OP277 Rapid Development Of An Evaluation Framework: Capturing The Impact Of COVID-19 Activities By A Health Technology Assessment Body

2021 ◽  
Vol 37 (S1) ◽  
pp. 10-10
Author(s):  
Lauren Elston ◽  
Sophie Hughes ◽  
Susan Myles
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Social Care ◽  
Health Technology ◽  
Evaluation Framework ◽  
Data Capture ◽  
Care Providers ◽  
Health And Social Care ◽  
Informal Feedback ◽  
The Impact

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.

scholarly journals SUITABILITY OF CURRENT EVALUATION FRAMEWORKS FOR USE IN THE HEALTH TECHNOLOGY ASSESSMENT OF MOBILE MEDICAL APPLICATIONS: A SYSTEMATIC REVIEW

2018 ◽  
Vol 34 (5) ◽  
pp. 464-475 ◽  
Author(s):  
Magdalena Ruth Moshi ◽  
Rebecca Tooher ◽  
Tracy Merlin
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Data Privacy ◽  
Ethical Issues ◽  
Health Technology ◽  
Evaluation Framework ◽  
Bibliographic Databases ◽  
Medical Applications ◽  
Inaccurate Information ◽  
The Impact

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.

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

2021 ◽  
Vol 37 (S1) ◽  
pp. 9-10
Author(s):  
Margherita Neri ◽  
Simon Brassel ◽  
Lotte Steuten
Keyword(s):  
Antimicrobial Resistance ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Healthcare Systems ◽  
Evaluation Framework ◽  
Added Value ◽  
Nice Guidelines ◽  
The Impact ◽  
Selection Of

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.

scholarly journals Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Surrogate Endpoint ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
Patient Centered ◽  
Statistical Validation ◽  
Level Of Evidence ◽  
The Impact

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.

CAPACITY BUILDING IN AGENCIES FOR EFFICIENT AND EFFECTIVE HEALTH TECHNOLOGY ASSESSMENT

2016 ◽  
Vol 32 (4) ◽  
pp. 292-299 ◽  
Author(s):  
Debjani Mueller ◽  
Iñaki Gutiérrez-Ibarluzea ◽  
Tara Schuller ◽  
Marco Chiumente ◽  
Jeonghoon Ahn ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Capacity Building ◽  
Technology Assessment ◽  
Health Technology ◽  
Group Discussions ◽  
Middle Income ◽  
Working Together ◽  
Effective Decision ◽  
Effective Decision Making ◽  
The Impact

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.

Health Technology Assessment for Radiologists: Basic Principles and Evaluation Framework

2009 ◽  
Vol 6 (5) ◽  
pp. 299-306 ◽  
Author(s):  
Morgan E. Lim ◽  
Daria O'Reilly ◽  
Jean-Eric Tarride ◽  
Natasha Burke ◽  
Ilia L. Ferrusi ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Evaluation Framework ◽  
Basic Principles

scholarly journals History of health technology assessment in Belgium

2009 ◽  
Vol 25 (S1) ◽  
pp. 82-87 ◽  
Author(s):  
Irina Cleemput ◽  
Philippe Van Wilder
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Good Clinical Practice ◽  
Health Technology ◽  
Services Research ◽  
Drug Reimbursement ◽  
History Of ◽  
The Impact ◽  
Further Development

Objectives: This paper gives an overview of health technology assessment (HTA) in Belgium.Methods: The information included in the overview is based on legal documents and publicly available year reports of the Belgian Health Care Knowledge Centre (KCE).Results: Belgium has a relatively young history in HTA. The principle of evidence-based medicine (EBM) was introduced in the drug reimbursement procedure in 2001, with the establishment of the Drug Reimbursement Committee (DRC). The DRC assesses the efficacy, safety, convenience, applicability, and effectiveness of a drug relative to existing treatment alternatives. For some drugs, relative cost-effectiveness is also evaluated. The activities of the DRC can, therefore, be considered to be the first official HTA activities in Belgium. Later, in 2003, KCE was established. Its mission was to perform policy preparing research in the healthcare and health insurance sector and to give advice to policy makers about how they can obtain an efficient allocation of limited healthcare resources that optimizes the quality and accessibility of health care. This broad mission has been operationalized by activities in three domains of research: HTA, health services research, and good clinical practice. KCE is independent from the policy maker. Its HTAs contain policy recommendations that may inform policy decisions but are not binding.Conclusions: Although the Belgian history of HTA is relatively short, its foundations are strong and the impact of HTA increasing. Nevertheless KCE has many challenges for the future, including continued quality assurance, further development of international collaboration, and further development of methodological guidance for HTA.

TeCHO+ program in Gujarat: a protocol for health technology assessment

2020 ◽  
Vol 6 (4) ◽  
pp. 209-214
Author(s):  
Somen Saha ◽  
Priya Kotwani ◽  
Apurvakumar Pandya ◽  
Deepak Saxena ◽  
Tapasvi Puwar ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Community Health ◽  
Technology Assessment ◽  
Tracking System ◽  
Newborn Care ◽  
Health Technology ◽  
The State ◽  
Family Welfare ◽  
The Impact

The Health and Family Welfare Department, Government of Gujarat, is implementing a program named Technology for Community Health Operation or TeCHO+ addressing state’s priority health issues. This program envisages replacing the existing mother and child tracking system or e-Mamta application in the state. This program is based on ImTeCHO—Innovative Mobile Technology for Community Health Operations—which was piloted in Jhagadia, Bharuch district of Gujarat in 2013. The program showed improvements not only in terms of coverage of maternal and newborn care packages averting malnutrition but also was cost-effective. This paper details the protocol for health technology assessment to assess the impact of TeCHO+ program on data quality, improvement in service delivery coverage, reduction in morbidity and mortality as well as assess the cost-effectiveness. The study will be conducted in five districts of the state. A mixed-method approach will be adopted. Data will be validated in a phased manner over a period of 3 years along with an assessment of key outcome indicators. Additionally, key informant interviews will be conducted and cost data will be gathered to perform cost-effectiveness analysis. The study will inform policymakers about the impact of TeCHO+ program on quality, access and cost-effectiveness of healthcare services.

VP08 Real-World Data Use In Health Technology Assessments: A Comparison Of Five Health Technology Assessment Agencies

2017 ◽  
Vol 33 (S1) ◽  
pp. 149-150
Author(s):  
Amr Makady ◽  
Ard van Veelen ◽  
Anthonius de Boer ◽  
Hans Hillege ◽  
Olaf Klunger ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Relative Effectiveness ◽  
Internal Validity ◽  
Health Technology ◽  
Real World Data ◽  
World Data ◽  
The Impact

INTRODUCTION:Reimbursement decisions are usually based on evidence from randomized controlled trials (RCT) with high internal validity but lower external validity. Real-World Data (RWD) may provide complimentary evidence for relative effectiveness assessments (REA's) and cost-effectiveness assessments (CEA's) of treatments. This study explores to which extent RWD is incorporated in REA's and CEA's of drugs used to treat metastatic melanoma (MM) by five Health Technology Assessment (HTA) agencies.METHODS:Dossiers for MM drugs published between 1 January 2011 and 31 December 2016 were retrieved for HTA agencies in five countries: the United Kingdom (NICE), Scotland (SMC), France (HAS), Germany (IQWiG) and the Netherlands (ZIN). A standardized data-extraction form was used to extract data on RWD mentioned in the assessment and its impact on appraisal (for example, positive, negative, neutral or unknown) for both REA and CEA.RESULTS:In total, fourty-nine dossiers were retrieved: NICE = 10, SMC = 13, IQWiG = 16, HAS = 8 and ZIN = 2. Nine dossiers (18.4 percent) included RWD in REA's for several parameters: to describe effectiveness (n = 5) and/or the safety (n = 2) of the drug, and/or the prevalence of MM (n = 4). CEA's were included in 25/49 dossiers (IQWiG and HAS did not perform CEA's). Of the twenty-five CEA's, twenty (80 percent) included RWD to extrapolate long-term effectiveness (n = 19), and/or identify costs associated with treatments (n = 7). When RWD was included in REA's (n = 9), its impact on the appraisal was negative (n = 4), neutral (n = 2), unknown (n = 1) or was not discussed in the appraisal (n = 2). When RWD was included in CEA's (n = 11), its impact on the appraisal varied between positive (n = 2), negative (n = 5) and unknown (n = 4).CONCLUSIONS:Generally, RWD is more often included in CEA's than REA's (80 percent versus 18.4 percent, respectively). When included, RWD was mostly used to describe the effectiveness of the drug (REA) or to predict long-term effectiveness (CEA). The impact of RWD on the appraisal varied greatly within both REA's and CEA's.

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.

OP157 Quo Vadis Romanian Health Technology Assessment?

2018 ◽  
Vol 34 (S1) ◽  
pp. 57-57
Author(s):  
Adrian Pana ◽  
Ioana Cristina Cosa
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Impact Analysis ◽  
Negative Impact ◽  
Health Technology ◽  
Evaluation Framework ◽  
New Drugs ◽  
Ministry Of Health ◽  
Healthcare Budget ◽  
Health Technologies

Introduction:The Romanian healthcare system has been struggling to use a more transparent approach in evaluating health care technologies for more than 10 years. No systemic and satisfactory approach to evaluate health technologies was implemented until the present. The objective of the presentation is to describe the characteristics of the HTA system used by the Romanian healthcare authority as well as the consequences of the drug assessments by using the actual Romanian health technology assessment (HTA) evaluation framework, from the initiation in May 2014 to the end of year 2017.Methods:The drug reimbursement context and the healthcare legislation regarding HTA evaluation were studied. A critical appraisal of the scorecard was conducted, taking into consideration general principles of the health technology assessment. A descriptive analysis covering the assessment drug reports issued by the National Agency for Drug and Medical Devices (NADMD) issued between May 2014 and December 2017 was presented, together with the decision made by the Ministry of Health and the Romanian government.Results:During the analyzed period of time, more than 10 updates of the reimbursement list were implemented by the Ministry of Health. By November 2017, more than 180 drugs (new INN, new indications or fix dose combinations) were included in the reimbursement system with conditional or unconditional reimbursement; more than 230 reports were assessed by the NADMD. While the new drugs reimbursed between May 2014 and November 2017, in the most part demonstrated cost savings, a lot of new innovative drugs proposed to be evaluated were rejected since the drugs had no comparators on the Romanian market and their costs were considered to have a negative impact on the healthcare budget.Conclusions:The rapid HTA assessment has many strengths, by using a proper scorecard. Limitations and weakness of the actual scorecard were identified, mainly regarding the lack of a basic budget impact analysis which must include at least the direct healthcare cost, as well as the imported results of different healthcare environments that are not matching the Romanian context. Opportunities to implement a more rapid and accurate HTA evaluation are identified since the scorecard could be updated in order to address the HTA general principles.

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