A value framework for diagnostics in Latin America

That is the topic of a recent paper by Augustovski et al. (2021). The authors conduct a targeted literature review of previous diagnostics value frameworks in other countries. A full list of these articles is below. Then the researchers pool the criteria and created a proposed value framework. A panel of experts was then met to weigh in on the value framework.

The final framework is just that–a framework. There are no points or scales assigned but just relevant domains and subdomains. While this may be less specific than some may have hoped, it does provide flexibility for decision-makers to adapt the framework to different situations. The key essential domains of the Augustovski value framework were:

• Clinical benefit and test performance. This category includes: the clinical consequences of the use of the test, and test performance
• Safety and unwanted consequences. This category includes: procedural safety, consequences of the wrong diagnosis, safety of test preparation, and safety of test operators.
• Quality of scientific evidence.
• Economic aspects. This category includes economic evaluation (clinical effectiveness and/or budget impact analysis) as well as other relevant costs.
• Organizational aspects and feasibility within the clinical path. This category includes: the impact on the health services provision system and the impact on the path of patient care.

Other domains that were listed as being not essential but of high importance were:

• Health priority of the health system
• Disease burden
• Equity. This category includes whether this is a neglected diseases test, whether the test is in a communicable diseases and high prevalence, or if there are issues of low access to health services
• Ethical and legal aspect
• Severity of the disease
• Absence of alternative diagnostic technologies

Nonclinical benefits (e.g., impact on caregivers, test processing time), environmental impact, and broader social impact–surprisingly (to me at least)–were ranked only as medium importance. The degree of innovation of the test had low importance.

The relevant diagnostic value frameworks that informed the Latin American adaptation included:

• Palmetto G.B.A. Molecular Diagnostic Program (MolDX®) coverage, coding, and pricing standard requirements.https://palmettogba.com/Palmetto/moldx.Nsf/files/MolDX_Manual.pdf/$File/MolDX_Manual.pdf Date accessed: May 9, 2019
• Bojke L. Grigore B. Jankovic D. Peters J. Soares M. Stein K. Informing reimbursement decisions using cost-effectiveness modelling: a guide to the process of generating elicited priors to capture model uncertainties.Pharmacoeconomics. 2017; 35: 867-877
• Mann G. Squire S.B. Bissell K. et al. State of the Art. Beyond accuracy: creating a comprehensive evidence base for tuberculosis diagnostic tools. Int J Tuberc Lung Dis. 2010; 14: 1518-1524
• Canestaro W.J. Pritchard D.E. Garrison L.P. Dubois R. Veenstra D.L. Improving the efficiency and quality of the value assessment process for companion diagnostic tests: the Companion test Assessment Tool (CAT).J Manag Care Spec Pharm. 2016; 21: 700-712
• Anonychuk A. Beastall G. Shorter S. Kloss-Wolf R. Neumann P. A framework for assessing the value of laboratory diagnostics.Healthc Manag Forum. 2012; 25: S4
• EUnetHTA. HTA Core Model for Diagnostic Technologies v 1.0r Work Package 4.www.eunethta.net
• EuroGentest. Instrument for quality self-assessment in provision of genetic counselling.http://www.eurogentest.org/index.php?id=160
• Calonge N. Green N.S. Rinaldo P. et al. Committee report: method for evaluating conditions nominated for population-based screening of newborns and children. Genet Med. 2010; 12: 153-159
• Rosenkötter N. Vondeling H. Blancquaert I. Mekel O.C.L. Kristensen F.B. Brand A. The contribution of health technology assessment, health needs assessment, and health impact assessment to the assessment and translation of technologies in the field of public health genomics. Public Health Genomics. 2010; 14: 43-52
• Rousseau F. Lindsay C. Charland M. et al. Development and description of GETT: a genetic testing evidence tracking tool: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) – IFCC Sientific Division Committee on Molecular Diagnostics.Clin Chem Lab Med. 2010; 48: 1397-1407
• UK Genetic Testing Network. Evaluation of new genetic tests for NHS services.https://ukgtn.nhs.uk/fileadmin/uploads/ukgtn/Documents/Resources/Library/Reports_Guidelines/Briefing_Report_Gene_Test_Recommendations_CSAG_MAR17.pdf
• Palmetto G.B.A. Molecular Diagnostic Program (MolDX®) coverage, coding, and pricing standard requirements.https://palmettogba.com/Palmetto/moldx.Nsf/files/MolDX_Manual.pdf/$File/MolDX_Manual.pdf Date accessed: May 9, 2019
• Bojke L. Grigore B. Jankovic D. Peters J. Soares M. Stein K. Informing reimbursement decisions using cost-effectiveness modelling: a guide to the process of generating elicited priors to capture model uncertainties.Pharmacoeconomics. 2017; 35: 867-877
• Mann G. Squire S.B. Bissell K. et al. State of the Art. Beyond accuracy: creating a comprehensive evidence base for tuberculosis diagnostic tools. Int J Tuberc Lung Dis. 2010; 14: 1518-1524
• Canestaro W.J. Pritchard D.E. Garrison L.P. Dubois R. Veenstra D.L. Improving the efficiency and quality of the value assessment process for companion diagnostic tests: the Companion test Assessment Tool (CAT).J Manag Care Spec Pharm. 2016; 21: 700-712
• Anonychuk A. Beastall G. Shorter S. Kloss-Wolf R. Neumann P. A framework for assessing the value of laboratory diagnostics.Healthc Manag Forum. 2012; 25: S4
• EUnetHTA. HTA Core Model for Diagnostic Technologies v 1.0r Work Package 4.www.eunethta.net
• EuroGentest. Instrument for quality self-assessment in provision of genetic counselling.http://www.eurogentest.org/index.php?id=160
• Calonge N. Green N.S. Rinaldo P. et al. Committee report: method for evaluating conditions nominated for population-based screening of newborns and children. Genet Med. 2010; 12: 153-159
• Rosenkötter N. Vondeling H. Blancquaert I. Mekel O.C.L. Kristensen F.B. Brand A. The contribution of health technology assessment, health needs assessment, and health impact assessment to the assessment and translation of technologies in the field of public health genomics. Public Health Genomics. 2010; 14: 43-52
• Rousseau F. Lindsay C. Charland M. et al. Development and description of GETT: a genetic testing evidence tracking tool: International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) – IFCC Sientific Division Committee on Molecular Diagnostics.Clin Chem Lab Med. 2010; 48: 1397-1407
• UK Genetic Testing Network. Evaluation of new genetic tests for NHS services.https://ukgtn.nhs.uk/fileadmin/uploads/ukgtn/Documents/Resources/Library/Reports_Guidelines/Briefing_Report_Gene_Test_Recommendations_CSAG_MAR17.pdf
• Lee D.W. Neumann P.J. Rizzo J.A. Understanding the medical and nonmedical value of diagnostic testing.Value Health. 2010; 13: 310-314
• National Institute for Health and Care Excellence. Diagnostics Assessment Programme Manual.http://www.nice.org.uk/media/A0B/97/DAPManualFINAL.pdf
• Medical Services Advisory Committee. Guidelines for the assessment of diagnostic technologies.http://www.ag.gov.au/cca
• Merlin T. Farah C. Schubert C. Mitchell A. Hiller J.E. Ryan P. Assessing personalized medicines in Australia: a national framework for reviewing codependent technologies. Med Decis Mak. 2013; 33: 333-342
• Teutsch S.M. Bradley L.A. Palomaki G.E. et al. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: methods of the EGAPP Working Group. Genet Med. 2009; 11: 3
• Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. General methods: version 5.0.https://www.iqwig.de/download/General-Methods_Version-5-0.pdf
• Institut national d’excellence en santé et services sociaux. Assessment mechanism for medical biology tests at INESSS.https://www.inesss.qc.ca/en/themes/sante/medical-biology-procedures/assessment-mechanism-for-medical-biology-tests-at-inesss.html
• AdvaMed. A framework for comprehensive assessment of the value of diagnostic tests.https://www.advamed.org/sites/default/files/resource/advameddiagnosticframeworkreport_09.pdf
• Frueh F.W. Quinn B. Molecular diagnostics clinical utility strategy: a six-part framework.Expert Rev Mol Diagn. 2014; 14: 777-786

Source:

• Augustovski F, Alfie V, Alcaraz A, Martí SG, Drummond M, Pichon-Riviere A. A Value Framework for the Assessment of Diagnostic Technologies: A Proposal Based on a Targeted Systematic Review and a Multistakeholder Deliberative Process in Latin America. Value in Health. 2021 Jan 16.

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