Policy and regulation stand in the way of NHS use of unlicensed eye injection drug with potential to save millions of pounds

Eye injection drugs recommended by
NICE cost the NHS up to £447 million annually, but could be replaced by an
unlicensed drug, bevacizumab, costing as much as ten times less. Use of the two
licensed drugs, ranibizumab and aflibercept, has increased three-fold over the
last five years, with some parts of England treating five times as many
patients as others.

NIHR-funded researchers at the
University of Bristol investigated NHS use of ranibizumab and aflibercept in
treating a range of eye conditions that lead to blindness. Their paper,
published in
BMJ Open,
shows that the NHS is spending the equivalent of a large clinical commissioning
group’s (CCG) entire annual budget on these drugs alone.

A growing body of evidence
indicates that bevacizumab is equally effective and safe in treating eye
conditions. But CCGs and clinicians aren’t allowed by law to prescribe the
cheaper alternative as it’s not recommended by the UK’s regulatory framework,
which demands that a drug must be licensed for a specific use before NICE can
recommend it.

The drug company that owns
ranibizumab also owns bevacizumab, which is licensed for use as a cancer
treatment in the UK. While it is widely used to treat eye conditions in other
countries, including the US, there is no commercial incentive for the company
to seek a licence for the cheaper drug for use in eyes.

Professor Will Hollingworth from
the Bristol Medical School: Population Health Sciences, who led the research,
said:

“In a time of huge financial pressure on the NHS, these restrictions are
limiting CCGs’ ability to choose a cheaper but equally effective treatment. It
is unacceptable that current interpretation of the regulatory framework is
standing in the way of making this cheaper alternative treatment universally
available on the NHS.

“Each area in England is being
asked to make massive savings. In this context, the widespread use of these
more expensive drugs doesn’t add up. There is a desperate need for policies
around drug licensing to change, and we are calling on politicians and the
Department of Health to make the necessary changes.”

Paper

‘Changes in the frequency and cost of anti-vascular endothelial therapy, and inequalities in access, in England between 2005 and 2015’ by William
Hollingworth, Tim Jones, Barnaby C Reeves, Tunde Peto, in
BMJ Open