Avastin bevacizumab regulatory update

The U.K.'s NICE issued a second preliminary appraisal recommending against the use of Roche's Avastin bevacizumab in combination with oxaliplatin and either 5-fluorouracil plus folinic acid or capecitabine to treat metastatic colorectal cancer (mCRC). The recommendations are in line with the first appraisal, issued last November, in which the agency said the drug could not be considered a cost-effective use of NHS resources despite Roche's inclusion of a patient access scheme for first-line mCRC. NICE conducted the second review after Roche revised the scheme to add an undisclosed upfront payment to the NHS for each person starting treatment to the company's original plan, which entailed the company supplying Avastin at a fixed cost of L20,800 ($31,200) per patient for one year, with Avastin free after 12 months of cumulative treatment and oxaliplatin free throughout (see BioCentury, Dec. 7, 2009).

The committee had concerns about the revised plan's complexity and noted that operating costs would likely be higher than Roche's estimates. The mAb against VEGF is approved in the U.K. in combination with fluoropyrimidine-based chemotherapy to treat metastatic carcinoma of the colon or the rectum. Comments are due Sept. 15, with the next appraisal meeting scheduled for Sept. 28. ...