“In 2002, the National Institute of Clinical Excellence [NICE], which is the U.K. body that sets the guidelines that decide what should be available under the National Health Service, concluded that beta-interferon and glatiramer acetate were not cost effective during the short-term, and thus it recommended that it couldn’t be available under the NHS at that stage,” Dr. Palace explained.
The NICE did notice, however, that if the drug effect was maintained over the long term it might be cost effective and invited the Department of Health to “try and find a way to make the drugs available in a cost-effective manner,” she said.
“This was the birth of the Risk-Sharing Scheme, and it is a way of providing disease-modifying therapies to patients cost effectively,” she said.
At the start of the scheme, the drug prices were reduced in line with a cost-effective requirement using the NICE model, which equated to about $58,400/quality-adjusted life-year..
“We were allowed to reach this target over a 20-year lifespan, and the idea was to monitor a clinical cohort of patients, measuring their EDSS scores,” she said.
The natural history dataset was used as a “virtual placebo,” and a price adjustment would be required if the outcomes of the treated patients were less than predicted to be on target for cost effectiveness.
The findings of this study – the largest observational study to measure the effect and cost-effectiveness of interferon beta-1a and glatiramer acetate – provide evidence that the treatment alters the natural history of relapsing-remitting MS in the real life setting, she concluded.
Dr. Palace reported receiving support for scientific meetings and honorariums for advisory work from Teva, which makes glatiramer acetate, and Bayer Schering, which makes interferon beta-1a, as well as other companies that market drugs for MS. She’s also received unrestricted grants from Bayer Schering and other companies that market drugs for MS.