Though most would acknowledge that the United Kingdom’s Cancer Drugs Fund (CDF) was in desperate need of reform once the current structure expired in April 2016, many were disappointed when the government suggested that the National Institute for Care and Health Excellence (NICE) would take over the reins as the fund came to the end of its life. After all, the fund was created to bypass NICE’s health technology assessment (HTA), as expensive oncology drugs were often not recommended based on their high cost and lack of cost-effectiveness as measured in ICERs. However, despite the objections of some industry and patient group stakeholders, the NICE board confirmed on March 16, 2016 that NICE will be responsible for the fund starting in July 2016.
According to Sir Andrew Dillon, the Chief Executive of NICE, the new CDF will provide access to oncology drugs faster than anywhere in Europe, in a way that is fair to taxpayers. The latter point is a particularly sore-spot for many, as in September 2015, the National Audit Office found that no information or data had been collected on the over 74,000 patients that were treated using the fund at a cost of almost £1 billion ($1.45 billion USD). As a result, it was impossible to know if the treatments were effective. A February 2016 report from the Public Accounts Committee confirmed that because there was no data, there was no evidence that the fund was benefiting patients or taxpayers and demanded that the National Health Service (NHS) submit the necessary data and analysis before the new fund is launched.
When reform was announced in November 2015, it was clear that the CDF would have to take on a new form. Instead of being a “slush fund” of sorts – one which had gone over its budget and saw its cost rise by over 130% between 2013 and 2015 – the new fund would be a managed access fund with a fixed budget and NICE overseeing it. In an effort to overcome the issue that expensive but effective oncology drugs had prior to the creation of the CDF in 2011, HTA for oncology drugs will take on a slightly different form to the usual NICE process. Oncology drugs would either be recommended for routine use in the NHS, would be rejected for routine use, or would be granted a conditional approval for use within the CDF. Drugs approved conditionally for the CDF would be used for a specific timeframe (up to two years). At the end of the set timeframe, NICE would use the gathered evidence and shortened process to re-appraise the drug and the drug would either move out of the CDF into routine use, or would be removed from the CDF and would only be available through individual funding requests.
There are many reasons to be cautiously optimistic about the fund’s new structure. The fixed budget will be welcomed by tax payers and government spending watchdogs, as the old fund exceeded its budget by £100 million ($140.8 million USD) in the 2014-2015 fiscal year alone, threatening overburdened government healthcare spending in general. The chance for drugs to prove their worth instead of facing outright rejection is also a reason to be optimistic. Drugs will be given up to two years to prove their clinical and cost effectiveness. Many, especially the Public Accounts Committee, will be pleased that the new fund will monitor whether the fund’s £340 million ($474 million USD) annual budget is truly benefiting patients and society.
One of the key selling points of the new CDF is also the improved access time. As part of the new structure, NICE will issue guidance on new oncology drugs and significant new license indications before they receive marketing approval in the United Kingdom. That means that recommended drugs will be funded from the point of license. Under normal conditions, NICE guidance would be issued within 90 days of license approval.
Despite the many positives, many industry and patient groups are concerned about the new structure. Specifically, after 25 treatments were defunded last year due to financial difficulty, many are worried that even more drugs will be removed from the list for cost reasons. As part of the transition, NICE will re-appraise the drugs on the CDF list and potentially remove them, including 23 drugs that were previously rejected by NICE. The Association of British Pharmaceutical Industry (ABPI) estimated that up to two-thirds of drugs on the current list will be unavailable by the end of year under the new system. Patient and cancer organizations have also criticized the new reform, with the Rarer Cancers Foundation estimating that 22,000 patients per year will lose access to life-saving drugs. The CEO of the Beating Bowel Cancer U.K. charity argued that the reform ignores patient needs in favor of cost savings.
Over the next 18 months, drugs migrating from the old CDF to the new one will be re-appraised and new drugs will be eligible for appraisal when new fund launches in July 2016. The new fund is certainly more sustainable, and patients will welcome quicker access to new drugs. However, it is uncertain whether the problems that led to the creation of the CDF in the first place will be sufficiently avoided with the ability to grant temporary conditional funding. Despite what industry wanted, an entire overhaul of how NICE assesses cancer drugs was never likely, so perhaps this was the best compromise. One thing is known for certain - the oncology market in the United Kingdom should be bracing itself for a dynamic rest of 2016.