UK-Style Insurance Risk-Sharing Could Affect Medicaid Rebates, Part B ASPs
U.S. biopharma manufacturers should be cautious about importing the British National Institute for Health and Clinical Excellence's approaches to reimbursement risk-sharing, as such schemes could have unanticipated consequences for obligations such as Medicaid rebates
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UK's National Institute for Health and Clinical Excellence makes a preliminary positive recommendation for use of Celgene's Revlimid (lenalidomide) as a second-line therapeutic for multiple myeloma. After receiving the recommendation, the National Health Service is expected to make a final decision during the second quarter. If NHS agrees, it would fully fund use of oral Revlimid, given along with dexamethasone, for 26 treatment cycles of 28 days per cycle (normally two years). Celgene says it will pick up the tab for UK patients who choose to remain on the drug for longer. In the U.S., Revlimid is approved for treatment of MM patients who have received at least one prior therapy and for transfusion-dependent anemia in those with myelodysplastic syndromes. It also is listed on several compendia and used off-label in newly diagnosed MM patients (1"The Pink Sheet," Dec. 15, 2008, p. 11). The biologic hit $1.3 billion in worldwide sales in 2008. Celgene plans to file in the U.S. for approval as a front-line therapy for MM in 2009
An innovative cost-sharing arrangement in which Johnson & Johnson will rebate the cost of the cancer drug Velcade (bortezomib) when patients have a minimal response will be implemented in the U.K. by early 2008
CMS should consider a process to allow revisions of Part B average sales prices for drugs sold through bundled arrangements, to enhance the accuracy of ASPs, the advisory panel group suggests to agency.