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ICER to Evaluate Value of Amgen's Multiple Myeloma Treatment

(AJMC) Apr 7, 2016 - Drug developer Amgen is questioning the assessment of its multiple myeloma treatments at the hands of the Institute for Clinical and Economic Review.

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William McGivney, PhD (Posted: April 18, 2016)

quotes ICER: A Threat to OS in the US Bill McGivney Interestingly, as the quantitative, economic, QALY-oriented methods of the National Institute for Health and Care Excellence (NICE) translate into the lowest survival rates across tumor types in Western Europe for the populace of the UK, there is a move to bring these obscure, robotic recommendations to policy-setting in the United States through the Institute for Clinical and Economic Review (ICER). How do such methods persist when bodies like the European Commission conclude (October 2014) that: “QALYs produce hugely inconsistent, wrong results upon which important decisions are made”? The 32-page ICER user guide will take the reader through a tortuous, mind-numbing description of the methods and conclusions that are intended to calculate recommendations about the appropriate use of drugs and biologics. Make no mistake, the bald-faced, boldness of non-clinicians, including those who do not practice beyond training, to sit at computers believing that they are deriving formulaic masterpieces that can best guide decisions about patients with serious and life-threatening illnesses belies all sense of personal and even population-based compassion. It is critical for those who would put forward policy recommendations of any kind in health care to be sure that at any point in life that they could live absolutely with the decisions (i.e., individual medical necessity) provided if it were for their mother, their brother, their daughter, etc. It is important that they, in actually being tasked with such decisions, read the patient records, the requests of patient and caregivers, etc. I know for I have developed both coverage policy and made over 1,000 patient decisions based upon the same such policies in my tenure as VP of Clinical and Coverage Policy at Aetna. I state with surety that such decisions are daunting and cannot be derived from any Babelonian calculus. quotes

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