Clinical trials and drug cost savings for Italian health service

D'Ambrosio, Francesca Romana; Feo, Gianfranco De; Botti, Gerardo; Capasso, Arturo; Pignata, Sandro; Maiolino, Piera; Triassi, Maria; Nardone, Antonio; Perrone, F.; Piezzo, Michela; Grimaldi, Antonio; Palazzo, I.; Stasio, Immacolata De; D’Aniello, R.; Morabito, Alessandro; Pascarella, Giacomo

doi:10.1186/s12913-020-05928-6

Cited by 11 publications

(13 citation statements)

References 10 publications

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“…These findings cannot be fully compared with the economic impact of a CT. If Italian studies on CT avoided costs are considered, regarding only medicines [ 31 , 32 ] and diagnostic procedures [ 30 ], the mean savings per patient treated are higher in our findings. This is mainly caused by the higher cost of the hypothetical SoC used in clinical practice.…”

Section: Discussionmentioning

confidence: 54%

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: Discussionmentioning

confidence: 54%

The economic impact of compassionate use of medicines

Jommi

Pantellini

Stagi

et al. 2021

BMC Health Serv Res

View full text Add to dashboard Cite

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“…To estimate the DCA, we used the price of the best standard of care, resulting in ~5.1 million euros (Table 1). Other DCA estimations performed in a single institution have shown similar saving percentages for the hospital or institution budget 11,12 . Thus, supporting the idea that the DCA from oncological clinical trials provides economic savings, and may help to sustain the national health system.…”

Section: Discussionmentioning

confidence: 64%

Drug Cost Avoidance Analysis of Cancer Clinical Trials in Spain: A Study on Cost Contributors and Their Impact

Domingo

Salas-Lucia

Jiang

et al. 2022

Preprint

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Objective: Analyze the cost contributors and their impact on the drug cost avoidance (DCA) resulting from cancer clinical trials over the period of 2015-2020 in a tertiary-level hospital in Spain (HCUVA). Methods: We performed a cross-sectional, observational, retrospective study of a total of 53 clinical trials with 363 patients enrolled. We calculated the DCA from the price of the best standard of care (i.e.: drugs that the institution would otherwise fund). A linear regression model was used to determine cost contributors and estimate their impact. Results: The total DCA was ~5.1 million euros (31 clinical trials; 177 enrollees), representing 30% and 0,05% approximately of the annual pharmaceutical expenditures at the HCUVA and for the Spanish Health System, respectively. Cancer type analysis showed that lung cancer had the highest average DCA by trial, indicating that treatments in these trials were the most expensive. Linear regression analysis showed that the number of patients in a trial did not significantly affect that trial's DCA. Instead, cancer type, phase trials, and intention of treatment were significant cost contributors to DCA. Compared to digestive cancer trials, breast and lung trials were significantly more expensive, (p < 0.05 and p < 0.1, respectively). Phase III trials were more expensive than Phase II (p < 0.05) and adjuvant trials were less expensive than palliative (p < 0.001). Conclusion: We identified key cancer clinical trial characteristics that significantly impacted the estimated DCA. Our work provides the groundwork to explore DCA contributors with potential to enhance public relations material and serve as a negotiating tool for budgeting, thus playing an important role to inform decisions about resource allocation.

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“…Some studies have estimated the drug cost avoidance based on the price of investigational drugs, and when this price is not available, taking as a reference the price of a control drug or standard treatment ( 11 , 18 , 21 ). However, some other studies like ours have used the standard therapy as a comparator ( 10 , 12 , 16 ), which we believe provides a more comprehensive analysis since clinical trials with novel agents with price not available are not excluded, as observed in other studies ( 11 , 14 , 15 ). In fact, among all the active oncology clinical trials in our hospital, only the multi-tumor trials were excluded from the economic analysis since a suitable comparator was not found.…”

Section: Discussionmentioning

confidence: 97%

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

et al. 2022

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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.

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Clinical trials and drug cost savings for Italian health service

Cited by 11 publications

References 10 publications

The economic impact of compassionate use of medicines

The economic impact of compassionate use of medicines

Drug Cost Avoidance Analysis of Cancer Clinical Trials in Spain: A Study on Cost Contributors and Their Impact

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

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