Does a mandatory non-medical switch from originator to biosimilar etanercept lead to increase in healthcare use and costs? A Danish register-based study of patients with inflammatory arthritis

Abstract

ObjectivesIn year 2016, Danish national guidelines included a mandatory switch of patients with inflammatory rheumatic diseases treated with originator etanercept (ETA) to biosimilar SB4 in routine care. We aimed to explore if switching lead to increased healthcare utilisation and costs.MethodsObservational cohort study. Adult patients who switched from ETA to SB4 were identified in the Danish nationwide DANBIO registry. In the National Patient Registry, we identified health utilisation (hospital admissions/hospital days/outpatient visits/prescription medication use) and comorbidities. Estimation of health utilisation included average use and costs 1 year before/after switch, changes after the switch, and whether patient characteristics affected changes. Analyses were by adjusted two-step gamma distributed regression models, and for changes over time a generalized estimation equations (GEE) model was applied. Impact of comorbidities was explored as interaction terms in the model. Medication costs of ETA and SB4 were not included in model.Results1620 patients were included (mean age 55 years (SD 14.7), 40% male). Costs before and after switching were mainly driven by outpatient visits (67%/72% of all costs). Monthly fluctuations of costs were similar before/after switch. After switching, use (8%) and costs (7%) of outpatient services increased, whereas costs of admissions (55%) and medication (5%) decreased. Patients with longer ETA treatment duration had an increase in use and costs of healthcare resources, whereas gender and comorbidities had no impact. Higher age was associated with an increase in costs of inpatient services.ConclusionWe demonstrated no obvious changes in overall use and costs of healthcare services following switch from originator to biosimilar etanercept.

Rapid monitoring of health services utilization following a shift in coverage from brand name to biosimilar drugs in British Columbia—An interim report

“…8 Most of the increased cost was unrelated to diseases of the musculoskeletal system and connective tissue. 8 Additionally, a longer period of treatment with etanercept before the transition to the biosimilar version was associated with an increase in outpatient visits, outpatient total costs, and costs of general practitioner services after the transition. 8 Patients in Turkey who transitioned to an infliximab biosimilar, regardless of the condition indicated for treatment, 17 had higher outpatient, inpatient, and pharmacy costs than patients who continued treatment with infliximab.…”

“…[5][6][7] An increase in visits to physicians was expected for patients and physicians to discuss the transition to biosimilar drugs. 8 We present results of the analysis for the first three months after the policy's introduction.…”

A rapid monitoring plan following a shift in coverage from brand name to biosimilar drugs for rheumatoid arthritis in British Columbia

“…we also estimate that we will observe an increase in visits to physicians and specialists to discuss switching to the biosimilar products. 13 We will consider these possible effects when interpreting the results of the rapid monitoring plan. Should the plan detect a trend in the postpolicy cohort that is significantly different from the historical control data, a carefully designed assessment will be undertaken.…”

The Importance of Countering Biosimilar Disparagement and Misinformation

“…Another example of negative framing is the pervasive use of the term “non-medical switching” or “non-medical substitution” when describing the transition from reference product to a biosimilar. This phrase has been used by both publications that support this practice as well as by those that warn against it [ 38 , 45 ]. However, the terms non-medical switching and non-medical substitution actually refer to formulary-driven changes between drug options that are thought to be therapeutically equivalent, but that are very different in structure [ 46 ].…”