Lidocaine Topical – ZTlido 1.8% Patch Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior Authorization and Quantity Limit Criteria for Approval

ZTlido 1.8% topical patch system will be approved when ALL of the following are met:

1. The patient has ONE of the following diagnoses:
   1. Pain associated with postherpetic neuralgia (PHN)
      OR
   2. Neuropathic pain associated with cancer, or cancer treatment
      OR
   3. Another diagnosis that is supported in CMS approved compendia for the requested medication
      AND
2. ONE of the following:
   1. The patient has tried and had an inadequate response to generic lidocaine 5% patch
      OR
   2. The patient has an intolerance or hypersensitivity to generic lidocaine 5% patch
      OR
   3. The patient has an FDA labeled contraindication to generic lidocaine 5% patch
      AND
3. ONE of the following:
   1. The patient has tried and had an inadequate response to a conventional therapy [e.g., gabapentin, pregabalin, oral prescription NSAID (non-steroidal anti-inflammatory drug)] for the requested indication
      OR
   2. The patient has an intolerance or hypersensitivity to a conventional therapy
      OR
   3. The patient has an FDA labeled contraindication to conventional therapy
      AND
4. ONE of the following:
   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR
   2. BOTH of the following:
      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months