- It only takes into consideration the costs of the disease and drug to the NHS, and not broader socioeconomic costs (such as ability to stay in work or burden on carers, though this may be changing);
- It can be slow to reach conclusions;
- It has led to conclusions that make the U.K. look much more restrictive in allowing access to biologics than other developed countries. For example, for an RA patient to have access to a first biologic drug, they must have a DAS28 score greater than 5.1 on two occasions at least one month apart, and they must have failed to improve using two conventional DMARDs, with one usually being methotrexate. In my practice in Derby in the Midlands in England, I have 15% of my inflammatory arthritis patients being treated with biologics. This compares with around 50% of patients treated at the U.S. center of excellence that I visited. This may mean that I am not allowed to use enough biologics for the needs of my patients, or alternatively, my U.S. colleagues are using too much. It may be that I am forced to make more use of conventional therapies, or that I am making too much use of them and not putting patients onto biologic therapies who would gain more benefit from them than from conventional DMARD regimens. My U.S. colleagues appeared to make little, if any, use of short-term steroids, and if their patient failed on methotrexate monotherapy, there was a good chance they would move straight onto biologic drug therapy. If I behaved in the same way, I would be in breach of NICE guidelines, and local commissioners would not pay for the therapies.
As with all complex systems, I am sure that the best approach lies somewhere between our practices. I wish I had greater access to biologics for some of my patients where the NICE eligibility criteria appear unduly restrictive, but I also believe, particularly at a time of financial stringency, that my U.S. colleagues might make more use of conventional therapies. There is an increasing evidence base from a number of randomized controlled trials that intensive conventional therapy regimens can decrease the need to use biologics. In Derby, we have data showing less use of anti–tumor necrosis factor drugs over time, in part because we are increasingly seeing patients early and treating them intensively with conventional DMARDs. In financially restrictive times, the U.S. might learn from U.K. practice, as I would wish to incorporate some lessons learned from my American colleagues.
