Japan's Eisai Co. (4523.TO) and Pfizer Inc (PFE) said Friday they will challenge the U.K. medical advisory body's recommendation to stop using the company's drug for treating mild cases of Alzheimer's disease, saying the organization hadn't disclosed enough information on the decision-making process.
Shire PLC (SHP), the U.K.'s third largest pharmaceutical company and maker of Alzheimer's drug Reminyl, also said it supports Eisai's and Pfizer's proposed challenge.
The Tokyo-based pharmaceutical company said it will seek a judicial review of the process by which the advisory body, the National Institute for Health and Clinical Excellence, or Nice, reached the decision to ban its Aricept drug for treating mild Alzheimer's disease.
Aricept, one of a small number of Alzheimer's disease treatments available, is Eisai's best-selling drug. Pfizer, a promotion partner for the drug, is joining Eisai in challenging Nice's guidance for the National Health Service.
"Nice has left no option but for us to proceed in this way to ensure that patients with Alzheimer's disease are protected from failures in process," Olivier Brandicourt, managing director of Pfizer U.K., said in a statement.
In a separate statement, Eisai said: "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".
Many of the conclusions drawn by Nice cannot be supported legally or are irrational, and these views are supported by patient groups, caregivers and medical experts, Eisai added.
Eisai and Pfizer will call on Nice to withdraw the recommendation in its "Final Appraisal Determination," or FAD, and postpone issuing the new guidance on Nov. 22, the Japanese company said.
They will seek the disclosure of cost effectiveness calculations used in Nice's evaluation and development of a new FAD.
This will be the first time a Nice decision has been contested at this level, Eisai said.
Eisai said it will submit a letter outlining the grounds for the judicial review request. Nice has 14 days to respond, after which Eisai can apply to the High Court for permission to proceed to judicial review.
In an emailed statement, Nice said it plans to respond to Eisai's letter and "act appropriately in any court proceedings which may follow."
However, the drug advisory body said it still expects to publish its recommendation on the care for all types of dementia and the use of drugs for treating Alzheimer's disease on Nov. 22.
Eisai has been marketing Aricept as a treatment for mild and moderate cases of Alzheimer's disease in the U.S., Japan and other markets. It recently received U.S. approval to use the drug to treat severe cases of the disease.
Eisai's and Pfizer's move follows an announcement by Nice last month, when the advisory body said an appeal against its recommendation to restrict the use of Alzheimer's drugs to patients with a moderate form of the disease had been rejected.
Swiss drugmaker Novartis AG (NVS), which markets Alzheimer's drug Exelon, one of the drugs which use was restricted, did not appeal against NICE's recommendation, a spokesman said.
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