OP256 Recognising The Broader Value Of Vaccines In Health Technology Assessment: Worth A Shot?

Author(s):  
Margherita Neri ◽  
Simon Brassel ◽  
Lotte Steuten

IntroductionThe COVID-19 pandemic shows that the impact of effective vaccines extends well beyond vaccinated individuals and healthcare systems. Yet, these externalities are not typically considered in health technology assessments (HTA) which may underestimate vaccines’ broader value. We explored to what extent future vaccines relevant to England might exhibit such broader value.MethodsWe compared the ten value elements of an existing vaccine evaluation framework to the value elements considered in England according to the Joint Committee on Vaccine and Immunisation (JCVI) and the National Institute for Health and Care Excellence's (NICE) guidelines. Using literature and expert opinion we then explored, for a selection of ten vaccines with an expected UK-launch within five years, on which value elements each vaccine might potentially show added value.ResultsUp to five of ten value elements are unlikely to be considered by JCVI or NICE, including patient and carer productivity, enablement value, impact on antimicrobial resistance and transmission value. Of vaccines studied, 100 percent will potentially generate value on at least one broader value element that is currently ignored; 60 percent to 80 percent may increase vaccinee/patient or carer productivity respectively.ConclusionsThere is a substantial gap between value generation and value recognition of vaccines in HTA in England. This might lead to undervaluation and underutilization of vaccines, leaving societies more vulnerable than needed when faced with infectious diseases.

2016 ◽  
Vol 20 (76) ◽  
pp. 1-254 ◽  
Author(s):  
James Raftery ◽  
Steve Hanney ◽  
Trish Greenhalgh ◽  
Matthew Glover ◽  
Amanda Blatch-Jones

BackgroundThis report reviews approaches and tools for measuring the impact of research programmes, building on, and extending, a 2007 review.Objectives(1) To identify the range of theoretical models and empirical approaches for measuring the impact of health research programmes; (2) to develop a taxonomy of models and approaches; (3) to summarise the evidence on the application and use of these models; and (4) to evaluate the different options for the Health Technology Assessment (HTA) programme.Data sourcesWe searched databases including Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library from January 2005 to August 2014.Review methodsThis narrative systematic literature review comprised an update, extension and analysis/discussion. We systematically searched eight databases, supplemented by personal knowledge, in August 2014 through to March 2015.ResultsThe literature on impact assessment has much expanded. The Payback Framework, with adaptations, remains the most widely used approach. It draws on different philosophical traditions, enhancing an underlying logic model with an interpretative case study element and attention to context. Besides the logic model, other ideal type approaches included constructionist, realist, critical and performative. Most models in practice drew pragmatically on elements of several ideal types. Monetisation of impact, an increasingly popular approach, shows a high return from research but relies heavily on assumptions about the extent to which health gains depend on research. Despite usually requiring systematic reviews before funding trials, the HTA programme does not routinely examine the impact of those trials on subsequent systematic reviews. The York/Patient-Centered Outcomes Research Institute and the Grading of Recommendations Assessment, Development and Evaluation toolkits provide ways of assessing such impact, but need to be evaluated. The literature, as reviewed here, provides very few instances of a randomised trial playing a major role in stopping the use of a new technology. The few trials funded by the HTA programme that may have played such a role were outliers.DiscussionThe findings of this review support the continued use of the Payback Framework by the HTA programme. Changes in the structure of the NHS, the development of NHS England and changes in the National Institute for Health and Care Excellence’s remit pose new challenges for identifying and meeting current and future research needs. Future assessments of the impact of the HTA programme will have to take account of wider changes, especially as the Research Excellence Framework (REF), which assesses the quality of universities’ research, seems likely to continue to rely on case studies to measure impact. The HTA programme should consider how the format and selection of case studies might be improved to aid more systematic assessment. The selection of case studies, such as in the REF, but also more generally, tends to be biased towards high-impact rather than low-impact stories. Experience for other industries indicate that much can be learnt from the latter. The adoption of researchfish®(researchfish Ltd, Cambridge, UK) by most major UK research funders has implications for future assessments of impact. Although the routine capture of indexed research publications has merit, the degree to which researchfish will succeed in collecting other, non-indexed outputs and activities remains to be established.LimitationsThere were limitations in how far we could address challenges that faced us as we extended the focus beyond that of the 2007 review, and well beyond a narrow focus just on the HTA programme.ConclusionsResearch funders can benefit from continuing to monitor and evaluate the impacts of the studies they fund. They should also review the contribution of case studies and expand work on linking trials to meta-analyses and to guidelines.FundingThe National Institute for Health Research HTA programme.


2018 ◽  
Vol 34 (5) ◽  
pp. 464-475 ◽  
Author(s):  
Magdalena Ruth Moshi ◽  
Rebecca Tooher ◽  
Tracy Merlin

Objectives:To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies.Methods:Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework.Results:A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed.Conclusion:None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics. Implications: Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers.


2020 ◽  
Vol 11 ◽  
Author(s):  
Ting Wang ◽  
Neil McAuslane ◽  
Lawrence Liberti ◽  
Helga Gardarsdottir ◽  
Wim Goettsch ◽  
...  

Background: Health technology assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Thus, pharmaceutical companies need to address the HTA requirements early during development to improve reimbursement outcomes. Currently, there is a lack of research to assess the impact of HTA on development and jurisdictional outcome from companies’ perspectives. This study aimed to assess companies’ HTA strategy and characterise HTA practice in seven jurisdictions.Methods: A multi-year, annual study collected information for individual products, focusing on development activities regarding inclusion of HTA requirements and selection of global comparators. The generation of local contextual information, submission strategies and predictability of HTA outcomes was examined jurisdictionally in Australia, Canada, England, France, Germany, Italy and Spain. The study questionnaire was built into a secure online data collection platform and data were provided annually by participating companies.Results: Data for 169 compounds were provided by nine international companies between 2014 and 2018. HTA requirements were implemented in evidence generation plan for 63% of products during development. Global comparators were accepted by HTA bodies for more than half of studied products; Spain showed the highest acceptance rate (85%). Companies took advantages of parallel process in Australia and Canada to shorten product rollout time. Australia demonstrated general consistency in HTA review time, and England had the longest variation (interquartile range, 216 days). Requirements for additional information after submission occurred at all HTA bodies. Germany and Italy showed the highest percentage of products being reimbursed as per regulatory label (80 and 68%, respectively). Canada was the most predictable jurisdiction, with the highest proportion of review outcome (90%) that met companies’ expectations.Conclusion: Companies are addressing HTA requirements during development for many products; however, they are challenged by varying requirements and practices and product success ultimately depends on how HTA organisations and payers assess added value in the context of the national healthcare systems. This ongoing study created a baseline to help capture fact-based changes for company HTA strategies and HTA body practices.


2014 ◽  
Vol 30 (5) ◽  
pp. 544-551 ◽  
Author(s):  
Eleanor Woodford Guegan ◽  
Andrew Cook

Objectives: Evaluation is essential for the management of international projects or networks in health technology assessment (HTA). It extends beyond the normal process of project management by incorporating qualitative dimensions and provides information about a project's effectiveness and achievements. This article aimed to identify the factors that are important for the success of international HTA projects. The European network for Health Technology Assessment Joint Action (EUnetHTA JA) is presented as an exemplar.Methods: Methods for the evaluation of international HTA projects include interviews, focus groups, questionnaires, observations and documentary review, and the key points of these approaches have been summarized. The impact and effectiveness of the EUnetHTA JA was evaluated by questionnaires of project participants and external stakeholders, and by documentary review.Results: The response rate for the three annual questionnaires sent to project participants ranged from 86 percent to 88 percent and for external stakeholders ranged from 65 percent to 88 percent. Key factors for project success included production of deliverables according to the workplan, achievement of objectives, added value generated, effective communication, involvement of external stakeholders, workstream management and progress from the preceding EUnetHTA 2006–2008 project.Conclusions: The experience of this project can inform the evaluation of future international HTA collaborations, such as the EUnetHTA 2nd Joint Action and HTAsiaLink. A high response rate was achieved to the self-completion questionnaires and the strategy followed is recommended for evaluation of international HTA projects. Future assessments of international HTA projects should strive to measure outcomes and impact, not just outputs and process.


2021 ◽  
Vol 37 (S1) ◽  
pp. 10-10
Author(s):  
Lauren Elston ◽  
Sophie Hughes ◽  
Susan Myles

IntroductionHealth Technology Wales (HTW) is committed to evaluating the impact of our work. In March 2020, HTW directed efforts to support Welsh Government and health and social care providers in response to the COVID-19 pandemic. We adapted the HTW evaluation framework to specifically capture the impact of our additional COVID-19 work. Here we analyze data collected since the framework was implemented.MethodsBoth formal and informal feedback was analyzed. Formal feedback was obtained through the HTW Impact Questionnaire, which was developed to support more formalized data capture for all HTW workstreams and to facilitate feedback from all stakeholder groups. It was piloted with a targeted list of individuals and responses were received for COVID-19 work. Informal feedback included feedback received via email or through word of mouth.ResultsHTW COVID-19 products to date include Topic Exploration Reports, rapid evidence summaries and an Evidence Appraisal Report (EAR) on COVID-19 diagnostic tests (molecular and antibody tests). Stakeholders were positive about these outputs, describing them as valuable and informative. Reported impacts included informing policy and decision making, reducing duplication of efforts and helping to target development. The EAR received national and international focus, leading to HTW involvement in the European Network for Health Technology Assessment (EUnetHTA) COVID-19 reviews. Survey participants who gave feedback on COVID-19 activities included two members of Health Technology Assessment organizations, a health board representative and an industry representative; all agreed that HTW's COVID-19 work was useful, that the methods were reliable and robust and that HTW is responsive. All participants also felt that HTW's COVID-19 work had a positive impact in the wider health and social care context.ConclusionsHTW was able to respond rapidly to the COVID-19 pandemic and adapt current evaluation practices to capture the impact of COVID-19 work. We will continue to evaluate our COVID-19 activities. Future work will involve following up on the developing impact of our COVID-19 work and expanding our methods for data capture, for example conducting stakeholder interviews.


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.


2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  

Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation. Results Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports ( k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55). Conclusions Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.


Author(s):  
Hannah Sievers ◽  
Angelika Joos ◽  
Mickaël Hiligsmann

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.


2016 ◽  
Vol 32 (4) ◽  
pp. 292-299 ◽  
Author(s):  
Debjani Mueller ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
Tara Schuller ◽  
Marco Chiumente ◽  
Jeonghoon Ahn ◽  
...  

Objectives: Health technology assessment (HTA) yields information that can be ideally used to address deficiencies in health systems and to create a wider understanding of the impact of different policy considerations around technology reimbursement and use. The structure of HTA programs varies across different jurisdictions according to decision-maker needs. Moreover, conducting HTA requires specialized skills. Effective decision making should include multiple criteria (medical, economic, technical, ethical, social, legal, and cultural) and requires multi-disciplinary teams of experts working together to produce these assessments. A workshop explored the multi-disciplinary skills and competencies required to build an effective and efficient HTA team, with a focus on low- and middle-income settings.Methods: This proceeding summarizes main points from a workshop on capacity building, drawing on presentations and group discussions among attendees including different points of view.Results and Conclusions: The workshop and thus this study would have benefited from a larger variety of stakeholders. Therefore, the conclusions arising from the workshop are not the opinion of a representative sample of HTA professionals. Nonetheless, organizations and speakers were carefully selected to provide a valuable approach to this theme. Thus, these proceedings highlight some of the gaps and needs in the education and training programs offered worldwide and calls for further investigation.


2009 ◽  
Vol 6 (5) ◽  
pp. 299-306 ◽  
Author(s):  
Morgan E. Lim ◽  
Daria O'Reilly ◽  
Jean-Eric Tarride ◽  
Natasha Burke ◽  
Ilia L. Ferrusi ◽  
...  

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