Cancer patients in the United Kingdom are to be denied access to a number of cancer drugs; funding to the controversial Cancer Drugs Fund (CDF) was slashed yesterday after a major review.
These cancer drugs are already not available on the National Health Service (NHS), because they were not allowed by the National Institute for Health and Care Excellence (NICE), which is the health watchdog. The CDF had allowed some patients to have access to these cancer drugs, but not anymore.
After the review, the list of cancer indications that the CDF will pay for was reduced from 84 to 59; these changes affect 21 cancer drugs, and nine cancer drugs have been removed from the list entirely. This will be accompanied by a number of other changes to the way the CDF operates to prevent its budget from spiraling out of control. NHS England, which runs the CDF, estimates that by 2015/16, the annual CDF budget would have to be more than £400 million ($606 million), which is more than double its 2013/14 spending.
In the United Kingdom, the only way to access a drug not approved by NICE is to pay for it privately, which is out of the reach of the majority of people.
The CDF, a flagship scheme of the current government, was a temporary answer to this problem. It was set up in 2010, but it covers only England. As previously reported by Medscape Medical News, the aim was to give cancer patients access to drugs not routinely covered by the NHS, either because they were rejected by NICE or were not yet approved.
The CDF, which was set up at the behest of Prime Minister David Cameron, was broadly welcomed by doctors, charities, and patient groups. It has allowed more than 55,000 cancer patients to receive drugs that they would otherwise have had difficulties accessing.
However, it was controversial, and the very concept of the CDF has been questioned by some experts. In fact, concerns about the ethical implications have been raised throughout its existence.
"The Cancer Drugs Fund was a cheap political fix," Richard Sullivan, MD, PhD, director of policy and global health at Kings College London, told The Guardian.
"Worse, it is unethical. You cannot give priority to cancer over all other serious illnesses, including coronary ailments and dementia. These types of patients are just as deserving of expensive medicines as are cancer patients," he said.
Maintaining Access
When the changes take effect, patients receiving a drug through the CDF will continue to do so, even if the drug has been removed from the CDF list. And clinicians will still be able to apply for drugs not available through the CDF on an exceptional basis.
Peter Clark, MD, chair of the CDF, defended the cuts. "We have been through a robust, evidence-based process to ensure the drugs available offer the best clinical benefit, getting the most for patients from every pound," he explained in a release.
"There were drugs that did not offer sufficient clinical benefit so we simply cannot go on funding those. There were others that offered some benefit but were costly and I am pleased that a number of pharmaceutical firms worked with us to make prices more affordable, saving millions of pounds that can now be reinvested in other treatments," he added.
"These are difficult decisions, but if we don't prioritize the drugs that offer the best value, many people could miss out on promising, more effective treatments that are in the pipeline," Dr Clark said.
Containing an Ever-growing Budget
The new measures will be accompanied by an increase in the CDF's budget, from £200 million ($303 million) in 2013/14 to £280 million ($424 million) in 2014/15 and then to an estimated £340 million ($515 million) in 2015/16, an increase over 2 years of 70%.
Nevertheless, NHS England stated in a release that, unchecked, the budget for the CDF would have risen to an unsustainable £420 million ($606 million), requiring cuts to other NHS cancer services. With the changes, which incorporate a number of across-the-board measures, the projected cost savings will be £80 million ($121 million).
To achieve this, 21 cancer drugs, used in a total of 25 indications, that are currently on the approved CDF list will be removed as of March 12.
Table. Some Removals Coming Into Effect March 12
| Drug | Indication to Be Removed |
| Aflibercept | second-line treatment of metastatic colorectal cancer |
| Bendamustine | rituximab-refractory low-grade lymphoma |
| Bevacizumab | first-line treatment of advanced colorectal cancer and second-line treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer |
| Cabazitaxel | castrate-resistant metastatic prostate cancer |
| Eribulin | advanced breast cancer |
| Everolimus | advanced breast cancer, well-differentiated pancreatic neuroendocrine carcinomas, and metastatic renal cell carcinoma |
| Lapatinib | advanced breast cancer |
| Ofatumumab | chronic lymphocytic leukemia |
| Pemetrexed | maintenance and second-line treatment of advanced nonsquamous non-small cell lung cancer |
New indications, however, will be added to the CDF list, including panitumumab for the treatment of bowel cancer and ibrutinib for both mantle cell lymphoma and chronic lymphocytic leukemia.
The changes follow a review of the indications of drugs available through the CDF, during which oncologists, pharmacists, and patient representatives reviewed clinical benefits, survival, and quality of life associated with each drug. They also examined the toxicity and safety of each treatment, the level of unmet need, and the median cost per patient.
In cases where high cost would have resulted in the exclusion of a drug from the list, the relevant pharmaceutical companies were offered the chance to lower their prices.
NHS England confirmed the changes to the CDF drugs list after a 4-week consultation period that ended in October 2014, which garnered 189 responses, including 104 from NHS organizations, 25 from pharmaceutical companies, and 23 from charities.
The consultation report revealed that there was broad agreement among respondents that action was required in the short term to ensure the sustainability of the CDF, and that the more fundamental issue of routine access to cancer drugs through the NHS needs to be addressed.
Unwelcome Changes
Despite the consultation process and the recognized need for action, the changes were not welcomed by many charities. Andrew Wilson, MD, chief executive of the Rarer Cancers Foundation, estimates that 7724 patients a year will miss out on treatment as a result of the cuts.
Dr Wilson described the situation as a "mess" when speaking to The Daily Mail, and added that "if the Prime Minister is serious about his promise to cancer patients, he needs to bring together NHS England and the drugs companies to broker a deal to protect access to these drugs before the March deadline."
In the same report, Samia al Qadhi, chief executive at Breast Cancer Care, was quoted as saying: "Thousands of breast cancer patients have today been denied the chance of improved quality of life and extra time with their loved ones. This news is devastating for them.
"The Cancer Drugs Fund is falling apart when there is still no long-term solution in place," added Alison Birtle, MB BS, consultant clinical oncologist at Lancashire Teaching Hospitals NHS Foundation Trust.
The need for a long-term solution was underlined by Sarah Rawlings, PhD, from the Breakthrough Breast Cancer charity. "The Cancer Drugs Fund was always intended to be a short-term solution to soaring cancer drugs costs. We need to set up a proper mechanism to deal with the problem," she told The Guardian.
"Charities, the NHS, NICE, pharmaceuticals, and doctors have all got to sit down and work one out — though it won't be easy. If it was, we would have done it by now," she said.
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Cite this: UK Cancer Patients Denied Access to Drugs After CDF Review - Medscape - Jan 13, 2015.
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