Local Health Technology Assessment Research Articles

Designing a Roadmap for Health Technology Assessment Implementation in Algeria.

Background The scarcity of resources restricts healthcare financing decisions, affecting the population's health. Health technology assessment (HTA) balances restricted budgets with the best possible health outcomes. We aim to characterize the current status of HTA in Algeria and describe the future directions for HTA implementation according to the priorities set by local stakeholders. Methods Stakeholders from the public and private sectors responded to a policy survey about the current and preferred future status of HTA implementation in Algeria. The survey was administered during an online workshop and used a widely accepted international scorecard covering eight domains: capacity building, HTA financing, process and organizational structure, scope of HTA implementation, decision criteria, standardization of methodology, use of local data, and international collaboration. After that, one-on-one interviews with another local expert were conducted to validate and modify the draft recommendations. The interviewees were representatives from government agencies, hospitals, and pharmaceutical companies. Results Thirty-one experts filled out the HTA scorecard survey; most of them were from the public sector (74%). They highlighted that project-based HTA workshops or short courses were the most common form of HTA education in Algeria and recommended the establishment of postgraduate HTA training programs in the future to build sustainable capacities. They reported a lack of funding for HTA research and critical appraisal and recommended an increased public budget for HTA and the introduction of submission fees by manufacturers. There was consensus about the need for local HTA evidence generation in the future. Most of the experts advocated an explicit soft decision threshold. The interviewees further recommended using multi-criteria decision analysis in the short term. The application of quality indicators was believed to improve the reliability of the HTA process. Conclusion The results of our policy research delineate the gap between the current and preferred future status of HTA in Algeria based on insights from multiple stakeholders. The need to improve the educational HTA programs in Algeria, use local data in policy decisions, and increase funding for HTA were the most advocated recommendations.

Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks.

Introduction: The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies in Europe. This research aimed to assess the impact of the regulation on national HTAs, the strategic implications for health technology developers, and its influence on price and reimbursement negotiations. Methods: A scoping literature review encompassing peer-reviewed literature as well as grey literature was conducted. Between February and March 2023, semi-structured interviews (n = 20) were performed with stakeholders from Belgian governmental institutions, European institutions, advanced therapy medicinal product developers, academics, and sickness funds. The interviews were analyzed using the framework analysis method. Results: Numerous steps, such as the development of implementing acts and procedural guidelines remain to be taken. At member state level, national/regional HTA bodies and payers must act to adopt the new concepts of Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) within their national legislation, as well as revise their timelines and prepare for interactions at a European level. Compiling a harmonized PICO (Population, Intervention, Comparator, and Outcome), adapting local procedures, and increasing capacity to actively take part in the JSC and JCA are seen as primary barriers by several stakeholders. Training and education will help HTA bodies, payers, and health technology developers to participate in the European processes. Conclusion: While practical and legal challenges were identified, recommendations (such as actively preparing for the upcoming changes and increasing capacity while providing training) were provided to adapt national and European procedures to the needs of the HTA Regulation 2021/2282. The importance of fostering collaborations and aligning local HTA procedures with the new way of working set out by the Regulation was demonstrated with this study.

PP146 Seeing Eye-To-Eye on Real-World Evidence: Are Guidance from Japan and China Consistent with Recommendations from REALISE in Asia?

IntroductionThe REAL World Data (RWD) In Asia for Health Technology Assessment (HTA) guidance was developed by a regional working group to facilitate the increasing acceptance of real-world evidence (RWE) in Asia. We compared the consistency of REALISE against guidance from Japan and China.MethodsCountry-specific guidance for RWE/RWD use in pharmaceutical development were identified in May 2022 through governmental websites, with validation searches via Google. Sections from local guidance were mapped onto REALISE and categorized as “agree”, “mixed”, “disagree” or “missing” based on coverage and consistency.ResultsFive Japanese and three Chinese documents were mapped. Most sections in Chinese guidance (77%) and 36 percent of sections in Japanese guidance were tagged “agree” or “mixed”, with general alignment on definitions and good practice considerations (study design, accountability); however, 63 percent of Japanese sections were tagged “missing” from REALISE. As local documents took the regulatory perspective, they lacked REALISE’s discussion of translating RWD to RWE for HTA/economic evaluations specifically. Local guidance focused on practicalities of RWD collection in local contexts, including descriptions of specific actions (e.g., evaluating RWD sources, ensuring data security) rather than overarching principles described in REALISE; specifically, Japanese guidance described how to access and analyze databases/registries, reflecting Japan’s landscape of robust sources of national healthcare data, but lacked discussion of other RWE study types, data sources and specialized analytical methods. While Chinese guidance had a broader view of RWD types (more similar to REALISE), they also contained discussions on pharmacovigilance and omics data, communication with regulatory bodies, and incorporation of RWE into the approval pathway for traditional Chinese medicines.ConclusionsDespite differing purposes (with no RWE guidance from local HTA bodies), local and regional guidance align on general principles/good practice in generating/using RWE, providing common ground for increasing usage of RWE in HTA in Asia.

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.

PP69 Health Technology Assessment And University Health Center Affiliation Agreement: Current Situation And Potential Developments In Quebec

IntroductionAccording to the Quebec law on health and social services, health technology assessment (HTA) is part of university hospital centers’ mission, together with training, research and care. However, unlike these other functions, HTA is not covered in current affiliation agreements that bind a university with academic health institutions. Université Laval and its affiliated health institutions set up a consultation committee whose mandate is to propose the terms of an agreement to specify collaboration regarding HTA between the university and its affiliated institutions. This study investigates perceptions and needs of stakeholders from Université Laval and its affiliated health institutions with respect to the HTA mission.MethodsSemi-structured interviews were conducted with four types of participants, namely university faculty members, health professionals and managers from institutions with and without HTA units, as well as external partners. Interview guides were developed based on the integrated analysis framework of Greenhalgh et al., and adapted to each group of respondents. Most interviews were conducted in groups and were facilitated by a research associate and a senior investigator. Interviews were recorded and uploaded to NVivo 1.6.2 software for codification and analysis.ResultsA total of 57 people were interviewed (nine group interviews and 35 individual interviews). Three main themes emerged, namely knowledge of HTA, factors related to the relevance of the HTA function, and organizational factors. Results showed that half of the respondents have a vague knowledge of HTA or have never heard of it. Most of the respondents agreed that the HTA function fits well with the mission of a health institution. They would accept getting involved with HTA activities at different levels if all conditions are met. Nevertheless, almost half of respondents believed that others strategies than including HTA into contracts of affiliation should be explored to regulate this function. Finally, organizational obstacles such as the lack of funding, shortage of staff and the lack of well-structured collaborations were highlighted by respondents.ConclusionsDespite recognition of the importance of the HTA function in university health centers, interventions will be required at different levels to support the development of local HTA capacity. In particular, popularization of the HTA function and collaboration networks through specific projects should be developed.

PP138 Awareness Of Health Technology Assessment And Its Predictors Among Medical Students In Public Universities In Klang Valley, Malaysia

IntroductionLack of awareness has been recognized as one of the most important barriers in the implementation of health technology assessment (HTA) across numerous countries. Medical students have been identified as a vital target group to instill an awareness, basic knowledge, and positive attitude towards HTA from the beginning of their medical career. Presently, there was no study found conducted on HTA awareness in medical students in Malaysia. This study aims to determine the level of awareness of HTA, and its predictors among clinical year medical students in public universities in Klang Valley, Malaysia.MethodsA cross-sectional study using the stratified random sampling method was conducted among clinical year medical students in four public universities in Klang Valley, Malaysia. The data on level of awareness of HTA and its associated factors were collected using a self-administered online questionnaire. Data were analyzed using IBM SPSS version 27 to determine the level of awareness of HTA, its associated factors and predictors.ResultsThe total number of study participants was 323 and the response rate was 90 percent. The analysis showed that 69 percent of respondents had low level of awareness of HTA while 31 percent had high level of awareness of HTA. Factors associated with the level of awareness of HTA was attitude towards HTA (p < 0.001). The predictors of level of awareness of HTA were attitude towards HTA (Adjusted Odds Ratio (AOR) = 7.417, 95% confidence interval [CI]: 3.491, 15.758), peer interaction on HTA (AOR = 0.320, 95% CI: 0.115, 0.888), and previous training on HTA (AOR = 4.849, 95% CI: 1.096, 21.444).ConclusionsThe majority of clinical year medical students in public university have low awareness of HTA which can be predicted by the level of attitude, peer interaction and training of HTA. Therefore, it is important to increase awareness among these future medical practitioners to encourage evidence-based decision-making. Early exposure and introduction of HTA in the current university curriculum in collaboration with a local HTA agency can be recommended to increase awareness as well as to improve students’ attitude towards HTA.

Abstract PS10-28: Neratinib as extended adjuvant therapy in patients with HER2-positive/HR-positive early breast cancer: HTA-driven analyses from the ExteNET study

Abstract Background: Neratinib is indicated in Europe for the extended adjuvant treatment of patients with HER2-positive/HR-positive early breast cancer having completed trastuzumab-based therapy less than one year ago. Here we report post-hoc analyses of the HR-positive subgroup (N=1’631) from the ExteNET-trial (neratinib vs. placebo) performed for the German health technology assessment (HTA) procedure. Methods: The study endpoints were re-analyzed according to local HTA requirements. For the evaluation of efficacy time-to-event endpoints, stratified Cox regression models were used. The evaluation of tolerability endpoints was performed in the same way based on non-stratified models and tests. Patient-reported endpoints were analyzed using a mixed model for repeated measures. Overall survival analyses have not been performed, as - in accordance with the study protocol - the required number of events (248 deaths) had not been reached at the time-point of HTA [Nov. 2019]. Results: Baseline characteristics in the analyzed population were well balanced between treatment arms, comparable with the overall ExteNET-population and consistent with the typical configuration of patients with early breast cancer. The median treatment duration at the time of the primary data cut was 11.5 months in the neratinib and 11.9 months in the placebo arm. After a median follow-up of 2 years and in-line with the overall ExteNET-results, time-to-event analyses revealed a significant advantage in disease-free survival (DFS) for neratinib vs. placebo (HR [95%-CI]: 0.45 [0.29; 0.69]; p=0.0002). The incidence based analysis confirmed this benefit (RR [95%-CI]: 0.44 [0.29; 0.68]; p=0.0002). These results were consistent with the analysis of distant disease-free survival (DDFS; HR [95%-CI): 0.52 [0.32; 0,84]; p=0.0082). The analysis after 5 years of follow-up based on the latest data cut confirmed the 2-year results, with 7.4% of patients in the neratinib and 13.0% of patients in the placebo arm having experienced at least one relapse event. The time-to-event analysis supported the significant advantage with regards to the DFS (HR [95%-CI]: 0.57 [0.41; 0.78]; p=0.0005), with a 5-year DFS-rate of 91.2 vs. 86.8%. These results were again consistent with the DDFS analysis (HR [95%-CI]: 0.60 [0.42; 0.85]; p=0.0037), with a 5-year DDFS-rate of 92.7 vs. 88.7%. The neratinib tolerability profile is consistent with class effects and thus predictable for the inhibition of HER-receptors, with domination of gastrointestinal (especially diarrhea; all grades: 94.4%; grade 3: 39.4%; cumulative duration all grades: 54.5 days; no systematic diarrhea prophylaxis), general (especially fatigue; all grades: 28.1%; grade 3: 1.9%) and cutaneous (especially rash; all grades: 14.3%; grade 3: 0.4%) events. No cumulative or irreversible toxicities have been observed. As shown in the CONTROL study and instituted via a risk management plan, adequate diarrhea prophylaxis and management can reduce the frequency (all grade: 79.6-96.7%), cumulative duration (all grades: 14.0-24.0 days) and severity of diarrhea (grade 3: 15.0-33.7%). Conclusion: Extended adjuvant neratinib provides a clinically relevant benefit with further reduction of relapse risk in the curative situation of patients with HER2-positive/HR-positive early breast cancer. Accordingly, German HTA-authorities have granted an added benefit for this new treatment option. Citation Format: Diana Lüftner, Hans Tesch, Marcus Schmidt, Andreas Hartkopf, Sarah Streicher, Anna Resch, Luca Genovese, Christian Rosé, Roberta Valenti, Nadia Harbeck. Neratinib as extended adjuvant therapy in patients with HER2-positive/HR-positive early breast cancer: HTA-driven analyses from the ExteNET study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS10-28.

Common Problems, Common Data Model Solutions: Evidence Generation for Health Technology Assessment.

There is growing interest in using observational data to assess the safety, effectiveness, and cost effectiveness of medical technologies, but operational, technical, and methodological challenges limit its more widespread use. Common data models and federated data networks offer a potential solution to many of these problems. The open-source Observational and Medical Outcomes Partnerships (OMOP) common data model standardises the structure, format, and terminologies of otherwise disparate datasets, enabling the execution of common analytical code across a federated data network in which only code and aggregate results are shared. While common data models are increasingly used in regulatory decision making, relatively little attention has been given to their use in health technology assessment (HTA). We show that the common data model has the potential to facilitate access to relevant data, enable multidatabase studies to enhance statistical power and transfer results across populations and settings to meet the needs of local HTA decision makers, and validate findings. The use of open-source and standardised analytics improves transparency and reduces coding errors, thereby increasing confidence in the results. Further engagement from the HTA community is required to inform the appropriate standards for mapping data to the common data model and to design tools that can support evidence generation and decision making.

Importance of involving patients and public in health research in Bangladesh and Nepal.

Patient and public involvement/engagement (PPI/E) in public health research and health technology assessment (HTA) in high-income countries (HICs) have significantly increased over the past decade. PPI/E helps to improve research and HTA, ultimately benefitting patients and service users. PPI/E is a very new concept in many low- and middle-income countries (LMICs). This paper considers the importance of PPI in public health research and HTA in the development and implementation of technology in the health sector in South Asia. Currently, in this region, health technology is frequently adopted from HICs without local research and HTA. It also discusses the importance of local co-creation of technology to reflect the needs of users within a culturally appropriate setting. It is important for LMIC-based researchers to understand the potential of PPI/E and how it can contribute to it to improve health care and research, especially perhaps in the era of COVID-19.

Patients, users, caregivers, and citizens' involvement in local health technology assessment unit in Quebec: a survey.

Increasing emphasis is given on involving patients in health technology assessment (HTA). While this is mainly done at the level of regional and national HTA agencies, this tendency is also emerging in local HTA units. In this study, we provide the results of a survey conducted in local HTA units in the province of Quebec, Canada. The aim of the survey was to provide an overview of local HTA unit practices to involve patients, users, caregivers, and citizens in their process, their interest in doing so, and their information needs for this. The survey was conducted in 2017 with a response rate of eleven units over a possibility of twelve. Three units out of eleven (27.3 percent) never involved patients or members of the public in their processes and all indicated that they will involve them in the next few years. The three most important needs for support identified in the HTA units were in: recruiting and selecting patients; integrating experiential knowledge; and knowing and implementing the best methods and practices for partnership. Patient involvement in local HTA units is quickly evolving and that is why they urgently need tools to involve more effectively patients and members of the public in their process.

Experiences of using Cochrane systematic reviews by local HTA units

Abstract The aim of this study is to evaluate the utilisation of CSRs by Quebec's local health technology assessment (HTA) units to promote efficiency in hospital decision-making. A survey was conducted using a structured online questionnaire to examine: Characteristics of the HTA units; Knowledge about works and services from the Cochrane Collaboration; Level of satisfaction about the use of CSRs; Facilitating factors and barriers to the implementation of CSRs evidence in a local context; Suggestions to improve the use of CSRs. Data accuracy was checked by two independent evaluators (TGP and CAB). Ten HTA units participated. Mean number of staff was 6.3 [2-18], producing about 4.7 reports per year [2-7.3]. From their implementation a total of 321 HTA reports were published (49.8% included a SR). Works and services provided by the Cochrane collaboration were very well known and HTA units were highly satisfied with CSRs (80-100%). However, only 24.7% (21/85) of topics were searched with success. As regards to applicability in HTA and use of CSRs, major strengths were as follow: Useful as resource for search terms and background material; May reduce the workload (e.g. brief review instead of full SR); Use to update a current review. Major weaknesses were: Limited use since no CSRs were available for many HTA projects; Difficulty to apply findings to local context (lack of contextualisation); Focused only on efficacy and innocuity; Cannot be used as a substitute to a full HTA report. This study provided a unique context of assessment with a familiar group of producers, users and disseminators of CSRs in hospital setting. HTA units generally use other articles from the literature or produce an original systematic review in complement with CSRs. These results led to some suggestions to improve the use of CSRs by HTA units. However, the main limit for the use of CRS in local HTA will remain its lack of contextualisation. Key messages The main limit for the use of CRS in local HTA will remain its lack of contextualization. Context and scientific data are complementary.

Patients, users, caregivers and citizens’ involvement in local HTA unit in Quebec: a survey

Abstract Increasing emphasis is given on involving patients in health technology assessment (HTA). While this is mainly done at the level of regional and national HTA agencies, this tendency is also emerging in local HTA units. In this study we provide the results of a survey conducted in local HTA units in the province of Quebec, Canada. The aim of the survey was to provide a panorama of local HTA units practices to involve patients in their process, their interest in doing so, and their information needs for this. The survey was conducted in 2017 with a response rate of 11 units over a possibility of 12. Results indicate that only 3 units over 11 never involved patients or members of the public in their process and that all will involve them in the next few years. The three most important needs identified in the HTA units were: recruiting and selecting patients; integrating experiential knowledge; and knowing and implementing the winning conditions for partnership. To conclude, patient involvement in local HTA units is quickly evolving; that is why the latter urgently need tools to involve more effectively patients and members of the public in their process. Key messages There is a need to develop tools to involve patients in HTA process. Patient involvement in local HTA units is quickly evolving.

Experiences of Using Cochrane Systematic Reviews by Local HTA Units.

This study evaluated the use of Cochrane systematic reviews (CSRs) by Quebec’s local health technology assessment (HTA) units to promote efficiency in hospital decision-making. An online survey was conducted to examine: Characteristics of the HTA units; Knowledge about works and services from the Cochrane Collaboration; Level of satisfaction about the use of CSRs; Facilitating factors and barriers to the implementation of CSRs evidence in a local context; Suggestions to improve the use of CSRs. Data accuracy was checked by 2 independent evaluators. Ten HTA units participated. From their implementation a total of 321 HTA reports were published (49.8% included a SR). Works and services provided by the Cochrane collaboration were very well-known and HTA units were highly satisfied with CSRs (80%-100%). As regards to applicability in HTA and use of CSRs, major strengths were as follow: Useful as resource for search terms and background material; May reduce the workload (eg, brief review instead of full SR); Use to update a current review. Major weaknesses were: Limited use since no CSRs were available for many HTA projects; Difficulty to apply findings to local context; Focused only on efficacy and innocuity; Cannot be used as a substitute to a full HTA report. This study provided a unique context of assessment with a familiar group of producers, users and disseminators of CSRs in hospital setting. Since they generally used other articles from the literature or produce an original SR in complement with CSRs, this led to suggestions to improve their use of CSRs. However, the main limit for the use of CRS in local HTA will remain its lack of contextualisation. As such, this study reinforces the need to consider the notion of complementarity of experimental data informing us about causality and contextual data, allowing decision-making adapted to local issues.

PRS10 COST-UTILITY ANALYSIS OF MEPOLIZUMAB VERSUS BENRALIZUMAB FOR SEVERE EOSINOPHILIC ASTHMA IN THE COLOMBIAN HEALTHCARE SYSTEM

BACKGROUND: Adding mepolizumab to standard treatment with inhaled corticosteroids and controller medications decreases asthma exacerbations and long-term oral corticosteroid use in patients with severe eosinophilic asthma. However, since new biological therapies are available in the Colombian healthcare system, it is necessary to establish their cost-effectiveness to inform local payers and decision-makers. To evaluate the cost-effectiveness of new biologics, mepolizumab and benralizumab, to treat adults with severe eosinophilic asthma in Colombia. A Markovian model was used to determine the incremental cost per quality-adjusted life year (QALY) of mepolizumab plus standard of care (SoC) versus benralizumab plus SoC from the payer’s perspective. In a monthly cycle, patients could transition between five health states (three asthma treatment states, asthma related death, and all-cause mortality) and three types of exacerbation events (exacerbations requiring either OCS burst, emergency department visit or hospitalization). Lifetime horizon was used. A network metanalysis (Busse 2019) was used for efficacy data, and local life tables for death probabilities. Costs were estimated following the methods recommended by the local health technology assessment agency. Costs and benefits were discounted at 5% and expressed in 2018 USD (1 USD = 2,956 COP). At the end of the simulation, mean cost of prevention of exacerbations and long-term oral steroid were $69.22 less per patient in mepolizumab, and mean therapy cost was $6,990.0 less per patient in mepolizumab. Treatment with mepolizumab plus SoC and benralizumab plus SoC resulted in 8.97 and 8.73 QALYs respectively. Findings were consistent in the probabilistic sensitivity analysis. Mepolizumab is a dominating alternative compared with benralizumab in the treatment of adults with severe eosinophilic asthma in Colombia from the payer’s perspective. Funding: GSK (PRJ2813).

PP193 How Does HTA Address Social Expectations Now? An International Survey.

IntroductionAfter surveying its members on ethical issues (2003), the International Network of Agencies for Health Technology Assessment (INAHTA) mandated its Ethics Working Group (2005) to reflect on the role of health technology assessment (HTA) organizations in meeting social expectations. Some aspects of these have since been clarified by two studies addressing either the official position of INAHTA's members or the publication authors. An international survey was carried out on the perception of HTA professionals’ expectations when producing HTA reports: how to fulfil HTA's social role, which value judgments should be made explicit and what should be the status of ethical analysis.MethodsA twenty-two question, web-based, anonymous survey was devised from our recent systematic review on the integration of ethics into HTA and carried from April to July 2018. The information on 328 HTA agencies/contact persons from seventy-five countries was collected from the website of INAHTA, Health Technology Assessment International (HTAi), the European Network for Health Technology Assessment (EUnetHTA), EuroScan International Network, the HTA Network of the Americas (RedETSA) and the HTA Network of Asia (HTAsiaLink), a 2015 World Health Organization survey, HTAi members, and our local HTA network (Québec, Canada).ResultsEighty-nine participants completed and submitted a finalized survey for a 27 percent participation rate representing thirty-three countries. Regarding how the HTA reports should fulfil their social role, our results showed that over 84 percent of the respondents agreed upon the necessity to address it to decision makers, patients and citizens. At a lower and more variable level, the same result was found about the necessity to make value judgements explicit in different sections of the report, including ethical analysis. This contrasts with the variability of responses obtained on the status of ethical analysis although an agreement on the expertise required was observed. Variability in the usefulness of patient, public or stakeholder participation was observed.ConclusionsAt the dawn of this decade, this study reveals high expectations on context-dependent decisions in HTA: the necessity to integrate the ‘explicitation’ of value judgements and systematic ethical analysis to fulfil HTA's social role.

Health technology assessments conducted in health care facilities: A strategic practice? Findings from a content analysis of HTA reports

In this paper, we test the hypothesis that health technology assessment units located in hospitals tend to be more optimistic toward technologies that are currently in use in their organization than technologies that are not. The data include 108 health technologies assessed in 87 full-scale health technology assessment reports produced by the four main local health technology assessment units in Quebec (Canada) on behalf of decision makers from the same facility. We found that 58 (53.7 percent) of the 108 technologies were currently in use within the hospital during their assessment. Based on the assessors' interpretation of the scientific evidence regarding the efficacy of the technologies, 67.3 percent of the technologies that were in use in the hospital during the evaluation were effective (56 percent for those that were not currently being used), but the difference is not statistically significant (chi-square 1.38; p = 0.24). Controlling for the efficacy judgment, the type of technologies (i.e. preventive, diagnostic, therapeutic or organizational), the number of technologies assessed in the report and the assessment unit, we found that the technologies that were currently in use in the facility during the evaluation were 62 percent more likely to be recommended favorably by the assessment unit than the technologies that were not currently being used (RR = 1.62; 95 percent CI = 1.06–1.88). This suggests that the local health technology units that were examined in the study tended to be more optimistic toward technologies that were currently in use in their hospital at the time of the evaluation.

CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE

The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

PHP95 - Global Value Dossiers (GVDS): How to Ensure the Value Isn’t Lost in Translation

While GVDs are considered a critical component of a new product’s global market access/reimbursement plan, anecdotal evidence suggests variability across organizations in perceptions of purpose and utility. A web-based survey was fielded to global and regional employees of pharmaceutical manufacturers with responsibility in developing and/or executing market access strategy for new products. A total of 42 industry employees participated in the survey; regions represented included Europe, North America, and Asia-Pacific. The perceived primary purposes of a GVD were to assist in preparing local health technology assessment (HTA) submissions and/or provide comprehensive disease state and product review (73%); 20% felt the primary purpose was to highlight product value. However, only 50% of respondents indicated that the GVD adequately addressed their purposes. Only 23 of 36 respondents who have developed a local HTA submission reported having a GVD “the last time” they prepared/reviewed a local HTA submission, and only 31% (n=7/23) felt the GVD provided value. Greatest barriers to use were lack of relevancy to country/region (57%), lack of comprehensive content (39%), language (English) (35%), and cumbersome format (30%). Of elements commonly included in GVDs, those most important for local HTA submissions were clinical efficacy (95%), epidemiology (87%), unmet needs (87%), and product description (76%). In comparison, cost-effectiveness (21%) and budget impact (11%) were deemed the least important. Utility of these sections is likely driven by specific country HTA/reimbursement schema, although the sample size was too small to draw meaningful conclusions. Most respondents indicated the most useful time to have a GVD was 6-12 months pre-approval (65%); 20% would prefer earlier (2+ years pre-approval). One of the greatest challenges with GVDs is balancing comprehensiveness with specificity. Opportunity for improvement remains in the timely provision of valuable data to affiliates responsible for local HTA submissions.

LOCAL HEALTH TECHNOLOGY ASSESSMENT IN CANADA: CURRENT STATE AND NEXT STEPS

Canada has witnessed expansion of the health technology assessment (HTA) infrastructure in the last 25 years. Local HTA entities at the hospital or regional level are emerging to assist decision makers in the acquisition, implementation, maintenance, and disinvestment of healthcare technologies. There is a need to facilitate collaboration and exchange of expertise and knowledge between these entities regarding the role of local HTA in Canada. In November 2013, the pan-Canadian Collaborative hosted a symposium, Hospital/Regional HTA: Local Evidence-based Decisions for Health Care Sustainability, bringing together over 60 HTA producers, researchers, stakeholders, and manufacturers involved in local HTA across Canada. The objective was to showcase the diversity of local HTA in Canada, while highlighting common gaps to be addressed. The Symposium focused on current practices in local HTA in Canada to support informed decision making, and opportunities for information sharing and provide equal access to timely evidence-based information to decision makers. The main themes included assessment of evidence for local HTA, contextualization, stakeholder engagement in local HTA, knowledge translation and impact of recommendations, and challenges and opportunities for local HTA. Local HTA in Canada complements HTAs conducted at the provincial and federal levels to improve the efficient and effective health service delivery in institutions or regions faced with limited resources. Some challenges faced by local HTA producers to influence hospital policies and clinical practice involve the engagement of healthcare professionals and potential lack of training and support necessary for the introduction of a new technology.

Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians.

Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders' perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as 'new', 'safe' and 'effective', whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital-based health technology assessment has been developed to support decisions. However, little is known about the different perceptions of innovative medical devices among practitioners and how different perceptions may affect decision making. What does this paper add? This paper compares and understands the perceptions of two groups of health professionals concerning innovative devices in the university hospital environment. What are the implications for practitioners? Such a comparison of viewpoints could facilitate improvements in current practices and decision-making processes in local health technology assessment for these medical products.