scholarly journals Economic impact of compassionate use of medicines.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18840-e18840
Author(s):  
Claudio Jommi ◽  
Federico Pantellini ◽  
Lisa Stagi ◽  
Marianna Cavazza

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.

2021 ◽  
Author(s):  
Claudio Jommi ◽  
Federico Pantellini ◽  
Lisa Stagi ◽  
Maria Verykiou ◽  
Marianna Cavazza

Abstract 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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Claudio Jommi ◽  
Federico Pantellini ◽  
Lisa Stagi ◽  
Maria Verykiou ◽  
Marianna Cavazza

Abstract 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.


Author(s):  
M Sobrino-García

Background: The prevalence of hypersensitivity reactions to radiological contrast media (RCM) is increasing due to the greater performance of diagnostic and therapeutic tests that require RCMs. Objective: We carried out a year-long real-life observational study to prospectively evaluate the patients referred to the Allergy Service from Primary Care, Emergency Room, and other Services with suspected moderate to severe RCM hypersensitivity. Methods: To study the costs of RCM hypersensitivity evaluation, we systematically recorded direct and indirect costs. Results: Sixty-nine patients with previous reactions to RCM were evaluated in the Allergy Service from June 1st, 2017, to May 31st, 2018. Total direct health care costs were € 10715.84, with a mean cost per patient of € 155.30 ± 77.08. Specifically, direct non-health costs reached € 1605.42 (mean € 23.27 ± 41.14), and indirect costs were € 6490.85 (mean € 94.07 ± 110.61). In summary, the total cost was € 18812.11, which means a mean cost of € 272.64 ± 164.77. Conclusions: Our study reflects that the costs of an elective evaluation of hypersensitivity to RCM are low. This fact reaffirms that correct and safe management of these patients could be cost-effective, so our efforts should be directed to implement the necessary logistics.


2018 ◽  
Vol 15 (2) ◽  
pp. 11-23
Author(s):  
S Islam ◽  
D M S Islam ◽  
R Khanum

The present study was conducted to assess the economic impact of practicing Integrated Pest Management technology on bitter gourd production in Chandina upazila under Comilla district of Bangladesh. Sample survey was carried out over 70 bitter gourd producing farms. Out of 70 farmers, 35 for IPM and 35 for Non-IPM farmers were selected. The study revealed that majority of the farmers had moderately favorable attitude towards IPM technology for producing bitter gourd as shown by farmers’ attitude index. IPM farmers earned more profit than Non-IPM farmers on bitter gourd production. The average total cost of bitter gourd production per hectare  was estimated at about Tk 3,68,335 and  4,44,508 for IPM and Non-IPM farmers, respectively. The average gross returns per hectare were found at about Tk 8,60,016; 8,55,642; and 8,15,947 for marginal, small and medium IPM farmers, respectively. The same were Tk 8,22,654; 7,53,373 and 7,48,255 for marginal, small, and medium Non-IPM farmers, respectively. The estimated BCR was higher for IPM farmers (2.29) than Non-IPM farmers (1.69). Partial budget analysis showed that IPM technology was more profitable and net benefit was Tk 1,61,557. Although bitter gourd production was profitable, farmers faced several problems such as lack of training and technical knowledge, inadequate extension services, lack of marketing facilities etc. in using IPM technology.The Agriculturists 2017; 15(2) 11-23


2021 ◽  
Vol 13 (22) ◽  
pp. 12436
Author(s):  
Daniel Rey Aldana ◽  
Francisco Reyes Santias ◽  
Pilar Mazón Ramos ◽  
Manuel Portela Romero ◽  
Sergio Cinza Sanjurjo ◽  
...  

Background: Telemedicine has been incorporated into daily clinical practice. The purpose of this paper is to evaluate the economic impact of electronic consultation as a means of referring patients between Primary Care (PC) services and the referral Cardiology Service (CS) of a tertiary hospital, in particular, the cost of reduced air pollution. Methods: The direct and indirect costs associated with all the interconsultations between PC and a CS of a tertiary hospital were analyzed under a universal single act model versus a prior e-consultation model that selected patients who would later attend the single-act consultation. The cost of pollution from private motor vehicle travel by road has been analyzed with a Cobb–Douglas cost function. Results: The total cost per patient, including the costs associated with death, represented a saving in the model with e-consultation of 25.6%. The economic value for the reduction of contamination would be EUR 12.86 per patient. Conclusions: The introduction of e-consultation in the outpatient management of patients referred from PC to a CS, helps to reduce direct and indirect costs for the patient and the Health Care System. The cost of pollution associated with the trips explains the total cost to a greater extent, except for the first face-to-face consultation.


Author(s):  
Paul E. Jenkins

Abstract Purpose This study examined economic costs associated with untreated eating disorders (EDs) characterised by regular binge eating in the absence of low weight. Both direct and indirect costs were assessed, reporting a limited societal perspective of economic impact as some costs were not included. Methods One hundred and twenty six adults seeking treatment for recurrent binge eating were asked to report impairment associated with an ED. Costs were calculated using 2017 prices, including an examination of variables associated with costs. Results Estimated societal costs for the year preceding assessment were £3268.47 (€3758.54) per person. In multivariate analyses, no reliable baseline associates of cost were identified. Conclusion The economic burden of EDs characterised by regular binge eating is significant, and underscores the need for efficacious and cost-effective treatments. Individuals with binge-eating disorders report work impairment and healthcare use that may cost the United Kingdom economy upwards of £3.5 billion (€4bn) per annum. Further studies should consider academic impairment and the economic impact of EDs on families. Level of evidence III: evidence obtained from well-designed cohort or case–control analytic studies.


2021 ◽  
Vol 13 (3) ◽  
pp. 1104
Author(s):  
Ke-Liang Wang ◽  
Fu-Qin Zhang

With environmental problems becoming increasingly serious worldwide, scholars’ research views on innovation have begun to pay more attention to the technological value from an ecological perspective, instead of simply analyzing the importance of technological innovation from the perspective of economic value. Currently, improving green innovation efficiency (GIE) has been considered as a critical path to realizing economic transformation and green development. Based on the global Super-Epsilon-based measure (EBM) model, Moran index, vector autoregression (VAR) model, and block model, this study investigated the temporal and spatial characteristics of GIE in 30 provinces in China from 2009 to 2017, and analyzed the spatial heterogeneity and spatial correlation network characteristics. The results showed that in spatial terms, China’s GIE presented an extremely unbalanced development model. In provinces with a higher GIE, there was an overall improvement of GIE, but there was a lower impact in provinces with a lower GIE. The efficiency of China’s green innovation could be divided into four blocks. The first block was the main overflow, the second block was the broker, the third block was the bilateral spillover, and the fourth block was the net benefit. The four blocks had their own functions, and a very significant correlation was observed among them.


2021 ◽  
Vol 24 ◽  
pp. S7
Author(s):  
C. Jommi ◽  
F. Pantellini ◽  
L. Stagi ◽  
M. Cavazza

Author(s):  
Julia Gonzalez ◽  
Diana Carolina Andrade ◽  
JianLi Niu

Abstract Background Acute bacterial skin and skin structure infections (ABSSSIs) are common infectious diseases that cause a significant economic burden on the healthcare system. This study aimed to compare the cost-effectiveness of dalbavancin vs standard of care (SoC) in the treatment of ABSSSI in a community-based healthcare system. Methods This was a retrospective study of adult patients with ABSSSI treated with dalbavancin or SoC during a 27-month period. Patients were matched based on age and body mass index. The primary outcome was average net cost of care to the healthcare system per patient, calculated as the difference between reimbursement payments and the total cost to provide care to the patient. The secondary outcome was proportion of cases successfully treated, defined as no ABSSSI-related readmission within 30 days after the initiation of treatment. Results Of the 418 matched patients, 209 received SoC and 209 received dalbavancin. The average total cost of care per patient was greater with dalbavancin vs SoC ($4770 vs $2709, P < .0001). The average reimbursement per patient was $3084 with dalbavancin vs $2633 SoC (P = .527). The net cost, calculated as revenue minus total cost, was $1685 with dalbavancin vs $75 with SoC (P = .013). The overall treatment success rate was 74% with dalbavancin vs 85% with SoC (P = .004). Conclusions Dalbavancin was more costly than SoC for the treatment of ABSSSI, with a higher 30-day readmission rate. Dalbavancin does not offer an economic or efficacy advantage.


Plant Disease ◽  
1997 ◽  
Vol 81 (1) ◽  
pp. 103-106 ◽  
Author(s):  
D. A. Johnson ◽  
T. F. Cummings ◽  
P. B. Hamm ◽  
R. C. Rowe ◽  
J. S. Miller ◽  
...  

The cost of managing late blight in potatoes during a severe epidemic caused by new, aggressive strains of Phytophthora infestans in the Columbia Basin of Washington and Oregon in 1995 was documented. The mean number of fungicide applications per field varied from 5.1 to 6.3 for early- and midseason potatoes, and from 8.2 to 12.3 for late-season potatoes in the northern and southern Columbia Basin, respectively. In 1994, a year when late blight was not severe, the mean number of fungicide applications per field made to early- and midseason potatoes was 2.0; whereas late-season potatoes received a mean of 2.5 applications. The mean per acre cost of individual fungicides applied varied from $4.90 for copper hydroxide to $36.00 for propamocarb + chlorothalonil. Total per acre expenses (application costs plus fungicide material) for protecting the crop from late blight during 1995 ranged from $106.77 to $110.08 for early and midseason potatoes in different regions of the Columbia Basin and from $149.30 to $226.75 for lateseason potatoes in the northern and southern Columbia Basin, respectively. Approximately 28% of the crop was chemically desiccated before harvest as a disease management practice for the first time in 1995, resulting in an additional mean cost of $34.48/acre or $1.3 million for the region. Harvested yields were 4 to 6% less than in 1994. The total cost of managing late blight in the Columbia Basin in 1995 is estimated to have approached $30 million.


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