Progress toward Health System Readiness for Genome-Based Testing in Canada.

(1) Background: Genomic medicine harbors the real potential to improve the health and healthcare journey of patients, care provider experiences, and improve the health system efficiency-even reducing healthcare costs. There is expected to be an exponential growth in medically necessary new genome-based tests and test approaches in the coming years. Testing can also create scientific research and commercial opportunities beyond healthcare decision making. The purpose of this research is to generate a better understanding of Canada's state of readiness for genomic medicine, and to provide some insights for other healthcare systems. (2) Methods: A mixed-methods approach of a review of the literature and key informant interviews with a purposive sample of experts was used. The health system readiness was assessed using a previously published set of conditions. (3) Results: Canada has created some of the established conditions, but further action needs to be taken to improve the state of readiness for genome-based medicine. The important gaps to be filled are the need for linked information systems and data integration; evaluative processes that are timely and transparent; navigational tools for care providers; dedicated funding to facilitate rapid onboarding and support test development and proficiency testing; and broader engagement with innovation stakeholders beyond care providers and patients. These findings highlight the role of the organizational context, social influence, and other factors that are known to affect the diffusion of innovation within health systems.

Return on investment from service transformation for young people experiencing mental health problems: Approach to economic evaluations in ACCESS Open Minds (Esprits ouverts), a multi-site pan-Canadian youth mental health project.

Introduction: Mental health problems are common globally, and typically have their onset in adolescence and early adulthood-making youth (aged 11-25) an optimal target for prevention and early intervention efforts. While increasing numbers of youth mental health (YMH) initiatives are now underway, thus far few have been subject to economic evaluations. Here we describe an approach to determining the return on investment of YMH service transformation via the pan-Canadian ACCESS Open Minds (AOM) project, for which a key focus is on improving access to mental health care and reducing unmet need in community settings. Approach: As a complex intervention package, it is hoped that the AOM transformation will: (i) enable early intervention through accessible, community-based services; (ii) shift care away toward these primary/community settings and away from acute hospital and emergency services; and (iii) offset at least some of the increased costs of primary care/community-based mental health services with reductions in the volume of more resource-intensive acute, emergency, hospital or specialist services utilized. Co-designed with three diverse sites that represent different Canadian contexts, a return on investment analysis will (separately at each site) compare the costs generated by the intervention, including volumes and expenditures associated with the AOM service transformation and any contemporaneous changes in acute, emergency, hospital or service utilization (vs. historical or parallel comparators). Available data from health system partners are being mobilized to assess these hypotheses. Anticipated results: Across urban, semi-urban and Indigenous sites, the additional costs of the AOM transformation and its implementation in community settings are expected to be at least partially offset by a reduction in the need for acute, emergency, hospital or specialist care. Discussion: Complex interventions such as AOM aim to shift care "upstream": away from acute, emergency, hospital and specialist services and toward community-based programming which is more easily accessible, often more appropriate for early-stage presentations, and more resource-efficient. Carrying out economic evaluations of such interventions is challenging given the constraints of available data and health system organization. Nonetheless, such analyses can advance knowledge, strengthen stakeholder engagement, and further implementation of this public health priority.

Effective and Efficient Delivery of Genome-Based Testing-What Conditions Are Necessary for Health System Readiness?

Health systems internationally must prepare for a future of genetic/genomic testing to inform healthcare decision-making while creating research opportunities. High functioning testing services will require additional considerations and health system conditions beyond traditional diagnostic testing. Based on a literature review of good practices, key informant interviews, and expert discussion, this article attempts to synthesize what conditions are necessary, and what good practice may look like. It is intended to aid policymakers and others designing future systems of genome-based care and care prevention. These conditions include creating communities of practice and healthcare system networks; resource planning; across-region informatics; having a clear entry/exit point for innovation; evaluative function(s); concentrated or coordinated service models; mechanisms for awareness and care navigation; integrating innovation and healthcare delivery functions; and revisiting approaches to financing, education and training, regulation, and data privacy and security. The list of conditions we propose was developed with an emphasis on describing conditions that would be applicable to any healthcare system, regardless of capacity, organizational structure, financing, population characteristics, standardization of care processes, or underlying culture.

Optimizing the delivery of genetic and advanced diagnostic testing in the province of Ontario: challenges and implications for laboratory technology assessment and management in decentralized healthcare systems.

AIMS: The Canadian province of Ontario provides full coverage for its residents (pop.14.8 M) for hospital-based diagnostic testing. Historical governance of the healthcare system and a legacy scheme of health technology assessment (HTA) and financing has led to a suboptimal approach of adopting advanced diagnostic technology (i.e. protein expression, cytogenetic, and molecular/genetic) for guiding therapeutic decisions. The aim of this research is to explore systemic barriers and provide guidance to improve patient and care provider experiences by reducing delays and inequity of access to testing, while benefitting laboratory innovators and maximizing system efficiency. MATERIALS AND METHODS: A mixed-methods approach including literature review, semi-structured interviews, and a multi-stakeholder forum involving patient representatives (n = 1), laboratory leaders (n = 6), physicians (n = 5), Ministry personnel (n = 4), administrators (n = 3), extra-provincial experts, and researchers (n = 7), as well as pharmaceutical (n = 5) and diagnostic companies (n = 2). The forum considered evidence of good practices in adoption, implementation, and financing laboratory services and identified barriers as well as feasible options for improving advanced diagnostic testing in Ontario. RESULTS: Overarching challenges identified included: barriers to define what is needed; need for a clear approach to adoption; and the need for more oversight and coordination. Recommendations to address these included a shift to an anticipatory system of test adoption, creating a fit-for-purpose system of health technology management that consolidates existing evaluation processes, and modernizing the governance and financing of testing so that it is managed at a care-delivery level. CONCLUSIONS: The proposals for change in Ontario highlight the role that HTA, governance, and financing of health technology play along the continuum of a health technology life cycle within a healthcare system where decision-making is highly decentralized. Resource availability and capacity were not a concern - instead, solutions require higher levels of coordination and system integration along with innovative approaches to HTA.

Can you afford to keep practising? Family medicine finances transformed by COVID-19 in Alberta.

OBJECTIVE: To estimate the impact of the coronavirus disease 2019 (COVID-19) pandemic on FP finances in Alberta. DESIGN: A financial model that included fees, visits per day, number of days of practice, and overhead costs. SETTING: Alberta before, during, and after the COVID-19 pandemic. PARTICIPANTS: Hypothetical fee-for-service FP practices. INTERVENTIONS: Changes in practice modes caused by the pandemic and changes to fees set by the Government of Alberta (no interventions were controlled by the researchers). MAIN OUTCOME MEASURES: Annual average FP billings and annual average FP income after overhead expenses. RESULTS: Practice changes related to COVID-19 could result in a reduction in average FP income (billings after expenses) of 27% to 78%. CONCLUSION: Practice pattern changes, including the rapid adoption of telemedicine owing to the COVID-19 pandemic, will reduce incomes for fee-for-service community FP practices in Alberta. Fees at current levels could make some practices unsustainable.

Gross profits of Canadian pharmacies: A changing policy regime.

Recently, both the Canadian and provincial governments have instituted policies to reduce manufacturers' prices for generic ($250 million sales annually) and brand name ($1,300 million sales annually) drugs. Both government groups made estimates of the financial magnitude of changes in drug prices, but neither has estimated the impact on retail pharmacies. We used a Cost-Volume-Profit model combined with operational data collected nationally to estimate the national impact of the pricing policy changes on pharmacy gross profits. Results show the average value of gross profits per pharmacy per year was approximately $440,000. It is estimated that the policy changes will lead to a 6.8% reduction in gross profits. Adding reductions in rebates for generic drugs, the pharmacies' reductions in gross profits will be 7.2%. In conclusion, policy-makers often ignore how their pricing changes influence the financial position of pharmacies, even though the impact can be substantial.

The Costs of Industry-Sponsored Drug Trials in Canada.

OBJECTIVE: The objective of this study was to estimate the provincial and nationwide costs of industry-sponsored drug clinical trials (CTs) in Canada. METHODS: We used the Aggregate Analysis of ClinicalTrials.gov (AACT) database, and included all industry-sponsored drug CTs that were conducted in Canada and completed in 2016. We estimated the costs of the study drugs using the market price. Estimates of the costs of management and patient services were based on industry contracts. RESULTS: The sample included 394 CTs that were conducted in 2039 facilities in Canada and provided services for 20,126 Canadian enrollees. Two-thirds of the CTs (277 of 394) were in the non-cancer category. On average, the drug costs per patient were 89,680 Canadian dollars ($Can) during the lifespan of the CTs, and were higher in cancer CTs than in non-cancer CTs ($Can216,876 vs. $Can65,274). The total costs of industry-sponsored drug CTs completed in 2016 was $Can2093.7 million. Drug costs accounted for the majority of this total ($Can1804.9 million). Ontario ($Can781.2 million) and Quebec ($Can757.5 million) had the highest costs. CONCLUSION: The costs of industry-sponsored drug CTs completed in 2016 when measured in terms of market prices in Canada were valued at $Can2.1 billion.

Publicly funded clinical research in Canada.

Clinical research is funded by industry, governments, charities, and hospitals. It is important to know the economic commitment of the various funding bodies, but until now there has been no national source available which provides these data. We surveyed the major funders to provide such a measure. There is evidence that government and charity funding of medical research is a trigger for private sector research investment; therefore, tracking all sources of funding for clinical research will provide policy-makers with an overall picture of health research funding. These data support policy decision-making related to clinical research in Canada.

Corrigendum to "Cost-Effectiveness of the Aerobika® Oscillating Positive Expiratory Pressure Device in the Management of Chronic Obstructive Pulmonary Disease Exacerbations in Canada".

[This corrects the article DOI: 10.1155/2019/9176504.].

The Costs of Industry-Sponsored Medical Device Clinical Trials in Alberta.

OBJECTIVE: Our objective was to describe the costs of industry-sponsored clinical trials for medical devices in Northern Alberta, Canada. METHODS: We used centralized data to identify all industry-sponsored medical device clinical trials initiated in Northern Alberta from 2012 to 2016. For each arm of each trial, we calculated the price of devices provided by the sponsor and the cost of clinical and administrative services that were incurred to clinically operationalize the treatment. RESULTS: Our sample consisted of 18 device trials initiated between January 2012 and January 2016. The overall cost (Canadian dollars [$Can], year 2018 values) per enrolee was $Can18,243 for the experimental arm and $Can13,827 for the control arm. Devices were the highest cost component, at $Can13,446 per enrollee in the experimental arm. Clinical costs in the control arms were higher on average ($Can7202 vs. 2504) than those in the experimental arms. CONCLUSION: Data from industry-sponsored clinical trials can provide important information on the full costs of device-related interventions. As device costs rise, and as policy makers require more evidence on device-related treatments, the cost of medical device-driven interventions should be documented along with their effectiveness.

Use of Real-World Data Sources for Canadian Drug Pricing and Reimbursement Decisions: Stakeholder Views and Lessons for Other Countries.

BACKGROUND: Canada has a long history of the use of clinical evidence to support healthcare decision making. Given improvements in data holdings and analytic capacity in Canada and stakeholder interest, the purpose of this study is to reflect on perceptions of the value of real-world evidence in pricing and reimbursement decisions, barriers to its optimal use in pricing and reimbursement, current initiatives that may lead to its increased use, and what role the pharmaceutical industry may play in this.Methods/ResultsTo capture stakeholder perceptions, ninety-one participants identified as key stakeholders were identified according to background roles and geography and invited to participate in four round table discussions conducted under Chatham House rule. Important themes emerging from these discussions included: (i) the need to understand what "real world" evidence means; (ii) barriers to using real world evidence from differences in access, governance, inter-operability, system structures, expertise, and quality across Canadian health systems; (iii) differing views on industry's role. CONCLUSIONS: The use of real-world data in Canada to inform pricing and reimbursement decisions is far from routine but nascent and slowly increasing. Barriers, including interoperability concerns, may also apply to other federated health systems that need to focus on the networking of healthcare administrative data across provincial jurisdictional boundaries. There also appears to be a desire to see better use of pragmatic trials linked to these administrative data sets. Emerging initiatives are under way to use real world evidence more broadly, and include identification of common data elements and approaches to networking data.

Cost-Effectiveness of the Aerobika® Oscillating Positive Expiratory Pressure Device in the Management of Chronic Obstructive Pulmonary Disease Exacerbations in Canada.

Background: The Aerobika® oscillating positive expiratory pressure (OPEP) device is a hand-held, drug-free medical device that has been shown to improve lung function and improve health-related quality of life in patients with chronic obstructive pulmonary disease (COPD). We estimated the cost-effectiveness of this device among postexacerbation COPD patients in the Canadian healthcare system. Methods: We performed a cost-utility analysis using a Markov model to compare both costs and outcome of patients with COPD who had recently experienced an exacerbation between 2 treatment arms: patients who used the Aerobika® device and patients who did not use the Aerobika® device. This cost-utility analysis included costs based on the Alberta healthcare system perspective as these represent Canadian experience. A one-year horizon with 12 monthly cycles was used. Results: For a patient after 1 year, the use of the Aerobika® device would save $694 in healthcare costs and produce 0.04 more in quality-adjusted life years (QALYs) in comparison with no positive expiratory pressure (PEP)/OPEP therapy. In other words, the economic outcome of the device was dominant (i.e., more effective and less costly). The probability for this device to be the dominant strategy was 72%. With a willingness to pay (WTP) threshold of $50,000 per QALY gained, the probability for the Aerobika® device to be cost-effective was 77%. Conclusions: Given one of the major treatment goals in the GOLD guidelines is to minimize the negative impact of exacerbations and prevent re-exacerbations, the Aerobika® OPEP device should be viewed as a potential component of a treatment strategy to improve symptom control and reduce the risk of re-exacerbations in patients with COPD.

The Public Cost of Mental Health- and Addiction-Related Services for Youth (Ages 12-17) in Alberta.

OBJECTIVE: To measure the provincial government cost of mental health-related activities for youth ages 12 to 17 in Alberta in 2014 to 2015. METHODS: The target population was Alberta youth ages 12 to 17 (the federal justice definition) who received or were funded for mental health-related or complementary services from Alberta Health Services, Alberta Health, Alberta Human Services, Alberta Justice and Solicitor General, and Alberta Education (public schools). Data on services and expenditures were obtained from each source for the target youth population. RESULTS: Costs for mental health-related services for all ministries were $175 million for 27,169 youth who used mental health services as defined by Policy Wise, $6460 per youth. Public school special education supplements for youth with emotional problems was the largest group, amounting to 30% of all costs. Other prominent sources of expenditures were hospital inpatient mental health services (18%), community mental health services (11%), physician mental health services (10%), and secure services with treatment requiring judicial approval (9%). CONCLUSION: Economists in several countries have developed countrywide measures of mental health expenditures and have used these to generate national benchmarks for mental health spending. We have estimated spending for Alberta provincial mental health and addiction services for a distinct and highly vulnerable group. This measure can be used to develop measures and benchmarks for other provinces, which will be valuable policy indicators.

Public Expenditures for Mental Health Services in Canadian Provinces: Dépenses publiques pour les services de santé mentale dans les provinces canadiennes.

OBJECTIVE: The purpose of this study is to measure provincial spending for mental health services in fiscal year (FY) 2013 and to compare these cost estimates to those of FY 2003. METHODS: This study estimated the costs of publicly funded provincial mental health services in FY 2013 and compared them to the estimates for FY 2003 from a previously published report. Our data were obtained from publicly accessible databases. The cross-year cost comparisons for provincial mental health services were restricted to general and psychiatric hospital inpatients, clinical payments to physicians and psychologists, and prescribed psychotropic medications. Total public expenditures were inflation adjusted and expressed per capita and as a percentage of the total provincial health spending. RESULTS: Total public spending for mental health and addiction programs/services was estimated to be $6.75 billion for FY 2013. The largest component of the expenditures was hospital inpatient services ($4.02 billion, 59.6%), followed by clinical payments to physicians or psychologists ($1.69 billion, 25%), and then publicly funded prescribed psychotherapeutic medications ($1.04 billion, 15.4%). Nationally, the portion of total public spending on health that was spent on mental health decreased from FY 2003 to FY 2013 from 5.4% to 4.9%. CONCLUSION: Our results reveal that mental health spending, as a proportion of public health care expenditures, decreased in the decade from FY 2003 to FY 2013. Due to large differences in how the provinces report community mental health services, we still lack a comprehensive picture of the mental health system.

The Economic Contribution of Industry-Sponsored Pharmaceutical Clinical Trials.

PURPOSE: In pharmaceutical clinical trials, industrial sponsors pay for study drugs and related healthcare services. We conducted a study to determine industry's economic contribution of these trials to the Alberta healthcare system.  Methods: We used data from two trial centers for cancer and non-cancer trials at the University of Alberta. For each trial (cancer, non-cancer), we calculated the cost of drugs provided by the sponsors using the market price, the cost of clinical services, and the cost of administrative services that they paid. We extrapolated these results to all trials in Alberta based on information obtained from the registration website ClinicalTrials.gov.  Results: Our sample consisted of 40 non-cancer and 39 cancer drug trials which were initiated in 2012. The monetary value of the industry sponsors' contribution was $799,055 per non-cancer and $630,243 per cancer drug trial. Drugs (in-trial and post-trial) accounted for 84% of the total contribution of the non-cancer drug trials whereas it represented 93% of all trial-related contributions in the cancer category. The total province-wide contribution of industry-sponsored drug trials which were initiated in 2012 was estimated to be $101 million, including open-label drugs in the non-cancer category.  Conclusions: Industry-sponsored pharmaceutical trials represent a major economic contributor to clinical research within the province.

Benefit of adjunct universal rectal screening for Chlamydia genital infections in women attending Canadian sexually transmitted infection clinics.

Adding universal rectal screening to urogenital screening should positively impact rectal Chlamydia trachomatis (CT) incidence in affected populations. A dynamic Markov model was used to evaluate costs and outcomes of three rectal CT screening strategies among women attending sexually transmitted infection clinics in Alberta, Canada: universal urogenital-only screening (UG-only), additional selected (exposure-based) rectal screening (UG+SR), and additional universal rectal screening (UG+UR). The model included two mutually exclusive health states: infected and susceptible. Additionally, the model included two rounds of transmission: male sex partners of women infected with rectal-only CT and female sex partners of those men. CT complications impacting patients' quality of life (QALY) were considered. Alberta and Canadian data were used to estimate model inputs. We used a health care perspective, a time period of 10 years, and a discount rate of 3% for analyses. Compared to UG-only screening, the incremental cost effectiveness ratios (ICERs) were CA$34,000 and CA$49,000 per QALY gained for UG+SR and UG+UR screening strategies, respectively. Compared to UG+SR, the ICER was CA$62,000 per QALY gained for the UG+UR strategy. Both adjunct selected and universal rectal screening strategies are cost effective compared to UG-only screening, and UG+UR screening is cost effective when compared to UG+SR screening.

Forecasting Pharmaceutical Prices for Economic Evaluations When There Is No Market: A Review.

BACKGROUND: Economic evaluation helps policy makers and healthcare payers make decisions on drug listing, coverage, and reimbursement. When economic evaluations are conducted before a product launch, the prices of the pharmaceuticals have to be forecast. OBJECTIVE: The aim of this study was to examine the methods of establishing proxy prices and their accuracies compared with actual market prices after the product launch. METHODS: We searched the literature for evaluations for drugs that were licensed in the US between 2010 and 2015. We reviewed the studies for the forecasting strategies used, and then estimated the difference between actual 2016 post-launch prices and what the proxy prices would be if the forecast was carried out in the US in 2016. RESULTS: We identified six such studies, with seven drugs. Four studies used substitute drugs as proxies for the study drug, and three used other methods. The range of the values of actual minus proxy price varied considerably, and no trend was observed. CONCLUSION: Forecasting drug prices is as precarious as forecasting in other areas of the economy. We urge caution in reviewing and accepting a cost-effectiveness ratio that is based on forecast prices.

Trends and Regional Variation in Hospital Mortality, Length of Stay and Cost in Hospital of Ischemic Stroke Patients in Alberta Accompanying the Provincial Reorganization of Stroke Care.

OBJECTIVES: This study aimed to evaluate the trends and regional variation of stroke hospital care in 30-day in-hospital mortality, hospital length of stay (LOS), and 1-year total hospitalization cost after implementation of the Alberta Provincial Stroke Strategy. METHODS: New ischemic stroke patients (N = 7632) admitted to Alberta acute care hospitals between 2006 and 2011 were followed for 1 year. We analyzed in-hospital mortality with logistic regression, LOS with negative binomial regression, and the hospital costs with generalized gamma model (log link). The risk-adjusted results were compared over years and between zones using observed/expected results. RESULTS: The risk-adjusted mortality rates decreased from 12.6% in 2006/2007 to 9.9% in 2010/2011. The regional variations in mortality decreased from 8.3% units in 2008/2009 to 5.6 in 2010/2011. The LOS of the first episode dropped significantly in 2010/2011 after a 4-year slight increase. The regional variation in LOS was 15.5 days in 2006/2007 and decreased to 10.9 days in 2010/2011. The 1-year hospitalization cost increased initially, and then kept on declining during the last 3 years. The South and Calgary zones had the lowest costs over the study period. However, this gap was diminishing. CONCLUSIONS: After implementation of the Alberta Provincial Stroke Strategy, both mortality and hospital costs demonstrated a decreasing trend during the later years of study. The LOS increased slightly during the first 4 years but had a significant drop at the last year. In general, the regional variations in all 3 indicators had a diminishing trend.