Economic Impact of Clinical Research to Research Centers and Opportunity Cost for the Reimbursement System in Turkey

Kockaya, G.; Demir, Meral; Kockaya, P. Daylan; Tatar, Mehtap; Üresin, Ali Yağız

doi:10.4236/health.2015.79128

Cited by 5 publications

(7 citation statements)

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“…The mean cost to treat an event of grade 3 nausea was € 12135 and the mean cost to treat an event of grade 3-4 thrombocytopenia was € 3678 when including hospitalization costs. [7,8,9] were able to provide projected annual cost avoidance estimates on a national scale which average 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: Clinical Trial Datamentioning

confidence: 99%

The Economic Impact of Compassionate Use of Medicines

Jommi¹,

Pantellini²,

Stagi³

et al. 2021

Preprint

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BACKGROUND: Compassionate use programs (CUP) for medicines respond to the ethical imperative of providing earlier access to medicines to patients not recruited in trials. While the economic impact of clinical trials has been already investigated, no evidence on the net economic benefit of CUP exists. This research aims to fill the information gap by estimating the economic consequences of 11 CUP in Italy conducted between May 2015 and December 2020 from the perspective of health care payers. Eight programs concern cancer treatments, two refer to drugs for spinal muscular atrophy, and one is indicated for multiple sclerosis.METHODS: The net economic benefit includes the avoided costs from the Standard of Care (SoC) the patients would have received if they had not joined the CUP, and costs not covered by the pharmaceutical industry but instead sustained by payers, such as those associated to adverse events (only severe sides effects resulting in hospitalisation and attributed to CUP medicines), and 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: 2,712 patients were treated in the 11 CUP, where SoC was identified. The SoC mean cost per patient ranges 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 from €26.5 million to €50.6 million (€17.8 million - €42.0 million for cancer treatments). CONCLUSIONS: Despite research limitations, this paper illustrates for the first time the net economic impact of CUP in oncology patients from a 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: Clinical Trial Datamentioning

confidence: 99%

The Economic Impact of Compassionate Use of Medicines

Jommi¹,

Pantellini²,

Stagi³

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…The total reported avoided costs ranged from €4,601 for 97 patients to €212.5 million for 14,370 patients. Finally, three studies [7,8,9] were able to provide projected annual cost avoidance estimates on a national scale which average 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: Introductionmentioning

confidence: 99%

Economic impact of compassionate use of medicines.

Jommi

Pantellini

Stagi

et al. 2021

JCO

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e18840 Background: The economic impact of clinical trials in the perspective of trial sites has been already investigated. Instead, there is no evidence on the economic net benefit of compassionate use programs for medicines (CUP). This research aims to fill the information gap, investigating the economic consequences of 8 CUP in Italy carried out from May 2015 to December 2020 in the hospitals’ perspective. These programs concern five cancer medicines (alectinib, atezolizumab, cobimetinib, polatuzumab vedotin, trastuzumab emtansine TDM-1), for a total of 8 programs. Methods: Economic net benefit includes avoided costs for standard of care (SoC) the patient would have received if he/she has not joined the CUP and costs not covered by the pharmaceutical industry and sustained by the hospital hosting CUP. The latter include costs of adverse event (only severe sides effects generating hospitalisation and ascribed to medicines used in CUP), combination therapies and diagnostic procedures not covered by the sponsor. SoC costing relied on publicly available estimation. Adverse events and diagnostic procedures were retrieved from the CUP and monetized using the relevant fee for episode. Results: 1635 cancer patients were treated in eight CUPs. The SoC mean cost per patient ranges from €13355 to €28098 for all cancer drugs. The total cost of the SoC ranges from €21.8 - €45.9 million. The mean cost per patient covered by hospitals hosting CUP was equal to €2732 for cancer drugs, with a total cost of €4.5 million. The net economic benefit ranges from €17.4 million to €41.5 million for cancer treatments. Conclusions: Despite its limitations this paper illustrates for the first time the net economic impact of CUP in oncology patients in the perspective of payers. Additional evaluations are ongoing to better understand the overall effects of CUP implementation, i.e. the economic value of the comparative benefit profile of medicines used in CUP versus the SoC, including potential effects on indirect costs.

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“…In addition, $10 billion was spent for clinical research directly in performing the CTs by biopharmaceutical industry in United States (US) in this year 10 . Pharmaceutical industry sponsored $107 million for clinical trials research in Turkey 11 .…”

mentioning

confidence: 99%

“…These benefits include the recruitment of staff, contractors, and the free treatment for thousands of patients who participate in CTs. For example, it is estimated that Turkish government saved almost $31,10,96,130 during 2006-2010 because of free medicines provided to patients in CTs which it would probably have to finance otherwise 11 . 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.…”

mentioning

confidence: 99%

“…The largest CTs average annual growth from 2005 to 2012 occurred exactly in lower-middle income (33%) and low-income (21%) regions of the world 18 . Payment for participating in CTs or even giving expensive medicines for free also unacceptably raises the risk of "unjust influence" or disproportionate representation of poor people in these regions and countries 11 . The reason for this phenomenon might be increasing barriers for conducting CTs in more developed countries 19 .…”

mentioning

confidence: 99%

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