Mon, 30 Apr 2012
Mike O’Brien QC, the former Minister of Health who now practises public law at No5 Chambers, has criticised the Swiss pharmaceutical company Novartis for trying to force the NHS to use an expensive medicine “Lucentis” rather than equally effective but less expensive medicine “Avastin” to treat patients with the eye condition “wet age-related macular degeneration” or AMD. Novartis has now started a Judicial Review to force the NHS to use the more expensive medicine.
Mike O’Brien says: “The company is putting profits before the NHS. It wants to force the NHS to provide a more expensive medicine so it can make bigger profits. Avastin is as reliable as Lucentis, but Lucentis costs ten times more.”
Novartis says NICE has not approved Avastin for treating AMD. However, Mike O’Brien explains: “Medicines need a license from NICE to be marketed to treat a condition. Importantly, a license is about approval for marketing not medicinal efficacy. The NHS can use an unlicensed medicine and often does so.
“Lucentis is licensed to treat AMD. Avastin is only licensed for cancer. The two medicines are owned by one company Hoffman La Roche who market Lucentis through Novartis. The companies refuse to apply for a license for Avastin to be marketed to treat AMD. The reason is profit. If Avastin is licensed the profits on Lucentis will fall.
“When I was Health Minister I became aware of the games that these companies were playing. I asked NICE whether they could do their own research and give approval for Avastin. NICE was enthusiastic to look at this but warned that without cooperation from the company it would take years to put together all the data. It knows Avastin ought to replace Lucentis. After all, Avastin is used to treat AMD in 60% of the American market; it’s used by the US Veterans Administration and is the main medication used for AMD in New Zealand. Private patients in the UK will often be prescribed Avastin. NICE has looked at Avastin and published a positive interim report.
“The Health Secretary should condemn what Novartis is doing. Andrew Lansley should refuse to allow the NHS to be bullied by Novartis. The interests of the patient and the NHS must come first.”
A “licence” for a drug is not a licence for doctors to use but a licence for a pharmaceutical company to market the drug. Doctors lawfully use both unlicensed drugs and drugs off licence all the time and it is perfectly lawful to do so. There are a number of examples of the NHS using cheaper, clinically effective but unlicensed drugs where there is licensed alternative. This scenario is not unique to AMD.
Novartis says that there is an issue of patient safety but Mr O’Brien dismisses this, saying: “This is a commercial reason not a safety reason. The evidence is that Avastin is as safe as Lucentis. Over 60% of wet AMD patients in the United States are treated with Avastin and not Lucentis. The HMOs have taken the view that Avastin is just as acceptable and good and so will not fund Lucentis.
“So the argument that this is about patient safety is frankly nonsense. The only safety element is that Avastin is supplied in large vials for cancer treatment. Novartis could supply it in smaller vials for eye treatment. It refuses to do so. The cancer vials therefore have to be separated and Novartis claims this is a safety issue. It is a only a safety issue because of the commercial stand of Novartis.”
The US Military Veterans organisation used Avastin, then stopped, conducted an analysis and it now uses Avastin again and will not fund Lucentis. The NHS equivalent in New Zealand has refused to fund Lucentis and uses Avastin.
Patients who suffer from AMD are treated with Avastin by minute doses being injected into their eyes. The NHS used to treat patients with Avastin in this way until 2008, when NICE approved Lucentis. Some areas of the NHS still use Avastin.
Professor of Health Law at Reading University, Chris Newdick, has advised some PCTs on the legal position regarding Lucentis and Avastin. “It has been suggested by the Prime Minister, David Cameron, that we are all members of the Big Society,” comments Professor Newdick.
“I interpret this as meaning that, up and down the country, regardless of social or economic position, we should all pull together to help Britain through some challenging times.
“This should apply as much to multi-national organisations as to any member of the public and so corporations might forego some profit to contribute to the greater well-being of the wider community. I’m not sure how this might sit with the boards of some big businesses but Mr Cameron might agree. Both drugs are effective, so why shouldn’t the NHS seek out best value for patients in the same way as many businesses strive for best shareholder value?”
Mike O’Brien QC concludes: “Both Lucentis and Avastin are manufactured by the American company Genentech, which is owned by Hoffman La Roche HLR. HLR will not apply for Avastin to be given a licence to treat wet AMD. Novartis is licensed by HLR to market the drug in Europe but the ultimate rights’ holder remains HLR. HLR has admitted that it has not applied for a licence for commercial reasons. Hence HLR gets paid whether the NHS uses Lucentis or Avastin but, if the NHS uses Lucentis, then both Novartis and HLR get paid and it is 10 times more expensive.”
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