RWE & HEOR
In an ever-evolving healthcare market, our RWE & HEOR team expertly utilizes real-world data (RWD) and scientifically sound statistical and economic methods to generate real-world evidence. This evidence uncovers unmet needs, the clinical and economic burden of disease, quantifies the effectiveness and safety of your product over the standard of care or competitor products, and enhances product coverage and adoption in light of complex market challenges.
Magnolia supports any and all phases of your HEOR strategic planning, execution, and dissemination.
HEOR Planning Begins At Prediscovery
It is never too early to begin building and executing your HEOR and RWE strategy. Our clients know that market challenges are growing, and the evidence manufacturers must put in front of regulators, providers and payers to support product labeling and coverage needs to be more sophisticated than ever before. By leveraging RWD and RWE generation, our team finds bold and innovative ways to tell your story, ensuring your product’s value proposition resonates with key stakeholders.
Strategy: Identify fit-for-purpose data, study design, analytics, and outcomes, then interpret the results to generate evidence. Next execute a scientific dissemination plan that is customizable for your key stakeholder messaging.
Tactics:
Develop evidence strategy and generation plan starting with where you are in the product lifecycle and the stakeholders you need to influence.
Demonstrate unmet needs in the current diagnostic or treatment landscape and quantify the clinical and economic burden of testing or disease.
Identify relevant social determinants of health within your target population to recruit more diverse trial participants.
Estimate and project incidence and prevalence over time.
Identify surrogate endpoints for clinical trials.
Define real-world controls for single arm trials.
Develop early pricing models.
Study Design, Execution, and Dissemination
Once your diagnostic or product is approved, evidence generation continues through launch to patent expiration. We design and execute real-world studies empowering our clients with the most fit-for-purpose data. All of this, together, helps your organization transform industry paradigms and drive meaningful change in the marketplace. Magnolia supports any and all phases of your HEOR strategic plan.
Strategy: Identify fit-for-purpose data, develop customized study protocols and analysis plans, define outcomes, and generate the evidence supporting your product’s value proposition. Magnolia interprets the findings and in collaboration executes a scientific dissemination plan that is customizable for messaging to your key stakeholders.
Tactics:
Simulate head-to-head trials by conducting indirect treatment comparisons of the efficacy and safety observed in your clinical trials to those of your competitors.
Research the current data landscape to identify and evaluate global RWD supporting country-specific launch, coverage, and post-launch market access plans.
Design, analyze, interpret, and report non-interventional and observational studies within and outside of your HEOR and RWE strategic plans.
Build predictive models of clinical and economic outcomes.
Conduct prospective data collection for custom patient cohorts in response to regulatory monitoring requests and registries.
Support scientific writing efforts including study protocols, study reports, conference submissions, presentations, and publication support.
Does your data meet the needs of your business and research objectives?
We know data, and we also know this is a huge investment for our clients. For those who have not purchased data, or are shopping around for data sources, Magnolia DRIVE (Data Repository for Innovation and Value Evidence) may be a great solution for your needs. We also have a BYOD (Bring Your Own Data) policy for customers who have access to data but want an experienced partner to collaborate with when designing and executing a targeted scientific strategy.
Strategy: Cast a wide net to identify and evaluate data sources for fit-for-purpose use. Review and select fit-for-purpose data while cruising through Magnolia DRIVE and other RWD repositories.
We have extensive experience analyzing a large variety of secondary databases, including…
In-House (Magnolia DRIVE) and Externally Licensed
External Other
In-House Licensed (part of Magnolia DRIVE)
External Licensed
Our in-house and custom-curated data sets are HIPAA-compliant and can be linked to external data sources through tokenization.
Contracting is a black box. HEOR shines the light.
We build budget impact, cost-effectiveness and outcomes models to demonstrate the economic and clinical benefits your product offers to support your pricing and contracting strategies in the marketplace.
Strategy: Demonstrate the clinical and economic value of your product to support optimal payer contracting and patient access.
Tactics:
Promote use of surrogate endpoints from clinical trials.
Develop budget impact and cost-effectiveness models, including country adaptations.
Define metrics for value-based payer contracts.
Evaluate performance of value-based and alternative contracting strategies using payer or other representative data.