The Cancer Drugs Fund (CDF) was launched in 2011 to enable patients to access drugs that would not otherwise have been routinely available from the NHS in England.
In September 2015, the National Audit Office reported that to date the fund had cost nearly £1billion, having funded the treatment of over 74,000 patients. However, for over 50% of these patients, this has meant funding drugs that have been appraised but not recommended by the National Institute for Health and Care Excellence (NICE), largely on the basis of cost-effectiveness.
This had led some independent observers to suggest that the fund does more harm than good in that it diverts limited funds away from more cost-effective therapies and, therefore, reduces the overall health gain that could be achieved within the NHS.
Against the background of a cost-constrained NHS, the cost of the CDF has risen by over £200 million to £416 million for the two years leading up to March 2015. The budget for this period was £280 million.
Figure 1. Cancer Drugs Fund costs
It is hardly surprising then that NHS England has had to take action in an attempt to control these spiraling costs.
In March, we saw 25 drugs removed from the national CDF list following a review of clinical effectiveness and cost, while a number of other drugs remained only as a result of discounting by manufacturers.
On October 4, a further 16 medicines used for 27 indications were expected to be delisted, in a move which has been met by outrage from the lay press and cancer charities alike.
One high-profile casualty of the latest review is Avastin (bevacizumab) [for breast and bowel cancer], which accounted for 19% of patients supported by the CDF between April 2013 and March 2015. Other delisted therapies include Celgene’s Imnovid (pomalidomide) and Revlimid (lenalidomide) for patients with myeloma who have failed on two prior therapies. Roche’s secondary breast cancer therapy, Kadcyla (ado-trastuzumab emtansine) has avoided the chop on appeal, but has come under pressure from the charity Breast Cancer Now, because of the cost, with the full list price estimated to be around £90,000 per patient.
So what next for the Cancer Drugs Fund?
Well, the Cancer Drug Fund Working Party, which is chaired by the National Clinical Director for Cancer and includes representatives from the department, NHS England, NICE, cancer charities, the Ethical Medicines Industry Group and the Association of the British Pharmaceutical Industry, has been set up to “create a better way forward for appraising and commissioning new cancer drugs”.However, in July 2015, NHS England announced that the work of the group would be “paused” while it considered how the work should progress.
This coincided with the publication of the Independent Cancer Taskforce’s report on “Achieving world-class cancer outcomes – a strategy for England 2015–2020“. The taskforce noted that the CDF had “enabled some pharmaceutical companies to bypass NICE cost-effectiveness assessments” and advocated a solution that allowed access to new cancer drugs while managing within a defined budget and aligning with NICE appraisal processes.
NHS England has in principle accepted this recommendation and proposed that the CDF should become a “Managed Access Fund”, with clear entry and exit criteria.
In theory, this would see funding for a set period prior to the availability of NICE guidance, plus additional time for the generation of “real-world evidence” to support a more informed NICE appraisal process. The critical difference for this Managed Access Fund is that it would no longer fund drugs that have been appraised but not recommended by NICE.
NHS England is planning to implement the new arrangements beginning April 2016, following a period of consultation this autumn.
For further information, please contact Tim Fitzgerald.
National Audit Office. Investigation into the Cancer Drugs Fund. Published September 17, 2015.