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PseudoB, While my doctorates do not include an M.D., I've sat in on a lot of high-level meetings on drug reimbursement, strategy and deciding what indication(s) to do clinical trials on. I'm not an expert in this area, but it seems to me that the "payors" do not balk at reimbursing off-label uses of drugs as long as the use is relatively mainstream. If they can justify their holding back as protecting their constituencies, since the use is "experimental" (read very expensive and they think they can get away with this), they will. But if a drug use is reasonably related to the approved indication, I do not know of any hesitancy to cover it. In fact, the majority use, certainly reimbursed, of quite a few prescription drugs is not label indications. For example, up till this year Prozac was only approved for major depression and obsessive-compulsive disorder, but hundreds of thousands of people with other problems were routinely getting it as the most mainstream treatment for conditions like eating disorders, panic disorders, etc. And I've never heard of reimbursement problems. Another: most major antibiotics are not approved for treating more than several specific bugs, but docs use them all the time for off-label treatments. Ex. Metranidazole is a major treatment for H. pylori, but that was never an approved indication. I could go on. I don't think Idec is very worried about reimbursement for major off-label uses of Rituxan. |
