Sapropterin Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

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

1. The patient has a diagnosis of phenylketonuria (PKU)
   AND
2. The prescriber has submitted a baseline blood Phe level measured prior to initiation of therapy with the requested medication, which is above the recommended levels indicated for the patient’s age range or condition
   AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., metabolic or genetic disorders) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
4. The patient will NOT be using the requested medication in combination with Palynziq (pegvaliase-pqpz) for the requested indication
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval:

2 months if initial dose is 5 mg/kg/day to less than 20 mg/kg/day

1 month if initial dose is 20 mg/kg/day.

Renewal Evaluation

Sapropterin 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 phenylketonuria (PKU)
   AND

3. ONE of the following:

   1. The patient’s blood Phe levels are being maintained within the acceptable range
      OR
   2. The patient has had a decrease in blood Phe level from baseline
      AND

4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., metabolic or genetic disorders) 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 Palynziq (pegvaliase-pqpz) for the requested indication
   AND

6. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months