PP120 Health Technology Assessment Framework To Capture The Full Value Of Value Added Medicines

2017 ◽  
Vol 33 (S1) ◽  
pp. 128-129
Author(s):  
Mondher Toumi ◽  
Cecile Remuzat ◽  
Adam Plich
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Repositioning ◽  
Value Added ◽  
Health Technology ◽  
Access To Medicines ◽  
Deliberative Process ◽  
Study Objective ◽  
Healthcare Needs ◽  
Patient Reported

INTRODUCTION:Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.METHODS:HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.RESULTS:VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.CONCLUSIONS:Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.

scholarly journals Assessing potential cures: are there distinctive elements of value beyond health gain?

2021 ◽  
Vol 10 (4) ◽  
pp. 255-265
Author(s):  
Saskia Hendriks ◽  
Steven D Pearson
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Gain ◽  
Health Technology ◽  
Opportunity Costs ◽  
Double Counting ◽  
Deliberative Process ◽  
Potential Opportunity

Assessing the ‘value’ of potential cures can be challenging, as some have suggested that cures may offer distinctive benefits from noncurative treatments. We explore what these – previously unspecified – additional benefits may be. We suggest that three new elements of value seem distinctive to cures: liberation from the identity of being diseased, liberation from the stigma associated with the disease and liberation from the burden of ongoing therapy. However, including additional elements of value in health technology assessment may result in double counting and requires consideration of potential opportunity costs. We suggest health technology assessment should explore the relevance of these three elements of value and may have good reasons to – judiciously – integrate them through the deliberative process.

OP171 Does Parallel Regulatory-Health Technology Assessment Reviews Affect Time To Health Technology Assessment Decisions?

2018 ◽  
Vol 34 (S1) ◽  
pp. 62-63
Author(s):  
Jesmine Cai ◽  
Tina Wang ◽  
Neil McAuslane ◽  
Lawrence Liberti
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Review Process ◽  
Health Technology ◽  
Access To Medicines ◽  
Regulatory Approval ◽  
Regulatory Submission ◽  
Therapeutic Value ◽  
Assessment Decisions ◽  
Health Canada

Introduction:Timely recommendation by Health Technology Assessment (HTA) agencies for drug reimbursement is critical to ensure patient access to medicines of therapeutic value. In this study, HTA performance was examined in terms of their outcome and timing by looking at how 103 drugs, which gained regulatory approval from 2013 to 2015, were assessed by HTA agencies from 2014 to 2016.Methods:Products must have received regulatory approval from one of the following regulatory agencies: EMA (Europe), Health Canada (Canada) and TGA (Australia). The first HTA recommendations were then collected from PBAC (Australia), CADTH (Canada), HAS (France), IQWiG (Germany), SMC (Scotland) and TLV (Sweden). The HTA decisions were classified as positive, positive with restrictions, negative and multiple.Results:Eighty-four drugs were approved in Europe before Australia and Canada. Of the studied HTA agencies, PBAC had the highest percentage of products recommended within a year from regulatory approval (93 percent). In addition, Australia had the shortest median time between first regulatory submission by any of the three agencies and HTA recommendation (553 days) as compared to Europe (616 days) and Canada (722 days). This can be attributed to the TGA/PBAC parallel process. However, Australia has the highest proportion of products receiving a negative PBAC recommendation (62 percent).Conclusions:The majority of drugs were first submitted for reimbursement in Europe, but the time from regulatory submission to HTA decision was the fastest in Australia. This can be attributed to the TGA/PBAC parallel review process, which showed its benefit in reducing the overall time. A parallel review process is also available in Canada; however, it is not utilized as frequently by companies as in Australia.

Patients' perspectives in health technology assessment: A route to robust evidence and fair deliberation

2010 ◽  
Vol 26 (3) ◽  
pp. 334-340 ◽  
Author(s):  
Karen Facey ◽  
Antoine Boivin ◽  
Javier Gracia ◽  
Helle Ploug Hansen ◽  
Alessandra Lo Scalzo ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Social Science Research ◽  
Science Research ◽  
Health Technology ◽  
Deliberative Process ◽  
Quantitative Evidence ◽  
Research Engagement ◽  
Robust Evidence

There is increasing emphasis on providing patient-focused health care and ensuring patient involvement in the design of health services. As health technology assessment (HTA) is meant to be a multidisciplinary, wide-ranging policy analysis that informs decision making, it would be expected that patients’ views should be incorporated into the assessment. However, HTA is still driven by collection of quantitative evidence to determine the clinical and cost effectiveness of a health technology. Patients’ perspectives about their illness and the technology are rarely included, perhaps because they are seen as anecdotal, biased views. There are two distinct but complementary ways in which HTAs can be strengthened by: (i) gathering robust evidence about the patients’ perspectives, and (ii) ensuring effective engagement of patients in the HTA process from scoping, through evidence gathering, assessment of value, development of recommendations and dissemination of findings. Robust evidence eliciting patients’ perspectives can be obtained through social science research that is well conducted, critically appraised and carefully reported, either through meta-synthesis of existing studies or new primary research. Engagement with patients can occur at several levels and we propose that HTA should seek to support effective patient participation to create a fair deliberative process. This should allow two-way flow of information, so that the views of patients are obtained in a supportive way and fed into decision-making processes in a transparent manner.

scholarly journals Principles for deliberative processes in health technology assessment

2020 ◽  
Vol 36 (4) ◽  
pp. 445-452 ◽  
Author(s):  
Kenneth Bond ◽  
Rebecca Stiffell ◽  
Daniel A. Ollendorf
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Group Discussion ◽  
Health Technology ◽  
Deliberative Process ◽  
Middle Income ◽  
Context Sensitive ◽  
Middle Income Countries ◽  
Deliberative Processes ◽  
Large Group Discussion

Deliberative processes are a well-established part of health technology assessment (HTA) programs in a number of high- and middle-income countries, and serve to combine complex sets of evidence, perspectives, and values to support open, transparent, and accountable decision making. Nevertheless, there is little documentation and research to inform the development of effective and efficient deliberative processes, and to evaluate their quality. This article summarizes the 2020 HTAi Global Policy Forum (GPF) discussion on deliberative processes in HTA.Through a combination of small and large group discussion and successive rounds of polling, the GPF members reached strong agreement on three core principles for deliberative processes in HTA: transparency, inclusivity, and impartiality. In addition, discussions revealed other important principles, such as respect, reviewability, consistency, and reasonableness, that may supplement the core set. A number of associated supporting actions for each of the principles are also described in order to make each principle realizable in a given HTA setting. The relative importance of the principles and actions are context-sensitive and must be considered in light of the political, legislative, and operational factors that may influence the functioning of any particular HTA environment within which the deliberative process is situated. The paper ends with suggested concrete next steps that HTA agencies, researchers, and stakeholders might take to move the field forward. The proposed principles and actions, and the next steps, provide a springboard for further research and better documentation of important aspects of deliberation that have historically been infrequently studied.

scholarly journals Why do health technology assessment drug reimbursement recommendations differ between countries? A parallel convergent mixed methods study

2019 ◽  
Vol 15 (3) ◽  
pp. 386-402 ◽  
Author(s):  
Elena Nicod ◽  
Laia Maynou ◽  
Erica Visintin ◽  
John Cairns
Keyword(s):  
Mixed Methods ◽  
Health Technology Assessment ◽  
Conceptual Framework ◽  
Technology Assessment ◽  
Health Technology ◽  
Deliberative Process ◽  
Drug Reimbursement ◽  
Quantitative And Qualitative Research ◽  
Research Designs ◽  
Stakeholder Input

AbstractUsing quantitative and qualitative research designs, respectively, two studies investigated why countries make different health technology assessment (HTA) drug reimbursement recommendations. Building on these, the objective of this study was to (a) develop a conceptual framework integrating the factors explaining these decisions, (b) explore their relationship and (c) assess if they are congruent, complementary or discrepant. A parallel convergent mixed methods design was used. Countries included in both previous studies were selected (England, Sweden, Scotland and France). A conceptual framework that integrated and organised the factors explaining the decisions from the two studies was developed. Relationships between factors were explored and illustrated through case studies. The framework distinguishes macro-level factors from micro-level ones. Only two of the factors common to both studies were congruent, while two others reached discrepant conclusions (stakeholder input and external review of the evidence processes). The remaining factors identified within one or both studies were complementary. Bringing together these findings contributed to generating a more complete picture of why countries make different HTA recommendations. Results were mostly complementary, explaining and enhancing each other. We conclude that differences often result from a combination of factors, with an important component relating to what occurs during the deliberative process.

scholarly journals PMU108 ASSESSING THE IMPACT OF PATIENT-REPORTED OUTCOMES IN HEALTH-TECHNOLOGY ASSESSMENT

2020 ◽  
Vol 23 ◽  
pp. S253
Author(s):  
Y.D. Hong ◽  
M. Hennig ◽  
Q. Shen ◽  
R. Alfonso ◽  
H. Kitchen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Reported Outcomes ◽  
Health Technology ◽  
Patient Reported ◽  
The Impact

Priority setting for health technology assessment at CADTH

2010 ◽  
Vol 26 (3) ◽  
pp. 341-347 ◽  
Author(s):  
Don Husereau ◽  
Michel Boucher ◽  
Hussein Noorani
Keyword(s):  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Contextual Information ◽  
Committee Member ◽  
Research Priorities ◽  
Health Technology ◽  
Deliberative Process ◽  
Comparison Approach ◽  
Available Information

Objectives: The aim of this study was to describe a current practical approach of priority setting of health technology assessment (HTA) research that involves multi-criteria decision analysis and a deliberative process.Methods: Criteria related to HTA prioritization were identified and grouped through a systematic review and consultation with a selection committee. Criteria were scored through a pair-wise comparison approach. Criteria were pruned based on the average weights obtained from consistent (consistency index < 0.2) responders and consensus. HTA proposals are ranked based on available information and a weighted criteria score. The rank, along with additional contextual information and discussion among committee members, is used to achieve consensus on HTA research priorities.Results: Six of eleven criteria represented > 75 percent of the weight behind committee member decisions to conduct an HTA. These criteria were disease burden, clinical impact, alternatives, budget impact, economic impact, and available evidence. Since May 2006, committees have considered 102 proposals at sixteen biannual in-person advisory committee meetings. These have selected twenty-nine research priorities for the HTA program.Conclusions: The approach works well and was easy to implement. Feedback from committee members has been positive. This approach may assist HTA and other research agencies in better priority setting by informing the selection of the most important and policy-relevant topics in the presence of a wide variety of research proposals. This may in turn lead to efficiently allocating resources available for HTA research.

VP09 Arthroplasty Registers As A Tool For Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 150-151
Author(s):  
Laia Domingo ◽  
Olga Martínez ◽  
Jorge Arias ◽  
Joan Nardi ◽  
Lluís Puig ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Revision Rate ◽  
Health Technology ◽  
Decision Makers ◽  
Joint Analysis ◽  
List Type ◽  
Implant Survival ◽  
Joint Replacement Surgery ◽  
Patient Reported

INTRODUCTION:Our purpose is to present the potential for health technology assessment that arthroplasty registers may offer.METHODS:A revision of the health assessment uses and information collected by arthroplasty registers was made. The information provided from international networks like NORE, ISAR and ICOR was also considered. Arthroplasty registers collect data of patients undergoing joint replacement surgery (mainly hip and knee) along with implant information. They provide longitudinal information useful to assess implant survival (expressed as revision rate and calculated from the primary surgery to implant revision). They also data from the surgical procedure and, more recently, a number of registries incorporate patient reported outcomes (PROMs) information.RESULTS:Arthroplasty registers provide information from multiple perspectives: (i)Decision-makers and healthcare providers/authorities: the comparison of revision rates by using funnel plots is a useful methodology to benchmark implants and to identify outliers, or models with significantly different revision rate in comparison to their peers. Besides, data available in registers has proven to be useful to define sets of indicators related to safety, effectiveness, efficiency, patient-centered healthcare and perceived health outcomes.(ii)Surgeons: Some ongoing initiatives, like ODEP, aiming at providing a benchmark rating for implant survivorship, are gaining interest by professionals promoting an evidence-based clinical practice.(iii)Industry: the large amount of data recorded so far may allow obtaining robust information of prosthesis behavior.(iv)Patients: there is an increasing number of registers that incorporate PROMs. Moreover, a growing interest to promote patient engagement in arthroplasty decision making has been observed.CONCLUSIONS:Long-standing arthroplasty registries have untapped potential. Beyond the assessment of implant survival, they have been consolidated as a useful tool for decision-makers, professionals, and patients. Next steps will be to promote joint analysis of national/regional registries to explore uncommon practices or new medical devices, and also to adapt to future regulations on implant traceability.

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

2021 ◽  
Vol 7 (3) ◽  
pp. 21-30
Author(s):  
O. M. Filiniuk ◽  
K. L. Kosyachenko ◽  
N. O. Datsiuk ◽  
V. V. Skrylov
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Scientific Information ◽  
Cost Optimization ◽  
Health Technology ◽  
State Budget ◽  
Access To Treatment ◽  
Health Technologies ◽  
Healthcare Needs ◽  
Need To Evaluate

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.

scholarly journals Blockchains, Property Rights and Health Technology Assessment in the Pharmaceutical and Device(s) Industries

2018 ◽  
Vol 9 (4) ◽  
pp. 1
Author(s):  
Paul Langley ◽  
Robert E Martin
Keyword(s):  
Property Rights ◽  
Health Technology Assessment ◽  
Health Information ◽  
Technology Assessment ◽  
Health Management ◽  
Value Added ◽  
Health Technology ◽  
Health Data ◽  
Blockchain Technology

Ongoing concerns with the security of health information, both from the perspective of the individual patient as well as health systems has led to increased attention being given to the potential role of blockchain technology in the secure storage of health information through encryption, the integration of diverse health record systems and the vesting of property and access rights to health data in the patient. While the security offered by blockchain technology has long been recognized in the finance sector with the emergence of a range of cryptocurrencies as a medium of exchange and store of value, demonstrating the value of blockchain technology in health management and health technology assessment has yet to be achieved. In this commentary, a number of questions are raised as to the potential value offered by blockchain technology as a complement to existing electronic medical record systems. Chief among these are: (i) the allocation of property rights as a necessary precondition for blockchain uptake; (ii) access and incentives for active as opposed to passive blockchain membership; (iii) monetization of blockchain access; (iv) capturing data from within the blockchain and the possibility of value added data; (v) the potential for blockchain platforms in formulary evaluations; (vi) the blockchain as a managed market for health data; and (vii) the role of intermediation in blockchain management.   Article Type: Commentary

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