CAM 063

Golimumab (Simponi) for subcutaneous use

Category:Prescription Drug   Last Reviewed:January 2021
Department(s):Medical Affairs   Next Review:January 2022
Original Date:January 2014    

Description:
Simponi is a recombinant human monoclonal antibody specific for human tumor necrosis factor alpha (TNFα).  Simponi neutralizes the biological activity of TNFα and inhibits binding of TNFα with its receptors.  TNF, a naturally occurring cytokine, mediates inflammation and modulates cellular immune responses.  Increased levels of TNF are found in the synovial fluid of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).  TNF has an important role in both the pathologic inflammation and the joint destruction that are characteristic of these diseases. 

Simponi is indicated for the following uses:

  • treatment of adults with moderately to severely active RA in combination with methotrexate (MTX); AND
  • treatment of adults with active PsA either alone or in combination with MTX or other non-biologic disease modifying antirheumatic drugs (DMARDs); AND
  • treatment of adults with active AS either alone or in combination with MTX or other non-biologic DMARDs; AND
  • inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, and achieving and sustaining clinical remission in induction responders  in adults with moderate-to-severe ulcerative colitis (UC) who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

Policy:
Rheumatoid Arthritis
The use of Golimumab (Simponi) may be considered MEDICALLY NECESSARY for the treatment of Rheumatoid Arthritis when the following criteria is met:

  • Patient is 18 years of age or older; and
  • Patient has moderately to severely active rheumatoid arthritis; and
  • Golimumab (Simponi) is used in combination with methotrexate unless there is a contraindication to taking methotrexate or a history of methotrexate intolerance; and
  • Patient has failed treatment to one or more disease-modifying anti-rheumatic drugs (DMARDs); and
  • Patient has failed treatment with adalimumab (Humira®) or etanercept (Enbrel®) after two months of use; and
  • Patient has a negative purified protein derivative (PPD) test prior to treatment. 

Psoriatic Arthritis
The use of Golimumab (Simponi) for the treatment of Psoriatic Arthritis may be considered MEDICALLY NECESSARY when the following criteria is met:. 

  • Patient is 18 years of age or older; and
  • Patient has active psoriatic arthritis; and
  • Golimumab (Simponi) is used alone or in combination with methotrexate; and
  • Patient has failed treatment to one or more disease-modifying anti-rheumatic drugs (DMARDs); and
  • Patient has failed treatment with Humira or Enbrel after two months of use; and
  • Patient has a negative purified protein derivative (PPD) test prior to treatment. 

Ankylosing Spondylitis
The use of Golimumab (Simponi) may be considered MEDICALLY NECESSARY when the following criteria is met: 

  • Patient is 18 years of age or older; and
  • Patient has active ankylosing spondylitis; and
  • Patient has failed treatment with at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or has documented contraindications to non steroidal anti-inflammatory drug usage; and
  • Patient has failed treatment with adalimumab (Humira) or etanercept (Enbrel) after two months of use; and 
  • Patient has a negative purified protein derivative (PPD) test prior to treatment. 

Ulcerative Colitis
The use of Golimumab (Simponi) may be considered MEDICALLY NECESSARY when the following criteria is met:  

  • Patient is 18 years of age or older; and
  • Patient has moderately to severely active ulcerative colitis; and
  • Patient has demonstrated corticosteroid dependence OR has failed treatment with oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine; and
  • Patient has failed treatment with adalimumab (Humira®)after two months of use; and
  • Patient has a negative purified protein derivative (PPD) test prior to treatment. 

Note: The FDA approved prescribing information recommends: 

  • Simponi should not be prescribed with other biologic products approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or ulcerative colitis (including, but not limited to tumor necrosis factor blockers, anakinra, and abatacept). 

Use of Golimumab (Simponi) for indications other than those listed above is considered INVESTIGATIONAL. 

Use of Golimumab (Simponi) if the criteria for the indications listed above are not met is considered NOT MEDICALLY NECESSARY.  

NOTE:  Please see CAM 149 Simponi ARIA for intravenous indications and uses. 

Rationale:
Simponi is a tumor necrosis factor (TNF) blocker approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC). Tumor necrosis factor is a naturally occurring cytokine that is involved with the inflammatory and immune responses. Excessive activation of immune effector cells and overproduction of TNF can cause severe inflammation and tissue damage. Inhibition of TNF activity in certain inflammatory diseases may alleviate symptoms and prevent disease progression. 

Simponi is a human IgG1қ monoclonal antibody specific for human tumor necrosis factor-α (TNF- α) that binds to both the soluble and transmembrane bioactive forms of human TNF-α. This interaction prevents the binding of TNF-α to its receptors, thereby inhibiting the biological activity of TNF-α (a cytokine protein). Elevated TNF-α levels in the blood, synovium and joints have been implicated in the pathophysiology of several chronic inflammatory diseases such as RA, PsA and AS. TNF-α is an important mediator of the articular inflammation that is characteristic of these diseases. 

Simponi is the first anti-TNF agent administered subcutaneously (SC) and dosed once a month for the treatment of RA, PsA and AS and has a loading period for UC followed by a monthly dose. The Simponi drug product is a sterile solution of the golimumab antibody supplied as either a single dose prefilled syringe (with a passive needle safety guard) or a single dose prefilled autoinjector. Simponi does not contain preservatives. The solution is clear to slightly opalescent, colorless to light yellow with a pH of approximately 5.5. Simponi is provided in one strength: 

  • 50mg of the golimumab antibody in 0.5mL of solution. Each 0.5mL of Simponi contains 50mg of the golimumab antibody, 0.44mg of L-histidine and L-histidine monohydrochloride monohydrate, 20.5mg of sorbitol, 0.08mg of polysorbate 80 and Water for Injection. 

Disease-Modifying Anti-Rheumatic Drugs (DMARDS)
Disease-modifying anti-rheumatic drugs are used as a second line defense for the treatment of RA, AS, PsA and lupus. These drugs slow the disease process by modifying the immune system: 

  • Methotrexate
  • Cyclosporine
  • Sulfasalazine
  • Mercaptopurine
  • Gold Compounds 

For patients with RA, Simponi should be given in combination with methotrexate (MTX) and for patients with PsA or AS, Simponi may be given with or without MTX or other non-biologic DMARDs. For patients with RA, PsA, UC or AS, corticosteroids, non-biologic DMARDs, and/or non steroidal anti-inflammatory drugs (NSAIDs) may be continued during treatment with Simponi. 

Rheumatoid Arthritis
Simponi, in combination with MTX, has been shown to improve RA signs and symptoms according to the American College of Rheumatology (ACR) responses, including tender and swollen joint count, pain, physician and patient global assessment scores, as well as disability index (HAQ-DI), and acute markers of inflammation, compared to MTX alone. Simponi + MTX efficacy in these parameters has been observed in MTX-naïve, MTX inadequate responders and patients previously treated with ≥ anti-TNF agent. Simponi dosing for RA is 50mg subQ once per month 

Psoriatic Arthritis
Available data from a Phase III clinical trial (GO-REVEAL) including patients with active PsA who had an inadequate response to NSAIDS or DMARDS suggests that Simponi provides dramatic improvement in both arthritis and psoriasis symptoms. Substantial efficacy of Simponi in patients with PsA has been observed using a dose of 50mg once monthly, with or without concomitant MTX, significantly reduced clinical signs and symptoms of PsA. 

Ankylosing Spondylitis 
Available data from a Phase III clinical trial (GO-RAISE) including adult patients with active AS despite current or previous NSAID or DMARD therapy suggests that Simponi provides dramatic improvement in spondylitis symptoms, including total back pain and morning stiffness as well as improvement in patient’s global assessment of disease activity and physical function according to the BASFI. Substantial efficacy of Simponi in patients with AS has been observed using a dose of 50mg once monthly. Results of this study indicate that Simponi significantly reduced clinical signs and symptoms of AS. Simponi dosing for AS is 50mg subQ once per month. 

Ulcerative Colitis
Available date from Phase III trials (UC-1 and UC-2) in adult patients with moderately to severely active ulcerative colitis show that a greater proportion of patients achieved clinical response, clinical remission and had improvement of endoscopic appearance of the mucosa. Simponi dosing for UC is 200mg subq at week 0, followed by 100mg at week 2, and then 100mg every 4 weeks. 

FDA or Other Governmental Regulatory Approval
U.S. Food and Drug Administration (FDA) 

Simponi is a TNF blocker indicated for the treatment of adult patients with: 

  • Moderately to severely active RA, in combination with MTX.
  • Active PsA, alone or in combination with MTX.
  • Active AS.
  • Moderately to severely active ulcerative colitis. 

WARNING RISK OF SERIOUS INFECTIONS
Patients treated with Simponi are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. 

Simponi should be discontinued if a patient develops a serious infection. 

Reported infections include: 

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Simponi use and during therapy. Treatment for latent infection should be initiated prior to Simponi use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens. 

The risks and benefits of treatment with Simponi should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Simponi, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

References:

  1. Food and Drug Administration .Labeling of the Drug Simponi www.fda.gov
  2. FDA Simponi Formulary Dossier
  3. Oldfield V, Plosker GL. Golimumab: in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. BioDrugs. 2009; 23(2):125-35.
  4. Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, Papp K, Zrubek J, Mudivarthy S, Mack M, Visvanathan S, Beutler A. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009 Apr; 60(4):976-86.
  5. Keystone EC, Genovese MC, Klareskog L, Hsia EC, Hall ST, Miranda PC, Pazdur J, Bae SC, Palmer W, Zrubek J, Wiekowski M, Visvanathan S, Wu Z, Rahman MU; GO-FORWARD Study. Golimumab, a human antibody to tumour sic necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2009 Jun; 68(6):789-96. Epub 2008 Dec 9.
  6. Inman RD, Davis JC Jr, Heijde D, Diekman L, Sieper J, Kim SI, Mack M, Han J, Visvanathan S, Xu Z, Hsu B, Beutler A, Braun J. Arthritis Rheum. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. 2008 Nov; 58(11):3402-12.
  7. Hutas G. Golimumab, a fully human monoclonal antibody against TNF alpha. Curr Opin Mol Ther. 2008 Aug; 10(4):393-406.
  8. Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, Pendley C, Jiao Q, Shankar G, Marciniak SJ, Cohen SB, Rahman MU, Baker D, Mascelli MA, Davis HM, Everitt DE. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol. 2007 Mar; 47(3):383-96.

Coding Section

Codes   Number    Description   
HCPCS   J1602 Injection, Golimumab, 1 mg, for Intravenous use  
  J3490 Unspecified code  
ICD-9 Diagnosis  556.0 Ulcerative (Chronic) Enterocolitis  
  556.1 Ulcerative (Chronic) Ileocolitis  
  556.2 Ulcerative (Chronic) Proctitis  
  556.3 Ulcerative (Chronic) Proctosigmoiditis  
  556.4 Pseudopolyposis of Colon  
  556.5 Left-Sided Ulcerative (chronic) Colitis  
  556.6 Universal Ulcerative (Chronic) Colitis  
  556.8 Oher Ulcerative Colitis  
  556.9 Ulcerative Colitis, unspecified  
  696.0 Psoriatic Arthropathy  
  696.1 Other Psoriasis  
  714.0 Rheumatoid Arthritis  
  714.2 Other Rheumatoid Arthritis with Visceral or Systemic Involvement  
  714.30 Polyarticular Juvenile Rheumatoid Arthritis, Chronic or Unspecified  
  714.31 Polyarticular Juvenile Rhematoid Arthritis, Acute  
  714.32 Pauciarticular Juvenile Rheumatoid Arthritis  
  714.33 Monoarticular Juvenile Rheeumatoid Arthritis  
  720.0 Ankylosing Spondylitis  
  V13.4 Personal History of Arthritis  
  V82.1 Screening for Rheumatoid Arthritis  
ICD-10-CM (effective 10/01/15) K5180  Other ulcerative colitis without complications   
  K5190  Ulcerative colitis, unspecified, without complications   
  K5120 Ulcerative (chronic) proctitis without complications   
  K5130  Ulcerative (chronic) rectosigmoiditis without complications   
  K5140  Inflammatory polyps of colon without complications   
  K5150  Left sided colitis without complications   
  K5100  Ulcerative (chronic) pancolitis without complications   
  L4054  Psoriatic juvenile arthropathy   
  L4059  Other psoriatic arthropathy   
  L400  Psoriasis vulgaris   
  L401  Generalized pustular psoriasis   
  L402  Acrodermatitis continua   
  L403  Pustulosis palmaris et plantaris   
  L404  Guttate psoriasis   
  L408  Other psoriasis   
  M069 Rheumatoid arthritis, unspecified   
  M0530  Rheumatoid heart disease with rheumatoid arthritis of unspecified site   
  M0560  Rheumatoid arthritis of unspecified site with involvement of other organs and systems   
  M061  Adult-onset Still's disease   
  M0800  Unspecified juvenile rheumatoid arthritis of unspecified site   
  M083  Juvenile rheumatoid polyarthritis (seronegative)   
  M0840  Pauciarticular juvenile rheumatoid arthritis, unspecified site   
  M459  Ankylosing spondylitis of unspecified sites in spine   
  Z8739  Personal history of other diseases of the musculoskeletal system and connective tissue   
  Z13828  Encounter for screening for other musculoskeletal disorder   

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/19/2021 

Annual review, no change to policy intent. 

01/27/2020 

Annual review. Added under Ankylosing Spondylitis statement patient has failed at least 2 non-steroidal anti-inflamatory drugs. No change to policy intent. 

01/03/2019 

Annual review, no change to policy intent. 

01/08/2018 

Annual review, no change to policy intent. 

01/23/2017 

Annual review, no change to policy intent. 

05/02/2016 

Removed "aria" from title. 

1/11/2016 

Annual Review. No significant changes. Please Review for Approval. 

11/04/2015 

Change Category from Medicine to Prescription Drug 

09/212/2015 

Added ICD-10 coding 

03/29/2015 

Title change to Golimumab (Simponi Aria)

01/12/2015 

Annual review. Added coding. No change to policy intent.

12/11/2013

NEW POLICY


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