scholarly journals Clinical trials and drug cost savings for Italian health service

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Francesca D’Ambrosio ◽  
Gianfranco De Feo ◽  
Gerardo Botti ◽  
Arturo Capasso ◽  
Sandro Pignata ◽  
...  

Abstract Background The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials. Methods We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation. Results From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5487 Euros saved per patients for a period of 4 weeks. Conclusions Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.

2020 ◽  
Author(s):  
Francesca D’Ambrosio ◽  
Gianfranco De Feo ◽  
Gerardo Botti ◽  
Arturo Capasso ◽  
Sandro Pignata ◽  
...  

Abstract Background: The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials.Methods: We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation. Results: From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5,487 Euros saved per patients for a period of four weeks.Conclusions: Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.


2020 ◽  
Author(s):  
Francesca D’Ambrosio ◽  
Gianfranco De Feo ◽  
Gerardo Botti ◽  
Arturo Capasso ◽  
Sandro Pignata ◽  
...  

Abstract Background: The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of anticancer drug cost reduction for Italian Health Service due to patient participation in clinical trials.Methods: We evaluated the cost of drugs administered to patients treated in clinical trials at National Cancer Institute of Naples in a four-week period. Patients with diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined for each patient the expected standard treatment and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used drug’s market price to determine cost saving value. Costs other than drugs were not included in the cost saving calculation.Results: From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, by using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. We calculated that the cost of antineoplastic drugs if these patients would been treated with conventional therapies in clinical practice would account for 517,658 Euros, with an average of 5,487 Euros saved per patients for a period of four weeks.Conclusions: Participating in clinical trials in which investigational antineoplastic drugs are provided free of charge by the Sponsor translates in considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.


2011 ◽  
Vol 14 (2) ◽  
Author(s):  
Thomas G Koch

Current estimates of obesity costs ignore the impact of future weight loss and gain, and may either over or underestimate economic consequences of weight loss. In light of this, I construct static and dynamic measures of medical costs associated with body mass index (BMI), to be balanced against the cost of one-time interventions. This study finds that ignoring the implications of weight loss and gain over time overstates the medical-cost savings of such interventions by an order of magnitude. When the relationship between spending and age is allowed to vary, weight-loss attempts appear to be cost-effective starting and ending with middle age. Some interventions recently proven to decrease weight may also be cost-effective.


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
N Paredes Hurtado ◽  
M Delgado Ortega ◽  
A Rodriguez Almodovar ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine  clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p <0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.


2021 ◽  
Vol 31 (2) ◽  
pp. 238-249
Author(s):  
E. G. Furman ◽  
V. V. Shadrina ◽  
T. Yu. Maksimycheva ◽  
V. D. Sherman ◽  
E. I. Kondratyeva

Despite the low prevalence of cystic fibrosis (CF), the costs of treating this disease are significant for the healthcare system. The aim of this economic study was to assess the total cost of drugs per year for children with CF, depending on age and course of the disease.Methods. For this pharmacoeconomic analysis, groups of “hypothetical” patients were formed according to the characteristics of the course of CF, taking into account the required volume of basic CF therapy, antibiotic therapy, and complications.Results. The cost of basic treatment for CF patients of different ages and disease progression in the hypothetical patient models can vary greatly. The cost of CF therapy increases significantly with age and Pseudomonas aeruginosa respiratory infection, especially in the patients with chronic infection, concomitant polyposis sinusitis, and low nutritional status.Conclusion. Patients with CF require regular follow-up with control of the microflora of the respiratory tract and effective eradication therapy for P. aeruginosa and other pathogenic microorganisms. Reducing infection rates and the severity of the disease can lead to significant cost savings.


2005 ◽  
Vol 25 (3_suppl) ◽  
pp. 95-98 ◽  
Author(s):  
David N. Churchill

The objective was to review the rationale for the Kidney Disease Outcomes Quality Initiative (K/DOQI) recommendations for adequacy of peritoneal dialysis and to evaluate the impact of these recommendations on clinical practice and patient survival. The K/DOQI recommendations were based on large observational studies; the target weekly Kt/V value of 2.0 assumed equivalence of peritoneal and renal clearances. This assumption is no longer considered correct. The impact on clinical practice was evaluated by an examination of temporal trends before and after publication of the guidelines in 1997. In the United States and The Netherlands, there had been a trend toward increased delivered total Kt/V prior to 1997, and there was no acceleration in this trend after 1997. Two randomized clinical trials have implemented these guidelines with increased peritoneal Kt/V (or creatinine clearance) used to achieve the K/DOQI target in the intervention group. This was not associated with improved survival, compared to a lower Kt/V, in either of the randomized clinical trials. Among the explanations for the failure to improve outcome are potential adverse effects of increasing the dialysis dose. These include increased intraperitoneal pressure associated with increased exchange volume, failure to increase clearance of middle molecules, and increased exposure to glucose. Strategies that increase peritoneal clearance without exposure to these potential adverse effects include more-frequent exchanges rather than increased exchange volume, and decreased exposure to glucose and glucose degradation products. Pending such studies, current K/DOQI guidelines should be updated in a timely manner.


2003 ◽  
Vol 8 (1) ◽  
pp. 18-24 ◽  
Author(s):  
Simon Dixon ◽  
Pat Coleman ◽  
Jon Nicholl ◽  
Alan Brennan ◽  
Sandra Touch

Objectives: To examine the influence of the English National Health Service (NHS) South and West (S&W) region Development and Evaluation Committee (DEC) technology appraisal reports on purchasing and clinical decisions in the S&W and elsewhere in the NHS, and to estimate the cost of the DEC process. Methods: Two postal questionnaires examining issues of awareness, influence and quality of the DEC reports were sent to samples of clinical and managerial health service staff in S&W NHS region, the North West NHS region, and three other randomly selected health authorities elsewhere. Supplementary telephone interviews were undertaken with a subsample of staff. Trends in utilisation before and after the publication of four S&W DEC reports were examined using routine health service data. Results: Survey response rates ranged between 73% and 85%. Within health authorities in the S&W, agreement about the impact of the DEC in informing policy and purchasing decisions was consistently high, although responses from clinicians were more equivocal. In the topic areas examined, the impact of the DEC reports could not be separated from wider influences on practice. The cost of each DEC report is estimated to have been £24 659. Conclusions: Health service staff perceived that the S&W DEC process had had an impact on policy decisions and clinical practice locally; however, any actual impact on practice could not be identified with routine data. The approach used in this study would be valuable in evaluating the impact of the English NHS National Institute for Clinical Excellence.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2265-2265
Author(s):  
Elias J. Jabbour ◽  
Martin F Mendiola ◽  
Melissa Lingohr-Smith ◽  
Brandy Menges ◽  
Jay Lin ◽  
...  

Abstract Introduction: In an Oncology Care Model (OCM) setting, practices may earn a Performance-Based Payment (PBP) for a reduction in the costs of treating participating Medicare patients during a 6-month episode of care. An Excel-based decision analytics model was developed to evaluate the cost-savings associated with implementing changes in the usage of tyrosine kinase inhibitors (TKIs) among patients with chronic myeloid leukemia (CML) within a typical OCM practice and the impact it could have on a practice potentially receiving a PBP. Methods: The default scenario is based on an OCM practice that treats 1,000 cancer patients during a 6-month episode of care. The types of cancers treated and the proportions of patients treated in the OCM practice were estimated from an OCM baseline report; all-cause healthcare costs for each cancer type were obtained from published literature. CML patients were stratified into newly-diagnosed and established TKI-treated patients. The percentages of CML patients on each of the TKIs (branded and generic imatinib [1st-gen TKIs], as well as dasatinib and nilotinib [2nd-gen TKIs]) within each stratum were estimated using market share data from April 2018. The 2018 Wholesales Acquisition Costs for the TKIs were obtained from RedBook. It was assumed that, if a practice implements the policy of restricting utilization of branded TKIs as a cost-cutting measure, 80% of the current market share of branded imatinib would shift to the generic and 50% of the current market shares of 2nd-gen TKIs would shift to generic imatinib. Among established TKI-treated patients, it was assumed that 80% of the current market share of branded imatinib would shift to the generic, whereas no patients treated with 2nd-gen TKIs would be switched to generic imatinib due to the lack of supporting evidence, physician and patient apprehension, some patients already having used imatinib, among other reasons. The relationship between the savings achieved from restricting utilization of 2nd-gen TKIs and the savings required for the OCM practice to receive a PBP using either a one-sided or two-sided risk model was evaluated. Results: The total healthcare costs of an OCM practice that treats 1,000 cancer patients for 6 months were estimated at $51,345,812. It was estimated that there would only be 4 CML patients in a 1,000-patient OCM practice, 1 newly-diagnosed and 3 established TKI-treated patients. Implementing the policy of restricting utilization of 2nd-gen TKIs for patients with CML would save a practice $12,970 during the 6-month episode of care, while $25,250 would be saved through a branded to generic imatinib shift (Table). For a 1,000-patient OCM practice participating in a one-sided risk model, a total cost-savings of $3,013,832 is required for it to be eligible for a PBP. In this scenario, the cost reduction associated with a shift from 2nd-gen TKIs to generic imatinib amounts to only 0.4% of the required total cost-savings threshold before the practice is eligible for a PBP. For a 1,000-patient OCM practice participating in a two-sided risk model, a total cost-savings of $2,372,010 is required for it to be eligible for a PBP. In this case, the cost reduction associated with a shift from 2nd-gen TKIs to generic imatinib amounts to only 0.5% of the required total cost-savings threshold before the practice is eligible for a PBP. Conclusions: This economic model indicates that the cost-savings associated with restricting branded TKI utilization among CML patients in an OCM setting will represent only a very small portion of the cost-savings required before an OCM practice is eligible for a PBP. Of the reduction in TKI costs, approximately two-thirds was attributed to the shift from branded to generic imatinib. Restricting utilization of the 2nd-gen TKIs contributed a negligible amount of savings required for a PBP. The cost-savings opportunities in CML in the OCM setting are limited by how few CML patients would be affected by restrictions. Disclosures Jabbour: Pfizer: Consultancy, Research Funding; Novartis: Research Funding; Takeda: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Abbvie: Research Funding. Mendiola:Bristol-Myers Squibb: Employment. Lingohr-Smith:Novosys Health: Employment. Menges:Novosys Health: Employment. Lin:Bristol-Myers Squibb: Consultancy; Novosys Health: Employment. Makenbaeva:Bristol-Myers Squibb: Employment.


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