Doptelet (avatrombopag tablets) — Medica

Initial criteria

• Immune thrombocytopenia, chronic or persistent: approve for 3 months if ALL of the following are met:
• Patient meets ONE of the following: (a) platelet count < 30 x 10^9/L (< 30,000/mcL); OR (b) BOTH: platelet count < 50 x 10^9/L (< 50,000/mcL) AND at increased risk of bleeding according to prescriber
• Patient has tried at least ONE other therapy (e.g., systemic corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin, eltrombopag olamine [Promacta, generic], Alvaiz, Nplate, Tavalisse, rituximab) OR has undergone splenectomy
• Medication is prescribed by or in consultation with a hematologist
• Thrombocytopenia in chronic liver disease: approve for 5 days if ALL of the following are met:
• Patient age ≥ 18 years
• Current platelet count < 50 x 10^9/L (< 50,000/mcL)
• Patient is scheduled to undergo a procedure within 10 to 13 days after starting Doptelet therapy

Reauthorization criteria

• Immune thrombocytopenia, chronic or persistent: approve for 1 year if BOTH are met:
• According to the prescriber, patient demonstrates a beneficial clinical response (e.g., increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes)
• Patient remains at risk for bleeding complications

Approval duration

3 months for initial, 1 year for reauthorization (ITP); 5 days (chronic liver disease)