The UK's Cancer Drugs Fund was poorly managed and - more than five years after the ring-fenced budget was established - its benefits to patients remain unclear, according to an influential committee of MPs.
The Public Accounts Committee (PAC) said the lack of patient outcomes data severely hindered the government's ability to adequately assess the impact of the Fund.
The Cancer Drugs Fund (CDF) was set up in 2010 by the then Conservative-Liberal Democrat coalition government as a temporary measure to improve patient access to cancer drugs not routinely available on the NHS.
But its initial £650m budget was soon exceeded, and the last two years alone saw spending increase by 138%. New arrangements for the CDF are due in April, by which point it is expected to have had a total lifetime budget of £1.27bn.
Meg Hillier MP, who chaired the committee, said: “It's clear the Fund requires significant and urgent reform if it is to be sustainable. A vital step in addressing the financial challenges must be to properly evaluate the health benefits of drugs provided through the Fund.
“If cancer patients seeking its support are to get the best possible treatment then there must be confidence that public money is being spent on the right medication, and at a fair price.”
Around 80,000 people have received drugs via the CDF, but for the two years 2013–14 and 2014–15 NHS England overspent its £480m budget by £167m.
Although NHS England did stop funding a number of drugs via the CDF last year, 2015 also saw the National Audit Office confirm the Fund was unsustainable in its current form.
There remains industry concern over patient access to new oncology treatments as well as the future shape of the Fund, with a consultation on its future shape due to close on 10 February.
UK trade body the ABPI said it shared the Public Accounts Committee's desire to achieve a “sustainable, affordable solution that provides rapid access to new medicines for NHS patients".
Dr Paul Catchpole, director - value and access, said: "At the moment too many patients miss out on access to new treatments. As the consultation on the way forward for the Cancer Drugs Fund comes to an end, we urge Government to seize the opportunity and transform the way cancer drugs are assessed by NICE to achieve a sustainable, affordable solution that provides rapid access to new medicines for NHS patients.”
Janssen UK & Ireland's managing director Mark Hicken appeared as a witness before the PAC's hearing.
He said: "We agree with the Committee that the Cancer Drugs Fund requires significant and urgent reform and share their concerns that NICE is not adequately resourced to implement the proposed new changes.
“Our primary concern is for patients to be given faster and earlier access to the best innovative medicines, in line with patients across Western Europe. We have offered, and will continue to offer, the NHS and NICE a number of options to help manage costs and ensure our medicines are routinely available on the NHS, as is the case in other European countries.”
But he said the current CDF reform proposals would “limit, rather than improve, access” by imposing even greater barriers.
“This will have a significant impact on the availability of many new cancer medicines and we are very worried for patients in England,” he added.
Responsibility for the CDF was transferred from the then 10 strategic health authorities to NHS England in April 2013 and it continued to pay for drugs that had either failed to win a NICE recommendation or had yet to be assessed by the cost-effectiveness watchdog.
Proposals in the current consultation would see the CDF turned into a 'managed access' fund to provide new treatments to patients before they have enough data to support a recommendation for routine prescribing.
NHS England's plans would see it provisional coverage decided based on a preliminary assessment by NICE, after which 'real world' evidence would be collected for up to two years on how well the drugs work in practice.
But the PAC said when the reformed CDF comes online NHS England must have clear objectives for it, be prepared to take tough decisions to ensure it does not overspend and look at whether “more flexible pricing arrangements covering a number of medicines could improve value for money”.
Regarding health benefits, the PAC's new report calls on NHS England to come back to the Committee by June 2016 "on what the available data indicate about the impact of the Fund on patient outcomes".
The PAC concluded: “We expect NHS England, in making changes, to take account of our recommendations and apply the clear lessons from the last five years to ensure that the new Fund is managed better in the future."