New lipid drug for a million patients
GPs will be expected to treat up to a million patients in England and Wales with a new add-on treatment for high cholesterol under a dramatic provisional ruling from NICE.
A draft technology appraisal of ezetimibe advises use of the drug whenever high-dose statin treatment fails to control cholesterol levels on its own.
More than a quarter of patients on statins will be eligible for combination treatment – landing PCTs with prescribing bills with the potential to run
into hundreds of millions of pounds.
Ezetimibe is set to become the first non-statin cholesterol treatment to be recommended by NICE, and is advised ahead
of second-line drugs such as
The final judgment will legally require PCTs to fund the drug and is set to put huge strain on budgets, with some GPs criticising the provisional ruling as an 'expensive option'.
An accompanying technology assessment report, commissioned by NICE, said 28 per
cent of all those on statin
treatment fail to hit targets and will meet criteria for the drug. That currently amounts to 784,000 patients, although the number on statins is rising all the time.
The report said the benefits of ezetimibe treatment were 'potentially large' if cholesterol reductions corresponded to falls in cardiovascular events, but admitted there was a lack of long-term data on efficacy and safety.
And it warned: 'Although
future uptake is unknown, if
all eligible patients are prescribed ezetimibe the impact on projected budgets could be substantial.'
Use of the drug is already
spiralling, with an estimated 157,000 people to receive it this year at a cost of some £54.3m. This is up from 56,960 in 2005, but still far short of the number eligible under the guidance.
GP cardiovascular experts were split over NICE's decision.
Dr Stewart Findlay, treasurer of the Primary Care Cardiovascular Society and a GP in Bishop Auckland, County Durham, said: 'If patients don't achieve control on simvastatin I add in ezetimibe all the time now. Quite clearly it gets your LDL down.'
But Dr George Kassianos, a GP in Bracknell, Berkshire, and member of the society, said: 'It's an expensive option. Ezetimibe is about £25, plus £3.50 for simvastatin. This compares with about £18 for rosuvastatin 10.'
NICE plans to issue the final appraisal in August, with the consultation open until 5 April.
Who will be eligible?
Consider ezetimibe for primary hypercholesterolaemia when:
• Cholesterol levels are not controlled after dose titration of current treatment
• Dose titration has been limited by statin intolerance