RNIB's position remains that patient safety is paramount. While we still have some concerns about the potential impact of a decision to appraise Avastin on the regulatory system and the future development of sight-saving treatments, RNIB would welcome:
a) a thorough regulatory review of the safety of Avastin carried out by an independent expert body, preferably the Medicines and Healthcare products Regulatory Agency (MHRA), and
b) a clear plan to monitor the ongoing usage of the treatment (pharmacovigilance), provided Avastin is found to be safe and cost effective.
RNIB statement following the publication of the report on NICE's website:
6 December 2010
Steve Winyard, RNIB Head of Campaigns and Policy, says: "RNIB has always pressed for patient safety to lie at the heart of any decision about drug treatments, so we are pleased to see this recognised in the conclusions drawn by NICE.
"We fully support a thorough regulatory review of the safety of Avastin (bevacizumab) for use in the eye if carried out by an expert body such as the Medicines and Healthcare products Regulatory Agency, and expect that evidence from the CATT and IVAN trials will inform these investigations. However, a safety review should take place before an appraisal of cost-effectiveness begins, as to run these in parallel risks a waste of resources should the drug not meet the safety criteria.
"RNIB also believes it is vital that a national body is identified to take responsibility for risk management and pharmacovigilance to monitor the on going usage of Avastin in the eye if it is found to be safe and cost-effective."
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For further information contact pressoffice@rnib.org.uk