Roche vs NICE: NICE right not to take up Avastin

Once again NICE, the NHS rationing ‘quango’, has been in the news with its decision not to recommend the Roche manufactured drug Avastin for metastatic bowel cancer. The roots of the decision and the history between Roche and NICE go back a bit further though.

Once again NICE, the NHS rationing ‘quango’, has been in the news with its decision not to recommend the Roche manufactured drug Avastin for metastatic bowel cancer. The roots of the decision and the history between Roche and NICE go back a bit further though.

Avastin is an antibody initially developed by Genentech, a smaller biotech company that was later bought by Roche for $47 billion. Its main therapeutic action is to repress a protein called VEGF-A that is important for the growth of new blood vessels.

This in turn can have an inhibitory effect on the growth of some tumours at some stages of their growth, including bowel, lung, kidney, and some brain cancers for which it has been licensed by the US FDA since 2004. Avastin is now Roche’s star drug accounting for about 13% of total sales last year, or ~$6 billion, or the no.1 cancer drug in the world by sales!

Then in 2008, citing early trial data, Roche pushed for Avastin to be granted ‘accelerated approval’ by the US Food and Drug Administration (FDA) for advanced breast cancer and happily for Roche the FDA agreed. However, a few weeks ago this license was revoked when two separate follow-up studies failed to replicate the benefits of the earlier study.

This decision was estimated to have cost Roche about $500m of annual sales. Avastin, it seemed, might delay growth of advanced breast cancer initially but the tumour caught up and life was little or not prolonged at all.

This reversal shocked a lot of US commentators, as the panel appeared to be making an economic judgment; that a short delay in progression of the cancer was not worth the cost. It appeared perhaps a little NICE-like. Indeed in the UK, judging that the costs were excessive compared to the benefits, NICE has previously rejected Avastin for treatments of breast, lung, and kidney.

Meanwhile doctors had noted that the blood vessel inhibitor Avastin could perhaps be used to treat Macular Degeneration (MD), another disease caused by abnormal growth of blood vessels in the retina. This proved successful and wonderfully economical, as the tiny dose required was a fraction of that needed for cancer treatment. Indeed a dose for MD cost about $50 per eye injection compared to about $1500 for a round of cancer therapy.

Unfortunately there really wasn’t a lot of profit in that for Roche so instead of asking for a license to treat MD, they developed a new drug Lucentis that cost ~$2000 per injection and applied for an MD license for that instead!

Now this decision really riled a lot of health professionals. Usually when justifying the cost of a drug pharma companies will point to the low success rate of alternative drugs and the cost of manufacture. However Lucentis is essentially the same drug as Avastin with the same mode of action against the same human protein VEGF-A, but with a few formulation ‘improvements’.

Lucentis was as close to a risk-free sure-thing as possible, and the minor changes to it’s formulation could not make it 40 times more expensive to manufacture! But most importantly a lot of doctors were really not convinced that Lucentis was much better than Avastin at treating MD.

Yet in 2008 here in the UK, NICE recommended Lucentis as Avastin was not offered for license. Yet  reports in 2010 suggest that the NHS, horrified by the escalating costs of Lucentis, have asked NICE to review Avastin for MD despite it being unlicensed. With a number of head-to-head trials comparing Avastin and Lucentis concluding next year the market for Lucentis looks shaky and an unfavourable decision by the highly influential NICE could undermine a $3.5B worldwide market for Roche.

And now a couple of weeks ago NICE rejected Avastin as a treatment for metastatic bowel cancer. The story was covered extensively in the press – and the Daily Mail and Telegraph continue to contrast NICE’s decision unfavourably with their £500,000 office refurbishment. However the cost of funding Avastin would have dwarfed this. Remember the Coalition has set aside £50m this year and £200m next year to cover the cost of cancer drugs previously rejected by NICE.

There are between 6-18,000 new cases of metastatic bowel cancer annually in the UK (I know it’s ridiculously imprecise), and the treatment costs about £2000 per week. So if all eligible patients were given (full price) Avastin the cost would be between £12 and £36 milllion per week (perhaps slightly less due to a patient access scheme (PAS), or perhaps not). In other words if everyone applied it would wipe out the Cancer Drug Fund in a couple of months.

All this for a drug that (according to NICE analysis) halts the progress of bowel cancer for about 6 weeks but does not extend life at all.

Like this article? Sign up to Left Foot Forward's weekday email for the latest progressive news and comment - and support campaigning journalism by making a donation today.