26 February 2016
When the Cancer Drugs Fund (CDF) was launched in 2010, it promised swift access to new cancer treatments for patients who could not afford to wait for the thorough but long regulatory evaluation processes – an early forerunner of Accelerated Access.
This made a lot of sense; cancer patients who had effectively exhausted available therapeutic options wanted to take part in trials of potential new treatments. Since they were likely to die relatively soon, many felt happy to accept a higher level of personal risk than a healthy person might, so it seemed only sensible for them to access the treatments. The information generated from use in patient volunteers would also be of value in strengthening the evidence base for subsequent assessment by regulators.
However, from the beginning there was a major flaw in the CDF, since it also provided funding for cancer treatments that had already been assessed and found by the National Institute for Health and Care Excellence (NICE) not to be cost-effective. That is, they might offer some marginal health benefit, on average, but at an unacceptably high cost of higher than the threshold level of around £30,000 per quality adjusted life year or QALY, a standard health economic measure.
To have a national fund effectively circumventing the national body charged with making decisions on cost effectiveness was nonsense from the start, and the consequences were arguably disastrous for a financially pressed health service: CDF spending rapidly escalated from an annual budget of £200 million to over £340 million.
As the price tag for new drugs made available via the CDF rose inexorably, some said that drug companies were exploiting the extra funding to push up the price for new treatments. Pharma companies disagreed; Richard Erwin of Roche told the Financial Times last year: “The UK has to work within the European pricing framework...There is no justification for the UK to have lower prices than the rest of Europe”. Nevertheless, NICE refused to approve Roche’s Kadcyla drug for general NHS use due to the £90,000 per person cost – despite access having been granted via the CDF.
In fact, as virtually the sole provider of healthcare for the UK’s population, the NHS does have a degree of negotiation power over drug pricing; at the end of the day, drug manufacturers do not have to sell to the NHS, if the price is not right. But the market is so large that many providers will accept reduced prices, and are well aware of NICE’s cost effectiveness assessment framework.
This is not to say that improving cancer treatments is not a vital and urgent task for innovative science. Several of my nearest and dearest have had cancer; some have it now; some have died from it. The more effectively we can treat cancer, the better; and the sooner the better too; I’m sure this is a very common, if not universal sentiment. However, the fact remains that the NHS has a massive job to do on an inadequate budget, and spending decisions have to be made. Ignoring the rational decision-making structures as the CDF did risks damaging care for other conditions; what we spend on cancer drugs, we cannot spend on incubators for premature babies, or dialysis for kidney patients. Or indeed services for rare diseases, as the PHG Foundation highlighted last year when it queried why the CDF was exempt from prioritisation processes for specialised services.
Jo Churchill MP, Chair of the new All-Party Parliamentary Group on Personalised Medicine, a self-proclaimed cancer survivor, herself observed in a House of Commons debate in January: “It must be remembered that the Cancer Drugs Fund is unique: cancer is the only condition with a dedicated fund…I am a little concerned that cancer is being labelled as a special disease. My surgery often includes patients with other diseases, and we must look across the piece. My concern is that we should have a road map from the accelerated access review so that we can learn how to drive forward advances not only for cancer, but for all areas of medicine”.
Fatally, the CDF also failed to properly evaluate the health benefits of the early and exceptional access to treatments for some 80,000 cancer patients – a failure slammed by the Public Accounts Committee (PAC) enquiry into the CDF that reported earlier this month, observing: "the Department of Health and NHS England do not have the data needed to assess the impact of the Fund on patient outcomes, such as extending patients’ lives, or to demonstrate whether this is a good use of taxpayers’ money". Meg Hillier MP, Chair of the PAC, said that the CDF required "significant and urgent reform if it is to be sustainable".
Now NHS England has announced that from July next year, the Cancer Drugs Fund will have a fixed budget of £340m and that, crucially, NICE will decide which drugs can be accessed by the fund. This should mean early access to the best innovative treatments for those cancer patients most in need, as opposed to exceptional access to expensive drugs with limited benefits.
The problem is that we are in a transitional stage on the journey towards personalised medicine. Developing innovative treatments is a costly business; companies are embracing the value of genomics in helping them to do so, but the products often fail to justify the prices in terms of their average effectiveness. Only by also using genomics to evaluate and appropriately stratify patients into sub-populations and identify those sub-groups in whom a treatment will genuinely be useful will we see the sort of effectiveness that we need to justify a high cost.