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

Prior Authorization and Quantity Limit Criteria for Approval

Initial Evaluation

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

1. The patient has a diagnosis of Primary Biliary Cholangitis (PBC) confirmed by at least TWO of the following:

   1. There is biochemical evidence of cholestasis with an alkaline phosphatase (ALP) elevation
   2. Presence of antimitochondrial antibody (AMA): a titer greater than 1:80 OR a level that is above the testing laboratory’s upper limit of the normal range
   3. If the AMA is negative or present only in low titer (less than or equal to 1:80), presence of other PBC-specific autoantibodies, including sp100 or gp210
   4. Histologic evidence of nonsuppurative destruction cholangitis and destruction of interlobular bile ducts
      AND

2. ONE of the following:

   1. The patient does NOT have cirrhosis
      OR
   2. The patient has compensated cirrhosis with NO evidence of portal hypertension
      AND

3. The prescriber has measured the patient’s alkaline phosphatase (ALP) level AND total bilirubin level
   AND

4. ONE of the following:

   1. BOTH of the following:

      1. The patient has tried and had an inadequate response to ursodiol
         AND
      2. The requested medication will be used in combination with ursodiol
         OR

   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ursodiol
      AND

5. The patient does NOT have any FDA labeled contraindications to the requested medication
   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) 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

Ocaliva 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 Primary Biliary Cholangitis (PBC)
   AND

3. ONE of the following:

   1. The patient does NOT have cirrhosis
      OR
   2. The patient has compensated cirrhosis with NO evidence of portal hypertension

4. ONE of the following:

   1. The requested medication will be used in combination with ursodiol
      OR
   2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ursodiol
      AND

5. The patient has had improvements or stabilization with the requested medication as indicated by BOTH of the following:

   1. Decrease in alkaline phosphatase (ALP) level from baseline
      AND
   2. Total bilirubin is less than or equal to the upper limit of normal (ULN)
      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:

      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