EC/FDA joint inspections


847 clinicians. “The challenge is to find a definition of value that is acceptable to all,” says Scott-Ram. Another, almost insoluble, problem is the choice of reference products. When a new drug is introduced, which existing product should it be compared against for pricing? “Developing a new drug is very expensive, even if it is only a minor improvement on existing products, but if NICE compares its price with an earlier drug in the class it will often come out uneconomic,” says Scott-Ram. “It’s even worse if the first-in-class product has become generic and thus much cheaper.” So if NICE is too ruthless in calculating the cost-effectiveness of incremental innovations, he says, it will end up throwing the baby out with the bathwater. “It was unrealistic to expect that we would come up with a new mechanism overnight,” says Burnand. “Whatever is meant by value for money will have to be decided in the future. If it is going to be done it needs to be done properly, and it can’t be done on the back of an envelope.” Moreover, she says, other European countries are closely observing the UK’s progress toward rational medicines pricing. “Their governments are wrestling with the same issues of cost effectiveness and early access to medicines as we are,” she says. “Many of them see the UK as setting a price benchmark that they can follow.” Ultimately, the UK and other European governments that run their own health services are all facing the same dilemma. Namely, they need to restrain the future medicines bill, while satisfying the expectations of their electorates and encouraging industry to innovate. It could be a reach too far. Peter Mitchell London role in medicines reimbursement, says Nick Scott-Ram, an industry consultant who represented the biotech industry in the recent negotiations. The industry now expects concessions in the detailed appraisal process: drug evaluations should take into account some of the wider socioeconomic issues, such as the cost of personal caregivers, which NICE doesn’t count at the moment. Various other ‘flexible measures’ are also being proposed that might blunt NICE’s claws. For example, when NICE uses early, incomplete data to assess a product as not cost effective, the sponsor could be told what extra data would be needed to prove cost effectiveness, and given time to collect and submit it, rather than having the product rejected out of hand. And NICE will be pushed to accelerate its assessment work. A Department of Health report published in late June promises that “improvements to the topic selection and appraisal process...will mean that NICE can issue the majority of its appraisal guidance within a few months of a new drug’s launch,” instead of the two years’ delay common today. “These are all encouraging words for the larger biotech companies, particularly those trying to launch innovative medicines focusing on niche indications, and first-in-class molecules,” says BIA’s Burnand. Significantly, though, the concept that was supposed to be at the root of the renegotiation—that is, a move to pricing medicines according to their therapeutic value—seems to have been kicked into the long grass. Almost no progress has been made on moving the idea forward, says Scott-Ram. One key obstacle to value-based pricing is that value means different things to different parties—to the government as payer, to patients and to Pharma to boycott UK?

DOI: 10.1038/nbt0808-847b

Cite this paper

@article{Nasto2008ECFDAJI, title={EC/FDA joint inspections}, author={Barbara Nasto}, journal={Nature Biotechnology}, year={2008}, volume={26}, pages={847-847} }