Incremental Drug Treatment Cost in HIV-Positive Patients in Industry-Sponsored Clinical Trials

2008 ◽  
Vol 42 (11) ◽  
pp. 1586-1591 ◽  
Author(s):  
Rosario Santolaya Perrín ◽  
Fernando J García López
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Therapy ◽  
Cost Savings ◽  
Drug Costs ◽  
Extra Cost ◽  
University Hospital ◽  
Study Entry ◽  
The Cost ◽  
Mean Cost

Background: Drugs used in clinical trials supported by the pharmaceutical industry are supplied free of charge by the companies. However, maintenance of treatment with those drugs when the trials have finished can generate extra cost for patients who participated in the trials. Objective: To assess whether HIV-infected patients' participation in clinical trials results in drug cost savings or increases. Methods: An analysis of alt antiretrovirals dispensed to HIV-infected outpatients prior to, during, and after their participation in clinical trials in a university hospital during a 2-year period was conducted. Only patients who completed the trial during the study period were included. The following outcomes were measured: (1) cost saved (difference between cost per day during the trial and cost per day before study entry), (2) cost generated (difference between cost per day at the end of the trial and cost per day before study entry), (3) balance between cost saved and cost generated, and (4) number of days that a patient received a drug once the trial was finished to generate cost, considering costs saved. All data were extracted from the hospital pharmacy database. A stratified analysis by type of clinical trial (ordinary or expanded use) was undertaken. Results: Data from 61 patients were analyzed. The cost of drug therapy during patient participation in a clinical trial was lower than the cost prior to inclusion. Therefore, mean drug savings of $10.38 (US) per patient day resulted (95% CI –5.9 to 14.84), The mean cost generated was $8.74 per patient day (95% CI 3.95 to 13.52). Conclusions: A patient's participation in a clinical trial or expanded-access clinical trial generated extra cost once the trial had finished because the cost of drug therapy was higher at the end of the study. In our study, the daily drug costs saved during the trial were similar to the daily drug costs generated.

scholarly journals Current aspects of risk management in clinical trials

2020 ◽  
pp. 45-52
Author(s):  
E. A. Polozova
Keyword(s):  
Clinical Trial ◽  
Risk Management ◽  
Clinical Trials ◽  
Cost Savings ◽  
Pharmaceutical Companies ◽  
Main Task ◽  
Legal Requirements ◽  
Financial Cost ◽  
The Cost

Improving the quality of drugs is the main task of the pharmaceutical industry as a whole. Getting safe and eff ective medications is directly related to minimizing the risks of conducting clinical trials. Maintaining the quality of clinical research based on risk management is a continuous, constant and dynamic process ensuring the success of the study, which in turn leads to the integrity of the data collected, the safety of subjects and compliance with legal requirements, as well as to the financial cost savings of pharmaceutical companies. The cost of research is growing inexorably, and the quality of their research is rapidly declining, so it is important to use a risk-based approach when developing the upcoming clinical trial project.

Direct impact of clinical research in metastatic renal cell carcinoma (mRCC): A cost-effectiveness analysis of patient care outcomes and cost savings in a real-life scenario of a large public university hospital in Spain.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 637-637
Author(s):  
Silvia Garcia-Garro ◽  
Pablo Gajate ◽  
Esther Gómez-de-Salazar ◽  
Teresa Alonso Gordoa ◽  
Miguel Angel Rodriguez-Sagrado ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Research ◽  
Public Health System ◽  
Real Life ◽  
Cost Savings ◽  
University Hospital ◽  
Direct Impact

637 Background: Public health sustainability is a major concern worldwide. Clinical research is considered to leverage patient care outcome but also can lead costs savings and, subsequently, to maintain public health system. Thus, we analyzed the direct impact of clinical research in terms of improvement in clinical outcomes and costs related to research in patients with mRCC in real-life setting. Methods: We retrospectively collected data related to overall survival (OS) and direct health care costs from all mRCC patients who were treated with oral anti-tumour medication and followed at the Medical Oncology Department of Ramón y Cajal University Hospital in Madrid, between January 2010 and February 2017. A statistical analysis comparing the outcomes of patients included in clinical trials versus those not included was conducted. Results: In the study period, 65 patients were newly diagnosed with mRCC and received treatment. Those patients included in clinical trials showed higher median OS (91 vs. 29 months. HR 0.389; 95% CI: 0.150: 1.000; p=0.04). Median direct cost per mRCC patient in ‘real-life’ was €67,376. Median cost for a patient enrolled in at least one clinical trial was €53,673 vs. €63,834 for those who were never recruited for a trial. Participation in clinical trials contributed to a decrease in total health expenditure by 9.02% (€362,367), mainly due to reduction in the cost of medications and diagnostic tests (91.46% vs. 8.54%, respectively). Furthermore, clinical trial participants have required less number of hospitalizations (0.08 vs. 1.75) and emergency visits (0.39 vs. 3.2) per patient. Conclusions: Under the public health system perspective, participation in clinical trials is related to an improvement in overall survival as well as direct and indirect cost savings in mRCC patients.

Drug cost savings in phase III hematological oncology clinical trials in a university hospital

2020 ◽  
Vol 38 (4) ◽  
pp. 576-583
Author(s):  
Chloé Herledan ◽  
Florence Ranchon ◽  
Vérane Schwiertz ◽  
Amandine Baudouin ◽  
Lionel Karlin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Cost ◽  
Cost Savings ◽  
University Hospital ◽  
Phase Iii ◽  
Oncology Clinical Trials

scholarly journals Costs of care provided in a university hospital for children exposed to or infected with the HIV/AIDS

2007 ◽  
Vol 23 (suppl 3) ◽  
pp. S402-S413 ◽  
Author(s):  
Heloisa Helena de Sousa Marques ◽  
Bernard François Couttolenc ◽  
Maria do Rosário Dias de Oliveira Latorre ◽  
Maria Zilda de Aquino ◽  
Maria Ignez Garcia Aveiro ◽  
...  
Keyword(s):  
Medical Records ◽  
University Hospital ◽  
Accounting System ◽  
Cost Of Treatment ◽  
Costs Of Treatment ◽  
The Mean ◽  
Cost Accounting System ◽  
The Cost ◽  
Mean Cost ◽  
Hiv Aids

The objective of this study was to estimate and analyze the costs of treating children with HIV/AIDS at a university hospital in São Paulo, Brazil. The study collected and analyzed data from 291 medical records of children treated at the hospital as of March 2002. The costs of treatment were estimated for each category of patient (exposed and infected) and severity, based on the quantity of inputs and procedures used in treating each child, based on the cost accounting system used at the hospital. The total cost of treatment for children exposed to the HIV was R$ 956.41 and for those infected with HIV R$ 8,092.71 per year. The mean cost of ambulatory care was R$ 6,047.28 for children with severe conditions, R$ 3,714.45 for those with light/moderate conditions, and R$ 948.63 for the exposed. Hospitalized children had annual costs of R$ 19,353.34, R$ 18,823.16, and R$ 871.03, respectively. The medication was a major factor in the cost of treatment. Our estimates are comparable to the findings from other studies, but lower than corresponding findings from the international literature.

P1383ECONOMIC BENEFITS OF SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS ERTHROPOIESIS-SIMULATING AGENTS THERAPY FOR MANAGEMENT OF ANEMIA IN HEMODIALYSIS PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Bhanu Prasad ◽  
Maryam Jafari ◽  
Joanne Kappel ◽  
Julie Toppings ◽  
Linda Gross
Keyword(s):  
Transferrin Saturation ◽  
Cost Savings ◽  
Hemodialysis Patients ◽  
T Test ◽  
Epoetin Alfa ◽  
Epoetin Alpha ◽  
Iv Iron ◽  
The Mean ◽  
The Cost ◽  
Mean Cost

Abstract Background and Aims Erythropoiesis stimulating agents (ESA’s) were introduced in the treatment of anemia in 1989 and it immediately led to a marked decline in the number of blood transfusions and improved quality of life in patients across the spectrum of chronic kidney disease. Several studies from the mid 1990s have shown that the required doses of Epoetin alpha were lower when administered subcutaneously (SQ). These studies led to guidelines by NKF (1997) and KDOQI (2001) recommending the use of SQ over intravenous (IV) as considerable cost savings could be achieved without compromising care. The rise in the reported cases of pure red cell aplasia (PRCA) led to a change in guidelines in 2006 and led to units changing exclusively to IV route. It was subsequently identified that polysorbate 80 from uncoated rubber stoppers in pre-filled syringes rather than the route of administration was the most plausible cause of PRCA. However, higher doses of ESAs, have been associated with adverse health outcomes across all hematocrit categories in hemodialysis patients. While the current practice is to administer ESAs to patients through IV route, SQ ESAs achieve the same target hemoglobin level at a reduced dose and cost. Given the dose -sparing advantages of SQ Epoetin alpha administration, we decided to gradually transition our patients to SQ and examined the cost of IV versus SQ treatment. The objective of our study was to determine the economic benefit of the change in the route of administration from IV to SQ ESA in hemodialysis patients. Method We conducted a retrospective cohort study in 215 hemodialysis patients who transitioned from IV Epoetin alfa to SQ at four hemodialysis sites in the province of Saskatchewan, Canada from September 2014 to July 2017. The dose and cost of different routes of Epoetin alfa administration per patient per month was calculated. Also, blood hemoglobin, markers of erythropoiesis (transferrin saturation and Ferritin), IV iron dose and cost were determined in relation to route of Epoetin alfa administration. The dependent t-test was used to compare mean variables between pre-switch and post-switch period. Differences in variables across three serum hemoglobin ranges (<95, 95-115, >115 gram/liter) were assessed using the independent t-test. Results The mean Epoetin alfa doses per patient per month (47,327.9±33,133.0 international unit) during pre-switch (IV) period were greater than of post-switch (SQ) period (34,253±24,858.1), a decrease of 27.62% (p<0.001). The mean hemoglobin concentration for patients in both periods remained stable (103.3±9.2 versus 104.3±13.3, p=0.34) and within the target range. The reduction in the dose of Epoetin alfa per patient per month (IU± standard deviation) upon conversion remained similar (IV versus SQ) in all the subcategories: hemoglobin <95 g/L (65,941 versus 52,717), hemoglobin 95-115g/L (42,120 versus 29,619) and (35,289 versus 17,651) for hemoglobin >115 g/L. There were no significant differences in transferrin saturation, Ferritin and IV iron dose and cost between the two study periods. The mean cost (CAD± SD) of Epoetin alfa per patient per month decreased from 674.4±477.4 pre-switch to 484.8±354.3 post-switch (p<0.001), a decrease of 28.11%; whereas, the cost of IV iron remained similar in pre- and post-switch period. Conclusion The (mean) cost of Epoetin alfa per patient per year in our study when given IV was $ 8,088 (CAD) and once converted to SQ was $ 5,817 (CAD) while achieving equivalent hemoglobin levels, a saving of $ 2271 (CAD) per year. Based on these values, if we extrapolate our savings to 900 prevalent patients to SQ Epoetin alfa we can realize a cost saving of $2,043,900 per year. Conversion of Epoetin alfa from IV to SQ led to substantial cost savings at our hemodialysis units.

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 ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Health Service ◽  
Market Price ◽  
Cost Savings ◽  
Antineoplastic Drugs ◽  
Experimental Drugs ◽  
Cost Of Drugs ◽  
The Cost ◽  
The Impact

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.

scholarly journals Financial Impact of Cancer Drug Wastage and Potential Cost Savings From Mitigation Strategies

2017 ◽  
Vol 13 (7) ◽  
pp. e646-e652 ◽  
Author(s):  
Caitlyn Y.W. Leung ◽  
Matthew C. Cheung ◽  
Lauren F. Charbonneau ◽  
Anca Prica ◽  
Pamela Ng ◽  
...  
Keyword(s):  
Cost Savings ◽  
Mitigation Strategies ◽  
Drug Costs ◽  
Financial Impact ◽  
Cancer Drug ◽  
Total Drug ◽  
Potential Cost ◽  
Cross Sectional ◽  
Drug Wastage ◽  
The Cost

Purpose: Cancer drug wastage occurs when a parenteral drug within a fixed vial is not administered fully to a patient. This study investigated the extent of drug wastage, the financial impact on the hospital budget, and the cost savings associated with current mitigation strategies. Methods: We conducted a cross-sectional study in three University of Toronto–affiliated hospitals of various sizes. We recorded the actual amount of drug wasted over a 2-week period while using current mitigation strategies. Single-dose vial cancer drugs with the highest wastage potentials were identified (14 drugs). To calculate the hypothetical drug wastage with no mitigation strategies, we determined how many vials of drugs would be needed to fill a single prescription. Results: The total drug costs over the 2 weeks ranged from $50,257 to $716,983 in the three institutions. With existing mitigation strategies, the actual drug wastage over the 2 weeks ranged from $928 to $5,472, which was approximately 1% to 2% of the total drug costs. In the hypothetical model with no mitigation strategies implemented, the projected drug cost wastage would have been $11,232 to $149,131, which accounted for 16% to 18% of the total drug costs. As a result, the potential annual savings while using current mitigation strategies range from 15% to 17%. Conclusion: The financial impact of drug wastage is substantial. Mitigation strategies lead to substantial cost savings, with the opportunity to reinvest those savings. More research is needed to determine the appropriate methods to minimize risk to patients while using the cost-saving mitigation strategies.

The impact of the COVID-19 pandemic on oncology clinical trial recruitment in an Irish cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18756-e18756
Author(s):  
Ronan Andrew McLaughlin ◽  
Valerie Madigan ◽  
Maureen O'Grady ◽  
Thamir Andrew Mahgoub ◽  
Roshni Andrew Kalachand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Treatment Options ◽  
Cancer Clinical Trial ◽  
University Hospital ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Number Of Patients ◽  
The Impact

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.

scholarly journals Community-based continuity of midwifery care versus standard hospital care: a cost analysis

2001 ◽  
Vol 24 (1) ◽  
pp. 85 ◽  
Author(s):  
Caroline S Homer ◽  
Deborah V Matha ◽  
Lesley G Jordan ◽  
Jo Wills ◽  
Gregory K Davis
Keyword(s):  
Standard Care ◽  
Caesarean Section Rate ◽  
Cost Savings ◽  
Model Of Care ◽  
Community Based ◽  
Midwifery Care ◽  
New Model ◽  
The Mean ◽  
The Cost ◽  
Mean Cost

This paper reports the costs of providing a new model of maternity care compared to standard care in anAustralian public hospital. The mean cost of providing care per woman was lower in the group who had the newmodel of care compared with standard care ($2 579 versus $3 483). Cost savings associated with new model of carewere maintained even after costs associated with admission to special care nursery were excluded. The cost saving wasalso sustained even when the caesarean section rate in the new model of care increased to beyond that of the standardcare group.

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