Revlimid Runs a NICE Gauntlet, FDA Micromanaging ESA Dosing

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  • 09/18/2007
Steve Usdin makes the point in this week's Biocentury that companies who fail to come up with personalized algorithms for dosing and medicines will find themselves at the mercy of micromanagers and second-guessers at FDA panels, CMS and cost cutters generally. But the challenges, legal, economic, regulatory are great in this era of of no good deed going unpunished or sued. As Usdin writes "These studies, along with observational data, paint a complex, nuanced picture. Indeed, the panel members spent much of the meeting focused on an apparent paradox: attempting to increase Hb in kidney disease patients to levels approximating those in healthy individuals is harmful, but actually achieving higher Hb levels is usually beneficial.
The committee also grappled with the potential association between increased mortality risk and low response rates to ESAs, a circumstance that could affect as many as 40% of dialysis patients."

So much for the value of randomized trials in personalizing dosing regimens.

Meanwhile, as if we did not need another reminder that it won't stop at ESAs, Biocentury has a story about how patients waiting for Revlimid in the UK will have to wait years to produce comparative effectiveness data of the sort that Hillary's Best Practice Institute will generate.

According to Biocentury:

"Multiple myeloma patients in the U.K. will have only limited
access to one of the newer drugs for the disease, Velcade bortezomib, as a result of NICE’s recent recommendation to shave the number of patients who would be indicated for the drug. And they will have limited access in the foreseeable future
to another new drug, Revlimid lenalidomide from Celgene Corp., which is in no hurry to undergo the NICE process..."

Who can blame them, because it takes at least a year and, in the case of the UK, years to get reimbursement approval.

The pace is going to be slower in the U.K. Although Revlimid is available to patients who have private insurance, going through the country’s reimbursement
process is not near the top of CELG’s list because NICE takes such a long time.
Indeed, Gill said the company does not even have a timeline for when it will begin the process. “We will work with NICE as expeditiously as possible, but historically it takes years.”

Best Practice Indeed

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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