- An English drug cost-effectiveness agency on Friday recommended against national coverage for GW Pharma's epilepsy treatment, citing hang-ups over insufficient long-term clinical results and the company's economic case.
- GW's cannabis-derived medicine has not yet been approved in Europe, but is expected to receive a regulatory OK in October for two rare types of childhood epilepsy. In the U.S., Epidiolex is off to a strong start after launching last November and has surpassed Wall Street's initial sales forecasts.
- Friday's conclusions from NICE, or the National Institute for Health and Care Excellence, are a draft version, with finalization expected by year's end. The agency and GW said they are working together to resolve these issues.
Deliberations between GW and NICE are still early — with the process starting well before regulatory approval — but highlight some of the technical issues GW will need to address to gain coverage in the U.K., one of Europe's largest markets.
The U.K. agency emphasized problems with the company's economic model, calling it flawed and leading to invalid results.
GW presented two models, one for Epidyolex (cannabidiol) and one for usual care. When reviewers put the same clinical inputs into each model, they found the model for GW's drug turned out a higher quality-of-life result when both models should have been equal.
A company spokesperson told BioPharma Dive that GW is working with NICE on these issues. The company also plans to provide a detailed subgroup analysis from its open-label extension study to address NICE's concerns on long-term clinical data.
"We are committed to working with NICE to address the technical questions it has raised, with the aim of ensuring patients can access the medicine on the NHS as soon as possible following regulatory approval," a company spokesperson said in a statement. "We remain hopeful that NICE will recommend cannabidiol oral solution at the end of its appraisal process."
These differences predate the actual cost-effectiveness analysis from NICE. As the drug has yet to be approved in Europe, the company has yet to disclose a list price for the region. Last year, the company faced some criticism for setting its U.S. list price at $32,500 per year.
NICE estimates the UK having populations of about 600 people with Dravet syndrome and 4,000 people with Lennox-Gastaut syndrome, the two types of epilepsy for which Epidyolex is seeking approval.