Zokinvy Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Prior authorization criteria for approval

Initial Evaluation

Zokinvy will be approved when ALL of the following are met:

1. ONE of the following:

   1. BOTH of the following:

      1. The patient has a diagnosis of Hutchinson-Gilford progeria syndrome (HGPS)
         AND
      2. Genetic testing has confirmed a pathogenic variant in the LMNA gene that results in production of progerin
         OR

   2. The patient has a diagnosis of processing-deficient progeroid laminopathy AND ONE of the following:

      1. Genetic testing has confirmed heterozygous LMNA mutation with progerin-like protein accumulation
         OR
      2. Genetic testing has confirmed homozygous or compound heterozygous ZMPSTE24 mutations
         AND

2. The patient is within the FDA labeled age for the requested medication
   AND

3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND

4. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND

5. ONE of the following:

   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR

   2. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

Renewal Evaluation

Zokinvy will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND

2. The patient has a diagnosis of ONE of the following:

   1. Hutchinson-Gilford progeria syndrome (HGPS)
      OR
   2. Processing-deficient progeroid laminopathies with either: heterozygous LMNA mutation with progerin-like protein accumulation OR homozygous or compound heterozygous ZMPSTE24 mutations
      AND

3. The patient is within the FDA labeled age for the requested medication
   AND

4. The patient has had clinical benefit with the requested medication
   AND

5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND

6. The patient does NOT have any FDA labeled contraindications to the requested medication
   AND

7. ONE of the following:

   1. The requested quantity (dose) does NOT exceed the program quantity limit
      OR

   2. ALL of the following:  i. The requested quantity (dose) is greater than the program quantity limit
      AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed 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