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RCOphth recommends appraisal of the use of bevacizumab (Avastin) for age related macular degeneration

1 November 2014

The Royal College of Ophthalmologists recommends UK regulatory bodies appraise the use of bevacizumab (Avastin) for age related macular degeneration potentially saving the NHS over £100million a year Age related macular degeneration (AMD) is the commonest cause of blindness among elderly people in the developed world1.

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. Ranibizumab (Lucentis), the first drug used to treat this condition was licensed for AMD treatment and approved by NICE in 2008. Two major studies, the CATT2 and the IVAN3 studies, found that an alternative drug, bevacizumab (Avastin), which is licensed for the treatment of some cancers, but does not have a licence for use in AMD, was as effective as the licensed ranibizumab. Several other studies and a Cochrane review have supported the effectiveness and safety of the two similar drugs.

The IVAN study also identified that using bevacizumab could save NHS England £102million a year4, money which could be used to relieve the capacity issues in hospital eye clinics which can result in avoidable sight loss for patients. Drugs are appraised for cost and clinical effectiveness by the National Institute for Health and Care Excellence (NICE) after being licensed by the Medicines and Healthcare products Regulatory Agency (MHRA)7. Drugs are normally submitted for approval by the pharmaceutical company that owns them.

Roche, which owns bevacizumab, has not applied for a licence for its use to treat AMD. Professor Andrew Lotery, RCOphth consultant member and co-author of the editorial ‘What is stopping the NHS from using bevacizumab for macular degeneration and other retinal disorders?’ published online at the BMJ today, said ‘I feel it is important to highlight the evidence of an effective drug treatment. Not only does bevacizumab provide benefits for patients, it provides ophthalmologists with alternative treatments and provides savings for the NHS. This is particularly important at this time when we have been asked to preserve and innovate health services. We know funding is limited and will be for some time’.

Licensed medicines can be used to treat diseases and conditions that they were not originally licensed for. When used in this way, they are called ‘off-label’. However, the General Medical Council (GMC) states that doctors should prescribe unlicensed drugs only if ‘there is no suitably licensed medicine that will meet the patient’s need’5. Therefore, in the context of AMD where licensed alternatives exist it is difficult for ophthalmologists to prescribe bevacizumab because it is not licensed for this purpose. In countries where this guidance does not apply bevacizumab is widely used. For example in the US, bevacizumab is the market leading drug for neovascular AMD6.

RCOphth is asking that the regulators find a way to license a drug or NICE to find a way to consider an off-label drug that is not being sponsored or submitted for appraisal by the company which owns it. In doing so, ophthalmologists will have the option to use bevacizumab as an effective treatment for their AMD patients in the UK, saving the NHS millions of pounds a year and relieving some of the capacity issues.

RCOphth provides ophthalmic expertise to the UK’s regulatory organisations to support the use of this drug which has a body of evidence for its effectiveness and safety and has had wide clinical use worldwide.

Notes to Editors

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.

Sources

  1. 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.
  2. 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. Dakin HA, Wordsworth S, Rogers CA, Abangma G, Raftery J, Harding SP, et al. Cost effectiveness of ranibizumab and bevacizumab for age-related macular degeneration: 2-year findings from the IVAN randomised trial. BMJ Open 2014;4:e005094.
  5. GMC. Prescribing guidance: prescribing unlicensed medicines. 2013. http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp
  6. Curtis LH, Hammill BG, Schulman KA, Cousins SW. Risks of mortality, myocardial infarction, bleeding, and stroke associated with therapies for age-related macular degeneration. Arch Ophthalmol 2010;128:1273-9.
  7. MHRA  https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk