MHRA clarifies position on Avastin for AMD

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new review of its previous published statements (from 2009 and 2011) on the supply and use of bevacizumab (Avastin) for intravitreal administration, clarifying its position on the licensing status of the medicine if used for the treatment of wet age-related macular degeneration (wet AMD).

The review follows a request from the High Court to examine whether the process of ‘compounding’ bevacizumab (ie producing multiple small-volume aliquots in plastic syringes for a purpose other than its authorised use) exceeds what is permissible for ‘off-label’ use, resulting an unlicensed medicine. This is in light of the judicial review brought by Bayer and Novartis against the policy of 12 CCGs to commission bevacizumab for use in wet AMD. Judgment in favour of the CCGs was given in September 2018.

The MHRA has clarified that the processing of bevacizumab for intravitreal use does not in itself create an unlicensed medicine, and that prescription or use by a healthcare professional in this way would fall under the scope of ‘off-label’ use. However, the agency added that if single-dose syringes for intravitreal use were placed on the market, that product would require a new or extended marketing authorisation, or an exemption from the need for one.

The MHRA explains that a distinction needs to be drawn between the functions of the European medicines regulatory system and the clinical use of products within that market. The regulatory process legislates for placing medicinal products on the market; however, it does not legislate for how medicines are to be prescribed and used by healthcare professionals once they have been placed on the market.

The MHRA also reminds prescribers of their additional responsibility when prescribing medicines ‘off-label’. It has published prescribing guidance (MHRA guidance note 14) on medicines supplied as ‘specials’ (ie unlicensed medicinal products), and it adds that this should be taken into consideration.

 

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