[co-author: Jean-Baptiste Chagnon]

On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance, published a methodological guide on the organizational impacts for the evaluation of new pharmaceutical products, medical devices, and professional acts.

Finally! As an extension of its 2019-2024 Strategic Plan, one of the main thrusts of which is to make innovation a driving force, and its Action Plan for Innovative Medicines, on 31 December 2020, the French National Authority for Health published a methodological guide on the organizational impacts for the assessment of new pharmaceutical products, medical devices, and professional acts.

We regularly advocate for the implementation of multi-factorial health technology assessment criteria for innovative pharmaceutical products and medical devices in order to enable their fast and appropriate assessment, and consequently, a pricing and reimbursement system that is consistent with their impact on patient care in all its dimensions. The current health technology assessment criteria appear to be unsuitable to innovations, particularly in the context of rare diseases or "one-shot" treatments.

Without guaranteeing their method of assessment, the HAS thus proposes three macro-criteria, the first of which aims to identify and quantify the "organizational impacts" of health technologies on patients' care and quality of life.

Although the health technology assessment criteria still tend to further improvements, this guide constitutes a first step in taking into account the organizational impacts of health care innovations, which remain insufficiently measured in the scientific and medico-economic assessment.

Next steps

It remains for manufacturers to take up the challenge and propose concrete solutions to document these organizational impacts.

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