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Driving the Right Stakeholder Dialogue (Part 1 of 5)
Integrated Evidence Planning: Build the Business Case, Realize the Value
Mar 19, 2024
Physicians, payers, policymakers, and patients rely on evidence to make decisions about a biopharma product at every stage of its lifecycle. For an organization developing or commercializing a treatment, there are always evidence-related variables that cannot be controlled. An integrated evidence plan (IEP) is a strategic framework for identifying, prioritizing, and then addressing evidence gaps that might otherwise impact adoption and reimbursement.
By advocating for integrated evidence planning, Medical Affairs teams can help increase the odds of success. In some cases, they may encounter resistance to investing in an IEP. Stakeholders may believe that the effort is redundant to another group’s strategy or project. They may voice concerns about how much time and budget it would take to create an IEP. Or they may argue against crafting an IEP before there’s a solid proof-of-concept (POC) for the therapeutic.
For Medical Affairs teams, it is both possible—and worthwhile—to overcome these objections.
Consider, for example, that IQVIA Launch Excellence studies have found that compared to other launches, excellent launches have 47% more real-world evidence published by volume. Other IQVIA studies suggest that adopting an IEP can make the process of building evidence more efficient by driving a 17% reduction in duplicated effort across a sponsor’s operations.
Through our collective experience, we’ve identified two keys to success for securing funding and executing a great IEP: building a business case to justify the IEP, and taking a strategic approach to realizing its value.
Build the business case for integrated evidence planning
As with any business case, the goal is to persuade stakeholders to invest time and budget in building an IEP. Focus on answering some fundamental questions: What are the expected benefits of an IEP? How much will it cost? How will the organization make it happen?
IQVIA’s and other industry studies help underscore potential benefits, but there will also be organization-specific advantages to highlight. For example, if RWE, Biomarker, Health Economics and Outcomes Research, and Medical Affairs teams are working in siloes, how much time and money are lost to inefficient designs and data sharing? How many strategic opportunities are missed from lack of communication and collaboration?
Breaking through siloes makes it possible to identify and address evidence needs with greater consistency and efficiency while maintaining high scientific integrity. Rather than waiting for a POC, Medical Affairs can proactively lead the effort to map cross-functional requirements and track evidence development over time. Another recurring benefit is early and active involvement of clinical stakeholders in an IEP. It’s critical to obtain clinical buy-in and willingness to incorporate outputs into the clinical development plan.
In terms of costs, an IEP can be developed and managed in a “lean” way. Initial development may require no more than half a day of time from members of other teams. If a vendor is involved, there may be some external costs, but an IEP can also help avoid other costs through more integrated planning and/or reduction in duplication of effort.
Once you have a clear strategy for securing resources for the IEP—and after socializing the idea to build secure internal support and momentum—step up and make the case.
Realize the value of the IEP
Experience with evidence planning has yielded several key learnings about how to get the most from an IEP:
- Get specific about scope. It sounds simple enough: Document evidence needs and gaps. Prioritize them. Then move into study planning. In practice, it’s helpful to approach the process like a detective. Make no assumptions when unearthing what the organization really needs to be successful. Maybe it makes sense to drive all near-term evidence to address critical regulatory concerns for a particular asset. Or maybe the organization is in a post-marketing situation where competitor launches have created a crucial gap related to patient-centered endpoints.
- Connect to wider priorities and business outcomes. Some of this connection should occur organically when building and securing stakeholder approval of the business case. But don’t stop there. Be intentional about staying looped in throughout the organization—particularly with clinical teams. That may lead to discoveries that specific teams have emerging evidence needs or are developing evidence that can be valuable to other functions.
- Stay integrated in clinical development plans. It’s critical for Medical Affairs to stay integrated with the development program. To be sure, the clinical development team likely has their own projects and stakeholders at play. Strive to keep the IEP work linked into those efforts. Ideally, the IEP leader will be someone with the depth of knowledge and experience to bring together the people, functions, and ideas needed to close evidence gaps throughout development.
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At IQVIA, we partner with you to navigate your strategic Medical Affairs journey, utilizing trusted medical evidence from clinical development through commercialization.
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