A New Methodology to Estimate Drug Cost Avoidance in Clinical Trials: Development and Application

Abstract

BackgroundOncology clinical trials can lead to relevant financial savings in drug acquisition for healthcare providers. Considerable methodological heterogeneity is observed among previous studies estimating these savings.MethodsWe developed a methodology to estimate the economic benefit obtained from the enrollment of patients into clinical trials through the analysis of drug cost avoidance. We designed a decision algorithm to determine if a clinical trial is associated with drug cost avoidance. This algorithm is based on five scenarios according to the availability or not of standard treatment, the presence or absence of a control arm (placebo or active treatment), and the provider of the medication. We considered as reference the cost of the standard treatment that the patient would have received in routine clinical practice. We standardized drug doses and treatment durations according to the literature. Costs were considered from a National Health System perspective. We applied this methodology at a single, research-active University Hospital in 2019. A cost avoidance analysis per trial and patient was carried out on cancer patients.ResultsWe analyzed 140 trials in which 198 patients were recruited. Drug cost avoidance was found in 120 trials (85.7%). The estimated total drug cost avoidance amounted to over €3,200,000. Melanoma and genitourinary tumors were the tumor types associated with the highest cost avoidance. The average drug cost avoidance per patient was €16,245.ConclusionWe describe a standardized method to estimate drug cost avoidance in clinical trials. We have applied it to all ongoing oncology clinical trials in our center. This methodology could be valuable for other centers to analyze the potential saving of clinical trials.

Evaluation of drug cost savings related to clinical trials from the perspective of a university hospital

“…In our study, cancer diseases represent the highest cost-avoidance disease category (79.1%, €6 004 966/€7 591 612). This figure is slightly higher than in previous studies published in 2000 (70%)12 and 2008 (75%) 11. This shift in the share of cancer treatments could be linked to changes in the time horizon and the development of increasingly targeted and expensive therapies and immunotherapies 21 22…”

“…Again, the timeline was not the same and our site was not involved in many studies at the time of this work in onco-gynaecology (three clinical trials). For the other most recent studies,12–14 major cost savings were observed for melanoma, breast cancer and genitourinary cancer. The difference between repartition could be explain by the specific expertise of each centre.…”

“…Trials eligible for potential savings were selected, provided they included at least one patient enrolled in the group that generated cost savings. The same method of defining cost saving tests was used by Garcia-Sánchez et al 12 and Herledan et al 8…”

“…These legal requirements could lead to a new opportunity for clinical trials, namely the potential for cost savings related to the coverage of ‘best standard of care’ (BSC) expenditure. The literature reports studies primarily focused on cost saving in oncology studies,5–14 with a variable follow-up period (1 to 18 years),5–14 with a variable number of patients (136 to 3195 patients)5–14 and of the trials involved (5 to 88 trials) 5–14. Finally, only a few studies take into account the avoided costs of all clinical trials15–17 and over a wider follow-up period (1 to 2 years).…”

Optimising oncology drug expenditure in Ireland

“…One clinical trials unit included in this analysis reported that each €1 in grant funding received, yielded €3 in income from industry for trials, supporting the need for continued expansion and investment in cancer research units nationwide. In international studies, average drug cost avoidance per patient has been estimated at €10,000 to €16,000 [9,10], with cost savings per centre up to €6 million a year [11], significantly exceeding the costs associated with running a clinical trial [12].…”