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Tavalisse — Blue Cross Blue Shield of Kansas

severe aplastic anemia

Initial criteria

  • The patient will use the requested agent as first-line treatment AND the patient will use the requested agent in combination with standard immunosuppressive therapy (antithymocyte globulin [ATG] AND cyclosporine) OR
  • The patient has tried and had an inadequate response to BOTH ATG AND cyclosporine OR has intolerance/hypersensitivity/contraindication to BOTH ATG AND cyclosporine OR
  • The patient has persistent or chronic ITP (≥3 months) AND platelet count ≤30 x 10^9/L OR 30–50 x 10^9/L with symptomatic bleeding or increased bleeding risk AND has tried/intolerance/contraindication to corticosteroid(s) OR inadequate response to immunoglobulins (IVIg or anti-D) OR inadequate response to splenectomy OR inadequate response to rituximab OR
  • The patient has another FDA labeled indication or a compendia-supported indication for the requested agent and route of administration OR
  • If the requested agent is Alvaiz (eltrombopag), the patient must have either (a) hepatitis C associated thrombocytopenia with platelet count <75 x 10^9/L when initiating interferon therapy or risk for discontinuing interferon due to thrombocytopenia, OR (b) severe aplastic anemia meeting specified blood and marrow criteria AND inadequate response/intolerance/contraindication to BOTH ATG AND cyclosporine OR
  • If the requested agent is Tavalisse (fostamatinib disodium hexahydrate), patient must have chronic ITP (≥12 months) AND platelet count ≤30 x 10^9/L OR 30–50 x 10^9/L with symptomatic bleeding or increased bleeding risk AND has tried/intolerance/contraindication to corticosteroid(s) OR inadequate response to another thrombopoietin receptor agonist (e.g., Doptelet, Nplate, Promacta) OR inadequate response to immunoglobulins (IVIg or Anti-D) OR inadequate response to splenectomy OR inadequate response to rituximab.
  • The patient’s age is within FDA labeling or supported in compendia for requested indication AND
  • The requested agent will NOT be used in combination with another agent in this program AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

  • Patient has previously been approved for the requested agent through plan’s PA process (except new cases as defined).
  • For ITP: platelet count ≥50 x 10^9/L OR platelet count has increased sufficiently to avoid clinically significant bleeding OR
  • For hepatitis C associated thrombocytopenia: patient initiating or maintaining hepatitis C therapy with interferon AND platelet count ≥90 x 10^9/L OR platelet count increased sufficiently to initiate or maintain interferon therapy OR
  • For other indications: patient has had clinical benefit with the requested agent.
  • The requested agent is NOT used in combination with another agent in the program AND
  • The patient has no FDA labeled contraindications to the requested agent.

Approval duration

Doptelet: 1 month (thrombocytopenia in chronic liver disease before procedure); 6 months (all other indications); Mulpleta: 1 month (thrombocytopenia in chronic liver disease before procedure); 6 months (all other indications); Promacta: ITP 2 months; HCV thrombocytopenia 3 months; first-line severe aplastic anemia 6 months; other severe aplastic anemia 4 months; all other indications 6 months; Alvaiz: ITP 2 months; HCV thrombocytopenia 3 months; severe aplastic anemia 4 months; all other indications 6 months; Tavalisse: 6 months; Reauthorization: hepatitis C 6 months; all others 12 months