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Modelling necessities for HTA in Europe’s huge 5 economies

Written by Oliver Burn, Advisor Well being Economist, and Margaret Petrou, Advisor Well being Economist

Adapting a worldwide financial mannequin for Well being Expertise Evaluation (HTA) submissions in a number of international locations might be difficult, as necessities can differ significantly between international locations. It is very important preserve differing nation necessities in thoughts when designing a worldwide mannequin, to make sure it’s each simply adaptable to completely different international locations, and to keep away from pitfalls, equivalent to lacking a key element required for a profitable HTA submission.

We now have in contrast the HTA necessities and methodologies throughout Europe’s huge 5 economies (UK [England and Wales, and Scotland]), France, Germany, Italy and Spain) (1-6). Standards are predominantly centered on strategies that might require structural variations inside a mannequin:

      • Perspective
      • Sensitivity evaluation necessities
      • Utilities (inclusion of carer utility)
      • Threshold
      • Severity modifiers

Our findings are summarised in Desk 1 and detailed beneath.

Every nation requires a distinct mannequin perspective, subsequently fashions ought to be simply adaptable to incorporate several types of prices, equivalent to societal prices. One-way, probabilistic, and situation analyses are typically required for all international locations, nevertheless fashions must even be adaptable to make use of extra outcomes, equivalent to internet well being profit and to incorporate performance for probabilistic situation evaluation. EQ-5D is essentially the most generally most well-liked utility measure, and though carer high quality of life (QoL) just isn’t mentioned by all international locations, it’s typically accepted if there’s robust justification. Many international locations shouldn’t have formal willingness to pay thresholds or severity modifiers; nevertheless, to accommodate those who do, the calculations for severity modifiers and suppleness for the inclusion of thresholds ought to be integrated.

In abstract, you will need to keep in mind what will likely be required early on in world mannequin improvement to permit flexibility for all international locations by which reimbursement will likely be pursued. It will assist to keep away from unnecessarily lengthy adaptation occasions throughout submission. Extra data on the steps for a profitable world mannequin might be discovered right here.

Desk 1: HTA steerage abstract

Abbreviations: CE, cost-effectiveness; CEAC, cost-effectiveness acceptability curve; CEESP, Fee on Environmental, Financial and Social Coverage; DHSC, Division of Well being and Social Care; DSA, deterministic sensitivity evaluation; HST, extremely specialised expertise; ICER, incremental cost-effectiveness ratio; ISPOR, Worldwide Society for Pharmacoeconomics and Outcomes; NHB, internet well being profit; NHS, Nationwide Well being Service; OWSA, one-way sensitivity evaluation; PACE, Affected person and Clinician Engagement; PSA, probabilistic sensitivity evaluation; PSS, Private Social Providers, QALY, high quality adjusted life 12 months; QoL, high quality of life; SHI, statutory medical health insurance; SMC, Scottish Medicines Consortium; SMDM; Society for Medical Determination Making; WTP, willingness to pay


  1. Nationwide Institute for Well being and Care Excellence. NICE well being expertise evaluations: the guide. 2022.
  2. Scottish Medicines Consortium. Steering to submitting firms for completion of New Product Evaluation Kind (NPAF). Obtainable at: https://wwwscottishmedicinesorguk/making-a-submission/. 2022.
  3. Haute Autorite de Sante. Decisions in strategies for financial analysis – HAS. Obtainable at https://wwwhas-santefr/add/docs/software/pdf/2020-11/methodological_guidance_2020_-choices_in_methods_for_economic_evaluationpdf 2020.
  4. Agenzia Itaiana del farmaco. PER LA COMPILAZIONE DEL DOSSIER A SUPPORTO DELLA DOMANDA DI RIMBORSABILITÀ E PREZZO DI UN MEDICINALE. Obtainable at https://wwwaifagovit/paperwork/20142/1307543/20210122_estratto_linee_guida_sezione_Epdf. 2019.
  5. IQWIG. Common Strategies. Obtainable at https://wwwiqwigde/methoden/general-methods_version-6-1pdf 2022.
  6. López-Bastida J, Oliva J, Antonanzas F, García-Altés A, Gisbert R, Mar J, et al. Spanish suggestions on financial analysis of well being applied sciences. The European Journal of Well being Economics. 2010;11(5):513-20.

If you want to study extra about world financial fashions or talk about a present problem, please contact us at Supply Well being Economics, a rising HEOR consultancy specialising in proof technology, well being economics, well being expertise evaluation, and worth communication.



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