Log in or register to see all Alerts
New HTA Decisions in England
April 2019
Drug name
DARZALAX® & VELCADE® (Daratumumab and Bortezomib)
Company
Janssen & Takeda
Decision date
10/04/2019
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Decision
Recommended with restrictions (CDF)
Indication
Daratumumab plus bortezomib plus dexamethasone is recommended for use within the Cancer Drugs Fund as an option for treating relapsed multiple myeloma.
Decision Detail
It is recommended only in people who have had one previous treatment, and only if the managed access agreement for daratumumab plus bortezomib plus dexamethasone are followed.
Summary
The clinical evidence for this recommendation came from the open-label international trial CASTOR. The results showed that, as a second treatment, daratumumab plus bortezomib plus dexamethasone improves how long people live for before the disease gets worse when compared with bortezomib plus dexamethasone. The results also suggest that people who have daratumumab plus bortezomib plus dexamethasone live longer. However, how much longer they live in total is unclear because there are no long-term trial data. The estimates of cost-effectiveness presented by the company and evidence review group differed greatly. These differences depend mostly on the estimates of how much longer people will live if they have daratumumab plus bortezomib plus dexamethasone, rather than bortezomib plus dexamethasone. If the company's estimates are confirmed by extra trial data, there is potential for daratumumab plus bortezomib plus dexamethasone to be cost effective. Therefore it is recommended for use in the Cancer Drugs Fund while extra data on long-term survival are collected.