Off-label use of Avastin in Wet-AMD – Are NHS Trusts really undermining the regulatory process?

Novartis (a major pharmaceutical company) is asking for a judicial review of the decision by some NHS trusts to pay for off-label use of Avastin to treat wet-AMD (age-related macular degeneration). They have expressed concern that regulatory process for safeguarding patients is being undermined and their safety put at risk.

 Instead, I would argue, it is the behaviour of pharmaceutical companies in this case which is undermining the regulatory process and obstructing healthcare providers from supplying safe and cost-effective treatments to patients. If Novartis and Roche are concerned with safeguarding patients, then Avastin should be submitted for licensing for use in wet-AMD. Unless large-scale randomised clinical trials show that there is an unacceptable level of adverse effects with use of split-doses of Avastin, then the NHS should be allowed to pay for its use.

 The reason that an unlicensed treatment is currently in use is largely because its manufacturer (Roche) is unwilling to submit it for licensing for wet-AMD. In a March 2012 Journal of Medical Ethics article (doi:10.1136/medethics-2011-100032), we argued that NICE should be able to appraise bevacizumab (Avastin) for use in the treatment of eye conditions, even in the absence of a request by its manufacturer for licensing.

 Roche has developed another drug – Lucentis – which is licensed for use for wet-AMD, but is much more expensive than using split doses of Avastin. Avastin – widely approved for use in treatment of various cancers – has been used off-label by ophthalmologists since 2005. A recent comparative trial in the US has shown the two drugs to have equivalent effectiveness in both monthly and ‘as needed’ treatment regimes (doi: 10.1056/NEJMoa1102673).

 Of course, it is legitimate for companies who have made significant investments in developing pharmaceuticals to charge a price that allows them to make some profit. Roche and Novartis have already had substantial income from sales of Avastin and Lucentis, and are likely to continue to do so (Roche’s 2011 Financial Report shows Avastin sales of 5,292 million Swiss francs (about £3600 million) and Lucentis sales of 1523 million Swiss francs (about £1037 million). The public makes significant investments in health care (and scientific research and development) through taxation and private payments for drugs. NHS Trusts, as representatives of the public should not be expected to pay over the odds for drugs.

It is worth questioning whether a regulatory process that would force the NHS to pay for the more expensive drug in this case is a process that truly safeguards patients, since resources are finite and choosing to fund a cheaper alternative with a similar clinical efficacy and safety profile would free up resources for other areas.

A commentary by Catherine Rhodes, Research Fellow in Science Ethics, Institute for Science, Ethics and Innovation.

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One thought on “Off-label use of Avastin in Wet-AMD – Are NHS Trusts really undermining the regulatory process?

  1. I completely agree with you Catherine. Big pharmaceuticals giants have the tendency to be greedy and come up with absurd reasons to block cheap and alternative medication.

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