NICE seeks more data on J&J’s Velcade for multiple myeloma

In draft guidance, published today (November 12), the UK’s drugs watchdog the National Institute of Health and Care Excellence (NICE) has asked Janssen Cilag, a European subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), to provide more data on the effectiveness of its Velcade (bortezomib) as a treatment for some patients with newly-diagnosed multiple myeloma.

This appraisal is examining the use of bortezomib for treating multiple myeloma in combination with dexamethasone and thalidomide. The draft guidance has been issued for consultation and the manufacturer now has an opportunity to respond to the independent Appraisal Committee’s considerations and requests.

The NICE has requested further evidence on the clinical and cost effectiveness of bortezomib in combination with dexamethasone compared with current standard treatment of newly diagnosed patients who are suitable for high dose chemotherapy with haematopoietic stem cell transplantation. Standard treatment in the UK is a combination of cyclophosphamide, thalidomide and dexamethasone. The draft guidance does not currently recommend bortezomib in combination with thalidomide and dexamethasone.

Lack of information to assess cost-effectiveness

Carole Longson, Health Technology Evaluation Centre Director at the NICE, said: “The independent Appraisal Committee could not assess whether bortezomib in combination with dexamethasone is a cost-effective treatment option because it did not have sufficient information to do so. The next step in the NICE process is for the manufacturer to consider the Committee’s comments and respond to its request for further evidence.”

Consultees, including the manufacturer, health care professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

Cost structure