Over 1,300 cancer patients in England have been “left to die” in the last 20 months because they were not deemed “exceptional” enough to receive cancer treatment on the National Health Service, the Rarer Cancers Forum patient group has claimed.

5,000 English patients “have been forced to demonstrate their exceptionality” in the period, in order to receive cancer treatments not recommended by the National Institute for Health and Clinical Excellence, and 1,300 of them have had their requests rejected, says the Forum in a report, Taking Exception. This details the results of an audit conducted by the group into the policies and processes used by Primary Care Trusts to determine “exceptional funding” requests.

The audit found huge variations between these processes, with some PCTs approving all requests and some approving none at all. It also revealed a “worrying lack of understanding amongst PCTs of the rules surrounding exceptional cases, and of the Department of Health’s policy to improve transparency in decision-making,” says the group.

Each year, there are around 3,000 applications in England for exceptional funding for cancer patients, of which about 2,200 are approved and 800 denied, it says. The vast majority of exceptional case applications are for drugs for very advanced cancer, ie, those normally used in the last few months of life, with PCTs receiving most requests for Pfizer’s Sutent (sunitinib), for advanced kidney cancer and gastrointestinal stromal tumour (GIST), Bristol-Myers Squibb/Merck KGaA/ImClone’s Erbitux (cetuximab) for advanced colorectal cancer, Genentech’s Tarceva (erlotinib) for non-small cell lung cancer and pancreatic cancer and Johnson & Johnson’s Velcade (bortezomib) for multiple myeloma.

The system for determining exceptional cases is confusing for patients, says the Forum; in one PCT a case will be processed through a “priorities panel,” while in another it will be a “commissioning advisory group” and in another by an “exceptional cases panel.” Moreover, the information held by the vast majority of PCTs is so poor that they are unable to answer simple requests for information on the process they use, the number of cases they have assessed and the outcome of these cases, it adds. There are widespread variations in the processes used by PCTs, and not all Trusts even have written protocols to explain how their process works.

The audit also reveals a “postcode lottery” in the proportion of applications for cancer treatment accepted and rejected; of the 62 PCTs from which the Forum received directly comparable information on this issue, 11 approved all requests and two approved none.

Among the Forum’s recommendations for improvements are for national guidance on how PCTs should process exceptional cases, and for them to be assessed on how well they implement this guidance as part of the World Class Commissioning Performance Framework.

A target should be set for PCTs to process exceptional case applications quickly, the group adds, suggesting a maximum waiting time of five working days for decisions on urgent cases, and no more than an additional five working days for an appeal to be heard.

The Department of Health should investigate why there is such a significant variation in both the number of exceptional case requests submitted to different PCTs and the outcomes of these requests, and also urgently assess the cost of funding all rejected exceptional cases, says the Forum. Given the small volume of exceptional case applications, it should also consider establishing a regional or central panel to assess requests or creating an exceptional cases fund to cover the cost of funding these treatments, which have already been recommended by clinicians.

The Forum also calls for NICE’s appraisal process to be improved and speeded up to minimise the number of patients needing to make an exceptional funding request. Where, for whatever reason, NICE guidance has not been published within a certain number of months of licensing, the Department should stipulate to PCTs what other guidance should be used; this could be Scottish Medicines Consortium (SMC) guidance or a consensus opinion by clinical experts, it suggests.

Morevoer, performance sanctions should be introduced when NICE fails to deliver guidance within a set timeframe, and these could include requiring the Institute to report to Parliament on the reasons for the delay, the Forum proposes.