Full Health Technology Assessment Research Articles

Validating the rigour of adaptive methods of economic evaluation

BackgroundThere has been a lot of debate on how to ‘generalise’ or ‘translate’ findings of economic evaluation (EE) or health technology assessment (HTA) to other country contexts. Researchers have used...

HPR37 Comparing Reimbursement of New Drugs During the COVID-19 Pandemic in Ireland and Scotland

Following the onset of the COVID-19 pandemic, the Scottish Medicines Consortium (SMC) suspended monthly meetings from April to August 2020, to support the National Health Service (NHS) Scotland in maintaining essential work. Following the return of meetings, a fast-track process was introduced to expedite reimbursement for certain medicines. Conversely, the Irish health technology assessment (HTA) agency, the National Centre for Pharmacoeconomics (NCPE), continued to assess new reimbursement applications throughout this period, using the two-stage process of a rapid review (RR), followed by full HTA for some medicines. This research explores how these different approaches impacted reimbursement submissions and recommendations during this time. A database was developed using published data (from 01/03/2020 to 01/03/2022) on the NCPE, SMC and Irish Health Service Executive (HSE) websites, including; • Breakdown of submissions received • Assessment outcomes • Breakdown of reimbursement recommendations Data was extracted into Excel® and analysed using summary and descriptive statistics. SMC advice for 169 medicines were identified (n=89 full submissions; n=36 abbreviated submissions; n=28 non-submissions; n=13 resubmissions; n=3 ultra-orphan assessments). Positive reimbursement recommendations were made for 136 of these medicines (n=68 accepted for use, n=58 accepted for restricted use, n=7 accepted on interim basis, n=3 available under ultra-orphan assessment), with 48 recommendations made using the fast-track process. Contrastingly, the NCPE published 148 RR outcomes and 61 HTA outcomes, with 70 reimbursement recommendations published by the HSE (n=38 positive recommendations, n=11 restricted reimbursement, n=21 reimbursement not recommended). While a similar number of submissions were assessed by the Irish and Scottish HTA agencies during the COViD-19 period, there was a significantly higher number of positive reimbursement recommendations from the SMC, which may be explained by the SMC fast-track process. This research further explores the reimbursement recommendations for each category of submission and compares the reimbursement timelines for each jurisdiction.

Health technology assessment of whole genome sequencing in the diagnosis of genetic disorders: a scoping review of the literature.

The aim of this scoping review is to map the available evidence about the use of health technology assessment (HTA) in the assessment of whole genome sequencing (WGS). A scoping review methodology was adopted. The population, concept, and context framework was used to build up the research question and to establish the eligibility criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews was adopted to implement a comprehensive search strategy. Evidence was retrieved from scientific databases and HTA organizations Web sites. Reports were classified as full HTA, mini-HTA, rapid reviews or other. The search strategy identified seven reports. Five HTA organizations from five countries elaborated the reports: one full HTA, four rapid reviews, and two classified as others. The reports were mainly focused on the evaluation of the clinical utility and cost-effectiveness of genome-wide sequencing as well as informing policy questions by providing analyses of organizational and ethical considerations. Few HTA organizations are drafting reports for WGS. It is essential to stimulate a critical reflection during the elaboration of HTA reports for WGS to steer choices of decision makers in the establishment of priorities for research and policy and reimbursement rates.

Health Technology Assessment for COVID19: an approach for the Horizon Scanning of health innovations

BackgroundThe COVID-19 pandemic definitely changed the approach to technologies evaluation, firstly in terms of timeliness. In order to answer to this need, a new methodology was proposed, joining the elements of horizon scanning with the Multi-Criteria Decision Analysis (MCDA). In this work we describe the results of 2 case studies of application.MethodsBy means of an assessment matrix, a multidisciplinary expert panel gave a score based on a Likert scale and related to potential value and perceived risk for each technology. Economic, clinical and ethical criteria were considered as a summary of Health Technology Assessment (HTA) main domains. The final scores were then weighted by the MCDA and a scatter plot defined 4 positioning scenarios according to the balance of values and risks resulted, each conducting to an appropriate recommendation (full HTA report or reject). A Monte Carlo simulation was also carried out for the assessment of variability of results.ResultsAn individual protection device for COVID-19 and a contact tracing app were assessed. The first technology was placed in the “Danger Zone” of the graph, because of its high costs and organizational complexity. The second one was placed in the “Comfort Zone” of the graph, due to low costs and easiness of implementation and management. For this innovation a recommendation for a full HTA and a pilot testing was given. In both cases, the Monte Carlo simulation confirmed the results of previous analyses.ConclusionsThe implementation of this new tool presented for the large amount of innovations created in response to COVID-19 could be supportive for decision makers, especially in pandemic times when a rapid answer is necessary. Improvements in the subjective judgement process, by introducing an objective approach, is now ongoing as it could enhance the strength of the final decision.Key messages In a pandemic time as the current, HTA should be as rapid as possible without losing scientific robustness.The methodology described could be an answer in support to the decision-making process, allowing an adequate and quick priority setting.

The Utility of a Rapid Review Evaluation Process to a National HTA Agency.

Background and ObjectiveIn Ireland, similar to other jurisdictions, health technology assessment (HTA) is used to inform the health payer’s drug reimbursement decisions. These HTAs are conducted by the National Centre for Pharmacoeconomics (NCPE). In 2009, the NCPE introduced the Rapid Review process to identify drugs that do not require further assessment in the form of the previously established full HTA process.MethodsA retrospective analysis of all Rapid Reviews submitted to the NCPE from 2010 to 2019, inclusive, was conducted. Rapid Review recommendation was recorded (i.e. full HTA required or not required). For those submitted from 2012 to 2019, additional data relating to the drug, economic and clinical evidence-related factors were collected. Multivariable logistic regression methods were used to model the relationship between these factors and the likelihood of requiring a full HTA. An exploratory analysis estimated the additional NCPE appraisal time that would have been required to evaluate all drugs, had the Rapid Review process not been established.ResultsOf the 446 Rapid Reviews submitted, approximately half (49.6%) were deemed to require a full HTA. Drugs for cancer indications, drugs designated first-in-class status, and high-cost drugs were positively and significantly associated with the likelihood of requiring a full HTA. No significant association was found for drugs for orphan indications when factors relating to cost and clinical evidence were included in the model. Without the Rapid Review process, an estimated additional 15,631 NCPE appraisal days would have been required to evaluate all drugs submitted over the 10-year period.ConclusionsThis is the first study to use data uniquely available to the NCPE to evaluate factors associated with the requirement for a full HTA following a Rapid Review. The process has reduced the NCPE appraisal time required to evaluate all submissions over the study period. The NCPE’s Rapid Review process allows for appropriate resource prioritisation within a national HTA agency.

Cost-effectiveness evidence on approved cancer drugs in Ireland: the limits of data availability and implications for public accountability

BackgroundWe surveyed evidence published by Ireland’s National Centre for Pharmacoeconomics (NCPE) on the cost-effectiveness of cancer drugs approved for funding within the Irish public healthcare system. The purpose is threefold: to assess the completeness and clarity of publicly available cost-effectiveness data of such therapies; to provide summary estimates of that data; to consider the implications of constraints on data availability for accountability regarding healthcare resource allocation.MethodsThe National Cancer Control Programme lists 91 drug-indication pairs approved between June 2012 and July 2020. Records were retrieved from the NCPE website for each drug-indication pair, including, where available, health technology assessment (HTA) summary reports. We assessed what cost-effectiveness data regarding approved interventions is available, aggregated it and considered the consequences of reporting constraints.ResultsAmong the 91 drug-indication pairs 61 were reimbursed following full HTA, 22 after a rapid review process and 8 have no corresponding NCPE record. Of the 61 where an HTA report was available, 41 presented costs and quality-adjusted life-year (QALY) estimates of the interventions compared. Cost estimates and corresponding incremental cost-effectiveness ratios (ICERs) are based on prices on application for reimbursement. Reimbursed prices are not published. Aggregating over the drug-indication pairs for which data is available, we find a mean incremental health gain of 0.85 QALY and an aggregate ICER of €100,295/QALY, which exceeds Ireland’s cost-effectiveness threshold of €45,000/QALY.ConclusionReimbursement applications by pharmaceutical manufacturers for cancer drugs typically exceed Ireland’s cost-effectiveness threshold, often by a considerable margin. On aggregate, the additional total net cost of new drugs relative to current treatments needs to be more than halved for the prices sought on application to be justified for reimbursement. Commercial confidentiality regarding prices and cost-effectiveness upon reimbursement compromises accountability regarding the fair and efficient allocation of scarce healthcare resources.

Topic selection for health technology assessment: An approach combining multiple attribute decision making and decision rules.

Background: Various studies have used multiple attribute decision making (MADM) techniques to assess and rank health technologies. The goal of the present study was to prioritize health technologies using various techniques of MADMs in combination with decision rules. Methods: The study is an applied research using multi-attribute decision making (MADM) methods. This study extracted the attributes related to health technology assessment from global literature and experts’ opinions. In this study, two different types of experts were consulted: the first type, including three experts in the field of the decision-making techniques, on the subject of setting priority on health focusing on MADM; and the second one consists of seven experts in the field of HTA, asked about the selection of attributes and determination their importance. Candidate health technologies were individually weighted and ranked using TOPSIS, SAW and VIKOR by the weight and decision matrix. The results obtained from various techniques were combined and ranked using Copeland’s technique to obtain the final ranking of health technologies. To determine HTA type reports, decision rules were defined. All models were designed via MS Excel. Results: This study chose eight technologies according to six tradeoff attributes. These attributes included health benefits at the population level, vulnerable population size, availability of alternative technologies, budget impact, financial protection, and quality of evidence. Their exact weights were 0.25, 0.121, 0.146, 0.132, 0.167 and 0.181, respectively. Also, safety and uncertainty about the cost-effectiveness were considered as the veto and decision rules respectively. Copeland’s method was therefore used to combine the methods: Whereas HT2 (The technology for treating patients suffering from varicose) was ranked the highest priority and HT3 (The palliative method for patients who suffer from various cancers) was ranked the lowest (for preventing from any ethical issue, the exact name of each technology wasn’t mentioned). Conclusion: Finally, in accordance with decision rules which are based on various conditions of "uncertainty about the cost-effectiveness", it is recommended that full health technology assessment report be performed on three technologies, rapid health technology assessment report be performed on four others, and, finally no prioritizing for health technology assessment be made on one of them.

Ethics analysis of light and vitamin D therapies for seasonal affective disorder.

The aim of this ethics analysis was to highlight the overt and covert value issues with regard to two health technologies (light therapy and vitamin D therapy), the health technology assessment (HTA) and the disease of seasonal affective disorder (SAD). The present ethics analysis served as a chapter of a full HTA report that aimed to assist decision makers concerning the two technologies. First, we used the revised Socratic approach of Hofmann et al. to build overarching topics of ethical issues, and then, we conducted a hand search and a comprehensive systematic literature search on between 12 and 14 February 2019 in seven databases. The concrete ethical issues found concerned vulnerability of the target population and the imperative to treat depressive symptoms for the sake of preventing future harm. Further disease-related ethical issues concerned the questionable nature of SAD as a disease, autonomy, authenticity, and capacity for decision making of SAD patients, and the potential stigma related to the underdiagnosis of SAD, which is contrasted with the concern over unnecessary medicalization. Regarding the interventions and comparators, the ethical issues found concerned their benefit-harm ratios and the question of social inequality. The ethical issues related to the assessment process relate to the choice of comparators and the input data for the selected health economic studies. The concrete ethical issues related to the interventions, the disease, and the assessment process itself were made overt in this ethics analysis. The ethics analysis provided an (additional) value context for making future decisions regarding light and vitamin D therapies.

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.

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.

Ranking the Criteria Used in the Appraisal of Drugs for Reimbursement: A Stated Preferences Elicitation With Health Technology Assessment Stakeholders Across Jurisdictional Contexts

ObjectivesOur goal was to estimate the relative importance assigned to health technology assessment (HTA) criteria by stakeholders involved in the HTA process. HTA is an increasingly common framework used in the appraisal of drugs for public reimbursement. It identifies clinical, economic, social, and organizational criteria to be considered. The criteria can vary across jurisdictions and are typically appraised by multidisciplinary expert committees. Guidance on the relative weighing of criteria is often absent. MethodsWe elicited stakeholders’ preferences using a single-scenario discrete choice experiment and a best-worst scaling model with conviction scores to assess the weights assigned to selected criteria by HTA stakeholders. We recruited 111 HTA stakeholders across multiple jurisdictions, including members of expert committees, clinical and economic experts, patients, and public payer representatives. Each judged twelve hypothetical cancer drug profiles for suitability for public funding and identified which characteristics were best and worst. In addition to standard discrete choice experiment and best-worst scaling models, we estimated a hybrid model to obtain a ranking of criteria by importance they played in the appraisal. ResultsA strong clinical benefit proved the most important criterion, followed by cost considerations, presence of adverse events, and availability of other treatments. The importance of clinical benefit was moderated by unmet need, adverse events, and number of patients. ConclusionPolicymakers might want to consider providing an explicit weighing scheme, or moving to a 2-stage selection process with an assessment of the quality of clinical evidence as a gatekeeping step for a full HTA review.

PNS278 A REVIEW OF HEALTH TECHNOLOGY ASSESSMENT GUIDELINES ON THE APPROVAL OF BIOSIMILARS

Although biosimilars have been authorized by the European Medicines Agency, the US Food and Drug Administration, and other regulatory agencies as a cost saving alternative to more expensive biologics, their uptake has been slow. We aimed to study the health technology assessment (HTA) and reimbursement processes of biosimilars across different markets. We examined the HTA review process of biosimilars in the UK, Canada, Australia, Germany, France, and other European countries by reviewing the guidelines and position statements issued by their respective national agencies. This work noticed that HTA review process for biosimilars can vary considerably in the countries studied, given differing views on biological equivalence, importance of adverse events, comparability of resource use and relevance of reference product as comparator. In the UK, NICE reviews biosimilars in the context of a multiple technology appraisal along with their reference product and issues an evidence summary of the new medicine without any recommendations; SMC, however, does not review biosimilars when the reference product is approved for the same indication, in the same population, in other cases a full review is conducted. In Canada, CADTH has a tailored approach for the review of biosimilars with recommendations to switching for some biosimilars. PBAC in Australia recommends a minor submission to the new biosimilars without a need for any economic evaluation for the same indication, and it supports the biosimilar substitution at pharmacy level. Germany’s IQWiG does not assess biosimilars unless requested and has not made any recommendations regarding biosimilar substitution. HAS in France considers biosimilars as new drugs and a full review is required. Given that views on biosimilars varied across the majority of countries considered, the requirement for full HTA and economic evaluation differed and consequently guidelines for use, substitution and interchangeability of biosimilars similarly varied.

Health Technology Assessment of Drugs in Ireland: An Analysis of Timelines.

BackgroundThe National Centre for Pharmacoeconomics (NCPE) is commissioned by the Corporate Pharmaceutical Unit of the Health Service Executive (HSE-CPU) to assess the evidence for the comparative effectiveness and cost effectiveness of drugs for use by patients in Ireland. All new drugs are required to undergo rapid review (RR) appraisal by the NCPE. Following this, high-cost drugs or those predicted to have a significant budget impact then undergo a full health technology assessment (HTA) appraisal by the NCPE.ObjectiveThe objective of this paper was to quantify each stage of the timeline from marketing authorisation (MA) to completion of HTA appraisal and explore the association between submission features and the time to appraise RRs and HTAs.MethodsAll RRs and HTAs submitted to the NCPE (2015–2017 inclusive) were included in the dataset. Several dates and features of each submission were also listed for the purpose of analysis.ResultsA total of 158 RR and 49 HTA appraisals were completed by the NCPE between 2015 and 2017. The median time from MA to submission of RR was 59 days; the median time to appraise RR was 31.5 days. Only 49% of RRs appraised (2015–2017 inclusive) were recommended for HTA. The median time from RR decision to submission of HTA was 115 days, and the median time taken by the NCPE to appraise an HTA was 131 days.ConclusionThis paper identifies which stages of the process make a substantial contribution to the HTA timeline. Time to submission of RR varied widely between submissions, with only a few companies choosing to submit prior to an MA being granted. The average RR appraisal time was in line with the 4-week timeframe set out in a 2016 agreement. The time to appraise an HTA was longer than the 90-day timeframe.

Analysis of Health Technology Assessments of Orphan Drugs in Ireland from 2012 to 2017.

BackgroundIn Ireland, health technology assessment (HTA) submissions for orphan drugs or drugs for rare diseases have increased in recent years but have not been explicitly analysed. All evaluations are conducted by the National Centre for Pharmacoeconomics (NCPE).ObjectivesThe objectives of this study were to ascertain the number of orphan drug submissions to the NCPE and determine how these drugs proceeded through the NCPE critical evaluation process compared with non-orphan drug submissions.MethodsThis was a retrospective analysis of applicant rapid review submissions made to the NCPE from January 2012 to December 2017 inclusive. Drugs were categorised according to the following definitions: orphan (non-cancer) drug, orphan (cancer) drug and ultra-orphan drug. In each of the three categories, the outcome of rapid review appraisal, and where relevant, the outcome of the subsequent HTA was recorded.ResultsDuring the period of study, 280 rapid review submissions were made to the NCPE, of which 21 were for orphan (non-cancer) drugs, 24 were for orphan (cancer) and ten were for ultra-orphan drugs. After rapid review, 44%, 78% and 100% of orphan (non-cancer) drugs, orphan (cancer) drugs and ultra-orphan products, respectively, were recommended for full HTA. When the outcome of the rapid review process was compared between orphan drugs and non-orphan drugs, a statistically significant difference was detected in the proportion of rapid reviews for which the outcome was ‘HTA recommended’ (Pearson’s Chi-squared test; p = 0.04).ConclusionsThe number of submissions to the NCPE for orphan drugs has increased in recent years. The rapid review and HTA process in Ireland plays a role in supporting the reimbursement decision-making process for orphan drugs in a similar manner to the process established for non-orphan drugs. However, the outcome of the reimbursement process for orphan drugs versus non-orphan drugs (in terms of access for patients) has yet to be quantified.

Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment.

Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®. The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis. The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process. The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

Health Technology Assessments for Flash Glucose Monitoring and How to Use Them in Everyday Clinical Practice.

Various health technology assessment (HTA) agencies review new medical devices worldwide, and their recommendations can be useful in guiding clinical decision making. However, different agencies use different processes and methodologies, resulting in variation in recommendations. The objectives were to review full HTAs for a new technology for diabetes management, flash glucose monitoring (FGM), with the aim of summarizing similarities/differences in processes, methodologies, and recommendations from the perspective of everyday clinical practice. A literature review was conducted using online HTA resources. Four full HTAs were identified (Canary Islands, France, Catalunya, and Norway); one issued a conditional recommendation for patients with type 1 diabetes mellitus (T1DM) with controlled glycated hemoglobin (HbA1c) (Spain; Canary Islands), one issued a broader recommendation for patients with T1DM and T2DM (France), and two reported that there was insufficient evidence to support a recommendation (Spain [Catalunya] and Norway). The most comprehensive and stringent of the available HTAs were those in the Canary Islands and Norway, which included systematic literature reviews (SLRs), consultation with patient groups and clinicians, GRADE evidence quality assessments, and full economic models. Comprehensive HTAs either did not recommend FGM (Norway) or restricted the recommendation to a small subpopulation of the overall diabetes population (Canary Islands). HTAs represent a valuable additional resource for clinicians to consider alongside clinical evidence, guidelines, and consensus papers; however, interpreting recommendations requires an understanding of the processes behind these recommendations. In this review, comprehensive HTAs either recommended for a selected subpopulation based on RCT evidence or found insufficient evidence for a recommendation.

Health technology assessment of public health interventions: an analysis of characteristics and comparison of methods\u2014study protocol

BackgroundConducting a health technology assessment (HTA) of public health interventions (PHIs) poses some challenges. PHIs are often complex interventions, which affect the number and degree of interactions of the aspects to be assessed. Randomized controlled trials on PHIs are rare as they are difficult to conduct because of ethical or feasibility issues.The aim of this study is to provide an overview of the methodological characteristics and to compare the applied assessment methods in HTAs on PHIs.MethodsWe will systematically search HTA agencies for HTAs on PHIs published between 2012 and 2016. We will identify the HTAs by screening the webpages of members of international HTA organizations. One reviewer will screen the list of HTAs on the webpages of members of international HTA organization, and a second review will double-check the excluded records. For this methodological review, we define a PHI as a population-based intervention on health promotion or for primary prevention of chronic or non-chronic diseases. Only full HTA reports will be included. At maximum, we will include a sample of 100 HTAs. In the case that we identify more than 100 relevant HTAs, we will perform a random selection. We will extract data on effectiveness, safety and economic as well as on social, cultural, ethical and legal aspects in a priori piloted standardized tables. We will not assess the risk of bias as we focus on exploring methodological features. Data extraction will be performed by one reviewer and verified by a second. We will synthesize data using tables and in a structured narrative way.DiscussionOur analysis will provide a comprehensive and current overview of methods applied in HTAs on PHIs. We will discuss approaches that may be promising to overcome the challenges of evaluating PHIs.

Challenges to decision-making processes in the national HTA agency in Brazil: operational procedures, evidence use and recommendations

BackgroundThe quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures.MethodsThis is a descriptive study based on CONITEC official reports from July 2012 through December 2016. Data were collected with a specific extraction form and analysed using descriptive statistics.ResultsWe evaluated 199 CONITEC recommendation reports. The annual number of reports increased during the study period. The absolute annual number of new technologies incorporated in 2013 (n = 24) was similar to that observed for 2014 (n = 24) and 2015 (n = 22), decreasing in 2016 (n = 13). The type of technology most frequently evaluated was ‘drugs’ (68.3%), followed by ‘procedures’ (20.1%). Overall, 117 (58.8%) reports were internal demands, 75 (37.7%) were external demands and 7 (3.5%) were mixed demands. There were differences between internal and external demands in terms of the evidence used in the reports and the decision regarding the recommendation to incorporate the technologies. Among the internal demands, the recommendation to incorporate the new technology was made for 70.9% of the reports, only 9.6% of which included full HTAs. Among the external demands, the incorporation of the new technology was recommended for 17.3% of the reports, 76.9% of which included full HTAs. Of the 101 reports in which incorporation of the new technology was recommended, 88 (87.1%) did not include a full health economic evaluation and ICER calculation. There are compliance difficulties with the recommendations in the CONITEC internal regulations regarding the type and quality of evidence considered in the analysis of recommendation reports.ConclusionsThe characteristics of the evidence used in recommendation reports and those considered to be mandatory were very different, indicating problems in decision-making processes. There is a need to study, with a broader perspective, the factors that influence the type of evidence used in decision-making processes in order to contribute to the development of better practices and policies.

Why laparoscopists may opt for three-dimensional view: a summary of the full HTA report on 3D versus 2D laparoscopy by S.I.C.E. (Societ\xe0 Italiana di Chirurgia Endoscopica e Nuove Tecnologie)

BackgroundThree-dimensional view in laparoscopic general, gynaecologic and urologic surgery is an efficient, safe and sustainable innovation. The present paper is an extract taken from a full health technology assessment report on three-dimensional vision technology compared with standard two-dimensional laparoscopic systems.MethodsA health technology assessment approach was implemented in order to investigate all the economic, social, ethical and organisational implications related to the adoption of the innovative three-dimensional view. With the support of a multi-disciplinary team, composed of eight experts working in Italian hospitals and Universities, qualitative and quantitative data were collected, by means of literature evidence, validated questionnaire and self-reported interviews, applying a final MCDA quantitative approach, and considering the dimensions resulting from the EUnetHTA Core Model.ResultsFrom systematic search of literature, we retrieved the following studies: 9 on general surgery, 35 on gynaecology and urology, both concerning clinical setting. Considering simulated setting we included: 8 studies regarding pitfalls and drawbacks, 44 on teaching, 12 on surgeons’ confidence and comfort and 34 on surgeons’ performances. Three-dimensional laparoscopy was shown to have advantages for both the patients and the surgeons, and is confirmed to be a safe, efficacious and sustainable vision technology.ConclusionsThe objective of the present paper, under the patronage of Italian Society of Endoscopic Surgery, was achieved in that there has now been produced a scientific report, based on a HTA approach, that may be placed in the hands of surgeons and used to support the decision-making process of the health providers.