Don’t Lose Your Balance!

Putting all your “weight” into regulatory approval can be a costly mistake. In our 20+ years of experience, we’ve seen many market access pathways come toppling down by companies relying on regulatory approval to get to market and disregarding reimbursement pathways and/or value propositions. What’s to be learned from these companies?

Make early health economics a priority!

Three essential legs – FDA approval, reimbursement, and value (established through health economics) – must work together to support market access, and health economics can provide a significant segue into each.

The Three-Legged Stool of Market Access:
Don’t Lose Your Balance!

Successful market access requires health economics. Without all 3 legs firmly on the ground, you’ll jeopardize early market adoption and generation of revenue that meets, or exceeds, your targets.

Infographic showing the 3-legged stool of market access comprised of FDA approval, value, reimbursement, and health economics.

Did You Know:

  • FDA approval allows you to sell your product, but it doesn’t give payers a single reason to pay for it.
  • Reimbursement provides the framework to allow for success with your payers, but without establishing your technology’s combined clinical and economic value, you can’t build coverage.
  • Health economics allows you to demonstrate a technology’s economic and patient-focused value – the evidence you need to influence your stakeholders and hit your revenue targets, and can even be used as part of your regulatory approval strategy.

We realize that right now budgets are stretched thin and priorities are highly competitive. Our cost-effective health economics solutions are instrumental in achieving market access, we offer a variety of services to help you demonstrate your value to payers, providers, and facilities.

  • Cost-effectiveness models
  • Cost-avoidance models
  • Budgetary impact models
  • Optimal pricing models
  • Disease modeling
  • Interactive sales tools
  • “Piggyback” endpoints into planned prospective studies
  • Design and implementation of clinical-economic endpoints
  • HEOR protocol development (i.e., QoL, PRO instrument selection)

Case Study:
Establishing Value Through Multi-Faceted Health Economics and Market Access Support

410 Medical had obtained their first FDA approval and was seeking multi-faceted health economics and market access support to communicate their value story and navigate their technology through hospital VAC approval processes. TTi developed both pediatric and adult population budgetary impact models for consideration by VACs. Associated white papers, conference presentations, and peer-reviewed publications were also collaboratively produced form the findings of our models. Additionally, TTi engaged in multiple qualitative research initiatives with key clinical decision makers to better understand how to position the client’s technology for success. These efforts were instrumental in supporting the client’s market adoption at facilities across the US.

I’ve developed a lot of trust that when we set something out together, as a team, and establish a shared vision of what we are looking for, I can trust that they [TTi] will deliver.”

Kyle Chenet, CEO, 410 Medical

-Kyle Chenet, CEO | 410 Medical