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Health Care Value Assessments Versus Patients and Progress

Imagine you’re the inventor of a product that does something completely new, or something that’s never been done as well as your product does it. You’ve spent a decade and a fortune to develop the product. A tough review by independent regulators determines that your product is safe and that it does what you claim. You’re ready to make it available to customers. But then: groups of number-crunchers appear—with limited understanding of the nature of your business, the needs of your intended customers, or the product’s real potential—armed with algorithms that purport to determine the value of your invention to a hypothetical user. And these groups claim more and more power to determine what you should charge for your product and whether potential customers even should get access to it.

That dream-turned-nightmare is the growing reality that many inventors in the life sciences must face—uniquely among all innovation-based industries. The rise of so-called value-assessment mechanisms—and especially their potential adoption in U.S. health-care systems—poses a serious threat to the continuation of progress against disease. The financial risks of life-sciences R&D are sky high to begin with. If the resulting products are not given a chance to succeed on their merits, in real-world patient care, then investments in future discoveries simply will evaporate. And when you substitute the word “patients” for “customers”—because it is the needs of patients that we’re talking about in the life sciences—then the unintended consequences really come into focus.