Analysis by King’s into the drugs that were approved for use by the NHS Cancer Drugs Fund (CDF) in England has shown that the fund was not good value for patients and society and may have resulted in patients suffering unnecessarily from toxic side effects of the drugs.
In a study published in the leading cancer journal Annals of Oncology today, researchers led by Professor Richard Sullivan, director of the Institute of Cancer Policy at King’s, and Dr Ajay Aggarwal, academic clinical oncologist at London School of Hygiene and Tropical Medicine, looked at 29 drugs that had been approved for use through the CDF in January 2015 for 47 specific cancer conditions (or indications). Of these indications, only 18 (38%) were based on clinical trials that reported a statistically significant benefit from the drugs in terms of patients’ overall survival; the (median) average overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
When other factors such as quality of life and toxic side effects of the drugs were considered as part of criteria developed by oncologists to measure value to patients, the majority of the drugs failed to show any evidence of meaningful clinical benefit. In fact, the researchers say the benefit to patients in real world situations was probably even less than that found in the clinical trials, since clinical trial participants are carefully selected, have fewer other health problems and tend to be younger than patients not included in trials.
Professor Sullivan said: ‘A ring-fenced drugs fund was created despite a lack of evidence that prioritising drug expenditure would improve outcomes for cancer patients over and above greater investment in the whole cancer management pathway, which includes screening, diagnostics, radiotherapy, surgery and palliative care. We recommend that other countries that are considering similar ring-fenced drug access funds for high cost cancer drugs should adopt a more rational approach to funding high cost health technologies.
‘Our findings underline the importance of reimbursement decisions for all drugs, procedures and interventions in cancer care being made through appropriate health technology appraisal processes. Only in this way will decisions be made on the best available evidence so as to maximise the value for cancer patients and society as a whole.’
One of the failings of the CDF was that no data on the outcome of patients who accessed the fund are available. Basic information on date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse was supposed to have been collected by April 2012. But even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
‘We also lost a major opportunity to understand how these medicines work in the real world,’ said Prof Sullivan.
The CDF was closed in March 2016 because it had become financially unsustainable; a ‘new-look’ CDF came into force at the end of July 2016. The new CDF provides managed access to new cancer drugs for a time-limited period in circumstances where the clinical and cost effectiveness of the drug is deemed uncertain according to national guidance.
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