Tavalisse — Blue Cross Blue Shield of Illinois
Thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure
Initial criteria
- The patient has a baseline platelet count ≤ 30 × 10^9/L OR baseline platelet count > 30 × 10^9/L but < 50 × 10^9/L AND has symptomatic bleeding and/or increased risk for bleeding
- The patient has tried and had an inadequate response to ONE corticosteroid used for the treatment of ITP OR intolerance/hypersensitivity OR FDA-labeled contraindication to corticosteroids
- The patient has tried and had an inadequate response to immunoglobulins (IVIg or Anti-D), splenectomy, or rituximab
- The prescriber has documented stage IV advanced metastatic cancer use consistent with FDA label and evidence-based literature
- The patient has another FDA-labeled or compendia-supported indication for the requested agent
- If Tavalisse is requested, the patient has chronic (≥ 12 months) ITP, appropriate baseline platelet criteria, and has had an inadequate response to corticosteroid, another thrombopoietin receptor agonist (e.g., Doptelet, Nplate, Promacta), immunoglobulins, splenectomy, or rituximab
- The patient’s age is within or supported for the requested indication
- The patient will NOT use the medication in combination with another agent in this program unless Nplate for HS-ARS
- The patient does NOT have any FDA-labeled contraindications
Reauthorization criteria
- The patient was previously approved for the requested agent through prior authorization
- For ITP: platelet count ≥ 50 × 10^9/L OR platelet count increased sufficiently to avoid significant bleeding
- For hepatitis C thrombocytopenia: patient initiating or maintaining interferon therapy AND platelet count ≥ 90 × 10^9/L OR increased sufficiently to initiate/maintain interferon therapy
- For other indications: patient has had clinical benefit
- The patient will NOT use the requested agent in combination with another agent in this program
- The patient does NOT have any FDA-labeled contraindications
Approval duration
12 months (BCBSIL); others vary by indication: ITP 2–6 months, Hep C 3–6 months, chronic liver disease procedure 1–3 months, severe aplastic anemia 4–6 months, HS-ARS 1 time)