| Coverage Policy Manual | |
| Policy #: | 2009015 |
| Category: | Pharmacy |
| Initiated: | July 2009 |
| Last Review: | November 2023 |
|
|
|
|||||||||||
| Golimumab (e.g., Simponi Aria®) | |
|
|
|
| Description: |
Golimumab is a human monoclonal antibody specific for human tumor necrosis factor alpha (TNFa). It was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. It is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.
Golimumab binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα, which plays a role in the inflammatory process of RA, PsA, and AS.
Golimumab has a black box warning alerting prescribers to the potential for serious infections including tuberculosis (TB), bacterial sepsis, invasive fungal, and other opportunistic infections that could lead to hospitalization and/or death. Latent TB should be tested prior to initiating therapy and individuals should be monitored for active TB during treatment. Golimumab should be discontinued if individuals develop a serious infection or sepsis.
Simponi Aria® has 4 FDA labeled indications:
Regulatory Status
Golimumab (e.g., Simponi Aria®) for intravenous use received FDA approval in July 2009 for the treatment of adult individuals with moderately to severely active Rheumatoid Arthritis in combination with methotrexate. In October 2017, additional indications for psoriatic arthritis and ankylosing spondylosis were added. In September 2020, additional indications for individuals 2 years of age and older for the treatment of active psoriatic arthritis or active polyarticular juvenile idiopathic arthritis were added.
Coding
See CPT/HCPCS Code section below.
|
|
|
|
|
Policy/ Coverage: |
The use of Golimumab (e.g., Simponi Aria) subcutaneous injection is not covered under the medical benefit. Please check member’s pharmacy benefit for coverage of Golimumab subcutaneous injection.
The use of Golimumab intravenous injection (J1602) is covered under medical benefit.
Effective April 01, 2022 Prior Approval is required for golimumab.
The Step Therapy Medication Act is applicable to fully-insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective December 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab intravenous injection meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes when dosed in accordance with FDA approved labeling for intravenous AND when the following criteria are met based on diagnosis:
RHEUMATOID ARTHRITIS
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 1 year:
ANKYLOSING SPONDYLITIS
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 1 year:
ADULT PSORIATIC ARTHRITIS (PsA)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 1 year:
JUVENILE PSORIATIC ARTHRITIS
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 1 year:
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 1 year:
Policy Guidelines
Dosage and Administration
Dosing per FDA Guidelines
Adult individuals indicated for RA, PsA, AS: 2mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks.
Pediatric individuals 2 years of age and older indicated for pJIA and PA: 80mg/square meters intravenous infusion over 30 minutes at weeks 0 and 4, and then every 8 weeks.
Golimumab is available as 50 mg/mL (12.5 mg/mL) solution in a single-dose vial.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Golimumab, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, Golimumab, for any other use indication or circumstance not described above, is considered. Investigational services are specific contract exclusions in certificate of coverage.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
Golimumab intravenous injection meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes when dosed in accordance with FDA approved labeling for intravenous AND when the following criteria are met based on diagnosis:
CONTINUATION OF THERAPY for 12 months:
Dosage and Administration
Dosing per FDA Guidelines
Adult individuals indicated for RA, PsA, AS: 2mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks.
Pediatric individuals 2 years of age and older indicated for pJIA and PA: 80mg/square meters intravenous infusion over 30 minutes at weeks 0 and 4, and then every 8 weeks.
Golimumab is available as 50 mg/mL (12.5 mg/mL) solution in a single-dose vial.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
Golimumab, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, Golimumab, for any other use indication or circumstance not described above, is considered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biologic agents (i.e., Enbrel, Humira, Kineret, Cimzia, Remicade, etc.) does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective April 1, 2022 to October 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab intravenous injection meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for intravenous AND when the following criteria are met based on diagnosis:
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
Moderate to severe rheumatoid arthritis (RA)
Individual is 18 years of age or older and has a diagnosis of moderate to severely active RA AND
Active psoriatic arthritis (PsA)
Individual 2 years of age or older has a diagnosis of moderate to severe PsA AND
Active ankylosing spondylitis (AS)
Individual 18 years of age or older has a diagnosis of active AS AND
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Individual is 2 years of age or older and has a diagnosis of pJIA AND
CONTINUATION OF THERAPY for 12 months:
Dosage and Administration
Adult patients indicated for RA, PsA, AS: 2mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks.
Pediatric patients 2 years of age and older indicated for pJIA and PA: 80mg/m2 intravenous infusion over 30 minutes at weeks 0 and 4, and then every 8 weeks.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
Golimumab for any other use does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Golimumab for any other use is considered investigational and is not covered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biologic agents (i.e. Enbrel, Humira, Kineret, Cimzia, Remicade, etc) does not meet primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2021 to March 31, 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab intravenous injection meets member benefit certificate Primary Coverage Criteria that
there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for intravenous AND when the following criteria are met based on diagnosis:
Moderate to severe rheumatoid arthritis (RA)
Member is 18 years of age or older and has a diagnosis of moderate to severely active RA AND
Active psoriatic arthritis (PsA)
Member 2 years of age or older has a diagnosis of moderate to severe PsA AND
2. Member has had an inadequate response to conventional DMARD (i.e. methotrexate, sulfasalazine, or leflunomide) (Singh, 2018) OR
3. Member has an intolerance or contraindication to conventional DMARDs 2. (Singh, 2018)
Active ankylosing spondylitis (AS)
Member 18 years of age or older has a diagnosis of active AS AND
2. Member has experienced an inadequate response to continuous treatment with at least two non-steroidal anti-inflammatory drugs (NSAIDs) (Deodhar, 2018) OR
3. Member has an intolerance or contraindication to NSAIDs (Deodhar, 2018)
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Member is 2 years of age or older and has a diagnosis of pJIA AND
Dosage and Administration
Adult patients indicated for RA, PsA, AS: 2mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks.
Pediatric patients 2 years of age and older indicated for pJIA and PA: 80mg/m2 intravenous infusion over 30 minutes at weeks 0 and 4, and then every 8 weeks.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
Golimumab for any other use does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Golimumab for any other use is considered investigational and is not covered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biologic agents (i.e. Enbrel, Humira, Kineret, Cimzia, Remicade, etc) does not meet primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2020 to October 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab intravenous injection meets member benefit certificate Primary Coverage Criteria that
there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for intravenous AND when the following criteria are met based on diagnosis:
Moderate to severe rheumatoid arthritis (RA)
Member is 18 years of age or older and has a diagnosis of moderate to severely active RA AND
Active psoriatic arthritis (PsA)
Member 2 years of age or older has a diagnosis of moderate to severe PsA AND
Active ankylosing spondylitis (AS)
Member 18 years of age or older has a diagnosis of active AS AND
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Member is 2 years of age or older and has a diagnosis of pJIA AND
Dosage and administration
Adult patients indicated for RA, PsA, AS: 2mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks.
Pediatric patients 2 years of age and older indicated for pJIA and PA: 80mg/m2 intravenous infusion over 30 minutes at weeks 0 and 4, and then every 8 weeks.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
Golimumab for any other use does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Golimumab for any other use is considered investigational and is not covered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biologic agents (i.e. Enbrel, Humira, Kineret, Cimzia, Remicade, etc) does not meet primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit
certificates of coverage.
Effective January 2019 to October 2020
The use of Simponi® is covered under pharmacy benefits.
The use of Simponi Aria® (J1602) is covered under medical benefits.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab (Simponi®) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for SQ use for patients with a diagnosis of:
Golimumab (Simponi Aria®) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for intravenous use for patients with a diagnosis of:
Dosage and administration
Covered under pharmacy benefit
Covered under the medical benefit
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Golimumab (Simponi) for any other use does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Golimumab (Simponi) for any other use is considered investigational and is not covered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biologic agents (i.e. Enbrel, Humira, Kineret, Cimzia, Remicade, etc) does not meet primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective November 2018
The use of Simponi® (J3490) is covered under pharmacy benefits.
The use of Simponi Aria® (J1602) is covered under medical benefits.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab (Simponi®) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for SQ use for patients with a diagnosis of:
Golimumab (Simponi Aria®) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for intravenous use for patients with a diagnosis of:
Dosage and administration
Covered under pharmacy benefit
Covered under the medical benefit
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Golimumab (Simponi) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Golimumab (Simponi) is considered investigational and is not covered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biologic agents (i.e. Enbrel, Humira, Kineret, Cimzia, Remicade, etc) does not meet primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective July 2018
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab (Simponi) meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for SQ or IV preparation for patients with a diagnosis of:
Dosage and administration
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Golimumab (Simponi) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, Golimumab (Simponi) is considered investigational and is not covered. Investigational services are specific contract exclusions in certificate of coverage.
Concomitant use of other biological disease-modifying antirheumatic drugs (DMARDs) does not meet primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective January 2015
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Golimumab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness when dosed in accordance with FDA approved labeling for SQ or IV preparation for patients with a diagnosis of:
*Note: For use in rheumatoid arthritis, it must be used in combination with methotrexate.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Concomitant use of other biological disease-modifying antirheumatic drugs (DMARDs) does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Any other use of golimumab does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness. For contracts without Primary Coverage Criteria, any other use of golimumab is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
Effective June 2013 – December 2014
Golimumab meets member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness for patients with a diagnosis of:
Concomitant use of other biological disease-modifying antirheumatic drugs (DMARDs) does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Doses above 50 mg (0.5 mL) every four weeks do not meet Primary Coverage Criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, this use is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Any other use of golimumab does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness. For contracts without Primary Coverage Criteria, any other use of golimumab is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
Effective prior to June 2013
Golimumab meets member benefit contract Primary Coverage Criteria for effectiveness for patients with a diagnosis of:
For rheumatoid arthritis, it must be used in combination with methotrexate.
Concomitant use of other biological disease-modifying antirheumatic drugs (DMARDs) does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
Doses above 50 mg (0.5 mL) every four weeks do not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
Any other use of golimumab does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use of golimumab is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
|
|
|
|
| Rationale: |
This policy was initially developed in response to the FDA approval of this drug.
Simponi®
Patients with RA, PsA and AS treated with golimumab 50 mg and MTX had approximately 52%, 36% and 21% higher mean steady-state trough concentrations of golimumab, respectively compared with those treated with golimumab 50 mg without MTX. The presence of MTX also decreased anti-golimumab antibody incidence from 7% to 2%. The small number of patients positive for antibodies to golimumab limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures. For RA, golimumab should be used with MTX. In the PsA and AS trials, the presence or absence of concomitant MTX did not appear to influence clinical efficacy and safety parameters.
The FDA approved dosing for golimumab is 50 mg administered by subcutaneous (SC) injection once a month. In the clinical trials, it was given once every four weeks. For RA it should be given in combination with MTX. For PsA and AS, MTX is not required to be given concomitantly. Treatment with corticosteroids, non-biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs), and/or NSAIDs may be continued during golimumab treatment.
In the submitted clinical trials for RA, there was no clear evidence of improved ACR response with the higher golimumab dose groups (100 mg) compared to the lower golimumab dose groups (50 mg). In two of the RA clinical trials the golimumab monotherapy groups were not statistically different from the MTX monotherapy groups in ACR responses. In the submitted clinical trial for PsA, there was no clear evidence of improved ACR response with the higher golimumab dose group (100 mg) compared to the lower golimumab dose group (50 mg). In the submitted clinical trial for AS, there was no clear evidence of improved ASAS response with the higher golimumab dose group (100 mg) compared to the lower golimumab dose group (50 mg).
Population pharmacokinetic analyses showed there is no need to adjust the dosage of golimumab based on a patient’s weight or gender. No formal study of the effect of renal or hepatic impairment on the pharmacokinetics of golimumab was conducted. Safety and effectiveness of golimumab in pediatric patients less than 18 years of age have not been established. There were no differences in adverse effects or serious infections in the patient population older than 65 years compared to those younger than 65 years old.
Golimumab is intended for use under the guidance and supervision of a physician. After proper training in SC injection technique, a patient may self-inject if a physician determines that it is appropriate.
Simponi Aria®
1. RA - A large-scale, Phase 3, double-blind, placebo-controlled study involving 592 patients
GO-FURTHER: : 59% of patients receiving treatment with Simponi Aria plus methotrexate versus 25% of patients receiving placebo plus methotrexate a difference with 95% (CI 25.9, 41.4) experienced significant improvements in signs and symptoms at week 14, as demonstrated by at least 20% improvement in American College of Rheumatology criteria (ACR 20 – a standard measure used to assess clinical improvement in RA), the study's primary endpoint. A higher proportion of patients receiving SIMPONI ARIA plus methotrexate achieved at least a 50 percent improvement in ACR criteria (ACR 50) compared with patients receiving placebo plus methotrexate at week 14 (30 percent versus 9 percent, respectively, a difference with 95 percent CI 15.3, 27.2).
2. PsA & AS - Two large-scale, pivotal Phase 3 studies involving more than 600 patients:
a. GO-VIBRANT (PsA): 75% of patients > 18 years of age receiving Simponi Aria, compared with 22% of patients receiving placebo (P < 0.001), achieved at least a 20% improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with Simponi Aria resulted in the inhibition of the progression of structural joint damage and improvement in physical function associated with PsA at week 24.
b. GO-ALIVE (AS): 73% of patients > 18 years of age receiving Simponi Aria, compared with 26% of patients receiving placebo (P < 0.001), achieved at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16 (ASAS20 - a standard measure used to asses clinical improvement in AS.
3. pJIA – A multicenter, open-label, single-arm study in 127 children (2 to <18 years of age) with pJIA with active polyarthritis despite treatment with methotrexate for at least 2 months. All patients received SIMPONI ARIA 80 mg/m2 as an intravenous infusion at Week 0, 4, and every 8 weeks through Week 52. Patients continued stable doses of MTX weekly
through Week 28. The efficacy was generally consistent with responses in patients with RA.
2012 Update
A literature search was conducted through May 2012. There was no new literature or changes in the FDA approval that would prompt a change in the coverage statement.
2013 Update
In May 2013, golimumab received FDA approval for use in moderate to severe ulcerative colitis with an inadequate response or intolerance to prior treatment or when continuous steroid use is required. The coverage statement has been changed to include this new indication.
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Bingham and colleagues reported a randomized, multicenter, double-blind, placebo-controlled, phase III trial (Bingham, 2014). Adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0, Week 4, and every 8 weeks thereafter. All patients continued stable oral MTX (15-25 mg/wk). HRQOL assessments included Health Assessment Questionnaire-Disability Index (HAQ-DI; physical function), Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary (SF-36 PCS/MCS) scores, EQ-5D assessment of current health state, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire, and disease effect on productivity [10-cm visual analog scale (VAS)].
Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12, Week 16, and Week 24, and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001). Improvements in physical function, HRQOL, fatigue, and productivity significantly correlated with disease activity improvement. In active RA, IV golimumab + MTX significantly improved physical function, HRQOL, fatigue, and productivity using multiple measurement tools; all correlated with improvements in disease activity (NCT00973479, EudraCT 2008-006064-11).
van der Heijde and colleagures reported on a phase III GO-RAISE trial (van der Heijde, 2014); 356 patients were randomized to placebo with crossover to golimumab 50 mg at Week 24 (n = 78), golimumab 50 mg (n = 138), or golimumab 100 mg (n = 140) at baseline and every 4 weeks. The proportions of patients with ASDAS major improvement (improvement ≥ 2.0) or inactive disease (score < 1.3) were determined. HRQOL was assessed using the 36-item Medical Outcomes Study Short Form-36 physical/mental component summary (SF-36 PCS/MCS) scores (normal score ≥ 50). The effect of disease on productivity was assessed by visual analog scale (0-10). Regression analyses on the association of disease activity and HRQOL were performed. The final assessment was at Week 104. Significantly greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease at weeks 14 and 24 versus placebo. Through Week 104, patients who achieved ASDAS inactive disease or major improvement had significantly greater improvements in SF-36 PCS and MCS scores and productivity than did patients not meeting these targets. Among all patients, achieving ASDAS inactive disease at weeks 52 and 104 was associated with normalized SF-36 PCS/MCS scores and significant improvements in work productivity.
Ongoing Clinical Trial
(NCT 01900574) an industry sponsored or cosponsored trial. A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients with Moderate to Severe Active Ulcerative Colitis; planned enrollment 35; completion date August 2023.
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
A literature search conducted through January 2019 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
The efficacy of golimumab intravenous solution in pediatric patients with polyarticular juvenile idiopathic arthritis was based on pharmacokinetic exposure and extrapolation of data from golimumab intravenous solution in rheumatoid arthritis patients. Efficacy was also assessed in a multicenter, open-label, single-arm study in 127 patients (2 to < 18 years of age) with JIA with active polyarthritis despite treatment with methotrexate for at least 2 months. Patients received golimumab 80mg/m2 as an intravenous infusion at Week 0, 4, and every 8 weeks through Week 52. Patients could continue methotrexate doses. The efficacy was generally consistent with responses in patients with RA.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
The phase 3, double-blind, GO-ALIVE study randomized patients to IV golimumab 2 mg/kg at weeks 0 and 4 and then every 8 weeks through week 52, or placebo at weeks 0, 4, and 12 with crossover to IV golimumab at week 16. Clinical efficacy was assessed by ≥20% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS20), ≥50% improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), and Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 (inactive disease). Using self-reported duration of inflammatory back pain (IBP), patients were grouped into quartiles: first = ED and fourth = LD. Descriptive statistics summarized efficacy and safety findings through 1 year.
Early disease patients (n = 60) were ~10 years younger and had shorter median AS (IBP) symptom duration (2-3 years) versus LD patients (n = 52; 21-24 years). At week 16, numerically higher proportions of golimumab- than placebo-treated patients achieved ASAS20 (ED: 71% vs. 32%; LD: 67% vs. 21%), BASDAI 50 (ED: 40% vs. 12%; LD: 33% vs. 7%), and ASDAS <1.3 (ED: 17% vs. 4%; LD 8% vs. 0%) regardless of IBP duration. Efficacy was durable through 1 year of treatment; however, response rates were numerically higher in patients with ED versus LD. Through week 60, adverse events and serious adverse events, respectively, were reported by 46% and 3% of ED patients and 61% and 2% of LD patients.
Prompt diagnosis of AS and early treatment with IV golimumab may yield more robust improvements in disease activity. (Deodhar AA, Shiff NJ, Gong C, et.al., 2022)
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| References: |
Atul Deodhar, John D. Reveille, et al.(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 Dec 2017, jrheum.170487; DOI: 10.3899/jrheum.170487 Bingham CO 3rd, Weinblatt M, Han C, et al.(2014) 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 Rheumatol. 2014 Jun;41(6):1067-76. doi: 10.3899/jrheum.130864. Epub 2014 May 1. ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US).(2020) Identifier NCT02277444, A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (GO-VIVA); 2014 October 29 [cited 2020 November 24]. https://www.clinicaltrials.gov/ct2/show/results/NCT02277444?term=golimumab&cond=Polyarticular+Juvenile+Idiopathic+Arthritis&draw=2&rank=2 Deodhar A, Reveille J, Harrison D, et al.(2018) Safety and efficacy of golimumab administered intravenously in adults with ankylosing spondylitis: results through week 28 of the GO-ALIVE study. J of Rheumatology. March 2018 DOI: https://doi.org/10.3899/jrheum.170487 Deodhar AA, Shiff NJ, Gong C, Hsia EC, Lo KH, Kim L, Xu S, Reveille JD.(2022) Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study. J Clin Rheumatol. 2022 Aug 1;28(5):270-277. doi: 10.1097/RHU.0000000000001853. Epub 2022 Jun 1. PMID: 35653615; PMCID: PMC9336574. Fraenkel L, Bathon JM, England BR, et.al.(2021) 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. 2021;0(0)1-16. DOI:10.1002/acr.24596 Kavanaugh A, Husni E, Harrison, D. et al.(2017) Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: Results through week 24 of the GO-VIBRANT study. Arthritis and Rheumatology. Vol. 69, No 11, November 2017, pp. 2151-2161. Ringold S, Angeles-Han ST, Beukelman T, et. al.(2019) 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care & Research. 2019;71(6)717-734. DOI:10.1002/acr.23870. Ringold S, Weiss PF, Beukelman T, et al.(2013) Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Arthritis & Rheumatism. 2013;65:2499-2512 Siingh, Jasvinder A, et al.(2018) “2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.” Arthritis & Rheumatology, 71(1), 2018, pp. 5–32. Simponi Aria (golimumab) package insert Janssen Biotech, Inc Simponi prescribing information. Horsham, PA: Centocor Ortho Biotech, Inc; April 2009. Singh JA, Guyatt G, Ogdie A, et al.(2018) 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology. 2018;71(1)5-32. DOI:10.1002/art.40726 Singh JA, Saag KG, Bridges SL Jr, et al.(2016) 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatology. 2016;68(1)1-26. van der Heijde D, Deodhar A, Braun J, et al.(2014) The effect of golimumab therapy on disease activity and health-related quality of life in patients with ankylosing spondylitis: 2-year results of the GO-RAISE trial. J Rheumatol. 2014 Jun;41(6):1095-103. doi: 10.3899/jrheum.131003. Epub 2014 Apr 15. Ward, M, et al.(2019) “2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis Arthritis & Rheumatology, 71(10), pp.1599-1613. Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al.(2017) 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. |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
|