Judicial Review update

What happened last week?

Last week at the High Court (Monday 25 June to Friday 29 June), Judge Linda Dobbs heard the Judicial Review of the NICE decision to restrict access to Alzheimer's drugs to those in the moderate stage of the disease.

The Judicial Review claim was brought by the drug company Eisai, who jointly markets Aricept with Pfizer. The Alzheimer's Society took part in the Judicial Review as an 'interested party'.

The public gallery was packed for all of the five days of the hearing, showing the degree of public interest in the case. The media covered the opening of the case on the Monday and Tuesday in particular.

This is the first Judicial Review of a NICE decision and the first Judicial Review the Alzheimer's Society has ever been involved in.

What is the Society trying to achieve through the Judicial Review?

The Society went to Court to represent people with dementia and their carers. In doing so we have sought to show how we believe that the process used by NICE to evaluate the effectiveness of Aricept, Reminyl and Exelon has been flawed. We hope that the Court will find, as we believe, that the process has been flawed and that the NICE recommendation needs to be quashed, or the evaluation process re-run.

It is important to note that the Court cannot substitute its own view for that of NICE. This means that the Court will not say, for example, that people in the early stages of Alzheimer's should have access to drug treatment. What the Judge can do is quash the decision and force NICE to reconsider.

What grounds were put before the Court as to why the NICE decision should be quashed?

The Alzheimer's Society brought our case on three key grounds:

1. NICE failed to take account of the benefits which treatment brings to carers in its evaluation of cost effectiveness.
2. NICE failed to reflect the true costs of long term care in its calculations by claiming that the average cost of a care home place was £369 per week.
3. NICE breached duties under the Disability Discrimination Act and the Race Relations Act by recommending the rigid use of the Mini Mental State Examination and not offering specific advice regarding people with learning disabilities and people for whom their first language is not English.

In addition the drug company Eisai brought grounds against NICE relating to issues such as NICE's failure to behave in a transparent way through the consultation process.

Did anything significant come out in the Court proceedings?

The current legal position is that doctors are able to exercise their clinical judgement and decide what is in the best interests of their patients, whether or not that is consistent with NICE guidance on prescribing Alzheimer's drugs. However, in law to date, Primary Care Trusts and other NHS funding bodies have only been required to fund drug treatment which is recommended by NICE.

The current NICE guidance which we are challenging says that drug treatment should only be made available on the NHS for people with moderate Alzheimer's, classed under the guidance as people with Alzheimer's who have a Mini Mental State Examination score of between 10 and 20. Therefore the understanding has been that even if doctors want to prescribe to people in the early stages of Alzheimer's, PCTs can refuse to provide funding because treatment is not part of the core NICE recommendation.

This position seemed to change in Court. Under questioning from the Society's barrister Michael Fordham QC, NICE's barrister conceded that the legal requirement for the NHS goes far further than this and that the NHS has a responsibility to fund treatment under NICE guidance even if the doctor wants to prescribe outside the NICE core recommendations. This could be very important in ensuring that people who can benefit from treatment still remain able to do so. The Society will be providing advice to people with Alzheimer's, their carers and doctors shortly about this change, when this has been provided by our solicitor.

When will we know whether the Judicial Review has succeeded?

Judge Dobbs stated in closing that she hoped to come back with a Judgment in the case before the Courts close for the summer. This would be by early August. However, she stated that this depends on whether there has been sufficient time to go through all the arguments and reach a conclusion given the complexity of the case. This means that it is possible there will not be a result until the Autumn.

What could the result be?

There are a whole range of different results ranging from quashing the guidance and instructing NICE to re-run the appraisal again (which the Society would like to see) to upholding the NICE decision. The Judge could find in favour of the Society or Eisai on one of the grounds put, a number of them, or none.

Is the Society confident of success?

The Alzheimer's Society believes that there is a very strong case to quash the NICE guidance. It is up to the Court to decide whether the case is strong enough to find in our favour.

If the Judge finds against NICE what will it mean?

This depends very much on what 'relief' is granted. That is to say, what the Judge believes it is necessary for NICE to do in response to the findings of the Court.

If the Judge finds for NICE what will the Society do?

This depends on the Judgement and what the options for an appeal are. Following a Judgment any of the parties can ask the Court for permission to appeal the decision if they are not satisfied with the result of the case. If that happens a result could be months away.

Who represented the Society in the case?

The Society worked with John Halford of Bindman's solicitors and barristers Michael Fordham QC and Tim Ward, all experienced practitioners in public law.

Who paid for the Society's involvement in the legal action?

The Society's legal costs have been paid for by generous donations from members of the public. We are indebted to all of our donors and particularly to readers of the Daily Mail who have made it possible to proceed with this important case.

In addition we are grateful to our solicitor and barristers who have worked at a discount rate. Also, the Society secured a cost protection order from the Court so that we are not liable for costs of other parties in the event that we do not win the case.

We have not been offered and would not accept donations from pharmaceutical companies to fund this legal action. We went to Court to represent people with dementia and their carers. A copy of our policy on working with pharmaceutical companies is available on our website.