Exubera and NICE Harvard Case Solution & Analysis

Historically, the biggest obstacle that healthcare innovators, such as pharmaceutical and medical device manufacturers needed to overcome on the way to the market to ensure the approval of the U.S. Food and Drug Administration (FDA) or other international regulatory bodies. However, in the last decade, a new (and sometimes even more difficult) hurdle must be cleared: insurance and compensation. Payers - or public payers such as Medicare in the United States and the National Health Service (NHS) in the UK, or private commercial payers, such as Blue Cross / Blue Shield and UnitedHealth Grou - could deny coverage for a technology that has been obtained regulatory approval, if they decide that the evidence does not confirm to fully demonstrate that the technology is superior to existing treatment alternatives that have already been recovered. This had the potential to create a potentially adversarial relationship between payers and innovators in the cases where they have been conflicting interpretations of the evidence in relation to the costs, benefits and risks of new technologies. Challenges faced by innovators in the management of this conflict are illustrated in this case study. For example: In 2006, the UK National Health Service to deny coverage for Exubera, an inhaled insulin new forms of "Hide
by Stefanos Zenios, Robert Chess, Lyn Denend Source: Stanford Graduate School of Business 14 pages. Publication Date: January 2, 2008. Prod. #: OIT80-PDF-ENG

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