The ethical approval from the McGill Ethics Institutional Board in Canada was obtained in 2021. However, this McGill ethical approval was renewed and obtained under the same REB File Numberin June 2025. The International Ethical Standards for Biomedical Research Involving Human Persons were followed for the implementation of this work [17,18]. Two consents were obtained; 1) institutional administrative consent (electronic via email) provided by heads/leaders of the Swiss participating organizations by accepting the invitation sent via email to participate in the survey, and 2) both individual consents, written via email and verbal via phone, were obtained where participants accepted the interview invitation sent via email/phone. Additionally, participants were asked to give their second verbal consent before the interview began. These multiple consents were obtained to comply with ethical guidelines, ensure their voluntary participation, confidentiality, and the right to withdraw at any time, and their data would be discarded and not included in the final data set.

The HTA survey was adopted from the WHO global HTA survey [2]. This electronic survey consisted of six domains that cover the pillars of the HTA system, with each domain comprising relevant items (questions). These domains include understanding of HTA; the use and application of HTA; implementation of HTA; stewardship and management; resources and capacity; and impediments and insights for strengthening HTA. Further domains and questions of this survey on HTA processes, standardization, and HTA and decision-making were developed based on reviewing recent and relevant literature. The survey questions were closed-ended questions to collect data that reflects the technical, operational, and practical aspects of HTA. One survey was administered and completed by a member designated by the team in each of the nine organizations involved in HTA. The full survey is enclosed with Supplement 1.

The IDI guide was developed according to best practices for qualitative research [19–21], ensuring a rigorous and systematic approach to data collection. Unlike surveys, which gather standardized responses, qualitative interviews enable an in-depth exploration of participants’ policy perspectives, strategizing experiences, and decision-making processes. The IDI guide is enclosed in Supplement 2. The guide was designed using semi-structured interview techniques, providing a balance between consistency across interviews and flexibility to adapt to emergent themes. It aligns with established qualitative methodologies [22], and questions guided by the set of objectives and literature on HTA. Additionally, the guide adheres to recognized analysis and results reporting standards, such as COREQ (Consolidated Criteria for Reporting Qualitative Research) (enclosed in supplement 3) and SRQR (Standards for Reporting Qualitative Research), enhancing transparency, credibility, and analytical depth in HTA research. Both tools underwent a rigorous review and consultation process by ten recognized local and international experts in public health, health systems, digital technology, health economics, epidemiology, clinical specialties, and health policy and management. Feedback from these experts was incorporated into the final versions of the tools.

Maximum variation purposive sampling [23] was used for this study. The study identified two distinct groups of participants based on specific criteria. The first group included nine of the thirteen invited HTA-associated organizations operating in Switzerland’s health sector, representing governmental, academic, private, and non-governmental (NGO) organizations. The management of these organizations internally assigned a technical/operational team, who runs all HTA processes to complete one institutional survey on behalf of their organization. The second group comprised ten experts/leaders from these organizations responsible for overseeing HTA policies and strategic issues. All were invited, and eight participated in individual IDIs.

Two methods were used to identify the names and relevant information on key organizations and individuals (experts and leaders)1) a rapid review of grey and published literature, and 2) extensive consultations with local collaborators to guide identification of organizations and experts in Switzerland. These methods helped to generate comprehensive lists of organizations for the survey and experts for the IDIs based on predefined criteria and conditions. Our target was to select up to ten existing local and national organizations and up to ten experts from the prepared list. After applying the inclusion criteria, thirteen major, active, and relevant HTA-associated organizations were selected that met most of the following conditions: the organization was officially recognized by local and national health authorities, active at least one year since its establishment, had a defined mission for HTA stewardship, production, education, research, and funding; had any previous or current programs, projects, or interventions that directly or indirectly related to HTA; or participated in one or more of HTA activities. The organizations with no direct or indirect role in HTA and those that did not meet the inclusion criteria were excluded. A purposive sampling strategy, conducted in consultation with health authorities, was used to select the organizations that met the inclusion criteria. Thirteen selected organizations were invited to participate, and nine agreed. Their representatives were then asked to nominate or assign team members involved in technical and operational HTA processes within their organizations to complete the survey. Each team completed one survey on behalf of their respective organization. The inclusion criteria were also applied to the second group of experts, where ten experts responsible for and working in HTA policy, strategy, and systems were also identified from the same HTA-associated organizations in Switzerland. All ten experts were invited, and eight participated in the IDIs. Their roles are heads of HTA units, academics, policymakers, directors, and advisors. They had to be officially holding high-level positions in HTA or related to HTA at both local and national health systems, whether in HTA research, policy, management, or education. The experts with no direct or indirect role in HTA policy, strategy, and systems, and who did not meet the inclusion criteria, were excluded. Mixed sampling strategies were applied to determine the final and most relevant key informants and experts from the prepared lists. These sampling strategies included simple sampling, critical case, snowballing, convenience, and self-identified sampling [24]. These sampling strategies were also guided by the application of the pre-defined selection criteria that led to the selection of nine HTA-associated organizations and eight experts from the HTA community in Switzerland.

The research team, led by the Principal Investigator (MA), applied this selection approach to the recruitment of organizations and experts to ensure broad representation and consensus across sectors, organizations, and levels of research, policy, management, operations, and technical expertise. Given the limited size of the HTA community (i.e., organizations and experts working in HTA), the research team defined a sample size of five to ten organizations, with one individual recruited per organization.

The electronic HTA survey was developed using McGill's RedCap^TM cloud-based clinical software. Each of the nine HTA-associated organizations completed one survey. This was executed by sending an official invitation outlining the research objectives to the head of each organization for approval. Once approved, the research team distributed the survey via e-email to the nominated team leader of the organization to guide the technical, operational, practical, and managerial team/staff involved in HTA to complete the survey under the team leaders’ guidance. The research team allowed all organizations and assigned teams a two-month period to complete and return the survey, and support to address any anticipated questions or issues related to the survey. The IDIs were conducted via a web audio-video conferencing platform (Zoom Communications Inc., 2020), and each IDI lasted between 45–60 minutes. Eight IDIs were conducted with eight experts from policy and strategy levels from different sectors, disciplines, and levels. The PI (MA) and research assistant (AAB) communicated with the selected experts and coordinated and conducted the virtual IDIs. The PI and research assistant attended the IDIs, the PI led the IDI and discussion, and the assistant facilitated and reported the IDI.

All data on organization names, experts, and data from the survey and IDI were stored on a secure McGill server and only accessible by authorized members of the research team. Survey and IDI data was stored on a secured server and then imported into two software programs for data management and analysis. Survey data was analysed using the IBM SPSS Statistics version 29 software program. The survey data were analysed using descriptive statistics, including frequency distribution, percentages, categories, means, and standard deviation. Comparisons were made between organizations and sectors. IDI data was audio-recorded and then simultaneously translated and transcribed in English into MS Word sheets by the PI, assisted by trained co-investigators. Transcripts were imported into the software program, MAXQDA 12 (VERBI GmbH, Berlin), for qualitative data management and analysis. Transcripts were checked by the PI to ensure quality. Two coders and co-investigators constructed and validated codes in MAXQDA by classifying transcripts into IDI using a preset coding system that was derived from study objectives. To maintain consistency, a third independent reviewer resolved disagreements. Peer iterative review of themes, participant feedback, and triangulation with survey data were performed by the PI and reviewers to strengthen credibility. The methodological approach of this study was informed by similar studies [20,21,16,25,26]. The COREQ approach was followed for reporting the study results. The IDI transcripts were analyzed using thematic analysis, guided by both deductive and grounded theory approaches. The research team used a study framework, developed through expert consultation and literature review, based on six HTA system pillars to ensure systematic and rigorous interpretation. The sample size was guided by a maximum variation and determined based on availability and accessibility, relevance, diversity, and representation of the essential organizations and experts involved in HTA, taking into account the practical, operational, technical, policy, and scientific considerations raised from the consultations mentioned above.

Nine organizations in Switzerland completed the survey. The majority, 67% (n = 6), from academic organizations, 22% (n = 2) from the public sector (governmental), and 11% (n = 1) from the non-governmental sector. The majority of organizations were employed in medicine (67%, n = 6) and multidisciplinary fields (44%, n = 4), while 11% (n = 1) reported working in 11% (n = 1) in economics.

All nine surveyed organizations demonstrated a high level of understanding of HTA purpose and HTA concept, with 89% (n = 8) reporting a high level and 11% (n = 1) a moderate level of understanding, respectively. The findings also indicated that a good level of HTA application was reported within these organizations, as well as a strong recognition of HTA’s importance in their respective areas of work (67%, n = 6). Six organizations (67%, n = 6) indicated that the Swiss Federal Office of Public Health (12) was the central agency responsible for HTA management. Two organizations (22%, n = 2) indicated there was no central agency responsible for HTA management, and 11% (n = 1) indicated they did not know. Five organizations (56%, n = 5) reported they had a legislative requirement to consider the process and results of HTAs in the financing and public health decision-making process, while 22% (n = 2) reported they did not or did not know, respectively.

Concerning the HTA reports, only 44% (n = 4) of organizations reported that a national agency unit or committee produced HTA reports, while 44% (n = 4) reported they had not, and 11% (n = 1) that they did not know. Organizations mainly chose the Ministry of Health as the main recipient of the HTA reports (89%, n = 8), and at the same time minority of organizations chose also HTA reports were also intended for a National Independent committee related to HTA (22%, n = 2) and clinician associations (11%, n = 1) (Fig 1). All organizations indicated that publication and dissemination of HTA conclusions and reports occurred through organization websites (56%, n = 5) or public online platforms (44%, n = 4). Almost half of the surveyed organizations (56%) reported that civil society can give feedback on recommendations of an HTA report, and 67% (n = 6) also declared that stakeholders, including the community, can review a draft version of the assessment before the report is finalized.

In Fig 2, organizations highlighted that most of the HTA professionals were involved in various HTA processes: topic selection, scoping, systematic literature search, evidence collection, synthesis, modeling, and review, and they were mainly from public health and clinical science. Also, 88% (n = 8) of the organizations in Switzerland considered that HTA evaluations were conducted by other organizations or countries such as Germany, Austria, Haute Autorité de Santé (HAS) in France, NICE-UK, and Swiss Medical Board.

Regarding capacity support, only 11% (n = 1) of Swiss organizations reported measuring the impact of HTA on decision-making. In the 12 months preceding the survey, the Swiss Ministry of Health was the most frequent requester of assessments, either almost always (50%, n = 4) or frequently (25%, n = 2). Public healthcare providers requested assessments almost always (40%, n = 4) or sometimes (20%, n = 2). Similarly, public insurance bodies, reimbursement agencies, or national coverage institutions requested assessments almost always (33.3%, n = 3) or frequently (33.3%, n = 3) (Fig. 3).

All organizations estimated that less than 20 professional staff were involved in the HTA unit, agency, or committee: 60% (n = 5) estimated a number between 6 and 20 professionals, and 40% (n = 4) between 1 and 5 professionals. Fig 4 shows that the majority of professional human resources contributing to the preparation of HTA reports were involved in clinical interventions, including mainly professionals from public health and clinical science, as well as legal, engineering, and information science.

Fig 5 presents the most important dimensions of value for HTA that meet organizations’ or Switzerland's health priorities and needs. The most important dimensions of value were clinical effectiveness and costs and economic evaluation (89% each, n = 8). Dimensions of safety, equity, and equality issues came in second position with 44%, and feasibility considerations and ethical issues with 33% (n = 3).

Among all organizations, 67% (n = 6) indicated that assessments were most likely conducted for new technologies, while 56% (n = 5) noted the same for established or widely adopted practices. In contrast, only 22% (n = 2) reported that assessments addressed emerging technologies, further developments of existing technologies, or those in declining use. The frequency of covering different aspects of HTA by type of technology in Switzerland is presented in Fig 6. Safety, clinical effectiveness, costs, and economic evaluation were the most common aspects covered in HTA in all types of technologies. Patients/citizens’/community’ acceptability, views, communication and involvement, and feasibility considerations were the least common aspects covered in HTA.

Two-thirds of organizations (67%, n = 6) declared they used guidelines, models, frameworks, manuals, toolkits, or standards for preparing and developing HTA in their institutions in Switzerland, including 45% (n = 4) from EUnetHTA guidelines, 11% (n = 1) from WHO guidelines, and 11% (n = 1) from others.

Fig 7 shows the different areas where guidelines were applied/utilized for producing and preparing HTA reports, and where technical practices or procedures were applied for submitting HTA reports and mechanisms for communicating them. Guidelines were mainly used in medicines (78%, n = 7), followed by clinical interventions (67%, n = 6) and medical devices (56%, n = 5). Technical practices were also applied/utilized for clinical interventions (56%, n = 5), followed by medical devices and medicines (44.4% each, n = 4).

Timelines are very important in HTA processes, and Fig 8 shows the steps of the HTA process for which timelines did or did not exist, whether they were transparent or whether they were binding. For HTA conduction and HTA submission, 71.4% (n = 5) of organizations declared that transparent and binding timelines existed. Half of the organizations declared that timelines were not transparent for the appeal procedure and that no timeline existed for the decision process.

All organizations declared they have a formal process by which information was gathered to support decision-making on new devices, drugs, or vaccines. Organizations revealed that HTA was mainly used in Switzerland for reimbursement decisions (56%, n = 5) and support of clinical guidance (44% each, n = 4), as well as coverage (33%, n = 3). Some organizations also reported that HTA was initiated by manufacturers, authorities, or academia (22% each, n = 2) or by others (34%, n = 3), including hospitals or combinations of the previous answer. Only two organizations declared that an HTA question or area had been identified by a prioritization exercise or scientific advice and recommendation (25% each, n = 2), while 12% (n = 1) declared that it was by a decision from authorities, and the last 38% (n = 3) by some other method.

In Switzerland, 45% (n = 4) of organizations considered their information-gathering practices on new interventions as part of HTA, while 33% (n = 3) did not, and 22% (n = 2) were unsure. The main purpose of gathering information is to inform reimbursement and benefits package decisions (78%, n = 7) and the pricing of health products (56%, n = 5) (Fig 9).

In Switzerland, half of the organizations (50%, n = 4) relied primarily on secondary sources (e.g., databases, systematic reviews, gray literature) for HTA, while 38% (n = 3) used both primary (e.g., registries, observational studies) and secondary sources; one organization (12%, n = 1) was unsure. Only 38% (n = 3) of organizations declared that HTA data was collected by authorities, while 12% (n = 1) reported that it was submitted by a manufacturer and 50% (n = 4) by another method. The most important areas where HTA was used as an element of measurement in the decision-making process were clinical interventions and medical devices (89% each, n = 8), medicines (78%, n = 7), surgical interventions (67%, n = 6), and followed by population-level health interventions (56%, n = 5), vaccines (33%, n = 3) and digital technologies (11%, n = 1) (Fig 10).

In Switzerland, reports were used on a national basis by legislation for 38% (n = 3) of the organizations, on an institutional entity basis by 25% (n = 2), and both for 25% (n = 2). For half of the organizations, HTA is only one element of informing the decision, whereas the organization making the decision relied partially (25%, n = 2) or completely (12%, n = 1) on the conclusions of the assessment.

Fig 11 presents the most significant impediments at the country level to the use of HTA in health care policy decision-making. As reported by 56% (n = 5) of the organizations, the principal impediments were the lack of awareness and advocacy of the importance of HTA, the political support, and the institutional capacity, such as the setting-up process and well-functioning operations. The lack of qualified human resources (44%, n = 4) and institutionalization of HTA (33%, n = 3) were also noted. To strengthen HTA capabilities and production structure, the organizations highlighted actions as very important, such as awareness of HTA advantages and institutional strengthening (62.5% each, n = 6), and as fairly important as information availability (63%, n = 6) and budget increase (50%, n = 5), as illustrated in Fig 12.

The final section of this system analysis focuses on the academic or training programs supporting HTA capacity building in Switzerland. Findings reported (56%, n = 5) that these HTA programs are introduced and conducted through courses, seminars, or workshops. Fig 13 shows some interest by the Swiss organizations in international HTA training and knowledge platforms for enabling the continuous education on HTA in Switzerland.

A total of eight experts involved in HTA policies and strategies from various organizations across Switzerland attended IDIs. Of these experts, one was from the private sector, one from NGOs, and six were from academic organizations.

Experts demonstrated a strong understanding of the purpose and concept of HTA. Those from academic backgrounds, in particular, provided a comprehensive view of HTA, emphasizing its role as both a systematic evaluation process and a multidisciplinary endeavor. Several described HTA as “systematic and interdisciplinary scientific research,” with academic-affiliated experts.

Several experts also emphasized the significant impact HTA has on health outcomes and policy, noting its importance in ensuring that healthcare interventions are both effective and efficient. There was broad agreement that HTA is essential for rational decision-making in healthcare and HTA was viewed as a critical tool for improving transparency and accountability in health policy as well as for fostering evidence-based practice. However, some acknowledge that HTA benefits can vary depending on how well it is understood and applied across different sectors.

Most experts identified the FOPH as the principal regulatory body overseeing HTA in Switzerland, while also acknowledging the involvement of academia, insurance firms, health providers, and patients in the HTA process. However, there were divergent views on the existence of national HTA policies, with three experts noting the absence of a HTA national policy and one academician mentioning an initiative launched 12 years ago: “So the Swiss Academy of Medical Sciences and the conglomerate of all the cantons decided that we wanted to have HTA. It was, as I said about 12 years ago…” (Interviewee S6, Academic Expert).

Experts indicated that most professionals engaged in the HTA process came from clinical interventions and public health or clinical science backgrounds, with noticeably less involvement from professionals specializing in medical devices, medicines, or population-level health interventions. While the multidisciplinary nature of HTA was recognized, expertise was seen as concentrated in a few key areas.

Regarding HTA reports, experts expressed dissatisfaction with communication, coordination, and the practical use of HTA outputs. As one expert stated: “I’m not really satisfied. The Swiss Medical Board model was satisfying to quite an extent—it produced good, high-quality outputs and good dissemination—but it had no decision power, so it was poorly utilized” (Interviewee S2, Academic Expert). Conversely, a different expert noted positive trends in engagement and evidence use: “So I'm satisfied that there is a growing interest from clinicians and other actors in the system to get economic evidence, so that's a positive trend” (Interviewee S3, Academic Expert).

Experts consistently highlighted a significant lack of dedicated government funding for HTA in Switzerland, and many noted that costs are often covered by external stakeholders, such as private companies, rather than public authorities. One expert highlighted this challenge and said, “There is a lack of funds that go into HTA from the government or public authority sites; there needs to be funding for more people who can be trained” (Interviewee S7, Academic Expert).

Beyond the challenge of limited funding, experts also highlighted the need for multidisciplinary expertise and additional trained personnel as major barriers to expanding HTA capacity.

Clinical effectiveness and economic evaluation were identified as the most important value dimensions for HTA. Safety, equity, and ethical issues were mentioned less frequently, while patient/community acceptability, communication, involvement, and environmental or political aspects were rarely prioritized. HTA assessments were reported to be more commonly conducted on new technologies or established practices, with less attention given to emerging or declining technologies.

Guidelines and standards from international organizations (such as EUnetHTA, WHO, INAHTA, and ISPOR) were acknowledged as important references for HTA guidelines, especially in the context of medicines and clinical interventions. However, the application of such guidelines was described as variable, depending on the specific context and resources available.

Experts described HTA as being used primarily to inform reimbursement decisions (i.e., determining payment levels for covered medicines, services, technologies, or products), to support clinical guidance, and, to a lesser extent, to inform coverage decisions (i.e., whether technology is included in the health system). The initiation of HTA assessments varied, with manufacturers, authorities, academia, and hospitals all playing key roles, reflecting a collaborative and sometimes fragmented approach. Information gathered through HTA was primarily used for decisions on reimbursement, benefit package design, and health product pricing. HTA was most frequently applied to clinical interventions, medical devices, and medicines, with less common use in surgical and population-level interventions.

While experts agreed that HTA supports rational healthcare decision-making, they noted that its influence on policy is often limited, as political considerations frequently outweigh HTA recommendations. As one academician put it, “HTA is part of decision making but political aspects play a bigger role” (Interviewee S8, Academic Expert).

Strong interest in expanding HTA capacity in Switzerland was expressed, recognizing its value for evidence-based decision-making. However, significant impediments were consistently pointed out, including a lack of awareness and advocacy for HTA, insufficient political support, limited institutional capacity, and the persistent funding and training gap. Experts stressed the need for more multidisciplinary expertise and qualified personnel, noting that most current HTA professionals come from clinical and public health backgrounds, with fewer from other relevant fields. While academic and training programs exist in Switzerland, such as courses, seminars, and workshops, these were seen as insufficient to meet the growing demand for HTA skills.