England's revised Cancer Drugs Fund to begin in April
NICE will begin a new method of assessing drugs on England's Cancer Drugs Fund (CDF) from 1 April, when it will decide whether the medicines on the existing scheme have enough new cost-effectiveness data to support routine funding.
The changes, approved by NICE's board earlier this week, are in preparation for a new methodology coming into effect from July, when the cost-effectiveness body will begin issuing draft guidance on new cancer drugs before they have received marketing approval in the UK.
NICE said it will appraise drugs transferring from the old fund over the next 18 months, starting with those that have already been assessed.
From July, NICE will begin assessing new cancer drugs ahead of marketing authorisation so any drug given a positive draft recommendation would be funded by the NHS from the point of licence.
If the case for routine use is not clear, and more evidence is needed to prove cost effectiveness, NICE can recommend the drug for temporary, conditional use paid for by the CDF.
The drug will remain available within the fund for up to two years while the manufacturer gathers cost-effectiveness data.
After two years NICE will conduct a shortened review to consider the drug for routine funding on the NHS.
Under existing arrangements, the CDF is funding some drugs rejected by NICE, and some that have yet to be appraised.
The new arrangements are intended to speed up NICE's decision making and give patients faster access to innovative new cancer drugs.
This will either result in routine funding or, if the company has not been able to demonstrate its case, the drug will be made available on an exception basis only.
NICE said the changes are designed to be fairer to industry and the taxpayer, giving an opportunity for manufacturers make a case for funding while giving patients fast access to drugs deemed to be cost effective.
But the Association of the British Pharmaceutical Industry trade body's value and access director, Dr Paul Catchpole, said the changes "confirm a seemingly reduced level of ambition" for providing patients with access to the latest cancer drugs.
Catchpole added that minister for life sciences George Freeman's Accelerated Access Review, which is considering ways of making new drugs available in the UK, is due to publish findings in April.
This could "provide a further opportunity to consider the UK's ambition to provide patients with access to all new medicines, in a more coordinated way," said Catchpole.
The CDF was originally introduced in 2011, and provided £200 million per year for cancer drugs rejected by NICE.
But it consistently overspent and has now grown to £360 million a year, even though NHS England has removed many drugs following additional cost-effectiveness assessments.
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