Anthem Blue Cross California Benlysta (belimumab) Form

Overview Clinical criteria Overview Coding Document history References This document addresses the use of Benlysta (belimumab) for the treatment of active, antibody-positive systemic lupus erythematosus (SLE) and active lupus nephritis, as add-on treatment to standard therapy, such as corticosteroids, antimalarials, and/or immunosuppressants. Benlysta is an IV or SC administered human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, also known as B cell activation. Only the IV formulation of Benlysta was studied and approved in the pediatric population. Dosing between the IV and SC products differs in adult patients. The American College of Rheumatology (ACR) uses the ACR classification criteria to diagnose an individual with SLE. The ACR requires 4 of these 11 criteria simultaneously or in succession for an individual to be classified as having SLE: malar rash, discoid rash, photosensitivity, oral ulcers, arthritis, serositis, renal disorders, neurological disorder, hematological disorder, immunological disorder, and anti-nuclear antibody. The SELENA-SLEDAI (Safety of Estrogens in Systemic Lupus Erythematosus National Assessment -- Systemic Lupus Erythematosus Disease Activity Index) is a system used to evaluate the activity of lupus in clinical studies. This system is used for quantification of lupus disease, primarily for the purpose of determining whether a new drug evaluated for the disease is effective. The SELENA-SLEDAI is a slightly modified version of the SLEDAI and was developed by the NIH. It is a weighted index in which signs and symptoms, laboratory tests, and physician’s assessment for each of nine organ systems are given a weighted score and summed up if present at the time of the visit or in the preceding 10 days. The maximum theoretical score for the SELENA-SEDAI is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease. Lupus nephritis (LN), or kidney inflammation, is one of the most common and serious complications of systemic lupus erythematosus (SLE), an autoimmune disease which causes widespread inflammation and tissue damage. If poorly controlled, LN may lead to irreversible kidney damage and the eventual need for dialysis or kidney transplant. BLISS (Belimumab in Subjects with SLE) study groups included adult patients with a diagnosis of SLE according the ACR, active disease with SELENA-SLEDAI score greater than or equal to 6, and anti-nuclear antibody (ANA) greater than or equal to 1:80 and/or anti-dsDNA greater than or equal to 30 IU/mL. BLISS-LN study groups included adult patients with SLE and active lupus nephritis (class III, IV, or V) confirmed by renal biopsy. In both studies, Benlysta was added to standard therapy for treatment. 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. Benlysta (belimumab) Initial requests for intravenous Benlysta (belimumab) may be approved if the following criteria are met: I. Individual has a diagnosis of Systemic Lupus Erythematosus per the American College of Rheumatology (ACR); AND A. Documentation is provided that disease is active as shown by a SELENA-SLEDAI score greater than or equal to 6 while on current treatment regimen for SLE; AND B. Documentation is provided that individual has a positive anti-nuclear antibody (ANA) titer greater than or equal to 1:80 or C. anti-dsDNA greater than or equal to 30 IU/mL; AND Individual’s SLE disease remains active while on corticosteroids, antimalarials, or immunosuppressants (alone or as combination therapy) for at least the last 30 days; AND 1 OR II. D. Individual is using in combination with standard therapy (for example, corticosteroids, antimalarials, and/or immunosuppressants [but not other biologics or IV cyclophosphamide]). Individual has Class III, IV, or V lupus nephritis showing active or chronic lesions, and confirmed by renal biopsy; AND Individual has a diagnosis of active Lupus Nephritis; AND A. B. Documentation is provided that individual has a urinary protein to creatinine ratio of greater than or equal to 1; AND C. D. Individual did not have disease progression to lupus nephritis while on Benlysta therapy for SLE without LN; AND Individual’s disease remains active while on corticosteroids, antimalarials, or immunosuppressants (alone or as combination therapy) for at least the last 30 days; AND Individual is using in combination with standard therapy (for example, corticosteroids, antimalarials, and/or immunosuppressants [but not other biologics or IV cyclophosphamide]). E. Initial requests for subcutaneous Benlysta (belimumab) may be approved if the following criteria are met: I. Individual is 18 years of age or older, and has a diagnosis of Systemic Lupus Erythematosus per the American College of Rheumatology (ACR); AND A. Documentation is provided that disease is active as shown by a SELENA-SLEDAI score greater than or equal to 6 while on current treatment regimen for SLE; AND B. Documentation is provided that individual has a positive anti-nuclear antibody (ANA) titer greater than or equal to 1:80 or C. D. anti-dsDNA greater than or equal to 30 IU/mL; AND Individual’s SLE disease remains active while on corticosteroids, antimalarials, or immunosuppressants (alone or as combination therapy) for at least the last 30 days; AND Individual is using in combination with standard therapy (for example, corticosteroids, antimalarials, and/or immunosuppressants [but not other biologics or IV cyclophosphamide]); OR II. Individual is 18 years of age or older, and has a diagnosis of active Lupus Nephritis (LN); AND Individual has Class III, IV, or V lupus nephritis showing active or chronic lesions, and confirmed by renal biopsy; AND A. B. Documentation is provided that individual has a urinary protein to creatinine ratio of greater than or equal to 1; AND C. D. Individual did not have disease progression to lupus nephritis while on Benlysta therapy for SLE without LN; AND Individual’s disease remains active while on corticosteroids, antimalarials, or immunosuppressants (alone or as combination therapy) for at least the last 30 days; AND Individual is using in combination with standard therapy (for example, corticosteroids, antimalarials, and/or immunosuppressants [but not other biologics or IV cyclophosphamide]). E. Continuation of therapy with Benlysta (belimumab IV or subcutaneous) may be approved if all of the following criteria are met: I. II. III. Documentation is provided for previous improvement in disease activity following treatment with Benlysta (belimumab) indicating a therapeutic response, including lack of disease progression to lupus nephritis while on Benlysta if initially only using for SLE without LN; AND Individual has no evidence of active central nervous system lupus (such as psychosis or seizures); AND Individual is using in combination with standard therapy (for example, corticosteroids, antimalarials, and/or immunosuppressants [but not other biologics or IV cyclophosphamide]). Benlysta (belimumab IV or subcutaneous) may not be approved for the following: I. II. III. IV. V. Individual has evidence of active central nervous system lupus (such as psychosis or seizures); OR Individual is using in combination with IV cyclophosphamide (excluding cyclophosphamide use for induction therapy), voclosporin (Lupkynis), or intravenous immunoglobulin; OR Individual is using in combination with another biologic, including rituximab or any other B cell targeted therapy, and anifrolumab-fnia (Saphnelo); OR Individual has required treatment for an acute or chronic infection within the past 60 days (NCT00424476, NCT00410384); OR Individual has human immunodeficiency virus (HIV) infection, hepatitis B virus infection, or hepatitis C virus infection (NCT00424476, NCT00410384). Approval Duration: Initial requests: 6 months Continuation requests: 1 year Quantity Limits Benlysta (belimumab) Quantity Limits Drug Limit 2 Benlysta (belimumab) 200 mg/ml prefilled autoinjector or syringe for subcutaneous use** Benlysta (belimumab) 120 mg, 400 mg vial for intravenous (IV) infusion* 4 injections per 28 days 10 mg/kg every 4 weeks Override Criteria *Initiation of therapy of Benlysta vials for IV infusion, may approve 10mg/kg dosing at 2 week intervals for the first 3 doses. ** Initiation of therapy of subcutaneous Benlysta for active lupus nephritis, for individuals not transitioning from Benlysta IV, may approve 4 additional injections for the first 4 doses (i.e., 8 injections for the first 28 days). 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 J0490 ICD-10 Diagnosis Injection, belimumab, 10 mg [Benlysta] M32.10-M32.9 Systemic lupus erythematosus (SLE) Document History Revised: 08/18/2023