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Promacta (eltrombopag olamine tablets and oral suspension - Novartis, generic) — Cigna

Thrombocytopenia in a patient with chronic hepatitis C

Initial criteria

  • Aplastic Anemia: Approve for 4 months if ALL of the following: (i) Patient has low platelet counts at baseline (pretreatment) (example: platelet count < 30 x 10^9/L); AND (ii) EITHER (a) Patient had tried at least one immunosuppressant therapy OR (b) Patient will be using eltrombopag in combination with standard immunosuppressive therapy; AND (iii) The medication is prescribed by or in consultation with a hematologist.
  • Immune Thrombocytopenia: Approve for 3 months if ALL of the following: (i) EITHER (a) Patient has a platelet count < 30 x 10^9/L OR (b) BOTH (1) Patient has a platelet count < 50 x 10^9/L AND (2) Patient is at increased risk for bleeding; AND (ii) EITHER (a) Patient has tried at least one other therapy (examples: systemic corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin, Nplate, Tavalisse, Doptelet, rituximab) OR (b) Patient has undergone splenectomy; AND (iii) The medication is prescribed by or in consultation with a hematologist.
  • Thrombocytopenia in a Patient with Chronic Hepatitis C: Approve for 1 year if ALL of the following: (A) Patient has low platelet counts at baseline (pretreatment) (example: platelet count < 75 x 10^9/L); AND (B) [criteria continue beyond this section].

Reauthorization criteria

  • Aplastic Anemia: Approve for 1 year if, according to the prescriber, the patient demonstrates a beneficial clinical response (examples: increases in platelet counts, reduction in red blood cell transfusions, hemoglobin increase, and/or absolute neutrophil count increase).
  • Immune Thrombocytopenia: Approve for 1 year if BOTH (i) According to the prescriber, the patient demonstrates a beneficial clinical response (examples: increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes); AND (ii) Patient remains at risk for bleeding complications.

Approval duration

4 months (initial Aplastic Anemia); 3 months (initial ITP); 1 year (reauth or chronic hepatitis C)