NICE Should Revise Assessment Process After Relenza Review, ABPI Says

The Association of the British Pharmaceutical Industry is proposing an alternative procedure for the U.K.' s National Institute of Clinical Excellence to follow in its new drug assessments, following NICE's Oct. 8 decision to recommend against prescribing Glaxo Wellcome's Relenza for the 1999 flu season.

ABPI is proposing an "improved appraisal framework" be established for NICE, which would bring greater industry input into the assessment process over several stages.

As a first step, NICE and industry should work before the launch of a product "so that short factual summaries of the available information can be provided for the NHS."

Current proposals call for NICE to grade new therapies into three categories: recommended for use on the National Health Service; recommended for use in clinical trials only; and not recommended for routine use.

The U.K. drug industry suggests three alternative categories: Category I would apply to interventions recognized for routine use on the NHS. Category II would consist of therapies "available for clinical use in the NHS on the understanding that more research is necessary and that a further review will be carried out."

Category III would apply "where necessary, after reappraisal and possible appeal, indicating that the interventions are not recommended for routine use, but making them available for patients who may continue to need them," ABPI suggested.

"At the time of product launch, but without delay, a limited review of the medicine should be available, based on its MCA/EMEA approval, a review of its efficacy and whatever data on cost-effectiveness can be supplied by the company, which will then lead to categorization into either I or II above," ABPI said.

"After an agreed period of general use, the intervention should undergo appraisal, based on clinical update and expert reports provided by the company and relevant cost-effectiveness data, which will then lead to categorization into I, II or, rarely, III above."

The decision to uphold the conclusions of the NICE report on Relenza was Frank Dobson's last major act as Secretary of State for Health, coming two days before his decision to resign and run for mayor of London.

Dobson's resignation coincided with a major reshuffling of the Blair cabinet during the week of Oct. 11. Dobson has been succeeded by Alan Milburn, who has been a member of parliament since 1992. Milburn served most recently as Chief Secretary to the Treasury, after having acted as Minister of State at the Department of Health from May 1997 until December 1998.

Glaxo met with representatives from the NHS and NICE Oct. 11 to discuss measures that will allow for Relenza to be endorsed by the NHS for the 2000-2001 flu season. NICE's decision centered on insufficient clinical trial data in high-risk populations and concerns over the financial implications the neuraminidase inhibitor could have for the NHS (¹ (Also see "Relenza Use In U.K. For 2000 Season Will Await Four Ongoing Glaxo Trials" - Pink Sheet, 11 Oct, 1999.)).

The British Pharma Group is seeking to exert direct political pressure on the government regarding what it terms "the ban on Relenza." The three-member group, which consists of Glaxo, SmithKline Beecham and AstraZeneca, announced on Oct. 6 that it had written to Prime Minister Blair "to seek urgent discussions on the implications for the British-based pharmaceutical industry" of the NICE decision.

The U.K. drug industry's ability to launch new therapies in the country as soon as they have been cleared by the Medicines Control Agency "provides a crucial platform for sales into international markets," the British Pharma Group maintained.

"The emergence of NICE as a new obstacle to market entry serves to wipe out, at a stroke, a key element of the U.K.' s competitive advantage in the global pharmaceutical industry," the three firms declared.

"Any savings to the NHS resulting from restricting access to new medicines will be insignificant when set alongside the potential loss of the U.K.' s current international standing in the pharmaceutical industry," BPG said.

AstraZeneca CEO and BPG Chairman Tom McKillop suggested that "much damage has already been done to patients and industry by the signals sent out by NICE's recommendations on Relenza."