Tuesday, September 09, 2014

Which way now for the Cancer Drug Fund? by Andrew Jack

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g5524 (Published 09 September 2014)
Cite this as: BMJ 2014;349:g5524

Andrew Jack, deputy editor, analysis, Financial Times, London, UK

The government has extended the Cancer Drug Fund for a further two years and increased its budget. Andrew Jack explains how it works and why it is controversial

What is the Cancer Drug Fund?
The Cancer Drug Fund was created in 2010 by the coalition government to pay for new cancer drugs that the NHS would otherwise not have provided because the National Institute for Health and Care Excellence (NICE) considered they were not cost effective. A budget of £200m (€250m; $330m) a year was set for four years using money the government initially said had been saved by the NHS “through our pledge to stop the rise in employer National Insurance contributions from April 2011.”1

Oncologists can apply to the fund on a case by case basis, and they usually do this after a drug has been rejected by NICE. Committees of medical specialists decide whether to approve a drug for NHS use based on a 12 point scale for clinical effectiveness. Since it was created, the fund has approved about 43 drugs for 80 different indications,2 allowing an estimated 55 000 patients to receive treatment. Around 20 drugs (for 31 indications) have been refused.

Why was it set up?
NICE was rejecting a growing number of new cancer therapies because it considered them too expensive for their modest benefits (usually only a few months of extended life expectancy). It was attacked by patient groups and parts of the media, which highlighted cases of patients being refused treatment, criticised the agency’s methods, and pointed out the UK’s overall poor performance in successfully treating cancer compared with other countries.1 There was also argument over patients willing to pay out of their own pockets for drugs not recommended by NICE, and the obligations the NHS would have for their continued care.

Isn’t the fund a way of bypassing NICE?
Yes—critics say the creation of the fund was poor policy because it represents “onco-exceptionalism,” ignoring the cost effectiveness criteria by which most other drugs are assessed for reimbursement by the NHS and thus creating an inefficient allocation of scarce NHS resources not justified by evidence. NICE’s chief executive, Andrew Dillon, argues that it does not make sense that when NICE rejects a drug for routine use, “in most cases the Cancer Drug Fund then says yes to the treatments we have said no to.”3

The fund also takes away the incentive created by NICE for drug companies to reduce the prices of their new drugs for the NHS. Drug companies normally continue to apply to NICE for scrutiny of new cancer drugs and may offer discounts through “patient access programmes” if the initially proposed prices are judged too high. But if their products are rejected, they have recourse not available for other medicines: they can still seek approval from the Cancer Drug Fund at the price rejected by NICE

Why has the fund just been given additional resources and extended for two years?
As the fund has approved new, better drugs, none of the less effective products have been removed from its list and the number of patients on funded drugs has steadily risen. That has helped swell total demand, breaking the annual £200m budget originally agreed. In late August, it was expanded to £280m a year for an extra two years, 2014-16. On the current trajectory, it is set to spend up to £1.2bn in total.

Presumably that makes drug companies and patients very happy?
Not all of them. Roche, which produces many cancer drugs (including trastuzumab emtansine for breast cancer, which was rejected by NICE in August at £90 000 a treatment) has been a prime beneficiary. Others are less content. Under the terms of the most recent Pharmaceutical Price Regulation System agreed between the Department of Health and industry4 any increase this year in the total NHS medicines bill must be absorbed by companies. That means if the fund pays for more cancer drugs, the producers of drugs for other conditions must absorb the difference by reducing their prices.

Similarly, although cancer patients may be thrilled to have access to potentially life extending drugs, and politicians have stressed that the cancer fund’s annual budget does not displace other NHS spending, some clinicians have expressed concerns that the fund squeezed out money from other areas, especially at a time of intense cost cutting. Even some cancer specialists argue that better outcomes might have come from channelling additional funds into prevention, early diagnosis, radiotherapy, and surgery rather than expensive new treatments with limited effect. “It is inevitable if you choose to spend money on one thing you can’t spend it on something else,” says Dillon. “If you allocate more money to one condition, other conditions are getting less.”

Can NICE and the fund continue in their current form?
As part of its recent 40% funding increase, the Cancer Drug Fund has agreed to remove drugs from its list that are overpriced or produce little clinical benefit and try to align its assessment process more closely with that of NICE.5 The fund has also agreed to accelerate the process of gathering better data on the effects of supported cancer drugs in clinical practice. Currently the data collected are minimal. Better data would allow both a better assessment of the fund’s value and provide information to clinicians to help cancer patients more broadly. An evaluation of the fund’s performance suggested it had boosted use of drugs rejected by NICE but did not accelerate the uptake of treatments still under review by NICE that were subsequently approved.6 Uptake of some of these approved drugs was more rapid in neighbouring Wales (where the fund is not operating) than in England.

Andrew Dillon argues that the fund should be brought under the remit of NICE,3 but Stephen Whitehead, chief executive of the Association of British Pharmaceutical Industry, has argued that NICE’s process for assessing value needs urgent reform.5

Reform of the CDF is an early test for Simon Stevens as head of NHS England, who has chosen personally to lead the negotiation with patient groups, researchers, and NICE as part of new scrutiny to ensure clinically effective drugs are made available cost effectively—capping any further expansion of the NHS drugs bill. NICE continues to review its methods, and the latest statements suggest there is at the very least likely to be tighter collaboration.7 But scrapping the earmarked CDF now it has been created will prove politically sensitive.

Cite this as: BMJ 2014;349:g5524

Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare

Provenance and peer review: Commissioned; not externally peer reviewed.

↵HM Government. The coalition. Our programme for government. www.gov.uk/government/uploads/system/uploads/attachment_data/file/78977/coalition_programme_for_government.pdf.
↵NHS England. National cancer drugs fund list. Vers 2. 2014. www.england.nhs.uk/wp-content/uploads/2014/08/ncdf-list-july14.pdf.
↵Knapton S. Cancer Drugs Fund makes no sense, says head of drugs rationing body Nice. Telegraph 2014 Sep 2. www.telegraph.co.uk/health/healthnews/11071055/Cancer-Drugs-Fund-makes-no-sense-says-head-of-drugs-rationing-body-Nice.html
↵Department of Health. Pharmaceutical price regulation scheme 2014. www.gov.uk/government/publications/pharmaceutical-price-regulation-scheme-2014.
↵Hawkes N. Cancer Drugs Fund receives boost but will no longer fund “overpriced” drugs. BMJ 2013;349:g5382.
↵Chamberlain C, Collin SM, Stephens P, Donovan J, Bahl A, Hollingworth W. Does the cancer drugs fund lead to faster uptake of cost-effective drugs? A time-trend analysis comparing England and Wales. Br J Cancer2014 Feb 25. [Epub ahead of print.]
↵NHS England. NHS England sets out plan for a sustainable Cancer Drugs Fund. Press release, 28 August 2014. www.england.nhs.uk/2014/08/28/cdf-plan/.

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