· Aug 02, 2022

The HAS modified its criteria leading to health economic evaluation of healthcare products

The HAS has modified the criteria taken into account and the information requested from healthcare manufacturers in order to trigger a medico-economic evaluation of healthcare products claiming a major, important or moderate ASMR or ASA (levels I, II and III), in a decision that will come into force on January 1, 2023.
The modifications are as follows:

  • To determine whether a product has or is likely to have a significant impact on expenditure, the HAS will assess, in addition to the company's claims in terms of the product's impact on the organization of care, as was the case until now, the product's forecast or actual sales in the indication concerned by the application for reimbursement, and no longer "all indications combined", as previously.
  • The HAS College will now reason in terms of sales excluding taxes, and no longer including all taxes.
  • The turnover of the product in the indication concerned will be understood as the forecast turnover excluding taxes for the second year of marketing in the case of a first-time registration of the indication and as the turnover excluding taxes recorded during the 12 months preceding the application for renewal of registration of the indication.
  • The company must provide, at the time of filing, an estimate of the projected population per year over three years in the indication concerned in the case of initial registration or the population reached per year over three years in the indication concerned in the case of renewal of registration.

For medical devices claiming an ASA I to III, the medico-economic evaluation is required when the forecasted or actual sales are greater than or equal to 20 million euros per year, excluding tax. As an exception, the evaluation is not required when the application concerns a pediatric extension for which the use in adults is already reimbursed.


The HAS decision is available via this link: https://www.has-sante.fr/upload/docs/application/pdf/2022-08/decision_n2022.0212_dc_sed_sem_du_23_juin_2022_du_college_de_la_haute_autorite_de_sante_relative_a_limpact_significatif_sur_.pdf

Please do not hesitate to contact us should you have any question about this process.