Health Technology Assessment (HTA) and Access Policies

2020 ◽  
Vol 27 (3) ◽  
pp. 274-289
Author(s):  
Verena Stühlinger
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Member States ◽  
Eu Member States ◽  
Future Challenges ◽  
Pricing And Reimbursement ◽  
Application Decision ◽  
Access Policies

Abstract For patients, innovations in healthcare can be both a great blessing (when saving people’s life or improving quality of life), as well as a curse (when only few people have access, e.g., because of high prices). Thus, when healthcare innovations are proven safe and ready for application, decision makers have to apply access policies and sometimes face difficult assessments. In this context, health technology assessment (HTA) plays a crucial role at European Union level, forming an evidence-based, transparent basis for decision making through joint assessments. However, pricing and reimbursement aspects are exempt from collaborative assessments, since these are in the responsibility of the EU Member States: according to Art. 168(7) TFEU the ‘organisation and delivery of health services and medical care [… including] the allocation of the resources assigned to them’ remain an exclusive competence of Member States. However, future challenges may require further cooperation.

scholarly journals HTA Reshaping: Rethinking the Health Technology Assessment Framework in Portugal

2021 ◽  
pp. 1-12
Author(s):  
João Pereira ◽  
Joana Alves ◽  
Bernardo Rodrigues ◽  
Ricardo Caetano ◽  
Pedro  Brito-Cruz ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
National Level ◽  
Health Technology ◽  
Process Efficiency ◽  
Eu Member States ◽  
Future Challenges ◽  
System Interoperability ◽  
High Level ◽  
Level Of Agreement

<b><i>Introduction:</i></b> Health technology assessment (HTA) aims to provide decision makers with relevant data to make informed choices. Recent changes in the Portuguese HTA framework have altered substantially the assessment methodology with regard to economic evaluation, with potential impacts on access and process efficiency. The HTA Reshaping Project had as its main objective informing the debate on HTA in Portugal, thereby identifying improvement opportunities and solutions to the HTA framework that address future challenges. <b><i>Methods:</i></b> The project comprised several phases, i.e., (1) mapping and evaluation of different HTA frameworks across Europe, identifying best practices and key variables to consider in future frameworks; (2) conduction of in-depth interviews with relevant stakeholders (<i>n</i> = 11); and (3) development of 2 workshops – one with young professionals (<i>n</i> = 12) and another with relevant HTA stakeholders (<i>n</i> = 19) – to consolidate and further explore vital elements of HTA, aimed at brainstorming ideas and developing solutions to improve some of the most critical points, with a view to addressing future challenges. <b><i>Results:</i></b> The comparison of HTA frameworks showed that their purpose and sophistication vary across European countries. For example, the need for economic evidence is not unanimous, and reimbursement agreements vary considerably. Among the stakeholders interviewed there was a high level of agreement on priorities that should be addressed, e.g., expanding and creating national level registries and assuring patient participation throughout the HTA process. The possibility of using managed entry agreements to enhance patients’ access, applying multi-indication pricing for medicines with different therapeutic values per indication, and improvement of registry/system interoperability gathered a moderate level of agreement. <b><i>Conclusions:</i></b> The Portuguese HTA framework might be further adapted to upcoming challenges and should evolve to improve access to innovative therapies. There is still a long path towards the convergence of HTA frameworks in EU member states.

Opportunities to improve reporting of rapid response in health technology assessment

2021 ◽  
Vol 38 (1) ◽  
Author(s):  
Matheus O. de Almeida ◽  
Thais Montezuma ◽  
Haliton A. de Oliveira Júnior ◽  
Cleusa Pinheiro Ferri
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Epidemiologic Study ◽  
Health Technology ◽  
Risk Of Bias ◽  
Quality Of Reporting ◽  
Quality Of Evidence ◽  
Health Technologies ◽  
Study Selection

Abstract Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

OP135 Confirmatory Versus Explorative Endpoints In Drug Approval Versus Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 63-64
Author(s):  
Ines Niehaus ◽  
Charalabos-Markos Dintsios
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Approval ◽  
Health Technology ◽  
Benefit Assessment ◽  
Benefit Ratio ◽  
Early Benefit Assessment ◽  
The Impact ◽  
Early Benefit

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

OP127 Analysis Of The Competencies To Be Acquired In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 59-59 ◽  
Author(s):  
Marco Chiumente ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
Jani Mueller
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Core Competencies ◽  
Health Technology ◽  
Multidisciplinary Teams ◽  
Health Technologies ◽  
Program Description ◽  
To Receive ◽  
Masters Degree

INTRODUCTION:Health Technology Assessment (HTA) is a multidisciplinary activity that systematically examines different dimensions related to the direct and indirect consequences of health technologies when implemented in healthcare systems. HTA is developed by multidisciplinary teams in order to cover all the mentioned dimensions. However, the quality of the processes produced by HTA teams will depend upon the competencies that those teams will acquire and incorporate including knowledge, skills and attitudes (1). The aim of this research was to determine how well these dimensions and competencies are covered in HTA academic Masters degree courses and manuals.METHODS:We analyzed what had been done in terms of competencies definition in HTA: how it has been reflected; theoretically and according to the authors, and how competencies can be structured; know-how and values. We explored HTA manuals and HTA academic Masters degree courses. We searched in Google with specific terms: building capacities, HTA, programs, Masters, diplomas. We used the HTAi vortal and the information related to courses (for example Masters degrees) and HTA agencies and network webpages for programs. The inclusion criteria were formal programs that describe HTA capacity building and not partial teaching of certain aspects of HTA and we excluded non-recognized institutions, or where there was no description of the programs or lack of detail regarding objectives and competencies to be achieved.RESULTS:We found 105 courses or programs and analyzed 8 reports and 3 manuals. The main challenges that we faced were: that information was difficult to retrieve, not similarly structured, difficulties to find key information in webpages, no program description at all in some cases and the need to contact institutions staff or register as a student to receive the information and finally, it was difficult to obtain contact details of key people. We structured the information on competencies in knowledge, skills and attitudes.CONCLUSIONS:The analyzed Masters degree courses and manuals did not cover all of the dimensions of HTA analysis in an equal and standardized way. The ethical, legal, social and organizational aspects were lacking in some of the programs, while, on the contrary, clinical and economic aspects were substantially included. On the basis of the information retrieved it would be good to define core competencies for HTA.

scholarly journals Health Technology Assessment Report on Vagus Nerve Stimulation in Drug-Resistant Epilepsy

2020 ◽  
Vol 17 (17) ◽  
pp. 6150
Author(s):  
Carlo Efisio Marras ◽  
Gabriella Colicchio ◽  
Luca De Palma ◽  
Alessandro De Benedictis ◽  
Giancarlo Di Gennaro ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Technology Assessment ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Technology Assessment ◽  
Vagus Nerve Stimulation ◽  
Palliative Treatment ◽  
Health Technology ◽  
Drug Resistant

Background: Vagus nerve stimulation (VNS) is a palliative treatment for medical intractable epileptic syndromes not eligible for resective surgery. Health technology assessment (HTA) represents a modern approach to the analysis of technologies used for healthcare. The purpose of this study is to assess the clinical, organizational, financial, and economic impact of VNS therapy in drug-resistant epilepsies and to establish the congruity between costs incurred and health service reimbursement. Methods: The present study used an HTA approach. It is based on an extensive detailed bibliographic search on databases (Medline, Pubmed, Embase and Cochrane, sites of scientific societies and institutional sites). The HTA study includes the following issues: (a) social impact and costs of the disease; (b) VNS eligibility and clinical results; (c) quality of life (QoL) after VNS therapy; (d) economic impact and productivity regained after VNS; and (e) costs of VNS. Results: Literature data indicate VNS as an effective treatment with a potential positive impact on social aspects and on quality of life. The diagnosis-related group (DRG) financing, both on national and regional levels, does not cover the cost of the medical device. There was an evident insufficient coverage of the DRG compared to the full cost of implanting the device. Conclusions: VNS is a palliative treatment for reducing seizure frequency and intensity. Despite its economic cost, VNS should improve patients’ quality of life and reduce care needs.

The Alberta hip and knee replacement project: A model for health technology assessment based on comparative effectiveness of clinical pathways

2009 ◽  
Vol 25 (02) ◽  
pp. 113-123 ◽  
Author(s):  
Katherine L. Gooch ◽  
Douglas Smith ◽  
Tracy Wasylak ◽  
Peter D. Faris ◽  
Deborah A. Marshall ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Knee Replacement ◽  
Study Design ◽  
Technology Assessment ◽  
Comparative Effectiveness ◽  
Clinical Pathways ◽  
Controlled Trial ◽  
Health Technology ◽  
Randomized Controlled

Background:The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways.Methods:A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data.Results:The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar.Conclusions:The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.

PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA

2017 ◽  
Vol 33 (3) ◽  
pp. 365-370 ◽  
Author(s):  
Tatyana Benisheva-Dimitrova ◽  
Dobriana Sidjimova ◽  
Daniela Cherneva ◽  
Nikolay Kralimarkov
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Objective Assessment ◽  
Historical Analysis ◽  
Health Technology ◽  
National Council ◽  
The European Union ◽  
Medicinal Products ◽  
Policy Objective ◽  
Pricing And Reimbursement

Objectives: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000–15 and health technology assessment (HTA) role in these processes.Methods: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis.Results: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013–14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses.Conclusions: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

scholarly journals HTA principles need rigorous review

2010 ◽  
Vol 26 (4) ◽  
pp. 428-429 ◽  
Author(s):  
J. Mark Gibson ◽  
Alison Little
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Current Article

In the article “Are key principles for improved health technology assessment supported and used by health technology assessment organizations?” by Neumann et al. (3), the authors set out to evaluate the quality of processes used by health technology assessment (HTA) programs based on a set of principles they published in this journal previously (2). We believe that portions of the current article, as they relate to our own organization, are misleading or inaccurate, and welcome this opportunity to correct the inaccuracies.

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