Impact Of Health Technology Assessment Research Articles

OP149 How To Improve The Impact Of Health Technology Assessment: Stakeholders’ Perspectives In Spain

IntroductionHealth technology assessment (HTA) agencies in Spain have an important role in informing decisions about the introduction and use of health technologies in the Spanish National Health System. However, although different approaches have been taken to measure and improve their impact, no study to date has explored the perceived impact of HTA products at the national level. The aim of this study was to explore the perspectives of macro-, meso-, and micro-level decision makers on how to improve the impact of HTA.MethodsThree online focus groups were conducted with policy makers, healthcare managers, clinicians, and patients. The transcripts were evaluated using a deductive thematic analysis based on a multidimensional framework to explore mechanisms of impact.ResultsFour key themes were identified:(i)Timeliness and use of HTA assessments: Although the quality of the reports was recognized, the time taken for the elaboration and extension of reports negatively affected their use. Participants considered that reports should be tailored to the needs of end users (e.g., briefer versions available for meso-and micro-level use);(ii)Effective engagement and external communications: The engagement of multiple stakeholders (policy makers, manufacturers, clinicians, and patients) in the elaboration process was considered crucial to improve HTA impact and ensure adequate communication of results;(iii)Good institutional reputation and fit within the healthcare and policy making system: Stakeholders agreed on the need to strengthen collaboration at the national level and increase public understanding of the value of HTA and its use in healthcare decision-making; and(iv)Effective implementation of policy change regarding health technologies: Stakeholders were very receptive to the results and recommendations of HTA reports when new technologies are demanded, but the identification and selection process should be improved to guarantee that these reports are available on time.ConclusionsThis study has identified different proposals and mechanisms that could improve the impact of HTA in Spain.

Main Challenges of Incorporating Environmental Impacts in the Economic Evaluation of Health Technology Assessment: A Scoping Review

Health technology assessment (HTA) provides evidence-based information on healthcare technology to support decision making in many countries. Environmental impact is a relevant dimension of a health technology's value, but it has been poorly addressed in HTA processes in spite of the commitment that the health sector must have to contribute to mitigating the effects of climate change. This study aims to identify the state of the art and challenges for quantifying environmental impacts that could be incorporated into the economic evaluation (EE) of HTA. We performed a scoping review that included 22 articles grouped into four types of contribution: (1) concepts to draw up a theoretical framework, (2) HTA reports, (3) parameter designs or suitable indicators, and (4) economic or budgetary impact assessments. This review shows that evaluation of the environmental impact of HTAs is still very incipient. Small steps are being taken in EE, such as carbon footprint estimations from a life-cycle approach of technologies and the entire care pathway.

The value and impact of health technology assessment: discussions and recommendations from the 2023 Health Technology Assessment International Global Policy Forum.

Health technology assessment (HTA) programs inform decision making about the value and reimbursement of new and existing health technologies; however, they are under increasing pressure to demonstrate that they are a cost-effective use of finite healthcare resources themselves. The 2023 HTAi Global Policy Forum (GPF) discussed the value and impact of HTA, including how it is assessed and communicated, and how it could be enhanced in the future. This article summarizes the discussions held at the 2023 HTAi GPF, where the challenges and opportunities related to the value and impact of HTA were debated. Core themes and recommendations identified that defining the purpose of value and impact assessment is an essential first step prior to undertaking it, and that it can be done through the use and expansion of existing tools. Further work around aligning HTA programs with underlying societal values is needed to ensure the long-term value and impact of HTA. HTA could also have a role in assessing the efficiency of the wider health system by applying HTA methods or concepts to broader budgetary allocations and organizational aspects of health care. Stakeholders (particularly patients, industry, and clinicians but also payers, wider society, and the media) should ideally be actively engaged when undertaking the value and impact assessment of HTA. More concerted efforts in communicating the role and remit of HTA bodies would also help stakeholders to better understand the value and impact of HTA, which in turn could improve the implementation of HTA recommendations and application to future actions in the lifecycle of technologies.

National Health Technology Assessment in Turkiye after a decade: Are key principles followed?

Health technology assessment (HTA) is growing in low- and middle-income countries (LMICs) to ensure optimal use of limited resources. However, the impact of HTAs on decision making in LMICs has been limited. The study aimed to provide an overview of Turkiye's progress since establishing the first HTA agency in 2012. The web sites of three national HTA agencies in Turkiye were searched for HTA guidelines and national HTA reports. The HTA guidelines were assessed by two researchers independently against the key principles of HTA developed by Drummond et al., and the HTA reports against the national guidelines. The study included one HTA guideline and eight national HTA reports. The guideline included very limited technical guidance. Compliance with the principles was poor to moderate, and significant methodological limitations were identified. The reports were inconsistent regarding the scope and the HTA assessment criteria. The link between HTA findings, HTA decision making, and health policies were not clear. The inconsistencies between the reports and the methodological limitations demonstrate the need for national HTA guidelines. Improving the characteristics of the HTA might impact implementation. Among the key issues is transparency regarding priority setting, the HTA process, and decision making. Establishing and adopting national HTA guidelines at international standards is needed. Involving external scientific committees and health economists in the HTA processes might help ensure that the key principles of HTA are followed. The study findings might be helpful for countries that are developing their HTA systems.

PP148 The Impact Of Health Technology Wales Guidance For Autologous Hematopoietic Stem Cell Transplantation: Two Years Post-Publication

IntroductionEvaluating the impact of health technology assessment (HTA) is vital to measure its contribution to health and social care decision-making and improving citizen outcomes. Health Technology Wales (HTW) is a HTA body committed to evaluating the impact of our work. Here we present HTW’s impact evaluation approach with a case study for autologous hematopoietic stem cell transplantation (AHSCT) for highly active relapsing remitting multiple sclerosis (RRMS).MethodsUsing an outcomes-focused approach based on contribution analysis, HTW has worked with an external evaluation organization to develop a framework to measure the impact of our work. Data on impact was collected from both qualitative and quantitative sources, including social media metrics, surveys, and informal feedback from stakeholders. We engaged with various stakeholders, including clinicians, academics, patient organizations and other HTA bodies.ResultsThe technology appraisal and guidance were published in July 2020, recommending AHSCT for routine adoption to treat highly active RRMS. Patient groups welcomed the appraisal findings as an important step forward in recognising the needs of people with RRMS and felt that “people living with MS were listened to throughout the process”. Following publication online, the guidance has had approximately 500 views, and featured on the MS Trust website and in several news articles. The Welsh Health Specialist Services Committee, a commissioning body in Wales, recommended AHSCT for RRMS as a ‘high priority’ for funding in the WHSSC Integrated Commissioning Plan 2021-22.ConclusionsSince its publication, we have been able to prospectively capture the impact of this guidance through various stakeholders groups and sources. Overall, responses have been positive and the guidance has supported decision makers in Wales. Ongoing evidence capture, including through HTW’s adoption audit processes, will add further understanding to the potential impact of our work.

HTA and National Immunisation Program: an overview of competent bodies and of the impact of HTA on the decision-making process

Abstract Issue/problem The WHO has recommended for many years to adopt transparent and standardized methods to decide upon the introduction of vaccines at national level. For this purpose, the Global Vaccine Action Plan has envisaged the establishment of National Immunization Technical Advisory Groups (NITAGs) to issue independent advice relied on the assessment of vaccines efficacy and safety and health technology assessment (HTA). Description of the problem So far, 172 countries worldwide have a NITAG. Despite the growth in the number of NITAGs worldwide and their strengthening following process indicators identified by the WHO, the way how NITAGs issue recommendations and how they are considered in the development of vaccine policy still represent a matter to the attention of the scientific and policy community. Results The evidence shows that assessment frameworks vary across countries. Furthermore, the legal basis and the authority, namely binding or advisory, recognised to them could influence the way how NITAGs work and impact on vaccine policy. Eventually, the final decision is also led by other aspects, including financial and contextual factors that are less standardizable but should be always taken into consideration in health policy. In fact, the final decision on the inclusion of a vaccination into the national immunization program is made by the Ministry of Health also based on the evaluation of HTA bodies working in the country. Lessons Considering the central role of NITAGs in vaccine policy, some efforts should be done in order to make NITAGs more authoritative and collaborative. This could help, from one side, to make the relationship between final decision and NITAGs recommendations clearer and, on other one, to make it possible to have shared and timely evaluations. In this respect, Joint Clinical Assessment envisaged by the new EU regulation on HTA could prepare the way for a more transparent and timely vaccine policy at European level.

Impact of health technology assessment implementation with a special focus on middle-income countries

ObjectivesBuilding an efficient health technology assessment (HTA) system requires significant effort and political commitment, in addition to human and financial resources. Expectations of what HTA can offer to middle-income countries (MICs) are continuously rising, which drives health policymakers to raise the question of whether HTA could help secure the financial sustainability needed to implement universal health coverage. In this study, we explored the impact HTA adoption may have on the countries and its impact on health system objectives, as well as transferability of benefits and drawbacks observed in higher-income to middle-income countries. MethodsWe utilized secondary data from a systematic literature review and primary data by disseminating a survey among local stakeholders in three MICs across three continents to capture their perspective on the impact of HTA implementation from a local context. ResultsIt was evident from the results of both the literature review and survey that the positive impacts of HTA implementation outweigh the negative impacts. Most of the reviewed literature discussed the impact of HTA on the intermediate objectives of the health finance policy in relation to the broad health system goals. According to the survey respondents, the most evident benefit of HTA implementation is improving the transparency and accountability of healthcare decisions. ConclusionsOverall, HTA implementation can introduce a myriad of benefits to healthcare systems in MICs as well. Our findings show that while HTA implementation may have the potential to generate cost savings in specific areas, there is no guarantee that HTA can generate savings at the macro level. Public Interest SummaryHealth technologies (medicines, devices, and interventions) are rapidly increasing in complexity and cost. Health Technology Assessment (HTA) guides healthcare decision-makers in choosing the most suitable, effective, affordable, and acceptable health technology to invest limited healthcare resources. However, healthcare decision-makers in middle-income countries (MICS) are still uncertain about whether adopting HTA would help them achieve the financial sustainability needed to achieve universal health coverage. Thereforewe sought to gather evidence on how HTA has affected the health systems of countries that have already adopted it by reviewing published research reports. In addition, healthcare decision-makers from three MICs were questioned about their perception of how HTA implementation will affect their country's health system. Wefound that the positive effects of HTA implementation outweigh the negative ones; specifically, the transparency and accountability of decisions are improved. However, although HTA implementation may generate cost savings in specific areas, it may not significantly contribute to overall financial sustainability.

POSC269 Health Technology Assessment Implementation for Development of Basic Benefit Package in 2021 in Ukraine

The aim of the study is to determine the impact of health technology assessment (HTA) implementation for the basic benefit package to justify the medicines inclusion on the National list of essential medicines in Ukraine according to new legislation.

A model-based study to estimate the health and economic impact of health technology assessment in Thailand.

Health technology assessment (HTA) plays a central role in the coverage and reimbursement decision-making process for public health expenditure in many countries, including Thailand. However, there have been few attempts to quantitatively understand the benefits of using HTA to inform resource allocation decisions. The objective of this research was to simulate the expected net monetary benefit (NMB) from using HTA-based decision criteria compared to a first-come, first-served (FCFS) approach using data from Thailand. A previously published simulation model was adapted to the Thai context which aimed to simulate the impact of using different decision-making criteria to adopt or reject health technologies for public reimbursement. Specifically, the simulation model provides a quantitative comparison between an HTA-based funding rule and a counterfactual (FCFS) funding rule to make decisions on which health technologies should be funded. The primary output of the model was the NMB of using HTA-based decision criteria compared to the counterfactual approach. The HTA-based decision rule in the model involved measuring incremental cost-effectiveness ratios against a cost-effectiveness threshold. The counterfactual decision rule was a FCFS (random) selection of health technologies. The HTA-based decision rule was associated with a greater NMB compared to the counterfactual. In the investigated analyses, the NMB ranged from THB24,238 million (USD725 million) to THB759,328 million (USD22,719 million). HTA-based decisions led to fewer costs, superior health outcomes (more quality-adjusted life-years). The results support the hypothesis that HTA can provide health and economic benefits by improving the efficiency of resource allocation decision making.

Expectations for the Development of Health Technology Assessment in Brazil.

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts’ expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

Assessing the performance of health technology assessment (HTA) agencies: developing a multi-country, multi-stakeholder, and multi-dimensional framework to explore mechanisms of impact

BackgroundHealth technology assessment (HTA) agencies have an important role to play in managing the rising demands on health systems. However, creating and running such agencies potentially diverts resources from frontline services. A large number of studies address the question of ‘what is the impact of HTA?’. Several points of heterogeneity in this literature include: purpose of the study, definition of HTA, definition of impact, and scope and rigour of evaluations. Our study seeks to address several limitations in this literature. This study aims to explore the mechanisms of impact of an HTA agency. In doing so, we consider HTA as an institution rather than a knowledge product to build an impact evaluation framework from an international, multi-stakeholder and multi-dimensional perspective.MethodsWe conducted 9 key informant interviews with experts from the international HTA community. We addressed several questions, informed by existing frameworks of impact within the literature, to understand their perspectives on the mechanisms of impact of an HTA agency. We analyse data using logic modelling and impact mapping, as tools to understand and visualise mechanisms of change.FindingsOur impact mapping highlights several distinct, but not necessarily mutually exclusive, mechanisms through which the overall impact of an HTA agency is achieved. These are: the effective conduct of HTA studies; effective use of HTA in agenda-setting and policy formulation processes; effective engagement and external communications; good institutional reputation and fit within the healthcare and policy-making system; effective use of HTA as a tool for the negotiation of health technology prices; and the effective implementation of policy change regarding health technologies. We also identify indicators of these effects.ConclusionsOur findings and resulting evaluation framework complement and add to existing literature by offering a new perspective on the mechanisms by which HTA agencies generate impact. This new perspective considers HTA as an institution rather than a knowledge product, is international, multi-dimensional, and includes multi-stakeholder views. We hope the analysis will be useful to countries interested in managing HTA performance.

Impact of health technology assessment on prescribing patterns of inhaled fixed-dose combination triple therapy in chronic obstructive pulmonary disease

ABSTRACT Background: Evidence suggests that triple therapy for patients with chronic obstructive pulmonary disease (COPD) is being used in a broader range of patients than recommended by guidelines, which may have health and cost implications. Objective: To explore the relationship between national health technology assessment (HTA) agency appraisals and market penetration of two fixed-dose combination (FDC) triple therapies. Study design: HTAs from Q3 2017 to Q1 2020 from 10 countries were evaluated. Intervention: Glycopyrronium bromide/formoterol fumarate/beclomethasone (Trimbow®) and umeclidinium/vilanterol/fluticasone furoate (Trelegy™ Ellipta®). Main outcome measure: HTA restrictions and prescribing rates (days of therapy). Results: Seven countries (70%) imposed restrictions on use including prescription only for patients stable on free-combination triple therapy or not controlled on dual therapy, requirement of a specialist prescription or therapeutic plan, prescription only for patients with severe COPD, and use as second-line therapy or later. In general, countries that have imposed restrictions on the use of FDC triple therapies have seen a lower than average uptake. Conclusion: Payer guidance on prescribing FDC triple therapy may potentially support more appropriate prescribing in line with clinical guidelines. It is important for payers to consider which restrictions would ensure the most efficient use of scarce resources.

Companies' Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study.

Background: Health technology assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Thus, pharmaceutical companies need to address the HTA requirements early during development to improve reimbursement outcomes. Currently, there is a lack of research to assess the impact of HTA on development and jurisdictional outcome from companies’ perspectives. This study aimed to assess companies’ HTA strategy and characterise HTA practice in seven jurisdictions. Methods: A multi-year, annual study collected information for individual products, focusing on development activities regarding inclusion of HTA requirements and selection of global comparators. The generation of local contextual information, submission strategies and predictability of HTA outcomes was examined jurisdictionally in Australia, Canada, England, France, Germany, Italy and Spain. The study questionnaire was built into a secure online data collection platform and data were provided annually by participating companies. Results: Data for 169 compounds were provided by nine international companies between 2014 and 2018. HTA requirements were implemented in evidence generation plan for 63% of products during development. Global comparators were accepted by HTA bodies for more than half of studied products; Spain showed the highest acceptance rate (85%). Companies took advantages of parallel process in Australia and Canada to shorten product rollout time. Australia demonstrated general consistency in HTA review time, and England had the longest variation (interquartile range, 216 days). Requirements for additional information after submission occurred at all HTA bodies. Germany and Italy showed the highest percentage of products being reimbursed as per regulatory label (80 and 68%, respectively). Canada was the most predictable jurisdiction, with the highest proportion of review outcome (90%) that met companies’ expectations. Conclusion: Companies are addressing HTA requirements during development for many products; however, they are challenged by varying requirements and practices and product success ultimately depends on how HTA organisations and payers assess added value in the context of the national healthcare systems. This ongoing study created a baseline to help capture fact-based changes for company HTA strategies and HTA body practices.

PRS60 IMPACT of Health Technology Assessment (HTA) Recommendations on the Use of Fixed-Dose Combination (FDC) Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD)

PRS60 IMPACT of Health Technology Assessment (HTA) Recommendations on the Use of Fixed-Dose Combination (FDC) Triple Therapy for Patients with Chronic Obstructive Pulmonary Disease (COPD)

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.

Modes of coordination for health technology adoption: Health Technology Assessment agencies and Group Procurement Organizations in a polycentric regulatory regime.

The challenge of novel and high cost health technologies has encouraged the growth of regulatory agencies such as Health Technology Assessment (HTA) organizations and Group Procurement Organizations (GPO). Yet the existence of several agencies in the same polycentric regulatory regime raises questions about whether and how their work can be coordinated. Drawing on a case study of GPOs and HTA agencies across four provinces in Canada, involving document review and key informant interviews (n=44) conducted between 2013 and 2016, we explore the separate evolution of these agencies, emerging connections between them for non-drug technologies, and the organizational processes and evaluative judgments that underpin coordination efforts. HTA agencies and GPOs developed separately; connections emerged recently in three provinces and suggest four modes of coordination. One mode aligns most closely with that recommended by health economists and HTA practitioners, whereby HTA precedes procurement, with coverage decisions informing technology acquisition. The second mode is a version of the first, where procurement refers cases to HTA for coverage or technology management support; unlike the first, it recognizes procurement's evaluative strengths. Yet both the first and second modes focus on exceptional cases and will be infrequent. The third mode is more systemic, reflecting a generalized complementary of purpose as public agencies. HTA could support GPOs in contested technology acquisition efforts through timely and responsive input, while procurement could expand HTA's impact and inform HTA's growing interest in responsible innovation and environmental sustainability. The final mode is non-coordination, reflecting the potential for agencies to occupy quite distinct regulatory niches within the same regime. We conclude that consistency and convergence around a single model of resource allocation is not inevitable; nor is it necessary for coordinated effort. Thus, where differences in regulatory practice and epistemology persist, mutual accommodation and shared learning may prove most productive.

Comparative characteristics of types of medical technologies assessment

This article presents the results obtained during the analysis of different types of health technology assessment (HTA). In the world HTA agencies can be organized at the national (federal), regional or local levels; they can have various levels of dependence on public authorities (independent, public, dependent), various sources of financing (state, mixed). The nature of the tasks and the range of powers of the institutions for HTA differ: regulatory, organizational or advisory. They themselves can initiate HTA (proactive), or they can conduct HTA at the suggestion of the applicants and analyze the quality of the HTA reports provided (reactively). HTA can be focused on economic assessment, comparative clinical assessment, as well as balanced, both on economic and comparative clinical assessments. HTA may be conducted on drugs, medical devices, and other medical technologies. The methods for conducting HTA significantly depend on its subject. In terms of the scope of the assessment, it is possible to single out full OMT, mini-OMT and express-OMT, as well as fast-track-OMT, proposed by the HTA agency in the UK. The final users of HTA (administration, suppliers, patients) and its perceptions (instrumental, conceptual, or formal) are specified. The impact of HTA on decision-making is progressively increasing, as the number of medical technologies that should be assessed to maintain budget discipline is increasing. The versatility of HTA indicates its universality and can contribute to the further expansion of its application at various levels of medical care around the world.

PNS219 TARGETED LITERATURE REVIEW AND PAYERS' PERSPECTIVES ON THE CURRENT PROGRESS OF HTA SYSTEM IMPLEMENTATION IN THE MENA REGION

In the MENA region, the application of Health Technology Assessment (HTA) for access, pricing and reimbursement decisions, is less prominent compared to other countries where there is an established link between decisions and evidence. The objective of this research was to explore the progress made by countries in the MENA region (Egypt, Jordan, Kuwait, Lebanon, Oman, Saudi Arabia, Tunisia, United Arab Emirates) regarding the implementation of an official HTA agency since the ISPOR conference in Dubai, and to gather payer’s perceptions on progress. An open internet search using key words (HTA, cost-effectiveness, budget impact, clinical effectiveness, comparative effectiveness) was used to review publications in the scope markets from Sept-2018 to May-2019. In addition, payers/advisors from the region have been contacted about the main decision criteria for assessment, the value and expected challenges of implementing an HTA system, the timelines for implementation, as well as, the impact of HTA on the access of treatments using Ipsos Dimensions survey software. HTA agency has been established in Tunisia at a national level and Jordan at a local level. The remaining scope countries have not yet established an agency; however, Kuwait is discussing the integration of an HTA system, while Lebanon and the United Arab Emirates have started making use of HTA. Egypt and Saudi Arabia have included the development of HTA agency in their 2030 healthcare vision goals and are rolling out trainings. Data from the survey is being analysed and we expect this to provide additional insight on implementation progress and payer perceptions. The MENA region is moving towards utilising HTAs in funding decisions, however, progress is at different stages across the region. The timescale for implementation of HTA is unclear and varies between countries. Only Saudi Arabia and Egypt have established clear timelines for HTA agency development.

Impact of health technology assessment and managed entry schemes on reimbursement decisions of centrally authorised medicinal products in Belgium.

Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product's value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium. We selected all reimbursement submissions for new centrally authorised medicinal products in the 2010-2015 period. We retrieved data relating to the reimbursement decision, the HTA outcome and the use of a managed entry scheme. The decision of the Minister was available for 115 dossiers, covering 36 (31.3%) orphan medicinal products (OMPs) and 79 ATV products. A MES was used in 41 submissions. A positive reimbursement decision was obtained in 65% of cases. The significant factors affecting the reimbursement decision were the approval of ATV, the medical need if it was considered 'important or major' and the use of a managed entry scheme. Price, budget impact and efficiency had no significant impact. Added therapeutic value and high medical need increase the odds for a positive reimbursement decision. No impact could be demonstrated of the cost-related HTA criteria. Cost elements may be biased by the use of a confidential MES. Without a MES, only 53% of the centrally authorised medicinal products, including OMPs, are reimbursed in Belgium.

PP151 Establishing Health Technology Assessment Impact Evaluation With Stakeholder Input From Day One

IntroductionHealth Technology Wales (HTW) is a relatively new Health Technology Assessment (HTA) agency which focuses on non-medicines. In common with other HTA organizations, it identifies and appraises a range of technologies. However, HTW is also looking beyond the publication of guidance, to assess the adoption of advice and its eventual impact.MethodsHTW commissioned development of an Evaluation Plan from independent experts (Matter of Focus). A literature review was carried out to inform an options appraisal of methods for assessing impact. The selected approach was Contribution Analysis, which estimates the counterfactual through engagement of stakeholders.ResultsWhilst it is too early to report the full impact of HTW's guidance, a number of activities have taken place to prepare for evaluation. The core HTW team developed a series of logic models to describe the anticipated impact, the mechanisms by which it would be achieved, and key assumptions. Stakeholders were consulted for insight from a range of perspectives, and to manage expectations. This was achieved through individual interviews, presentation and discussion at committee meetings, and the sharing of written materials for feedback. This information was collated to populate bespoke software (OutNav). The collection of data relating to processes, outputs and outcomes is already an ongoing routine task of researchers and support staff.ConclusionsHTW has an opportunity to build impact evaluation into its culture from the beginning. This will facilitate the future reporting of HTW's influence using a well-designed, evidence-based approach. Furthermore, this pioneering work will clearly demonstrate the value of HTA to funders, commissioners, governments, and other decision-making bodies.