FDAnews
www.fdanews.com/articles/94317-uk-institute-recommends-velcade-with-payback-scheme

UK Institute Recommends Velcade With Payback Scheme

June 6, 2007

The UK’s National Institute for Health and Clinical Excellence (NICE) said that Johnson & Johnson’s (J&J) Velcade is cost-effective if the firm refunds the cost of multiple myeloma treatment when patients do not demonstrate at least a partial response, the institute writes in a draft guidance June 4.

NICE says that the product is an effective use of the UK National Health Service’s resources when treatment is continued beyond four cycles in those that have a complete or partial response, if J&J refunds the cost of the medication when patients do not respond.

Proteasome inhibitor Velcade (bortezomib), which is approved in the UK for the treatment of progressive multiple myeloma in patients that have received at least one prior therapy, costs $49,796 for an eight-cycle treatment course and $17,927 for a three-cycle course, NICE says.

J&J would refund the full cost of the medication when patients have less than a 50 percent reduction in their serum M-protein levels following four weeks of treatment, NICE writes. The company proposed the rebates after NICE concluded that Velcade was not cost-effective.

J&J markets the product in Europe, and both J&J and Millennium Pharmaceuticals sell the cancer drug in the U.S. The companies co-developed Velcade.

The NICE committee that conducted the reappraisal for the drug said that comparison studies with other multiple myeloma agents are needed. It notes that Celgene’s Thalomid (thalidomide) is considered an important treatment option in both the first-line and relapsed multiple myeloma treatment settings, and that Velcade’s efficacy would likely be increased when the product is used in combination with high-dose dexamethasone and/or cytotoxic drugs.