What are the implications of the court ruling that bevacizumab may be prescribed for wet AMD?
Association of the British Pharmaceutical Industry (ABPI) officials have been shocked by an ‘extraordinary’ court judgement on the use of bevacizumab (Avastin) for treating wet age-related macular degeneration (wet AMD).
Mrs Justice Whipple ruled that the European Medicines Agency does not have exclusive competence to determine whether bevacizumab is effective and safe.
Both the National Institute for Health and Care Excellence (NICE) and clinical commissioning groups (CCGs) are competent in this area, she said, and treating clinicians could lawfully prescribe bevacizumab on grounds of cost.
She added that the Medicines and Healthcare Products Regulatory Agency (MHRA) guidance that bevacizumab is an unlicensed treatment in wet AMD should be reviewed.
ABPI deputy chief scientific officer Dr Sheuli Porkess said the industry association would consider the judgment carefully.
‘This extraordinary judgment potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.
‘As we exit the EU and the UK Government is looking for regulatory co-operation between the UK and the EU, this confusion is deeply unhelpful.’
The case was brought by 12 northern clinical commissioning groups. Estimates have suggested potential savings of up to £500m from using bevacizumab in the UK, rather than two more expensive alternatives developed for the purpose, ranibizumab (Lucentis) and aflibercept (Eylea).