In a 272 to 234 vote on Tuesday, French lawmakers amended its social security budget bill to support the use of Roche's cancer drug Avastin as an inexpensive treatment for the eye disease wet age-related macular degeneration (AMD). However, this move has raised some eyebrows; drug makers and medical experts believe that allowing this medication (currently unapproved as an AMD treatment) to be used as such could pose a risk to patients’ health and to the profits of Novartis and Bayer, which currently market AMD drugs.
However, the French government said that one of the currently authorized AMD treatments, Lucentis, was a leading reimbursement charge in its healthcare budget last year, costing the social security around 430 million euros, according to Reuters. (Bayer and Regeneron’s Eylea is the other approved AMD treatment.)
France isn't the only country that’s noticed the potential monetary benefits of going with Avastin. Doctors in the U.S. and Europe already prescribe the cheaper Avastin for this off-label use. Plus Medicare would save $3 billion a year “if doctors abandoned the $2,000-per-dose Lucentis and instead used Avastin, which costs 40 times less than the eye drug.”
"The economic arguments are obvious," analysts at Berenberg explained. "If financial arguments prevail, this could put a big dent in these franchises for Novartis — and to a lesser extent Roche, which receives royalties – and Bayer, with implications for originator Regeneron, which receives royalties on European sales.”
However, these recent developments have sparked serious safety questions amongst drug makers and other medical experts. One such concern is that Avastin is not safely formulated as an eye injection. Even though a 2011 U.S. government-sponsored study showed Avastin worked just as well as Lucentis in AMD, it caused more adverse effects.
Avastin works in a similar way as Lucentis, blocking the overproduction of a protein called vascular endothelial growth factor (VEGF) thus preventing the growth of new blood vessels that feed tumors. However, both Novartis and Roche say it’s not a good idea to swap out the drugs because they were meant to be used for different therapeutic purposes.
Novartis told Reuters that, “We do not see how reimbursing off-label use for cost reasons in France is justified in the interest of public health, where there are licensed alternatives.”
Indeed, drug makers and medical experts worry that endorsing off-label drug usage without adequate clinical trials significantly increase health risks, including infections, which places company profits ahead of patients’ health and wellbeing.