After five years of by-passing NICE, England’s Cancer Drugs Fund will now be managed by the health technology assessor as the future of the siloed budget looks in doubt.
This is according to NHS England’s board meeting papers, where the health service’s top commissioning body wants the CDF to become a ‘managed access’ fund for new cancer drugs, with “clear entry and exit criteria”.
The papers add: “It [the CDF] would be used to resource those drugs which appear promising, but where NICE indicates that there is insufficient evidence to support a recommendation for routine commissioning, and where additional evidence would be likely to enable a more informed NICE appraisal decision.
“Instead of a simple failure to recommend, the drug would be given ‘conditional approval’ by NICE and provided through the Fund for a defined period, whilst further evidence from real world use was collected.
“At the end of this period, the drug would go through an abbreviated NICE appraisal, using this additional evidence and the company’s offer price, and then either attract a NICE positive recommendation at which point it would move out of the Fund into mainstream commissioning, or a NICE negative recommendation at which point it would move out of the Fund and become available only on the basis of individual patient referral.”
This is in stark contrast to the original motives behind the Fund, which was established in 2010 to essentially by-pass NICE, and fund new cancer products that had been rejected by England’s health technology assessor, or while they were under assessment.
It was meant to just be an interim budget to help bridge the gap in access to these treatments before the creation of a new drug pricing system, known as Value-Based Pricing.
VBP however failed to be approved and the issues around access from 2010 remain today; politically it has also proved difficult for the government to remove this Fund as it has proven popular with the media and patients.
This latest announcement however may be the first step that will see the government quietly dismantle the Fund, and eventually allowing NICE full control over these medicines once again.
NHS England said that the future of the Fund will be discussed at its next meeting in September – it is currently due to end in March of next year, although this comes after several extensions to its original end dates.
Overspend
NICE has continued to assess these drugs, but the now £340m a year Fund has been there as an option to pay for drugs not deemed cost-effective. Since October 2010, around £1bn has been injected into this silo budget.
In the first three years of the Fund there was in fact a sizeable underspend of the annual budget, but as knowledge of the CDF spread and NICE rejected more new cancer drugs, NHS England is now dealing with a major overspend, with the spend for 2014-2015 being £80m higher than budgeted for.
This led to drastic action earlier this year when NHS England for the first time began to look at the price of these medicines, and decided to cull more than a dozen drugs from its approved funding list, leading to anger from patients and pharma alike.
NHS England said it had to do this in order to keep costs down, but this was moving the body closer to NICE in terms of its role, with many health economists arguing that this was simply a duplication of effort between the two bodies, which were saying ‘no’ to the same drugs twice.
In fact, NICE argued the same in a parliamentary hearing in September last year after its chairman Professor David Haslam said that NHS England should be using its processes to assess these drugs. A year later, this is now going to happen.
Removing the ‘sticking plaster’
Paul Catchpole, director of value and access at the ABPI welcomed the news, saying the UK trade group “broadly supports” the move – but with the caveat that cancer patients can continue to access the medicines they need.
Catchpole said: “We have said all along that the Cancer Drugs Fund was nothing more than a sticking plaster, albeit one that has enabled thousands of patients to access cancer medicines, and that NICE, along with NHS England, needs to develop a longer-term sustainable solution to the evaluation and commissioning of cancer medicines.
“This move should help provide a much needed bridge to greater reform of NICE so that all patients can benefit from improved access to new medicines.”
He added: “We are pleased to see that the new proposals intend to address some of the key areas for change that the ABPI has been calling for and in particular a new system aligned with NICE to deliver a more robust and rapid evaluation process, flexibilities around the use of the current end-of-life criteria and the introduction of conditional NICE approvals for promising medicines until additional evidence can be collected. There is more to be addressed but it is a very encouraging start.”