Rayos — Blue Cross Blue Shield of Oklahoma
FDA labeled indications for Rayos
Initial criteria
- The patient has an FDA labeled indication for the requested agent AND
- The patient’s age is within FDA labeling for the requested indication for the requested agent OR there is support for using the requested agent for the patient’s age for the requested indication AND
- ONE of the following: (A) BOTH of the following: (1) The prescriber has stated or documented that the patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer or an associated condition; AND (2) Use is consistent with best practices, evidence-based literature, and FDA approval; OR (B) The patient is currently being treated with and stable on the requested agent (with chart notes); OR (C) The patient has tried and had an 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, diminished effect, or adverse event (chart notes required); OR (E) The patient has an intolerance or hypersensitivity to BOTH a generic oral prednisone AND at least one other different generic oral corticosteroid not expected with the requested agent (chart notes required); OR (F) The patient has an FDA labeled contraindication to ALL generic oral corticosteroids not expected to occur with the requested agent (chart notes required); OR (G) Generic oral prednisone AND at least one other different generic oral corticosteroid are expected to be ineffective or cause adherence barriers, comorbid worsening, or adverse effects hindering functional ability (chart notes required); OR (H) Generic oral prednisone AND at least one other different generic oral 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 the same pharmacologic class or with the same mechanism of action and it was discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required); AND
- The patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
BCBSIL: 12 months; all other plans: 6 months