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Non-Formulary Exception Criteria Medicare Part D

Medicare Medical Policy

Last Review: 01/01/2025

Non-Formulary Exception Criteria for Approval

  1. The member must have tried at least three alternative formulary medications that have a similar mechanism of action as the requested medication AND the member either did not respond to or did not tolerate the formulary alternative medications. If three medications with a similar mechanism of action are not available on formulary, the member must have tried three alternative formulary medications that are medically acceptable to treat the member’s condition (NOTE: If the requested medication is a multi-source brand and the generic equivalent is covered on the formulary, the member must have tried and failed the generic medication equivalent as one of the three required formulary alternatives). OR 
  2. The prescriber provides an explanation of why formulary alternative medications would not be as effective in treating the member’s condition and/or would cause the member to have adverse effects.

Length of approval: 12 months