Siklos - Xromi- NC Standard

Restricted Product(s)

• Siklos® (hydroxyurea)
• Xromi^® (hydroxyurea oral solution)

FDA Approved Use

• Siklos 
  • Indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adults and pediatric patients 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises.
• Xromi
  • Indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older with sickle cell anemia with recurrent moderate to severe painful crises.

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of sickle cell anemia with a history of moderate to severe painful crises; AND
   1. The patient is at least 6 months but less than 2 years of age; AND
      1. The patient will receive Xromi; OR
   2. The patient is 2 years of age or older; AND
      1. The patient is unable to obtain the appropriate dosing with either hydroxyurea 500 mg capsules or Droxia (hydroxyurea) 200 mg, 300 mg, and/or 400mg capsules; OR
      2. The patient cannot swallow capsules and is taking no other oral tablet/capsule formulations; AND
2. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

National Heart, Lung, and Blood Institute. Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014. Bethesda, MD: National Heart, Lung, and Blood Institute, US Department of Health and Human Services; 2014.
Available at: http://www.nhlbi.nih.gov/health-pro/guidelines/sickle-cell-disease-guidelines/

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 Q2 annually.

March 2025: Criteria change: Added new to market Xromi (hydroxyurea oral soln) to policy. Added P&T statement.     

January 2022: Criteria update: Updated indication for expanded age to include adults.

September 2021: Criteria update: Annual criteria review. No changes to policy.

June 2018: Original utilization management criteria issued.