The pharmaceutical industry in the UK says the regulatory system and patient safety could be under threat after doctors called for the removal of “current barriers” preventing them from prescribing Roche’s cancer blockbuster off-label for wet age-related macular degeneration.
Some 120 Clinical Commissioning Groups, representing almost 60% of all CCGs, have called on the General Medical Council, the Department of Health and NHS England to make it easier for them to give Avastin (ranibizumab) for unlicensed use. They speak about this barriers which they claim are “conspiring” to stop them “acting on the evidence of cost effectiveness and safety”, resulting in “ongoing ‘lost savings’ to the local NHS of around £102 million per annum”.
Avastin is already used off-label for wet AMD which is much cheaper (about £60) than licensed products - Roche’s own Lucentis (ranibizumab), marketed in the UK by Novartis, costs around £700 - and Bayer’s Eylea (aflibercept).
Want NICE appraisal
Now the NHS Clinical Commissioners are asking the GMC to provide a “specific exception to their standard guidance” to support doctors who prescribe Avastin for use in the eye “on the basis of clinical and cost effectiveness”. They also want the health secretary to ask the National Institute for Health and Care Excellence to look again at current guidance for AMD and authorise a “multiple treatment appraisal” looking at the comparative cost effectiveness of Avastin with Lucentis and Eylea.
The NHSCC also wants NHS England chief Simon Stevens to “support the case for change” and back clinical commissioners who wish to prescribe Avastin.
Amanda Doyle, co-chair of NHSCC, said “we are seeing an increase in the incidence of this chronic eye condition due to an ageing population, and as commissioners we have a responsibility to ensure that every pound spent is done so to the best effect”. She cited a recent Cochrane Review which she claims shows that Avastin has been proven to be comparable, arguing that “members of the public would be baffled if they knew the sums of money being spent on expensive drugs when there is an alternative available that is cheaper and as effective”.
The move echoes the situation in certain parts of mainland Europe, notably Italy, where legislation was introduced promoting the use of medicines “for an indication for which they do not have a marketing authorisation, purely for economic reasons”.
In response, Paul Catchpole, the Association of the British Pharmaceutical Industry’s director of value and access, said: “Be in no doubt - seeking to bypass the regulatory system by calling for local clinical commissioning groups to prescribe an unlicensed medicine on the grounds of cost alone potentially threatens patient safety”.
ABPI: guidance on cost alone 'completely inappropriate'
He noted that the Medicines and Healthcare products Regulatory Agency (MHRA) and NICE “are the proper authorities to issue guidance to the NHS on the safety, quality and clinical and cost effectiveness of medicines and commissioners are legally obliged to implement NICE guidance”. Mr Catchpole went on to say “NHSCC's call to bypass national guidance on economic grounds is completely inappropriate”.
A Department of Health spokesperson stressed that whilst only the manufacturer is able to apply for a new licence, doctors are free to prescribe off-label drugs “if they feel they are clinically appropriate”.
Roche has repeatedly stated it has no notion of applying for a licence for Avastin in wet AMD and issued a statement saying it is not developed and manufactured “to meet intraocular standards”. To get a licence would require years of further trials, time which it feels would be better spent investigating new eye therapies.