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. 2019 Nov;37(11):1321-1327.
doi: 10.1007/s40273-019-00832-2.

Achieving Appropriate Model Transparency: Challenges and Potential Solutions for Making Value-Based Decisions in the United States

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Achieving Appropriate Model Transparency: Challenges and Potential Solutions for Making Value-Based Decisions in the United States

Josh J Carlson et al. Pharmacoeconomics. 2019 Nov.

Abstract

Transparency in decision modeling remains a topic of rigorous debate among healthcare stakeholders, given tensions between the potential benefits of external access during model development and the need to protect intellectual property and reward research investments. Strategies to increase decision model transparency by allowing direct external access to a model's structure, source code, and data can take on many forms but are bounded between the status quo and free publicly available open-source models. Importantly, some level of transparency already exists in terms of methods and other technical specifications for published models. The purpose of this paper is to delineate pertinent issues surrounding efforts to increase transparency via direct access to models and to offer key considerations for the field of health economics and outcomes research moving forward from a US academic perspective. Given the current environment faced by modelers in academic settings, expected benefits and challenges of allowing direct model access are discussed. The paper also includes suggestions for pathways toward increased transparency as well as an illustrative real-world example used in work with the Institute for Clinical and Economic Review to support assessments of the value of new health interventions. Potential options to increase transparency via direct model access during model development include adequate funding to support the additional effort required and mechanisms to maintain security of the underlying intellectual property. Ultimately, the appropriate level of transparency requires balancing the interests of several groups but, if done right, has the potential to improve models and better integrate them into healthcare priority setting and decision making in the US context.

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Conflict of interest statement

The work described in the manuscript is relevant to Dr. Carlson’s current grant from ICER. Dr. Carlson has carried out consulting work with pharmaceutical companies that were included in the work described in the manuscript. Some of the work described in the manuscript is relevant to Dr. Walton’s and Dr. Touchette’s current contract-related funding from ICER. Specific transparency efforts related to a project with ICER described here that involved Dr. Walton and Dr. Touchette were funded by Allergan, Amgen, and Teva Pharmaceuticals. Drs. Campbell, McQueen, and Whittington have received project-related funding from ICER. Drs Basu and Veenstra work at the University of Washington, which has a contract with ICER. Drs Chapman and Pearson are employees, and Dr. Ollendorf is a former employee, of ICER, whose efforts are funded by the Laura and John Arnold Foundation and the California Healthcare Foundation. Over the past 3 years, ICER as an organization has received membership dues—unrelated to these activities—from a variety of payer and life science companies.

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