Novartis is going on the offensive, challenging the use of a cheaper alternative to its drug Lucentis in certain parts of southern Britain. The company is calling for a judicial review of prescribing decisions because it believes patient safety is being compromised by off-label prescriptions for the less expensive Avastin.
Lucentis generated $567 million in sales in the first quarter of 2012 and is approved by the European Medicines Agency for wet-aged macular degeneration, a condition that leads to loss of vision in older adults. The drug already been recommended by Britain’s health cost watchdog, the National Institute for Health and Clinical Excellence. Avastin by contrast is neither approved by the EMA nor recommended by NICE for the treatment of wet-AMD.
The Avastin versus Lucentis debate began in the United States when ophthalmologists realized that a small amount of Avastin worked as well as Lucentis in slowing the progress of wet age-related macular degeneration but can be administered is smaller doses at less than a tenth of the cost of Lucentis, which runs around $1,200 per shot.
This same sort of off-label treatment has found its way to the U.K., where some local health authorities have been prescribing Avastin instead of Lucentis. The off-label treatment is allowed on the basis that doctors have the discretion to treat patients the best way they see fit.
A U.S.-based clinical trial last year found that Avastin worked just as well as Lucentis in treating vision loss due to AMD. But it also found that Avastin caused more adverse reactions. Based on that data, Novartis claims that doctors using Avastin to treat wet-AMD are putting cost-savings ahead of patient safety.
“It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available,” Novartis said in a statement. “It undermines the regulatory process that was introduced to safeguard patients.”
But the potential for savings is resonating in Europe, where cash-strapped governments dealing with debt crises have taken measures to curb healthcare spending to resolve budget deficits. Britain’s coalition government has mandated that its National Health Service trim $30 billion from its budget by 2015 as part of a national austerity drive.
John Harris, chair and director of the Institute of Science Ethics and Innovation at the University of Manchester argues it is legitimate for health providers to use treatments that are much cheaper than ones that are already licensed, according to The Guardian. “Companies like Novartis should not be in the position to block treatments in order to maximize their profits,” he says.
April 23, 2012
http://www.burrillreport.com/article-novartis_challenging_avastin_use_for_eye_disease_in_the_u_k_.html