Patient-Reported Outcomes within Health Technology Assessment Decision Making: Current Status and Implications for Future Policy

IntroductionTurkey's health reforms, which started in 2003, have led to increased access to health care and pharmaceuticals as well as rising public pharmaceutical expenditures. The need to improve healthcare decision making by implementing health technology assessment (HTA) has become an important priority for Turkey. This study sought to provide a tailor-made HTA implementation roadmap, drawing on insights from national stakeholders.Our study aimed to describe the current HTA environment in Turkey and to explore long-term perspectives and suggestions from a wide spectrum of Turkish stakeholders regarding the preferred status of HTA in ten years (by 2029).MethodsWe conducted an online survey using a questionnaire previously applied in other HTA research. We assessed the current evaluation of medical and economic decision-making processes and examined the need for HTA. We also ascertained stakeholder perspectives on potential developments that can be done together with policymakers, representatives of pharmaceutical companies, and patient organizations. We also included general information about the pharmaceutical market and decision making processes in Turkey.ResultsThe survey was sent to various stakeholders from different areas within the health system. Additional face-to-face interviews were conducted with a few respondents to clarify some of their answers. A total of twenty-seven Turkish stakeholders completed the survey. Of these, twenty-one (78%) participants were employed in the public sector and six (22%) were from the private sector. The majority of the participants would introduce HTA for all new health technologies being considered for public reimbursement and institute an additional review process for currently reimbursed technologies. Most of the respondents considered that only new technologies with significant budget impact should be evaluated in the next ten years.ConclusionsIt is clear that Turkey needs to implement an HTA process in the future. Our study shows stakeholder expectations, which will be helpful for creating an HTA implementation roadmap, and it is clear that different stakeholders have different views and expectations about HTA implementation in Turkey. The experiences of other countries will also be helpful during the implementation process.

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Usefulness of a short-term register for health technology assessment where the evidence base is poor

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462309990602 ◽

2010 ◽

Vol 26 (1) ◽

pp. 95-101 ◽

Cited By ~ 11

Author(s):

Hannah Patrick ◽

Sally Gallaugher ◽

Carolyn Czoski-Murray ◽

Robert Wheeler ◽

Marc Chattle ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Pectus Excavatum ◽

Patient Reported Outcomes ◽

Interventional Procedure ◽

Health Technology ◽

Assessment Process ◽

Nuss Procedure ◽

Short Term ◽

Patient Reported

Objectives: This study reviews the coverage and usefulness of a short-term register, established specifically for health technology assessment of a novel interventional procedure (minimally invasive repair of pectus excavatum, or the Nuss procedure).Methods: Coverage of the register during 2004–07 was assessed by comparison with Hospital Episodes Statistics (HES) for England. Its usefulness was assessed by comparing safety and efficacy data with the published literature and by feedback from committee members who in 2009 were involved in reviewing NICE's original guidance from 2003.Results: The register reported 260 cases from thirteen UK hospitals during nearly 9 years. During a coverage evaluation period of 3 years, there were 152 registered Nuss procedures. An additional 246 repairs of pectus excavatum were undertaken in twenty-six previously unidentified hospitals. Of the 246, 23 were Nuss procedures (from two hospitals), 140 were open procedures (from eleven hospitals), and 3 were coding errors. No details were available for eighty cases undertaken at ten hospitals. The quantity of published literature had increased substantially since publication of original guidance in 2003. It related mostly to technical and safety outcomes, whereas the register included patient reported outcomes. The literature and the register reported similar rates of major adverse events such as bar displacement (2–10 percent). Committee members considered that the Register made a useful contribution to guidance development.Conclusions: This study shows that a register set up to support a health technology assessment process can produce useful data both about safety and about patient-reported outcomes. Coverage may be improved by active follow-up based on routine hospital statistics. Improvement in coding for new procedures is needed in the United Kingdom.

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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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