Health Technology Assessment Process Research Articles

OP57 Consumer Engagement In Health Technology Assessment: An Australian Journey To Date

IntroductionAustralian health technology assessment (HTA) committees and processes at the national level have needed to consider an increasing focus on patient involvement and interactions within their scope. As various approaches have been explored, the visibility and impacts of patient involvement and consumer representation has evolved markedly over the most recent five years.MethodsProgram activities were developed from review of contemporary HTA models of practice across various HTA sectors internationally alongside input from individual patients and patient groups. Practical application of program pilots was influenced by specific requirements of the Office of HTA, the coordination of HTA Committee procedures and timelines, and involvement of HTA Committee consumer members.ResultsThe development of capacity building programs for HTA consumer committee members, the growth of external activity and communications targeting patient groups and networks, and the establishment of an expert position to develop the HTA Consumer Evidence and Engagement Unit within the Department’s Office of HTA, are all examples of the work delivered in this period to better integrate patient evidence and inputs into HTA processes and decision-making. Activities over the next period will seek to establish formal frameworks for meaningful involvement that can demonstrate these contributions to evaluations and decision-making.ConclusionsVarious examples of patient involvement and participation in processes have evolved over time. The scope and impacts of these experiences have illustrated important participatory demands and resourcing needs, as well potential benefits for deliberations. The Australian Government and Departmental frameworks for HTA currently seek to enhance the development of patient evidence inputs and participation. These developments will be informed by the Australian context and comprehensive consultation with Australian patient groups and their networks. Strategies for improvements are anticipated to be relevant across all HTA processes and Committees within HTA areas.

OP07 Eleven Years Of Conitec: Advances And Challenges Of Patient And Public Involvement In The Brazilian Health Technology Assessment Process

IntroductionPatient and public involvement (PPI) is a core element of the health technology assessment (HTA) process. Since its creation in 2011, the National Committee for Health Technology Incorporation (Conitec) has promoted initiatives to include stakeholders in HTA for the Brazilian Public Health System (SUS). This work aimed to present a report on the advances and challenges related to PPI in 11 years of Conitec.MethodsA retrospective analysis of PPI actions carried out at Conitec was conducted, based on an analysis of minutes and records of meetings and discussions held internally and documents published on Conitec´s website.ResultsEvents and meetings were held over the years with different actors interested in the HTA process. Since 2015, a plain-language version of the technical report has been made available to the public during public consultations for each HTA topic. Recently, a register of patients, specialists, and SUS managers was created to form a database and establish a network with the stakeholders. Since 2020, SUS users have been allocated time to speak at Conitec´s meetings. Qualitative analysis of public consultation documents started in 2021 and a pilot qualitative evidence synthesis was carried out in 2022. These initiatives, although not directly focused on PPI, increase the consideration of the perspectives of patients, family members, and caregivers in the HTA process.ConclusionsPPI actions implemented at Conitec have significantly promoted inclusiveness and exchanges among stakeholders, contributing to a greater transparency regarding Conitec’s actions. Nonetheless, we have important challenges on our horizon, such as strengthening connections with primary healthcare managers and professionals and social movements. It is also strategic to expand the technical and scientific discussion on PPI and qualitative approaches with HTA researchers and the voting members of Conitec. Finally, another aim is to improve knowledge of HTA and public health policy among law professionals and the pharmaceutical industry in Brazil.

OP10 Standardized Multilingual Reporting Of Health Technology Assessment And Stakeholder Involvement

IntroductionThere is currently no standardized way to share information about health technology assessment (HTA). Standardised Data on Initiatives (STARDIT) addresses current limitations and inconsistencies in sharing data about HTA processes by providing a way to report these data, including which stakeholders have been involved, their tasks, what methods and data sources were used, and any impacts or outcomes observed.MethodsSTARDIT development began in 2019 and was guided by participatory action research paradigms. A multidisciplinary international team of over 100 citizens, experts, and data users was involved in co-creating STARDIT. These co-creators include cancer patients, people affected by rare diseases, Indigenous peoples from multiple countries, representatives involved in HTA processes, health researchers, environmental researchers, economists, librarians, and academic publishers. Methods of involving people included public events, online discussions, and a public consultation process. STARDIT is free to use, and data can be submitted by anyone. Report authors can be verified to improve trust and transparency, and data can be checked for quality.ResultsSTARDIT can help create high-quality standardized information about HTA processes that can be accessed and edited by anyone. STARDIT enables data reporting at all stages of the HTA process and works in multiple languages. This allows stakeholders involved in or affected by HTA processes (including patients, the public, Indigenous peoples, and people from industry) to appraise and edit information and to self-identify the labels and terminology used to describe them. Organizations such as the Cochrane Collaboration, Australian Genomics, and multiple universities have created STARDIT reports. A link to the working beta version can be found at scienceforall.world/STARDIT.ConclusionsSTARDIT offers those conducting HTA access to standardized information that enables well-founded comparisons of the effectiveness of different HTA methods, including the most effective methods of involving stakeholders. STARDIT allows anyone to access data about HTA processes, which can support participatory ways of working and help improve the equity and quality of HTA processes worldwide.

HTA268 Key Issues in the Methods and Process of Health Technology Assessment in China: A National Expert Survey

HTA268 Key Issues in the Methods and Process of Health Technology Assessment in China: A National Expert Survey

OP19 Exploring The Environment/Capacity Of South African Citizen Actors To Contribute To Health Technology Assessment Processes, Policy Development And Institutionalization

IntroductionSeveral overarching health policy reform processes are currently underway in South Africa (SA), providing an opportunity to establish health technology assessment (HTA) and value-based assessment (VBA) frameworks that foster patient and citizen involvement (PCI). A mapping of the capacity, knowledge, and skill of SA PCI advocacy actors and understanding of the ‘middle-ground’ and influencing relationships that influence advocacy strategies for PCI in HTA, will allow us to determine the needs of PCI actors to entrench PCI principles in the emerging institutionalization of HTA in SA.MethodsAn analysis of national and international legislative and policy frameworks indicates current gaps and opportunities for PCI institutionalization in HTA in SA. A survey was conducted to determine SA patient and citizen advocacy actors’ capacity, knowledge, and skill across multiple disease areas. An analysis of decision maker’s opinions and positions about PCI in HTA and VBA policy, and their potential influence on the PCI process was undertaken.ResultsThe legislation and policy review indicate that engagement initiatives are positioned at the ‘involvement’ or ‘consultation’ stages of the engagement continuum, rather than higher-level engagement. Five percent of patient advocacy groups (PAGs) interviewed have formalized PCI HTA advocacy strategies. Few PAGs indicated employing processes to actively monitor the HTA and PCI-related activities of decision-makers.The majority of PAGs stated that collaborative efforts within larger networks would generate more success, if they engaged in PCI in HTA advocacy. Over eighty percent of civil society stakeholders face capacity constraints, such as lack of knowledge of the legislative framework and theory of HTA, funding and manpower to engage in PCI. The majority of HTA processes undertaken by funders in SA do not actively include PAGs or formalized PCI.ConclusionsExisting legislative and policy frameworks do not include PCI capacity-building strategies. This is impacted by the lack of coordination amongst patient and consumer groups, the willingness of existing HTA structures to formalize PCI, and the resources of the country’s PCI advocate actors to influence existing HTA processes.

OP55 Did It Matter? Developing A Common Framework For Characterizing Impact Of Patient Involvement In Health Technology Assessment

IntroductionWhile the impact of health technology assessments (HTAs) is often not evaluated, some HTA bodies measure the impact of patient involvement in their processes. Evaluating how patient involvement is perceived by all stakeholders may help to improve practices and avoid activities that unduly burden patient and HTA communities. Frameworks and tools have been designed to analyze the impact of patient engagement along the healthcare development lifecycle. Reporting on the impact of patient involvement in HTA-specific activities, however, continues to be infrequent, unstandardized, and not comprehensive.Having a common framework to characterize and report on the impact of patient involvement may enable this practice to be optimized and harmonized across HTA contexts.MethodsThe Patient and Citizen Involvement Interest Group (PCIG) within Health Technology Assessment International set out to contextualize this impact and support reporting. A questionnaire was developed, piloted, and rolled out to collect multistakeholder personal perceptions of the impact of patient involvement in individual HTAs. Questions included: “What difference did you feel patient involvement made in the HTA activity?” and “What would have been missed without patient involvement?”. From January 2019 to September 2021, 24 responses (including one joint submission) were collected through the PCIG’s network from HTA bodies (11), patient representatives (12), and industry representatives (2) from North America (5), South America (3), Europe (13), and Australia (3).ResultsCommon themes were extracted from these experiences to characterize the impact of patient participation in HTA processes. Based on these commonalities, a harmonized framework consisting of three “domains” is proposed: impact on the decision-making process; impact on patient stakeholders; and impact on the HTA body. The framework includes a set of items under each domain to support reporting.ConclusionsBy having common language and measures, the HTA community can harmonize processes across jurisdictions to evaluate and communicate the value of patient involvement in HTA. Improving consistent reporting may facilitate more efficient process improvement for meaningful integration of patient stakeholders into HTA decision-making.

PP67 What Patients Want – Optimizing Oncology Value Assessment To The Goals Of Patients

IntroductionCancer is now diagnosed and treated earlier, resulting in improved patient benefit and outcomes. While overall survival (OS) is crucial to patients, there are other value dimensions, such as quality of life (QoL) and reduction in severe side effects, that change patient lives while on treatment. Considering patient reported outcomes (PROs) in value assessments for decision-making can improve individual, population and societal outcomes.MethodsA multidisciplinary, international group of experts working in the cancer field was brought together to reach consensus on key principles of defining and assessing cancer treatment value. A Delphi-based approach including surveys, virtual panels, interviews and structured online discussions was used to reach consensus. This work was funded by AstraZeneca.ResultsUse of PROs in oncology value assessment is important because it can lead to: improvements in caregiver/patient/physician communication; unmet problem and needs detection; disease and treatment tracking; and better cost effectiveness. While some health technology assessment (HTA) bodies are already accepting QoL data, such as the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany and US Centers for Medicare and Medicaid (CMS), many others do not. It is important that there is consistency in use of QoL data and other PROs, ensuring inclusion and a standardized and simple way of capture. In trials, tolerability data collected via PROs and QoL should be routinely and consistently incorporated and emphasized in HTA value assessments together with safety, efficacy and effectiveness. Data from PROs should be considered in decision-making to help build a better picture of health-related QoL, morbidity and adverse events from the patient perspective.ConclusionsWe are calling on the cancer community to: continue to encourage the use of a broad set of oncology-relevant endpoints in clinical trials to further validate their relevance as endpoints either as predictors of clinical outcomes or endpoints with intrinsic value; collect complementary PRO data in clinical trials and as real-world evidence to better tailor treatment options to the outcomes that individual patients value most; involve patients in HTA processes.

PP13 Results Of An International Survey About Barriers In Patient Involvement In Health Technology Assessment Of Digital Health Technologies

IntroductionIn recent years, several efforts have been initiated by health technology assessment (HTA) agencies to increasingly incorporate patient involvement (PI) into their assessment processes. The rationale behind PI in HTA is that patients can give their perspective and experiences about health, illness and the use of health technologies, complementing clinical and healthcare system standpoints.A recent systematic review summarized current evidence on the barriers and facilitators of PI in HTA. Barriers and facilitators were classified according to the context in which they appear, as organizational, decision-making, political and community-related.Digital health technologies offer a singular opportunity to address some challenges faced by healthcare systems. However, we hypothesized that their intrinsic characteristics may have some implications for PI in digital HTA. We conducted a survey to gain knowledge about barriers in PI in digital HTA.MethodsThe survey was elaborated using Microsoft Forms and consisted of 31 questions divided into four blocks (organizational, decision-making, political and community-related). It was sent to three Spanish, one Catalan and one International patient umbrella organizations. The results were analysed using Microsoft Excel.ResultsA total of four responses were received from three Spanish and one Catalan patient umbrella organizations. Results showed high, partial, and low concordance among organizations in 65 percent, 19 percent and 16 percent of the answers received, respectively. According to the results, most of the barriers for PI seem to be the same for HTA of digital health technologies as for other types of health technologies. However, two or three of the four umbrella organizations consider that HTA of digital health technologies might pose greater challenges in terms of achieving significant patient participation, sufficient patient training and knowledge of HTA processes, proper preparation and tools of the HTA experts and logistics during the HTA process.ConclusionsBarriers in PI are mostly the same for digital or other types of health technologies. Few differences are related to patient training, tools, and logistics during HTA process.

OP151 Health Technology Assessment In Switzerland – Current And Future Challenges

IntroductionThe Swiss Health Technology Assessment (HTA) program is a unique, innovative program that connects research with policy making. In 2017, a HTA unit was established within the Federal Office of Public Health following a decision by the Federal Council in 2015 to intensify efforts in HTA.MethodsThe legal basis of the HTA program is Article 32 of the Federal Health Insurance Act, which specifies that health technologies (i.e., all preventive, diagnostic, and therapeutic interventions in health care) covered by the compulsory health insurance must be effective (E), appropriate (A), and economically efficient (E).Health technologies that do not meet the EAE criteria are not eligible for coverage. For health technologies that are already reimbursed, re-evaluation of the criteria can result in the removal of technologies from the catalog of benefits or limitations being placed on their reimbursement.ResultsThe initial focus of the HTA program was the re-evaluation of controversial health technologies. This focus was later expanded to evaluating new and upcoming technologies through horizon scanning. Challenges encountered since the start of the program include:•aligning the classic HTA domains with the EAE criteria;•identifying suitable re-evaluation topics;•tailoring HTA processes to regulation options and decision-making processes; and•involving stakeholders in the HTA process without jeopardizing the quality and objectivity of the research.ConclusionsDespite various initial challenges, the HTA program has become an acknowledged and appreciated actor within the Swiss reimbursement policy landscape. An outlook on the program’s future will also be shared.

OP09 Developing A Patient And Consumer Training Tool Explaining Health Technology Assessment And Patient/Consumer Participation: The French Experience

IntroductionThe French National Authority for Health’s (HAS) 2019-2024 strategic workplan called for “making public involvement a priority.” This project was designed within the roadmap validated in 2021; “Strengthening public involvement in health technology assessment (HTA) at the HAS”, including an action of building a means of training patient organizations for their contribution. The project’s overall objective was to develop with patients and consumers a first training tool, representing an online knowledge base targeting French patients and consumers to explain the HAS HTA process and assist their participation in these assessments.MethodsThree stages were designed to meet this objective. Firstly, an international benchmark was performed of available online HTA training tools for patients and consumers, notably those used by HTA bodies and European and international patient and consumer groups (PCGs). Secondly, an internal HAS search for e-learning tools, was conducted to identify whether they could meet the training needs of French patients and consumers. Finally, the training tool was developed via a working group composed of patients and HAS scientific officers.ResultsThe benchmark identified 82 online training tools selected according to the specified inclusion criteria. Sixteen international HTA agencies, nine European and international PCGs and 13 other bodies provided online HTA training tools for patients and consumers during the research period, but no journal articles identified such tools. Eleven formats and 12 key themes, divided into two main categories were identified: important content related to HTA, and important content related to public involvement in HTA. The HAS search for e-learning tools resulted in internal e-learning tools offered for clinical experts not meeting the needs and preferences of patients and consumers. Finally, HAS based its training tool development on these preferences and needs to create a PowerPoint in two blocks of modules covering the two main categories above (six modules in total).ConclusionsFrench patients and consumers preferences and needs for a HTA training tool were inspired by the international benchmark, dividing key themes into two main categories: important content related to HTA, and important content related to public involvement in HTA. This resulted in HAS development of two blocks of modules in PowerPoint format covering these two categories.

PP38 Designing A Training And Capacity Building Pathway In Patient Involvement

IntroductionThe Patient Involvement (PI) Interest Group of the Spanish Network of Health Technology Assessment Agencies (RedETS) was set up in 2017 by a group of health technology assessment (HTA) researchers interested in PI. Since its inception, training and capacity-building to support PI and patient-based evidence in HTA processes has been one of its main aims. The objective of this work was to identify the needs and priorities related to training and capacity building activities to be developed within the framework of the PI Interest Group.MethodsThe PI Interest Group met on November 14, 2022, for its Annual Meeting. The group discussed the needs, priorities and possibilities on training, and carried out a prioritization exercise. For this purpose, a self-reported and anonymous questionnaire was used, which included 16 training activities. Every item was scored with a Likert-type scale ranging from 0 to 10.ResultsThe questionnaire was answered by twenty participants. The most highly rated training activities (mean less than or equal to 8) were: qualitative evidence synthesis (8.75); PI case studies (basic (8.65) and advanced (8.56) level); quality assessment tools for qualitative evidence (8.37); and qualitative research (8.11). Other proposals scoring above 7 points were: ethical aspects related to PI, evaluation of patient participation and impact, identification and recruitment procedures, and discrete choice experiments. The group agreed to organize bi-monthly webinars and three structured training activities for the whole RedETS network on: Qualitative Evidence Synthesis, Qualitative Research and PI Case Studies.ConclusionsThe prioritization of training activities according to PI Interest Group members allowed planning a tailored capacity-building program adapted to the needs of RedETS.

OP08 International Benchmarking Of Health Technology Assessment Training Tools And Materials For Patients And Consumers

IntroductionThe objective was to conduct a benchmarking study of available online health technology assessment (HTA) training tools for patients, specifically those used by HTA agencies and major European and international patient and consumer groups (PCGs). We compared existing online training tools on this topic in order to develop in-house HTA training tools for French patients and consumers.MethodsA literature search and a scoping review of websites was conducted by including the websites of HTA agencies, European and international PCGs, and other bodies. This was supplemented with videoconference interviews with selected HTA agencies and patient groups. The inclusion criterion was the existence of content describing HTA and patient and public involvement (PPI) in HTA that PCGs could use (regardless of its format).ResultsEighty-two online training tools were selected according to the specified inclusion criterion. Sixteen international HTA bodies, nine European and international PCGs, and 13 other bodies provided online HTA training tools available for patients and consumers. No journal articles matching the inclusion criterion were found. Two broad categories of content were identified: the first relating to HTA and the second relating to PPI in HTA. Moreover, the formats of these tools ranged from interactive to non-interactive, with varying accessibility (freely available or with a paywall) and assessment methods.ConclusionsThese results should be considered together with budget requirements, project time constraints, human resources, and the preferences of HAS and patients when developing HTA training tools to improve the participation of patients and consumers in the HTA process at HAS.

HTA241 Health Equity and the Health Technology Assessment Process: Are Children and Young People Being Overlooked? A Review of Pediatric National Institute of Health and Care Excellence Technology Appraisals

HTA241 Health Equity and the Health Technology Assessment Process: Are Children and Young People Being Overlooked? A Review of Pediatric National Institute of Health and Care Excellence Technology Appraisals

HTA131 Cost-Effectiveness Threshold in Denmark's New Health Technology Assessment Process: What Do We Know so Far?

HTA131 Cost-Effectiveness Threshold in Denmark's New Health Technology Assessment Process: What Do We Know so Far?

OP137 A Qualitative Exploration Of The National Institute For Health And Care Excellence’s Impact On International Health Technology Assessment

IntroductionThe National Institute For Health And Care Excellence (NICE) is widely acknowledged as a seminal health technology assessment (HTA) body, known for its transparent and accountable approach to decision-making. This research aimed to investigate the impact of NICE methodology and decisions on international HTA bodies. We sought to identify direct and indirect factors that may influence an international HTA body’s methods or outcomes. To the best of our knowledge, this is the first research to use a qualitative approach to understand the influence of NICE on other HTA bodies.MethodsWe conducted 13 semi-structured qualitative interviews with HTA and market access experts from industry and academia from nine countries (Brazil, Israel, Italy, Japan, Poland, Saudi Arabia, South Korea, Sweden, and the United Arab Emirates). The interview script was organized into three main sections: comparing NICE methods and processes with other HTA bodies; the impact of specific NICE decisions; and Likert scale questions (to allow for comparability of opinions).ResultsMost interviewees believed their local HTA body would consider NICE’s decision when evaluating a medicine. However, the way and extent to which NICE influences HTA varied across countries. The most common means of considering a NICE decision was as background information or context for an HTA evaluation. Generally, interviewees suggested that negative NICE decisions had more impact on local decision-making than positive decisions. Nine of the 13 interviewees agreed or strongly agreed that their country’s HTA body considers the decisions of other HTA bodies in their decision-making process. Eleven of the 13 interviewees agreed or strongly agreed that the development of their country’s HTA body methods and processes was influenced by NICE.ConclusionsNICE is perceived to be a seminal HTA body, with continued influence on HTA agencies in other countries. However, the mechanisms and extent of this influence varies considerably between countries. We suggest that implicit factors are likely to contribute more to NICE’s influence than individual decisions. Nevertheless, further research is needed to reveal these factors and increase efficiency in international HTA decision-making processes.

OP116 Building Alignment Between Industry, Academia, And Patients On Health Technology Assessment Methods

IntroductionWith the announcement of the health technology assessment (HTA) review in Australia, a HTA Summit was organized by ISPOR Australia in November 2022. The aim of the Summit was to provide a forum for industry, academia, and patients to share ideas and find common ground with respect to HTA policy, processes, and methods. Topics were determined by a Steering Committee and included: managing uncertainty; patient engagement; second order effects; genetics, genomics and precision medicines; conditional listing; and real-world evidence. Presentations on each topic were conducted by industry and non-industry experts. Breakout sessions led by facilitators were also held for each topic with members of the audience.MethodsDiscussions were recorded during the event and a thematic analysis was performed.ResultsThe following themes were identified from the event.•There was a strong sentiment that participants enjoyed the opportunity to discuss ideas and work toward solutions.•There was a consistent theme that many of the issues arising in HTA were due to a lack of communication between sponsors, evaluators, patients, and decision makers.•It was noted that HTA encompasses several technical terms that have different meanings among various stakeholders.•There was a clear consensus that patients should be involved in HTA earlier and throughout the process.•HTA reform can help drive better access to real-world evidence.•To improve the efficiency of the process, uncertainty could be reframed as risk management, which incorporates the effect of uncertainty in the funding decision.•HTA includes policies, processes, and methods and is used as a tool by decision makers to make informed funding decisions. It was noted on several occasions during the Summit that funding decisions have a political element that should be separated from the HTA process.ConclusionsIt is possible to achieve better collaboration between industry, academic, and patient groups with respect to HTA reform. To promote more collaborative work a consistent conflict of interest definition would be helpful.

PP11 Patient Involvement In Drug Evaluations To Inform Funding Decisions: A Singapore Case Study

IntroductionPatient involvement has become increasingly integral to health technology assessment (HTA) processes globally due to greater recognition of the important contribution patients make to address uncertainties in the scientific evidence base and interpret results for real-world implementation. To align with best practices and encourage meaningful patient input in HTAs in Singapore, patient involvement processes were established by the Agency for Care Effectiveness (ACE) in 2021. This presentation discusses how patient groups were identified in Singapore and describes the new patient involvement processes.MethodsIn the absence of a centralized database, a stakeholder mapping exercise was undertaken in 2021 to identify all relevant patient and volunteer groups in Singapore. A comprehensive search of the Singapore Charity Portal, hospital websites, standard search engines and social media platforms was conducted.Identified groups were screened in line with specific inclusion criteria and contacted via email and cold calling to find out more about their remits. Plain English resources, targeted training materials and a process guide to encourage patient involvement in ACE’s work were co-developed with local patient organizations by drawing upon best practices from overseas HTA agencies contextualized to local patients’ needs. Supporting resources and processes were revised in 2022 based on ACE’s experience receiving inputs from patients and caregivers to inform drug HTAs.ResultsOne hundred and six patient groups covering 20 conditions were identified including registered organizations and informal support groups. In the first half of 2022, ACE received responses from 82 patients from ten patient organizations to inform seven drug HTAs for cancer, diabetes, HIV, and other conditions in line with the new patient involvement processes. Patient organizations viewed the opportunity to submit testimonials of their lived experience with different conditions as a meaningful and important activity for their members.ConclusionsPatient involvement processes have improved the legitimacy and acceptance of ACE’s work and will be continuously revised to ensure that they remain relevant and meet patients’ expectations and needs.

OP174 Health Technology Assessment And Economic Evaluations For A Genomic Strategy In Italy

IntroductionThe challenge to health systems is sustainability, not only in the economic and financial sense of compatibility of spending with allocated resources, but also in terms of equity in access to services and care, quality, safety, innovation and research, that is, in terms of the effectiveness of the right to health. Some countries, such as Italy, do not have formal health technology assessment (HTA) or other similar processes that take into account views outside the decision maker.MethodsIn the Italian national context, there is currently no single tariff for the reimbursability and pricing of genomic technologies. In fact, although genomic tests have been in clinical practice for many years now, to date they have not yet been included in the LEA (Minimum healthcare provision), especially in view of the fact that a defined and transparent process for updating the Essential Levels of Care has been operational since 2018. With the goal of structuring guidelines for the adaptability of economic evaluations to currently available and developing genomic technologies, a literature review was conducted.ResultsThe literature review showed that there are some methodological and practical issues that need to be carefully considered when designing and conducting economic evaluations of genomic tests. In more detail, five key concepts were identified in order to implement the most comprehensive economic evaluation of the technologies under study: the PICO model, the survey perspective, the costs included in the analysis, the effectiveness analysis, the time horizon, and the discount rate.ConclusionsAdequate definition of these concepts appears to be of paramount importance in view of the fact that genomic testing may have important consequences for future generations as well. For the purpose of sustainability of access of genomic technologies, the use of Budget Impact Analysis (BIA) is recommended in all analysis settings being essential for the regulator to tie access to its available budget capacity.

OP21 Patient Values Project (PVP): Patient Preferences For Cancer Treatments To Inform A Framework Incorporating Patient Values Into Health Technology Assessment

IntroductionThe methodology for explicitly incorporating patient preferences by expert committees engaged in deliberative health technology assessment (HTA) processes for drug reimbursement recommendations is a relatively unexplored area despite the growing emphasis on patient-reported outcomes and patient engagement. The Patient Values Project (PVP) aims to improve patient input to expert review committees and promote a better understanding of the patient perspective using quantitative data to support the rationale in assessing new cancer drugs. Using colorectal cancer as a starting point, the PVP aims to develop a framework to objectively incorporate quantitative patient values and preferences into Canada’s cancer drug HTA decision-making process. We report on results from the first phase.MethodsIn the first phase, we developed a bilingual survey informed by qualitative focus groups, literature review and feedback from clinicians, patients and experts. The survey includes background questions, general and cancer specific quality-of-life tools, two discrete choice experiments (DCE) and a best worst scaling (BWS) experiment. After pre-testing and pilot testing, the survey was administered across Canada to metastatic and non-metastatic colorectal cancer patients and caregivers, in addition to adults from the general population. In the next phases, we will use vignettes to explore how patient preferences could be incorporated explicitly into decision-making, and what approach to use in HTA submissions.ResultsDCE1 survey results (˜n=1,000) reflect trade-offs between health-related quality-of-life and survival; DCE2 results reflect trade-offs between treatment regimens, side effects and survival/risk of recurrence; BWS results ranked and weighted the tolerability of 25 possible side effects of treatment. We observed differences in preferences amongst the general population, patients with metastatic cancer, non-metastatic cancer and caregivers.ConclusionsPatients have unique perspectives and preferences about what is important and of value to them, which may impact patient adherence to treatment. In the next phases, we will explore how this evidence from patient preferences can be translated into values that could potentially be incorporated as an explicit element of the deliberative process for HTA decision-making.

OP120 Developing A Call To Action For Patient Involvement In Health Technology Assessment (HTA) In Southern Africa

IntroductionIn building health technology assessment (HTA) and related decision processes in Southern Africa, institutions and stakeholders face region-specific challenges such as disease prevalence and population makeup. These can be addressed by collaboratively discussing patient engagement solutions that fit the local culture and systems and serve to ensure equitable and sustainable access to patient-relevant health technologies. Our aim is to initiate a collaboration for driving patient involvement (PI) suitable for the Southern African context and Sub-Saharan patient communities. In addition, we explore current experiences in PI, including the stakeholder expectations, gaps, limitations, and new opportunities.MethodsA one-day hybrid multi-stakeholder PI in HTA workshop was held in Johannesburg, South Africa. Co-created by the participants, the outputs are a call to action and a concept draft for the vital success criteria for PI in the region. The content of the call to action is gathered from pre-workshop surveys, interviews, and outcomes from historic meetings held in conjunction with the Health Technology Assessment International (HTAi) PI workstream as well as facilitated discussion from the actual workshop.ResultsThe workshop was attended by 42 participants from nine countries, representing diverse stakeholder groups. The attendees represented multiple PI stakeholder groups. The workshop survey was completed by 44 respondents, while 12 participants completed the post-event survey. A workshop outcomes document highlighting a high level of alignment and identifying seven key success factors was developed. A workshop proceeding detailing the outcomes is now being drafted.ConclusionsOver 95 percent of respondents to pre-and post-surveys indicated an interest in contributing to a more in-depth description of PI in their country. While the majority of participants were from South Africa, participants from Tanzania, Ethiopia, Zambia, and Zimbabwe emphasized that trans-African-engagement for HTA will provide an additional opportunity for HTA in Africa and patient and community participation in HTA and healthcare decision-making. Hence, a collaborative platform could help all African countries to advance and benefit from improved healthcare decision processes.