Integrated evidence generation 2.0: A strategy for every stakeholder
- The data supporting regulatory approval alone are often insufficient for demonstrating the added benefit of a new therapy
- Planning in advance to continuously deliver data that illustrate value and post-launch, to not only the regulator, but payers, healthcare professionals, and patients results in more clinically meaningful benefits
- By working cross-functionally, biopharmaceutical teams can uncover evidence gaps and better shape registration trials to ensure the needs of as many stakeholders as possible are met
The evidence-generation process for biopharmaceutical companies has become far more challenging. The combination of high science and the nuances of the evolving landscape has led to greater evidence gaps for a growing number of stakeholders—from payers and regulators to patients and healthcare professionals—each of whom requires a more detailed understanding of the scientific data and relative benefits compared with the current standard of care and other novel therapies to help them make decisions.
Drug developers need to take an innovative and agile approach to evidence generation to meet the overlapping needs of stakeholders holistically if they are to achieve their vision and ensure novel therapies are maximizing their potential to deliver patient benefit and value to society.
Applying a multistakeholder lens to evidence generation
As the pharmaceutical landscape becomes more complex, achieving the vision for a product requires all stakeholders to understand, accept, and adopt the product’s value.
The data supporting regulatory approval alone are often insufficient for demonstrating the added benefit of a new therapy, and often do not reflect real-world usage in clinical practice or the implications of innovation in delivery techniques or biomarker testing requirements.
To maximize opportunities at launch and ensure success across the product life cycle early in the development process, biopharmaceutical companies need to understand the requirements of a wider group of stakeholders to fill their varying information gaps and demonstrate the incremental value of the product.
Planning in advance to continuously deliver data that illustrate the value and clinical utility of the therapy, post-launch, to not only the regulator, but payers, healthcare professionals, and patients will result in more clinically meaningful benefits that resonate with more stakeholders across the product life cycle.
Central to this approach is understanding that different stakeholders’ evidence requirements are often interconnected.
For example, payers require a rich understanding of the value of the product in the context of how it will be used, including how a healthcare professional will prescribe the product in the real world.
Clinicians often collaborate with health technology assessment (HTA) bodies, clinical commissioning groups, and formulary committees at national, regional, and local levels to shape payers’ thinking and understanding of complex and evolving treatment landscapes.
Increasingly, patients are also playing more of a role in shared decision-making and providing their perspective on the value of new treatments, sharing insights that feed into the HTA process. Additionally, payers and healthcare professionals work together and with patients to understand their evidence needs and make decisions about value and reimbursement.
A 360-degree view of evidence needs
While the requirements for regulatory approval are clear and prescribed, the value drivers for other stakeholders are more nuanced and evolve across the customer journey. So it is important to consider these stakeholders’ needs early in the product development cycle—before committing to pivotal or registration trials.
However, siloed internal structures often prevent a holistic understanding and actioning of stakeholders’ evidence requirements. For example, data are often generated through multiple channels, but responsibilities for those channels can be devolved across different functions.
A multistakeholder approach provides a holistic understanding of the product value and maximizes return on investment. By working cross-functionally, biopharmaceutical teams can uncover evidence gaps and better shape registration trials to ensure the needs of as many stakeholders as possible are met. In turn, helping manage internal stakeholders’ expectations of the HTA outcome, inform scenario planning, and positioning at product launch.
The strategy involves breaking down internal siloes and ensuring collaboration between clinical development, medical affairs, market access, and health economics and outcomes research to provide a complete view of the stakeholders, identify overlapping needs, and uncover untapped opportunities.
It is grounded in cross-capability collaboration and is built on clear insights based on deep research into each stakeholder group’s challenges and needs.
Through this integrated approach, opportunities can be leveraged, and duplication in efforts can be avoided. All evidence gaps can be anticipated and prioritized, and it is easier to uncover overlapping evidence requirements across stakeholder groups. Biopharmaceutical teams can then target resources to address the most critical areas and prepare for the impact of the remaining gaps.
New report: Reinventing value
This is an excerpt from Fishawack Health’s new report, “Reinventing Value,” in which our medical, strategic, policy, access, value, and evidence specialists have come together to provide exclusive recommendations for maximizing biopharmaceutical product and portfolio value.
Download the publication for more advice on applying a multistakeholder lens to your value strategy and ensuring your product’s benefits resonate with every stakeholder.
About the Authors
Sarah Feaver, PhD, Senior Director, Scientific Strategy
Sarah is a medical communications specialist with 16+ years’ agency experience across the full breadth of medical affairs and publications support.
She supports numerous clients with medical strategy, focusing on medical plans, scientific platforms, and evidence-generation strategy plans across the full product life cycle.
Andrée Rose, Senior Director, Scientific Strategy
Andrée collaborates with cross‑functional medical affairs teams to provide strategic leadership across a range of projects, including global medical plans, scientific narratives/platforms, and integrated evidence-generation plans. Recent therapy area experience includes oncology, hemophilia and other rare coagulation disorders, renal anemia of chronic kidney disease, and respiratory disease.
Samara Ferguson, Executive Director, Market Access
Samara brings nearly 25 years’ experience in market access and health economics, having worked in industry for 20 years and in consultancy for almost five years, building and communicating the value of products to global payers. She has worked across many disease areas, including oncology, immunology, cardiovascular, and metabolism.
About Fishawack Health
Fishawack Health (FH) is a leading global commercialization partner for the biopharmaceutical, medical technology, and wellness industries. The future of health is fast-paced and complex, demanding a different approach. Established in 2001, our 1,500+ healthcare experts combine their knowledge and expertise across our 4 core disciplines—Medical; Marketing; Policy, Access, Value, and Evidence; and Consulting.
We imagine a healthier world and build the connections to make it happen.