England’s Cancer Drugs Fund: Naughty or NICE?

As reported by PMLiVE last week the budget for England’s Cancer Drugs Fund (CDF) is to be increased from £200m to £280m a year, a total increase of £160m until 2016. The boost to the Fund, which was launched in 2010 with an initial budget of £600m over three years, has been universally welcomed by cancer charities. Yet, with nine months to go until the UK’s general election, is this generous boost to the CDF all that it seems?

Critics have suggested this measure may be stop-gap solution from the Coalition Conservative/Liberal Democrat Government to prevent cancer funding becoming a political issue and sidestep any Labour attempt to capitalise on a crisis in treatment funding. There are also questions that Simon Stevens, chief executive of NHS England, has gone further and agreed to measures that effectively entrench the Fund after 2016. It’s worth asking if the CDF about to become the naughty twin of NICE.

Delisting
The Fund was first initiated around the Conservative autumn party conference in 2009, just before the last UK general election. It was a political solution to a cost-effective problem. The Labour Government was struggling to find a way to provide cancer treatments that NICE was unable to recommend. Following the election one of the first acts of the newly formed Coalition was to get the Fund up and running. It was only ever meant as a very temporary solution – running to 2014. Drug reimbursement based on value-based pricing was the Conservative panacea that would resolve the tricky question of access to cancer treatments on the NHS. But skip ahead to September 2013, once again party conference time, and Prime Minister David Cameron announced the Fund would be extended to 2016 noting that if he were re-elected he would recommend extending it beyond 2016.

The announcement made last week does more than give the Fund a financial boost. In the letters exchanged between Simon Stevens and the chair of the Cancer Drugs Fund, Prof Peter Clark, we see the counterweight to this new money: the prospect of delisting drugs.

Prof Clark’s letter states: “Drugs which are excessively priced would be potentially removed from the CDF unless the pharmaceutical company makes an appropriate adjustment.” The letter goes further in outlining plans for a “re-evaluation process which will assess the drugs of least clinical benefit and remove those which represent the lowest levels of such clinical benefit.”

But what does this re-evaluation process mean? And does this process mean the start of a parallel cost-effective funding system exclusively for cancer? Furthermore, if those drugs of “least clinical benefit” are removed, will they effectively be blacklisted?

Many of those cancer treatments funded by the CDF are for types of cancer with small patient groups, often falling into the specialised commissioning category, which is itself in flux due to the changes from the Health and Social Care Act 2012. It may not be the choice of Clinical Commissioning Groups to fund these “delisted” medicines, and if it is, surely they would look to the CDF’s own assessment as an indication that it is not cost-effective to fund them. Does this leave patients and their doctors with the unsatisfactory process of Independent Funding Requests (IFRs)?

10 most requested medicines on the Cancer Drugs Fund
April 2013 to March 2014

Free pricing
Since the creation of the National Institute for Health and Care Excellence (NICE) in 1999, the pharmaceutical industry has fiercely protected its right to “free pricing” and subsequent governments have never challenged it. In order to promote UK ltd both Labour and now the Coalition have been keen to foster good relationships with internal pharmaceutical and biotech companies. However, the challenge to reduce the increasing cost of medicines has always been a priority. Throughout the lengthy negotiations about the latest pharmaceutical pricing regulation scheme (PPRS) and the value-based assessment, free pricing was never on the table. Is it possible the publication of Prof Clark’s letter is the first tentative steps towards challenging this sacred cow?

If the CDF can remove a drug from the list unless the company “makes an appropriate judgement” this is arguably the equivalent of NICE withholding recommendations unless a patient access scheme is offered. When more details are revealed all those interested would be wise to watch for any possible sign that access to the NHS market will be withheld based on whether the drug is “excessively priced” unless they make “an appropriate adjustment”. We can assume that this may be some of the focus of Simon Stevens’ partnership discussions on “future options for…alignment between…the CDF and NICE”

Quality QALYs
The threshold for the Quality Adjusted Life Years of £30,000 – £50,000 were set in 2009 and have not changed since or been adjusted for inflation in the intervening five years. In his reply to Professor Clark, Simon Stevens advises there should be close working between NICE, patient groups, and the ABPI “to develop future options for ensuring alignment between the important and distinctive work of the CDF and NICE”. If a new form of cost-effective model is to be developed those involved will need to be careful to not recreate the current NICE QALY model which struggles to assess today’s stratified medicines and those that extend life at the end of life.

In recent times there have been some high profile and controversial HTA submissions to NICE. What the announcement last week shows is that there is no longer an appetite for the “cost of bringing a drug to market” argument at NHS England. It may not be fair but somehow medicines have lost out in the PR battle to medical technology.

“Think like a patient, act like a taxpayer”
Simon Stevens famously uttered this phrase when he was in front of the Health Select Committee. His exchange of letters with Prof Clark is this mantra in practice. The CDF will still be with us in 2016, but those leading the new bodies in the NHS seem determined to pivot the Fund into some sort of NICE-lite. This may be the NHS’ way of actually entrenching the Fund ahead of a possible change of administration in May 2015. If Labour are elected in May 2015 and need to make cost savings, expensive drugs from private pharmaceutical companies could be a useful target. If CDF has become a body that can assess whether the drugs are financially worthwhile, rather than a Tory-created slush fund, then Labour will find it more difficult to sweep aside. Things are yet to be made clear, but this might be the beginning of NICE finding it has a partner in a newly strengthened CDF.