Doptelet Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Doptelet will be approved when ONE of the following is met:

1. The patient has a diagnosis of thrombocytopenia AND ALL of the following:
   1. The patient has chronic liver disease
      AND
   2. The patient has a platelet count less than 50 X 10^9/L
      AND
   3. The patient is scheduled to undergo a procedure with an associated risk of bleeding (e.g., gastrointestinal endoscopy, liver biopsy, bronchoscopy, dental procedure)
      AND
   4. The length of therapy of the requested medication is within the FDA labeled duration for the requested indication
      OR
2. The patient has a diagnosis of chronic immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following:
   1. The patient has tried and had an insufficient response to a corticosteroid, another thrombopoietin receptor agonist (e.g., Promacta), or immunoglobulin (IVIg or anti-D)
      OR
   2. The patient has an intolerance or hypersensitivity to a corticosteroid, another thrombopoietin receptor agonist (e.g., Promacta), or immunoglobulin (IVIg or anti-D)
      OR
   3. The patient has an FDA labeled contraindication to a corticosteroid, another thrombopoietin receptor agonist (e.g., Promacta), or immunoglobulin (IVIg or anti-D)
      OR
   4. The patient has had an insufficient response to a splenectomy
      AND
3. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval:

Thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure - 1 month

ITP - 6 months

Renewal Evaluation

Doptelet will be approved when BOTH 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. ONE of the following:
   1. The patient has a diagnosis of thrombocytopenia AND ALL of the following:
      1. The patient has chronic liver disease
         AND
      2. The patient has a platelet count less than 50 X 10^9/L
         AND
      3. The patient is scheduled to undergo a procedure with an associated risk of bleeding (e.g., gastrointestinal endoscopy, liver biopsy, bronchoscopy, dental procedure)
         AND
      4. The length of therapy of the requested medication is within the FDA labeled duration for the requested indication
         OR
   2. The patient has a diagnosis of chronic immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following:
      1. The patient’s platelet count is 50 x 10^9/L or greater
         OR
      2. The patient’s platelet count has increased sufficiently to avoid clinically significant bleeding
         AND
3. The requested dose is within FDA labeled dosing for the requested indication

Renewal Length of Approval:

Thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure - 1 month

ITP - 12 months