We’re all used to state AGs suing drug companies for inappropriate promotion of off-label indications (Neurontin comes to mind – among others). Now there’s an interesting new wrinkle.
16 state Attorneys General (Oklahoma, Alaska, Utah, Iowa, Colorado, Kansas, Maine, Missouri, Nebraska, New Mexico, North Carolina, Rhode Island, South Dakota, Texas, West Virginia, and Wyoming) have written to Abby Black (Director, Center for Drug and Health Plan Choice at CMS) to complain that Part D participating insurance companies are requiring that their customers fail on a variety of off-label therapies before they will be reimbursed for medicines that have the more appropriate, on-label indication relevant to their particular conditions.
The AGs write, “Just as it is inappropriate for pharmaceutical companies to market drugs for off-label uses, it is equally inappropriate for health insurance companies to refuse to reimburse for physician-prescribed medications unless a patient first undergoes treatment with drugs that are off-label. … This practice of requiring treatment with an off-label drug before reimbursing a patient for using a drug
Many issues here – particularly the validity of the FDA label for anything post Wyeth v. Levine – but an equally important question is when is off-label not off-label? At present, the answer seems to be; when it's on-formulary and off-patent.
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.
Here’s how the Sweet 16 end their letter to CMS:
“Insurance company requirements that patients utilize off-label treatments before being reimbursed for FDA-approved treatments are dangerous and should not be permitted. The same policy considerations that support a ban on off-label marketing by pharmaceutical companies support the prohibition of this insurance company practice.”
Here is the complete letter to CMS.
Are you paying attention Mr. Waxman?
