Introduction
Health technology assessment (HTA) is an evidence-based, multidisciplinary process that informs decision making by providing insight into the value of a health technology (Reference O’Rourke, Oortwijn and Schuller1). HTA has an established role in the management of health technologies which aims to support a high-quality, efficient, and equitable health system (Reference O’Rourke, Oortwijn and Schuller1). Traditionally, HTA determines if a single health technology (i.e., a medicine, device, test, procedure, or program) offers good value to the healthcare system and at what price.
HTAs respond to the needs of healthcare system decision makers, generally focused on individual coverage or reimbursement portfolios (e.g., outpatient drug coverage decisions are independent of public health intervention decision making). In Canada, CADTH pharmaceutical review committees issue recommendations to provincial and territorial drug programs and separately, and the Public Health Agency of Canada’s (PHAC) National Advisory Committee on Immunization (NACI) issues recommendations to provincial and territorial public health programs. Increasingly, there is recognition that decisions made in isolation from cognate considerations (e.g., isolating decisions about drug treatments for condition A from decisions about preventative treatments for condition A) could lead to ill-informed decisions, suboptimal care, and system inefficiencies (Reference Schünemann, Reinap and Piggott2). Further, decision makers are increasingly asking system-relevant questions that move beyond the traditional mold of assessing a single health technology and instead considering treatment sequencing, combination therapies, companion diagnostics (Reference Hogervorst, Vreman, Mantel-Teeuwisse and Goettsch3), or how best to respond to public health emergencies (Reference Ananthakrishnan, Luz and Kc4). Innovation in the application of HTA processes and methods are needed to respond to the shift in policy making challenges.
In response to the needs of individual decision makers, the decision space in HTA is classically concerned with intervention management, and often more narrowly, technology adoption. An alternate way to approach the HTA decision, and one that may respond to shifting priorities, is one of disease management (Reference Richardson, Ramsay, Bielecki, Berta and Sander5). Considering the disease as the unit of analysis for an HTA review may offer opportunities to consider a broader range of alternative interventions (i.e., primary prevention, screening, diagnostics, treatment, management), allow for systematic consideration of upstream interventions, and allow the system to question the optimal management of a disease versus a piecemeal or reactive approach that is characteristic of the current environment (Reference Waldman and Terzic6).
Our objective was to explore opportunities to implement a disease management approach to health technology assessment (HTA) in Canada. Specifically, we sought to understand how HTA experts perceive the value of using a disease management approach to HTA in Canada and the anticipated barriers and facilitators to using this approach.
Methods
Participants were purposefully sampled (Reference Coyne7) from national and provincial HTA agencies and related organizations in Canada. We sought to speak with individuals with sufficient knowledge of the HTA system in Canada to be able to critically assess the implications of a shift in HTA from one of intervention management to that of disease management. We anticipated that perspectives would vary depending on organizational affiliation (i.e., federal or provincial, and HTA organization, HTA committee, or health system decision maker), primary field of expertise (i.e., ethics, economics, clinical), intervention domain (i.e., prevention, screening, diagnostics, or treatment), and intervention type (i.e., vaccine, drug, nondrug), so we selected individuals with these affiliations. Where opportunities were identified to increase the depth of understanding of specific considerations – for example, differences between federal and provincial HTA processes, the use of economic methods, and perspectives from decision makers and HTA producers, we sampled additional informants with this expertise (Reference Fossey, Harvey, McDermott and Davidson8). The targeted sampling of individuals with health economics training, for example, allowed for deeper exploration of barriers and facilitators of initiatives similar to a disease management approach that have predominantly originated from an economics orientation (e.g., whole disease modeling). Invitations were sent to potential informants via email in four rounds (4 to 6 invitations in each round) between March 2022 and October 2022. Staggering the invitations allowed for assessment of data saturation, revisions to the interview guide, and data analysis to proceed after each round. A sample email, information letter, and consent form are included in the Supplementary material.
All interviews were conducted one to one by a researcher, M.R., with qualitative research training through doctoral degree coursework. Interviews were semistructured using an interview guide shown in Supplementary Table S1. The interview guide evolved as interviews were conducted and analyses were undertaken (Reference Fossey, Harvey, McDermott and Davidson8). The interview guide was based on three key domains: conceptualization, value, and implementation of a disease management approach to HTA. During the data collection phase, we initially used the phrase “care pathway approach” because we judged that it would be a more intuitive phrase to support discussion. A care pathway approach was presented to informants as an opportunity to broaden the system of analysis in HTA from one of a single intervention assessment to one that considers the interactions between the full suite of intervention domains (i.e., preventative, screening, diagnostics, treatment, management) that a patient would encounter over the course of a particular disease. To support clarity in the study informant’s interpretation of the approach, we evolved our terminology and definition of a care pathway approach in our interview guide after our first two interviews to read as a “disease management approach.” The disease management approach was described as a focus on managing a disease in the context of interventions instead of the traditional approach that aims to manage a single intervention within the context of a disease care pathway. The questions included in the interview guide were discussed with the research team and piloted by documenting anticipated responses and potential probing questions. Interviews were conducted via MS Teams (audio and video) and were transcribed verbatim following the interview. Field notes taken during the interview were added to each transcript and documented as comments and in a separate file (Reference Phillippi and Lauderdale9).
We approached data analysis with a conventional content analysis orientation (Reference Sandelowski10). Three key questions from our interview guide were used as an organizing infrastructure for our data analysis. We used manual line by line coding of the data to identify key themes. The analysis was deepened by reading, re-reading, and writing about the content of the transcripts and discussing findings with the research team (Reference Patton11). Content was revisited repeatedly, and themes identified were further refined in a phase of analysis that was supported by a review of the literature. The identification of relevant literature provided sensitizing concepts that helped frame and further enrich our data analysis (Reference Bowen12). A schematic of the analysis process can be found in Supplementary Figure S1.
One author (M.R.) coded the data, and findings were independently verified by a second author (C.M.). The second author coded a subset (4/18) of transcripts to ensure descriptive adequacy, while still allowing for interpretative freedom in the analysis. Findings were discussed (between M.R. and C.M.) to confirm all relevant codes were generated and were descriptively clear. Analyses were completed in Microsoft Word and Excel. We followed the Consolidated criteria for Reporting Qualitative research (COREQ) checklist for reporting which can be found in the Supplementary material (Reference Tong, Sainsbury and Craig13). Relevant quotes and associated manuscript text were shared with informants for validation.
Results
Twenty-four invitations were sent out, and eighteen individuals agreed to participate. Six invited individuals did not participate due to a lack of response (n = 3) or lack of time (n = 3). Interviews were conducted between April 2022 and October 2022 and lasted between 30 and 75 minutes in duration. Table 1 describes the key characteristics of participants.
Table 1. Characteristics of study participants
Abbreviation: HTA, health technology assessment.
What follows is a summary of the discourse related to three key questions that were addressed during the interviews: (i) The conceptualization of a care pathway approach to HTA; (ii) The value of a care pathway approach to HTA; (iii) The system capacity to shift to a care pathway approach in HTA.
Conceptualizing a care pathway approach to HTA
We first capture how informants engaged with the idea of a care pathway approach to HTA by considering what it meant to informants and what sets it apart from other initiatives in the system.
How is a care pathway approach interpreted?
Some informants were unclear on the meaning or practical significance of a care pathway approach. There was some variability in how the concept was interpreted; that said, each interpretation was generally understood to have three key features that collectively differ from the conventional HTA process in Canada. First, the care pathway approach involves considering multiple interventions along a care pathway instead of “…thinking only about one intervention compared to its exact correlate comparator.” (IN02) Second, a care pathway approach focuses on managing a disease instead of managing intervention(s) in the context of a disease. Informants perceived this approach as “…looking more holistically at the system and what could be advantageous or beneficial” (IN02) or framing thinking about the conduct of HTA as, “…here’s the disease and you can treat the disease in the following ways.” (IN08) Third, informants generally recognized that the care pathway approach did not simply mean looking at each individual intervention along the disease pathway, but that it considered the relationships between interventions. The relationships between interventions could play out in different ways – communicated by informants as synergies, optimization, trade-offs or choices, sequencing, and interplay, and could impact priorities for innovation as well as how HTA assessments and recommendations are structured. One informant illustrated this feature with an example of the importance of recognizing the relationship between screening and treatment: “[when you think about] what kind of screening program would be optimal … you cannot disconnect that from the question at the time of who are you going to pay for treatment…?” (IN10).
How does a care pathway approach compare to other initiatives tested or currently in place within HTA?
A care pathway approach to HTA was generally not interpreted by informants as a new idea; however, there was recognition that a single-intervention, technology-centered approach remains the predominant HTA framework in practice. Some informants have had discussions in their organizations about strategically moving in the direction of a broader, system-level approach, or saw their organizations as already implementing elements of a care pathway approach in their HTA assessments. Yet there was recognition by several informants that “… the HTA framework that is used for some of these … interventions doesn’t maybe go as far as what you’re proposing” (IN02). The general impression was that there are no systems internationally that take a care pathway approach; “NICE might be the closest one to thinking about maybe a model of care kind of approach or something” (IN08). Initiatives such as condition-level reviews or therapeutic reviews at the federal level, or mega-analyses and health evidence reviews at the provincial level were flagged as initiatives that would be considered larger disease-level reviews versus the traditional HTA. Likewise, whole disease modeling and OncoSim models were identified as disease-based decision-analytic modeling approaches; however, none of the initiatives discussed were thought to completely align with what a care pathway approach is intended to achieve.
Value of a care pathway approach in HTA
We next explored perspectives on the potential value of a care pathway approach. In this section, we discern if the informants interpreted the features of a care pathway approach as ones that would enhance the impact of HTA and if the approach could be used to address HTA or health system challenges.
Is there value to a care pathway approach in HTA?
There was some hesitation to affirming or rejecting a care pathway approach to HTA without knowing exactly what it would look like. One informant suggested that the HTA process has worked well for years, indicating that there may not be a need for change. Generally, however, informants engaged with the idea of a potential future state of HTA defined by a care pathway approach and suggested specific features of the approach that, if achieved, could be valuable to the practice of HTA. “…I can anticipate a future where … we might be interested in trying to balance out the cost effectiveness of the prophylactic intervention compared to treatments, and I think we’re going to get challenged if we’re trying to do that.” (IN02) A care pathway approach was generally interpreted to provide value if it could meet certain timelines, demonstrate the impact it has on the system as a whole and population health, and considered aspects of diversity, equity, and inclusion. It was clear that there were priority areas (e.g., certain diseases like COVID, or in high-cost diseases) where a care pathway approach would be most relevant. One informant indicated that “…when we go to psychiatrists who care for people with major depression, they’re all over this work. They don’t want to think about one technology.” (IN14).
How can a care pathway approach be used to address an HTA or health system challenge?
The themes that emerged from informants about the value of the care pathway approach could be interpreted to align with the original triple aim (Reference Berwick, Nolan and Whittington14) – the pursuit of specific goals to achieve high-value health care: improving population health, enhancing the patient experience, and reducing the per capita cost of care. It was evident that the idea that a care pathway approach could be used to address challenges that the HTA and health system are currently facing resonated with informants. For example, informing discussions around patient choice and suboptimal care: “I do see value in finding ways for the public and patients to better understand the package of care and the choices.” (IN01), creating a space where “…both arms of the government could come together and talk.” (IN10) and setting up a platform for open dialogue about managing high-cost areas. The care pathway approach could be used to promote a proactive healthcare system. Informants suggested that this approach could enable more effective and efficient decision making across a technology’s lifecycle.
What is the system capacity to shift to a care pathway approach to HTA?
In this final section, we explored informant’s perspectives of key barriers and facilitators to implementing a care pathway approach in HTA.
What are the barriers and facilitators to implementing a care pathway approach in HTA?
Four key themes captured the barriers and facilitators to implementing a care pathway approach to HTA that were highlighted by informants: capacity concerns, data and analytic considerations, system constraints, and political considerations (illustrated in Tables 2–5). We have linked the barriers and facilitators within each of the four themes described as they represented the flip sides of the same phenomenon. It was clear that the barriers to implementing a care pathway approach were not perceived as insurmountable; informants identified opportunities to build on the strengths of the system with this approach.
Table 2. Capacity considerations (expertise and education, financial, and comfort with uncertainty)
Note: The table describes the theme, subthemes, and provides illustrative quotes.
Informants identified capacity concerns (Table 2) as a key consideration for the implementation of a care pathway approach to HTA. This idea included ensuring that appropriate expertise and education are in place both at the assessment (reviewer and analytical expertise) and appraisal level (committee expertise), ensuring there are sufficient financial resources, and that there is an appetite or skill set to embrace uncertainty. Existing HTA concepts that factor into understanding a care pathway approach such as opportunity cost, and equity and ethical considerations were described by informants as commonly misunderstood. There was recognition, however, that some concepts have the potential to become clearer with the implementation of a care pathway approach.
Data and analytic considerations (Table 3) were particularly concerning for informants with the implementation of a care pathway approach to HTA. There was recognition that provinces are information-rich and making use of data available at this level of the system would be important. The complexity of the analytic task and the limited experience that HTA has in reviewing medical devices and clinical interventions were also highlighted as potential challenges.
Table 3. Data and analytic considerations (data availability, experience with medical devices and clinical interventions, complexity)
Note: The table describes the theme, subthemes, and provides illustrative quotes.
System constraints (Table 4) generally shared a common concern about the siloed nature of the healthcare system – from budgetary, program, and organizational silos, to silos between pharmaceuticals and nonpharmaceutical interventions, public health and the healthcare system, and health and nonhealth sectors. Informants described examples of the HTA community and organizations starting to bridge the gaps between silos, and that some of these silos – such as integration of a vaccine and drug recommendation – would be best accomplished with HTA at the provincial level.
Table 4. System considerations (budgetary and program silos, organizational silos – HTA assessment processes, silos between pharmaceuticals and nonpharmaceutical interventions and their delivery, and silos between public health and the rest of the health system and health and nonhealth sectors)
Note: The table describes the theme, subthemes, and provides illustrative quotes.
Political considerations (Table 5) highlighted by informants included the pressures on decision makers, incentives for change, and the multistakeholder HTA environment. Appropriately managing political pressures could include respecting provincial and territorial autonomy, identifying priority areas, and ensuring that the approach is “thoughtfully characterized” (IN01). Other constraints expressed by informants were not unique to the integration of a care pathway approach – reflecting common constraints on change agendas in HTA or other environments.
Table 5. Political considerations (political pressures, change management, multistakeholder environment)
Note: The table describes the theme, subthemes, and provides illustrative quotes.
Discussion
A care pathway approach to HTA is a disease-based, multi-interventional, and dynamic approach to supporting evidence-based healthcare decision making. Informants generally saw value in this approach as a methodological and structural advancement – that is, generating evidence that supports consideration of intervention options across the disease trajectory, and creating opportunities for system level deliberation. A sentiment emerged that a care pathway approach may not be needed every time, and selecting the most impactful cases would be important. There are opportunities for a care pathway approach to be implemented as a complement to the current approach without major restructuring of the HTA system – ones that build on the strengths of the existing system in Canada and involve a shared responsibility and ownership between federal organizations and provincial decision makers to balance resource constraints, efficiencies, and relevance.
A care pathway approach was not necessarily interpreted by informants as a new idea – discussions regarding this concept have occurred at the pan-Canadian level (CADTH) and similar types of thinking have taken place at the provincial level with mega-analyses in Ontario, health evidence reviews in Alberta, and as a standard practice for all reviews in Quebec (i.e., a drug submission offers the opportunity to ask what is the best option for the health system). Although these initiatives emulate the idea of thinking about the decision problem in HTA as going beyond the traditional mold of assessing a single health technology, the current HTA framework remains predominantly technology centered. A care pathway approach requires a shift in thinking to have the focal point of an HTA as the disease and not the technology. Three key features collectively distinguished a care pathway approach to HTA from the conventional HTA approach in Canada: disease-based, multi-interventional, and dynamic. We compare a care pathway approach to other initiatives, ideas, and methods that were mentioned by informants in Supplementary Table S2. Other approaches to HTA, such as Optimal Use reports at CADTH and pathway approaches at Cancer Care Ontario (CCO), that were not mentioned by informants may also be interpreted as similar to our work. These approaches may offer more comprehensive assessments; however, our interpretation is that optimal use reports are still generally focused on single domain of interventions, and pathway approaches at CCO are closer to reflecting clinical guidelines which are not intended to optimize the care pathway at the population level. A “disease management approach” to HTA was thought to better reflect the intent of what, in our interviews, we initially defined as a “care pathway approach.” We did not endeavor to do an in-depth comparison between a disease management approach and other initiatives; however, future research could comprehensively assess the similarities and differences between HTA process initiatives.
One could argue that over the past decade, HTA has been experiencing a paradigm shift. The idea of “living” HTAs, lifecycle assessments, and health technology management continue to be primary considerations in HTA discourse. Several informants in our study highlighted the parallels between a disease management approach and these more mainstream HTA paradigms. For example, one informant saw a disease management approaching fitting in with the idea of health technology management, or that a disease management approach could be deployed as an approach to manage suboptimal use of health interventions. We view these parallels as a strength of a disease management approach. A disease management approach could be used to operationalize a health technology management strategy in HTA by creating an inherent need to reassess technologies each time a disease-based review is undertaken.
The barriers and facilitators to implementing a disease management approach were similar to those that have previously been identified for other proposed “change” agendas in HTA. For example, Hopman et al. (Reference Hopman, Crowcroft, Cesuroglu and Langley15) identified accessibility (availability and knowledge) and acceptability (scientific/technical, structural/institutional, and ethical and political) barriers to including economic evaluation in immunization policy making. Findings from Clausen et al. (Reference Clausen, Mighton and Kiflen16) highlighted the need for a cultural shift, improved data infrastructure, committed investment, and increased collaboration to optimize the implementation of real-world evidence in cancer drug funding decisions in Canada. Stojanovic et al. (Reference Stojanovic, Wübbeler and Geis17) identified data, conflicting stakeholder priorities, and appropriate methodology as common challenges. At the broadest level, the ISPOR-identified top 10 challenges (Reference O’Rourke, Werkö, Merlin, Huang and Schuller18) in HTA overlap with the barriers we identified. These findings suggest that although there are likely barriers to the implementation of a disease management approach to HTA, the field will continue to grapple with these challenges regardless of any proposed change agenda.
We anticipate that creating platforms for assessments at the disease level could facilitate opportunities for early-phase horizon scanning initiatives, optimization between typically separate intervention domains (i.e., primary prevention, screening, diagnostics, and treatment), and for considerations of “what-if” scenarios in the context of future innovations. The platform would also have the potential to continue to advance patient and public engagement in HTA by creating opportunities for elicitation of patient preferences across intervention domains, facilitating greater public involvement, and creating long-run assessment efficiencies and expertise. Public health and preventative interventions are typically underrepresented in HTA analyses (Reference Ananthakrishnan, Luz and Kc4;Reference Stojanovic, Wübbeler and Geis17), so a disease management approach could allow for greater traction for these and other typically underassessed intervention types. These opportunities are anticipated to contribute to a more proactive system in Canada and align with other calls for HTA reform (Reference Husereau, Henshall, Sampietro-Colom and Thomas19), It is likely that if a disease management approach to HTA were to be established in the current system, existing HTA prioritization processes and tools (Reference Qiu, Thokala, Dixon, Marchand and Xiao20–Reference Noorani, Husereau, Boudreau and Skidmore22), patient, clinician, and guideline groups that are predominantly disease-focused, and disease classification systems within data holding systems could be used to help identify the most relevant and impactful cases.
Limitations
There are several limitations to our study. First, many informants struggled to gain clarity about the idea of a “care pathway approach” to HTA, in some cases identifying the approach as inherent in the HTA framework. The care pathway approach has not previously been conceptualized and it was our intent to be open to informant’s interpretation of the approach, stimulate discussion of comparisons to other initiatives, and to share thoughts on how the approach could be implemented in practice. Despite some misinterpretation of the distinguishing features of the care pathway approach, informants were able to constructively identify its elements and impact. Second, there may be other ways of conceptualizing the decision problem in HTA beyond that of disease management. Arguably, a disease management approach to HTA could still be considered technology centric. In selecting a disease-level system of analysis, we believed that this would be an incremental and feasible step for HTA to shift the focal point of assessments to be one that at a macrolevel is more patient-centered and more aligned with a broader health system perspective compared to a predominantly technology-focused, patient-informed approach. Third, our sample population consisted primarily of individuals working as HTA “producers” (federally or provincially) and primarily in the diagnostic and treatment space. We sought to include individuals who were in decision-making roles and those whose work focuses on primary prevention; however, representatives with this expertise were few. Further exploration of a disease management concept with these individuals would be valuable. Additionally, we specifically targeted the inclusion of some individuals who had professional training in health economics and individuals who had experience working in jurisdictions that have sought to broaden the evaluative space in HTA assessments (e.g., British Columbia, Alberta, and Quebec). This focus may have led to overly optimistic views of the value of a disease management approach to HTA. We balanced these perspectives in our results by highlighting areas where skepticism of the disease management approach was apparent. Fourth, interviews, transcription, and analysis were performed by a single reviewer. This may have an impact on the trustworthiness of our results; however, research suggests that this approach is reasonable especially when using inductive content analysis (Reference Elo, Kääriäinen and Kanste23). We mitigated this potential limitation by having a second reviewer (C.M) code a subset of transcripts and confirm the appropriateness of key themes and subthemes identified. Furthermore, our research team had several meetings as data analysis proceeded to ensure the rigor of the analysis. This included achieving consensus on the key question sets that framed the foundation for the analysis and that the analysis trail was clearly documented and substantiated by informant quotes. Lastly, our research did not set out to explore the value of a disease management approach to other system stakeholders such as local or hospital-based HTA organizations, patient representatives, the public, manufacturers, or private payers. It was our intent to focus on HTA system capacity and understand the constraints to the assessment and appraisal process for federal/provincial recommendations and decision making; however, additional perspectives on this approach is an important contribution in future work.
Strengths
Our research has several strengths. In our analysis, we drew on existing literature to frame the barriers and facilitators to implementing a disease management approach to HTA. Further, we offered a unique framing of these findings in linking the potential barriers with potential facilitators. Second, our sample population offered wide-ranging and insightful comments that highlighted potential optimism and skepticism of a disease management approach to HTA. Third, we implemented a rigorous analytical process to derive key themes and subthemes that resonated with those found in existing literature. Lastly, we sought to ensure credibility, transferability, dependability, and confirmability in our research (Reference Thomas and Magilvy24). Credibility was established by continuous revisiting of transcript data and comparing it to themes, continuously comparing ideas and insights between transcripts, linking results with existing literature, and sharing the draft results with informants. We aimed to facilitate transferability of findings by describing the contextual conditions associated with the data to the extent possible. We discussed, documented, and illustrated our approach to analysis continuously within our research team and by sharing this process transparently within the manuscript to ensure dependability. Lastly, we documented and reflected on potential biases before, during, and after each interview as well as engaged in continual reflexivity during analysis to ensure confirmability.
Conclusions
HTA has a strong presence in the Canadian healthcare system, and efforts to play to its strengths and shift with the fluid needs of the system are important for delivering appropriate evidence to decision makers. Our research aimed to inform the consideration of an HTA process change, a disease management approach to HTA, that could be considered as a complimentary approach to existing processes to better inform a proactive, resilient, and sustainable healthcare system in Canada. Moving from intervention management to disease management is one option for a purposeful systems-thinking approach to enhancing the impact of HTA.
Supplementary material
The supplementary material for this article can be found at https://doi.org/10.1017/S0266462323002696.
Funding statement
M.R. is supported by a Canadian Institute of Health Research (CIHR) Doctoral Research Award – Frederick Banting and Charles Best Canada Graduate Scholarship (Funding Reference Number 164205). B.S. is supported by a Canada Research Chair in Economics of Infectious Diseases (CRC-950-232429).
Competing interest
M.R. is an Institute for Clinical and Economic Review (ICER) employee. The current work was unrelated to her employment, and ICER had no role in the funding, design, or oversight of the work reported.
Ethical standard
Ethics approval was received from the Health Sciences Research Ethics Board at the University of Toronto.
Open access
