Janssen says it is disappointed that NHS cost regulators are not backing NHS use of Darzalez (daratumumab) plus bortezomib and dexamethasone (DBd) for previously treated multiple myeloma in adults.

According to Janssen, the decision comes despite the consultation papers highlighting the regimen as an innovative treatment combination, which the firm said boosts overall survival and slashes the risk of death by 50 percent.

However, the National Institute for Health and Care Excellence noted that the size of the DBd’s benefit in the long-term is “unclear”, because currently available trial data were collected over a short period of time.

Also, the benefits of DBd compared with alternative therapy carfilzomib plus dexamethasone “are less clear because they haven’t been compared directly in a trial”, according to the draft guidelines.

Should NICE’s decision become final, up to 2,900 eligible patients in England will be unable to access “this much-needed treatment option” after their first relapse on the NHS, Janssen said.

“This will leave patients with relapsed or refractory multiple myeloma (RRMM) facing further treatment with less effective options at this crucial stage of their disease.”

“Despite being recommended by clinical guidelines, there are currently no triple therapies recommended by NICE at second-line, yet there is a clear unmet need for efficacious products in this setting,” noted Jennifer Lee, director of health economics, market access and reimbursement (HEMAR) and advocacy at Janssen UK.

UK charity Myeloma UK said it was disappointed with the decision, but pleased that the Committee “has recognised evidence from Myeloma UK and leading clinicians that this is a ‘game-changing’ treatment, which delivers significant and clinically important survival benefits for patients.

“It is therefore vital that NICE and the company explore every possible option to deliver a positive outcome. We will also continue to do everything we can to secure a ‘yes’ for myeloma patients and their families.”

Janssen said it will continue to work closely with NICE and NHS England “to do everything we can to ensure that DBd becomes routinely available at second-line for eligible patients in England as soon as possible.”