Cost-Effectiveness Analysis Comparing Biopsy in Advance of Ablation versus Concurrent Biopsy and Ablation for Small Renal Masses 1 to 3 cm.

PURPOSE: To analyze the cost-effectiveness of performing a renal mass biopsy in advance of ablation or concurrent with a percutaneous ablation procedure for the management of small renal masses (SRMs). METHODS: A decision-analytic model was developed with a cohort of 65-year-old male patients with an incidental, unilateral 1 to 3 cm SRM. A decision tree modeled the first year of clinical intervention, following which patients entered a Markov Model with a lifetime horizon. Patients were assumed to be treated in accordance to established clinical practice guidelines, including surveillance, repeat ablation for recurrence, and systemic therapy for metastasis. Healthcare cost and utility values were determined from published literature or local hospital estimates, discounted at 1.5%. Total lifetime costs were calculated from the perspective of a Canadian health-care payer and converted to 2022 Canadian dollars. The primary outcome was incremental cost effectiveness ratio (ICER), at a willingness-to-pay threshold of $50,000 per quality-adjusted life-years gained. The secondary outcome was ICER at a willingness-to-pay threshold of 50,000 $/LY gained. RESULTS: Concurrent biopsy and ablation resulted in a gain of 16.4 quality-adjusted days, at an incremental cost of $386, with an ICER of 8494 $/QALY. The concurrent strategy was the dominant for prevalence of benign mass below 5%. Sequential biopsy and ablation was only cost effective when life-years were not quality-adjusted, and ablation cost was greater than $4300 or benign mass prevalence was greater than 28%. CONCLUSION: Concurrent biopsy and ablation is cost-effective relative to pre-treatment diagnostic biopsy for management of incidental small renal masses.

A forecasting tool for a hospital to plan inbound transfers of COVID-19 patients from other regions.

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.

Cost-Effectiveness Analysis of Pharmacogenomics (PGx)-Based Warfarin, Apixaban, and Rivaroxaban Versus Standard Warfarin for the Management of Atrial Fibrillation in Ontario, Canada.

OBJECTIVE: To assess the cost-effectiveness of pharmacogenomics (PGx)-based warfarin (i.e., warfarin dosing following genetic testing), apixaban, and rivaroxaban oral anticoagulation versus standard warfarin for the treatment of newly diagnosed patients with nonvalvular atrial fibrillation (AF) aged ≥ 65 years. METHODS: We developed a Markov decision-analytic model to compare costs [2017 Canadian dollars (C$)] and quality-adjusted life years (QALYs) from the Ontario health care payer perspective over a life-time horizon. The parameters used in the model were derived from the published literature, the Ontario health care administrative database, and expert opinion. To account for the uncertainty of model parameters, we conducted extensive deterministic and probabilistic sensitivity analyses. The results were summarized using incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves. RESULTS: We found that PGx-based warfarin had an ICER of C$17,584/QALY compared with standard warfarin, and apixaban had an ICER of C$64,590/QALY compared with PGx-based warfarin in our base-case analysis. Rivaroxaban was extendedly dominated by PGx-based warfarin and apixaban. The probabilistic sensitivity analysis showed that apixaban, rivaroxaban, PGx-based warfarin, and standard warfarin were cost-effective at some willingness-to-pay (WTP) thresholds. PGx-based warfarin had a higher probability of being cost-effective than apixaban (51.3% versus 14.3%) at a WTP threshold of C$50,000/QALY. At a WTP threshold of C$100,000/QALY, apixaban had a higher probability of being cost-effective than PGx-based warfarin (54.6% versus 22.6%). CONCLUSION: We found that PGx-based warfarin for patients with AF is cost-effective at a WTP threshold of C$50,000/QALY. Apixaban had a higher probability of being cost-effective (> 50%) at a WTP threshold of C$93,000/QALY.

Primary care services and emergency department visits in blended fee-for-service and blended capitation models: evidence from Ontario, Canada.

INTRODUCTION: It is well-known that the way physicians are remunerated can affect delivery of health care services to the population. Fee-for-service (FFS) generally leads to oversupply of services, while capitation leads to undersupply of services. However, little evidence exists on the link between remuneration and emergency department (ED) visits. We fill this gap using two popular blended models introduced in Ontario, Canada: the Family Health Group (FHG), an enhanced/blended FFS model, and Family Health Organization (FHO), a blended capitation model. We compare primary care services and rates of emergency department ED visits between these two models. We also evaluate whether these outcomes vary by regular- and after-hours, and patient morbidity status. METHODS: Physicians practicing in an FHG or FHO between April 2012 and March 2017 and their enrolled adult patients were included for analyses. The covariate-balancing propensity score weighting method was used to remove the influence of observable confounding and negative-binomial and linear regression models were used to evaluate the rates of primary care services, ED visits, and the dollar value of primary care services delivered between FHGs and FHOs. Visits were stratified as regular- and after-hours. Patients were stratified into three morbidity groups: non-morbid, single-morbid, and multimorbid (two or more chronic conditions). RESULTS: 6184 physicians and their patients were available for analysis. Compared to FHG physicians, FHO physicians delivered 14% (95% CI 13%, 15%) fewer primary care services per patient per year, with 27% fewer services during after-hours (95% CI 25%, 29%). Patients enrolled to FHO physicians made 27% more less-urgent (95% CI 23%, 31%) and 10% more urgent (95% CI 7%, 13%) ED visits per patient per year, with no difference in very-urgent ED visits. Differences in the pattern of ED visits were similar during regular- and after-hours. Although FHO physicians provided fewer services, multimorbid patients in FHOs made fewer very-urgent and urgent ED visits, with no difference in less-urgent ED visits. CONCLUSION: Primary care physicians practicing in Ontario's blended capitation model provide fewer primary care services compared to those practicing in a blended FFS model. Although the overall rate of ED visits was higher among patients enrolled to FHO physicians, multimorbid patients of FHO physicians make fewer urgent and very-urgent ED visits.

Forecasting ICU Census by Combining Time Series and Survival Models.

Capacity planning of ICUs is essential for effective management of health safety, quality of patient care, and the allocation of ICU resources. Whereas ICU length of stay (LOS) may be estimated using patient information such as severity of illness scoring systems, ICU census is impacted by both patient LOS and arrival patterns. We set out to develop and evaluate an ICU census forecasting algorithm using the Multiple Organ Dysfunction Score (MODS) and the Nine Equivalents of Nursing Manpower Use Score (NEMS) for capacity planning purposes. DESIGN: Retrospective observational study. SETTING: We developed the algorithm using data from the Medical-Surgical ICU (MSICU) at University Hospital, London, Canada and validated using data from the Critical Care Trauma Centre (CCTC) at Victoria Hospital, London, Canada. PATIENTS: Adult patient admissions (7,434) to the MSICU and (9,075) to the CCTC from 2015 to 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We developed an Autoregressive integrated moving average time series model that forecasts patients arriving in the ICU and a survival model using MODS, NEMS, and other factors to estimate patient LOS. The models were combined to create an algorithm that forecasts ICU census for planning horizons ranging from 1 to 7 days. We evaluated the algorithm quality using several fit metrics. The root mean squared error ranged from 2.055 to 2.890 beds/d and the mean absolute percentage error from 9.4% to 13.2%. We show that this forecasting algorithm provides a better fit when compared with a moving average or a time series model that directly forecasts ICU census. Additionally, we evaluated the performance of the algorithm using data during the global COVID-19 pandemic and found that the error of the forecasts increased proportionally with the number of COVID-19 patients in the ICU. CONCLUSIONS: It is possible to develop accurate tools to forecast ICU census. This type of algorithm may be important to clinicians and managers when planning ICU capacity as well as staffing and surgical demand planning over a short time horizon.

Pfizer and Palbociclib in China: Analyzing an Oncology Pay-for-Performance Plan.

OBJECTIVES: China is poised to become the world's second-largest oncology drug market. Its ability to continue broadening health coverage is in question. Institutional innovations such as performance-based risk-sharing agreements (PBRSAs) have been developed to promote access to novel therapeutics beyond that provided by public health insurance and central procurement systems. We examine in depth the financial implications of a PBRSA developed in China for the breast cancer drug palbociclib. METHODS: We generated a 2-state Markov model from PBRSA information made publicly available. Model inputs included breast cancer outcomes data from the published literature. The primary analysis estimates the percentage reduction in overall drug expenditures due to the PBRSA. Sensitivity analyses explored the financial impact of varied computed tomography scan utilization, rebate rate, and rebate duration. RESULTS: Estimated palbociclib expenditures for the PBRSA cohort totaled $36 278 000. Based on the publicly available information for the PBRSA, an effective discount of 1.3% was estimated. The effective discount was insensitive to changes in computed tomography scan utilization. CONCLUSIONS: The palbociclib PBRSA likely had negligible impact on patient access to therapy and limited downstream financial impact to patients and payers. The short duration of the rebate window, small rebate, and disease indolence contributed to the low expected rebate percentage.

Impact of university re-opening on total community COVID-19 burden.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. INTERPRETATION: 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.

Re-Accessing Mental Health Care After Age 18: A Longitudinal Cohort Study of Youth Involved with Community-based Child and Youth Mental Health Agencies in Ontario.

OBJECTIVE: About 20-26% of children and youth with a mental health disorder (depending on age and respondent) report receiving services from a community-based Child and Youth Mental Health (CYMH) agency. However, because agencies have an upper age limit of 18-years old, youth requiring ongoing mental health services must "transition" to adult-oriented care. General healthcare providers (e.g., family physicians) likely provide this care. The objective of this study was to compare the likelihood of receiving physician-based mental health services after age 18 between youth who had received community-based mental health services and a matched population sample. METHOD: A longitudinal matched cohort study was conducted in Ontario, Canada. A CYMH cohort that received mental health care at one of five CYMH agencies, aged 7-14 years at their first visit (N=2,822), was compared to age, sex, region-matched controls (N=8,466). RESULTS: CYMH youth were twice as likely as the comparison sample to have a physician-based mental health visit (i.e., by a family physician, pediatrician, psychiatrists) after age 18; median time to first visit was 3.3 years. Having a physician mental health visit before age 18 was associated with a greater likelihood of experiencing the outcome than community-based CYMH services alone. CONCLUSION: Most youth involved in community-based CYMH agencies will re-access services from physicians as adults. Youth receiving mental health services only within community agencies, and not from physicians, may be less likely to receive physician-based mental health services as adults. Collaboration between CYMH agencies and family physicians may be important for youth who require ongoing care into adulthood.

OBJECTIF: Environ 20 à 26 % des enfants et des adolescents souffrant d'un trouble de santé mentale (dépendant de l'âge et du répondant) déclarent recevoir des services d'un organisme communautaire de santé mentale pour enfants et adolescents (SMEA) Toutefois, puisque les organismes ont une limite d'âge supérieur de 18 ans, les jeunes nécessitant des services de santé mentale doivent faire la « transition ¼ aux soins pour adultes. Les prestataires de soins de santé généraux (p. ex., les médecins de famille) dispensent probablement ces services. La présente étude visait à comparer la probabilité de recevoir des services de santé mentale par un médecin après l'âge de 18 ans entre un jeune qui avait reçu des services de santé mentale et un échantillon apparié dans la population. MÉTHODE: Une étude de cohorte longitudinale appariée a été menée en Ontario, Canada. Une cohorte SMEA qui recevait des soins de santé mentale à l'un des cinq organismes SMEA, âgés entre 7 et 14 ans à leur première visite (N = 2,822), a été comparée pour l'âge, le sexe, les contrôles appariés par région (N = 8,466). RÉSULTATS: Les jeunes des SMEA étaient deux fois plus susceptibles que l'échantillon de comparaison d'avoir une visite de santé mentale par un médecin (c.-à-d. par un pédiatre médecin de famille, des psychiatres) après l'âge de 18 ans le temps moyen avant une première visite était 3,3 ans. Avoir une visite de santé mentale avec un médecin avant l'âge de 18 ans était associé à une plus grande probabilité de connaître le résultat que par les services SMEA communautaires à eux seuls. CONCLUSION: La plupart des jeunes impliqués dans les organismes communautaires SMEA accéderont de nouveau aux services de médecins en tant qu'adulte. Les jeunes recevant des services de santé mentale uniquement d'organismes communautaires et non de médecins peuvent être moins susceptibles de recevoir des services de santé mentale par un médecin en tant qu'adultes. La collaboration entre les organismes SMEA et les médecins de famille peut être importante pour les jeunes qui nécessitent des soins constants à l'âge adulte.

How Risky Is That Risk Sharing Agreement? Mean-Variance Tradeoffs and Unintended Consequences of Six Common Risk Sharing Agreements.

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.

Emergency department use following incentives to provide after-hours primary care: a retrospective cohort study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. INTERPRETATION: 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.

Quality of Diabetes Care in Blended Fee-for-Service and Blended Capitation Payment Systems.

OBJECTIVES: In the middle to late 2000s, many family physicians switched from a Family Health Group (FHG; a blended fee-for-service model) to a Family Health Organization (FHO; a blended capitation model) in Ontario, Canada. The evidence on the link between physician remuneration schemes and quality of diabetes care is mixed in the literature. We examined whether physicians who switched from the FHG to FHO model provided better care for individuals living with diabetes relative to those who remained in the FHG model. METHODS: Using longitudinal health administrative data from 2006 to 2016, we investigated the impact of physicians switching from FHG to FHO on 8 quality indicators related to diabetes care. Because FHO physicians are likely to be systematically different from FHGs, we employed propensity-score-based inverse probability-weighted fixed-effects regression models. All analyses were conducted at the physician level. RESULTS: We found that FHO physicians were more likely to provide glycated hemoglobin testing by 2.75% (95% confidence interval [CI], 1.89% to 3.60%), lipid assessment by 2.76% (CI, 1.95% to 3.57%), nephropathy screening by 1.08% (95% CI, 0.51% to 1.66%) and statin prescription by 1.08% (95% CI, 0.51% to 1.66%). Patients under FHOs had a lower estimated risk of mortality by 0.0124% (95% CI, 0.0123% to 0.0126%) per physician per year. However, FHG and FHO physicians were similar for annual eye examination, prescription of angiotensin-converting enzyme inhibitors (or angiotensin II receptor blockers) and patients' risk of avoidable diabetes-related hospitalizations. CONCLUSIONS: Compared with blended fee-for-service, blended capitation payment is associated with a small, but statistically significant, improvement in some aspects of diabetes care.

Is SABR Cost-Effective in Oligometastatic Cancer? An Economic Analysis of the SABR-COMET Randomized Trial.

PURPOSE: The phase 2 randomized study SABR-COMET demonstrated that in patients with controlled primary tumors and 1 to 5 oligometastatic lesions, SABR was associated with improved progression-free survival (PFS) compared with standard of care (SoC), but with higher costs and treatment-related toxicities. The aim of this study was to assess the cost-effectiveness of SABR versus SoC in this setting. METHODS AND MATERIALS: A Markov model was constructed to perform a cost-utility analysis from the Canadian health care system perspective. Utility values and transition probabilities were derived from individual-level data from the SABR-COMET trial. One-way, 2-way, and probabilistic sensitivity analyses were performed. Costs were expressed in 2018 CAD. A separate analysis based on US payer's perspective was performed. An incremental cost-effectiveness ratio (ICER) at a willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) was used. RESULTS: In the base case scenario, SABR was cost-effective at an ICER of $37,157 per QALY gained. This finding was most sensitive to the number of metastatic lesions treated with SABR (ICER: $28,066 per QALY for 2, increasing to $64,429 per QALY for 5), difference in chemotherapy use (ICER: $27,173-$53,738 per QALY), and PFS hazard ratio (HR) between strategies (ICER: $31,548-$53,273 per QALY). Probabilistic sensitivity analysis revealed that SABR was cost-effective in 97% of all iterations. Two-way sensitivity analysis demonstrated a nonlinear relationship between the number of lesions and the PFS HR. To maintain cost-effectiveness for each additional metastasis, the HR must decrease by approximately 0.047. The US cost analysis yielded similar results, with an ICER of $54,564 (2018 USD per QALY) for SABR. CONCLUSIONS: SABR is cost-effective for patients with 1 to 5 oligometastatic lesions compared with SoC.

Stirring the pot: Switching from blended fee-for-service to blended capitation models of physician remuneration.

In Canada's most populous province, Ontario, family physicians may choose between the blended fee-for-service (Family Health Group [FHG]) and blended capitation (Family Health Organization [FHO] payment models). Both models incentivize physicians to provide after-hours (AH) and comprehensive care, but FHO physicians receive a capitation payment per enrolled patient adjusted for age and sex, plus a reduced fee-for-service while FHG physicians are paid by fee-for-service. We develop a theoretical model of physician labor supply with multitasking to predict their behavior under FHG and FHO, and estimable equations are derived to test the predictions empirically. Using health administrative data from 2006 to 2014 and a two-stage estimation strategy, we study the impact of switching from FHG to FHO on the production of a capitated basket of services, after-hours services and nonincentivized services. Our results reveal that switching from the FHG to FHO reduces the production of capitated services to enrolled patients and services to nonenrolled patients by 15% and 5% per annum and increases the production of after-hours and nonincentivized services by 8% and 15% per annum.

The impact of the diabetes management incentive on diabetes-related services: evidence from Ontario, Canada.

Financial incentives have been introduced in several countries to improve diabetes management. In Ontario, the most populous province in Canada, a Diabetes Management Incentive (DMI) was introduced to family physicians practicing in patient enrollment models in 2006. This paper examines the impact of the DMI on diabetes-related services provided to individuals with diabetes in Ontario. Longitudinal health administrative data were obtained for adults diagnosed with diabetes and their family physicians. The study population consisted of two groups: DMI group (patients enrolled with a family physician exposed to DMI for 3 years), and comparison group (patients affiliated with a family physician ineligible for DMI throughout the study period). Diabetes-related services was measured using the Diabetic Management Assessment (DMA) billing code claimed by patient's physician. The impact of DMI on diabetes-related services was assessed using difference-in-differences regression models. After adjusting for patient- and physician-level characteristics, patient fixed-effects and patient-specific time trend, we found that DMI increased the probability of having at least one DMA fee code claimed by patient's physician by 9.3% points, and the probability of having at least three DMA fee codes claimed by 2.1% points. Subgroup analyses revealed the impact of DMI was slightly larger in males compared to females. We found that Ontario's DMI was effective in increasing the diabetes-related services provided to patients diagnosed with diabetes in Ontario. Financial incentives for physicians help improve the provision of targeted diabetes-related services.

The impact of improved access to after-hours primary care on emergency department and primary care utilization: A systematic review.

Access to after-hours primary care is problematic in many developed countries, leading patients to instead visit the emergency department for non-urgent conditions. However, emergency department utilization for conditions treatable in primary care settings may contribute to emergency department overcrowding and increased health system costs. This systematic review examines the impact of various initiatives by developed countries to improve access to after-hours primary care on emergency department and primary care utilization. We performed a systematic review on the impact of improved access to after-hours primary and searched CINAHL, EMBASE, MEDLINE, and Scopus. We identified 20 studies that examined the impact of improved access to after-hours primary care on ED utilization and 6 studies that examined the impact on primary care utilization. Improved access to after-hours primary care was associated with increased primary care utilization, but had a mixed effect on emergency department utilization, with limited evidence of a reduction in non-urgent and semi-urgent emergency department visits. Although our review suggests that improved access to after-hours primary care may limit emergency department utilization by shifting patient care from the emergency department back to primary care, rigorous research in a given institutional context is required before introducing any initiative to improve access to after-hours primary care.

Cost-effectiveness analysis of multigene expression profiling assays to guide adjuvant therapy decisions in women with invasive early-stage breast cancer.

Gene expression profiling (GEP) testing using 12-gene recurrence score (RS) assay (EndoPredict®), 58-gene RS assay (Prosigna®), and 21-gene RS assay (Oncotype DX®) is available to aid in chemotherapy decision-making when traditional clinicopathological predictors are insufficient to accurately determine recurrence risk in women with axillary lymph node-negative, hormone receptor-positive, and human epidermal growth factor-receptor 2-negative early-stage breast cancer. We examined the cost-effectiveness of incorporating these assays into standard practice. A decision model was built to project lifetime clinical and economic consequences of different adjuvant treatment-guiding strategies. The model was parameterized using follow-up data from a secondary analysis of the Anastrozole or Tamoxifen Alone or Combined randomized trial, cost data (2017 Canadian dollars) from the London Regional Cancer Program (Canada) and secondary Canadian sources. The 12-gene, 58-gene, and 21-gene RS assays were associated with cost-effectiveness ratios of $36,274, $48,525, and $74,911/quality-adjusted life year (QALY) gained and resulted in total gains of 379, 284.3, and 189.5 QALYs/year and total budgets of $12.9, $14.2, and $16.6 million/year, respectively. The total expected-value of perfect information about GEP assays' utility was $10.4 million/year. GEP testing using any of these assays is likely clinically and economically attractive. The 12-gene and 58-gene RS assays may improve the cost-effectiveness of GEP testing and offer higher value for money, although prospective evidence is still needed. Comparative field evaluations of GEP assays in real-world practice are associated with a large societal benefit and warranted to determine the optimal and most cost-effective assay for routine use.

Predicting patterns of service utilization within children's mental health agencies.

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.

The impact of pharmaceutical marketing on market access, treatment coverage, pricing, and social welfare.

Pharmaceutical spending in the United States, Canada, and the EU is growing. Public payers cover a large portion of these costs and have responded by instituting various pricing and access policies to limit their expenditure. One challenge that public payers face is additional demand induced by a manufacturer's marketing effort. We use a game theoretic approach to study the impact of pharmaceutical marketing on six practical pricing and access policies: negotiated pricing, open pricing, controlled pricing, a listing process, a risk-sharing arrangement, and a value-based pricing with risk-sharing arrangement. We find that all non-value-based policies result in either restricted access or suboptimal treatment coverage. We find that marketing is the highest in the first-best setting where all decisions are made by a social planner. We also find that the value-based pricing with risk-sharing arrangement is preferred by the manufacturer and from a societal perspective whereas no policy is universally preferred by a health care payer. A value-based pricing with risk-sharing arrangement always results in zero net monetary benefit for a health care payer. Therefore, considering non-value-based arrangements, we find that a negotiated pricing policy, a controlled pricing policy, or a risk-sharing arrangement may be socially preferred.