NICE Greenlights Bortezomib Coverage for Multiple Myeloma

The United Kingdom’s National Institute for Health and Care Excellence announced last week that people with newly diagnosed multiple myeloma will be guaranteed access to treatment with the proteasome inhibitor bortezomib (Velcade).

“We are pleased to recommend bortezomib as a first treatment for people with multiple myeloma before bone marrow transplant,” Professor Carole Longson, director of the NICE centre for health technology evaluation, said in a statement. “The evidence presented to our independent committee showed that having bortezomib at this stage will help more patients go on to a bone marrow transplant, and consequently prevent the disease from progressing for longer.”

The main efficacy data considered for this decision was from the phase III PETHEMA, GIMEMA, and the Intergroupe Francophone du Myelome (IFM) trials. Results from PETHEMA and GIMEMA showed that patients assigned bortezomib had significantly better overall response rate after induction compared with patients assigned to a thalidomide regimen. This difference was maintained even after transplant. Similarly, in the IFM trial, patients assigned bortezomib had a significantly improved overall response after induction treatment compared with patients assigned vincristine, doxorubicin, and dexamethasone; however, the difference was not maintained after transplant.

In a comment published in the Lancet, representatives from NICE wrote, “The committee agreed that although there was uncertainty in the magnitude of overall survival associated with bortezomib, the drug’s effect on induction response could be associated with improved overall survival. However, the committee also emphasized that no evidence was available to compare the efficacy against cyclophosphamide, thalidomide, and dexamethasone-the standard induction treatment in the UK.”

According to NICE, the cost per quality-adjusted life-year gained for bortezomib, thalidomide, and dexamethasone compared with thalidomide and dexamethasone; and for bortezomib and dexamethasone compared with cyclophosphamide, thalidomide, and dexamethasone, and with vincristine, doxorubicin, and dexamethasone, were likely to be below £30,000 per quality-adjusted life-year gained, and so bortezomib was considered an acceptable use of National Health Service resources.

Prior to this decision, bortezomib was only available to patients with progressive myeloma who were at first relapse after receiving one prior therapy, or who had undergone or were ineligible for bone marrow transplantation.

In the United States, bortezomib was approved in 2005 for the treatment of patients with multiple myeloma who had received at least one prior therapy and in 2003 for the treatment of more refractory multiple myeloma. In 2008, the agency approved the drug as an initial treatment for patients with multiple myeloma.