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RCOphth welcomes EU Court of Justice Advocate General’s new opinion on the use of ‘off-label’ drug Avastin

31 October 2017

The Royal College of Ophthalmologists (RCOphth) believes that ophthalmologists should have the discretion to prescribe Bevacizumab (Avastin) or alternatives such as Ranibizumab (Lucentis) or Aflibercept (Eylea), whichever is the most appropriate treatment of age related macular degeneration (AMD) for the patient, and provided the patient gives informed consent.

The RCOphth has long petitioned a review on Bevacizumab being available for wider use for AMD in the NHS.  Not only does this cheaper alternative to Ranibizumab or Aflibercept potentially save the NHS over £100million1 a year, as identified by the IVAN study in 2012 but is clinically proven as safe and as effective by two major studies, CATT2 and IVAN3, and the Cochrane review in 2014.

Professor Andrew Lotery, RCOphth Scientific Chair says, ‘A review to remove the current legal ruling and subsequent GMC guidance4 would benefit patients by providing the best treatment for their individual needs; and the potential to release funds for much-needed reinvestment into over-stretched hospital eye services.’

The new opinion from the EU Court of Justice considers that ‘pharmaceutical products do not need to be specifically authorised for treating particular diseases to be considered as rivals to products formally licensed for such purposes to be considered as active in the same market’.

The ageing population in the UK and associated eye conditions and diseases is adding to the capacity issues facing many hospital eye care services, impacting resources and funding. AMD is the commonest cause of blindness among elderly people in the developed world5. Ranibizumab was licensed for AMD treatment and approved by NICE in 2008 and Aflibercept was similarly approved by NICE for AMD treatment in 2013.

Drugs are appraised for cost and clinical effectiveness by the National Institute for Health and Care Excellence (NICE)6 after being licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA)7.

Professor Lotery continued, ‘When the NHS is asking all clinicians and commissioners to save funds and innovate services for the benefit of patients, all responsible organisations should be working with the pharmaceutical industry to bring about a successful conclusion to this ongoing question over Avastin.’

RCOphth is asking that the UK regulatory and legal bodies find a way to license Avastin for use with AMD for the benefit of patients and the NHS.

#ends#

Liz Price, Communications Manager, [email protected]

Notes to Editors

  1. Licence to save: a UK survey of anti-VEGF use for the eye in 2015, EYE Journal Eye30, 1404-1406 (November 2016) | doi:10.1038/eye.2016.154 (Restricted access, please contact [email protected])
  2. IVAN study: Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011;364:1897-908.
  3. Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Culliford LA, et al. Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet 2013;382:1258-67.
  4. GMC: Prescribing guidance: prescribing unlicensed medicines. 2013. http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp
  5. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355:1419-31.
  6. NICE: https://www.nice.org.uk/guidance/conditions-and-diseases/eye-conditions/macular-degeneration
  7. MHRA: https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk

Further reading

http://www.bmj.com/content/349/bmj.g6887

The editorial ‘What is stopping the NHS from using bevacizumab for macular degeneration and other retinal disorders?’ is co-authored by Professor Caroline MacEwen, President RCOphth and Professor Andrew Lotery, RCOphth consultant member.