Symdeko Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

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

1. The patient has a diagnosis of cystic fibrosis
   AND

2. ONE of the following:

   1. The patient has the presence of the F508del mutation on both alleles (homozygous) of the CFTR gene confirmed by genetic testing
      OR
   2. The patient has ONE of the CFTR gene mutations or a mutation in the CFTR gene that is responsive based on in vitro data, as indicated in the FDA label, confirmed by genetic testing
      OR
   3. The patient has another CFTR gene mutation(s) that is responsive to the requested medication, as indicated in the FDA label, confirmed by genetic testing
      AND

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

4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND

5. The patient will NOT be using the requested medication in combination with another CFTR modulator medication for the requested indication
   AND

6. 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) does NOT exceed the maximum FDA labeled dose for the requested indication
         AND
      3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         OR

   3. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication
         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

Symdeko 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 cystic fibrosis
   AND

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

4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cystic fibrosis, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND

5. The patient has had improvement or stabilization with the requested medication [e.g., improvement in FEV1 from baseline, increase in weight/BMI, improvement from baseline Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain score, improvements in respiratory symptoms (cough, sputum production, and difficulty breathing), and/or reduced number of pulmonary exacerbations]
   AND

6. The patient will NOT be using the requested medication in combination with another CFTR modulator medication for the requested indication
   AND

7. 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) does NOT exceed the maximum FDA labeled dose for the requested indication
         AND
      3. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit
         OR

   3. ALL of the following:

      1. The requested quantity (dose) is greater than the program quantity limit
         AND
      2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication
         AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months