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Health Technology Assessment programme

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Health Technology Assessment programme
NameHealth Technology Assessment programme
Established1970s
TypeResearch and evaluation programme
PurposeAssessment of medical technologies, devices, diagnostics, drugs, procedures
HeadquartersMultiple institutions

Health Technology Assessment programme The Health Technology Assessment programme evaluates medical devices, pharmaceuticals, diagnostics, and clinical procedures to inform policy and practice. Its work is cited by agencies such as National Institute for Health and Care Excellence, European Medicines Agency, World Health Organization, US Food and Drug Administration, and Organisation for Economic Co-operation and Development to guide reimbursement, regulation, and clinical guidelines. The programme interacts with universities, hospitals, and research funders including National Institutes of Health, Medical Research Council, Wellcome Trust, European Commission, and Canadian Institutes of Health Research.

Overview

Health Technology Assessment programmes operate within frameworks developed by organizations such as European Network for Health Technology Assessment, Agency for Healthcare Research and Quality, Health Technology Assessment International, International Society for Pharmacoeconomics and Outcomes Research, and Institute for Clinical and Economic Review. They draw on methods from institutions like University of Oxford, Harvard Medical School, Johns Hopkins University, Karolinska Institutet, and McMaster University and inform decisions by payers such as NHS England, Medicare (United States), Canadian Agency for Drugs and Technologies in Health, Bundesinstitut für Arzneimittel und Medizinprodukte, and Pharmaceutical Benefits Advisory Committee. The programme’s outputs influence clinical practice guidelines issued by Royal College of Physicians, American College of Cardiology, European Society of Cardiology, Infectious Diseases Society of America, and American Thoracic Society.

Objectives and Scope

Primary objectives include comparative effectiveness research promoted by bodies like Cochrane Collaboration, National Institute for Health Research, and Evidence-Based Medicine Working Group to support formulary decisions at organizations such as Kaiser Permanente, Bupa, and Blue Cross Blue Shield. Scope covers pharmaceuticals approved by European Commission (health) and US Food and Drug Administration; diagnostics regulated by International Medical Device Regulators Forum and Notified bodies; surgical interventions evaluated in centers like Mayo Clinic and Cleveland Clinic; and public health technologies endorsed by Centers for Disease Control and Prevention, Public Health England, and World Health Organization. The programme addresses cost-effectiveness analyses used by NICE Technology Appraisal Committee, IQWiG, and PBAC to set reimbursement thresholds and influence procurement by entities such as Gavi, the Vaccine Alliance and Global Fund.

Methodology and Processes

Methodological approaches follow guidance from Cochrane Handbook for Systematic Reviews, PRISMA Statement, CHEERS statement, GRADE Working Group, and CONSORT for trials. Processes integrate randomized controlled trials from networks like International Clinical Trials Registry Platform, observational studies from Clinical Practice Research Datalink, modelling techniques from ISPOR standards, and real-world evidence sources such as Electronic health records at NHS Digital and registries like the European Cancer Registry. Economic evaluation uses health utility measures including EQ-5D and metrics employed by Global Burden of Disease collaborators. Stakeholder engagement includes patient groups like National Voices, professional societies like Royal College of Surgeons, and manufacturers represented by European Federation of Pharmaceutical Industries and Associations.

Governance and Funding

Governance structures mirror those of National Institute for Health and Care Excellence advisory panels, European Commission expert groups, and boards akin to Wellcome Trust or Bill & Melinda Gates Foundation grant committees. Funding sources include public funders such as National Institutes of Health, Medical Research Council, European Commission Horizon 2020, and charitable funders like Wellcome Trust and Robert Wood Johnson Foundation. Procurement and contracting involve frameworks used by Crown Commercial Service, GSA (U.S. government), and multilateral initiatives administered through World Bank and United Nations Development Programme.

Impact and Outcomes

Outcomes include guideline changes referenced by NICE guidance, cost-containment measures adopted by NHS England, and regulatory decisions enforced by European Medicines Agency and US Food and Drug Administration. The programme’s assessments have affected coverage decisions by Medicare and Medicaid, tender outcomes for devices in European Union markets, and vaccine introduction strategies supported by Gavi, the Vaccine Alliance and World Health Organization Strategic Advisory Group of Experts. Published reports appear in journals such as The Lancet, BMJ, Health Technology Assessment (journal), Annals of Internal Medicine, and Value in Health.

International Collaboration and Standards

International cooperation occurs through networks like European Network for Health Technology Assessment, Health Technology Assessment International, and multilateral settings including World Health Organization meetings and Organisation for Economic Co-operation and Development health policy forums. Standards referenced include those developed by International Organization for Standardization, International Electrotechnical Commission, and regulatory alignment efforts by International Medical Device Regulators Forum to harmonize assessment criteria across jurisdictions such as European Union, United States, Canada, Australia, and Japan.

Criticisms and Challenges

Critiques have been raised by stakeholders including patient advocacy groups like PatientsLikeMe, industry associations such as European Federation of Pharmaceutical Industries and Associations, and policy analysts at Brookings Institution and RAND Corporation regarding timeliness, transparency, and methodological biases. Challenges include integrating adaptive trial data from initiatives such as RECOVERY trial, assessing digital health technologies emerging from companies like Apple Inc. and Google (Alphabet Inc.), managing conflicts involving pharmaceutical companies like Pfizer, Roche, Novartis, and dealing with cross-jurisdictional legal issues seen in European Court of Justice rulings. Future directions involve methodological innovation from groups at Imperial College London, Stanford University, and University College London to address real-world evidence, equity concerns promoted by Amnesty International and Oxfam, and sustainability goals highlighted by United Nations.

Category:Health assessment