NICE Warns Of Potential Delays as Court Rules Drug Evaluations Should Be More Transparent

Japanese pharmaceutical company Eisai and U.S. marketing partner Pfizer (U.S.) have secured a victory in their challenge against the U.K. National Institute for Health and Clinical Excellence (NICE)'s decision to restrict the use of Alzheimer's drugs within the National Health Service (NHS), reports the BBC. Indeed, a U.K. Court of Appeal ruled yesterday that the cost-effectiveness watchdog did not comply with its principles of procedural fairness by giving Eisai and Pfizer access to a "read only version" and not an "executable" version of the economic model used to reach the decision. The ruling found that NICE should be more transparent when it comes to disclosing the computing models used during its cost-effectiveness assessments, as failure to do so puts manufacturers at "significant disadvantage" should they wish to challenge NICE's conclusions.

As a result of the ruling, Eisai will obtain an executable version of the cost-analysis template. The company will be able to test it and make comments, which NICE will have to take into account and possibly amend its guidance. Commenting on the court's decision, NICE chief executive Andrew Dillon warned that this "will increase the complexity of [NICE's] drug appraisals in some cases and make them longer as a result". In the meantime, the guidance remains unchanged and Aricept remains recommended for use on the NHS in England and Wales for the treatment of patients with moderate Alzheimer's disease.

The dispute between Eisai and NICE stems from NICE's decision not to publicly subsidise Aricept together with other Alzheimer's disease drugs in patients suffering from early stages of the disease (see United Kingdom: 11 October 2006: NICE Rejects Appeal on Alzheimer's Drugs). Eisai, with the support of Pfizer, Shire Pharmaceuticals (U.K.) and the Alzheimer's Society, brought the challenge to the U.K. high court (see United Kingdom: 26 June 2007: NICE’s Controversial Ruling on Alzheimer’s Finally Reaches U.K. High Court), which ruled in favour of NICE (see United Kingdom: 13 August 2007: High Court Upholds NICE's Restriction on Alzheimer’s Drugs in U.K.). Eisai was granted an appeal hearing last month.

Outlook and Implications

The pharmaceutical industry and patients associations are sure to see the ruling as a milestone. As it stands, the court's decision is likely to become a thorn in the side of the cost-effectiveness watchdog, which, according to The Times, may bring the case to the House of Lords on the grounds that the computer programmes used during economic evaluations should be protected under intellectual property (IP) laws. Indeed, the cost-effectiveness analysis is often the area of contention between NICE and rebuked manufacturers, as the watchdog finds manufacturers' economic analysis usually too optimistic and therefore carries out its own (see United Kingdom: 4 April 2008: NICE to Take Little Action After Examining Parliamentary Report). Allowing manufacturers to fiddle with NICE's model may not necessarily result in amendments in guidance but it is sure to give drug-makers additional grounds to challenge NICE's decisions. Eisai's victory is likely to prompt other rebuked manufacturers to follow suit and ask for the full calculations of NICE's assessment on their drug to be released.

Whether the ruling truly benefits patients and the industry-at-large remains to be seen. On one hand, there is no guarantee that fiddling with NICE's economic model will allow manufacturers to successfully challenge its decisions and secure public funding for their drug, benefiting as a result both patients and their top-line. On the other hand, additional challenges to NICE's decisions may slow down the body's output, possibly delaying the evaluation of cost-effective drugs and their subsidised access for patients. It currently takes NICE an average of 18 months to release reimbursement guidance on a drug.

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