Eisai awarded judicial review over NICE Aricept rejection

Japanese pharmaceutical company, Eisai, which holds the licence to Alzheimer's disease drug Aricept (donepezil), has revealed that the UK High Court has granted permission for it to proceed to a Judicial Review challenging the process by which the National Institute for Health and Clinical Excellence (NICE) reached its decision to ban anti-dementia medicines for NHS patients with newly diagnosed mild Alzheimer's disease. 

Eisai, with the full support and the backing of US pharma giant, Pfizer, which is its co-promotion partner for Aricept, applied for permission to proceed to Judicial Review regarding the following complaints regarding NICE's original ruling: 

1) Since NICE has repeatedly refused to disclose a fully working version of the cost effectiveness model used to determine the value of treatment in patients with mild Alzheimer's disease, the process leading to the Final Appraisal Determination (FAD) and the new treatment guidance breached the principles of procedural fairness.
2) Some of the assumptions made or conclusions drawn in the FAD are irrational or cannot be supported      
3) The use of MMSE (Mini Mental State Examination) scores as a rigid diagnostic tool discriminates against certain patient groups

The granting of a judicial review is the first time a pharmaceutical company has successfully challenged a NICE ruling and could open the flood gates to judicial review grants.

Another company who may press for a judicial review could be Merck KGaA, who had its request for metastatic colo-rectal cancer (mCRC) treatement, Erbitux (cetuximab), rejected at the end of January 2007.

The NICE rejection of Erbitux was reported as ironic by UK doctors, because British scientists had led on efficacy trials. Dr Mark Saunders of the Christie Hospital NHS trust was reported as saying that NICE would not review the decision before 2009.

Developed by US biopharmaceutical company ImClone Systems, Erbitux is a chimeraic monoclonal antibody (MAb) targeted at epidermal growth factor receptor (EGFR). One of several new cancer biotherapies, Erbitux is indicated for the treatment of metastatic colorectal cancer and locally advanced cancer of the head and neck.

The UK is currently the only European member state where patients with mCRC do not have routine access to Erbitux. Oncologists say it has produced some of the longest survival rates ever seen. In March 2005, NICE ruled that all drug treatments for Alzheimer's disease should not be prescribed on the NHS because of cost. Following overwhelming condemnation from the public, professionals and campaigns NICE changed its position to allow limited access to the treatments.

Commenting on the High Court's decision to grant permission, Dr Paul Hooper, Managing Director of Eisai Limited said: "We welcome the fact that the High Court has given us permission to launch this unprecedented legal challenge, and await confirmation of a date for the hearing."

"We accept that NICE has an important role to play on behalf of the NHS and our issue is not what NICE do, but how it has reached this decision," concluded Mr John Young, Managing Director of Pfizer.

Neil Hunt, CEO of the UK's Alzheimer's Society, said of the ruling: "Today is an important step forward in our fight for the rights of people with Alzheimer's disease and their carers who have been forgotten in this decision. We are delighted that the judge has recognised the importance of hearing their voices in court. Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical. Our legal team will also demonstrate that the decision is fundamentally flawed."

In response to the announcement, NICE's CEO, Andrew Dillon, said in a press statement: "Alzheimer's is a cruel and devastating illness and we understand that people living with the condition and those who care for them will want the best care they can get. That's why our guideline published in November 2006 on the treatment of dementia goes much further than just the drug treatment available. The reality is that, for Alzheimer's disease, drugs are only part of the care that needs to be offered. Non-drug interventions have an important part to play and the evidence indicates that drugs are simply not effective for some patients."

"The application for judicial review of the process by which NICE developed guidance on the use of drugs for treating Alzheimer's disease has been made by two well-resourced pharmaceutical companies, Eisai Limited, supported by their co-promotion partner Pfizer Limited, who are unhappy with our assessment of the efficacy of their products," added Dillon.

"We are disappointed that Eisai Limited has taken this step.We consider their claim without foundation and it will require us to divert energy and funding from the work we do to support patients and health professionals and get the most out of the resources available to the NHS. It was widely expected that the application for review would pass the technical hurdle of obtaining judicial permission to be heard. We did not formally oppose this application in order to reduce the cost and prevent delay to the proceedings,  However, that does not diminish our clear view that there is no case for us to answer," Dillon countered.

Dillon concluded: "Health service funding is limited, and it is our job to assess the clinical and cost-effectiveness of both drug and non-drug interventions to ensure the money spent by the NHS is well-spent. Our consultation, decision-making and appeals processes are transparent and fair. We share our methodology and enable our stakeholders to see the basis on which our experts arrive at their decisions. We invite patients, medical professionals and anyone who has an interest to express their views and comment on our proposals."

The upcoming judicial review adds weight to claims that NICE could face significant change in the next two years. Questions about the future of NICE have already been raised following the report from the Office of Fair Trading on February 20 which suggested scrapping the Pharmaceutical Pricing Regulation Scheme: a move that would pave the way for a new price setting body either to sit along side NICE or extend its current remit and, potentially, its powers.