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Background. Pharmaceutical risk sharing agreements (RSAs) are commonly used to manage uncertainties in costs and/or clinical benefits when new drugs are added to a formulary. However, existing mathematical models of RSAs ignore the impact of RSAs on clinical and financial risk. Methods. We develop a model in which the number of patients, total drug consumption per patient, and incremental health benefits per patient are uncertain at the time of the introduction of a new drug. We use the model to evaluate the impact of six common RSAs on total drug costs and total net monetary benefit (NMB). Results. We show that, relative to not having an RSA in place, each RSA reduces expected total drug costs and increases expected total NMB. Each RSA also improves two measures of risk by reducing the probability that total drug costs exceed any threshold and reducing the probability of obtaining negative NMB. However, the effects on variance in both NMB and total drug costs are mixed. In some cases, relative to not having an RSA in place, implementing an RSA can increase variability in total drug costs or total NMB. We also show that, for some RSAs, when their parameters are adjusted so that they have the same impact on expected total drug cost, they can be rank-ordered in terms of their impact on variance in drug costs. Conclusions. Although all RSAs reduce expected total drug costs and increase expected total NMB, some RSAs may actually have the undesirable effect of increasing risk. Payers and formulary managers should be aware of these mean-variance tradeoffs and the potentially unintended results of RSAs when designing and negotiating RSAs.

Background In April 2021, the province of Ontario, Canada, was at the peak of its third wave of the COVID-19 pandemic. Intensive Care Unit (ICU) capacity in the Toronto metropolitan area was insufficient to handle local COVID patients. As a result, some patients from the Toronto metropolitan area were transferred to other regions. Methods A spreadsheet-based Monte Carlo simulation tool was built to help a large tertiary hospital plan and make informed decisions about the number of transfer patients it could accept from other hospitals. The model was implemented in Microsoft Excel to enable it to be widely distributed and easily used. The model estimates the probability that each ward will be overcapacity and percentiles of utilization daily for a one-week planning horizon. Results The model was used from May 2021 to February 2022 to support decisions about the ability to accept transfers from other hospitals. The model was also used to ensure adequate inpatient bed capacity and human resources in response to various COVID-related scenarios, such as changes in hospital admission rates, managing the impact of intra-hospital outbreaks and balancing the COVID response with planned hospital activity. Conclusions Coordination between hospitals was necessary due to the high stress on the health care system. A simple planning tool can help to understand the impact of patient transfers on capacity utilization and improve the confidence of hospital leaders when making transfer decisions. The model was also helpful in investigating other operational scenarios and may be helpful when preparing for future outbreaks or public health emergencies.

Access to primary care outside of regular working hours is limited in many countries. This study investigates the relation between the after-hours premium, an incentive for primary care physicians to provide services after hours, and less-urgent visits to the emergency department in Ontario, Canada. We analyzed a retrospective cohort of a random sample of Ontario residents from April 2002 to March 2006, and a subcohort of patients followed from April 2005 to March 2016. We linked patient and primary care physician data with emergency department visit data. We used fixed-effects regression models to analyze the association between the introduction of the after-hours premium, as well as subsequent increases in the value of the premium, and the number of monthly emergency department visits. The sample consisted of 586 534 patients between 2002 and 2006, and 201 594 patients from 2005 to 2016. After controlling for patient and physician characteristics, seasonality and time-invariant patient confounding factors, introduction of the after-hours premium was associated with a reduction of 1.26 less-urgent visits to the emergency department per 1000 patients per month (95% confidence interval −1.48 to −1.04). Most of this reduction was observed in after-hours visits. Sensitivity analysis showed that the monthly reduction in less-urgent visits to the emergency department was in the range of −1.24 to −1.16 per 1000 patients. Subsequent increases in the after-hours premium were associated with a small reduction in less-urgent visits to the emergency department. Ontario’s experience suggests that incentivizing physicians to improve access to after-hours primary care reduces some less-urgent visits to the emergency department. Other jurisdictions may consider incentives to limit less-urgent visits to the emergency department.

University students have higher average number of contacts than the general population. Students returning to university campuses may exacerbate COVID-19 dynamics in the surrounding community. We developed a dynamic transmission model of COVID-19 in a mid-sized city currently experiencing a low infection rate. We evaluated the impact of 20,000 university students arriving on September 1 in terms of cumulative COVID-19 infections, time to peak infections, and the timing and peak level of critical care occupancy. We also considered how these impacts might be mitigated through screening interventions targeted to students. If arriving students reduce their contacts by 40% compared to pre-COVID levels, the total number of infections in the community increases by 115% (from 3,515 to 7,551), with 70% of the incremental infections occurring in the general population, and an incremental 19 COVID-19 deaths. Screening students every 5 days reduces the number of infections attributable to the student population by 42% and the total COVID-19 deaths by 8. One-time mass screening of students prevents fewer infections than 5-day screening, but is more efficient, requiring 196 tests needed to avert one infection instead of 237. University students are highly inter-connected with the surrounding off-campus community. Screening targeted at this population provides significant public health benefits to the community through averted infections, critical care admissions, and COVID-19 deaths.

The cost-effectiveness of Canada's only supervised injection facility has not been rigorously evaluated. We estimated the impact of the facility on survival, rates of HIV and hepatitis C virus infection, referral to methadone maintenance treatment and associated costs. We simulated the population of Vancouver, British Columbia, including injection drug users and persons infected with HIV and hepatitis C virus. The model used a time horizon of 10 years and the perspective of the health care system. We compared the situation of the supervised injection facility with one that had no facility but that had other interventions, such as needle-exchange programs. The effects considered were decreased needle sharing, increased use of safe injection practices and increased referral to methadone maintenance treatment. Outcomes included life-years gained, costs, and incremental cost-effectiveness ratios discounted at 5% per year. Focusing on the base assumption of decreased needle sharing as the only effect of the supervised injection facility, we found that the facility was associated with an incremental net savings of almost $14 million and 920 life-years gained over 10 years. When we also considered the health effect of increased use of safe injection practices, the incremental net savings increased to more than $20 million and the number of life-years gained to 1070. Further increases were estimated when we considered all 3 health benefits: the incremental net savings was more than $18 million and the number of life-years gained 1175. Results were sensitive to assumptions related to injection frequency, the risk of HIV transmission through needle sharing, the frequency of safe injection practices among users of the facility, the costs of HIV-related care and of operating the facility, and the proportion of users who inject in the facility. Vancouver's supervised injection site is associated with improved health and cost savings, even with conservative estimates of efficacy. Une version française de ce résumé est disponible à l'adresse www.cmaj.ca/cgi/content/full/179/11/1143/DC1

To assess the cost effectiveness of adding cetuximab to platinum-based chemotherapy in first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) from the perspective of the Canadian public healthcare system. We developed a Markov state transition model to project the lifetime clinical and economic consequences of recurrent or metastatic HNSCC. Transition probabilities were derived from a phase III trial of cetuximab in patients with recurrent or metastatic HNSCC. Cost estimates were obtained from London Health Sciences Centre and the Ontario Case Costing Initiative, and expressed in 2011 CAD. A three year time horizon was used. Future costs and health benefits were discounted at 5%. In the base case, cetuximab plus platinum-based chemotherapy compared to platinum-based chemotherapy alone led to an increase of 0.093 QALY and an increase in cost of $36,000 per person, resulting in an incremental cost effectiveness ratio (ICER) of $386,000 per QALY gained. The cost effectiveness ratio was most sensitive to the cost per mg of cetuximab and the absolute risk of progression among patients receiving cetuximab. The addition of cetuximab to standard platinum-based chemotherapy in first-line treatment of patients with recurrent or metastatic HNSCC has an ICER that exceeds $100,000 per QALY gained. Cetuximab can only be economically attractive in this patient population if the cost of cetuximab is substantially reduced or if future research can identify predictive markers to select patients most likely to benefit from the addition of cetuximab to chemotherapy.

Background Some children with mental health (MH) problems have been found to receive ongoing care, either continuously or episodically. We sought to replicate patterns of MH service use over extended time periods, and test predictors of these patterns. Methods Latent class analyses were applied to 4 years of visit data from five MH agencies and nearly 6000 children, 4- to 13-years-old at their first visit. Results Five patterns of service use were identified, replicating previous findings. Overall, 14% of cases had two or more episodes of care and 23% were involved for more than 2 years. Most children (53%) were seen for just a few visits within a few months. Two patterns represented cases with two or more episodes of care spanning multiple years. In the two remaining patterns, children tended to have just one episode of care, but the number of sessions and length of involvement varied. Using discriminant function analyses, we were able to predict with just over 50% accuracy children’s pattern of service use. Severe externalizing behaviors, high impairment, and high family burden predicted service use patterns with long durations of involvement and frequent visits. Conclusions Optimal treatment approaches for children seen for repeated episodes of care or for care lasting multiple years need to be developed. Children with the highest level of need (severe pathology, impairment, and burden) are probably best served by providing high intensity services at the start of care.

To estimate the cost, effectiveness, and cost effectiveness of HIV and HCV screening of injection drug users (IDUs) in opioid replacement therapy (ORT). Dynamic compartmental model of HIV and HCV in a population of IDUs and non-IDUs for a representative U.S. urban center with 2.5 million adults (age 15-59). We considered strategies of screening individuals in ORT for HIV, HCV, or both infections by antibody or antibody and viral RNA testing. We evaluated one-time and repeat screening at intervals from annually to once every 3 months. We calculated the number of HIV and HCV infections, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). Adding HIV and HCV viral RNA testing to antibody testing averts 14.8-30.3 HIV and 3.7-7.7 HCV infections in a screened population of 26,100 IDUs entering ORT over 20 years, depending on screening frequency. Screening for HIV antibodies every 6 months costs $30,700/QALY gained. Screening for HIV antibodies and viral RNA every 6 months has an ICER of $65,900/QALY gained. Strategies including HCV testing have ICERs exceeding $100,000/QALY gained unless awareness of HCV-infection status results in a substantial reduction in needle-sharing behavior. Although annual screening for antibodies to HIV and HCV is modestly cost effective compared to no screening, more frequent screening for HIV provides additional benefit at less cost. Screening individuals in ORT every 3-6 months for HIV infection using both antibody and viral RNA technologies and initiating ART for acute HIV infection appears cost effective.

Background A 21-gene recurrence score (RS) assay may inform adjuvant systematic treatment decisions in women with early stage breast cancer. We sought to investigate the cost effectiveness of using the RS-assay versus current clinical practice (CCP) in women with early-stage estrogen- or progesterone-receptor-positive, axilliary lymph-node negative breast cancer (ER+/ PR + LN- ESBC) from the perspective of the Canadian public healthcare system. Methods We developed a Markov model to project the lifetime clinical and economic consequences of ESBC. We evaluated adjuvant therapy separately in post- and pre-menopausal women with ER+/ PR + LN- ESBC. We assumed that the RS-assay would reclassify pre- and post-menopausal women among risk levels (low, intermediate and high) and guide adjuvant systematic treatment decisions. The model was parameterized using 7 year follow up data from the Manitoba Cancer Registry, cost data from Manitoba administrative databases, and secondary sources. Costs are presented in 2010 CAD. Future costs and benefits were discounted at 5%. Results The RS-assay compared to CCP generated cost-savings in pre-menopausal women and had an ICER of $60,000 per QALY gained in post-menopausal women. The cost effectiveness was most sensitive to the proportion of women classified as intermediate risk by the RS-assay who receive adjuvant chemotherapy and the risk of relapse in the RS-assay model. Conclusions The RS-assay is likely to be cost effective in the Canadian healthcare system and should be considered for adoption in women with ER+/ PR + LN- ESBC. However, ongoing assessment and validation of the assay in real-world clinical practice is warranted.

Background We sought to determine the impact of delays to admission from the Emergency Department (ED) on inpatient length of stay (LOS), and IP cost. Methods We conducted a retrospective analysis of 13,460 adult (≥ 18 yrs) ED visits between April 1 2006 and March 30 2007 at a tertiary care teaching hospital with two ED sites in which the mode of disposition was admission to ICU, surgery or inpatient wards. We defined ED Admission Delay as ED time to decision to admit > 12 hours. The primary outcomes were IP LOS, and total IP cost. Results Approximately 11.6% (n = 1558) of admitted patients experienced admission delay. In multivariate analysis we found that admission delay was associated with 12.4% longer IP LOS (95% CI 6.6% - 18.5%) and 11.0% greater total IP cost (6.0% - 16.4%). We estimated the cumulative impact of delay on all delayed patients as an additional 2,183 inpatient days and an increase in IP cost of $2,109,173 at the study institution. Conclusions Delays to admission from the ED are associated with increased IP LOS and IP cost. Improving patient flow through the ED may reduce hospital costs and improve quality of care. There may be a business case for investments to reduce emergency department admission delays.