scholarly journals LEGITIMACY OF MEDICINES FUNDING IN THE ERA OF ACCELERATED ACCESS

2017 ◽  
Vol 33 (6) ◽  
pp. 700-707
Author(s):  
Jessica Pace ◽  
Sallie-Anne Pearson ◽  
Wendy Lipworth

Objectives: In recent years, numerous frameworks have been developed to enhance the legitimacy of health technology assessment processes. Despite efforts to implement these “legitimacy frameworks,” medicines funding decisions can still be perceived as lacking in legitimacy. We, therefore, sought to examine stakeholder views on factors that they think should be considered when making decisions about the funding of high-cost breast cancer therapies, focusing on those that are not included in current frameworks and processes.Methods: We analyzed published discourse on the funding of high-cost breast-cancer therapies. Relevant materials were identified by searching the databases Google, Google Scholar, and Factiva in August 2014 and July 2016 and these were analyzed thematically.Results: We analyzed fifty published materials and found that stakeholders, for the most part, want to be able to access medicines more quickly and at the same time as other patients and for decision makers to be more flexible with regards to evidence requirements and to use a wider range of criteria when evaluating therapies. Many also advocated for existing process to be accelerated or bypassed to improve access to therapies.Conclusions: Our results illustrate that a stakeholder-derived conceptualization of legitimacy emphasizes principles of accelerated access and is not fully accounted for by existing frameworks and processes aimed at promoting legitimacy. However, further research examining the ethical, political, and clinical implications of the stakeholder claims raised here is needed before firm policy recommendations can be made.

2004 ◽  
Vol 20 (4) ◽  
pp. 493-497 ◽  
Author(s):  
Jane Royle ◽  
Sandy Oliver

Objectives: This study aims to describe a cycle of development leading to sustainable methods for involving consumers in the management of a program commissioning health technology assessment.Methods: Staff time was dedicated to developing procedures for recruiting and briefing consumers to participate in prioritizing, commissioning, and reporting research. Resources and support were developed in light of early feedback from consumers and those working with them. These were piloted and amended before being used routinely.Results: Over 4 years, procedures and resources have been developed to support six consumers attending seven to eight prioritization meetings a year; thirty to forty-five consumers each year commenting on research need for particular topics; thirty consumers a year commenting on research proposals, and twenty a year commenting on research reports. The procedures include clear job descriptions, induction and development days, clear briefing materials, payment for substantial tasks, and regularly seeking feedback to improve procedures.Conclusions: Explicit, inclusive, and reproducible methods for supporting consumer involvement that satisfy National Health Service policy recommendations for involving consumers in research require dedicated staff time to support a cycle of organizational development.


Author(s):  
Maria Benkhalti ◽  
Manuel Espinoza ◽  
Richard Cookson ◽  
Vivian Welch ◽  
Peter Tugwell ◽  
...  

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.


Cephalalgia ◽  
2021 ◽  
pp. 033310242198924
Author(s):  
Hans Christoph Diener ◽  
Messoud Ashina ◽  
Isabelle Durand-Zaleski ◽  
Tobias Kurth ◽  
Michel Lantéri-Minet ◽  
...  

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.


2018 ◽  
Vol 34 (5) ◽  
pp. 434-441 ◽  
Author(s):  
Anthony J. Culyer

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.


2017 ◽  
Vol 33 (S1) ◽  
pp. 122-123
Author(s):  
Roza Yagudina ◽  
Andrey Kulikov ◽  
Dzhumber Ugrekhelidze

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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