When the government created the Cancer Drugs Fund (CDF) in 2010 to pay for cancer drugs rejected by the National Institute for Care and Health Excellence (Nice), it was intended as a short-term stopgap until a longer-term solution to the problem of evaluating and funding cancer drugs for terminally ill patients could be developed.
The fund, which was given £200m a year to spend on drugs, was set up in a context of media stories about cancer patients being denied life-extending drugs. Since then, 60,000 patients have received drug treatments funded by the CDF. Although initially welcomed by cancer charities, many feel it has outstayed its welcome.
Owen Sharp, chief executive of Prostate Cancer UK, says it creates an additional layer of bureaucracy, with the result that patients in some parts of the country are less likely to receive drugs from the fund than others, adding: “The fund was set up as a short- to medium-term fix, and I think it has proved to be exactly that.”
It soon became clear that the fund was going to overspend its budget, and in January NHS England announced that it would remove funding for 25 of the drugs currently paid for from the CDF (although it also added four new drugs). While patients already on those drugs will continue to receive them, they will not be available for new patients. Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry (ABPI), has reservations about the process by which the decision was reached: “Nice uses a very sophisticated approach to evaluate medicines, taking all the different costs and benefits into account, whereas the approach that NHS England took is a much more blunt instrument.”
Cancer charities, too, are unhappy with the decision. Diana Jupp, director of services and campaigns of Breast Cancer Care, says that women who might have benefited from being moved on to certain drugs would now be denied them: “Taking away that potential option of a longer extended lifetime with your family is really frightening.”
The CDF is now being propped up with more money: it will receive £280m in 2014–15 and £340m in 2015–16. In the meantime, the proportion of new cancer drugs rejected by Nice has grown: in 2011–12 Nice rejected nearly 60% of new cancer drugs put forward for approval, compared with 46% in 2009–10.
The government is committed to maintaining the CDF until March 2016, and has said it will consider what arrangements should be put in place in the longer term. The Labour party has said it will create a £330m Cancer Treatments Fund, starting when the CDF runs out, which will fund the latest forms of radiotherapy and surgery as well as drugs. The Liberal Democrats have not yet made an announcement about their plans.
Yet there is widespread agreement among stakeholders that the fund is not viable in the long term, and that a better solution needs to be found. A working party was set up last month with representatives from NHS England, the Department of Health, cancer charities, Nice, the Ethical Medicines Industry Group and the ABPI to agree a system to replace the CDF – which may well entail giving decision-making back to Nice. Emlyn Samuel, senior policy manager at Cancer Research UK, argues that this would give Nice “a lot more control over negotiations with pharmaceutical industries about how drugs can be priced appropriately for the NHS”.
However, deciding which drugs provide value for money and which don’t is not straightforward. The cancer drugs approved by the CDF extend life rather than offer a cure. They are expensive: a drug known to prolong life for a few months may cost tens of thousands of pounds – though Mark Flanagan, CEO of Beating Bowel Cancer, points out that the market price often quoted is higher than the discounted price offered to individual trusts.
Nice uses a measure known as quality-adjusted life years to evaluate whether a drug gives value for money, and is based on the quality and quantity of additional life a drug would provide. The figures are set against the particular cost of a drug. As Flanagan says: “It gives a health economist’s measure of what is valuable, which is different from what life tells us is valuable.”
Sharp agrees: Many patients would prefer a drug that gave, say, two years of good quality life over five years of poor quality, he says. And Jupp argues that, while reports on clinical trials show a drug extending life for three to six months, for individual women, it may give two years or more: “Many women living with secondary breast cancer are still at work, they’re still looking after their children, caring for their parents, so that value is quite high.”
There are other reasons why the current system is less than satisfactory. Flanagan says that Nice’s evaluation of cancer drugs is based on clinical trial data that is by nature short-term. In the real world, a cancer drug may shrink a tumour, which then makes it possible to remove the tumour by surgery. That cumulative benefit, he says, is “completely ignored in the assessment of the drug’s value and clinical effectiveness”.
Furthermore, he argues, cancer doctors take an increasingly targeted approach to treating patients in the knowledge that individual patients with particular types of tumour will respond differently to treatment: “We’re getting to the stage where you’re getting smaller and smaller patient populations and you need to have a very complex and real life approach to what works.”
So, what should be the long-term approach to funding cancer drugs? Flanagan suggests a system of paying drug companies according to how effectively their drug performs in practice. Catchpole would like to see an approach where, once a drug has been approved by the regulator, access could be granted while data is collected about its real life impact: “It means that patients can continue to benefit and at the same time we start to gather more evidence.”
In practice, the approach will have to be hammered out by the industry working in partnership with patient groups, Nice and the Department of Health. Everyone agrees that it will be difficult, but there is a consensus that the CDF is not the solution. As Samuel says: “We’d like to see a day when there isn’t a need for the Cancer Drugs Fund because Nice appraisal processes work effectively for cancer drugs.”
