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BIO Submits Comments to Steve Pearson re: ICER Value Framework

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Steven D. Pearson, MD, MSc, FRCP</div>
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President, Institute for Clinical and Economic Review</div>
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One State Street</div>
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Suite 1050</div>
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Boston, MA 02109 USA</div>
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BY ELECTRONIC DELIVERY</div>
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RE: Institute for Clinical and Economic Review (ICER) Value Framework</div>
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Dear Dr. Pearson:</div>
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On behalf of the Biotechnology Industry Organization (BIO), I would like to submit the following feedback with respect to ICER&rsquo;s Value Framework, presented on September 15, 2015. BIO advocates on behalf of biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO&rsquo;s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members&rsquo; novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.</div>

Dear Dr. Pearson:
 
On behalf of the Biotechnology Industry Organization (BIO), I would like to submit the following feedback with respect to ICER’s Value Framework, presented on September 15, 2015. BIO advocates on behalf of biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.
 
BIO represents an industry that is devoted to discovering, and ensuring patient access to, innovative treatments. Accordingly, we monitor and engage in discussions around the value of innovative therapies to ensure that patient access and the need to sustain future innovation are appropriately considered by public payors, policymakers, and government regulators. Of principal concern to BIO is that this and any value framework that may be used by such stakeholders: appropriately capture long term benefits of therapeutic interventions; include model inputs that are evidence based; and ensure that the results of the analysis are meaningful to patients, their caregivers, and their healthcare providers. As such, we are keenly interested in ICER’s work on the Value Framework and its methodological underpinnings, particularly given ICER’s intention to utilize the Framework as the basis for its drug reviews that may be used by public and private payors. As a result, it is important that the Framework employs a reliable and validated methodology, especially since the Framework’s outputs will serve as a the primary, or potentially sole, source of information for the public voting process ICER has established to finalize its drug reviews.