The French government has come under heavy industry criticism for its decision to recommend the off-label use of the drug Avastin to treat patients with a common eye condition.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents pharma companies in the EU, said the draft law undermined the regulatory framework of the EU and was a concern for patient safety.
Earlier this month, the French National Assembly voted in favour of using Roche’s cancer drug Avastin (bevacizumab) as an alternative to the more expensive Lucentis (ranibizumab) for patients with wet age-related macular degeneration (AMD), despite the fact that Avastin is not recommended in this indication.
Both drugs act by inhibiting vascular endothelial growth factor (VEGF), but Avastin is only approved in oncology indications, such as breast cancer and lung cancer.
However, the drug is less expensive than Lucentis, which is marketed by Novartis in the EU and by Roche in the US, and France estimates swapping patients to Avastin will save some €200m a year, according to Reuters.
EFPIA’s director general Richard Bergström launched a scathing attack of the proposal, saying it was part of a “worrying trend across Europe” for governments to bypass safety regulations to save money in the short term.
“This is a serious public health issue which the European Commission must address urgently before it becomes more widespread,” said Bergström.
“EU Member States should not be creating secondary, national marketing authorisations for reasons that undermine the EU regulatory framework and could potentially put patients at risk, and deliver only short-term economic gains.”
Bergström also said the decision could have a lasting impact on pharma R&D, claiming companies might be “discouraged from undergoing the costly and time-consuming authorisation process for new indications”.
France is not the only country in Europe considering swapping wet AMD patients to Avastin, Italy is considering similar changes.
Italy is also investigating allegations that Roche and Novartis worked together to prevent doctors from using Avastin to treat eye conditions off-label.
Two years ago Novartis was forced to cut the UK price of Lucentis to prevent off-label use of Avastin.