Doptelet — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has a baseline platelet count ≤ 30 x 10^9/L OR baseline platelet count > 30 x 10^9/L but < 50 x 10^9/L AND has symptomatic bleeding and/or an increased risk for bleeding
• AND ONE of the following:
• BOTH of the following: prescriber has stated or documented that the patient has stage four advanced, metastatic cancer AND the requested agent is used to treat the cancer or an associated condition, AND the use is consistent with best practices, supported by peer-reviewed evidence and FDA approval OR
• The patient has tried and had an inadequate response to ONE corticosteroid used for ITP OR
• The patient has an intolerance or hypersensitivity to ONE corticosteroid used for ITP OR
• The patient has a contraindication to ALL corticosteroids used for ITP OR
• The patient has tried and had an inadequate response to immunoglobulins (IVIg or anti-D) OR
• The patient has had an inadequate response to a splenectomy OR
• The patient has tried and had an inadequate response to rituximab OR
• The patient has another FDA labeled indication for the requested agent and route of administration OR
• The patient has another indication supported in compendia for the requested agent and route of administration
• For Tavalisse requests: chronic ITP lasting ≥ 12 months with platelet count criteria as above AND ONE of the following: metastatic cancer criteria as above OR inadequate response/intolerance/contraindication to corticosteroid OR inadequate response to another thrombopoietin receptor agonist (Doptelet, Nplate, Promacta) OR inadequate response to immunoglobulin IVIg/Anti-D OR inadequate response to splenectomy OR inadequate response to rituximab
• If the patient has an FDA approved indication: the patient’s age is within FDA labeling for the requested indication OR there is support for use at that age
• ONE of the following: patient will NOT use the agent with another thrombopoietin receptor agonist OR patient will use in combination ONLY if Nplate with diagnosis of HS-ARS
• Patient does NOT have any FDA labeled contraindications to the requested agent
• If member resides in Ohio AND plan is Fully Insured or HIM Shop (SG): must have no contraindication AND have FDA labeled or compendia supported indication OR prescriber submitted 2 peer-reviewed journal articles showing efficacy and safety

Reauthorization criteria

• Patient previously approved through plan prior authorization process
• AND ONE of the following:
• For ITP: platelet count ≥ 50 x 10^9/L OR platelet count increased sufficiently to avoid clinically significant bleeding
• For hepatitis C-associated thrombocytopenia: patient will initiate or maintain interferon therapy AND platelet count ≥ 90 x 10^9/L OR increased sufficiently to initiate/maintain interferon
• For other diagnoses: patient has had clinical benefit with the requested agent
• Agent not used in combination with another thrombopoietin receptor agonist
• No FDA labeled contraindications to requested agent

Approval duration

Initial: up to 12 months depending on indication and plan (ranges 1–12 months, see table); Renewal: 6–12 months depending on plan and indication