NICE & the Cancer Drugs Fund – politics based medicine

It has been reported that Health Secretary, Andrew Lansley, is to alter the powers of the National Institude for Clincial Excellence (NICE) so that it cannot turn down new medicines for use on the NHS.  NICE was set up to provide an evidence based approach to healthcare advice and take often difficult drug funding decisions so that NHS healthcare is as equal as possible.  According to The Guardian:

The health secretary, Andrew Lansley, believes that Nice, the National Institute for Health and Clinical Excellence, should continue to write guidelines for doctors on the best treatments for their patients, but the Guardian understands he will remove its controversial power to ban the use of drugs it considers too expensive for the benefit they offer.

This is a hugely significant change as it could allow influence from patient lobby groups, pharmaceutical companies or newspaper headlines to undermine evidence based treatment decisions.  It is difficult to predict the outcome of any such change directly, especially as scarce detail is available of checks and balances one would assume would play a part.  However, we can look at how politicians use healthcare funds that are independent of NICE as a model to hypothesise about the future.  One such fund is the Cancer Drugs Fund, set up by recently by the Conservative and Liberal Democrat coalition government:

A Cancer Drugs Fund of £200 million a year to help cancer patients get greater access to cancer drugs that their doctors recommend for them was confirmed today by Health Secretary Andrew Lansley.The announcement follows the Coalition Government’s commitment to create a Cancer Drugs Fund to commence from 2011 to help thousands of patients get increased access to innovative new cancer drugs that extend life or improve quality of life. Following the Spending Review, £200 million a year in funding will be available for cancer drugs from April 2011 to the end of 2013.

In addition to this commitment, £50 million has been available since 1 October, until the end of March 2011, with clinically led panels now set up in each region. These panels put doctors in charge of deciding how this funding is spent for their patients locally, together with advice from patients’ cancer specialists.

The government have claimed that this fund will increase cancer survival rates.

we would save 5,000 lives a year. If we were to achieve cancer survival rates at the European best, we would save 10,000 lives a year.

The Department of Health (DoH) were asked ‘if this costing has been assessed by NICE, if not could you indicate if it has been subjected to external scrutiny by another body?‘. The reply:

The Department has not asked the National Institute for Health and Clinical Excellence (NICE) or any other external body to assess its costings

However information was provided on the reasoning behind the claim about survival rates:

As background information, we are not suggesting that the £164 million investment will result in a specific number of lives saved. We have said that we will aim to save between 5,000 and 10,000 cancer patients’ lives each year – 5,000 by bringing England in line with the European average and 10,000 by bringing survival rates in England in line with the best in Europe.
Increase detection through a revolutionary new bowel cancer screening technology flexible sigmoidoscopy (FS) – a£60 million investment over the next four years to incorporate the latest breakthrough in bowel cancer screening into our existing national programme – saving 3,000 lives a year. A randomised controlled trial funded by Cancer Research UK, the Medical Research Council and NHS R&D took place in 14 UK centres between 1994 and 2010, and evaluated screening for bowel cancer using a single FS between 55 and 64 years of age, removing small polyps by FS and providing colonoscopy for patients with high risk polyps.

The study reported in The Lancet in April 2010 and concluded that FS is a safe and practical test and, when offered only once between ages 55 and 64 years, confers a substantial and long-lasting benefit. The report showed that men and women attending a one-off FS screening test for bowel cancer can reduce their mortality from the disease by 43% (31% on a population basis) and reduce their incidence of bowel cancer by 33% (23% on a population basis)[1]. Based on these figures, the programme would prevent around 3,000 cancers every year ( FOB testing has never been shown to reduce the incidence of bowel cancer).

The Lancet paper can be found here and its findings are reported accurately by the DoH, however they omitted that the research found that ‘the numbers needed to be screened to prevent one colorectal cancer diagnosis or death, by the end of the study period, were 191 (95% CI 145—277) [for rectum cancer] and 489 (343—852) [for sigmoid colon cancer].‘. To save 3,000 lives ~2,000,000 people would have to be screened. Given that £60m is earmarked for this fund then the approximate costs per person screened would be ~£30. There is no recent data for the costs of the procedure, but a 2003 paper found as follows:

The health service costs of a flexible sigmoidoscopy was estimated at £56. The total costs of screening (including private costs) averaged £82 per person screened, although costs varied by center. The total health service costs of screening and subsequent management averaged approximately £91 per person screened, again with variations between centers.

Perhaps there has been a massive fall in prices since this paper was published, otherwise this money cannot possibly achieve the desired outcome. The private sector cannot be seen as an alternative as it offers the procedure at £650 – £1,075 according to some estimates.

The DoH also claim that they will:

Provide cutting-edge cancer therapies , through our commitment to invest £50 million in additional cancer drugs this year. The Rarer Cancers Foundation has estimated this would benefit over 2,000 cancer patients this year alone. We will also be consulting shortly on our proposals for the Cancer Drugs Fund from April 2011. Rarer cancer report:

http://www.rarercancers.org.uk/news/current/exceptional%20funding%20-%20final.pdf

The Rarer Cancers Foundation (RCF) is a charity set up to

draw together people with rare and less common cancers, thereby giving them a bigger collective voice to exact better services, and enabling them to support one another;
make all health professionals aware of issues related to rarer cancers, such as the often slow diagnosis and the need for successful treatment and symptom control pathways to be shared;
work with the Government, the NHS and Primary Care Trusts/Health Boards to ensure that people with rarer cancers have access to the best possible services across the United Kingdom.

While their report is not peer reviewed it does come from a charity claiming to represent patients who might normally struggle to be heard and it is right that politicians and civil servants pay attention to it. In particular they want the government to pay for more cancer drugs sooner.

Despite our strong support for the commitment in the Coalition’s Programme for Government, we were, however, concerned that the potential benefits the proposed Cancer Drugs Fund would bring to patients would be unnecessarily delayed by a year to April 2011, resulting in thousands more patients being denied the treatments they need. To put the pressing nature of the issue in context, to date NICE has rejected, or announced that it is minded to reject, 10 cancer treatments since the 6 May 2010 alone. A full list of the NICE appraisals published since the General Election is included in Annex 1.
The RCF therefore wrote to the Prime Minister on 19 July 2010 to ask him to bring forward the introduction of the fund.

The Prime Minister did indeed bring forward the introduction of the fund.

The list of drugs cited by the RCF, rejected by NICE, but presumably available to the Cancer Fund are listed below along with their manufacturer.

Sorafenib – Bayer
Lapatanib – GlaxoSmithKline
Trabectedin – Johnson & Johnson
Erlotinib – Roche
Pemetrexed – Eli Lilly & Co
Ofatumumab – Genmab
Imatinib – Novartis
Everolimus – Novartis
Trastuzuma – Roche
Bevacizumab – Roche
Mifamurtide – Takeda

Below are the sources of funding for the RCF from their last accounts.  The careful reader might note that not only is almost all of their funding from drug companies, but that many of those companies manufacture the drugs that the RCF want the government to pay for, against the advice of NICE.

The RCF is undoubtedly a lobby group whose interests align with those of its funders, the pharmaceutical industry.

If the Cancer Drugs Fund is to be used as a model for predicting the impact of the proposed changes to NICE then Lansley’s reforms are problematic.  The fund has not only got its sums wrong, but is swayed by lobbying from pharma funded charities disgruntled at evidence based assessments declining the products of said funders.  I hope that opposition politicians and members of the government committed to evidence based healthcare oppose these plans, the consequences of failing to do so could be disastrous.