Doctors, Not Politicians, Should Decide

In Alex Brill’s paper on “Overspending on Multi-Source Drugs in Medicaid,” he writes about “the potential savings that could have been achieved had Medicaid consistently used the lower-cost version” of 20 multi-source drugs.

While there is little or no debate about the need to control Medicaid spending, Brill’s recommendations could lead legislators to institute policies that would be even more aggressive in requiring use of generics unless doctors go through extraordinary steps to get around strict state Medicaid formularies. It is important to recognize there could be adverse impacts on patient care.

The conclusion of his paper is that states are overspending by allowing doctors to prescribe brand-name drugs when drugs with “identical active ingredients” are available. My earlier commentary responding to his paper pointed out that “limiting drug choices to generics can force patients to take medicines that may not be the right ones for their particular maladies.” (Brill responded to my commentary here.)

The Food and Drug Administration (FDA) is engaged in an active debate over concerns that generics in many categories do not behave identically in patients, even when the active ingredients are identical.

FDA guidelines say that generics do not have to be identical to the original branded medication as long as they fall within an allowable range of “bioequivalency.” While they must have the same active ingredient, they are allowed to vary other components of the medicine. In some patients, this can lead to very different results.

Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said recently that the FDA is discussing tightening the equivalence limits of generic medicines “so there is less variability.” The agency is concerned that its current standards for bioequivalence are not sufficient for narrow therapeutic index drugs.

Clearly, doctors know the difference based upon patient experiences. Brill’s study says that with the immunosuppressant Cellcept, doctors substitute a generic only 44 percent of the time and 68 percent of the time with the anticonvulsant Keppra. Yet many other drugs on his list have substitution rates in the 90 percentile. Clearly doctors are making decisions here about when a generic is appropriate and when it is not.

But Brill’s paper could lead state policy makers to conclude that they should tighten their formularies further, leading to adverse results for patients. I pointed in my commentary to just one example of the impressive body of research by Columbia Professor Frank Lichtenberg. I had referenced the Lichtenberg research to underscore the importance of allowing broad access to medicines and could have more carefully worded my reference to say that his work shows (rather than documents) the perverse impact of considering only drug costs and not the overall cost of care. Of course, the Lichtenberg study which I referenced predated the Brill study and therefore could not have been directly addressing it.

The message policy makers surely will hear from Brill’s paper is to strongly encourage the use of generics over brand-name drugs. But the longer-term costs, both to patients and the system, could be much higher when politicians, not doctors, are making decisions about patient care.

Posted on The Enterprise Blog, May 10, 2011.

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