Credit: Joyhill09 via Wikipedia

Novartis in eye drug row

The pharma firm is in the eye of a publicity storm after the British Medical Journal accuses it of blocking a cheap treatment for age-related macular degeneration.

by Adam Gale
Last Updated: 02 Apr 2015

The era of British socialism may be long gone, but when it comes to healthcare there’s no doubt most of us are still true believers. The NHS is sacrosanct, not to be despoiled by such profane things as cost or –heaven forbid – profit. Anyone who works in NHS commissioning will tell you, however, that business can’t just be separated from healthcare by some magic centrifuge.

Big pharma provides the drugs that keep the NHS functioning, but some criticise it for putting profits over people. Yesterday, the British Medical Journal (BMJ) published an article accusing pharmaceutical giants Roche and Novartis of resisting the use of a cheap alternative to Lucentis, the licensed medicine for age-related macular degeneration (AMD).

The anti-cancer drug Avastin, which the BMJ describes as ‘cheap, safe and effective’ for the treatment of AMD, is widely used in Europe and the US as an alternative to the much more expensive Lucentis (£740 a dose against roughly £60). Both medicines are owned by Roche, but Novartis markets Lucentis in the UK.

Doctors in the UK have for some time called for Avastin to be licensed for use treating AMD, which affects 26,000 people in the UK and causes blindness if left untreated. In February, 120 NHS clinical commissioning groups (CCGs) wrote to the Department of Health asking for them to intervene.

The issue is that Avastin is not licensed to treat AMD here, which means doctors are potentially liable if they go against General Medical Council (GMC – sorry for the acronyms, but that’s healthcare for you) guidance and prescribe it ‘off-label’, i.e. to treat a condition for which it’s not officially licensed. No one has been sued for this in the UK, but many doctors want Avastin to be licensed for AMD, or to have greater protection when they prescribe it off-label.

The BMJ claims to have evidence that Novartis and Roche tried to prevent this from happening. For a start, Roche has not sought the marketing authorisation necessary for Avastin to be licensed for us on AMD. ‘Minutes... show that Roche said decisions not to develop bevacizumab [Avastin] for ocular use have been "due to corporate considerations",’ the BMJ claimed.

The BMJ also claims that in 2011, commissioners at SHIP (Southampton, Hampshire, Isle of Wight, and Portsmouth - sorry), a primary care trust on the south coast, agreed to fund Avastin off-label, but withdrew the policy after a judicial review from Novartis. Both have also been fined £150m between them by Italy’s competition authority for allegedly colluding to prevent Avastin from being used to treat eye conditions.

Both firms have denied the accusations. A statement from Roche on the Italian fine said it ‘reiterates that the charges are unfounded and will appeal the verdict’, adding ‘Roche confirms there is no agreement between Roche and Novartis that restricts competition’.

Concerning the BMJ accusations, Novartis said it’s ‘committed to improving health outcomes for patients with serious eye disease’, and ‘continuously conducts clinical trials in the UK and other countries’.

However this resolves, the perhaps bitter pill at the centre of this row is that pharmaceutical companies need to be able to pursue a profit to be at their most effective. It’s easy to say ‘there’s a cheap and effective drug so let’s use it’, but that could lose the firms involved huge sums on their more expensive, made-for-purpose drugs.

If that can happen, the risk premium firms will have to pay on all drugs will go up, raising costs generally and stifling research into new drugs - and that’s not good for anyone, including the taxpayer.

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