Bridging the gap: Can International Consortium of Health Outcomes Measurement standard sets align outcomes accepted for regulatory and health technology assessment decision‐making of oncology medicines

Abstract Objective Although health technology assessment (HTA) and healthcare quality improvement are distinct processes, a greater level of alignment in outcome measures used may increase the quality and efficiency of data collection. This study evaluates the agreement in outcome measures used in oncology for healthcare quality improvement and HTAs, and how these align to the International Consortium for Health Outcomes Measurement (ICHOM) standard sets. Methods We conducted a cross-sectional comparative analysis of ICHOM sets focusing on oncological indications and publicly available measures for healthcare quality and HTA reports published by the National Health Care Institute from the Netherlands and the National Institute for Health and Care Excellence from the United Kingdom. Results All ICHOM sets and HTAs used overall survival, whereas quality improvement used different survival estimates. Different progression estimates for cancer were used in HTAs, ICHOM sets, and quality improvement. Data on health-related quality of life (HRQoL) was recommended in all ICHOM sets and all HTAs, but selectively for quality improvement. In HTAs, generic HRQoL questionnaires were preferred, whereas, in quality improvement and ICHOM sets, disease-specific questionnaires were recommended. Unfavorable outcomes were included in all HTAs and all ICHOM sets, but not always for quality improvement. Conclusions Although HTA and quality improvement use outcome measures from the same domains, a greater level of alignment seems possible. ICHOM may provide input on standardized outcome measures to support this alignment. However, residual discrepancies will remain due to the different objectives of HTA and quality improvement.

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Faculty Opinions recommendation of Bridging health technology assessment (HTA) and efficient health care decision making with multicriteria decision analysis (MCDA): applying the EVIDEM framework to medicines appraisal.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.716497858.791902865 ◽

2012 ◽

Author(s):

Janet Wale

Keyword(s):

Health Care ◽

Decision Making ◽

Decision Analysis ◽

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Multicriteria Decision Analysis ◽

Multicriteria Decision ◽

Health Care Decision ◽

Care Decision

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Faculty Opinions recommendation of Health technology assessment, value-based decision making, and innovation.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718106480.793483688 ◽

2013 ◽

Author(s):

Janet Wale

Keyword(s):

Decision Making ◽

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology

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Health technology assessment in sub-Saharan Africa: a descriptive analysis and narrative synthesis

Cost Effectiveness and Resource Allocation ◽

10.1186/s12962-021-00293-5 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Samantha Hollingworth ◽

Ama Pokuaa Fenny ◽

Su-Yeon Yu ◽

Francis Ruiz ◽

Kalipso Chalkidou

Keyword(s):

Decision Making ◽

Health Technology Assessment ◽

Technology Assessment ◽

Technical Assistance ◽

Health Technology ◽

Sub Saharan Africa ◽

Main Theme ◽

Narrative Synthesis ◽

Policy Makers ◽

Sub Saharan

Abstract Background Countries in Sub-Saharan Africa (SSA) are moving towards universal health coverage. The process of Health Technology Assessment (HTA) can support decisions relating to benefit package design and service coverage. HTA involves institutional cooperation with agreed methods and procedural standards. We systematically reviewed the literature on policies and capacity building to support HTA institutionalisation in SSA. Methods We systematically reviewed the literature by searching major databases (PubMed, Embase, etc.) until June 2019 using terms considering three aspects: HTA; health policy, decision making; and SSA. We quantitatively extracted and descriptively analysed content and conducted a narrative synthesis eliciting themes from the selected literature, which varied in study type and apporach. Results Half of the 49 papers identified were primary research studies and mostly qualitative. Five countries were represented in six of ten studies; South Africa, Ghana, Uganda, Cameroon, and Ethiopia. Half of first authors were from SSA. Most informants were policy makers. Five themes emerged: (1) use of HTA; (2) decision-making in HTA; (3) values and criteria for setting priority areas in HTA; (4) involving stakeholders in HTA; and (5) specific examples of progress in HTA in SSA. The first one was the main theme where there was little use of evidence and research in making policy. The awareness of HTA and economic evaluation was low, with inadequate expertise and a lack of local data and tools. Conclusions Despite growing interest in HTA in SSA countries, awareness remains low and HTA-related activities are uncoordinated and often disconnected from policy. Further training and skills development are needed, firmly linked to a strategy focusing on strengthening within-country partnerships, particularly among researchers and policy makers. The international community has an important role here by supporting policy- relevant technical assistance, highlighting that sustainable financing demands evidence-based processes for effective resource allocation, and catalysing knowledge-sharing opportunities among countries facing similar challenges.

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Determinants of Managed Entry Agreements in the context of Health Technology Assessment: a comparative analysis of oncology therapies in four countries

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321000039 ◽

2021 ◽

Vol 37 ◽

Author(s):

Olina Efthymiadou ◽

Panos Kanavos

Keyword(s):

Decision Making ◽

Health Technology Assessment ◽

Technology Assessment ◽

Best Practice ◽

Health Technology ◽

Future Research ◽

Best Practice Guidelines ◽

Chi Squared ◽

Decision Making Factors ◽

Managed Entry Agreements

Abstract Background Managed Entry Agreements (MEAs) are increasingly used to address uncertainties arising in the Health Technology Assessment (HTA) process due to immature evidence of new, high-cost medicines on their real-world performance and cost-effectiveness. The literature remains inconclusive on the HTA decision-making factors that influence the utilization of MEAs. We aimed to assess if the uptake of MEAs differs between countries and if so, to understand which HTA decision-making criteria play a role in determining such differences. Methods All oncology medicines approved since 2009 in Australia, England, Scotland, and Sweden were studied. Four categories of variables were collected from publicly available HTA reports of the above drugs: (i) Social Value Judgments (SVJs), (ii) Clinical/Economic evidence submitted, (iii) Interpretation of this evidence, and (iv) Funding decision. Conditional/restricted decisions were coded as Listed With Conditions (LWC) other than an MEA or LWC including an MEA (LWCMEA). Cohen's κ-scores measured the inter-rater agreement of countries on their LWCMEA outcomes and Pearson's chi-squared tests explored the association between HTA variables and LWCMEA outcomes. Results A total of 74 drug-indication pairs were found resulting in n = 296 observations; 8 percent (n = 23) were LWC and 55 percent (n = 163) were LWCMEA. A poor-to-moderate agreement existed between countries (−.29 < κ < .33) on LWCMEA decisions. Cross-country differences within the LWCMEA sample were partly driven by economic uncertainties and largely driven by SVJs considered across agencies. Conclusions A set of HTA-related variables driving the uptake of MEAs across countries was identified. These findings can be useful in future research aimed at informing country-specific, “best-practice” guidelines for successful MEA implementation.

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PP58 The Alliance Between Health Technology Assessment And Public Health In National Screening Policies

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462319002113 ◽

2019 ◽

Vol 35 (S1) ◽

pp. 48-48

Author(s):

Leonor Varela-Lema ◽

Janet Puñal-Riobóo ◽

Paula Cantero-Muñoz ◽

Maria José Faraldo-Vallés

Keyword(s):

Public Health ◽

Decision Making ◽

Newborn Screening ◽

Health Technology Assessment ◽

Technology Assessment ◽

National Health System ◽

Health Technology ◽

Screening Tests ◽

Special Focus ◽

Screening Programs

IntroductionDecision making regarding national population-based prenatal and newborn screening policies is recognized to be highly challenging. This paper aims to describe the formalized collaboration that has been established between the Spanish National Public Health Screening Advisory Committee (PHSAC) and the Spanish Network of Health Technology Assessment (HTA) agencies to support the development of evidence- and consensus-based recommendations to support this process.MethodsIn-depth description and analysis of the strategic and methodological processes that have been implemented within the Spanish National Health System prenatal and newborn screening frameworks, with special emphasis on the role, actions, and responsibilities of HTA agencies.ResultsThe role of HTA agencies is threefold: (i) support the PHSAC by providing evidence on safety, effectiveness and cost/effectiveness of the screening tests/strategies, as well as contextualized information regarding costs, organizational, social, legal and ethical issues; (ii) collaborate with the PHSAC in the development of formal evidence- and consensus-based recommendations for defining population screening programs, when required; (iii) analyze real-world data that is generated by piloted programs. This paper will provide real-life examples of how these processes were implemented in practice, with a special focus on the development of the non-invasive prenatal testing (NIPT) policy. Recommendations for NIPT were developed by a multidisciplinary group based on the European network for Health Technology Assessment (EUnetHTA) rapid assessment report and the predictive models that were built using national statistics and other contextualized data.ConclusionsThe current work represents an innovative approach for prenatal and newborn screening policymaking, which are commonly difficult to evaluate due to the low quality of evidence and the confounding public health issues. The paper raises awareness regarding the importance of joint collaborations in areas where evidence is commonly insufficient for decision making.

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HEALTH TECHNOLOGY ASSESSMENT AND PERSONALIZED MEDICINE: ARE ECONOMIC EVALUATION GUIDELINES SUFFICIENT TO SUPPORT DECISION MAKING?

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462314000142 ◽

2014 ◽

Vol 30 (2) ◽

pp. 179-187 ◽

Cited By ~ 16

Author(s):

Don Husereau ◽

Deborah A. Marshall ◽

Adrian R. Levy ◽

Stuart Peacock ◽

Jeffrey S. Hoch

Keyword(s):

Decision Making ◽

Economic Evaluation ◽

Personalized Medicine ◽

Health Technology Assessment ◽

Technology Assessment ◽

Health Technology ◽

Population Based ◽

New Paradigm ◽

Current Guidance ◽

Support Decision Making

Background: Many jurisdictions delivering health care, including Canada, have developed guidance for conducting economic evaluation, often in the service of larger health technology assessment (HTA) and reimbursement processes. Like any health intervention, personalized medical (PM) interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. However, current approaches to economic evaluation to support decision making have been largely developed from population-based approaches to therapy—that is, evaluating the costs and consequences of single interventions across single populations. This raises the issue as to whether these methods, as they are or more refined, are adequate to address more targeted approaches to therapy, or whether a new paradigm for assessing value in PM is required.Objectives: We describe specific issues relevant to the economic evaluation of diagnostics-based PM and assess whether current guidance for economic evaluation is sufficient to support decision making for PM interventions.Methods: Issues were identified through literature review and informal interviews with national and international experts (n = 10) in these analyses. This article elaborates on findings and discussion at a workshop held in Ottawa, Canada, in January 2012.Results: Specific issues related to better guiding economic evaluation of personalized medicine interventions include: how study questions are developed, populations are characterized, comparators are defined, effectiveness is evaluated, outcomes are valued and how resources are measured. Diagnostics-based PM also highlights the need for analyses outside of economic evaluation to support decision making.Conclusions: The consensus of this group of experts is that the economic evaluation of diagnostics-based PM may not require a new paradigm. However, greater complexity means that existing approaches and tools may require improvement to undertake these more analyses.

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INTRODUCTION: HEALTH TECHNOLOGY ASSESSMENT AND THE EUROPEAN UNION

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462300101011 ◽

2000 ◽

Vol 16 (2) ◽

pp. 299-302 ◽

Cited By ~ 28

Author(s):

David Banta ◽

Wija Oortwijn

Keyword(s):

Public Health ◽

Decision Making ◽

European Union ◽

Health Technology Assessment ◽

European Commission ◽

Technology Assessment ◽

Health Technology ◽

The European Union ◽

European Level

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.

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OP69 Hospital-based Health Technology Assessment Is Applicable To Investment Decision-Making Process

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317001507 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 30-31

Author(s):

Tuija Ikonen ◽

Heli Lähteenmäki

Keyword(s):

Decision Making ◽

Health Technology Assessment ◽

Technology Assessment ◽

Ad Hoc ◽

Investment Decision ◽

Tertiary Care ◽

Health Technology ◽

University Hospital ◽

Investment Planning ◽

Budget Planning

INTRODUCTION:Hospital mangers need information for decision making (1). Hospital-based health technology assessment (HTA) methods were tested out to support the budget planning of investments for a new building to be constructed for diagnostic and teaching units at a publicly funded tertiary care university hospital. The hospital board nominated an ad hoc working group to reassess all investment proposals for devices, equipment and furniture for the diagnostic or teaching units that intended to move into the new building. The need for assessment was obliged when the submitted proposals of the units exceeded two-fold the initially allocated investment budget.METHODS:Depending on the level of expenditure, all proposals were assessed by one of the following processes: (i) Proposals over EUR250,000 were evaluated by three to five person expert groups using multi-domain assessment adapting Hospital-based HTA-principles; (ii) Proposals between EUR50,000 and EUR250,000 were returned to the units for miniHTA-assessments by clinicians who submitted the initial proposals and (iii) All proposals below EUR50,000 were prioritized by the units to cut the expenditure by at least 25 percent, with a special emphasis on synergistic use of devices and equipment among the units.RESULTS:The expert groups suggested significant reductions to the proposals, including the withdrawal of a Magnetic Resonance Imaging (MRI)-unit considered to be suboptimally located. Furthermore, the need for a new scanner was declined by promoting adherence to evidence-based diagnostic guidelines and more efficient utilization of existing scanners. Self-assessed MiniHTAs revealed proposals that were unnecessary or the specifications for devices needed re-adjustments. Prioritization revealed excess numbers of devices, for instance the number of cold storage appliances could be reduced. Altogether, the investment proposals were cut by over EUR3.8 million to reach the initial budgetary allocation.CONCLUSIONS:Innovative and flexible usage of hospital-based HTA methodology can be applied to budget planning and evaluation of investment proposals to support decision making. Based on encouraging results, hospital-based HTA was accepted to become a part of hospital strategy as a tool for the annual investment planning.

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HEALTH TECHNOLOGY ASSESSMENT AND CLINICAL DECISION MAKING:

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462399153121 ◽

1999 ◽

Vol 15 (3) ◽

pp. 585-592 ◽

Cited By ~ 18

Author(s):

Alicia Granados

Keyword(s):

Health Care ◽

Decision Making ◽

Health Technology Assessment ◽

Case Studies ◽

Technology Assessment ◽

Clinical Decision Making ◽

Clinical Decision ◽

Health Technology ◽

Evidence Based ◽

Systematic Process

This paper examines the rationality of the concepts underlying evidence—based medicineand health technology assessment (HTA), which are part of a new current aimed at promoting the use of the results of scientific studies for decision making in health care. It describes the different approaches and purposes of this worldwide movement, in relation to clinical decision making, through a summarized set of specific HTA case studies from Catalonia, Spain. The examples illustrate how the systematic process of HTA can help in several types of uncertainties related to clinical decision making.

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