Major overhaul of Cancer Drugs Fund proposed

NHS England plans to introduce conditional NICE approval and real world data to make Cancer Drugs Fund sustainable. Andrew McConaghie reports.

The Cancer Drugs Fund (CDF) is to undergo a major overhaul from April 2016, aimed at still allowing access to new cancer treatments, but controlling costs and bringing it in to line with NICE.

The CDF was launched in late 2010 because of a growing outcry about patients being denied access to new cancer treatments – since then the fund has helped 72,000 patients, but its costs have spun out of control, causing a huge overspend for the NHS in England.

After several months of discussions behind closed doors, NHS England has put forward an 'emerging proposal' to reform the CDF.

NHS England released the proposal yesterday, which is to be discussed at today's monthly board meeting. The board paper states:

'The emerging proposal is that in future the CDF should become a 'managed access' fund for new cancer drugs, with clear entry and exit criteria. It 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.'

Download the proposal in full here.

Currently, NICE can only recommend or not recommend (i.e. reject) new drugs but, under the plans, treatments would be given a new 'conditional approval' by NICE. Funding would then be provided through the CDF for a defined period (as yet to be determined). During this time, further evidence from 'real-world' use would be collected.

At the end of this period, the drug would then undergo an abbreviated NICE appraisal, using the additional real-world evidence, and the company's offer price. NICE would then give either a positive recommendation (and move out of the CDF into mainstream commissioning) or a negative recommendation, exiting the CDF and becoming available solely through so-called 'individual patient referral'.

Another major change proposed would be to NICE's end-of-life criteria. This is a special mechanism introduced some years ago to take into account the value of a few extra months at the end of a life. However it has rarely been used, as most drugs don't meet its strict criteria. Tweaking this would give some leeway to promising drugs which don't have much robust efficacy data at launch.

Benefits for patients, NHS and pharma

The need for reform is based on the ever-rising CDF budget, which from next year increases to £340 million. The Fund is one of the biggest sources of overspend within the NHS England budget, but cancer's 'special status' within healthcare has made the CDF difficult to reform.

In January this year, efforts to trim the CDF budget, and weed out drugs considered not clinically or cost effective were made, via 'de-listing'. However it has been clear that this approach was not enough to solve the CDF's problems; even the pharma industry and cancer patient groups have long agreed that it is a 'sticking plaster' solution to a much bigger problem.

NHS England's document has set out benefits for the NHS, the pharmaceutical industry and patients. It says patients will gain access to drugs for which there is 'insufficient data to support routine use, but which may, nevertheless be the right choice for them'.

For the NHS, it says the new approach would be a 'careful process', which contains costs and only selects drugs where there is reason to believe that additional data can be collected to prove its value.

For pharma, it says the process will be a more 'transparent and contestable process' – something which pharma and patient groups agreed has not been the case with the current CDF.

NHS England added that 'new mechanisms will also need to be built into the fund to enable expenditure to be controlled within the allocated budget'.

Stop pharma getting away with it?

The CDF's chairman Professor Peter Clark made it clear a year ago that he believed the CDF needed to be reformed, and not least because it allowed pharma companies to bypass NICE's cost-effectiveness scrutiny.

NHS England's proposal quotes this week's report from the Independent Cancer Taskforce, which made similar comments.

While noting its benefits to cancer patients, the Taskforce report says: '...because it has also enabled some pharmaceutical companies to bypass NICE cost-effectiveness assessments, it is widely acknowledged that it is no longer sustainable or desirable for the Cancer Drugs Fund to continue in its current form'.

It said a solution was needed that ensured patients had 'routine access to a greater range of cancer drugs, including earlier access to innovative drugs, while ensuring that cost-effectiveness is maintained'.

NHS England says it aims to adopt this as its own position – a clear signal that pharma is likely to face new pressure to justify its prices. The NHS has been collecting real world data in connection with the CDF for some time (via SACT), but the system has been hampered by data collection issues. Once up and running, it is envisaged the SACT database will allow 'value based pricing' (VBP), based on real-world outcomes. The UK industry has been calling for greater VBP and flexible approaches – but it is by no means clear that this will inherently favour pharma's bargaining position.

That's because many crucial details have yet to be decided: the terms of how real-world evidence is collected, and how long drugs will be given 'conditional approval' in which to prove their value, for example.

The proposals will now be put out to consultation in September, with the aim of putting the new arrangement in place by April 2016.

NHS England staying in control

The new plan has been authored by NHS England's national medical director Sir Bruce Keogh and its chief financial officer Paul Baumann. The solution has emerged suddenly, most likely spurred on by several factors. Firstly, the CDF looks set for more drug de-listings, a process which plays badly in the media, and has been condemned as unfair and not transparent. Providing a long-term solution should help lessen the impact of any de-listings.

Secondly, the Accelerated Access Review (AAR) aimed at creating a 'lit pathway' for innovation entering the NHS is now in full swing, and is due to report by the end of this year. NHS England says it is 'clearly important' its proposals don't clash with those emerging with this initiative, and its plans for an accelerated access pathway. Clearly, NHS England wants to set the agenda, and didn't want to wait for the AAR review to reach its own conclusions first.

Finally, the most urgent reason is cost: the NHS is under huge financial strain, and must find £22 billion in efficiency savings over the next five years. For NHS England, the CDF's ballooning cost has been one of its biggest headaches, causing a £214 million overspend in its specialist commissioning budget in 2014/15. The CDF budget will rise to £340 million in this financial year, but has threatened to keep on rising without further intervention.

Pharma industry reaction

Paul Catchpole, ABPI Director of Value and Access has welcomed the news, saying it was "a move that the ABPI broadly supports, as long as cancer patients can continue to access the medicines they need."

He added: "We have said all along that the Cancer Drugs Fund (CDF) 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."

But Catchpole said there should be further reform, calling the move "a much-needed bridge to greater reform of NICE" so that all patients can benefit from improved access to new medicines. He indicated that the AAR could bring about this larger change.

He said the reforms could help the UK match the levels of access to cancer drugs seen in other European countries.

The new proposals address some key areas the ABPI has been lobbying for for some time, including a more flexible NICE 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," Catchpole concluded.

NHS England's board meets today to discuss the plan, and patient charities will be watching for further details before declaring their own verdicts on this major overhaul.

Watch the NHS England board meeting live today from 10.30am (UK time) here.

Read the NHS England board papers for today's meeting (23 July) here.