Prior Authorization Criteria for Approval

Initial Evaluation

Promacta will be approved when

1. ONE of the following is met:

1. The patient has a diagnosis of persistent or chronic immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following: 
   1. The patient has tried and had an insufficient response to a corticosteroid or immunoglobulin (IVIg or anti-D)
      OR
   2. The patient has an intolerance or hypersensitivity to a corticosteroid or immunoglobulin (IVIg or anti-D)
      OR
   3. The patient has an FDA labeled contraindication to a corticosteroid or immunoglobulin (IVIg or anti-D)
      OR
   4. The patient has had an insufficient response to a splenectomy
      OR
2. The patient has a diagnosis of hepatitis C associated thrombocytopenia AND ONE of the following:
   1. The patient’s platelet count is less than 75 X 109/L AND the intent is to increase platelet counts sufficiently to initiate interferon therapy
      OR
   2. The patient is on concurrent therapy with interferon therapy AND is at risk for discontinuing hepatitis C therapy due to thrombocytopenia
      OR
3. The patient has a diagnosis of severe aplastic anemia (SAA) AND ALL of the following:
   1. The patient has at least 2 of the following blood criteria:
      1. Neutrophils less than 0.5 X 109/L
         OR
      2. Platelets less than 30 X 109/L
         OR
      3. Reticulocyte count less than 60 X 109/L
         AND
   2. The patient has at least 1 of the following marrow criteria:
      1. Severe hypocellularity is less than 25%
         OR
      2. Moderate hypocellularity is 25-50% with hematopoietic cells representing less than 30% of residual cells
         AND
   3. ONE of the following:
      1. The patient has tried and had an insufficient response to BOTH antithymocyte globulin (ATG) AND cyclosporine therapy
         OR
      2. BOTH of the following:
         1. The patient will be using the requested medication as first-line treatment (i.e., has not been treated with ATG and/or cyclosporine)
            AND
         2. The patient will use the requested medication in combination with standard immunosuppressive therapy [i.e., ATG AND cyclosporine]
            OR
4. The patient has another indication that is supported in CMS approved compendia for the requested medication
   AND 

2. The requested dose is within FDA labeled dosing or supported in CMS approved compendia dosing for the requested indication

Initial Length of Approval:

ITP: 6 months

Hepatitis C associated thrombocytopenia: 48 weeks

First-line therapy in severe aplastic anemia: 6 months

SAA: 16 weeks

All other indications: 12 months

*Promacta should be discontinued when antiviral therapy is discontinued

All other indications: 12 months

Renewal Evaluation

Promacta 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 persistent or chronic immune (idiopathic) thrombocytopenia (ITP) AND ONE of the following:
      1. The patient’s platelet count is 50 x 10⁹/L or greater
         OR
      2. The patient’s platelet count has increased sufficiently to avoid clinically significant bleeding
         OR
   2. The patient has a diagnosis of hepatitis C associated thrombocytopenia AND BOTH of the following:
      1. ONE of the following:
         1. The patient will be initiating hepatitis C therapy with interferon therapy
            OR
         2. The patient will be maintaining hepatitis C therapy with interferon therapy at the same time as the requested medication
            AND
      2. ONE of the following:
         1. The patient’s platelet count is 90 X 10⁹/L or greater
            OR
         2. The patient’s platelet count has increased sufficiently to initiate or maintain interferon based therapy for the treatment of hepatitis C
            OR
   3. The patient has a diagnosis of severe aplastic anemia (SAA) AND the patient has had clinical benefit with the requested medication
      OR
   4. The patient has another indication that is supported in CMS approved compendia and has had clinical benefit with the requested medication
      AND
3. The requested dose is within FDA labeled dosing or supported in CMS approved compendia dosing for the requested indication

Renewal Length of Approval:

ITP: 12 months

Hepatitis C associated thrombocytopenia: 48 weeks

SAA: 12 months

All other indications: 12 months

Promacta should be discontinued when antiviral therapy is discontinued