Bureaucratic red tape is not unique to the American healthcare system. Due to recent rulings by the UK's National Institute for Health and Clinical Excellence (NICE), most patients in that nation's healthcare system will not have access to fingolimod (Gilenya, Novartis). The authorizing body states that the benefits of the therapy simply do not justify the costs—even though Novartis offered to discount the drug from the price the Institute rebuffed earlier this year. Clearly regulators felt the drug was worthy of market authorization; the bean counters say it's not worth it. For any neurologist who deals with third party payors—and that's most of them—the scenario may not seem particularly unusual.
This hurdle for fingolimod, the first oral disease-modifying therapy to come to market, may temper enthusiasm about other MS therapies currently in development. In the wake of the Joint Trienniel Congress of the European Committee for Treatment and Research in MS and the Americas Committee for Treatment and Research in MS (ECTRIMS/ACTRIMS), reports of promising study results were inescapable. New drug applications have been submitted to the FDA in the past several weeks, and others may be close to submission. Hopefully expansion of the treatment armamentarium will allow more patients with MS to gain control of their lives and maintain a high level of function and quality of life.
Of course, the established therapies that have already been on the market for MS are effective for a good number of patients and may be more cost effective than some emerging options. The bottom line, forgive the pun, is that treatment decisions ought not be made on a financial basis alone. Of course costs play a role in decision-making, but they should not be a determinant. If a less expensive drug is expected to provide benefits for a patient, then the patient might as well use it. For the patient who needs a different intervention, then a costlier option warrants consideration. Should it be dismissed out of hand by an oversight committee that has never even seen that patient? As technology and science evolve, therapies may grow costlier. All parties must work together to understand how to best use treatments to optimize patient care while respecting healthcare resources and limitations.