Economic impact of industry-sponsored clinical trials of pharmaceutical products in Austria

Walter, E.; Eichhober, G.; Voit, M.; Baumgartner, Christian; Celedin, Alexander; Holzhauser, Christa; Mraz, Bernhard; Ornauer, C.; Pleiner-Duxneuner, Johannes; Ponner, Botond; Presch, Isabella; Pum, Georg; Tieben, H.; Weingartmann, G.; Baltic, Dejan; Bonitz, Wolfgang; Kaehler, S.

doi:10.1080/13696998.2020.1728977

Cited by 8 publications

(12 citation statements)

References 10 publications

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“…The total reported cost savings ranged from €4,601 (97 patients in CT) to €212.5 million (14,370 patients in CT). Finally, three studies [ 25 , 32 , 38 ] were able to provide projected annual cost avoidance estimates on a national scale, which averaged to €217.7 million per year. As evidenced in Table 1 , studies were included that reported total costs for multiple pathologies and multiple clinical trial phases.…”

Section: Resultsmentioning

confidence: 99%

The economic impact of compassionate use of medicines

Jommi

Pantellini

Stagi

et al. 2021

BMC Health Serv Res

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Background Compassionate use programs (CUP) for medicines respond to the ethical imperative of providing access to medicines before marketing approval to patients not recruited in trials. The economic impact of clinical trials has previously been investigated. No evidence on the net economic benefit of CUP exists. This research aims to address this information gap by estimating the economic consequences of 11 CUP in Italy conducted between March 2015 and December 2020 from the perspective of public health care system in Italy (National Health Service). Eight programs concern cancer treatments, two refer to spinal muscular atrophy, and one is indicated for multiple sclerosis. Methods Since CUP medicines are covered by the industry, the net economic benefit includes: (i) avoided costs of the Standard of Care (SoC) the patients would have received had they not joined the CUP, (ii) costs not covered by the pharmaceutical industry sponsor, but instead sustained by payers, such as those associated with adverse events (only severe side effects resulting in hospitalisation and attributable to CUP medicines), and (iii) costs for combination therapies and diagnostic procedures not used with the SoC. The SoC costing relied on publicly available data. Information on adverse events and diagnostic procedures was retrieved from the CUP and monetized using the relevant fee for episode or service. One CUP was excluded since a SoC was not identified. Results 2,713 patients were treated in the 11 CUP where a SoC was identified. The SoC mean cost per patient ranged from €11,415 to €20,299. The total cost of the SoC ranged between €31.0 and €55.1 million. The mean cost per patient covered by hospitals hosting CUP was equal to €1,646, with a total cost of €4.5 million. The net economic benefit ranged €26.5 million - €50.6 million. Conclusions Despite research limitations, this paper illustrates for the first time the net economic impact of CUP from a public payer perspective. It is important to integrate these estimates with the prospective effects of CUP implementation, i.e., the economic value of the comparative benefit profile of medicines used in CUP versus the SoC, including effects from a societal perspective.

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Section: Resultsmentioning

confidence: 99%

The economic impact of compassionate use of medicines

Jommi

Pantellini

Stagi

et al. 2021

BMC Health Serv Res

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“…Recent studies indicate that every € invested in clinical trials by the pharmaceutical industry generates between 1.95 and 2.50 € of added value for the economy as a whole ( Walter et al, 2020 ), ( Grueber, 2015 ) along positive effects on employment, with the use of highly specialised professional profiles, both medical and managerial. Indeed, the aforementioned study estimated the “employment multiplier” effect of clinical research being 1.66.…”

Section: Introductionmentioning

confidence: 99%

Economic impact of industry-sponsored clinical trials in inflammatory bowel diseases: Results from the national institute of gastroenterology “Saverio de Bellis”

et al. 2022

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Introduction: The majority of the money spent on possible new medications’ clinical trials is accounted for by the innovative pharmaceutical sector, which also stimulates the economy of a nation. The objective of this study was to evaluate the impact of pharmaceutical industry-sponsored clinical trials (ISCTs) in inflammatory bowel diseases (IBDs) towards the national health service (NHS) in terms of avoided costs and leverage effect.Methodology: The research was conducted at National Institute of Gastroenterology, “Saverio De Bellis”, Castellana Grotte (Apulia, Italy) collecting data from profit ISCTs of pharmaceutical products conducted over the time period 2018-2020 with focus on inflammatory bowel diseases. After the quantification of health services and drug costs from the latter studies, avoided costs and leverage effects were then estimated.Results: The results on the avoided costs for healthcare facilities deriving from the conduct of clinical studies show that, in relation to the sample of five drug companies participating in our 2018-2020 analysis, out of a total of 235,102.46 €, identified as direct investment, 628,158.21 € of avoided costs for the NHS were measured, with an additional saving (leverage effect) for the NHS of 3.67 € for each € invested by the companies promoting clinical trials.Conclusion: Conducting profit clinical trials has practical benefits and a favourable macroeconomic impact that, by completing its limited resources, helps to sustain one country NHS thanks to the avoided costs while also contributing to locational and industrial policy while guaranteeing novel therapeutics and health services for the patients enrolled.

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“…This study also indicated that industry sponsored clinical trials (ISCTs) are not only beneficial for the advancement of healthcare and science but they have positive effects on the society's economy. In fact, the study concluded that every euro spent on ISCTs approximately doubles its value in the overall economy 12 . Despite many economic benefits to the countries due to CTs studies, according to CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials 13 there are serious concerns about possible bias due to funding these studies by pharmaceutical industry.…”

mentioning

confidence: 99%

“…The study by Walter et al in the June 2020 issue of Journal of Medical Economics, demonstrated that in Austria the total gross production value of performing industry sponsored CTs was almost e116.22 million in 2018. Pharmaceutical companies' investment in supporting CTs studies generated the added value of e144.2 million in 2018 12 . This study also indicated that industry sponsored clinical trials (ISCTs) are not only beneficial for the advancement of healthcare and science but they have positive effects on the society's economy.…”

mentioning

confidence: 99%

“…These participants would need extra health care service which might impose additional financial burden to the economy. Finally, since the study was performed over a relatively long timespan, adding a sensitivity analysis would contribute to the study robustness 12 . As SNA evaluates budgets based on retrospective datasets, the representativeness of the observed data is important.…”

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confidence: 99%

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