The UK National Institute for Health and Clinical Excellence’s provision of early-stage scientific advice to drugmakers, pioneered in a successful pilot project run by NICE with Novartis, is a welcome attempt to break the cycle of inefficient and confrontational relationships between healthcare stakeholders, but there could be unintended consequences, experts at IMS have warned.

To date, 40% of all NICE’s published appraisals have been appealed by manufacturers or patient groups, and last year 50% were appealed, Murray Aitkin, senior vice president at IMS’ Healthcare Insight, told a meeting in London. However, Novartis’ initiative has opened “a fresh approach to dialogue” with Health Technology Assessments, he said, and forecast that it would lead to “many more.”

NICE says it wants to offer drugmakers this new service, providing early scientific advice ahead of Phase III, to help them develop the evidence it needs to assess the clinical and cost-effectiveness of new treatments, thus fostering the development of, and accelerating access to, innovative new therapies. However, the Institute is providing no guarantees, warns Mr Aitken; when Novartis submits the dossier for the drug on which the pilot was based – a potential treatment for psoriasis - for appraisal, NICE could still decide not to recommend its use on the National Health Service in England and Wales. If this is the case, the old confrontations could return, he says.

Another danger is that companies could be tempted to design trials that meet NICE’s requirements but miss endpoints, he added.

Harbingers of change
The Novartis/NICE pilot is one of a number of “harbingers of change” identified by IMS’ new Intelligence 360 report as “events that are significant in the ramifications they suggest for the pharmaceutical market in the near term…and the magnitude of the responses that various stakeholders will need to take.”

Novartis has taken the lead on August 2006’s recommendation by the American Pharmaceutical Group to Sir David Cooksey’s Review of UK Health Research that “an earlier dialogue between NICE and clinical researchers could help to better direct research to ensure a satisfactory and speedy NICE appraisal.”

The optimistic viewpoint is that experiments such as Novartis’ may lead to a consensus around targets for R&D, in order to gain endorsement for access and reimbursement, says IMS. With HTAs becoming increasingly important to the market success of new drugs, manufacturers “simply can’t overvalue the scientific contribution of their innovations or ignore the influence of [HTAs],” it stresses, adding that Novartis’ “bold experiment” could signal the end of pharmaceutical companies’ “isolationist ethos.”