Estimation of cost savings between 2011 and 2014 attributed to infliximab biosimilar in the South Korean healthcare market: real‐world evidence using a nationwide database

Kim, Jiyoun; Ha, Dongmun; Song, Inmyung; Park, Haesun; Lee, Sang‐Won; Lee, Eui-Kyung; Shin, Ju Young

doi:10.1111/1756-185x.13295

Cited by 12 publications

(10 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In view of the relatively truncated development pathway with respect to that for the reference biologic, biosimilars offer potential savings on cost, and their adoption can expand patients' access to effective biologic therapy, potentially providing considerable health benefits from both a patient and a societal perspective [18][19][20][21][22][23]. Implementation of postmarketing pharmacovigilance or risk-management plans is frequently a key regulatory requirement of biosimilar manufacturers [24].…”

Section: Introductionmentioning

confidence: 99%

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

et al. 2020

View full text Add to dashboard Cite

Objective Our objective was to evaluate the long-term efficacy, safety, and immunogenicity of the infliximab biosimilar, PF-06438179/GP1111 (PF-SZ-IFX), in patients with rheumatoid arthritis (RA) who continued biosimilar treatment throughout 78 weeks or who switched from reference infliximab (Remicade ®) sourced from the EU (IFX-EU) at week 30 or week 54 in the REFLECTIONS B537-02 study. Methods In this phase III, double-blind, active-controlled study, patients with moderate-to-severe active RA were initially randomized to PF-SZ-IFX or IFX-EU, each with methotrexate (treatment period [TP] 1; N = 650). At week 30, patients receiving PF-SZ-IFX continued PF-SZ-IFX; patients receiving IFX-EU were re-randomized to continue IFX-EU or switch to PF-SZ-IFX (TP2; n = 566). From weeks 54 to 78, all patients received open-label treatment with PF-SZ-IFX (TP3; n = 505). Efficacy, safety, and immunogenicity data were analyzed during TP3. Results Efficacy was sustained and comparable across groups at week 78, with American College of Rheumatology criteria for ≥ 20% clinical improvement response rates of 75.9% (biosimilar group), 77.8% (week 30 switch group), and 68.3% (week 54 switch group). The incidence of treatment-emergent adverse events was 28.9%, 29.4%, and 30.2%, respectively. The proportion of patients who were antidrug antibody (ADA) positive and neutralizing antibody positive (as a percentage of ADA-positive patients) was stable and comparable between groups. Conclusions Results to week 78 continue to support the efficacy, safety, and immunogenicity of PF-SZ-IFX in patients with moderate-to-severe active RA. There were no clinically meaningful differences between groups, independent of a single treatment transition from IFX-EU to PF-SZ-IFX at week 30 or week 54. Trial Registration Number NCT02222493.

show abstract

Section: Introductionmentioning

confidence: 99%

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

et al. 2020

View full text Add to dashboard Cite

show abstract

“…In the Health Insurance Review and Assessment database from South Korea, drug codes for specific brand names are recorded but not released for research. As a result, researchers have presented information of biosimilars combined with respective reference biologics . Further advantages of administrative claims databases include reliable data on health care utilization outcomes, high generalizability due to inclusion of population‐based and often times nationally representative cohorts, and ease of access; however, a major limitation is the unavailability of data on important clinical measures such as disease activity scores, cancer staging, laboratory parameters, and other disease severity markers.…”

Section: Recommendations For Noninterventional Studies Of Reference Bmentioning

confidence: 99%

Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars

Desai

Kim

Curtis

et al. 2019

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

Purpose: As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real-world evidence to inform clinical practices and policy decisions. Ensuring sound methodology is critical for making valid inferences from these studies. Methods: The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) convened a workgroup consisting of academic researchers, industry scientists, and practicing clinicians to establish best practice recommendations for the conduct of noninterventional studies of biosimilar and reference biologic switching. The workgroup members participated in eight teleconferences between August 2017 and February 2018 to discuss specific topics and build consensus. Results: This report provides workgroup recommendations covering five main considerations relating to noninterventional studies describing reference biologic to biosimilar switching and comparing reference biologic to biosimilars for safety and effectiveness in the presence of switching at treatment initiation and during followup: (a) selecting appropriate data sources from a range of available options including insurance claims, electronic health records, and registries; (b) study designs; (c) outcomes of interest including health care utilization and clinical endpoints; (d) analytic approaches including propensity scores, disease risk scores, and instrumental variables; and (e) special considerations including avoiding designs that ignore history of biologic use, avoiding immortal time bias, exposure misclassification, and accounting for postindex switching. Conclusion: Recommendations provided in this report provide a framework that may be helpful in designing and critically evaluating postapproval noninterventional studies involving reference biologic to biosimilar switching.

show abstract

“…Such cost savings could significantly impact CT-P13 uptake and, consequently, healthcare budgets in many countries [11,38]. Direct medical costs for both patients and the payer were reduced following the introduction of biosimilar infliximab in the South Korean healthcare market, which could potentially be used to increase patient access to biologics [39]. Moreover, the introduction of infliximab biosimilars in the United Kingdom resulted in substantial cost-savings in the first 2 years of use [40], and considerable budget reductions are predicted for the roll out of infliximab biosimilars in other European countries [35,41].…”

Section: Ct-p13 Reference Infliximabmentioning

confidence: 99%

Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry

Kim

Lee

et al. 2019

BioDrugs

View full text Add to dashboard Cite

Objective The aim was to evaluate long-term drug retention, discontinuation, efficacy and safety of CT-P13 and reference infliximab in patients with rheumatoid arthritis (RA) enrolled in the Korean College of Rheumatology Biologics (KOBIO) registry. Methods Patients included adults with RA who received CT-P13 or reference infliximab between December 2012 and December 2017. Drug retention, efficacy (Disease Activity Score in 28 joints [DAS28]-erythrocyte sedimentation rate [ESR] or DAS28-C-reactive protein [CRP] and American College of Rheumatology [ACR] core set measure), and adverse events (AEs) were assessed over 4-years' follow-up. Results Data from 199 RA patients (CT-P13: n = 147; reference infliximab: n = 52) were analyzed. Median treatment duration was 1.22 years for CT-P13 and 1.40 years for reference infliximab (p = 0.67). Overall, 82% of patients received first-line therapy. Drug retention of CT-P13 versus reference infliximab was comparable for the overall population (p = 0.84) and for first-line (p = 0.66) and subsequent treatment lines (p = 0.96). Treatment changes or discontinuations occurred in 65.2% of patients with CT-P13 and 69.6% with reference infliximab. The most common reason for treatment changes or discontinuing treatment was lack of efficacy (CT-P13: 31.9%; reference infliximab: 34.8%). CT-P13 demonstrated comparable improvements in DAS28-ESR, DAS28-CRP and ACR responses to reference infliximab. Overall, 19 grade 3 AEs were reported for CT-P13 and eight for reference infliximab. Conclusion Long-term data from patients with RA treated in routine clinical practice in Korea showed that CT-P13 had a comparable drug retention rate to reference infliximab, with similar efficacy and an acceptable safety profile. ClinicalTrials.gov identifier NCT01965132.

show abstract

Estimation of cost savings between 2011 and 2014 attributed to infliximab biosimilar in the South Korean healthcare market: real‐world evidence using a nationwide database

Abstract: The introduction of infliximab biosimilar reduced direct medical costs for both patients and the payer, which could then be used to increase patient access to biologic medicines. The entry of infliximab biosimilar could result in further reductions in healthcare costs.

Cited by 12 publications

References 21 publications

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54–78 Data From a Randomized, Double-Blind, Phase III Trial

Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars

Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry

Contact Info

Product

Resources

About