ICER Scientific Advice (ISA): Setting Your Company Up For Success

The Challenge

The key to a successful Health Technology Assessment (HTA), aka “value assessment”, is generating the right kind of evidence. Primarily, clinical trial programs are designed to measure efficacy and safety. But developing evidence to support robust value assessment requires more than that.  

Moreover, in today’s environment, payers and health systems want to see proof of value—and if you don’t have the right evidence, even effective treatments can struggle with pricing, reimbursement, and market access. 

The Solution

We advise life sciences companies on clinical trial design programs that will meet the needs of HTA, payer, and prescriber audiences alike, all within the context of the FDA’s potential regulatory requirements.  

ISA is aimed at life sciences companies with clinical stage assets interested in confidential engagement on evidence generation strategies to support future value assessment.

What We Do For You 

1. Smarter Clinical Trial Design 

We’ve conducted over 100 value assessments. We know what works. We’ll advise you on: 

  • Which trial types will satisfy regulators AND produce the value assessment results payers want 
  • The right comparators to choose 
  • Which patient populations to include 
  • The outcome measures that matter most for value assessment 

2. Patient-Centered Evidence 

We’ll help you understand what outcomes patients actually care about through structured focus groups, and advise on recruiting diverse patient populations. 

3. Pricing Reality Check 

Based on potential trial results and analogous conditions, we’ll show you potential evidence ratings and realistic price ranges—giving you a clear view of what different outcomes could mean for your commercial strategy. 

4. Coverage Strategy 

We’ll connect the dots between your evidence plan and eventual payer coverage, showing you exactly what payers and prescribers will want to see. 

How We Work

Complete Confidentiality: Everything we discuss stays confidential. This engagement is entirely separate from ICER’s public assessment work. 

Brutally Honest Advice: We’ve built our reputation on rigorous, independent analysis. Expect straight talk about your asset’s strengths and gaps. 

No Strings Attached: Our advice is non-binding. Use what helps you; ignore what doesn’t. Your call. 

No Impact on Future Reviews: Working with us doesn’t increase or decrease the likelihood of a future ICER assessment, and won’t influence our independence if we do review your product. 

Customizable Package: Advice tailored to your development stage and specific needs over the course of 4-6 months.

Testimonials

“We were able to participate in ICER’s Scientific Advice initiative recently and found it to be extremely valuable from beginning to end.  ICER has thought very carefully about the components needed to provide a bespoke analysis, which is not something that AI can accomplish, given that this is the common question we needed to face given our commitment to disciplined resource allocation.

ICER utilized their internal expertise to conduct primary and secondary research that led to a unique product based on an interactive and iterative process.  This was because ICER has institutional knowledge, reference points and context that we needed to hear as we are still in the early stages of product development.  It is *exactly* at these early stages where relatively modest pivots or refined strategy become substantially amplified downstream.  ICER solicited and analyzed expert input against their backdrop of understanding how value gets developed, recognized, assigned, and reimbursed. These standards ultimately serve Shareholders, patients, regulators and payors.

Furthermore, the unique benefit of having access to the ICER ‘brand’ adds prestige and helps many stakeholders better understand and appreciate our commitment to building impactful and successful medicines.”  

Ready to Talk?

If you’re in clinical development and are interested in learning more, let’s discuss how we can help. 

Inquire here.

Learn more about why ICER decided to launch ICER Scientific Advice.