Implications of the upcoming changes to French ATU (Autorisation Temporaire d’Utilisation) programme

CONTEXT:  From July of 2021manufacturers will be required to make all early access authorisation requests to the HAS (Haute Autorité do Santé – the French HTA body) instead of the ANSM (Agence nationale de sécurité du médicament et des produits de santé – the French regulatory agency).  The change is intended to simplify the process, but given the ballooning costs of the programme (now over €1billion a year) it seems likely that part of the rationale for change is to try and contain costs.  The result of these changes could well mean fewer innovative products being approved for early access to patients and certainly a higher bar for pharma companies to clear in terms of the standardised approach being mandated.

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1. “The ATU programme, previously divided into six systems, has now been grouped into two: an early access authorisation programme (Autorisation d’accès précoce, AAP) which includes the cATU and a compassionate access programme (Autorisation d’accès compassionnel, AAC) which includes nATU, among others.” 

2. “The temporary authorisation programme in France is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need (i.e. with no authorised therapeutic alternatives available).” 

3. “As a result of expanded use of ATUs over recent years, funding of new products through the system has grown to over €1 billion a year.1. Access to pre-authorised medications in France may be granted through the nominative ATU (nATU) or cohort ATU (cATU).” 

4. “Like the AAP requirements, the AAC criteria are now stricter as the manufacturer needs to demonstrate that the efficacy and safety of a product is “strongly presumed,” as opposed to ‘’considered’’ to be favourable under the old system.3,4 The manufacturer must not only follow a well-established clinical protocol and collect data during the period required by HAS, but also needs to demonstrate that trials have started.” 

5. “While it remains to be seen how the AAP and AAC systems will impact pricing and market access in the future, the French authorities seem to have increased the hurdles to early access.” 

Source URL: https://www.epmmagazine.com/pharma-manufacturing-news/new-drug-development-approvals-regulatory-news/reforms-in-the-french-atu-system-increased-payer-recognition/