Value-based healthcare: Il nuovo approccio di AIFA alla determinazione multidimensionale del valore
AIFA’s new approach to multidimensional value determination
In this viewpoint, we discuss the approach promoted by the Italian Drug Agency (AIFA) to the assessment of the value of new pharmaceuticals in the Italian Healthcare Service. On top of traditionally acknowledged components, such as quality adjusted life years gained and net costs, the overall value framework might include other elements such as productivity and adherence, equity, severity of disease, reduction in uncertainty, spillover effects. There is a residual dimension in the value framework that may capture the option value or reduction in fear of contagion for infectious disease treatments. We debate measurement issues on these elements of value and discuss open issues from a methodological and policy standpoint.
Kristensen F. EUnetHTA and health policy-making in Europe. Euro-Health. 2006;12:36-8.
Methods for the economic evaluation of health care programmes. Michael F. Drummond, Mark J. Sculpher, Karl Claxton, Oxford University Press, United Kingdom 2015 4th Edition.
AIFA. Le valutazioni economiche sottomesse ad AIFA nei dossier di richiesta della rimborsabilità e del prezzo (P&R). https://www.aifa.gov.it/documents/20142/1028586/valutazioni_economiche_AIFA_PR_11_2019.pdf/8114ff8c-f4a6-60e2-6c6a-7789d6539204
Husereau D, Drummond M, Petrou S et al. Consolidated health economic evaluation reporting standards (CHEERS) statement. Cost Eff Resourc Alloc. 2013;11(1):6.
Sullivan SD, Mauskopf JA, Augustovski F et al. Budget impact analysis—principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014;17(1):5-14.
Ciani O, Federici CB. Value lies in the eye of the patients: the why, what, and how of patient-reported outcomes measures [published online ahead of print, 2020 Jan 10]. Clin Ther. 2020;42(1):25-33. doi:10.1016/j.clinthera.2019.11.016
Neumann PJ, Cohen JT. QALYs in 2018—Advantages and Concerns. JAMA 2018;319(24):2473-4. doi:10.1001/jama.2018.6072
Sculpher MS, Claxton K, Pearson SD. Developing a value framework: the need to reflect the opportunity costs of funding decisions. Value Health. 2017;20(2):234-9.
Jommi C, Armeni P, Costa F et al. Implementation of value-based pricing for medicines. Clin Ther. 2020 Jan;42(1):15-24.
ISPOR. 2019 TOP 10 HEOR TRENDS. https://www.ispor.org/docs/default-source/about-ispor/ispor-top-10-heor-trends-2019_00120190107_2-2.pdf?sfvrsn=c8d9948b_0
Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br Med Bull. 2010;96:5-21.
Jan S. Proceduralism and its role in economic evaluation and priority setting in health. Soc Sci Med. 2014 May;108:257-61.
Hughes D, Cowell W, Koncz T et al. Methods for integrating medication compliance and persistence in pharmacoeconomic evaluations. Value Health. 2007;10:498-509.
Goldman DP, Gupta C, Vasudeva E et al. The value of diagnostic testing in personalized medicine. Forum Health Econ Policy. 2013;16:S87-99.
National institute for Health and Clinical Excellence. Appraising life-extending, end of life treatments. https://www.nice.org.uk/guidance/gid-tag387/documents/appraising-life-extending-end-of-life-treatments-paper2
Ministero della Salute. I principi del Servizio sanitario nazionale (SSN). http://www.salute.gov.it/portale/lea/dettaglioContenutiLea.jsp?lingua=italiano&id=5073&area=Lea&menu=vuoto
Vreman RA, Heikkinen I, Schuurman A et al. Unmet medical need: an introduction to definitions and stakeholder perceptions. Value Health. 2019;22(11):1275-82.
Verguet S, Kim JJ, Jamison DT. Extended cost-effectiveness analysis for health policy assessment: a tutorial. Pharmacoeconomics. 2016;34:913-23.
Asaria M, Griffin S, Cookson R. Distributional cost-effectiveness analysis: a tutorial. Med Decis Making. 2016;36:8-19.
Armeni P, Costa F. Farmaci e rimborsabilità debole: i legami mancanti per una tutela equa del diritto alle terapie. Il Sole 24 ORE Sanità 25 Ottobre 2018. https://www.sanita24.ilsole24ore.com/art/dal-governo/2018-10-25/farmaci-e-rimborsabilita-debole-legami-mancanti-una-tutela-equa-diritto-terapie-120907.php?uuid=AEwG1XVG
Garrison LP, Kamal-Bahl S, Towse A. Toward a broader concept of value: identifying and defining elements for an expanded cost-effectiveness analysis. Value Health. 2017;20:213-6.
Schoenen J, Pascual J, Rasmussen S et al. Patient preference for eletriptan 80 mg versus subcutaneous sumatriptan 6 mg: results of a crossover study in patients who have recently used subcutaneous sumatriptan. Eur J Neurol. 2005 Feb;12(2):108-17.
Al-Janabi H, Van Exel J, Brouwer W et al. Measuring health spillovers for economic evaluation: a case study in meningitis. Health Econ. 2016 Dec; 25(12):1529-44.
Lakdawalla DN, Doshi JA, Garrison Jr LP et al. Defining elements of value in health care—a health economics approach: an ISPOR Special Task Force report . Value Health. 2018;21(2):131-9.
Li M, Basu A, Bennette C et al. How does option value affect the potential cost-effectiveness of a treatment? The case of ipilimumab for metastatic melanoma. Value Health. 2019;22(7):777-84.
Thornton Snider J, Seabury S, Tebeka MG et al. The option value of innovative treatments for metastatic melanoma. Forum Health Econ Policy. 2018 Jun 21;21(1).
Thornton Snider J, Batt K, Wu Y et al. The option value of innovative treatments for non-small cell lung cancer and renal cell carcinoma. Am J Manag Care. 2017 Oct 1;23(10):e340-e346.
Kolasa K, Zah V, Kowalczyk M. How can multi criteria decision analysis support value assessment of pharmaceuticals? – Findings from a systematic literature review. Expert Rev Pharmacoecon Outcomes Res. 2018;18(4):379-91. doi: https://doi.org/10.1080/14737167.2018.1467759
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