The U.K.'s cost-effectiveness apparatus may have rejected GlaxoSmithKline's appeal to reconsider its Tyverb drug, but it's offering a back-door route to a possible thumbs-up. That route would require more data crunching, but if regulators get the O.K. from their higher-ups, they'll start that new appraisal "as quickly as possible," chief watchdog Sir Andrew Dillon says.
The National Institute for Health and Clinical Excellence's appeals panel affirmed the agency's earlier refusal to add the cancer drug to the National Health Service's formulary. But as Dillon explains, NICE wants to compare Tyverb to Roche's Herceptin in patients with advanced, worsening breast cancer, which could lead to Tyverb approval for that precise use.
"[W]e have decided not to issue guidance at this stage," Dillon says. "This is because we now believe that a better way of assessing the value of [Tyverb] is to consider it alongside the use of trastuzumab, or Herceptin, beyond progression."
Herceptin isn't approved for that use in the U.K., but NHS doctors often prescribe it off-label to these advanced cancer patients. Apparently, NICE thinks Tyverb might be a cost-effective alternative to Herceptin. We'll see what the data shows.
- get the NICE release
- read the Wall Street Journal story
- see the news from Reuters