Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Golimumab (Simponi Aria®) Intravenous (IV) Injection

Policy #:08.01.15d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Note: This policy only addresses Simponi Aria®, the intravenous (IV) form of golimumab, which is covered under the medical benefits of the Company when the medical necessity criteria listed in this medical policy are met. This policy does not address Simponi®, the subcutaneous form of golimumab, which may be available under any applicable pharmacy benefit.

MEDICALLY NECESSARY

ANKYLOSING SPONDYLITIS (AS)
Golimumab (Simponi Aria®) is considered medically necessary and, therefore, covered for the treatment of active ankylosing spondylitis when all of the following criteria are met:
  • The individual is at least 18 years old.
  • Documentation of failure, contraindication, or intolerance to either of the following:
    • At least a 4-week trial of two nonsteroidal anti-inflammatory drugs (NSAIDs) at maximum recommended or tolerated anti-inflammatory dose.
    • At least a 3-month trial of one disease-modifying antirheumatic drug (DMARD) (e.g., sulfasalazine, methotrexate, hydroxychloroquine).
  • Active or latent tuberculosis (TB) has been ruled out.

PSORIATIC ARTHRITIS (PsA)
Golimumab (Simponi Aria®) is considered medically necessary and, therefore, covered for the treatment of active psoriatic arthritis when all of the following criteria are met:
  • The individual is at least 18 years old.
  • Documentation of failure, contraindication or intolerance to either of the following:
    • At least a 4-week trial of any nonsteroidal anti-inflammatory drugs (NSAIDs) at maximum recommended or tolerated anti-inflammatory dose.
    • At least a 3-month trial of one disease-modifying antirheumatic drug (DMARD) (e.g., methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine).
  • Active or latent tuberculosis (TB) has been ruled out.

RHEUMATOID ARTHRITIS (RA)
Golimumab (Simponi Aria®) is considered medically necessary and, therefore, covered for the treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX) (or a different DMARD when MTX is contraindicated or the individual is intolerant (e.g., sulfasalazine, hydroxychloroquine and leflunomide) when all of the following criteria are met:
  • The individual is at least 18 years old.
  • The individual has persistent disease despite at least three months of MTX.
    • In individuals where MTX is contraindicated or the individual is intolerant to MTX, a 3-month trial of a different disease-modifying antirheumatic drug (DMARD) (e.g., sulfasalazine, hydroxychloroquine and leflunomide) is acceptable.
  • Active or latent tuberculosis (TB) has been ruled out.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for golimumab (Simponi Aria®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

Individuals should be tested for latent tuberculosis (TB) prior to receiving golimumab (Simponi Aria®). If positive, treatment for TB should be started prior to starting (Simponi Aria®). In addition, individuals should be monitored for active TB during treatment, even if the initial latent TB test is negative.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, golimumab (Simponi Aria®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Golimumab (Simponi Aria®) was approved by the FDA on July 18, 2013 for the treatment of adult individuals with moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate. Supplemental approvals for golimumab (Simponi Aria®) have since been issued by the FDA.

The safety and effectiveness of golimumab (Simponi Aria®) have not been established in the pediatric population.

Description

Tumor necrosis factor (TNF) is a naturally occurring cytokine that is involved in the inflammatory and immune responses. Elevated TNF levels in the blood, synovium, and joints have been implicated in the pathophysiology of ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis. TNF is an important mediator of the articular inflammation that is characteristic of these diseases. Golimumab (Simponi Aria®) modulated the in vitro biological effects mediated by TNF in several bioassays, including the expression of adhesion proteins responsible for leukocyte infiltration (E-selectin, ICAM-1, and VCAM-1) and the secretion of proinflammatory cytokines (IL-6, IL-8, G-CSF and GM-CSF).

Golimumab (Simponi Aria®) is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNF alpha (TNF-α). This interaction prevents the binding of TNF-α to its receptors, thereby inhibiting the biological activity of TNF, a cytokine protein.

Note: Golimumab (Simponi Aria®) is an intravenous formulation that was approved by the US Food and Drug Administration (FDA) on July 18, 2013. There is also a subcutaneous formulation that was approved by the FDA on April 24, 2009.

ANKYLOSING SPONDYLITIS (AS)

The Spondyloarthritis (SpA) category of conditions are broken down into 2 major subtypes, ankylosing spondylitis (AS) and non-radiographic axial SpA (nr-axSpA). AS is a chronic inflammatory disease manifested by back pain and progressive spinal stiffness. AS characteristically affects young adults with a peak age of onset between 20 and 30 years. Although classically thought of as a spinal disease, transient acute arthritis of peripheral joints occurs in up to 50 percent of affected individuals. In addition, other organs such as the eyes, lungs, heart, and kidneys can be affected.

The US Food and Drug Administration (FDA) approved the intravenous (I.V.) form of golimumab (Simponi Aria®) on October 20, 2017 for the treatment of adults with active ankylosing spondylitis.

The safety and efficacy of golimumab (Simponi Aria®) was studied in a phase III, randomized, double-blind, placebo-controlled trial in 208 adults with active ankylosing spondylitis had an inadequate response or intolerance to NSAIDs (Deodhar, et al, 2017). Participants were randomized (1:1) to receive I.V. infusions of golimumab (Simponi Aria®) at weeks 0, 4, 12, and every 8 weeks, or placebo at weeks 0, 4, and 12, with crossover to golimumab (Simponi Aria®) at Week 16. The primary outcome was the clinical response, measured using the American College of Rheumatology (ACR) response criteria. The results are reported as a percentage of study participants who achieve ACR20 (20 percent improvement in swollen joints) at Week 16. The results showed a statistically significant improvement in the golimumab (Simponi Aria®) group (73% of participants) when compared to the placebo group (26% of participants) (p<0.001).

PSORIATIC ARTHRITIS (PsA)

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Similarly to rheumatoid arthritis, those with PsA present with pain and stiffness in the affected joints. Morning stiffness lasting more than 30 minutes occurs in one-half of patients. The stiffness is accentuated with prolonged immobility and is alleviated by physical activity. A history of psoriasis is present in about 70 percent of patients presenting with arthritis.


The FDA approved the intravenous (I.V.) form of golimumab (Simponi Aria®), on October 20, 2017 for the treatment of adults with active psoriatic arthritis.

The safety and efficacy of golimumab (Simponi Aria®) was studied in a phase III, randomized, double-blind, placebo-controlled trial in 480 adults with active psoriatic arthritis (Kavanaugh, et al, 2017). Participants had previous received DMARD therapy (≥3 months) and/or NSAID therapy (≥4 weeks) or demonstrated intolerance to these agents. Participants were randomized (1:1) to receive golimumab (Simponi Aria®) or placebo at weeks 0, 4, 12, and 20. The primary outcome of the study was the percentage of participants who met the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 14. The results showed a statistically significant improvement in the golimumab (Simponi Aria®) group (75% of participants) when compared to the placebo group (22% of participants) (p<0.001).

RHEUMATOID ARTHRITIS (RA)

Rheumatoid arthritis (RA) is an autoimmune disease that results in a chronic and systemic inflammatory disorder that affects tissues and organs. RA can cause pain, stiffness, swelling, and limited motion and function of many joints. In RA, the focus of the inflammation is in the synovium, the tissue that lines the joint. Immune cells release inflammation-causing chemicals. These chemicals can damage cartilage (the tissue that cushions between joints) and bone.

The FDA approved an intravenous (I.V.) form of golimumab (Simponi Aria®) on July 18, 2013 for the treatment of adult individuals with moderately to severely active RA, in combination with methotrexate (MTX). The FDA's approval of golimumab (Simponi Aria®) is based upon a double-blind, placebo-controlled clinical study involving 592 individuals. The study participants were 18 years and older, with moderately to severely active RA, who were simultaneously treated with MTX. The individuals in the study were diagnosed with RA according to the American College of Rheumatology (ACR) classification criteria three months prior to the start of the study. All participants were required to have at least six swollen and six tender joints. These individuals were randomized into either the treatment group (n=395) or the placebo group (n=197). Individuals in the treatment group received golimumab (Simponi Aria®) with MTX. The golimumab (Simponi Aria®) dose regimen administered was 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The placebo group received a placebo with MTX up until week 24. After week 24, individuals in the placebo group, while still blinded, received golimumab (Simponi Aria®) and MTX through week 52.

All participants completed 52 weeks of treatment. Participants were able to continue stable doses of concurrent low-dose corticosteriods (less than or equal to 10 mg of prednisone a day). The use of other disease-modifying antirheumatic drugs (DMARDS), including cytotoxic agents or other biologics, was prohibited.

The clinical response was measured using the American College of Rheumatology (ACR) response criteria for RA. The ACR criteria are used, in most clinical trials, to assess efficacy of the treatment for RA. The results are reported as a percentage of study participants who achieve ACR20 (20 percent improvement in swollen joints), ACR50 (50 percent improvement), and ACR70 (70 percent improvement) in three of the five criteria:

  • Acute phase reactant (e.g., sedimentation rate)
  • Patient assessment
  • Physician assessment
  • Pain scale
  • Disability/functional questionnaire

Fifty-nine percent of participants in the golimumab (Simponi Aria®) and MTX group achieved an ACR20 at week 14, with 63 percent achieving ACR20 at week 24. Twenty-five percent of participants in the placebo group achieved an ACR20 at week 14, with 32 percent achieving ACR20 at week 24. A higher percentage of participants in the treatment group achieved ACR50 and ACR70 when compared to the placebo group at weeks 14 and 24.

The data revealed that treatment with golimumab (Simponi Aria®) plus MTX significantly improved signs and symptoms and physical function at week 24, and inhibited the progression of structural damage in individuals with moderate to severe RA at weeks 24 and 52. A greater percentage of individuals who received golimumab (Simponi Aria®) and MTX had improvements in their RA when compared to the placebo group.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References


Aletaha D, Neoqi T, Silman AJ, et. al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.

American College of Rheumatology. ACR Preliminary Definition of Improvement in Rheumatoid Arthritis. Arthritis & Rheumatism. Vol. 38, No. 6, June 1995.

American Hospital Formulary Service (AHFS). Drug Information 2018. Golimumab (Simponi Aria®). [Lexicomp Online Web site]. 06/19/17. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed January 4, 2018.

Bingham CO, Mendelsohn AM, Kim L, et al. Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized, placebo-controlled trial. Arthritis Care Res.2015;67:1627-1636.

Bingham CO, Weinblatt M, Han C, et al. The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial. J Rhematol.2014;41:1067-1076.

Cohen S, Cannella A. Treatment of rheumatoid arthritis in adults resistant to initial nonbiologic DMARD therapy. 09/25/17. UpToDate.[UpToDate Web site]. Available at: https://www.uptodate.com/contents/treatment-of-rheumatoid-arthritis-in-adults-resistant-to-initial-nonbiologic-dmard-therapy?source=search_result&search=rheumatoid%20arthritis%20treatment&selectedTitle=3~150 [via subscription only]. Accessed January 5, 2018.

Deodhar A, Reveille JD, Harrison DD, et al. Safety and efficacy of golimumab administered intravenously in adults with ankylosing spondylitis: results through week 28 of the GO-ALIVE study. J Rheumatol. 2017 Dec 15. pii: jrheum.170487.

Elsevier’s Clinical Pharmacology Compendium. Golimumab (Simponi Aria®). 10/30/17. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed January 4, 2018.

Felson DT, Anderson JJ, Boers M, et al. The American College of Rheumatology Preliminary Core Set Of Disease Activity Measures For Rheumatoid Arthritis Clinical Trials. Arthritis & Rheumatism.Vol. 36, No. 6. June 1993.

Gladman DD, Ritchlin C. Clinical manifestations and diagnosis of psoriatic arthritis. 08/25/17. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-psoriatic-arthritis?search=PSORIATIC%20ARTHRITIS&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1 [via subscription only]. Accessed January 5, 2018.

Gladman DD, Ritchlin C. Treatment of psoriatic arthritis. 11/27/17. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/treatment-of-psoriatic-arthritis?search=PSORIATIC%20ARTHRITIS&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H133947860 [via subscription only]. Accessed January 4, 2018.

Golimumab (Simponi Aria®). Janssen Biotech, Inc. Golimumab (Simponi Aria®) [Labeling]. 10/2017. Available at:
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf . Accessed January 4, 2018.

Jani M, Barton A, Warren RB, et al. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory disease. Rheumatology.2014;53:213-222.

Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol. 2017 Nov;69(11):2151-2161.

Kremer J, Ritchlin C, Mendelsohn A, et al. Golimumab, a new human anti-tumor necrosis factor alpha antibody, administered intravenously in patients with active rheumatoid arthritis: forty-eight-week efficacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum.2010;62:917-928.

Lexi-Drugs Compendium. Golimumab (Simponi Aria®). 12/01/17. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed January 4, 2018.

Moreland LW, Cannella A. General principles of management of rheumatoid arthritis in adults. 07/22/16. UpToDate.[UpToDate Web site]. Available at: https://www.uptodate.com/contents/general-principles-of-management-of-rheumatoid-arthritis-in-adults?source=search_result&search=rheumatoid%20arthritis%20treatment&selectedTitle=1~150 [via subscription only]. Accessed January 5, 2018.

Singh JA, Furst DE, Bharat A, et al. 2012 update of the American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res.2012;64:625-639.

Singh JA, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology guidelines for the treatment of rheumatoid arthritis. Arthritis Care Res.2016;68:1-26.

Song IH, Poddubnyy DA, Rudwaleit M, Sieper J. Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum. 2008;58(4):929-38.

Smolen JS, Landewe R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis.2014;73:492-509.

Truven Health Analytics. Micromedex® DrugDex® Compendium. Golimumab. 10/24/17. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed January 4, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Biologics License Application (BLA): 2013. Golimumab (Simponi Aria®). [FDA Web site]. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125433Orig1s000ltr.pdf Accessed January 4, 2018.

US Food and Drug Administration (FDA). Golimumab (Simponi Aria) [prescribing information]. [FDA Web site]. Original 07/18/13. Updated 02/09/18. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ . Accessed February 12, 2018.

van der Heijde D, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978-991.

van der Heijde D, Sieper J, Maksymowych WP, et al. Assessment of SpondyloArthritis international Society. 2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis. Ann Rheum Dis.;70(6):905-8.

Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2016;68(2):282-98.

Weinblatt ME, Bingham CO, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis.2013;72:381-389.

Weinblatt ME, Westhovens R, Mendelsohn AM, et al. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. 2014;73:2152-2159.

Yu DT. Assessment and treatment of ankylosing spondylitis in adults. 04/21/16. UpToDate. [UpToDate Web site]. Available at: https://www.uptodate.com/contents/assessment-and-treatment-of-ankylosing-spondylitis-in-adults?search=ANKYLOSING%20SPONDYLITIS&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H22 [via subscription only]. Accessed January 4, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

J1602 Injection, golimumab, 1mg, for intravenous use


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Golimumab (Simponi Aria®) Intravenous (IV) Injection
Description: Medically Necessary ICD-10 Codes




Policy History

Revisions from 08.01.15d
03/13/2019This policy has been reissued in accordance with the Company's annual review process.
03/07/2018This policy has undergone a routine review, and the medical necessity criteria have been revised as follows:

Two new FDA-approved indications, ankylosing spondylitis and psoriatic arthritis, have been added to this policy.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 03/07/2018
Version Issued Date: 03/07/2018
Version Reissued Date: 03/14/2019

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