A prospective study of costs associated with the evaluation of allergic reactions to radiological contrast media

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.

The Challenge of Sustainability of High-Cost Oncological Drugs: A Budgeting Model in an Italian Cancer Center

In Italy, drug expenditure governance is achieved by setting caps based on the percentage increase in hospital spending compared to the previous year. This method is ineffective in identifying issues and opportunities as it does not consider an analysis of the number of treated cases and per capita consumption in local and regional settings. The IRCCS (Scientific hospitalization and treatment institute) Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori” in Meldola, has developed and adopted an effective management model designed to oversee pharmaceutical expenditure, guarantee prescription appropriateness and quality of care to patients. The budget setting follows a structured process which evaluates determining factors of the expenditure such as expected patients calculated according to the epidemiology and to national and regional indications of appropriateness, mean cost per patient calculated on the average period of demonstrated efficacy of the drug and use of drugs with the best cost-effectiveness ratio. Strict monitoring and integrated purchasing processes allow for immediate corrective actions on expenditures, as well as a continuous dialogue with the region in order to guarantee consistent funding of IRST activities. The model, presented in this article is efficient and implements concepts beyond the conventional “silos” approach and national and regional governance tools, in terms of patient centricity.

Trends in extent of surgical cytoreduction for patients with ovarian cancer

Purpose To identify patient and hospital characteristics associated with extended surgical cytoreduction in the treatment of ovarian cancer. Methods A retrospective analysis using the National Inpatient Sample (NIS) database identified women hospitalized for surgery to remove an ovarian malignancy between 2013 and 2017. Extended cytoreduction (ECR) was defined as surgery involving the bowel, liver, diaphragm, bladder, stomach, or spleen. Chi-square and logistic regression were used to analyze patient and hospital demographics related to ECR, and trends were assessed using the Cochran-Armitage test. Results Of the estimated 79,400 patients undergoing ovarian cancer surgery, 22% received ECR. Decreased adjusted odds of ECR were found in patients with lower Elixhauser Comorbidity Index (ECI) scores (OR 0.61, p<0.001 for ECI 2, versus ECI≥3) or residence outside the top income quartile (OR 0.71, p<0.001 for Q1, versus Q4), and increased odds were seen at hospitals with high ovarian cancer surgical volume (OR 1.25, p<0.001, versus low volume). From 2013 to 2017, there was a decrease in the proportion of cases with extended procedures (19% to 15%, p<0.001). There were significant decreases in the proportion of cases with small bowel, colon, and rectosigmoid resections (p<0.001). Patients who underwent ECR were more likely treated at a high surgical volume hospital (37% vs 31%, p<0.001) over the study period. For their hospital admission, patients who underwent ECR had increased mortality (1.6% vs. 0.5%, p<0.001), length of stay (9.6 days vs. 5.2 days, p<0.001), and mean cost ($32,132 vs. $17,363, p<0.001). Conclusions Likelihood of ECR was associated with increased medical comorbidity complexity, higher income, and undergoing the procedure at high surgical volume hospitals. The proportion of ovarian cancer cases with ECR has decreased from 2013–17, with more cases performed at high surgical volume hospitals.

Novel home use of mechanical negative pressure wound therapy in diabetic foot ulcers

Objective: Mechanical negative pressure wound therapy is an ultraportable, light weight and disposable single-use device that has been shown to promote wound healing. This study evaluated home use of a mechanically powered negative pressure wound therapy (NPWT) in diabetic foot wounds. Methods: Patients underwent revascularisation and/or debridement or amputation before starting mechanical NPWT. Wound outcomes and images of the wounds were recorded at each follow-up visit by the wound nurse. Patients were followed up until wound closure or end of therapy. Results: A total of 12 patients (each with one wound) were included in the study. Of the 12 wounds, 33.3% (n=4) of wounds achieved primary wound closure while the remaining 66.6% (n=8) of wounds demonstrated a mean wound size reduction of 37.5±0.13%. Of the closed wounds, mean time to healing was 4.75±2.50 weeks. There was 100% limb salvage with no further debridement or amputations, and no 30-day unplanned readmissions. Mean length of hospital stay before starting home NPWT was 9.75±6.31 days. Mean number of NPWT changes was 8.33±2.67 sessions, while mean duration of therapy was 4.0±1.54 weeks. Mean cost of home NWPT therapy was US$1904±731 per patient. Conclusion: The home use of mechanically powered NPWT in diabetic foot wounds demonstrated excellent wound healing rates and 100% limb salvage, with no complications.

Cost-effectiveness of using stone cone, balloon dilator, stone basket, and entrapment device in ureteroscopic laser lithotripsy for ureteric stones

Objective To evaluate the costs and stone-free rates of ureteroscopic laser lithotripsy (ULL) performed with and without auxiliary equipment and to compare first-time ULL with total treatment. Methods One hundred patients who underwent first-time ULL without the use of auxiliary equipment because its unavailability comprised the no-device ULL (ndULL) group. Additionally, 100 patients who underwent first-time ULL with the use of auxiliary equipment when necessary comprised the device ULL (dULL) group. Results In the ndULL and dULL groups, the stone-free rates after first-time ULL were 72% and 94% and the mean cost was US $1037 ± 15.10 and US $1452 ± 19.80 per case, respectively, with a statistically significant difference. The stone-free rates at the end of treatment were 98% and 99%, respectively, without a statistically significant difference. When secondary treatment costs were added to the first ULL costs after failed treatment, the mean total cost was US $1625 ± 12.60 in the ndULL group and US $1566 ± 11.01 in the dULL group without a statistically significant difference. Conclusions The stone-free rates and costs after first-time ULL were significantly different between the groups. However, after total treatment, there was no statistically significant difference between the two groups.

Cerebrospinal fluid leakage costs after craniotomy and health economic assessment of incidence reduction from a hospital perspective in the Netherlands

ObjectivesWe aim to quantify the cost difference between patients with incisional cerebrospinal fluid (iCSF) leakage and those without after intradural cranial surgery. Second, the potential cost savings per patient when a decrease in iCSF leakage rate would be achieved with and without added costs for preventative measures of various price and efficacy are modelled.DesignHealth economic assessment from a hospital perspective based on a retrospective cohort study.SettingDutch tertiary referral centre.ParticipantsWe included 616 consecutive patients who underwent intradural cranial surgery between 1 September 2017 and 1 September 2018. Patients undergoing burr hole surgery or transsphenoidal surgery, or who died within 1 month after surgery or were lost to follow-up were excluded.Primary and secondary outcome measuresOutcomes of the cost analysis include a detailed breakdown of mean costs per patient for patients with postoperative iCSF leakage and patients without, and the mean cost difference. For the scenario analyses the outcomes are the potential cost savings per 1000 patients when a decrease in iCSF leakage would be achieved.ResultsMean cost difference between patients with and without iCSF leakage was €9665 (95%CI, €5125 to €14 205). The main cost driver was hospital stay with a difference of 8.5 days. A 25% incidence reduction would result in a mean cost saving of −€94 039 (95% CI, −€218 258 to −€7077) per 1000 patients. A maximum cost reduction of −€653 025 (95% CI, −€1 204 243 to −€169 120) per 1000 patients could be achieved if iCSF leakage would be reduced with 75% in all patients, with 72 cases of iCSF leakage avoided.ConclusionsPostoperative iCSF leakage after intradural cranial surgery increases healthcare costs significantly and substantially. From a health economic perspective preventative measures to avoid iCSF leakage should be pursued.

The economic impact of compassionate use of medicines

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.

Design and Testing of a WAAM Retrofit Kit for Repairing Operations on a Milling Machine

Repairing, remanufacturing, and refurbishing high value metal components are crucial to move towards a more sustainable economy. Nowadays, repairing operations on high value parts, such as dies, are generally performed using time-consuming manual approaches that rely on the operator’s expertise. The research idea of this paper is to develop a retrofit kit to provide additive capabilities to an existing milling machine, allowing automatic repairing of components thanks to a fast switch between additive and machining operations without a relevant economic investment such the acquisition of a brand-new machine: the final cost of the solution is lower than 10% with respect to the mean cost of a 5-axis milling machine. The additive technology used in this work is Wire Arc Additive Manufacturing (WAAM) that is characterized by a higher deposition rate and a simpler and cost-effective equipment with respect to other techniques (e.g., laser cladding). The design of the system is illustrated in the paper together with the analysis of the results achieved repairing a test case: a die casting mold made of AISI H13 tool steel.

Cost-effectiveness of eltrombopag versus intravenous immunoglobulin for the perioperative management of immune thrombocytopenia

Eltrombopag has been shown to be non-inferior to intravenous immunoglobulin (IVIG) for improving perioperative platelet counts in patients with immune thrombocytopenia (ITP) in a randomized trial; thus, cost is an important factor for treatment and policy decisions. We used patient-level data from the trial to conduct a cost-effectiveness analysis comparing perioperative eltrombopag 50mg daily starting dose, with IVIG 1 or 2g/kg (according to local practice) from a Canadian public healthcare payer's perspective over the observation period, from preoperative day 21 to postoperative day 28. Resource utilization data were obtained from the trial data (eltrombopag, n=38; IVIG, n=36) and unit costs were collected from the Ontario Schedule of Benefits, Ontario Drug Formulary, and secondary sources. All costs were adjusted to 2020 Canadian dollars. We calculated the incremental cost per patient for all patients randomized. Uncertainty was addressed using non-parametric bootstrapping. The use of perioperative eltrombopag for patients with ITP resulted in a cost-saving of $413 Canadian dollars per patient. Compared with IVIG, the probability of eltrombopag being cost-effective was 70% even with zero willingness to pay. In a sensitivity analysis based on IVIG dose, we found that with the higher dose of IVIG (2g/kg), eltrombopag saved $2,714 per patient; whereas with the lower dose of IVIG (1g/kg), eltrombopag had a higher mean cost of $562 per patient. In summary, based on data from the randomized trial that demonstrated non-inferiority, the use of eltrombopag for the management of ITP in the perioperative setting was less costly than IVIG.

Financial Toxicity Among Patients with Multiple Myeloma

Background: Treatment-related financial burden, or financial toxicity, can detract from mental health and quality of life and can lead patients to alter their care to offset treatment costs. In doing so, these patients compromise adherence which can contribute to disparities (Zafar Oncologist 2013). Among cancers, multiple myeloma treatment is particularly costly due to use of expensive, novel agents, often in combination, and for extended durations. One study found that patients with myeloma frequently reported financial toxicity and used coping strategies, including borrowing money or prematurely stopping treatment (Huntington Lancet Haematology 2015). In this study, we aim to measure financial toxicity in a cohort of patients with myeloma and examine relationships between financial toxicity and demographic, socioeconomic, and clinical factors. We further aim to follow this cohort longitudinally to examine the course of financial toxicity. Methods: We contacted individuals with multiple myeloma who had participated in our institutional banking study between 2018 and 2021. Patients who agreed to participate were sent a questionnaire which included the 11-item Comprehensive Score for financial Toxicity (COST). Scores range from 0-44 with lower scores indicating higher financial toxicity. Follow-up surveys will be completed after 3 and 6 months. This analysis included data from the initial survey only; follow-up survey data will be available at time of presentation. Results: At time of analysis, 234 patients were contacted and 122 (52%) had returned the survey. Ninety-four completed the COST at least 6 months following myeloma diagnosis and were included in the analysis. The median age at time of survey was 68 (range 37-88). The majority were Caucasian (95%), male (70%), college-educated (62%), and had left the workforce (70%). Seventy-two percent of patients were receiving first-line treatment for MM while 28% had relapsed or refractory disease. The median time from myeloma diagnosis to survey completion was 29 months (range 7-159 months). The median COST score was 28 (range 7-44); those below the median were considered to have higher financial toxicity. Patient characteristics are detailed in Table 1. Notably, 4 of the 5 African-American participants were in the higher financial toxicity group. The mean COST score for African-Americans was 18.4 (SD 8.0) compared to 27.7 (SD 9.2) for Caucasians (p = 0.03). In addition, those in the higher financial toxicity group were less likely to be college educated (52% versus 72%; p &lt;0.05) and the mean COST score for college educated patients was 28.9 (SD 9.3) compared to 24.1 (SD 8.7) for those without (p = 0.02). Interestingly, patients off treatment (n =11) had lower COST scores than patients receiving treatment (mean 21.5 [SD 9.6] compared to 27.9 [SD 9.1]; p = 0.03). Eighty-four patients had complete data and were included in the outcome analysis. Many trends were observed although none were statistically significant. Those with private insurance were more likely to be in the higher financial toxicity group. Those with college degrees or with higher socioeconomic status, approximated using the median household income from each patient's home census tract from the 2019 American Community Survey, were less likely to be in the higher financial toxicity group. Those receiving intravenous myeloma treatment were less likely to be in the higher financial toxicity group compared to those on oral only regimens or no treatment. Results from the analysis are detailed in Table 2. Conclusion: In this study, we observed relationships between demographics, socioeconomic status, and myeloma clinical characteristics with scores on the COST. However, none were independently associated with having a score below the median. Our findings are limited by sample composition, which was skewed toward patients who were Caucasian, college educated, and retired. In addition, because there is no established threshold for financial toxicity on the COST measure, we used our sample's median score; however, our median was higher than that of prior studies and this may have impacted the results. Nevertheless, these preliminary results show financial toxicity is a complex outcome that is difficult to predict. Our longitudinal data, which will be available at time of presentation, will build on these findings to assess the trajectory of financial toxicity over time. Figure 1 Figure 1. Disclosures Vij: BMS: Research Funding; Takeda: Honoraria, Research Funding; Sanofi: Honoraria, Research Funding; BMS: Honoraria; GSK: Honoraria; Oncopeptides: Honoraria; Karyopharm: Honoraria; CareDx: Honoraria; Legend: Honoraria; Biegene: Honoraria; Adaptive: Honoraria; Harpoon: Honoraria.