Subject:
Golimumab (Simponi Aria)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Golimumab (Simponi and Simponi Aria) is a human IgG1k monoclonal antibody that binds with high affinity and specificity to both the soluble and transmembrane forms of human tumor necrosis factor-α (TNF). This interaction prevents the binding of TNF-α to its receptors, thereby inhibiting biological activity of TNF-α (a cytokine protein). TNF-α is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of RA patients; in both the synovium and psoriatic plaques of patients with psoriatic arthritis and in the serum, synovium and sacroiliac joints in patients with ankylosing spondylitis.
Simponi Aria is available as an intravenous infusion, whereas Simponi is available as a subcutaneous injection. Simponi Aria is FDA approved to treat moderately to severely active Rheumatoid Arthritis (RA) in adults, in combination with methotrexate.
FDA approved indications for Simponi and Simponi Aria include:
- Moderately to severely active Rheumatoid Arthritis (RA) in adults, in combination with methotrexate
- Active Psoriatic Arthritis (PsA) in adults, alone or in combination with methotrexate
- Active Ankylosing Spondylitis in adults (AS)
- Ulcerative colitis (Simponi only)
The GO-FURTHER study evaluated the efficacy and safety of Simponi Aria in adults with rheumatoid arthritis (RA). The phase III, multicenter, double-blind, placebo-controlled trial included 592 patients diagnosed with moderately to severely active RA who had at least six tender and six swollen joints, an elevated C-reactive protein (CRP) levels, and who had been receiving background methotrexate for at least three months. Patients were randomized 2:1 to receive IV infusion of golimumab 2 mg/kg or placebo at weeks 0, 4, and then every 8 weeks; in both treatment arms, methotrexate was taken. The primary endpoint of the study was the proportion of patients having an improvement of at least 20 percent improvement in American College of Rheumatology criteria (ACR20) at 14 weeks. 59% of patients receiving golimumab (n=231/295) achieved ACR 20 versus placebo (n=49/197) at 14 weeks (a difference with 95%, CI 25.9, 41.4). As a secondary endpoint, 30% of patients receiving golimumab achieved ACR 50 compared with patients receiving placebo plus methotrexate at week 14 (difference with 95 %, CI 15.3, 27.2). Significant improvements in ACR 20 were observed as early as week 2, after a single golimumab infusion, as 33% of patients achieved an ACR 20 response versus 12 % of patients receiving placebo. Radiographic progression of the hands and feet were assessed by the change from baseline in van der Heijde-Sharp (vdH-S) scores, an X-ray measure of joint destruction, including joint erosion and joint space narrowing in which higher scores indicate greater structural damage.
The GO-VIBRANT study evaluated the safety and efficacy of golimumab in psoriatic arthritis (PsA). In this phase III, randomized, double-blind, placebo-controlled trial, adult patients were randomly assigned to receive IV placebo (n = 239) or golimumab at 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (ACR20) at week 14. As secondary endpoints, change from baseline in Health Assessment Questionnaire disability index (HAQ-DI) score at week 14, proportions of patients with ACR50 and ACR70 responses, ≥75% improvement on the Psoriasis Area and Severity Index (PASI75) at week 14, change from baseline at week 24 in the total modified Sharp/van der Heijde score (SHS) were evaluated. At week 14, an ACR20 response was achieved by 75.1% of patients in the golimumab group compared with 21.8% of patients in the placebo group (P < 0.001). Greater proportions of golimumab-treated patients had an ACR50 response (43.6% versus 6.3%), an ACR70 response (24.5% versus 2.1%), and a PASI75 response (59.2% versus 13.6%) at week 14 (P < 0.001 for all). Patients in the golimumab group had greater mean changes at week 14 in HAQ-DI score (-0.60 versus -0.12; P < 0.001).
The GO-ALIVE study evaluated the safety and efficacy of golimumab in ankylosing spondylitis (AS). In this phase III, randomized, double-blind, placebo-controlled trial, adult patients (n = 208) randomly assigned to receive IV golumumab at 2mg/kg at weeks 0, 4, and every 8 weeks or placebo at week 0, 4, and 12 with crossover to golumamb at week 16. The primary endpoint was 20% improvement in the Assessment in Anklyosing Spondylitis criteria (ASAS20). At week 16, 73% of patients receiving golimumab achieved ASAS response versus 26.2% of patients receiving placebo (p<0.001).
[INFORMATIONAL NOTE: The FDA-approved golimumab package insert has the following BLACK BOX WARNING:
Risk of serious infections:
Patients treated with Simponi and Simponi Aria 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 and Simponi Aria 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 anti-fungal 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 and Simponi Aria 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 and Simponi Aria, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, which also include Simponi and Simponi Aria ]
[INFORMATIONAL NOTE: In addition to tuberculosis, patients should also be tested for hepatitis B viral infection prior to initiation. Patients who test positive for hepatitis B virus are not contraindicated but should consult a physician with expertise in treating hepatitis B prior to initiation.]
[INFORMATIONAL NOTE: Simponi and Simponi Aria should not be initiated in patients with an active infection, including clinically significant localized infections.]
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Golimumab (Simponi Aria) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
I. Please refer to a separate policy on Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) under the Drug Section
II. Prior to starting therapy with golimumab the following must be documented:
- Member has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB; AND
- Patient is not on concurrent treatment with another biological response modifier, biologic DMARDs, or non-biologic agent (e.g apremilast); AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g. rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis
III. Golimumab (Simponi Aria), is considered medically necessary for the following when criteria are met:
A. Moderately to severely active adult rheumatoid arthritis:
1. Member has tried and failed at least a 3 month trial of ONE conventional agent such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine or has an intolerance or contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine); OR
2, Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of RA; AND
3. Prescribed in combination with methotrexate unless the member has documented contraindication or intolerance to methotrexate.
[INFORMATIONAL NOTE: The ACR 2008 recommendations on use of biological DMARDs in RA patients are based on duration, severity and prior exposure to non-biologic DMARDs.
In order to assess if a patient is a candidate for biologic DMARD therapy, RA disease activity should be measured as per the tests below:
Table 2. Disease activity cutoffs for each American College of Rheumatology-recommended disease activity measure* |
Disease activity measure | Scale | Remission | Low/Minimal | Moderate | High/severe |
| Patient-driven composite tools |
PAS | 0-10 | 0.00-0.25 | 0.26-3.70 | 3.71 to <8.0 | 8.00-10.00 |
PAS-II | 0-10 | 0.00-0.25 | 0.26-3.70 | 3.71 to <8.0 | 8.00-10.00 |
RAPID-3 | 0-10 | 0-1.0 | >1.0 to 2.0 | >2.0 to 4.0 | >4.0 to 10 |
| Patient and provider composite tool |
CDAI | 0-76 | ≤2.8 | >2.8 to 10.0 | >10.0 to 22.0 | >22.0 |
| Patient, provider, and laboratory composite tools |
DAS28 (ESR or CRP) | 0-9.4 | <2.6 | ≥2.6 to <3.2 | ≥3.2 to ≤5.1 | >5.1 |
SDAI | 0-86 | ≤3.3 | >3.3 to ≤11.0 | >11.0 to ≤26 | >26 |
| *PAS= Patient Activity Scale; RAPID-3= Routine Assessment of Patient Index Data with 3 measures; CDAI= Clinical Disease Activity Index; DAS28= Disease Activity Score with 28-joint counts; ESR= erythrocyte sedimentation rate; CRP= C-reactive protein; SDAI= Simplified Disease Activity Index |
Algorithm 1 - Once RA disease severity has been measured, they can be stratified in different treatments algorithms depending on the duration of the disease:
- Patients with Early RA (disease duration <6 months)
- Low disease activity or remission
- DMARD monotherapy is recommended
- High disease activity with poor prognostic features
- Anti-TNFá agents recommended with or without methotrexate. Infliximab is the only exception and the recommendation is to use it in combination with methotrexate, but not as monotherapy OR
- Combination DMARD therapy (including double and triple therapy)
- Patients with established RA (disease duration ≥6 months or meeting the 1987 ACR RA classification criteria)
- Low Disease Activity without Poor Prognosis
- DMARD monotherapy is recommended first-line then reassess at 3 months. If needed add methotrexate, hydroxychloroquine, or leflunomide. If after three months of intensified DMARD combination therapy or after a second DMARD has failed, the option is to add or switch to an anti-TNF biologic. If a serious adverse event occurs then it is recommended to switch to a non-TNF biologic
- Low disease activity with poor prognosis or Moderate/High Disease Activity
- Methotrexate monotherapy or combination DMARD therapy (including double and triple therapy) is recommended then reassess at 3 months.
- Add or switch to another DMARD then reassess and if needed add or switch to an anti-TNF biologic OR reassess and if needed add or switch to abatacept or rituximab
- After using either of the two options above, reassess, and if adverse effects occur switch to an anti-TNF biologic or non-TNF biologic
- Switching from DMARDs to biologic agents
- If a patient has moderate or high disease activity after 3 months of MTX monotherapy or DMARD combination therapy, as an alternative to the DMARD recommendation therapy, the panel recommends adding or switching to an anti-TNF biologic, abatacept, or rituximab
- If after 3 months of intensified DMARD combination therapy or after a second DMARD, a patient still has moderate or high disease activity, add or switch to an anti-TNF biologic
- Switching among biologic agents due to lack of benefit or loss of benefit
- If patient still has moderate or high disease activity after 3 months of anti-TNF biologic therapy and this is due to a lack of loss of benefit, switching to another anti-TNF biologic or a non-TNF biologic is recommended.]
B. Active Psoriatic Arthritis (PsA)
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- Member has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive OR
- Member has has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) OR
- Member has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months or member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine); OR
- Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of PsA
C. Active Ankylosing Spondylitis in adults (AS):
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- Member has tried and had an inadequate response to two different non-steroidal anti-inflammatory drugs (NSAIDs) used in the treatment of AS for at least a 4-week total trial or member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of ankylosing spondylitis OR
- Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of AS
IV. When golimumab (Simponi Aria) is considered medically necessary, initial therapy will be covered at the doses below based on FDA approved recommendations for a period of 12 months:
- Adult rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: 2 mg/kg IV infusion over 30 minutes at weeks 0 and 4, then maintenance therapy every 8 weeks thereafter (Simponi Aria)
[INFORMATIONAL NOTE: As per the FDA approved package insert, prior to initiating therapy, patients should be evaluated for Hepatitis B virus (HBV) risk, and if appropriate, HBV infection should be ruled out or treatment initiated.]
V. Continued therapy will be renewed annually for the following:
- Patient continues to meet initial review criteria; AND
- Absence of unacceptable toxicity from drug (e.g. serious infections, cardiotoxicity/heart failure, malignancy, demyelinating disorders, lupus-like syndrome, severe hypersensitivity reactions, severe hematologic cytopenias (e.g., pancytopenia, leukopenia, neutropenia, thrombocytopenia), etc.; AND
- Member has shown clinical improvement in signs and symptoms compared to baseline with the requested agent (i.e. slowing of disease progression or decrease in symptom severity and/or frequency
[INFORMATIONAL NOTE: As per the FDA approved package insert, there is a black box warning of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal (eg, histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab. Discontinue golimumab if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting golimumab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, of which golimumab is a member.]
VI. The combined use of golimumab (Simponi Aria) and a TNF, IL-1 inhibitor, T-cell modulator, or non-biologic agent such as apremilast, adalimumab, etanercept, abatacept infliximab, or anakinra, increases the risk of adverse events and has no additional benefit in efficacy; therefore, combination use is not medically necessary.
VII. Other uses of golimumab (Simponi Aria) are considered investigational, including but not limited to ulcerative colitis.
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon Policy. See generally: Local Coverage Article: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53049&ver=44&name=314*1&UpdatePeriod=711&bc=AQAAEAAAAAAAAA%3d%3d&.
**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Golimumab (Simponi Aria)
Simponi Aria (Golimumab)
References:
1. Simponi Aria (golimumab) Prescribing Information. Janssen Biotech Inc. Horsham, PA; September 2019.
2. Simponi(golimumab) Formulary Dossier. Centocor Ortho Biotech Inc. Horsham, PA; 2009.
3. American College of Rheumatology. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis 2008 update. Arthritis & Rheum. 2008 Jun; 59(6):762-84.
4. Inman RD, Davis JC, Van der Heijde D, et al. Efficacy and Safety of Golimumab in Patients with Ankylosing Spondylitis. Arthritis & Rheum. 2008;58:3402-12.
5. Kay J, Matteson EL, Dasgupta B, et al. Golimumab in Patients with Active Rheumatoid Arthritis Despite Treatment with Methotrexate. Arthritis & Rheum. 2008; 58: 964-75.
6. Kavanaugh A, McInnes I, Mease P, et al. Golimumab, a New Human Tumor Necrosis Factor α Antibody, Administered Every Four Weeks as a Subcutaneous Injection in Psoriatic Arthritis. Arthritis & Rheum. 2009; 60: 976-86.
7. Keystone EC, Genovese MC, Klareskog L, et al. Golimumab, a human antibody to tumour necrosis factor α given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study. Ann Rheum Dis. 2008 Nov [cited 2009 May 08] Available from: URL: http://ard.bmj.com/cgi/rapidpdf/ard.2008.099010v2
8. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology. 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis. Arthritis & Rheumatism 2008 June;59(6):762-784.
9. ClinicalTrials.gov. Golimumab in rheumatoid arthritis patients with inadequate response to etancercept (ENBREL) or adalimumab (HUMIRA). Available from: http://clinicaltrials.gov/ct2/show/NCT01004432?term=simponi&rank=1
10. ClinicalTrials.gov. A study of the effectiveness of CNTO 148 (golimumab) in patients with moderately to severely active ulcerative colitis (CRO141176). Available from: http://clinicaltrials.gov/ct2/show/NCT00487539?term=simponi&rank=4
11. ClinicalTrials.gov. A study to evaluate the safety and effectiveness of ustekinumab or golimumab administered subcutaneously (SC) in patients with sarcoidosis. Available from: http://clinicaltrials.gov/ct2/show/NCT00955279?term=simponi&rank=13
12. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
13. Altaha D, Neogi T, Silman A, et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism 2010;62(9):2569-2581.
14. Menter A, Korman N, Elmets C, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 6. Case-based presentations and evidence-based conclusions. American Academy of Dermatology Online publication, 7 February 2011.
15. Ritchlin C, Kavanaugh, Gladman D, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis 2009;68:1387-1394.
16. ClinicalTrials.gov. A study of the safety and efficacy of CNTO 148 (golimumab) in children with juvenile idiopathic arthritis (JIA) and multiple joint involvement who have poor response to methotrexate (GO KIDS). Available from: http://clinicaltrials.gov/ct2/show/NCT01230827?term=golimumab&rank=11
17. Singh JA, Furst DE, Bharat A, et al. 2012 Update of the 2008 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 (Hoboken). 2012 May;64(5):625-39.
18. Anderson J, Caplan L, Yazdany J, et al. Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice. Arthritis Care Res, 2012 May;64(5):640-47.
19. Kremer J, Ritchlin C, Mendelsohn A, et al. Golimumab, a new human anti-tumor necrosis factor α antibody, administered intravenously in patients with active rheumatoid arthritis: Forty-eight–week efcacy and safety results of a phase III randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2010;62(4):917–28.
20. Weinblatt ME, Bingham III 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. 2012. Published Online First June 1, 2012;doi:10.1136/annrheumdis-2012-201411.
21. Taylor PC, Ritchlin C, Mendelsohn A, et al. Maintenance of efcacy and safety with subcutaneous golimumab among patients with active rheumatoid arthritis who previously received intravenous golimumab. J Rheumatol. 2011;38(12):2572-80.
22. Lamberth S, Cherkas Y, Brodmerkel C, et al. Utility of Vectra-DA on assessment of rheumatoid arthritis disease activity and golimumab response: Results of a pilot study from a phase 3 trial in patients with active rheumatoid arthritis despite methotrexate therapy [abstract]. Arthritis Rheum. 2012;64(10, Suppl):S916. Abstract 2165.
23. Combe B, Dasgupta B, Louw I, et al. Efcacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs [abstract]. Arthritis Rheum. 2012;64(10, Suppl):S205. Abstract 471.
24. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
25. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.
26. 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;69(11):2151-2161.
27. Janssen Press Release. Janssen Receives Two U.S. FDA Approvals for Simponi Aria (golimumab) for the Treatment of Adults with Active Psoriatic Arthritis or Active Ankylosing Spondylitis. October 2017. Available at: https://www.jnj.com/media-center/press-releases/janssen-receives-two-us-fda-approvals-for-simponi-aria-golimumab-for-the-treatment-of-adults-with-active-psoriatic-arthritis-or-active-ankylosing-spondylitis. Accessed October 2017.
28. Clinicaltrials.gov. A Study of Golimumab in Participants With Active Ankylosing Spondylitis . Available at: https://clinicaltrials.gov/ct2/show/NCT02186873. Accessed October 2017.
29. Clinicaltrials.gov. A Study of Golimumab in Participants With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT02181673. Accessed October 2017.
30. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. doi: 10.1002/acr.22783.
31. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. pii: annrheumdis-2016-210715.
32. Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770
33. National Institute for Health and Care Excellence. NICE 2009. Rheumatoid Arthritis in Adults: Management. Published 25 February 2009. Clinical Guideline [CG79]. https://www.nice.org.uk/guidance/cg79/resources/rheumatoid-arthritis-in-adults-management-pdf-975636823525.
34. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi: 10.1002/art.38705
35. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology, vol. 71, no. 1, 2018, pp. 5–32., doi:10.1002/art.40726.
36. Micromedex® Healthcare Series. n.d. Thomson Healthcare, Greenwood Village, CO. August 2020. http://www.thomsonhc.com.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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