The U.K. Cancer Drugs Fund (CDF) is in danger of exacerbating existing regional discrepancies in access to, and choice of, innovative cancer treatments, according to the Association of the British Pharmaceutical Industry (ABPI). The industry group stresses that the government must heed lessons learned from the application and progress to date of an interim £50 million ($80 million) fund in order to ensure access equality across the country.

The £600 million CDF was launched on Oct. 27, 2010, and was put out to consultation until Jan 19, 2011. Its aim is to provide funding for new cancer drugs that have not been reviewed by the cost-effectiveness watchdog National Institute of Clinical Excellence or which have been reviewed and rejected on the basis of cost. The fund will provide £200 million per year until 2013, when a new value-based pricing system will come into force (Also see "UK Value-Based Pricing Proposals Aim To Increase Access, Broaden Assessment of Drug Benefits" - Pink Sheet, 17 December, 2010.).

Fears of the fund's potential to worsen regional access disparities already were raised in November 2010 when a consultation document was released (Also see "UK's New Cancer Drug Fund Might Not Alleviate Regional Access Disparities" - Pink Sheet, 1 November, 2010.). Based on evidence collected from companies' views concerning the regional operation of the interim fund and data from National Health Service sources, the ABPI says it's vital to standardize the way that regional health service authorities (SHAs) approach their prioritization lists. The lists are compiled on the basis of an assessment of a number of criteria concerning the drug, including: survival, benefit, quality of life, alternative available treatments, cost-effectiveness and strength of evidence. Each region compiles a list, which does not necessarily correspond to that of the interim fund. However, only drugs that currently are on this prioritization list will be funded from the interim fund.

London has drawn up a list based on the existing London Cancer New Drugs Prioritization process. This is overseen by the London Cancer New Drugs Group and aims to facilitate consistency of approach in London by informing the managed entry of new drugs in cancer treatments and to promote the cost-effective and equitable provision of all medicines used in cancer management. It identifies drugs that are not currently funded but are considered to meet quality and outcomes criteria for success in the interim fund.

Regional Health Authorities Have Their Own Prioritization Lists

To make matters more complex, other SHAs have their own prioritization lists that do not necessarily correspond with the interim fund list. Yorkshire and Humber SHA says that any patients who meet the criteria of their prioritization list will have access to the interim fund. In addition, individual applications can be made for drugs not yet considered by the interim fund panel - and therefore not on the list - or for off-label use of a drug. The panel will then consider these requests on a case-by-case basis and may fund them.

Meanwhile, South Central SHA does not have a priority list and applications appear to be considered on a case-by-case basis, although over the last couple of months, pro-forma application forms have been made available for a few drugs.

There also is a lack of consistency in the timing and clarity of some of the interim fund processes, ABPI reports. Some SHAs, like that in the East of England, state that an application for funding will be acknowledged within one day and the interim fund's decision granted within three working days, while the East Midlands and South Central SHAs aim to have the interim fund decision made within 10 working days. South East SHA merely talks of the need for "timely" decision making. But whatever the official policy, feedback to the ABPI from companies suggests that decisions generally are taking five to 10 days.

Regional variations also are apparent with regard to the extent of clinician involvement - leading, potentially, to wide variations in the standard of care received. There is no explicit mention in any area of patient involvement in decision panels, a fact that does not sit well with the ABPI. It has called for the inclusion of patient representatives in local decision-making panels and for the use of additional mechanisms to ensure broader patient involvement in the CDF at the national level.

ABPI has a number of further demands, such as regional data collection to ensure equitable division of funds and using such data to set the annual fund budget, with epidemiological data driving more appropriate fund allocation. Under the interim fund, £50 million has been distributed to the SHAs according to population size alone. The Department of Health left it open to each SHA to decide how the interim fund would work and be allocated within their local areas.

But the short timeframe over which the actual CDF is designed to operate makes it difficult to see how the changes proposed by the ABPI will have a chance to come into force, even if they are instigated.

Industry clearly is keen to adopt a U.K.-wide approach to funding new drugs for cancer. But the wider changes due to occur within the National Health Service as a whole - notably the devolution of funding and drug commissioning decisions to local GP consortia, as outlined in the Health and Social Care Bill published Jan. 19 - may, detractors say, lead to far greater regional discrepancies in drug access, across multiple therapeutic areas, than those appearing so far within the narrow context of the CDF.

-Faraz Kermani (F.Kermani@elsevier.com)

Regional Disparities Threaten Effectiveness Of U.K. Cancer Drugs Fund

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