Professor Sir Michael Rawlins, chairman of the NationalInstitute for Health and Clinical Excellence (NICE), has suggested that insteadof developing complex schemes such as rebates to increase patient access totheir innovative but expensive new treatments, drugmakers could simply offer theNHS deeper initial discounts.

NICE “broadly” supports the use of patient access schemes(PAS), because they can increase the cost-effectiveness of treatments and thereforepotentially help patients gain access to high-cost drugs, Sir Michael said inan interview with the Financial Times this week. However, he added that suchschemes require “substantial management input” and can be complicated for NHSTrusts to implement, and he suggested that a “simple discount” may eliminatethe need for such complex schemes.

More and more PAS are being introduced in the UK, but theyare not without their critics. The first scheme was agreed between drugmakers andthe Department of Health in 2002, after NICE ruled that four disease-modifyingdrugs (DMDs) – beta interferons and glatiramer acetate – used in the treatmentof multiple sclerosis (MS) were not cost-effective. According to researcherswriting in the British Medical Journal (BMJ) this June, the scheme had proved asuccess for the drugmakers, who had sold their drugs to the NHS at close tofull price, but for the NHS it had been “a costly failure” and should not becontinued

Also earlier this year, a leading patient spokesman toldMembers of Parliament (MPs) that PAS are not the “most appropriate” wayforward, in the long term, to improving access to medicines.

Discussing the landmark risk-sharing PAS for Janssen-Cilag’smultiple myeloma treatment Velcade (bortezomib), Myeloma UK chief executiveEric Low said that drugmakers need to have much more of an incentive to producebetter data and to think about price much earlier on the drug developmentprocess.

Commenting on Sir Michael’s proposal this week, JanetKnowles, partner and head of the UK biopharma team at law firm Eversheds,emphasises that drugmakers would need to be able to recover some of discountsif their products proved cost-effective for the NHS.

“NICE has pressed for patient access schemes to be based onthe cost-effectiveness of a drug but Sir Michael’s comments seem to suggestthat the NHS is not yet able to easily determine this,” she says, and suggeststhat the NHS should perhaps “shift its focus” towards ways of doing this easilyand effectively, which would satisfy both the NHS and the pharmaceuticalindustry.

“The key as ever when it comes to developing measures suchas this will be around ‘risk-sharing’ to ensure that both the NHS andpharmaceutical companies benefit,” says Ms Knowles.