The MHRA has today published a revised position on the use of Avastin (bevacizumab) for intravitreal administration such as in the treatment of wet AMD, a chronic eye disorder that causes blurred vision or a blind spot in the visual field. The MHRA “accepts that when prescribed and/or used by a healthcare professional, this does not create an unlicensed medicine and falls under the scope of ‘off-label’ use.”
Responding to the announcement, Julie Wood, chief executive of NHS Clinical Commissioners, the independent membership organisation for clinical commissioners, said:
“We are delighted to see MHRA has revised its position on the use and supply of Avastin to treat wet AMD. This decision is a step towards enabling the NHS to treat thousands of patients with wet AMD for a fraction of the cost, freeing much needed funds to spend on other NHS services. It also brings us in line with many other countries in how we are able to treat patients.
“This new MHRA position replaces its 2009 and 2011 guidance and accepts the process of compounding Avastin and it being prescribed or used by a healthcare profession is classified as ‘off-label’. NHSCC welcomes this new position as we have been working with colleagues on this issue since 2015. Since the 2018 Judicial Review which stated that CCGs in the North East acted lawfully in using the preferred treatment option for Avastin for the treatment of wet AMD, we have been pushing the Government and other NHS bodies on our members’ behalf to find a sensible and pragmatic way forward to help CCGs across the country introduce the cheaper but equally effective drug Avastin for the treatment of wet AMD.”
NHSCC has been active in this area on behalf of its members since 2015.
Avastin is not currently licensed for the treatment of wet AMD, but guidance released by the National Institute for Health and Care Excellence (NICE) in January 2018 concluded that there are “…no clinically significant differences in effectiveness and safety…” between Avastin and the current market authorised medicines, ranibizumab (Lucentis) and aflibercept (Eylea) for the treatment of this condition. Furthermore, Avastin is the most cost-effective treatment compared to the others available, with the potential to release millions of pounds of vital funding locally which can be reinvested in other frontline NHS services.
In early 2018, following the release of the NICE guidance we worked with the GMC to clarify their position regarding the use of off-label medicines and fitness to practice processes.
In September 2018, a Judicial Review ruled that a group of CCGs in the North East acted lawfully in introducing the preferred treatment option for Avastin. The pharmaceutical companies which produce Lucentis and Eylea have appealed the decision; the appeal is due to be heard in November 2019.
19 September 2019