Long-awaited plans for the future of England’s Cancer Drugs Fund have now been unveiled, with proposals centred on a system for commissioning new cancer drugs that is fully integrated into NICE’s appraisal process.
According to the Institute and NHS England, which worked together on the plans, the new-look CDF has been designed to “help patients receive new treatments with genuine promise, while real world evidence is collected for up to two years on how well they work in practice”.
Under the new process, drugs would be given a conditional recommendation by NICE and their use enabled by the CDF for a pre-determined period, whilst further evidence on the longer-term benefits, which may not be available at the time of licensing, is collected before deciding on their routine use on the NHS in future.
At the end of this period, the drug would go through a short NICE appraisal based on the additional evidence. At this point, a positive recommendation would take drug into routine commissioning, while a negative one would see it move out of the CDF and become available only on the basis of individual patient funding requests.
In its current shape the CDF will run until April next year, funding cancer drugs from a set budget that have not been approved by NICE or are awaiting an appraisal. Going forward, the idea is that the CDF will instead become a transitional, managed access fund, “with clear criteria for entry and exit”.
“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,” said NHS England chief executive of NHS England Simon Stevens.
And in a clear message to pharma, he stressed: “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”.
“While it won’t avoid the ongoing need to make difficult judgements about how best to use the NHS' funding for cancer care, the development of these proposals is a big step forward in ensuring a process which will get the most promising drugs to NHS patients at an affordable price as quickly as possible,” noted Bruce Keogh, National Medical Director, NHS England.
The Institute for Cancer Research has welcomed the plans. “It does make sense for the Cancer Drugs Fund to pay for new drugs only after a provisional green light from NICE, to avoid duplicating the processes for deciding whether drugs should be made available on the NHS,” said chief executive Paul Workman.
“There are also promising signs of a desire to address the bottleneck we have in cancer drugs being approved for use on the NHS. The proposals could speed up the drug evaluation system – which is good news for everyone – and would increase the number of drugs which would be available for consideration under end of life criteria”.
Alison Cook, Cancer Research UK’s director of policy, said: “We’d like to see a single system for drugs approvals that can respond to the needs of patients. We welcome this consultation and now need to assess whether the proposals it sets out will be an improvement”.
But Baroness Delyth Morgan, chief executive at Breast Cancer Now, said: “with just five months left until the current Fund expires, we remain extremely concerned that there is limited time to review these proposals and consult in a meaningful way”.
“The problems with our system of drug access as it stands are huge. That’s why it’s vital that there is sufficient time for any proposed changes to be thoroughly assessed before they are put in place”.
The Association of the British Medical Association said it agrees that there needs to be “rigorous scrutiny of medicines, and medicines pricing, so that the NHS is confident it is getting value for money”.
But it also stressed that “too many patients are routinely missing out, hence, these are just the first steps in what needs to be wholesale reform of NICE and the way new medicines are fairly assessed”.