Licensing status of Avastin updated by MHRA

Licensing status of Avastin updated by MHRA

The licensing status of Avastin has been updated by the Medicines and Healthcare products Regulatory Agency (MHRA).

The update concerns the licensing status of Avastin (bevacizumab) if intended to be placed on the market for intravitreal administration. It clarifies the MHRA’s position on the licensing regime that governs the placing of medicines on the market and replaces guidance published in 2009 and 2011.

This follows a request by the High Court to review whether the process of compounding bevacizumab (the manipulation of an authorised medicine, to produce multiple aliquots, usually in plastic syringes) exceeds what is permissible for ‘off-label’ use – the result being an unlicensed medicine which would require a marketing authorisation if placed on the market.

The Agency 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.  However, if placed on the market, the product would require a new or extended marketing authorisation, or an exemption from the need for one.

In reaching this conclusion, MHRA considers that a distinction needs to be drawn between the functions regulated in the European scheme of medicines regulation, and the clinical use of products within that marketplace.

The medicines regulatory regime legislates for the placing on the market of industrially produced medicinal products. The regime does not legislate how medicines are to be prescribed and used by healthcare professionals once they have been placed on the market.

A prescriber may use a medicine outside the conditions of its marketing authorisation, this is commonly referred to as ‘off-label’ use. The prescriber should be aware of their additional responsibility when prescribing ‘off-label’. Professional governance bodies have published advice to prescribers that should be taken into account.

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 clinical commissioning groups (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.”