Promacta (eltrombopag olamine) — Medica

Initial criteria

• For aplastic anemia (Promacta): Approve for 4 months if ALL: patient has low platelet counts at baseline (<30 x 10^9/L); AND patient has tried at least one immunosuppressant (e.g., cyclosporine, Atgam, mycophenolate mofetil, or sirolimus) OR will be using eltrombopag with standard immunosuppressive therapy; AND medication prescribed by or in consultation with a hematologist.
• For aplastic anemia (Alvaiz): Approve for 4 months if ALL: age ≥ 18 years; AND low platelet counts at baseline (<30 x 10^9/L); AND patient has tried at least one immunosuppressant OR will use eltrombopag with standard immunosuppressive therapy; AND prescribed by or in consultation with a hematologist.
• For immune thrombocytopenia (Promacta): Approve for 3 months if ALL: platelet count < 30 x 10^9/L OR platelet count < 50 x 10^9/L with increased bleeding risk; AND patient has tried at least one other therapy (e.g., corticosteroids, IVIG, anti-D, Nplate, Tavalisse, Doptelet, rituximab) OR undergone splenectomy; AND prescribed by or in consultation with a hematologist.
• For immune thrombocytopenia (Alvaiz): Approve for 3 months if ALL: age ≥ 6 years; AND platelet count < 30 x 10^9/L OR platelet count < 50 x 10^9/L with increased bleeding risk; AND patient has tried at least one other therapy OR undergone splenectomy; AND prescribed by or in consultation with a hematologist.
• For thrombocytopenia with chronic hepatitis C (Promacta): Approve for 1 year if ALL: low platelet counts at baseline (<75 x 10^9/L); AND patient will receive interferon-based therapy for chronic hepatitis C; AND prescribed by or in consultation with gastroenterologist, hepatologist, or infectious disease specialist.
• For thrombocytopenia with myelodysplastic syndrome (Promacta): Approve for 3 months if ALL: low- to intermediate-risk MDS; AND platelet count <30 x 10^9/L OR <50 x 10^9/L with increased bleeding risk; AND prescribed by or in consultation with hematologist or oncologist.
• For thrombocytopenia post-allogeneic transplant (Promacta): Approve for 3 months if ALL: patient has poor graft function; AND platelet count <50 x 10^9/L; AND prescribed by or in consultation with hematologist, oncologist, or transplant specialist.

Reauthorization criteria

• For aplastic anemia: Approve for 1 year if, per prescriber, patient demonstrates a beneficial clinical response (e.g., increased platelets, reduced transfusions, hemoglobin/neutrophil increase).
• For immune thrombocytopenia: Approve for 1 year if, per prescriber, patient has a beneficial response (increased or maintained platelets, fewer bleeding episodes) AND remains at risk for bleeding complications.
• For thrombocytopenia with chronic hepatitis C: Continue if patient remains on interferon-based therapy and initially met criteria.
• For thrombocytopenia with myelodysplastic syndrome: Approve for 1 year if, per prescriber, beneficial response (increased or stable platelets, fewer bleeds) AND remains at risk for bleeding.
• For thrombocytopenia post-allogeneic transplant: Approve for 6 months if, per prescriber, patient demonstrated beneficial clinical response (increased or maintained platelets, fewer bleeding episodes).

Approval duration

Varies by indication (3 months, 4 months, 6 months, or 1 year per above).