In 2011, the UK government introduced the Cancer Drugs Fund (CDF) in England, which funds cancer drugs which have not been deemed cost-effective or have not yet been assessed by the National Institute of Health and Care Excellence (NICE). This was seen as a victory for cancer patients who could access drugs included in the CDF, which would otherwise not be funded by the National Health Service (NHS). However the CDF was criticized by others due to a lack of price negotiation with pharma companies and prioritization of cancer over other diseases, such as diabetes and Alzheimer's disease. Despite increases in government funding, the CDF has been overspending its budget, 1 which has now led to the CDF announcing this week that they are no longer reimbursing 16 effective cancer drugs in 25 different therapy settings.
The reasons which the CDF cite for lack of coverage for some drugs in specific settings are controversial. For example, Avastin (Roche's bevacizumab--the world's biggest selling drug for the treatment of solid tumors) sees its highest use in England in terms of patients in the first-line treatment of colorectal cancer (CRC).3 In this setting, Avastin has consistently demonstrated a significant increase in overall survival compared with clinically relevant comparators, as seen in a pooled analysis of clinical trials. However the CDF, in its justification of removing funding for Avastin for the treatment of CRC, states that recent trials have not shown similar efficacy to Erbitux (which remains CDF approved), despite Erbitux being unsuitable for 50% of CRC patients, causing severe skin toxicities which can affect patient's quality-of-life, and has a 70% higher list price. Also, instead of using the pooled analysis of clinical trials (which do show a clinical benefit) when assessing Avastin, the CDF uses a trial in which Avastin treatment duration is lower than what is seen typically, and thus led the authors of this study to believe that this caused Avastin to not show as high efficacy as seen in other trials, and thus may be an underrepresentation of its true clinical effectiveness.
Despite the removal of Avastin funding for CRC, the CDF will continue to fund Avastin in the triple-negative breast cancer population. Avastin captures much less use in triple-negative breast cancer compared with CRC, it has never shown a survival benefit, and approval was revoked by the FDA due to an adverse risk/benefit profile.8 Furthermore, the CDF will no longer list Halaven (Eisai's eribulin) in breast cancer patients, which has previously received more CDF applications than any other breast cancer drug, even though it has demonstrated increased survival in breast cancer patients whereas Avastin has not. Therefore this leads to the situation whereby the CDF will fund drugs for indications in which they are not as effective and receive very little use, rather than fund the same drug in an indication (or a different drug in the same indication) that has shown greater efficacy and therefore is used by a much larger number of patients.
Another exclusion from the list is Stivarga (Bayer HealthCare's regorafenib) for previously treated gastrointestinal tumors (GIST). Stivarga has shown to be a vital lifeline for this terminally ill population, especially as GIST is a rare disease that typically has fewer drugs in development than other cancers. Stivarga was determined by the CDF to be clinically effective, however it did not qualify for rare disease pricing (and thus a higher reimbursement rate) as Stivarga is also approved for CRC, and thus had a funding stream. However this funding stream in practice does not exist in the UK because Stivarga is not funded by the CDF or NICE for CRC. Therefore, Stivarga is not publically funded in the UK for any indication, other than through the burdensome individual funding request route.
Much has been said about the cost of cancer drugs and their overall burden on the NHS and healthcare systems worldwide. However, let's not forget that the majority of cancer patients in the United Kingdom have been paying a significant amount of their salary towards the NHS through their national insurance payments, and thus should reasonably expect the NHS to pay for the most effective treatments (as a comparison, healthcare spending per head in the UK is $700 less per person per year than France, $1,000 less than Germany and $5,000 less than the United States).10 For a disease as serious as cancer, it is vitally important that reimbursement decisions are logical and transparent. The way the CDF has carried out recent decisions is less logical and transparent than appraisals carried out by NICE, especially as NICE are open about how they calculate the cost of quality-adjusted life years, whereas the CDF uses a confidential cost scoring system. Furthermore, the UK Pharmaceutical Price Regulation Scheme (PPRS) restricts spending on branded medicines in the UK (and therefore what pharmaceutical companies can charge for their drugs), and any increase in branded drug spending over the agreed limit will result in rebates back to the NHS.12 This means that pharmaceutical companies in the UK do not have free-reign over drug prices, which some have argued exists in the United States.
The only hope of the de-listed CDF therapies being prescribed to eligible cancer patients in England (which has low levels of private insurance in elderly populations) is for the patient to pay for the entire cost of the course of treatment themselves. For comparison, in the United States everybody over the age of 65 has their treatments covered at least in part by Medicare (with patient support programs in place for patients who struggle with their out-of-pocket expenses) which in practice covers the majority, if not all, FDA-approved drugs. The current system of reimbursement of cancer drugs in the UK is unsustainable and is of need of change. One could argue that reallocating the £340million pound CDF budget13 into the general NHS budget, and/or increasing healthcare spending per head in the UK to levels seen in France and Germany, would lead to the NHS being able to spend more than the £30,000 per quality-adjusted life year (QALY) threshold it currently sets, and therefore NICE being able to approve more cancer drugs in a fair and open way. This would eliminate the need for the CDF, stops the bias of cancer patients over patients who suffer from other diseases for funding, and would allow cancer patients to continue to access the most effective cancer medicines.
- Pharmaview. Decision Resources
- Naughton MJ, et al. Quality of life (QOL) and toxicity among patients in CALGB 80405. ASCO 2013
- Saltz LB, et al. Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study. Journal of Clinical Oncology 2008.
- Davis K, et al. Mirror, Mirror on the wall. How the Performance of the U.S. Health Care System Compares Internationally. The Commonwealth Fund 2013