This article is more than 5 years old. Information may no longer be current.
UK government criticized for ruling out Avastin on the basis of ‘confused, illogical’ arguments
Click Here to Manage Email Alerts
The arguments offered by George Freeman, UK Minister for Life Sciences, to rule out the use of Avastin to treat age-related macular degeneration because it is “unlawful” and “against the wider public interest” have been criticized by barrister David Lock, QC, as “confused and illogical,” according to a news article published April 16 in BMJ.
In the past few months, several calls have been made by NHS Clinical Commissioning Groups for the Department of Health, the General Medical Council (GMC) and the National Institute for Health and Care Excellence (NICE) to make Avastin (bevacizumab, Genentech/Roche) available alongside Lucentis (ranibizumab, Genentech/Novartis) and Eylea (aflibercept, Regeneron/Bayer), saving the NHS an estimated £102 million (approximately €140 million or $153 million).
On March 5, the GMC responded to Clinical Commissioners that, although it was theoretically in favor of changing GMC guidance to allow doctors to prescribe a cheaper but equally safe alternative medicine, it was hindered from doing so by the law.
“The European Court has in effect ruled out the adoption of blanket policies that permit the ‘off label’/unlicensed prescribing of medicines on the grounds of cost,” Niall Dickson, chief executive of the GMC, said.
A similar response came on March 23 from Freeman, who stated that, despite the positive recommendations from NICE technology appraisals, a policy for routine use of Avastin would be in contrast with the EU medicines licensing legislation, which “is essential to ensure that safe and effective medicines are available on the EU market.”
He also mentioned that the EU Court of Justice ruled against Poland “because unlicensed medicines were being imported on economic grounds when there were licensed alternatives.”
The BMJ reported that Lock criticized Freeman for not understanding “the difference between unlicensed drugs and licensed drugs which are marketed and sold lawfully and then used ‘off label’ by doctors.”
These new statements are likely to fuel further debate on an issue of great importance not only in the UK but all of Europe.
Usha Chakravarthy, MD, former member of the technology appraisal panel for NICE and chair of the Royal College of Ophthalmologists AMD Guidelines group, noted that the evidence that Avastin is as safe as other anti-VEGF drugs is supported by systematic reviews and a comprehensive meta-analysis of clinical trials in the field.
“Avastin continues to be used widely in the USA, other countries in Europe and in Australia to treat wet AMD as well as other conditions that also result in leakage of fluid into the retina. Furthermore, in the UK itself, Avastin is used off label to treat eye conditions for which a licensed preparation is not available. Avastin remains a clinically acceptable alternative to practicing retina specialists throughout the world,” she told Ocular Surgery News. – by Michela Cimberle
References:
Freeman G. NHS Commissioner Letter. www.theyworkforyou.com/wrans/?id=2015-03-16.227587.h. March 23, 2015.
GMC responds to calls to remove barriers preventing ‘off-licence’ use of Avastin. General Medical Council website. www.gmc-uk.org/news/26328.asp. March 5, 2015.
Kmietowicz Z. BMJ. 2015;doi:10.1136/bmj.h2050.
Click Here to Manage Email Alerts