England’s Cancer Drugs Fund is poor value for money and may be exposing patients to unnecessary harm, concludes new research published in the Annals of Oncology.

The CDF was set up in 2010 by the UK government in order to provide patients with access to cancer drugs not yet routinely available through the NHS, either because they had not been appraised or had been rejected by the National Institute of Health and Care Excellence (NICE).

Between its launch and the time it was merged into NICE processes as a managed access fund in July 2016, the CDF cost the UK taxpayer £1.27 billion, which equates to the total amount the NHS spends on all cancer drugs in one year.

But looking at 29 drugs cleared for use through the CDF in January 2015 for 47 cancer indications, researchers from King’s College London and the London School of Hygiene & Tropical Medicine found that just 18 (38 percent) had shown an overall survival (OS) benefit in clinical trials.

The median OS benefit was found to be 3.2 months, ranging from 1.4 months (hazard ratio 0.82) for aflibercept in metastatic bowel cancer to 15.7 months (HR 0.68) for pertuzumab in first line metastatic HER-2 positive breast cancer.

According to the research, 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 CDF funded drugs failed to show any evidence of meaningful clinical benefit.

When assessed according to clinical benefit scales, only 23 (48 percent) and 9 (18 percent) of the 47 drug indications met American Society of Clinical Oncology and European Society for Medical Oncology criteria, respectively. The researchers also note that the benefit to patients in "real world" settings was probably even less than that seen in clinical trials, since trial participants are normally carefully picked, often being younger and with less other health issues than those not taking part.

“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected,” said Dr Ajay Aggarwal, academic clinical oncologist at London School of Hygiene & Tropical Medicine.

“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,” added Professor Richard Sullivan, director of the Institute of Cancer Policy, King's College London.

“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”.

Sticking plaster
Commenting on the findings, Professor Paul Workman, chief executive of The Institute of Cancer Research, London, said: “The old Cancer Drugs Fund was always just a sticking plaster and we welcomed its overhaul because it was too expensive, unsustainable and provided little certainty to patients and their doctors. The new, more evidence-based system, where NICE appraises all cancer drugs, should address some of the issues highlighted in this study.

“But while we support the rigorous drug evaluation that NICE carries out, it’s essential that the new system continues to offer fast access to the most innovative and exciting cancer drugs. We need NICE to reform the way it evaluates drugs to place greater emphasis on how innovative they are, to ensure patients are not denied the most promising treatments purely because of their cost.”

However, Baroness Delyth Morgan, chief executive at Breast Cancer Now, also stressed that “for many living with incurable breast cancer, the CDF has had a totally transformational impact on their lives, offering significant and precious extra time with their loved ones.

“This analysis actually makes clear that breast cancer drugs Perjeta and Kadcyla – which were not approved by NICE but which the CDF made available – provide a substantial improvement upon the current NICE-approved standard of care.

“The Fund was only ever intended as a sticking plaster to enable patients to access effective modern cancer drugs while the significant flaws in the NICE appraisal process were fixed. But, unfortunately, no effective reform has been forthcoming.”