Preface to Medical Drug Management Guidelines New Medical Drug / Indication

Covered: case‑by‑case medical‑necessity approval may be granted for newly FDA‑approved drugs or new FDA‑approved indications for chronic, non‑cancer diseases, while simultaneous duplicate therapy is generally excluded unless clinical evidence supports it. Key requirements: documentation of FDA‑approved indication and dosing, adequate clinical trial evidence of effectiveness, absence of prescribing‑information contraindications, required lab/test results, and prior trial/failure of other appropriate therapies when specified (dosing follows FDA label if no guideline exists).

"The member does not have any contraindication(s) to the requested medical drug that are noted in the prescribing information."

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