Canada’s National Advisory Committee on Immunization (NACI) makes recommendations on the use of human vaccines. Provinces and territories subsequently use the advice to make decisions on public funding and program implementation. Traditionally, NACI reviewed vaccine characteristics and burden of illness.

With its recent expanded mandate, NACI now considers cost-effectiveness via economic evaluations, among other decision determinants. As such, new processes and guidelines were needed to formalize the incorporation of economic evidence into federal vaccine decision-making.

Two task groups were convened respectively to develop NACI’s “Economic Process” and “Guidelines for the Economic Evaluation of Vaccination Programs in Canada”. The groups conducted environmental scans to inform their work, as well as engaged with government partners, decision-makers, academics, national immunization technical advisory groups from other countries, health technology assessment agencies, industry, patient groups, among others.

The Economic Process outlines when and how NACI incorporates economic evidence for vaccine recommendation. For instance, it describes how policy questions are prioritized given institutional capacity constraints for generating economic evidence. It also describes how policy questions are assessed to determine the appropriate type of economic evidence required (i.e., systematic review, economic evaluation, multi-model comparison of external models).

The Economic Guidelines provide recommendations in 15 chapters on how to conduct economic evaluations (i.e., from defining the decision problem to reporting). Unlike other health technologies, vaccines have the potential to affect both vaccinated and unvaccinated individuals. Hence, the Guidelines consider population-level impacts such as externalities (e.g., herd immunity, age-shifting of disease) and spillover effects. They also discuss equity considerations and non-health impacts of vaccines such as to productivity, consumption and education.

The Economic Process and Economic Guidelines promote the generation and use of credible and standardized economic evidence. They advocate for transparency, allowing evidence to be used across jurisdictions beyond Canada. Next steps include documentation of user feedback, incorporation of Indigenous considerations, and formal evaluations.

This study estimates the maximum price at which mesenchymal stem cell (MSC) therapy is deemed cost-effective for septic shock patients and identifies parameters that are most important in making treatment decisions.

We developed a probabilistic Markov model according to the sepsis care trajectory to simulate costs and quality-adjusted life years (QALYs) of septic shock patients receiving either MSC therapy or usual care over their lifetime. We calculated the therapeutic headroom by multiplying the gains attributable to MSCs with willingness-to-pay (WTP) threshold and derived the maximum reimbursable price (MRP) from the expected net monetary benefit and savings attributable to MSCs. We performed scenario analyses to assess the impact of changes to assumptions on the study findings. A value of information analysis is performed to identify parameters with greatest impact on the uncertainty around the cost-effectiveness of MSC therapy.

At a WTP threshold of $50,000 per QALY, the therapeutic headroom and MRP of MSC therapy were $20,941 and $16,748, respectively; these estimates increased with the larger WTP values and the greater impact of MSCs on in-hospital mortality and hospital discharge rates. The parameters with greatest information value were MSC's impact on in-hospital mortality and the baseline septic shock in-hospital mortality.

At a common WTP of $50,000/QALY, MSC therapy is deemed to be economically attractive if its unit cost does not exceed $16,748. This ceiling price can be increased to $101,450 if the therapy significantly reduces both in-hospital mortality and increases hospital discharge rates.

Health technology assessment (HTA) is value-laden. Consideration of ethical, legal, and social issues (ELSI), and patient values (ELSI+), is challenged by lack of conceptual clarity and the multi-disciplinary nature of ELSI + . This study used concept mapping to identify key concepts in the ELSI+ domain and their interrelationships.

We conducted a scoping review using Medline and EMBASE (2000-2016, English language) with search terms related to ethics, legal/law, social/society/patient, “ELSI”, and HTA/technology/assessment. Items from the review and additional items from an expert brainstorming session were consolidated into 80 ELSI+-related statements which were entered into Concept Systems® Global MAX software. Participants (N = 38; 36 percent researchers, 21 percent academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups that made sense to them, and rated the statements on their importance in decision-making about adoption of technologies in Canada: 1 (not at all important), 5 (extremely important), 2, 3, and 4 (unlabeled). We used Concept Systems® Global MAX software to create and analyze concept maps with four to 16 clusters, which were reviewed by the study team.

We selected the map with five clusters because its clusters represented different concepts and the statements within each cluster represented the same concept. Based on the concepts, we named these clusters: patient preferences and experiences, patient quality of life and function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.

This study suggests an alternative approach to conceptualize the domains originally described as “ELSI+”. We identified clusters of relevant concepts that focus on patient perspectives (preferences, experiences, quality of life, function), burden and harm, fairness (individual and societal), and organizational issues. Basing ELSI+ on conceptual consonance, rather than academic disciplines or traditions, provides a framework for coherent consideration of ELSI+ in HTA.

Consideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment (HTA) is challenging because of a lack of conceptual clarity and the multi-disciplinary nature of ELSI+. We used concept mapping to identify key concepts and inter-relationships in the ELSI+ domain and provide a conceptual framework for consideration of ELSI+ in HTA.

We conducted a scoping review (Medline and EMBASE, 2000–2016) to identify ELSI+ issues in the HTA literature. Items from the scoping review and an expert brainstorming session were consolidated into eighty ELSI+-related statements, which were entered into Concept Systems® Global MAX™ software. Participants (N = 38; 36 percent worked as researchers, 21 percent as academics; 42 percent self-identified as HTA experts) sorted the statements into thematic groups, and rated them on importance in making decisions about adopting technologies in Canada, from 1 (not at all important) to 5 (extremely important). We used Concept Systems® Global MAX™ software to create and analyze concept maps with four to sixteen clusters.

Our final ELSI+ map consisted of five clusters, with each cluster representing a different concept and the statements within each cluster representing the same concept. Based on the concepts, we named these clusters: patient preferences/experiences, patient quality of life/function, patient burden/harm, fairness, and organizational. The highest mean importance ratings were for the statements in the patient burden/harm (3.82) and organizational (3.92) clusters.

This study suggests an alternative approach to ELSI+, based on conceptual coherence rather than academic disciplines. This will provide a foundation for incorporating ELSI+ into HTA.

Procurement's important role in healthcare decision making has encouraged criticism and calls for greater collaboration with health technology assessment (HTA), and necessitates detailed analysis of how procurement approaches the decision task.

We reviewed tender documents that solicit medical technologies for patient care in Canada, focusing on request for proposal (RFP) tenders that assess quality and cost, supplemented by a census of all tender types. We extracted data to assess (i) use of group purchasing organizations (GPOs) as buyers, (ii) evaluation criteria and rubrics, and (iii) contract terms, as indicators of supplier type and market conditions.

GPOs were dominant buyers for RFPs (54/97) and all tender types (120/226), and RFPs were the most common tender (92/226), with few price-only tenders (11/226). Evaluation criteria for quality were technical, including clinical or material specifications, as well as vendor experience and qualifications; “total cost” was frequently referenced (83/97), but inconsistently used. The most common (47/97) evaluative rubric was summed scores, or summed scores after excluding those below a mandatory minimum (22/97), with majority weight (64.1 percent, 62.9 percent) assigned to quality criteria. Where specified, expected contract lengths with successful suppliers were high (mean, 3.93 years; average renewal, 2.14 years), and most buyers (37/42) expected to award to a single supplier.

Procurement's evaluative approach is distinctive. While aiming to go beyond price in the acquisition of most medical technologies, it adopts a narrow approach to assessing quality and costs, but also attends to factors little considered by HTA, suggesting opportunities for mutual lesson learning.

In 2007, the Ontario Health Technology Advisory Committee (OHTAC) developed a decision framework to guide decision making around nondrug health technologies. In 2012, OHTAC commissioned a revision of this framework to enhance its usability and deepen its conceptual and theoretical foundations.

The committee overseeing this work used several methods: (a) a priori consensus on guiding principles, (b) a scoping review of decision attributes and processes used globally in health technology assessment (HTA), (c) presentations by methods experts and members of review committees, and (d) committee deliberations over a period of 3 years.

The committee adopted a multi-criteria decision-making approach, but rejected the formal use of multi-criteria decision analysis. Three broad categories of attributes were identified: (I) context criteria attributes included factors such as stakeholders, adoption pressures from neighboring jurisdictions, and potential conflicts of interest; (II) primary appraisal criteria attributes included (i) benefits and harms, (ii) economics, and (iii) patient-centered care; (III) feasibility criteria attributes included budget impact and organizational feasibility.

The revised Ontario Decision Framework is similar in some respects to frameworks used in HTA worldwide. Its distinctive characteristics are that: it is based on an explicit set of social values; HTA paradigms (evidence based medicine, economics, and bioethics/social science) are used to aggregate decision attributes; and that it is rooted in a theoretical framework of optimal decision making, rather than one related to broad social goals, such as health or welfare maximization.

High-quality cost estimates for hospital-acquired Clostridium difficile infection (CDI) are vital evidence for healthcare policy and decision-making.

To evaluate the costs attributable to hospital-acquired CDI from the healthcare payer perspective.

We conducted a population-based propensity-score matched cohort study of incident hospitalized subjects diagnosed with CDI (those with the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada code A04.7) from January 1, 2003, through December 31, 2010, in Ontario, Canada. Infected subjects were matched to uninfected subjects (those without the code A04.7) on age, sex, comorbidities, geography, and other variables, and followed up through December 31, 2011. We stratified results by elective and nonelective admissions. The main study outcomes were up-to-3-year costs, which were evaluated in 2014 Canadian dollars.

We identified 28,308 infected subjects (mean annual incidence, 27.9 per 100,000 population, 3.3 per 1,000 admissions), with a mean age of 71.5 years (range, 0–107 years), 54.0% female, and 8.0% elective admissions. For elective admission subjects, cumulative mean attributable 1-, 2-, and 3-year costs adjusted for survival (undiscounted) were $32,151 (95% CI, $28,192–$36,005), $34,843 ($29,298–$40,027), and $37,171 ($30,364–$43,415), respectively. For nonelective admission subjects, the corresponding costs were $21,909 ($21,221–$22,609), $26,074 ($25,180–$27,014), and $29,944 ($28,873–$31,086), respectively.

Hospital-acquired CDI is associated with substantial healthcare costs. To the best of our knowledge, this study is the first CDI costing study to present longitudinal costs. New strategies may be warranted to mitigate this costly infectious disease.

Infect Control Hosp Epidemiol 2016;37:1068–1078