Biogen Idec and Elan will be hoping for a rapid take-up of their multiple sclerosis product Tysabri (natalizumab) after the drug was placed on the National Institute for Health and Clinical Excellence's fast-track system.
NICE, the UK's cost-effectiveness body that determines whether approved products may be prescribed on the country's National Health System, introduced the so-called single technology appraisal process after mounting criticism of the time it took to make its decisions, particularly in light of the furore surrounding access to Roche's anticancer drug Herceptin (trastuzumab).
What has been happening in the UK is that - despite being approved by the European Commission or the UK's own Medicines and Healthcare products Regulatory Agency - cash-strapped primary care trusts are waiting for NICE's decision before allocating any budget. Now, assessment for those drugs allowed into the elite STA stable is six months, versus a normal assessment period which can be as long as two years.
So, after a rocky start, which saw Tysabri temporarily withdrawn from the US market after being linked to a rare brain infection and a small number of fatalities, the monoclonal antibody is back with a vengeance and is licensed across Europe in June for use in relapsing-remitting MS in patients who have severely active disease despite prior treatment with a beta-interferon. The approval was based on two-year data involving nearly 1,000 patients and showing a 42% reduction in the risk of progression to disability and a 68% relative reduction in the rate of clinical relapses over the study period.
Christine Jones, Chief Executive of the MS Trust, commented: “After the very lengthy process we had to endure with the NICE assessment of the current disease-modifying therapies, I am delighted in this instance the process will be rapid.” But she warned that MS patients and clinicians will need to proceed with caution as far as Tysabri is concerned until long-term data become available. “The long-term safety of Tysabri is not yet well documented [and we] strongly support close monitoring to reduce the risk of side effects and to look at long-term safety and efficacy.”