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RayosBlue Cross Blue Shield of Texas

FDA labeled indications for Rayos (prednisone delayed release)

Initial criteria

  • 1. The patient has an FDA labeled indication for the requested agent AND
  • 2. A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  • B. There is support for using the requested agent for the patient’s age for the requested indication AND
  • 3. ONE of the following:
  • A. BOTH of the following:
  • 1. ONE of the following:
  • A. The prescriber has stated that the patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • B. Documentation confirms diagnosis of stage four advanced metastatic cancer and agent is used to treat an associated condition related to stage four advanced metastatic cancer [chart notes required] AND
  • 2. The use is consistent with best practices, supported by peer-reviewed evidence-based literature, and FDA-approved; OR
  • B. The patient is currently treated with the requested agent and is stable on therapy [chart notes required] OR
  • C. The patient has tried and had inadequate response to BOTH a generic oral prednisone AND at least one other different generic oral corticosteroid (e.g., dexamethasone, methylprednisolone, prednisolone) [chart notes required] OR
  • D. Both a generic oral prednisone AND at least one other different generic oral corticosteroid were discontinued due to lack of efficacy, effectiveness, diminished effect, or adverse event [chart notes required] OR
  • E. The patient has intolerance or hypersensitivity to BOTH a generic oral prednisone AND at least one different generic oral corticosteroid not expected with the requested agent [chart notes required] OR
  • F. The patient has FDA labeled contraindication to ALL generic oral corticosteroids that is not expected to occur with the requested agent [chart notes required] OR
  • G. Generic oral prednisone AND another corticosteroid are expected to be ineffective or inappropriate due to patient-specific reasons (ineffectiveness, adherence barrier, comorbidities, functional impairment, adverse reaction, or harm) [chart notes required] OR
  • H. Generic oral prednisone AND another corticosteroid are not in the best interest of the patient based on medical necessity [chart notes required] OR
  • I. The patient has tried another prescription drug in same pharmacologic class as prednisone and other corticosteroid, discontinued due to lack of efficacy or adverse event [chart notes required] AND
  • 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSIL: 12 months; all other plans: 6 months