NHS England's siloed budget and its uncertain future
The Cancer Drugs Fund has been a major point of controversy over the past five years as health economists and politicians question why such a Fund should exist.
It was originally set up in October 2010 with a £50m budget to pay for new cancer drugs either rejected by NICE, or under appraisal by the watchdog. From April 2011, this budget was stretched to £200m a year.
The Fund [pronounced 'unsustainable' today by the National Audit Office] 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).
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.
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.
And after five years of by-passing NICE, this is set to happen, as England's Cancer Drugs Fund will now be managed by the health technology assessor.
NHS England, the health service's top commissioning body, has said it wants the CDF to become a 'managed access' fund for new cancer drugs, with “clear entry and exit criteria”.
The Board of NHS England said in a statement: “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 bypass NICE. It will now run parallel alongside it, with NICE's final decision having an impact on its place in the Fund.
This latest announcement 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.
The CDF is currently due to end in March 2016, although this comes after several extensions to its original end dates.
CDF a 'missed opportunity'
But despite uncertainties over its future, some continue to question its past - specifically what NICE, the government and pharma have been able to learn from the Fund.
According to the former health minister Paul Burstow, the CDF has been a 'missed opportunity' for all stakeholders.
Speaking to PME for its UK Pricing, Value and Access supplement, Burstow said: “Really, we've gained no insight or learning from the dozens of drugs being funded within the scheme. The quid pro quo of paying for these treatments was that there was proper and systematic reporting and recording of real-world data, so that was then capable of being fed back into the NICE process for a final decision about whether that drug should, or should not, be available.
“But this hasn't happened - and [data not being collected] is the main criticism coming from the National Audit Office and it's clear to see that the CDF process has missed that opportunity.”
NICE has effectively been an observer of the Fund, with no information from its use coming back to the Institute. Burstow believes the watchdog should have been able to access this data to help it decide whether the oncology treatments it rejected were in fact worthy of gaining NHS funding.
He also questioned whether, instead of having a silo fund just for cancer, if the government “could have operated patient access schemes in the context of the CDF” – ie, allowing some of these medicines to be funded by having pharma offering discounts, rather than just paying out the full price from the Fund.
Burstow also asked whether the CDF should be just for cancer - or, in fact, just for drugs. He explained: “I would personally propose a 'drugs and devices fund' that was broader in its scope than just for cancer - it has to be an aid to bringing drugs to access at an earlier stage.
“But again, the quid pro quo has to be that there are processes put in place to ensure that what we learn from it is meaningful, and can then inform judgements at a later stage by NICE.”
By Ben Adams, PMGroup editor