The Haute Autorité de Santé (HAS), recently announced changes to the conditions in which a drug with an ASMR rating I-III is required to undergo health economic evaluation. The changes set out will come into force on January 1st, 2023.
To determine whether a product has, or is likely to have a significant impact on health insurance expenditure HAS assesses the company’s claims of the turnover of the product in its stated indication. In the event of first registration of the indication, this is understood as the forecast pre-tax turnover for the second year of marketing and for renewal of the registration of the indication as the turnover pre-tax recorded during the preceding 12 months of the company’s application.
The company must cover in its application for submission to HAS:
- Its claims in terms of impact on the organisation of care, professional practices or the conditions of care for patients
- An estimate of the forecast turnover per year over three years, in the stated indication, in the event of initial registration, or in the event of renewal of registration the turnover recorded, in the stated indication
- An estimate of the projected population per year over three years, in the stated indication, in the event of initial registration or in the event of renewal of registration the population reached observed per year over three years, for the indication stated
Importantly, the information submitted regarding population and turnover must align with the company’s submission to Economic Committee for Health Products (CEPS)
Health economic evaluation is required:
- When the product concerned is an advanced therapy medicinal product (ATMP)
- When the turnover submitted by the company is greater than or equal to €20 million (exc. Tax)
- When the company claims an impact on the organisation of care, professional practices or the conditions of care of patients
Exceptions to the requirements are, as follows:
- If the medicinal product is not protected by any patent or any supplementary protection certificate
- If the application concerns an extension of a paediatric indication for which the indication in adults is already reimbursed
- If the application concerns an extension of the indication that leads to an increase in the treated population of less than 5% over two years
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 ‘Decision 2022.0212/DC/SED/SEM of June 23,2022” 23/06/2022