Evidence Generation & Synthesis: an Integration of Health Economics and Outcomes Research and Real-World Evidence

Will poor data quality eat into your reimbursement rates?

Evidence generation and synthesis through Health Economics and Outcomes Research (HEOR) and Real-World Evidence (RWE) is easy to put off until late in Phase III, but waiting until the last minute can crush your budget and decrease reimbursement rates. As you move towards commercialization, it’s vital to protect your resources and profits by ensuring your Evidence Generation plan and value story support all your needs across the product lifecycle.

The medical story drives the value of your therapeutic. If your value proposition is clear and evidence-based, it is easier to get investors' attention and funding, high-reimbursement from payers, and ultimately your product into the hands of more patients that need it. The medical story is built on a Value Narrative and real-world data derived through Evidence Generation.

Failure to codify your message and collect data early will lead to skyrocketing costs for collecting data on a shortened timeline.

Value Narrative creation and Evidence Generation planning doesn't pay dividends until later on but a small investment upfront can create outsized returns, which is why many biotechs wait longer than they should. Investing in these areas early by starting with the end in mind leads to a holistic Evidence Generation strategy that builds a 360-degree view of your program and efficiently identifies new insights, quality-of-life indicators, and evidence-generation gaps.

With a holistic view of the real-world data, you can create a strong and evidence-based Value Story with specific targets for reimbursement and payment strategy, investor requests, market differentiation, regulatory requirement changes, drug adoption, and program and corporate needs.

An agile support team

Your Evidence Generation needs ebb and flow. Hiring full-time employees with specialized skillsets only required in short sprints until key milestones are met may not be an efficient use of resources. And individual contractors aren’t always considering the entire cross-functional relationship required for effective Evidence Generation.

Our model is built around an agile approach. Instead of trying to find someone that can adequately fulfill disparate skill sets, you have access to experienced experts for your exact needs at the right time. We will wrap around your existing team and ensure decisions are made while considering the entire cross-functional picture. We can also be your team as you build your in-house capabilities.

We help our clients develop strategies, plans, and execute. We can program manage through a four-step process we call “Evidence Generation & Synthesis”:

Determine the value framework

  • Market Access
    • Early scientific advice support
  • Systematic literature review (SLR) to support clinical effectiveness, cost-effectiveness and budget impact
  • Understanding disease state and economic gaps
    • Quantifying the burden of illness
    • Developing a model analysis plan
    • Formulating health states for modeling disease progression
    • Providing strategic oversight for cost-effectiveness and budget impact around model development
  • Understanding global or regional markets you want to operate in now to gather the correct value prop, requirements, and messaging for specific regions

Measure the value of the model

  • Closing identified evidence gaps
  • Quantifying the disease and economic burden
  • Understanding how the disease and economic burden affect the value prop and how they can be communicated to stakeholders
    • Driving the value story - how does the clinical story drive the value story?
    • Going to payers and selling them on why they should reimburse
    • Quicker approval, quicker reimbursement

Realize value

  • Taking what we’ve measured and quantified in step two - evidence and value updates
  • Putting those into a value dossier
    • Regional specific requirements
    • How do we use what we’ve learned to make it relevant
  • RWE and evidence strategy and planning
    • Develop and implement RWE plans to support the product value proposition
      • Evidence generation and synthesis planning for evidence gap identification and prioritization
      • Publication strategy for RWE
      • Internal RWE Training
    • Internal HEOR training

Communicate value

  • Publication strategy to support the model implementation
  • Providing medical and scientific expertise to provide education of key stakeholders
  • Creating materials and forums to communicate the value
  • Creating forums for engagement
    • 1:1 payer engagements - someone from the client side meeting with a national insurer where they will bring a subset of materials - training and coaching for the person doing the 1:1 and prepping with materials - an expert from SSI can also attend those meetings

As your funding fluctuates and your Evidence-Generation requirements progress and change, we’ll work with you to meet milestones and de-risk your organization through proper planning, management documentation, and execution.

Don’t go it alone. We are here for you.

Let’s talk.

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