Regional Health Technology Assessment Research Articles

Costs and benefits in patients with NYHA class III heart failure treated with CardioMEMS in Italy.

CardioMEMS is a device suitable for telemedicine that is currently being evaluated by the Regional Health Technology Assessment (HTA) Committee of Tuscany. Two detailed HTA reports are available in the specialized literature, the results of which need to be transferred to our regional setting. These decisions in Tuscany are made by the so-called Centro Operativo HTA. To validate, with local cost-effectiveness data, the decision on CardioMEMS that will be made in the Tuscany region. Two detailed international HTA reports were rearranged and adapted to our regional setting to generate a simplified analysis that could form the basis of our decision. Two willingness-to-pay (WTP) thresholds of €20,000/quality-adjusted life year (QALY) and €50,000/QALY were considered. Based on epidemiological and regulatory information, the target population in Tuscany for this device is 166 cases. The value-based price of CardioMEMS is estimated to be €4,332 and €16,662 at WTP thresholds of 20,000/QALY and 50,000/QALY, respectively. Its current price in Italy is €12,000. In our region, the introduction of CardioMEMS is likely to be gradual, around 50 patients/year (or €0.60 million/year at current price). This example highlights the need to adapt the information published in the international literature to the local context in which the approval decision is made. In this context, simplified analyses are easier to apply than complex Markov models.

Some considerations on target estimands for health technology assessment.

Some considerations on target estimands for health technology assessment.

Estimation of Value-Based Price for Five High-Technology Medical Devices Approved by a Regional Health Technology Assessment Committee in Italy.

Background and objectivesValue-based pricing (VBP) is used quite frequently for medicines, but its application to medical devices is very limited. The objective of the present study was to conduct a pilot experience of systematic estimation of the value-based price of medical devices from the perspective of our national health system. Our experience was focused on high-technology devices (class IIb/III and active implantable). The objective was to evaluate the applicability of VBP in a real-world setting and to estimate the value-based price of devices in all cases where this estimation was feasible.MethodsThe dataset analysed in this work consists of 24 new devices approved consecutively in the Tuscany region over the period from January 2020 to December 2021. Since the calculation of value-based price requires the availability of a cost-effectiveness analysis, we searched for this information for each of these devices. The Cost-Effectiveness Analysis (CEA) Registry of Tufts Medical Center (US) and the health technology assessment (HTA) reports of our region were considered adequate sources of these data. Standard equations of cost-effectiveness were applied to determine the value-based price for these devices, and these prices were compared with the corresponding real prices charged in our region.ResultsWe found adequate information for five devices (21%) out of the total of 24. In three of these cases, the published analysis taken as a reference was based on Markov modelling. The comparison between value-based prices and real prices generally showed an acceptable concordance, though with a couple of outliers. An important finding is that, in a large proportion of cases (79%), the information needed for this calculation was lacking.ConclusionTo our knowledge, this is the first experience in which an institution of the healthcare system has tried a systematic application of VBP in the field of high-technology devices. Our results are encouraging and suggest a wider application of cost-effectiveness in this field.

Relationship Between Price and Diagnosis-Related Group Tariff for Medical Devices Assessed by a Regional Health Technology Assessment Committee

IntroductionMedical devices (MDs) make up an important share of total in-hospital expenditure. At the level of individual patients, this share is represented by the ratio of the cost of MD incurred by the patient vs. the total cost of in-hospital care for the same patient. If tariffs rather than costs are considered, the denominator of this ratio is given by the diagnosis-related group (DRG) and the ratio is the cost of MD over DRG tariff. The objective of this paper is to present a retrospective analysis comparing the ratio of price vs. DRG tariff for a group of devices belonging to risk class III or active implantable. These devices are those assessed in the years 2020 and 2021 by two committees of the Tuscany region in Italy.Materials and methodsThe information on price and DRG was taken from the health technology assessment (HTA) reports concerning MDs evaluated by the two above-mentioned regional committees in the years 2020 and 2021. In these reports, the information on the cost-effectiveness ratio was reported for a subset of MDs. In all cases, a preliminary qualitative assessment was carried out to determine the presence or absence of a healthcare impact in the post-discharge phase. In these preliminary analyses, the perspective of NHS was adopted.ResultsOur analysis was focused on 24 devices of either class III or active implantable. According to our results, a wide variability was found in the ratios between device price and DRG associated with its use. This ratio ranged from a minimum of about 3% in the case of the Hyalobarrier gel (Nordic Pharma GmbH, Zürich, Switzerland) for post-surgical adhesion to a maximum of 132% in the case of the Neovasc Reducer (EPS Vascular AB, Viken, Sweden), a device indicated in the narrowed coronary sinus. Three devices, i.e., PuraStat (3-D Matrix, Ltd., Tokyo, Japan), Ascyrus Medical Dissection Stent (AMDS, CryoLife, Inc., Kennesaw, GA), and Tendyne (Abbott Cardiovascular, Plymouth, MN), were found to be priced more than the reimbursement tariff (i.e., ratio > 100%). Ratios between 50% and 100% were found in about half of the devices. From our preliminary assessment on the presence of a post-discharge impact, 15 devices out of 24 (62%) were found to determine a substantial impact, while the remaining nine (38%) did not. In general, when costs and benefits of a device do not extend beyond the patients’ discharge, the presence of a ratio > 100% reliably suggests the conclusion that the device price needs to be reduced and/or the tariff needs to be increased. On the other hand, in cases where the device extends its impact beyond the patient’s hospital stay, the decision of reducing price or increasing tariff becomes more complex, and so these adjustments cannot be determined unless more information on some critical aspects is made available.ConclusionsUntil the above-mentioned improvements do not take place, rational interventions on DRG are virtually unfeasible owing to this lack of critical information. On the other hand, it is also difficult to intervene on device prices, again owing to the lack of critical information.

Erratum in: Cost per responder for upadacitinib vs abatacept in patients with moderate-to-severe Rheumatoid Arthritis in Italy.

In the article “Cost per responder for upadacitinib vs abatacept in patients with moderate-to-severe Rheumatoid Arthritis in Italy”, (1) which appeared in Volume 8, Issue 1 of Global & Regional Health Technology Assessment, the values appearing in Fig. 5 C and D, inadvertently repeated the values reported in Fig. 5 A and B. Affected data have been corrected in the article now appearing online. The authors apologize for any inconvenience caused to the readers by these changes, which do not affect the final results of the study. The final version of this article is available online and includes a reference to this correction.

Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers.

Some advanced therapy medicinal products (ATMPs) hold great promises for life-threatening diseases with high unmet needs. However, ATMPs are also associated with significant challenges in market access, which necessitates the joint efforts between all relevant stakeholders to navigate. In this review, we will elaborate on the importance of collaborations and harmonization across different stakeholders, to expedite the market access of promising ATMPs. Manufacturers of ATMPs should proactively establish collaborations with other stakeholders throughout the whole lifecycle of ATMPs, from early research to post-market activities. This covered engagements with (1) external developers (i.e., not-for-profit organizations and commercial players) to obtain complementary knowledge, technology, or infrastructures, (2) patient groups and healthcare providers to highlight their roles as active contributors, and (3) decision-makers, such as regulators, health technology assessment (HTA) agencies, and payers, to communicate the uncertainties in evidence package, where parallel consultation will be a powerful strategy. Harmonization between decision-makers is desired at (1) regulatory level, in terms of strengthening the international standardization of regulatory framework to minimize discrepancies in evidence requirements for market authorization, and (2) HTA level, in terms of enhancing alignments between regional and national HTA agencies to narrow inequity in patient access, and cross-border HTA cooperation to improve the quality and efficiency of HTA process. In conclusion, manufacturers and decision-makers shared the common goals to safeguard timely patient access to ATMPs. Collaboration and harmonization will be increasingly leveraged to enable the value delivery of ATMPs to all stakeholders.

Health technology assessment: features of national / regional and hospital-based medical technology assessment

The State Budget of Ukraine in 2021 is 159,2 billion UAH. It is 36.8 % more than in 2020, but this amount is still insufficient to cover all the healthcare needs in Ukraine. Economic hardships, the lack of funds in the healthcare system of Ukraine, as well as COVID-19 pandemic have increased the importance of Health Technology Assessment (HTA) as a tool of cost optimization. The introduction of hospital-based HTA along with national / regional HTA allows providing the use of effective, safe and economically justified health technologies that will give our citizens the access to treatment and the rational use of funds, in particular the budget ones. Aim. To analyze the world experience of using hospital-based HTA and its main differences from national / regional HTA. Materials and methods. The scientific information of international and domestic literary sources was analyzed. The methods of content analysis, historical, system-analytical and generalization were used during the research.Results. The authors reviewed the literature in Pubmed and Google Scholar databases devoted to the international experience of hospital-based HTA and its main differences from national / regional HTA. It has been determined that the transfer of the national / regional HTA results to the hospital level is hindered by a number of differences between the country as a whole and hospitals in particular. These include, first of all, features related to demographic indicators, epidemiology of diseases, the level of resistance, local approaches to treatment, various types of equipment used in hospitals, and others. In order to have practical benefits, HTA must be built taking into account the peculiarities of a medical institution where the health technologies studied will be used in the future.Conclusions. The need of effective management of hospital resources when a number of health technologies is increasing, the desire to improve clinical outcomes, improve the quality of life and its expectancy using health technologies with the proven effectiveness and safety, the need to evaluate medical equipment and consider organizational aspects related to introduction of a health technology, as well as assess the current equipment and treatment methods require to develop the scientific and practical approaches to hospital-based HTA and recommendations on collaboration between national / regional and hospitalbased HTA in Ukraine.

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.

Quality Assessment of HTA reports: a Critical Appraisal Toolkit within an institutional HTA program

Abstract Issue With population aging, increased demand for healthcare and limited availability of economic and human resources, well-functioning and sustainable health systems have to rely on rigorous and evidence-based assessments of complex technologies' clinical effectiveness and safety. The Lombardy Region in Northern Italy has a well-established HTA program that offers technical support to its hospitals' network to produce and to review Health Technology Assessment (HTA) reports. Description of the Problem To better coordinate the HTA network and to reduce self-referencing of University and Community hospitals, Lombardy Region carried out an intense field training and distance learning from year 2017, with a project aimed at involving health care professionals in an accurate evaluation of technologies in 18 HTA reports. The regional HTA Supporting Centre developed a Toolkit for the critical appraisal of reports and supporting literature to improve the quality of hospital-based reports. Results In compliance with the regional Law DGR XI/1046 17.12.2018 and the framework proposed, during year 2019 hospitals used the Toolkit to help writing complete and good quality HTA reports on 37 different technologies. With a Public Health resident internship, the Toolkit was revised, extended and then used in 2020 by the hospital's HTA network during the double blinded peer review, mandated by the regional Law DGR XI/2672 16.12.2019, of the year 2019 HTA reports. Detailed results will be presented at the conference. Lessons We observed an increase in number of HTA reports from 2018 to 2019, a greater language's and format's homogeneity and an improvement in the quality of some reports, which will be submitted to the Regional HTA Committee for appraisal and reimbursement. Key messages The development and use of a Critical Appraisal Toolkit in an Regional HTA program can help hospitals write complete and good quality HTA reports. A centrally supported quality improvement of distributed assessment activities in a network of hospitals can enhance the production of HTA reports, relevant to the needs of a local healthcare system.

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.

Does the use of health technology assessment have an impact on the utilisation of health care resources? Evidence from two European countries

ObjectivesA centralised approach to health technology assessment (HTA) may facilitate optimal use of HTA resources. A regional approach may increase the chances of local implementation of recommendations. This study aimed to compare assessment procedures in England (centralised HTA approach) with Spain (regional HTA approach) discussing key challenges and opportunities from both approaches.MethodsWe compared technology assessments of anticancer medicines in the two jurisdictions from 2008 to 2015. To assess the implementation of HTA recommendations, we assessed trends in medicine usage using regression methods. We used IQVIA data, from 2011 to 2016, for a sample of 11 medicines. We used CatSalut data from Catalonia to assess the implementation of local recommendations.ResultsIn England, 66 assessments were undertaken by the National Institute for Health and Care Excellence (NICE), using a standardised methodology. In Spain, there were 79 reports undertaken by a range of bodies using a shared process and coordinated through the GENESIS collaboration; the assessment methods used varied substantially. Overall, the recommendations in the two jurisdictions were similar. Regression analyses indicate that where there is a positive recommendation by HTA bodies, the usage of the medicine responds most strongly (p < 0.001) in Catalonia (4.892), followed by England (3.120) and Spain (1.693).ConclusionsThis study suggests that medicine utilisation does respond to the positive recommendations of HTA bodies. However, if HTA capacity is organised primarily regionally, considerable effort may be required in coordination, to ensure consistent and rigorous assessments and adequate implementation of HTA findings.

Driving factors and mode transformation regarding health technology assessment (HTA) in China: Problems and recommendations.

As the reform of Chinese medical and health undertakings has advanced (since 2015), the admission, pricing and payment policies regarding the new health technologies of China have undergone significant changes, and health technology assessment (HTA) has gradually become one of the current reform and research hotspots in China. Based on the perspective of HTA driving factors and the development mode, this paper proposes a two-stage mode of HTA development in China, namely, the mode driven by the management of new heath technology admission and another one driven by new health technology pricing and medical insurance payment. In addition, the paper also proposes the challenges that HTA faces in China under the current mode, including the development system, process standard, data mechanism, and policy application. Besides, recommendations are provided for the further development of HTA construction in China, including strengthening the development system of regional HTA centers, formulating HTA process guidance, building a database, improving evaluation quality and intensifying policy integration.

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.

OP91 Developing A Celtic Connections Regional Health Technology Assessment Alliance

IntroductionThe Irish, Scottish and Welsh national Health Technology Assessment (HTA) bodies (Health Information and Quality Authority, Health Technology Assessment Group, Scottish Health Technologies Group, Health Technology Wales) have recently (2018) established a ‘Celtic connections’ regional HTA alliance on non-medicine technologies. The primary purpose is to add value by realizing potential economies of scale and scope in non-medicine HTA efforts.MethodsA Memorandum of Understanding (MoU) was agreed to: formalize collaboration and partnership working; improve shared understanding of work programs and processes; collaborate on and co-produce evidence reviews of mutual interest; increase both the volume and range of technology topics for which advice is developed in each nation; promote knowledge exchange; and enhance professional and personal development for each agency's staff.ResultsEarly benefits include: collaboration on one technology topic resulting in the production of bespoke guidance in three countries; an update of a partner's rapid review; identification of a further potential topic collaboration (sacral nerve stimulation); a six month senior staff secondment; and reciprocal observer membership on each country's national committees. Other general benefits have included: reduced duplication of effort; improved quality assurance through ‘critical friend’ peer review; enhanced access to methodological advice and a broader range of stakeholders; and development of a forum for discussion and peer support.ConclusionsThe alliance offers real potential to optimize use of the scarce resources for non-medicine technologies across the three countries and increase evidence review and guidance volume through adapting or co-producing outputs. Longer term benefits are anticipated to include: improved knowledge exchange; advancing skills of staff; building and broadening capacity through shared learning and access to a wider professional peer group; improved staff recruitment and retention; production of joint publications and other modes of dissemination; and increased profile for each country's work.

PHP181 - HEALTH TECHNOLOGY ASSESSMENT OF ONCOLOGY THERAPIES IN SPAIN AND ITALY: KEY METRICS AND CONSIDERATIONS

Since 2015, national and regional health technology assessment (HTA) agencies in Italy and Spain have reviewed an increasing number of oncology therapies. This research examined the key metrics and considerations that paved the road to HTA success or failure in Spain and Italy, and compared the two decentralized markets. HTA reviews for non-orphan oncology drugs reviewed between January 2015 and December 2017 were identified in the Global Market Access Solution (GMAS) tool and corresponding HTA agency databases. 111 reviews published by national and regional Spanish and Italian HTA agencies were analyzed. Overall survival (OS), progression-free survival (PFS), safety, health-related quality-of-life, trial design and evidence quality were examined, as well as the HTA rating (recommended, restricted or rejected) for each drug. Spanish and Italian payers rarely rejected oncology therapies, instead preferring to restrict what patient populations were eligible to receive the therapy. 46% of restrictions related to an eligible patients’ ECOG score. Overall survival was the gold standard for measuring efficacy, but Spanish and Italian payers were willing to accept progression free survival, particularly in the event of immature OS data. Italian agencies place more emphasis on evidence quality, as demonstrated through a GRADE rating, than Spanish agencies, while Spanish agencies considered HRQoL more often than Italian payers. Concerns about clinical trial design were a common cause of restriction in Italy and Spain. In Italy, improper comparator was the most-cited concern, while Spanish payers most notably commented on a lack of blinding. The key metrics for oncology HTA decisions in Spain and Italy were similar in both countries, with a similar emphasis on efficacy. The decentralized nature of both healthcare systems means that there are multiple stakeholders across both countries, with varying methodologies. Spain recommended oncology drugs without restriction at a much higher rate than Italy.

PP41 Toward Rules For Stakeholders’ Involvement In Regional Health Technology Assessment Units

Introduction:Health services users must participate in health technology assessment (HTA) activities. Users, caregivers, and citizens have the practical experience of healthcare and social services. HTA outputs are more useful when values and preferences of patients, caregivers, and citizens are taken into account. Despite this, the best methods of stakeholders’ involvement, timing for doing so, selection of participants, and the type of users to recruit depending of methods and contexts remain unspecified. Herein, an involvement policy has been developed to formalize the participation of users, caregivers and citizens in the services offering of a regional HTA unit.Methods:A steering committee composed of stakeholders (i.e. user, caregiver, citizen, User Experience Service representative, manager, provincial HTA body representative, HTA unit members) was constituted to discuss user involvement in a regional HTA unit. A preliminary vision statement emerged from this committee, and included objectives and principles for users, caregivers, and citizens participation. This statement was deliberated using a Delphi consensus method. Three rounds of deliberations were needed to reach a strong consensus.Results:Four objectives and four principles that should underlie the development of an involvement policy reached consensus. Participants agreed that users, caregivers, and citizens should: i) propose principles of involvement for each HTA projects; ii) co-realize evaluations with HTA professionals; iii) contribute to evaluation processes; and, iv) be involved in some management decisions of regional HTA units. Four principles to formalize users, caregivers and citizens’ involvement in regional HTA units also emerged. These principles were about utility and feasibility of involvement as well as ethical and methodological considerations.Conclusions:Users, caregivers, and citizens must participate in the activities of regional HTA units. Each of them have different roles and can contribute to evaluation processes. Their involvement in HTA activities is warranted for co-producing better evaluation more adapted to users’ needs in healthcare and social services.

Corrigendum

Jommi C and Bertolani A. Patients’ Associations and HTA for medicines: actual and future role in Italy. Global & Regional Health Technology Assessment 2018. DOI: 10.1177/2284240318770966. The above-referenced article should be titled “Patients’ Associations and HTA for medicines: present and future role in Italy”.

VP83 How To Identify Technologies Eligible For Health Technology Assessment: A Bottom-Up Approach

INTRODUCTION:Governance of health technologies in Emilia-Romagna region, Italy, includes a local and a regional level. Medical devices (MDs) are requested by clinicians to hospital committees that may carry out an evaluation at local level or ask for a regional evaluation using Health Technology Assessment (HTA) methodology. Until the past year, committees weren't provided with a clear pathway to identify technologies for regional HTA evaluation. The aim of this study was to describe a bottom-up, shared approach to produce a tool with elements to be considered when judging if a technology is eligible for regional HTA or not.METHODS:To identify elements, we adopted a qualitative approach and the methodology of focus group (1,2) which consisted in starting from health professionals experience to build a shared knowledge. Two panels of stakeholders were convened, the first one comprising regional decision-makers deciding whether to reimburse and introduce a MD in Regional Health System; the second panel comprised regional clinicians that use, test and ask for MDs. Panels were asked to capture possible elements of MDs that should be considered for identifying the most promising and interesting ones for a regional HTA.RESULTS:The two panels (seventeen regional clinicians and twenty-two decision makers, respectively) had two operative meetings and worked in parallel. At the end of the second meeting, a draft of the tool with elements identified by both groups was built. Panels were asked to test the draft on few medical devices and identify possible tool's criticalities limiting transferability. Tool resulted user-friendly and complete, requiring no changes. The final version, approved by two panels convened together during the last meeting, reports thirty-two distinct items referred to five domains (that is, potential: innovativeness, clinical, economic, and organizational impact, environmental factors). Each item must be valued on a Likert scale. The tool will be applied on every MD requested by regional clinicians and before implementation it will be tested during a 6-month pilot phase beginning March 2017.CONCLUSIONS:The process was plain and feedback from stakeholders has been positive. The tool is expected to increase transparency and homogeneity in identifying technologies eligible for regional HTA.

Health technology assessment: A potential roadmap for India

Background: With the signing of the sustainable development goal document, India has embarked on the ambitious task of achieving Universal Health Coverage (UHC) by launching the National Health Assurance Mission (NHAM). However, India has not been able to meet many targets of the previous millennium development goals. Objectives: This article discusses the potential role of health technology assessment (HTA) for achieving UHC in the context of limited public health expenditure in India. Materials and Methods: Secondary literature review was conducted to review the existing HTA structures in different countries. In addition, key informant interviews were held with senior representatives (current and previous) of the National Institute of Healthcare and Clinical Excellence (NICE), Scottish Medicines Consortium (SMC), and evidence review group members from the University of Liverpool. Results: There are many potential applications for HTA in India and other low and middle-income countries. However, there are numerous contextual differences between India and other countries for adopting HTA and it is important to identify these differences and plan accordingly. Conclusions: The challenge for HTA in India is two-fold: data challenge and decision challenge. An incremental data to decision model based on the field practicum model of the Tata Institute of Social Sciences is recommended with the future objective of creating regional HTA hubs in India.