Study of Denmark's Mandatory Etanercept Switch Finds No Obvious Changes in Healthcare Utilization, Costs

Researchers examining the mandatory switch of patients with rheumatoid arthritis (RA) from the originator etanercept (Enbrel) to the biosimilar etanercept (Benepali) found no changes in overall healthcare utilization or cost of healthcare following the switch.

In the world of biosimilars, Denmark is famous for achieving biosimilar success in terms of uptake and reduced costs; one of its main strategies is mandatory switching, which began in 2016 with infliximab, following by etanercept in 2017.

In this observational cohort study, researchers identified adult patients in the Danish nationwide DANBIO registry with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who switched to biosimilar etanercept (n = 1620 patients, mean age 55 years, 40% male).

In the National Patient Registry, they identified healthcare utilization (defined as hospital admissions, hospital days, outpatient visits, and prescription medication use) and comorbidities.

Health utilization estimates included average use and costs 1 year before and after the switch, changes after the switch, and whether patient characteristics had any impact.

Analyses were by adjusted 2-step gamma distributed regression models, and for changes over time a generalized estimation equations (GEE) model was applied. The impact of comorbidities was explored as interaction terms in the model; medication costs of the originator and the biosimilar were not included in model.

Of the 1623 patients in DANBIO who switched, 3 patients were excluded due to data errors, leaving 1620 patients included in the analyses; a total of 848 patients (52.3%) had been treated with the reference product 5 years before index date.

Outpatient visits drove costs before and after switching, comprising 67% and 72% of all costs, respectively.

Monthly fluctuations of costs were similar before and after the switch. After switching, use (8%) and costs (7%) of outpatient services increased, while costs of admissions (55%) and medication (5%) fell.

Patients using Enbrel for a longer period of time before the switch had an increase in use in only outpatient services and costs of healthcare resources.

Gender and comorbidities had no impact, but higher age was linked with a rise in costs of inpatient services.

The authors noted that a previous study of theirs found no major changes in the number of healthcare services and the visit rate in rheumatology outpatient care 6 months after the switch to biosimilar infliximab. In addition, their other work on etanercept showed the switch had no negative impact on disease activity and flare rates within 6 months after the switch.

The current study adds to existing knowledge about switching to biosimilars by investigating the impact on healthcare use and costs.

The authors suggest that patients who have been treated with Enbrel for several years “deserve extra attention during the switch process.” Patient-related factors and non-specific drug effects seemed to affect retention to biosimilar and may be related to the nocebo effect.

Reference

Glintborg B, Ibsen R, Qwist Bilbo RE, Hetland ML, Kjellberg J. 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 (published online August 12, 2019). RMD Open. doi: 10.1136/rmdopen-2019-001016.