Feb 6, 2001
By NICHOLAS TIMMINS
The National Institute for Clinical Excellence has asked companies making treatments for multiple sclerosis to release patient-specific data to help it assess whether the NHS should adopt beta-interferons and other treatments for MS.
The data could help Nice decide whether some patients for whom beta- interferon is licensed may benefit more than others. If they do, that may alter Nice's assessment of whether the Pounds 10,000-a-year treatment is cost-effective.
The effect of such a decision, however, would be to give the companies easier access to a smaller market than the drug is actually licensed for: the NHS would pay for those patients for whom the drug was demonstrably effective, but not for all the patients for whom it was licensed. It is the first time Nice has asked if companies will release anonymised but patient-specific data, as opposed to grouped data from clinical trials.
It has done so because the institute is planning to build its own independent model of the cost-effectiveness of the controversial treatments.
Schering and Biogen, two important manufacturers, say they are considering the request. Industry insiders, however, challenged Nice's move, arguing that it undercut the role of the Medicines Commission, the licensing body, which has approved beta-interferon for all forms of relapsing-remitting MS. Some argue Nice is seeking to go beyond its remit.
That view was rejected by Andrew Dillon, Nice's chief executive. It was perfectly reasonable for Nice to ask "if there is any evidence at all that a sub-group of patients may benefit more from the treatment than others".
To assess that, "we would need to be able to see the results of the effect on individual patients, as opposed to the effects being presented in summary form.
"We are not questioning the regulator's decision . . . what we would like to know is if there are any groups within the total population for whom the drug is licensed who could benefit more, because if there are, it will almost certainly have an impact on the issue of how far the treatments are cost-effective. We see that as being in the interests of patients."
* Five million people will have access to their own electronic health records in two years time with the country covered by 2005, Alan Milburn, the health secretary, announced. The move is part of a Pounds 700m investment in IT aimed at delivering a more patient-centred NHS with online booked admissions, test results and other improvements. The electronic record, will contain only basic data, including name, address, NHS number, GP and contact details, conditions and medication and allergies.
Copyright: The Financial Times Limited