When is off-label not off-label? When it's on-formulary and off-patent of course.
At least that seems to be the position of some state Medicaid plans.
Case in point, pregabalin (Lyrica) and Iowa (coincidentally, the state represented in the United States Senate by Charles Grassley).
Iowa Medicaid requires preauthorization for pregabalin -- which is FDA-approved for (among other indications) fibromyalgia. In Iowa a patient with a diagnosis of fibromyalgia must first fail on at least two of the State's "preferred" agents -- trycyclic anti-depressants, topical lidocaine, or gabapentin. None of these three agents are approved by the FDA for the treatment of fibromyalgia.
But they are less expensive than the on-patent, on-indication product. So what we've got here is step-therapy based on off-label usage. Not unheard of, certainly , but it does start sending some interesting policy messages about the appropriateness of off-label use in various circumstances. (And it's more than a little bizarre when you consider that Pfizer, the manufacturer of pregabalin, had to pay a $430 million fine for off-label promotion of gabapentin.)
The actions of the Hawkeye State Department of Human Services are even more peculiar considering that Senator Grassley (R, IA) asked the U.S. Government Accounting Office (GAO) to investigate off-label prescribing -- and not because he thought it was a valuable tool for patient care.
So here's where we stand: Off-label use of on-patent medications is bad, but off-label use for generics is good. Translation: off-label use is good when it saves the payer money.
Is cost-based trial-and-error medicine really the path we want to take in the era of personalized medicine?
What about science?
What about relying on the professional judgment of the physician?
What about what's best for the patient?
At least that seems to be the position of some state Medicaid plans.
Case in point, pregabalin (Lyrica) and Iowa (coincidentally, the state represented in the United States Senate by Charles Grassley).
Iowa Medicaid requires preauthorization for pregabalin -- which is FDA-approved for (among other indications) fibromyalgia. In Iowa a patient with a diagnosis of fibromyalgia must first fail on at least two of the State's "preferred" agents -- trycyclic anti-depressants, topical lidocaine, or gabapentin. None of these three agents are approved by the FDA for the treatment of fibromyalgia.
But they are less expensive than the on-patent, on-indication product. So what we've got here is step-therapy based on off-label usage. Not unheard of, certainly , but it does start sending some interesting policy messages about the appropriateness of off-label use in various circumstances. (And it's more than a little bizarre when you consider that Pfizer, the manufacturer of pregabalin, had to pay a $430 million fine for off-label promotion of gabapentin.)
The actions of the Hawkeye State Department of Human Services are even more peculiar considering that Senator Grassley (R, IA) asked the U.S. Government Accounting Office (GAO) to investigate off-label prescribing -- and not because he thought it was a valuable tool for patient care.
So here's where we stand: Off-label use of on-patent medications is bad, but off-label use for generics is good. Translation: off-label use is good when it saves the payer money.
Is cost-based trial-and-error medicine really the path we want to take in the era of personalized medicine?
What about science?
What about relying on the professional judgment of the physician?
What about what's best for the patient?
