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possibly invasive tests, or at least a fair amount of paperwork. For relatively cheap medicines, these expenses would likely cost more than the drug itself. Drug manufacturers would also want to protect themselves from scammers who benefited from the drug, but seek refunds anyway to get it for free. Therefore, the burden would be on the patient (or more likely, his or her physician) to provide assurances that the drug did not work. This policy need not be mandated, either, but a money-back guarantee would certainly help convince an insurance company to pay for a particular treatment.
The primary difficulty here, of course, is coming up with an agreed-upon definition of whether or not the patient has “responded well” to the drug. Getting a clear, unambiguous agreement that would be acceptable to patients, the drug seller, and the insurance company will certainly be a challenge. While this is not a trivial issue, it should be a solvable problem. It should certainly be easier than the challenge of coming up with the drug in the first place. And suppose the initial diagnosis was wrong? Drug companies wouldn’t want to eat the expense of refunding medicines that didn’t work because the patient was misdiagnosed. However, this expense would be wrapped into the overall cost of doing business, lumped in with unproductive research programs and failed clinical trials.
Would linking drug performance to cost reimbursement result in an increase in the price of our drugs? One could argue that as the percentage of patients paying for a drug decreases, then the cost of the drug would necessarily increase. This would be balanced, to some degree, by an increase in the number of patients (financed by their insurance companies) willing to try the drug knowing that the expense would be reimbursed if it didn’t work. In countries where there are strict cost controls on the health care system, expensive drugs are effectively rationed and must demonstrate great benefit in order to be sold there.
Another question would be whether to apply this reimbursement policy to drugs sold for approved indications as well as “off label” uses. For example, many expensive drugs (e.g. TNF inhibitors for rheumatoid arthritis patients) are quite effective in a majority of patients, but provide no benefit to a smaller percentage. Venture capitalist Steve Burrill was recently cited as stating that 90 percent of drugs work in just 30 to 50 percent of patients. Why not refund the cost of their drugs to this latter group as well?
I have no hard answers here, but believe the subject is worth examining in greater detail as more and more high priced medicines come to market. Drug makers are currently focused on creating medicines that are more likely to be effective against smaller, well defined subsets of patients (e.g. those identified by using biomarkers) with particular diseases. Smaller patient populations will translate into higher priced drugs, but the model is viable. Some of Genzyme’s medicines, for example, can cost $200,000 dollars a year and up. Furthermore, it is increasingly likely that treating some diseases, such as cancer, will be done by prescribing a combination of drugs that hone in on specific targets, raising the potential cost of treatment to what many fear will be prohibitive rates.
Many drug are given away to doctors as free samples, so the idea of giving out medications on a trial basis is well established in clinical practice. And virtually all drug makers are happy to obtain the extra revenues earned when their drugs are prescribed for either legitimate (e.g. testing an anti-cancer medicine against a rare tumor) or illegitimate (e.g. use of epo by Tour de France cyclists) “off label” uses. We like to think that in a fair society, payment for a job is directly linked to performance. Perhaps the time has come for drug payments to be linked in the same manner.
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