NICE announced on 19 November 2015 that a 12-week consultation has started on draft proposals outlining new arrangements for the Cancer Drugs Fund (CDF). It will enable patients to receive new treatments that can't yet be recommended for routine use but which have genuine promise, while real world evidence is collected for up to two years on how well the drugs work in practice.
The proposals are aimed at providing patients with access to promising new medicines while the evidence is still emerging, in a financially sustainable way.
They are intended to create a system that captures data and information on new medicines and other technologies to develop a more robust evidence base.
The proposal is that the CDF will become a ‘managed access’ fund for new cancer drugs to give early access to those drugs which appear promising but which have currently uncertain evidence bases which are insufficient to support a recommendation for routine commissioning. The new scheme would operate from April 2016.
All new cancer drugs will normally receive a clear ‘yes’ (baseline commissioning), ‘maybe’ (CDF funding for time limited period), or ‘no’ funding decision within 90 days of market authorisation.
The new CDF will collect important information on longer-term benefits which may not be available at the time of licensing, as the chief executive of NICE, Sir Andrew Dillon, explained:
“Our joint proposals will ensure that the Cancer Drugs Fund is used to provide patients with promising medicines at a cost which reflects the uncertainty about their effectiveness and cost effectiveness and at the same time, generate additional data to help the NHS make a longer term decision on whether and how to use them.”
Simon Stevens, Chief Executive of NHS England, said: “Over the next five years we're likely to see many new cancer drugs coming on to the worldwide market - some of which will be major therapeutic breakthroughs, and some of which will turn out to offer little extra patient benefit but at enormous cost.
"The new Cancer Drugs Fund offers a route for sorting out the wheat from the chaff, so that patients in England get faster access to the genuinely most promising new treatments. For those drug companies willing to price their products affordably while sharing transparent information about 'real world' patient benefit, the new CDF will offer a new fast-track route to NHS funding.”
The original CDF was established in 2011 to fund cancer drugs in England that are not currently approved by NICE. The current CDF runs until April 2016.
The proposal issued on 19 November for public consultation outlines a new system, fully integrated into the NICE appraisal process, where the CDF becomes a transitional fund – with clear criteria for entry and exit.
This is in line with the recommendation of the recently published independent Cancer Taskforce report, which proposed that the new CDF should operate with NHS England and NICE.
It’s proposed that from April 2016, all new cancer drugs will be referred to NICE for appraisal. Cancer drugs would normally receive draft guidance from NICE before market authorisation, and final guidance normally within 90 days of market authorisation being granted.
The outcome of each initial NICE appraisal will be a recommendation falling into one of the following three categories:
Recommended for routine use
Not recommended for routine use
Recommended for use within the CDF
At the end of the period for use within the CDF, the drug will go through a short NICE appraisal, using the additional evidence.
The drug will then attract either a NICE positive recommendation, at which point it would move out of the CDF into routine commissioning. Alternatively, it will receive a NICE negative recommendation, meaning it would move out of the CDF and become available only on the basis of individual patient funding requests.
The consultation will run for 12 weeks until 11 February 2016.