Potential Cost-Savings From the Use of the Biosimilars in Slovakia

Tesař, Tomáš; Golias, Peter; Koblišková, Zuzana; Wawruch, Martin; Kawalec, Paweł; Inotai, András

doi:10.3389/fpubh.2020.00431

Cited by 8 publications

(10 citation statements)

References 29 publications

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“…Table 3 contains details of a number of activities by health authorities across Europe to enhance the prescribing of biosimilars and their impact. In addition, Tesar et al (2020) recently calculated that the health fund in Slovakia could have saved an estimated €35 to 50 million per year if biosimilars with marketing authorisations had been readily available and promoted [240], and such savings are likely to grow. It is imperative though that patients are involved in any switching programme to help negate any potential nocebo effect as well as provide feedback regarding any concerns with the effectiveness and safety of the biosimilars [235,241].…”

Section: Biosimilarsmentioning

confidence: 99%

Evidence-based public policy making for medicines across countries: findings and implications for the future

et al. 2021

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Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.

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Section: Biosimilarsmentioning

confidence: 99%

Evidence-based public policy making for medicines across countries: findings and implications for the future

et al. 2021

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“…Therefore, variations can be seen in the availability of biosimilars across Europe ( Kawalec et al, 2017 ). From 2016 to the middle of 2018, not a single biosimilar became available in Slovakia; in this respect, Slovakia lagged behind other V4 and other EU countries ( Tesar et al, 2020 ). This trend changed during the second half of 2018, in which six other biosimilars were reimbursed in Slovakia.…”

Section: Discussionmentioning

confidence: 99%

“…A previous study has also shown that Slovakia is one of the states within the European Union that has significant potential to improve health outcomes without increasing financial resources ( Kuenzel and Solanic, 2018 ). Therefore, it is important that we implement reimbursement practices for off-patent medicines that maximize the social benefits of generic and biosimilar medicines for patients in Slovakia ( Tesar et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

Tesař

Golias²,

Masaryková

et al. 2021

Front. Pharmacol.

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Background: The aim of this study was to investigate the impact of selected legislative initiatives and their implementation for off-patent medicinal products in Slovakia compared with the rest of the Visegrád Group (V4 countries).Methods: We analyzed the development of applications for the reimbursement of generic and biosimilar drugs. Particular emphasis was placed on a) the availability and penetration of biosimilars from 2006 to 2020 in Slovakia, b) a comparative analysis of biosimilars in V4 countries based on the national reimbursement lists of medicinal products for August 2021. Data relating to the sales of generic and biosimilar medicines in Czechia, Hungary, Poland, and Slovakia were based on the IQVIA MIDAS MAT July 2021.Results: The number of applications for the reimbursement of generic drugs decreased from 296 in 2016 to 165 in 2020. In financial terms, the sales of generic medicines in Slovakia increased from 21.7% in 2015 to 22.3% in 2020. Over the same period, the sales of generic drugs in Poland fell from 40.4% in 2015 to 35.0% in 2020, from 26.2 to 22.1% in Hungary, and from 29.6 to 20.4% in Czechia. When considering the 66 biosimilars registered by the European Medicines Agency 38 drugs (58%) were available on the Slovak market as of August 1, 2021; this compared to 32 drugs (48%) in Poland, 38 drugs (58%) in Hungary, and 40 drugs (61%) in Czechia. In financial terms, the sales of biosimilars in Slovakia increased from 0.94% in 2015 to 2.00% in 2020. Over the same period, the sales of biosimilars in Poland increased from 0.59% in 2015 to 1.29% in 2020, from 0.72 to 2.23% in Hungary, and from 0.76 to 2.15% in Czechia.Conclusion: To intensify the use of generic and biosimilar medicines, we suggest the comprehensive re-evaluation of combinations of the three-threshold entry, the amount of mandatory price reductions, and external reference pricing requirements (as the average of the three lowest prices among the official prices of a medicinal product in other Member States) for generic and biosimilar drugs. We also suggest cancellation of the exception from the fixed co-payment of the insured.

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“…Following the recent patent expiration of originator etanercept, the more affordable biosimilar versions of etanercept are available. Switching patients from originator etanercept to its biosimilars as part of routine clinical practice may result in significant public and private drug cost savings [ 5 , 6 ]. The biosimilar products Brenzys and Erelzi were approved by Health Canada in August 2016 and April 2017 respectively [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Rapid monitoring of health services use following a policy to switch patients from originator to biosimilar etanercept—a cohort study in British Columbia

et al. 2022

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Background Drug coverage policies that incentivize switching patients from originator to biosimilar products may result in significant health care savings. Our study aimed to detect early impacts on health services utilization following a mandated switch from originator to biosimilar etanercept in British Columbia (BC), Canada. Methods We conducted a prospective, population-based cohort study using linked administrative health data from BC (2010–2020). The policy cohort consisted of patients with inflammatory arthritis who used originator etanercept in 2019, prior to BC’s Biosimilars Initiative switching policy. Three historical cohorts included patients with inflammatory arthritis who used originator etanercept in the years 2016, 2017, and 2018. We compared the daily cumulative incidences of drug refills and outpatient and inpatient services between the policy and historical cohorts. A likelihood ratio sustained (≥ 31 days) at 7.1 or higher compared with the null hypothesis was chosen a priori as a threshold for a potential impact of the policy. Results Each cohort contained between 1694 and 1963 patients. We detected several potential impacts: 1) a transient increase in etanercept refills between months three and eight (cumulative incidence difference of + 3.0%); 2) an anticipated increase in visits to physicians of any specialty between months three and eight (+ 2.6%); and 3) an anticipated increase in visits to a rheumatologist from the end of month three onwards (+ 12.8%). The policy had no impact on incidences of switching to a different biologic antirheumatic drug, visits to emergency departments, or admissions to hospitals. Conclusions Only transient and/or anticipated increases in drug refills and physician visits were observed during the study period. Additional research on clinical outcomes is recommended to strengthen the evidence that no long-term unintended negative health impacts are associated with BC’s Biosimilars Initiative [switching policy].

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Potential Cost-Savings From the Use of the Biosimilars in Slovakia

Cited by 8 publications

References 29 publications

Evidence-based public policy making for medicines across countries: findings and implications for the future

Evidence-based public policy making for medicines across countries: findings and implications for the future

The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

Rapid monitoring of health services use following a policy to switch patients from originator to biosimilar etanercept—a cohort study in British Columbia

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