France’s temporary authorisation system (autorisation temporaire d’utilisation, ATU) was developed to provide early market access for treatments in therapeutic areas with unmet medical need, limited therapeutic alternatives, or where no authorised alternatives are available. Last year, the French National Authority for Health (HAS) expanded its remit (previously under the control of Agence nationale de sécurité du médicament et des produits de santé [ANSM]) to include early access authorisation decisions and related public funding coverage.
This reform created newly defined tools such as pre-market authorisation early access (formerly ATUc), post-marketing authorisation early access (AP), and compassionate access (AC), which formerly incorporated the ‘ATU’ nominative (ATUn) and ‘Recommandation Temporaire d’Utilisation’ RTU schemes. Considering the changes applied last year, GlobalData looks at the price impact following full marketing authorisation following an early access/ATU.
Medicines experience a 16% price drop on average post-ATU/early access
Post-early access/ATU, a negotiated price and reimbursement level is determined according to the clinical value rating (Service Médical Rend, SMR) and Amélioration du Service Médical Rendu (ASMR) rating, evaluated by the Transparency Commission (TC) of HAS. According to GlobalData’s Price Intelligence (Poli) database, a drug price determined as part of the final reimbursement procedure is set lower than the price set under early access.
GlobalData identified 17 medicines, including eight orphan medicines, that were first available under an early access programme or previous ATU and that are now priced under standard pricing and reimbursement procedures. Upon evaluation, their price negotiation triggered an average reduction of 15.9%.
53% of medicines under ATU/early access treat oncology indications
A total of 53% of products priced under ATU/early access provide treatment within oncology, followed by neurological conditions (18%). Other therapy areas include infectious disease, endocrinology and haematology. Details regarding the distribution of medicines under ATU/early access by therapy are available in Figure 2.
41% of brands priced under early access reach their final reimbursement price and subsequent cut in less than one year
ATU/early access status is typically granted for a fixed one-year period with the opportunity for annual renewal. The time to price negotiation varies across the drugs analysed, ranging from 116 days to 1,354 days, with an average of 628 days (1.7 years).
Data from GlobalData’s Price Intelligence database confirms that 41% of medicines priced under ATU/early access reached their final reimbursement price and subsequent cut in less than one year. Only 12% maintain their ATU/early access price for three years or more.
Early access/ATU drugs enter the French market earlier in Europe
An analysis of the average European launch sequence of these 17 early access/ATU therapies shows that these programmes enable pharmaceutical companies to speed up market access in France. While medicines are typically launched in the French market at the 10.9th position within Europe, its ranking decreases to 5.5 for medicines under the ATU/early access programs.
Early access/ATU medicines, for which prices are available in official sources, are therefore launched in France earlier compared to all drugs. Consequently, an earlier launch in France could improve market access conditions in other countries by offering these medicines the potential to achieve higher prices in the European markets.
Compared to the prices established under early access/ATU, medicines in France receive a lower set price during final reimbursement by HAS, often in under one year. These drugs typically treat orphan oncology indications and enter the French market earlier compared to all medicines.