Health Technology Assessment Unit Research Articles

Establishing a Health Technology Assessment Evidence Ecosystem in India’s Pradhan Mantri Jan Arogya Yojana

ABSTRACT The introduction of the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) scheme in India was a significant step toward universal health coverage. The PM-JAY scheme has made notable progress since its inception, including increasing the number of people covered and expanding the range of services provided under the health benefit package (HBP). The creation of the Health Financing and Technology Assessment (HeFTA) unit within the National Health Authority (NHA) further enhanced evidence-based decision-making processes. We outline the journey of HeFTA and highlight significant cost savings to the PM-JAY as a result of health technology assessment (HTA). Our paper also discusses the application of HTA evidence for decisions related to inclusions or exclusions in HBP, framing standard treatment guidelines as well as other policies. We recommend that future financing reforms for strategic purchasing should strengthen strategic purchasing arrangements and adopt value-based pricing (VBP). Integrating HTA and VBP is a progressive approach toward health care financing reforms for large government-funded schemes like the PM-JAY.

PP14 The Role Of Health Technology Assessment In The Public Hospitals Of The National Health Service Of Catalonia

IntroductionHospitals play an essential role to facilitate the appropriate introduction of health technologies into the National Health System. We aimed to analyze if the decision-making at the hospital level is based on health technology assessment (HTA).MethodsWe developed a seventeen-question survey to assess the decision-making mechanisms for the introduction of health innovation into the public hospitals of the National Health Service (NHS) of Catalonia. All questions were related to the field of HTA and health innovation. We asked about the process of new health technology acquisition, the existence of HTA units, and the impact those units might have within the center. We invited the three main public healthcare providers (n= 68 centers). We performed a quantitative analysis grouping the results by type of healthcare provider.ResultsThirty-five different health providers (51.5%) remitted forty-two responses. We identified two differential mechanisms for the introduction of health innovation in those centers: 51.4 percent used a directive committee for decision-making, whereas 37.1 percent employed a technical commission. Some centers (8.6%) used both options. Both the directive committees and technical commissions predominantly considered the professional experience or scientific evidence provided by the healthcare professionals of the center (80%) or external HTA reports or clinical practice guidelines (65.7%) to guide their decision-making. Using HTA products developed within the center was less frequent (34.3%). Only 57.1 percent of the healthcare providers had an HTA unit, but 75 percent of them declared that HTA products had a direct and quantifiable impact on their decision-making regarding the introduction of innovation. Healthcare providers without HTA units manifested their willingness to adopt HTA practices into their decision-making processes.ConclusionsHTA at the hospital level is not a common practice when deciding to introduce innovative health technologies in the NHS of Catalonia. However, the main healthcare providers agreed that the introduction of HTA is necessary for improving their decision-making and that the HTA agency, Agency for Health Quality and Assessment of Catalonia (AQuAS) will play a key role (training, promoting, and assessing).

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.

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.

OP148 Influence Of The Hospital-Based Health Technology Assessment Unit On New Technologies Transfer At The National Level In Kazakhstan

IntroductionThe hospital-based Health Technology Assessment (HB-HTA) Unit in the Hospital of the President’s Affairs Administration has been operating since 2015 and is the first example of the implementation of the HB-HTA system in Kazakhstani hospitals. In addition to assessing the feasibility of implementing new health technologies (HTs) into the hospital’s practice, the Unit also interacts with the National Regulatory Authority (NRA) to transfer new technologies into the National Reimbursement System (NRS). We report on the transformation of the HB-HTA Unit from a stand-alone entity to an integrated, specialized agency.MethodsData were drawn from reports of the HB-HTA Unit and internal NRA documents. Inclusion of new HTs into the NRS consists of the following sequential stages: (i) implementing the technology in at least one hospital; (ii) filing an application with the Ministry of Health Care (MoH) in the field of HTA to resolve the issue of reimbursement at the national level; (iii) in case of a positive decision, approval at the national level of the clinical protocol for using the medical intervention; (iv) agreement on the reimbursement price of the technology.ResultsBased on positive recommendations from the HB-HTA report in 2015, the hospital implemented 19 new nuclear medicine technologies. In 2016, the hospital initiated an application to the MoH to include these technologies in the NRS (previously, these technologies were carried out only for a fee or with private insurance). From 2016 to 2020, a positive decision from the MoH was received, protocols for medical interventions were published at the national level, and cost estimates were formulated. In 2021, 19 new medical services in nuclear imaging and scintigraphy were included in the NRS.ConclusionsDespite the long and bureaucratic process of including new HTs in the NRS, the HB-HTA Unit managed to speed up this process. One of the main priorities of the integrated HB-HTA Unit is to promote the transfer of HTs into the health system at the national level.

TELEMED: Database on Evidence-Based Telemedicine in a Hospital Setting

Background The use of telemedicine services has increased worldwide during recent years as a result of national strategies for the digitalization of health care and the COVID-19 pandemic. However, health care professionals often express uncertainty regarding the evidence and effectiveness of telemedicine interventions. Therefore, the Centre for Innovative Medical Technology at Odense University Hospital introduced the TELEMED database, an evidence-based telemedicine database. Objective This study aimed to ensure that hospital managers, health care professionals, and other stakeholders gain access to information about scientific studies of telemedicine interventions and their effectiveness. Methods The database constitutes a structured literature search in PubMed for randomized controlled trials or controlled trials on the effect of telemedicine for somatic diseases treated at hospitals. The search was conducted by staff members in the Health Technology Assessment unit at the Centre for Innovative Medical Technology. First, identified studies were sorted by screening titles and abstracts and, subsequently, by reading full-text versions. The data extracted from the studies included the setting, intervention, patient group, type of telemedicine, clinical effect, patient perception, and implementation challenges. Finally, the value of each study was assessed with respect to effectiveness. Results A total of 518 articles were included for data extraction and assessment. The database provides results from 22 different specialties and can be searched using the following criteria: medical specialty, country, technology, clinical effect, patient experience, and economic effect. The database serves as a platform for the dialogue with clinical departments who wish to implement telemedicine services and has a large potential for supporting the digital transformation during COVID-19 as evidence-based information on patient groups, relevant technologies, and their effect is easily accessible. Conclusions The TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services. The database is freely available and is expected to be continuously improved and broadened over time. Conflicts of Interest None declared.

ASSESSING INNOVATIVE ASSISTIVE TECHNOLOGIES (ATS) FOR OLDER ADULTS: AN EXECUTIVE SPONSOR'S PERSPECTIVE

Abstract The BC Ministry of Health (BC MoH)’s Health Technology Assessment unit is part of the Partnerships and Innovation Division. Our interest in this project concerns the status of ATs and the health technology assessment (HTA) process. The role of AT implementation as a key feature of the potential for new ATs to maximize health impact for older adults is something the Ministry sees as critical to meet the goal of enhancing healthy ageing and sustaining independence and autonomy. Methods: From the beginning of the project, as Executive Sponsor, the Partnerships and Innovation Division helped to co-create the research program and played a key role in developing partnerships with health authorities and other stakeholders. With monthly meetings and several other research activities, the project has provided multiple opportunities for genuine policy engagement. Results: The results so far have seen the project extend the scope of its partnerships with key stakeholders in BC. The Ministry was on a local reference group of knowledge users for a rapid realist review of participatory co-design, and Mr. Saini is a co-author on a publication based on that work. The project received additional funding from the BC MoH, and recently the Ministry collaborated on a successful University of Victoria Research Acceleration Fund grant application. Conclusions: The BC MoH sees this as a key implementation science project, which will provide guidance to the HTA process, as it inevitably confronts increased demand for the public provision of ATs for older adults, particularly vulnerable and disadvantaged groups.

A roadmap toward implementing health technology assessment in Egypt.

The Egyptian healthcare system is currently in the early phase of health technology assessment (HTA) implementation. The aim of this study is to propose an implementation roadmap based on the national healthcare system status. A survey was conducted among Egyptian healthcare sector decision-makers to assess the current and future (preferred) HTA implementation status in Egypt based on a widely used international scorecard methodology. Subsequently, interviews were conducted with experts representing middle- and top-tier management in the Egyptian healthcare system to interpret the survey results and recommend specific actions. Experts recommended more capacity-building programs for HTA and health economics. Additionally, they proposed establishing HTA units in separate healthcare authorities and merging them into a single central HTA unit in the long term. Regarding the scope of implementation, experts recommended commencing with the assessment of innovative pharmaceuticals, and thereafter, expanding the scope to cover all health technologies in the long term. Additionally, they recommended using innovative tools such as "multi-criteria decision analysis (MCDA)" for tendering, and "managed entry agreements" for reimbursement decisions. Local burden of diseases and costing studies were also recommended to facilitate the implementation of HTA. Experts agreed that several actions are required for successful HTA implementation in Egypt, including coordination between HTA bodies, application of an explicit MCDA framework, and strengthening of local evidence generation. To implement these actions, investment in technical capacity-building is indispensable. Most experts favored using multiple and soft cost-effectiveness thresholds. Efforts should be made to publish HTA submission guidelines and timelines of the processes.

PP76 Database On Evidence-Based Telemedicine In A Hospital Setting

IntroductionThe use of telemedicine services has increased worldwide during recent years because of national strategies for digitalization of health care and the coronavirus disease 2019 (COVID-19) pandemic. However, healthcare professionals often express uncertainty regarding the effectiveness of telemedicine interventions. The TELEMED database (https://telemedicine.cimt.dk/) was introduced by the Centre for Innovative Medical Technology (CIMT) at Odense University Hospital to ensure that hospital managers, healthcare professionals, and other stakeholders have access to scientific studies of telemedicine interventions.MethodsThe database constitutes a structured literature search in PubMed for randomized and non-randomized controlled trials on the use of telemedicine for treating somatic diseases in the hospital setting. The search was conducted by staff members in the health technology assessment unit at CIMT. Identified studies were sorted by first screening titles and abstracts and then by reading full-text versions. The data extracted from the studies included setting, intervention, patient group, type of telemedicine, clinical effect, patient perception, and implementation challenges. The value of each study was also assessed with respect to effectiveness.ResultsA total of 510 articles were selected for data extraction and assessment. The database provides results from 22 different specialties and can be searched using the criteria of medical specialty, country, technology, clinical effect, patient experience, and economic effect. The database serves as an information platform for clinical departments who wish to implement telemedicine services. It has great potential for supporting digital transformation during COVID-19 by providing accessible evidence-based information on patient groups and relevant technologies and their effects. More than 95 percent of the studies in the database that compared telemedicine with a control group showed either statistically significant improvements in clinical outcomes with telemedicine or no statistically significant difference between the two groups.ConclusionsThe TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services. The database is freely available and is expected to be continuously improved and broadened over time.

PCN167 High-Cost Drugs Assessment: Two-Year Experience of a Health Technology Assessment Unit in a Referral Cancer Center

PCN167 High-Cost Drugs Assessment: Two-Year Experience of a Health Technology Assessment Unit in a Referral Cancer Center

PCN145 Clinical Pathways As Input to HTA Processes: Lessons from the Experience of a Referral Cancer Centre

Over 95,000 patients annually receive medical attention at Arturo López Pérez Foundation Oncology Institute (FALP). In 2019, to address the challenges faced by decision makers regarding oncological interventions, the FALP Health Technology Assessment unit (FALP-HTA) developed a process to design and implement clinical pathways (CPs).

Hospital-based health technology assessment in Brazil: current experiences and challenges

Abstract In Brazil, there is no consensus on the concept of hospital-based health technology assessment (HB-HTA). There is great variability in the existing models and difficulty in evaluating their results—whether in respect of clinical decisions, quality of care, and hospital policy and management or in respect of optimizing the use of resources. This study aims to discuss the experiences of HB-HTA, its integration into the regulatory system for the adoption of new technologies into the Brazilian public (SUS) (Unified Health System), and its main challenges. During a workshop, a panel of specialists in HTA and/or HB-HTA was formed, representative of four different perspectives: (i) Health services and health technology assessment units, (ii) Academia, (iii) Secretary of State for Health, and (iv) the Federal SUS sector. This was followed by discussion, a preliminary consensus, contributions from the audience, a plenary session, and a final consensus. HB-HTA is not institutionalized, nor is it part of the regulation system for the adoption of new technologies in the SUS. The main challenges are the difficulties in creating qualified teams, financial support, and sustainability. The work of these bodies in respect of the evaluation of new technologies deserves further studies analyzing the relationship between the pressure for adoption from the hospital team and industry professionals and legal rulings. It is necessary to strengthen HB-HTA culture and implement this policy in hospital management, making assessment bodies a part of managerial and decision-making processes in hospitals, and develop regional collaborative networks and a national network of HTA.

PP499 Disinvestment Supported By A Hospital-Based Health Technology Assessment Unit: A Case Of A Teaching Hospital In Brazil

IntroductionThe Hospital de Clínicas de Porto Alegre (HCPA), a public teaching hospital, has a Hospital-based Health Technology Assessment (HB-HTA) unit to support the decision-making process on technology incorporation, rationalization or disinvestment. In 2017, the plastic adhesive drape was standardized at HCPA for use in cardiovascular, digestive, orthopedic, and neurological surgery for the purpose of preventing surgical site infection (SSI). This study evaluated whether the plastic adhesive drape technology is more effective than the no adhesive drapes in the surgical procedures in which it is used in the HCPA, so as to support the medical board's decision regarding the rationalization of use.MethodsThe primary outcome was the surgical site infection rate (SSI). Searches were performed in PubMed, Cochrane and national and international health agencies: World Health Organization (WHO), National Institute for Health and Care Excellence (NICE), Centers for Disease Control and Prevention (CDC), Society for Healthcare Epidemiology of America (SHEA), Brazilian National Commission for the Incorporation of Technologies (CONITEC) and Brazilian National Health Surveillance Agency (ANVISA) databases. The search strategy combined terms related to the technology and types of surgery in which it is used in the HCPA. The quality of the included studies was assessed. Additionally, data on technology utilization and costs in the hospital were analyzed.ResultsTechnology assessment followed AdHopHTA project recommendations. Data from the hospital showed that the technology has been used in fifteen surgical specialties, different from the proposed incorporation, with a progressive increase in consumption from 2017 to 2018. The literature review included a systematic review with seven clinical trials, which concluded that the plastic adhesive drape lacks benefits, with potential for increased risk of SSI. The evidence was of moderate quality.ConclusionsThe expenses associated with the use of the technology were considered unjustified as it is not reimbursed by the Brazilian Ministry of Health and its disinvestment was recommended. The Medical Board approved the disinvestment of the technology based on the evidence found by the HB-HTA unit, and the medical staff complied with the decision.

PP506 Health Technology Reassessment (HTR) Of A Non-Drug Technology: Methods Used By A Regional HTA Unit

IntroductionAn environmental scan conducted by the Canadian Agency for Drugs and Technologies (CADTH-March-2019) revealed that several health technology assessment (HTA) organisations are currently developing standard health technology reassessment (HTR) processes. Here we present methods used to conduct an HTR of a prioritization programme for non-immediate life-threatening urgent surgeries implemented in 2017 at a tertiary referral hospital in (Quebec-Canada). This HTR initiative was conducted by a regional HTA unit to optimize the programme efficiency and resources utilization as well as to motivate change in the clinical community of other hospitals within its healthcare network. Patient and healthcare personnel satisfaction levels towards the programme were also considered.MethodsIn this case study, HTR methods and outputs were elaborated using elements presented in the CADTH environmental scan and relevant publications identified through PubMed and in the grey literature. Documents in English and French, published between January 2002 and March 2019 were considered. Key stakeholders were consulted to identify barriers of the programme implementation to other hospitals in regards to aspects related either to the local medical practice or organizational factors.ResultsThe prioritization process was conducted using the same tool applied for HTA appraisal with the additional criterion that the HTR could facilitate the programme implementation. The research processes used in this HTR included: i) systematic review of the literature, ii) hospital database search (efficacy and resource utilization), iii) perceptions of healthcare teams and patients. HTR outputs consist of specific recommendations on implementation barriers and methods to monitor the impacts of the programme.ConclusionsIn this evolving field, sharing lessons from HTR methods provides information to develop standard adaptable processes to different contexts. Hence, this work applies HTR to a healthcare programme while most of the literature focuses on the HTR processes on drug and interventional medicine disinvestment. These elements represented HTR methods used from prioritization appraisal, research processes for evaluation and outputs used to plan the implementation and finally monitoring from a regional HTA unit. It also showcases that HTR being conducted as a structured evidence-based assessment adds value to a healthcare programme and could also facilitate its implementation.

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.

PIH61 ASSEMBLING EVIDENCE ABOUT THE USEFULNESS OF HARMONIC SCALPEL IN PEDIATRIC LAPAROSCOPIC FUNDOPLICATION

Paucity of data concerning many surgical procedures and its particular techniques often sustain utilization based on surgeon’s own preferences and/or experiences. Experts are also subjected to marketing strategies and persuasion. The hospital administration of a tertiary care teaching center in southern Brazil requested hospital-based Health Technology Assessment unit to provide the best current evidence for use of ultrasonic vessel sealing technology (harmonic scalpel) in laparoscopic fundoplication in children presenting with gastroesophageal reflux disease. Initial English-language database search using the Medical Subject Headings (MeSH) terms “child”, “gastroesophageal reflux” and “fundoplication” with all publication dates up to and including November 2019 was conducted. Then, a narrower research question was built with terms “child”, “laparoscopy”, “fundoplication”, “ultrasonic device”, “harmonic scalpel” in all their variants. Any additional articles identified in the references of relevant papers were also included. The original goal was to select only randomized clinical trials (RCT) and meta-analysis of RCTs. However, due to scarce data, non-interventional studies ended up being assessed as well. Database search did not return any RCT either comparing medical treatment versus fundoplication or assessing laparoscopic versus open surgery in pediatric patients. One meta-analysis of observational studies concluded that fundoplication did not improve symptoms or hospital admission rates. Specifically in children with neurological impairment, another meta-analysis of observational studies found that fundoplication after gastrostomy was related to increased perioperative morbidity and did not reduce gastroesophageal reflux symptoms. Likewise, none RCT was found regarding performance of ultrasonic vessel sealing technology on laparoscopic fundoplication among children. Current scientific knowledge raises serious concerns about effectiveness and safety of fundoplication in children with gastroesophageal reflux. To the extent of our knowledge, indication of such procedure is highly debatable. Limited data regarding ultrasonic vessel sealing technology (harmonic scalpel) compromise agreement and consensus of all parties.

PNS143 PRIORITIZATION OF DRUGS FOR REIMBURSEMENT IN THE MALTESE HEALTH SYSTEM.

Governments often experience difficulties in striking an optimal balance between ensuring access to promising drugs while sustaining the healthcare system. We investigated, how Malta, the smallest EU country, prioritizes drugs for inclusion in the basic benefit package. Our descriptive analysis of the Maltese reimbursement system was based on policy documents and semi-structured interviews guided by the Hutton Framework. We interviewed 33 key stakeholders including policymakers, committee members, clinicians, pharmacists, hospital managers and representatives of patients, pharmaceutical industry, and procurement department. In Malta, drugs for reimbursement pass through the Health Technology Assessment (HTA) unit for drawing up an assessment report of the drug, two committees advising the Minister for Health, and a procurement unit (CPSU). The first committee, the Government Formulary List Advisory Committee (GFLAC) prioritizes the drug based on health benefits and estimated costs compared to other drugs within a clinical pathway. GFLAC advises the second committee, the Advisory Committee on Health Care Benefits (ACHCB). The ACHCB further prioritizes the drug based on affordability (i.e., budget impact), sustainability and capacity of the system. Between 2014 and 2017, the committees recommended 34% of the 190 new drugs and rejected 45%. For 21% of the drugs, the decision is pending. Drugs recommended by the ACHCB are subsequently endorsed by the minister. As final decision-maker, the minister can also prioritize clinical pathways at assessment. For example, since 2017 specific annual budgets have been allocated to oncology and diabetes. For other recommended drugs (without clinical pathways), CPSU additionally prioritizes which medicines to procure first since procurement of approved drugs often exceeds CPSU’s available budget. Decision-making at multiple levels complicates the prioritization of drugs in Malta. Pending decisions further impact the prioritization process. The main criteria for prioritisation at each level seems, however, to be budget impact and allocation of sufficient funding.