Europe’s drugmakers have criticised the French government’s move to expand off-label use, specifically for Roche’s Avastin as a treatment for wet age-related macular degeneration, for economic reasons.
Their fears follow a French National Assembly vote on a draft law proposal, which would potentially allow doctors to prescribe drugs to be used for unapproved indications even if there is an alternative drug approved. It has still to be reviewed by the French Senate and a review by the French Constitutional Court is also possible, but the European Federation of Pharmaceutical Industries and Associations is not best pleased.
Richard Bergstrom, EFPIA director-general, said that “a worrying trend is growing across Europe with governments bypassing important health safeguards and making public health decisions based purely on short-term economic considerations. This move is a material breach of the regulatory framework created to preserve the highest standard of patient safety in Europe”.
The draft law specifically references Roche’s cancer blockbuster Avastin (bevacizumab) and its unlicensed use for wet AMD. The drug is used off-label instead of Novartis' Lucentis (ranibizumab), which in some territories costs ten times as much, and a newer treatment, Bayer’s Eylea (aflibercept).
France’s move follows Italian regulators recently deciding to permit off-label drug use to be reimbursed even if an alternative authorised treatment is available. Mr Bergstrom added that if public authorities continue to promote off-label use of other, less costly, medicines that have not undergone stringent safety and efficacy assessments, pharmaceutical companies will be discouraged from undergoing the costly and time-consuming authorisation process for new indications”.
EFPIA called on the European Commission to ensure that member states “adhere to the European regulatory framework and that financial considerations do not take precedence over the safety of patients”.