Outcome raises stakes in confrontation between doctors and pharmaceutical companies fighting to protect high prices
A groundbreaking trial funded by the NHS has shown that a cheap, unlicensed drug to prevent blindness is just as effective as the expensive one marketed by a major pharmaceutical company.
If all patients needing treatment were given unlicensed Avastin injections instead of Lucentis, the NHS could save £84.5m, the researchers calculate.
The first year’s results of the trial, called Ivan, which compared the two drugs head to head, shows that Lucentis, at £741 a vial, is no better than Avastin, at £40. It also shows that treating patients when a checkup reveals they need it, rather than every month, leads to equally good results and further reduces the bill.
The results raise the stakes in what has been seen as a confrontation between pharmaceutical companies fighting to protect the high prices they charge for their drugs and some doctors and others in the NHS who fear the bill for treating the estimated 513,000 people with wet macular degeneration could become unaffordable. As the ageing population grows, the numbers affected are expected to rise to 679,000 by 2020.
The trial is highly unusual because it is rare for the NHS to pay for straight comparisons of drugs. The vast majority of drug trials are funded by the pharmaceutical company which hopes to sell it and usually has no interest in finding out how well it works compared with a rival medicine.
Avastin is a bowel cancer drug that was originally used to treat age-related wet macular degeneration – the most common form of blindness – by ophthalmologists in the United States. Because they split one dose of Avastin into hundreds of tiny doses suitable for injecting into the eye, the cost dropped dramatically.
Avastin and Lucentis were both made by Genentech, a US biotech company now owned by Roche, which markets Avastin and refuses to license it in small doses for eyes. That leaves Lucentis, owned by Novartis, as the only licensed treatment.
Doctors can use unlicensed drugs on their patients – but they are responsible if something goes wrong. As reports have grown of the success of Avastin treatment, more UK ophthalmologists have been prepared to use it and some primary care trusts now offer patients the choice.
The one-year results of Ivan were presented on Sunday at an international research meeting in Fort Lauderdale, Florida.
The trial compared the drugs in 610 patients, making it one of the largest carried out in eye disease in the UK. Scientists and eye specialists from 23 hospitals and academic institutions, including Queen’s University Belfast, and the universities of Bristol, Liverpool, Southampton and Oxford, took part.
Prof Usha Chakravarthy of Queen’s University Belfast’s centre for vision and vascular science, who led the research study team, said: “The Ivan results at the end of the first year show that Lucentis and Avastin have similar effectiveness. Regardless of the drug received, or treating monthly or as needed, sight in the affected eye improved by between one and two lines on a standard eye test.”
The Ivan study adds to evidence from a similar trial in the US called Catt, which also found the two drugs behaved similarly.
The studies looked carefully for potential side-effects. Given the age of the participants, it was expected that there would be some heart attacks or strokes during the trials. There was no difference in the number of deaths between those on Avastin and those on Lucentis.
“If anything, we found a higher number of [events such as] stroke and heart failure in the Lucentis arm and we found a slight excess of other adverse events in the Avastin arm, which did not reach statistical significance in our study,” said Chakravarthy. When the results from Ivan were combined with those from Catt, the exra Lucentis adverse events disappeared.
“The only place where there remains cause for concern is in hospitalisations for other events,” she said. These included a range of issues, including kidney and stomach problems but, she said, but they would not necessarily be a reason not to use Avastin.
Novartis, however, disagreed. In a statement on the Catt results, it said that the increased side-effects in Avastin use and, it claimed, the better performance of Lucentis over Avastin – which the US researchers did not consider significant – meant that “it would be inappropriate to advocate use of unlicensed bevacizumab (Avastin) for wet AMD on the basis of these trials.”