Government wrong to push for Avastin in eye disease, says charity
pharmafile | May 12, 2011 | News story | Research and Development, Sales and Marketing | Lucentis, RNIB, avastin, wet AMD
The UK government’s pursuit of Avastin for use in ophthalmology is bad for patients, says the Royal National Institute of Blind People (RNIB).
The charity has added its voice to the controversy around Avastin’s off label use in patients with wet age-related macular degeneration (AMD) in place of the more expensive, but licensed Lucentis.
Despite opposition from the charity and pharma companies, it looks increasingly likely that Avastin will gain official consent for use in AMD – contrary to the wishes of licence holders Roche and Novartis.
US and European ophthalmologists have been using Avastin (bevacizumab) off label to treat AMD for some time because of its close similarity to the licensed treatment Lucentis, but far lower cost in these patients. Marketed by Novartis in Europe, Lucentis (ranibizumab) is currently priced at £10,000 per year, whilst Roche’s Avastin when used off label is far cheaper, costing as little as just £250.
But the safety and efficacy of Avastin in ophthalmology has never been established, so in an exceptional move, the US, UK and other European governments are sponsoring head-to-head trials of Avastin versus Lucentis. Supporters of the move say it could help healthcare systems save millions, and, most significantly, undermine pharma company tactics of overpricing their medicines.
But opponents say the Avastin trials put cost saving ahead of patient safety.
Speaking to Pharmafocus, an RNIB spokeswoman said: “We believe that safety should not be compromised by cost and ultimately, this is what the government is looking to do.
“Health bodies and the government should look into making savings,” she said, “but they are making a bad move by encouraging Avastin’s use given the ongoing safety concerns surrounding the drug.”
She said that Lucentis has been approved by regulatory bodies as safe and effective and judged to be cost-effective by NICE.
“From a patient’s perspective, this is what we require and right now Avastin simply doesn’t have this.”
She added that changing the regulatory system to help save money on one drug for one particular therapy area was ‘very problematic’, and could only lead to further complications in the future.
Results from the UK government’s head-to-head study, named IVAN, will be presented later this year, and will be used to make Avastin’s use official.
NICE ready to review Avastin
NICE recently confirmed that it could assess Avastin once a regulatory body had looked at its drug’s safety profile and deemed it safe for patients. A DH spokesman said health ministers, alongside UK regulator the MHRA, are now to decide whether NICE should assess Avastin, adding that the decision will be influenced by the IVAN trial results.
A very similar trial funded by the US government called CATT has just found Avastin and Lucentis equally effective in treating AMD. This sets up a confrontation with Roche and its subsidiary Genentech, which develops and markets both Avastin and Lucentis in the US.
Genentech has long been accused of overpricing Lucentis, and now the use of Avastin is one step closer to being officially sanctioned in the US. The US National Eye Institute’s CATT trial has the scale and thoroughness of a pharma sponsored trial, and as such challenges pharma’s monopoly on data from large-scale trials. It found that both drugs were equally effective at improving vision for wet AMD, but found statistically significant higher levels of adverse events recorded in the Avastin arm of the trial.
The trial investigators believed the adverse events could be down come from pre-existing conditions relating to age, as the average study participant was over 80 years old. There is now a second ongoing trial looking at the safety aspects of Avastin with results expected next year.
Meanwhile Roche has funded a study in the US to support its position. This observation trial suggests that patients on the Avastin arm had higher rates of death and stroke than those on the Lucentis side, but the investigators said that the study was limited by incomplete information that may have affected the data.
The US government’s move is supported by many US ophthalmologists, as well as health insurance companies.
The New England Journal of Medicine published the CATT trial, and its editorial concluded: “Healthcare providers and payers worldwide will now have to justify the cost of using ranibizumab.”
There remain numerous clinical and regulatory obstacles, however.
The NEJM points out that national medicines regulators will have to reconsider policies on the legality of off label drug use, but suggests such changes would support increased access to effective VEGF treatment for the condition.
There are six similar head-to-head trials under way in Europe – Vibera in Germany, Gefal in France, Manta in Austria, AxL-2009 in Spain, Lucas in Norway and Bramd in the Netherlands.
Unless evidence of greater safety concerns emerge, these trials are likely to persuade ophthalmologists around the world to use Avastin instead of Lucentis.
The trials could have significance far beyond Lucentis, however. The funding of these head-to-head trials will set a precedent for governments funding research, which will have major implications for the industry and its prices.
Ben Adams
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