scholarly journals Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society

Cephalalgia ◽  
2021 ◽  
pp. 033310242198924
Author(s):  
Hans Christoph Diener ◽  
Messoud Ashina ◽  
Isabelle Durand-Zaleski ◽  
Tobias Kurth ◽  
Michel Lantéri-Minet ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Health Technology ◽  
Position Statement ◽  
Decision Makers ◽  
Synthetic Approach ◽  
Multiple Data ◽  
Real World Evidence

The Clinical Trials Subcommittee of the International Headache Society presents the first Health Technology Assessment for the Acute Treatment of Migraine Attacks and Prevention of Migraine. Health technology assessments are systematic evaluations of the properties, effects, and consequences of healthcare technologies; this position statement is designed to inform decision makers about access to and reimbursement for medications and devices for the acute and preventive treatment of migraine. This position statement extends beyond the already available guidelines on randomized controlled trials for migraine to incorporate real-world evidence and a synthetic approach for considering multiple data sources and modelling methods when assessing the value of migraine treatments.

HEALTH TECHNOLOGY ASSESSMENT

2002 ◽  
Vol 18 (2) ◽  
pp. 184-191 ◽  
Author(s):  
Francois Schubert
Keyword(s):  
Clinical Trials ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Clinical Endpoints ◽  
Real World Evidence ◽  
The Many

Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations.

scholarly journals Development of a checklist to guide equity considerations in health technology assessment

2021 ◽  
Vol 37 ◽  
Author(s):  
Maria Benkhalti ◽  
Manuel Espinoza ◽  
Richard Cookson ◽  
Vivian Welch ◽  
Peter Tugwell ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Literature Search ◽  
Health Inequities ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Pilot Test

Abstract Objectives Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. Methods A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. Results ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. Conclusions ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

scholarly journals Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements

2021 ◽  
Vol 37 ◽  
Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Health Technology ◽  
Practical Experience ◽  
Added Value ◽  
Real World Data ◽  
Conflicting Demands ◽  
Real World Evidence ◽  
Semistructured Interviews

Abstract Objective This study aims to assess stakeholder perceptions on the challenges and value of real-world evidence (RWE) post approval, the differences in regulatory and health technology assessment (HTA) real-world data (RWD) collection requirements under the German regulation for more safety in drug supply (GSAV), and future alignment opportunities to create a complementary framework for postapproval RWE requirements. Methods Eleven semistructured interviews were conducted purposively with pharmaceutical industry experts, regulatory authorities, health technology assessment bodies (HTAbs), and academia. The interview questions focused on the role of RWE post approval, the added value and challenges of RWE, the most important requirements for RWD collection, experience with registries as a source of RWD, perceptions on the GSAV law, RWE requirements in other countries, and the differences between regulatory and HTA requirements and alignment opportunities. The interviews were recorded, transcribed, and translated for coding in Nvivo to summarize the findings. Results All experts agree that RWE could close evidence gaps by showing the actual value of medicines in patients under real-world conditions. However, experts acknowledged certain challenges such as: (i) heterogeneous perspectives and differences in outcome measures for RWE generation and (ii) missing practical experience with RWD collected through mandatory registries within the German benefit assessment due to an unclear implementation of the GSAV. Conclusions This study revealed that all stakeholder groups recognize the added value of RWE but experience conflicting demands for RWD collection. Harmonizing requirements can be achieved through common postlicensing evidence generation (PLEG) plans and joint scientific advice to address uncertainties regarding evidence needs and to optimize drug development.

scholarly journals COST, CONTEXT, AND DECISIONS IN HEALTH ECONOMICS AND HEALTH TECHNOLOGY ASSESSMENT

2018 ◽  
Vol 34 (5) ◽  
pp. 434-441 ◽  
Author(s):  
Anthony J. Culyer
Keyword(s):  
Health Economics ◽  
Health Technology Assessment ◽  
Decision Maker ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Negative Consequences ◽  
Middle Income ◽  
Middle Income Countries ◽  
Context Dependent

Objectives:This study is an attempt to demystify and clarify the idea of cost in health economics and health technology assessment (HTA).Methods:Its method draws on standard concepts in economics. Cost is a more elusive concept than is commonly thought and can be particularly elusive in multidisciplinary territory like HTA.Results:The article explains that cost is more completely defined as opportunity cost, why cost is necessarily associated with a decision, and that it will always vary according to the context of that decision: whether choice is about inputs or outputs, what the alternatives are, the timing of the consequences of the decision, the nature of the commitment to which a decision maker is committed, who the decision maker is, and the constraints and discretion limiting or liberating the decision maker. Distinctions between short and long runs and between fixed and variable inputs are matters of choice, not technology, and are similarly context-dependent. Harms or negative consequences are, in general, not costs. Whether so-called “clinically unrelated” future costs and benefits should be counted in current decisions again depends on context.Conclusions:The costs of entire health programs are context-dependent, relating to planned rates of activity, volumes, and timings. The implications for the methods of HTA are different in the contexts of low- and middle-income countries compared with high-income countries, and further differ contextually according to the budget constraints (fixed or variable) facing decision makers.

PP108 Health Technology Assessment Educational Programs In The Russian Federation

2017 ◽  
Vol 33 (S1) ◽  
pp. 122-123
Author(s):  
Roza Yagudina ◽  
Andrey Kulikov ◽  
Dzhumber Ugrekhelidze
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Pharmacoeconomic Analysis ◽  
Health Technology ◽  
Educational Process ◽  
Regional Level ◽  
Decision Makers ◽  
Health Technologies ◽  
Legislative Changes ◽  
Data Requirements

INTRODUCTION:Health Technology Assessment (HTA) processes are extensively used during making decisions on the inclusion of medicinal products in Essential medicines lists. There is a high interest in HTA among specialists in the healthcare sphere and decision makers in Russia. According to a survey of chief physicians 62 percent of them would like to attend HTA educational programs. One of the steps necessary to disseminate HTA in Russia is the exploration of experience and best practices.METHODS:Information retrieval using websites of medical institutions in Russia were observed.RESULTS:As a result, it was found that educational program “Modern requirements for conducting health technology assessment” for decision makers in the area of health care is held in Department of organization of medicinal provision and pharmacoeconomics of the I.M. Sechenov First Moscow State Medical University. During this course basic methods of pharmacoeconomic analysis and their practical application, modern schemes of treatment and peculiarities of the conduct of pharmacoeconomic studies in different diseases, issues of HTA at different levels of the health system are covered. More than 1,900 specialists from 12 subjects of Russia (Samara, Nizhny Novgorod, Rostov, Orenburg, Bryansk, Astrakhan regions, Khanty-Mansi Autonomous Okrug, Altai, Krasnoyarsk, Stavropol and Perm territories, the Republic of Tatarstan) attended seminars including heads of regional health authorities, chief specialists of the ministries, chief physicians of hospitals, and heads of pharmacies.CONCLUSIONS:During the educational process the results of pharmacoeconomic analysis and their interpretation at the regional level, legislative changes in the sphere of health technologies circulation, the data requirements for inclusion of a medicinal product in the state lists, the rules of state procurement, and the interchangeability of medicines are highlighted. During educational process the results of pharmacoeconomic analysis and their interpretation at the regional level, legislative changes in the sphere of health technologies circulation, the data requirements for inclusion of a medicinal product in the state Lists, the rules of state procurement, and the interchangeability of medicines are highlighted.

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