Plans by the National Institute for Health and Clinical Excellence to establish a new service offering drugmakers early scientific advice on products in development, ahead of Phase III trials, represent a “very, very important strategic development” for the Institute, according to Dr Carole Longson, NICE’s director of health technology evaluation.

Following the completion of a successful pilot programme conducted by NICE with Novartis, involving a potential psoriasis treatment currently in development at the company, Dr Longson expressed confidence that NICE can provide companies with a “robust, pretty formalised” scientific advice service, to run alongside their regulatory discussions about new products with the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMEA).

She told the Pharmaceutical Pricing and Market Access Outlook meeting organised by Health Network Communications in London yesterday that she is due to present a business case for the initiative to the Board of NICE in May. The Board will need to be convinced of the proposed new service’s viability: eg, - is it something which companies want? - can it be offered at a reasonable cost? – and can NICE’s resource costs for providing the service be recovered?

However, the meeting also heard a note of caution from Anne-Toni Rogers, director of government affairs and public policy for Europe at Baxter, who felt that the fact that the pilot scheme has been run with a pharma major could disadvantage smaller companies, because the standards which it establishes may be set too high for them. Smaller players fear that the market could be captured by the larger firms, she said, and asked: “do other companies even know what’s being discussed?”

Ms Rogers expressed similar concerns about government/manufacturer risk-sharing agreements for new treatments whose therapeutic benefits are uncertain at launch, the first of which in the UK was for Millennium Pharmaceutical and Janssen Cilag’s previously rejected cancer drug Velcade (bortezomib); in June 2007, the National Health Service (NHS) agreed to fund the drug provided patients show a “full or partial response” to it - if there was no response, the cost would be refunded by the product’s manufacturer.

It is widely assumed that such deals are mainly proposed by governments, but in fact most recent agreements have been driven by industry, she Ms Rogers. Again, some smaller drugmakers believe that these deals are being used by large firms to capture the market. Governments can used them to ease their drugs bill but, she said that, as a patient, she was not sure that all the right checks and balances are in place. Risk sharing presents many opportunities, but Ms Rogers asked whether they are being effectively managed at present.

In principle, risk-sharing schemes make a lot of sense, said Kees de Joncheere, regional adviser for health technology and pharmaceuticals at the World Health Organisation (WHO). He asked: when there is uncertainty about a product’s therapeutic benefit at launch, what is the alternative?

NICE stresses: “we don’t want drug pricing role”

Last week, the UK government was expected to issue its public consultation on the future of the Pharmaceutical Price Regulation Scheme (PPRS), but its negotations with the Association of the British Pharmaceutical Industry (ABPI) have now gone into extra time, the meeting heard. Several speakers suggested that, currently, discussions are favouring the introduction of speedy assessment of new products at launch, a process in which NICE could play a significant role.

Dr Longson reminded delegates that the Institute has no powers over pricing (or affordability – it is vital to distinguish this from cost-effectiveness, she said) nor is it seeking such a role. The health technology assessment (HTA) process should be used to inform discussions but not make decisions, she said.