Siklos — Medical Mutual

Initial criteria

• The product is used to reduce the frequency of painful crises; AND
• The product is being used to reduce the need for blood transfusions; AND
• The patient experiences recurrent, moderate to severe painful crises; AND
• For Siklos requests, the patient meets one of the following (a or b): a) The 100 mg or 1,000 mg tablets are required to achieve a dosage that cannot be achieved with other available formulations of hydroxyurea (e.g. Droxia capsules); OR b) The patient cannot swallow or has difficulty swallowing.; AND
• The patient meets one of the following (a or b): a) For Siklos requests the patient is age ≥ 2 years; OR b) For Xromi requests the patient is aged 6 months to < 2 years.

Reauthorization criteria

• A response to therapy is required for continuation of therapy.

Approval duration

1 year initial, 1 year reauth