A new report, Exceptional Scotland?, published today by the Rarer Cancers Forum, demonstrates for the first time the wide variations in decision-making processes between NHS Boards in Scotland.

The report builds on the work undertaken last year by the Rarer Cancers Forum which exposed similarly widespread variations between NHS organisations in England in their use of ‘exceptional case’ processes.

Conducted using requests submitted to NHS Boards under the Freedom of Information (Scotland) Act, the findings contained in Exceptional Scotland?  include the following:

• Every year on average, there are 589 ‘exceptional case’ or individual funding requests for cancer treatment in Scotland – almost twice as many per head as in England
• Of the 589 requests made, 498 (85%) are approved and 91 (15%) are rejected. The cost of providing the 91 rejected treatments on the NHS would be just £1.9 million a year.
•  There are huge variations in the number of exceptional case requests made to NHS Boards, and the proportion which are approved: NHS Greater Glasgow and Clyde received 98 times the number of exceptional case requests than NHS Grampian and Orkney; and four NHS Boards approved every request whilst two approved none

Exceptional Scotland?’s recommendations include:

• The Scottish Government should make the implementation of Scottish Medicines Consortium guidance mandatory, to reduce the number of patients who must launch exceptional case applications for treatments which have already been recommended nationally
• The Scottish Government should develop a mechanism for producing national guidance on medicines which are most often used in near-label circumstances. This would also help reduce the number of patients who must launch exceptional case applications
• The Scottish Government should commission a study to investigate the differences in approval rates between NHS Boards

Commenting, Rarer Cancers Forum Executive Director Stella Pendleton said:

“Patients with rarer cancers face enough hurdles in getting treatment, and many of the treatments they need are not even licensed. They should get the treatment they need on the basis of clinical need alone, not on the media interest that is shown in their case.”

“If doctors want their patients to receive treatment, then patients expect the NHS to provide it. 200 cancer patients have found out that the NHS will not be there for them. Many hundreds of others have been forced to rely on confusing, bureaucratic and demeaning processes.

“The Government must act to end this tragic lottery.”

Notes

The Rarer Cancers Forum offers advice and information to people affected by rare and less common cancers.  Feedback from the people we support indicates that there are significant problems with the exceptional cases process.  Decisions often take too long, are taken according to variable criteria, without the contribution of genuine experts and are not then fully explained to patients and their clinicians.

The Rarer Cancers Forum conducted the audit of NHS Boards exceptional cases processes via Freedom of Information Act requests to Scotland’s 14 NHS Boards. The information asked for included:

• Details of written protocols on exceptional requests for cancer treatment
• Details of the committees used to determine exceptional requests
• How many exceptional requests were accepted and rejected since October 2006
• Which cancer treatments were funded and not funded following exceptional requests since 1 October 2006

All NHS Boards responded to our survey. 

The report resulting from the audit, Exceptional Scotland?, recommends the following ten-point plan to address the problems identified in the audit:

1. In order to protect the confidentiality of patients with rare conditions and to ensure appropriate levels of transparency, the Scottish Government should issue clear guidance to NHS Boards on how to respond to requests for information on issues where patient identifiable data may be revealed.

2. The Scottish Government should remind all NHS bodies of their responsibilities under the Freedom of Information (Scotland) Act and the importance of transparency in making funding decisions on issues of public interest.

3. NHS Boards should be required to develop and publish a written guide on how they process exceptional case applications, setting out:

· The criteria which will be used to make the decision
· The composition of the panel involved in making the decision
· The process for appealing
· Where a patient can go to seek advice on their case

4. The Scottish Government should issue guidance on how NHS Boards should make decisions on exceptional cases. This should make clear that:

· Processes must not be influenced by the profile of a patient’s condition or by political interference
· Decisions should not be made by one individual, but instead by a committee or panel
· The committee should include lay representation and draw on appropriate clinical expertise
· There are maximum acceptable timelines for making decisions. We suggest a maximum waiting time of five working days for decisions on urgent cases, with a maximum of an additional five working days for an appeal to be heard. All cancer patients should be considered as urgent

5. A formal programme of peer review of exceptional case decision-making processes should be undertaken, enabling NHS Boards to compare the quality of their decision-making processes against that of others.

6. The Scottish Government should undertake further work to understand the reasons for the greater use of the exceptional cases processes in Scotland, when compared with England. This work should also consider the cost of conducting exceptional cases processes and whether this is a good use of resources.

7. The Scottish Government should conduct as a matter of urgency a national audit of exceptional cases processes to help determine why there is such a wide variation in the number of applications received by NHS Boards. The reason for this variation between NHS Boards should be explored. Given the public interest in the issues, the results of the audit should be reported to the Scottish Parliament.

8. The Scottish Government should commission a study to investigate the differences in approval rates between NHS Boards.

9. The Scottish Government should introduce measures to minimise the need to use exceptional funding processes for cancer treatments. These might include:

· Making the implementation of SMC guidance mandatory, even if alternative treatments exist, so that clinicians are empowered to prescribe the treatment which they feel is most appropriate for their patient
· Developing a mechanism for producing national guidance on medicines which are used in ‘near-label’ circumstances on a relatively frequent basis. This might include convening a group of experts to produce consensus guidance based on international clinical practice and early phase trial data
· Adopting a more flexible approach to evaluating new treatments

10. Given that the overall costs associated with adopting a more permissive attitude towards the use of cancer treatment are modest, the Scottish Government should urgently consider the case for making more cancer treatments available.

Acknowledgements

The research contributing to the report was kindly supported by unrestricted grants from Amgen, AstraZeneca, Bayer Healthcare, Bristol‐Myers Squibb, Celgene, Merck Sharp and Dohme, Novartis Pharmaceuticals, Pfizer, PharmaMar, Roche Products and Wyeth Pharmaceuticals.

For media enquiries, please contact Bill Morgan on 0777 965 5912.