The UK’s Cancer Drugs Fund, established by the government in 2010 to cover the costs of expensive medicines not available by the National Institute for Health and Care Excellence (NICE), was not beneficial for patients or society, and in some cases may have even caused “unnecessary” suffering, according to a report published in the Annals of Oncology.

The CDF had an initial budget of £50 million per year, with the intent to move toward a value-based pricing plan by 2014.

But the Fund spent £1.3 billion in taxpayer money from 2010 to 2016, the equivalent of one year’s total spend on all cancer drugs in the National Health Service, according to the analysis.

The goal of the program was to improve patients’ access to cancer drugs and reduce delays in NICE’s drug approval process. The drugs chosen for reimbursement through the CDF were not available through NHS for several reasons – the drugs had yet to be appraised, were in the process of being appraised, or were appraised but not recommended by NICE.

The study authors analyzed the potential value delivered by the CDF using six criteria points, including cost-effectiveness, trial evidence of drug efficacy and observational studies assessing a drug’s effectiveness in “real-world” populations, among others.

The analysis focused on 29 cancer drugs approved for 47 indications, or types of treatment (some were approved to treat multiples forms of cancer). Nearly 100,000 patients received CDF-approved cancer treatments from 2010 to 2016.

The researchers found that out of the 47 CDF-approved indications, 18 (38 percent) were deemed significantly beneficial toward overall survival. These drugs extended patients’ lives by an average of 3.1 months, but it ranged based on the patient from 1.4 months to 15.7 months.

Twenty-six of the drugs were previously rejected by NICE for being not cost-effective enough to gain approval.

In terms of clinical benefit, only 23 (48 percent) of the 47 drug indications met criteria from the American Society of Clinical Oncology, and nine (18 percent) met criteria from the European Society for Medical Oncology.

The report goes as far as to say that some patients may have actually “suffered unnecessarily” from toxic side effects of the drugs they were taking.

“We conclude the CDF has not delivered meaningful value to patients or society. There is no empirical evidence to support a ‘drug only’ ring fenced cancer fund relative to concomitant investments in other cancer domains such as surgery and radiotherapy, or other noncancer medicines,” stated the authors.

In 2016, after years of exceeding budgets, the CDF underwent a three-month consultation. The Fund conducted its own assessment of trial evidence of the drugs it was paying for and removed more than half of the indications due to insufficient evidence of clinical benefit.

Eighteen of the drugs were removed based on evidence that already existed when the fund originated, compounding the authors’ beliefs that money and resources were misused.

The CDF was briefly shut down in March 2016 after being considered financially unsustainable. It was reorganized and opened again later in 2016. Now, the CDF is a managed access fund through the NHS and NICE. The CDF now supports the collection of evidence on the performance of promising new drugs.

To ensure patients’ still receive swift access to potentially life-saving treatments, the NICE appraisal process now begins much earlier.

In an accompanying editorial, Kapil Dhingra, associate editor of Annals of Oncology, noted the controversy of the CDF from its initiation, saying critics argued that “politics and heightened emotions” played a significant role in the decision-making surrounding CDF-reimbursement, instead of scientific data.

Dhingra also addresses one key limitation of the study authors’ analysis – the real-world outcome data from patients who received CDF-approved drugs was lacking (through no fault of the study authors, Dhingra notes). He continues by saying the data should have been routinely collected starting in April 2012, but the authors had to rely on other published data – drawing attention to what critics consider the failed execution of the program.