Dataset Information

A Cost-Utility Analysis of Switching from Reference to Biosimilar Infliximab Compared to Maintaining Reference Infliximab in Adult Patients with Crohn's Disease.

ABSTRACT:

Background and aims

Lower-cost biosimilar infliximab may address affordability concerns in the treatment of adults with Crohn's disease (CD), however, evidence regarding the cost-effectiveness of switching from reference to biosimilar is warranted. The aim of this research was to assess the incremental cost of switching from treatment with reference infliximab to biosimilar compared with maintaining reference infliximab in adults with CD per quality-adjusted life year (QALY) gained.

Methods

A probabilistic cohort Markov model with 8-week cycle lengths was constructed to estimate the incremental costs and effects of switching over a 5-year time horizon from a public payer perspective. Base-case clinical inputs were obtained from NOR-SWITCH subgroup analyses and other published trials. Costs were obtained from Canadian sources. A total of 10,000 simulations were run. Sensitivity analysis was used to test the robustness of the results to variations in uncertain parameters.

Results

Switching to biosimilar infliximab was less costly but also less effective with incremental savings of $46,194 (95% confidence interval [CI]: $42,420, $50,455) and a loss in QALYs of -0.13 (95% CI: -0.16, -0.07). Eighty-three per cent of the simulations demonstrated incremental cost savings and an incremental loss of effectiveness. The model was sensitive to differences in rates of disease worsening between reference and biosimilar infliximab.

Conclusions

While biosimilar infliximab is associated with incremental savings for patients on maintenance therapy who are switched from reference infliximab, funding decision makers must decide whether a small loss of effectiveness is justified. Further evidence will help to inform reimbursement policy.

SUBMITTER: Hughes A

PROVIDER: S-EPMC7898373 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMultiple switches (transitions) between biosimilars of the same reference biologic are now a reality, and they are expected to become more common in the future as more biosimilars enter the market. Switching between two biosimilars of the same reference biologic is generally driven by affordability, formulary requirements, or the relocation/travel of the patient. Evidence of whether switching between biosimilars of the same reference biologic provides similar safety and efficacy profiles is reviewed here.MethodsA systematic search was undertaken using electronic databases (to December 2021): Biosis, Embase, MEDLINE, and EBM Reviews/Cochrane Database of Systematic Reviews via Ovid. Publications were evaluated for effectiveness and/or safety data linked to switching from one biosimilar to another.ResultsThe systematic search yielded 982 citations. After eliminating duplicates, 626 citations remained for the initial title/abstract screening phase. Following the initial screening, 240 records were chosen; more thorough examination yielded 35 citations. After comprehensive screening and expert advice, 23 studies were selected, of which 13 were published in peer-reviewed journals; the remainder have been published as abstracts. Overall, 3657 patients were included in these studies. All studies were observational in nature; no randomized clinical trials were identified. The studies were heterogeneous in size, design, and endpoints. Across the studies, data are provided on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns. The majority of studies examined switches between biosimilar infliximabs, although switches between biosimilar adalimumabs, etanercepts, and rituximabs were also identified. Two use-pattern studies and one case report were also detected and are discussed.ConclusionWithin the limitations of this systematic review, available data suggests that biosimilar-to-biosimilar switching is a safe and effective clinical practice, although it is not covered by current health authority regulations or guidance. No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date.