Earlier this week, EFPIA, Europe's pharmaceutical industry association, announced it had filed a complaint with the European Commission against the French “RTU Regime.” promoting the use of Roche's cancer drug Avastin for the off-label treatment of wet age-related macular degeneration (AMD). The decree allows the French medicines regulator (ANSM) to issue a temporary authorization for use of a product in an unauthorized indication, purely for economic purposes, notwithstanding the existence of an authorized alternative treatment. This development is troubling and contravenes European Community law and jurisprudence, writes EFPIA, along with EUCOPE and EuopaBio. “The regime allows [ANSM] to issue a temporary authorisation for use of a product in an unauthorised indication, also for economic purposes, notwithstanding the existence of an authorised alternative treatment,” the trade groups wrote in their recent press release. “This development is troubling and contravenes European Union law and jurisprudence.”
View the trade groups' Press Release here.
While Roche's Avastin is not approved by health regulators as a treatment for AMD, it works in a similar way to the treatments currently authorized for AMD, such as Lucentis, marketed by Novartis and Roche, and Eylea, from Bayer and Regeneron. France has argued that encouraging the use of Avastin, which costs around 30 times less than those rival treatments, could result in annual savings of some 200 million. The most publicized switch has traditionally been Avastin for Lucentis--doctors have prescribed Avastin for AMD because it is much cheaper and according to publicly-funded trials is as effective as as Lucentis. See, for example, a 2013 Washington Post article entitled “An effective eye drug is available for $50. But many doctors choose a $2,000 alternative.”
The price and comparable effectiveness of off-label AMD treatment is one side of the story; EFPIA also argues that such legislation may put lawmakers in charge of medical decision-making. “It is simply not acceptable for policy makers concerned with the size of healthcare spending to introduce legislation that not only contradicts EU law, but also puts the overall EU regulatory system aimed at guaranteeing the highest patient safety standards at risk," said EFPIA director general Richard Bergstrom. (See Reuters) "The pharmaceutical industry collectively calls on the European Commission to address this public health issue urgently and preserve those safeguards that have been put in place.”
“Off-label prescribing of medicines should only occur in very specific situations where there is no approved therapeutic alternative and making sure that all safety measures and precautions have been respected,” EFPIA adds. “Furthermore, patients should be made fully aware of the risks associated with the use of an off-label medicine and explicitly consent to its prescription.”