weigh more than 25 kg: 9 mg orally once daily for up to 8 weeks, followed by 6 mg once daily for 2 weeks
• Recommended Dose for Maintenance of Clinical Remission of Mild to Moderate Crohn's Disease:
  • 6 mg orally once daily for maintenance of clinical remission up to 3 months
  • For maintenance of clinical remission of mild to moderate Crohn’s disease, continued treatment with Ortikos 6 mg for more than 3 months has not been shown to provide substantial clinical benefit
• Avoid use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine)

Policy Updates:

• 8/30/2022 – New policy approved by P&T

References:

• Ortikos Prescribing Information. Ferring Pharmaceuticals Inc. Parsippany, NJ. October 2019.