Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of romiplostim (Nplate) may be considered medically necessary when the following criteria are met:
Immune Thrombocytopenic Purpura (ITP)
- The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- Romiplostim (Nplate) must be prescribed by, or in consult with, a specialist in the individual's treated diagnosis; and
- The individual has diagnosis of immune thrombocytopenic purpura (ITP) lasting greater than three (3) months; and
- Documentation of platelet count of less than 30 x 10 9 /L; and
- The individual must have experienced an inadequate response after one of the following:
- The individual must have failed a trial of appropriate duration of a corticosteroid or immunoglobulins, as evidenced by paid claims or pharmacy print outs; or
- Rituximab; or
- The individual must have undergone a splenectomy.
Initial approval: Four (4) months
Reauthorization Criteria
Continuation of therapy with romiplostim (Nplate) may be considered medically necessary when ALL of the following are met:
- Platelet counts must have achieved greater than or equal to 50 x 10 9 /L in response to therapy (supported by documentation).
Continuation Authorization: 12 months
Hematopoietic Syndrome of Acute Radiation Syndrome
- The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational)
- Romiplostim (Nplate) must be prescribed by, or in consult with, a hematologist or oncologist.
- The individual meets one of the following:
- The individual has had a greater than or equal to two (2) gray exposure to radiation; or
- The individual has had exposure to radiation and experiencing one of the following:
- Gross blood loss; or
- greater than 10% decrease in hemoglobin; or
- Platelet count less than 50,000/microL; or
- Absolute neutrophil count less than 1000 cells/microL; or
- Absolute lymphocyte count less than 1000 cells/microL
The use of romiplostim (Nplate) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
