Earlier this month, European regulators approved Roche’s Perjeta for some postsurgery patients with early breast cancer. But England’s cost watchdogs are blocking its path.
Friday, the National Institute for Health and Care Excellence released draft guidance recommending against NHS use of Perjeta, in combination with fellow Roche cancer-fighter Herception and chemo, in HER2-positive early breast cancer patients who face a high risk of their cancer returning after surgery.
The reasons? For one, an evaluation committee concluded that adding Perjeta to the Herceptin-chemo regimen “made only a small difference in the proportion of people who remained free of invasive disease,” NICE said in a statement, adding it doesn’t yet have evidence that Perjeta increases overall survival.
NICE isn’t the only group not to find Roche’s Perjata postsurgery data somewhat underwhelming. When details dropped at last year’s American Society of Clinical Oncology (ASCO) meeting—and later when the combo picked up FDA approval—industry watchers and analysts labeled the performance “weak.”
With that in mind, NICE couldn’t recommend Perjeta as a clinically and cost-effective option, Meindert Boysen, director of NICE’s Centre for Technology Evaluation, said in a statement, though “we would welcome further discussions with the company about what steps can be taken to address the concerns raised by the committee.”
One step that usually helps do the trick is a price break, as Roche well knows. Its public struggles with NICE are well-documented thanks to colorful language from its CEO, but it’s also managed to change minds at the gatekeeper—including on Perjeta—with discounts. This time around, it has until July 6 to negotiate ahead of final guidance, which NICE expects to put out in October.
Meanwhile, Richard Erwin, general manager for the Swiss drugmaker, said the company was “disappointed” but determined not to “walk away from this group of women.”
“As ever, we remain committed to working openly with NICE, NHS England and the wider patient group community to discuss the data and find a positive way forward to ensure that patients in England can access this medicine, as quickly as possible,” he said.