|57894-0350-XX SIMPONI ARIA 50MG/4ML Solution (JANSSEN BIOTECH)|
Golimumab is a human IgG1K monoclonal antibody specific for tumor necrosis factor alpha (TNFα), a cytokine protein. It is considered an immune modulator and TNF-blocker. Golimumab binds to bioactive forms of human TNFα and inhibits their biological activity by preventing them from binding to their receptors. Elevated TNFα levels are found in the blood, synovium, and joints in multiple chronic inflammatory conditions.
Golimumab for intravenous infusion for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ankylosing Spondylitis (AS)
Psoriatic Arthritis (PsA)
Rheumatoid Arthritis (RA)
Golimumab for intravenous infusion for the treatment for the treatment of other conditions/diseases is considered investigational.
Golimumab for intravenous infusion is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual has been screened and evaluated for the presence of ALL of the following prior to initiating treatment:
Latent TB infection
Hepatitis B virus (HBV)
Active infection, including clinically important localized infections
Individual will not receive live vaccines while receiving agent
Individual is not on concurrent treatment with another TNF inhibitor, a biologic response modifier or non-biologic agent (e.g., apremilast, tofacitinib, baricitinib)
Physician has assessed baseline disease severity utilizing an objective measure/tool
Diagnosis of ANY ONE of the following:
Ankylosing Spondylitis (AS) if ALL of the following:
Documented active disease
Adequatetrial and failure of minimum of TWO (2) non-steroidal anti-inflammatory agents (NSAIDS) unless use is contraindicated
Psoriatic Arthritis (PsA) if ALL of the following:
Disease is ANY ONE of the following:
Predominantly axial disease OR active enthesitis and/or dactylitis after an adequate trial with failure of at least TWO (2) non-steroidal anti-inflammatory agents (NSAIDs) unless use is contraindicated
Peripheral arthritis after a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, or hydroxychloroquine
Rheumatoid Arthritis (RA) if ALL of the following:
Documented moderate to severe active disease
Minimum 3 month trial and failure of previous therapy with one oral disease modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine sulfate, penicillamine, sulfasalazine or leflunomide
Treatment in combination with methotrexate unless contraindicated
Golimumab for intravenous infusion is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug, e.g., severe infections, cardiotoxicity/heart failure, neurotoxicity, lupus-like syndrome, malignancy, demyelinating disorders, severe hypersensitivity reactions, severe hematologic cytopenias, including but not limited to, pancytopenia, leukopenia, neutropenia, thrombocytopenia, etc.
Ongoing monitoring for TB and other infections
Disease response as indicated for ANY ONE of the following:
Ankylosing Spondylitis by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool (e.g., ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI])
Psoriatic Arthritis by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool (i.e., defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria [PsARC], one of which must be joint tenderness or swelling score, with no worsening in any of the four criteria.)
Rheumatoid Arthritis by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool (e.g. an improvement on a composite scoring index such as Disease Activity Score-28 [DAS28] of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 [ACR20] criteria)
DOSAGE & ADMINISTRATION
2 mg/kg intravenous infusion at weeks 0, and 4, then every 8 weeks thereafter
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information)..
Deodhar, A., Reveille, J. D., Harrison, D. D., Kim, L. Lo, K., Leu, J. H., Hsia, E. C. (2017). Safety and efficacy of golimumab administered intravenously in adults with ankylosing spondylitis: results through week 28 of the GO-ALIVE study. The Journal of Rheumatology. Retrieved January 11, 2018 from http://www.jrheum.org/content/early/2017/12/18/jrheum.170487.
Kavanaugh, A., Husni, M. E., Harrison, D. D., Kim, L., Lo, K. H., Leu, J. H., Hsia, E., C. (2017, October). Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis and Rheumatology, 69 (11), 2151-2161.
Lexicomp Online. (2019). AHFS DI. Golimumab. Retrieved September 5, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, June). Golimumab. Retrieved September 5, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, February). Center for Drug Evaluation and Research. Simponi Aria® (golimumab) injection for intravenous use. Retrieved September 5, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/4/2013
MOST RECENT REVIEW DATE: 10/8/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg