Anthem Blue Cross California Nplate (romiplostim) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Nplate (romiplostim). Nplate is a thrombopoietin (TPO) receptor agonists primarily used in the treatment of children and adults with immune thrombocytopenia, an autoimmune disorder that can cause uncontrolled bleeding if left untreated. Immune thrombocytopenia (ITP) is also called idiopathic thrombocytopenia purpura and immune thrombocytopenia purpura, which is an acquired autoimmune disorder characterized by low platelet counts caused by autoantibodies against platelet antigens. According to the National Institutes of Health, ITP occurs in approximately 1 in every 16,000 adults, causing unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Nplate is FDA approved for the treatment of thrombocytopenia in individuals with ITP who had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is FDA indicated for the following: • Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. • Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. • Adults and pediatrics (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]. Limitations of Use per label: • Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP • Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding • Nplate should not be used in an attempt to normalize platelet counts. Per specialty committee consensus opinion, ongoing treatment with Nplate (romiplostin) may be used to maintain an adequate platelet count (50 – 100 X 109/L) to decrease the risk of bleeding. For platelet count greater than 100,000/mm3, dose adjustments can be made using a cut-off platelet level of 100,000/mm3 as a substitute for 200,000/mm3 in the FDA dosage and administration recommendations. The NCCN Drugs and Biologics Compendium and NCCN Clinical Practice Guideline offers a Category 2A recommendation for the treatment of individuals with lower risk MDS disease with severe or refractory thrombocytopenia using romiplostim following disease progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial. “Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very low, low, intermediate)”. NCCN also provides a 2A recommendation for use of Nplate in chemotherapy-induced thrombocytopenia with the goal of allowing resumption of chemotherapy regimen when the benefits outweigh the risks. Definitions and Measures Aplastic anemia: A condition that occurs when the body stops producing enough new blood cells. Immune thrombocytopenia: A bleeding disorder where the blood is unable to clot, as a result of a low number of platelets or thrombocytes. The International Prognostic Scoring System (IPSS): IPSS is the most widely used prognostic classification system for myelodysplastic syndrome (MDS). The IPSS-R is the revised international prognostic scoring system in MDS to better predict outcomes in newly 1 diagnosed patients. The WHO classification-based Prognostic Scoring System (WPSS) allows for dynamic estimation of prognosis at multiple time points during the course of MDS. Maintenance therapy: Designed to maintain a condition to prevent a relapse. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. Nplate (romiplostim) Initial requests for Nplate (romiplostim) for ITP may be approved if the following criteria are met: I. Individual has a diagnosis of immune (idiopathic) thrombocytopenia (ITP) and the following are met: A. Documentation is provided that individual has a platelet count of less than 30 x 109/L or active bleeding (ASH, 2011; Hicks B. et al., 2014); AND Individual has had a prior trial and insufficient response to one of the following confirmed: 1. Corticosteroids; OR 2. 3. Splenectomy; Immunoglobulins (for example IVIg or anti-D); OR Continuation requests for Nplate (romiplostim) for ITP may be approved if the following criteria are met: I. Individual has a diagnosis of ITP and the following are met: A. Documentation is provided that individual has demonstrated a response to therapy as confirmed by increased platelet counts; AND B. Continuation of treatment is to maintain an adequate platelet count (50 – 100 X 109/L)* to decrease the risk of bleeding. Approval Duration for ITP: Initial requests: 6 months Continuation requests: 12 months Initial requests for Nplate (romiplostim) for MDS may be approved if the following criteria are met: I. II. Documentation is provided that individual has a diagnosis of lower risk myelodysplastic syndrome (MDS) [Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), WPSS (Very low, low, intermediate)] (NCCN 2A); AND Individual has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents or immunosuppressive therapy. Continuation requests for Nplate (romiplostim) for MDS may be approved if the following criteria are met (NCCN MDS V3.2021): I. Documentation is provided that individual has demonstrated a clinically significant response to therapy, such as an increase in platelet counts, decrease in bleeding events, or reduction in need for platelet transfusions. Approval Duration for MDS: Initial requests: 6 months Continuation requests: 12 months Requests for Nplate (romiplostim) for HS-ARS may be approved if the following criteria are met: I. II. Individual a diagnosis of Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS] (i.e., acute exposure to myelosuppressive doses of radiation); AND Individual has suspected or confirmed exposure to radiation levels greater than 2 gray (Gy). Approval Duration for HS-ARS: 1 single administration per episode Initial requests for Nplate (romiplostim) for CIT may be approved if the following criteria are met (NCCN 2A): I. II. III. Individual has a diagnosis of chemotherapy-induced thrombocytopenia (CIT); AND Individual meets one of the following criteria: A. B. Individual was using a cytotoxic chemotherapy agent that is known to cause thrombocytopenia; AND Individual has platelets less than 100 x 109/L for at least 3 weeks following the last chemotherapy administration; OR Individual has platelets less than 100 x 109/L and there are delays in chemotherapy related to thrombocytopenia; AND 2 IV. The goal of therapy is to maintain the dosing schedule and/or intensity of the chemotherapy regimen when such benefit outweighs the potential risks. Continuation requests for Nplate (romiplostim) for CIT may be approved if the following criteria are met: I. Individual has a diagnosis of CIT and the following are met: A. B. Continuation of treatment is to maintain an adequate platelet count (100 - 150 X 109/L) to allow for the resumption of Individual has demonstrated a response to therapy as confirmed by increased platelet counts; AND chemotherapy regimen as appropriate. Approval Duration for CIT: Initial requests: 6 months Continuation requests: 12 months Nplate (romiplostim) may not be approved for the following: I. II. Individual is using to normalize platelet counts; OR Individual is requesting for the treatment of low platelet count caused by any condition other than those conditions listed above; OR III. When the above criteria are not met and for all other indications. Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J2796 ICD-10 Diagnosis Injection, romiplostim, 10 micrograms [Nplate] D46.0-D46.9 Myelodysplastic syndromes D69.3 Immune thrombocytopenic purpura D69.41-D69.49 Other primary thrombocytopenia Document History Revised: 05/19/2023