Valorem Scientific / Work With Me

I work at the intersection of market access, HEOR, and RWE—
focused on one question.

How do FDA approvals actually translate into real-world access? The gap between approval and access is not random. And it's not inevitable—if you build for it before launch.

The objective
Ensure your evidence strategy holds up under payer scrutiny—before it gets tested in the market.
Who I work with

Leadership teams who own the access problem.

I work with VPs and Heads of Market Access, HEOR, and RWE to anticipate how payer and HTA dynamics will shape access before launch strategy is locked in.

Market Access
VP or Head of Market Access
You're approaching a launch window or managing access dynamics that aren't tracking with the forecast. You need an external read on where payer behavior is likely to diverge from the plan—and a structured way to de-risk it before it becomes a negotiation problem.
HEOR
Head of HEOR or Evidence Strategy
You're building the evidence package for an HTA submission or payer dossier. You need a rigorous pressure-test—against real ICER, NICE, and U.S. payer precedents—to surface vulnerabilities before decision-makers do.
RWE
RWE Lead or Real-World Evidence Director
You're designing evidence generation programs. The question isn't whether the study is publishable—it's whether the evidence addresses the specific uncertainties that are driving coverage restrictions. Most RWE programs aren't designed to answer that.
Consulting
Market Access Consultancies
You're a boutique or mid-size consultancy with a specific engagement that needs senior overflow capacity. PhD-level scientific rigor on the deliverable without adding headcount or a large-firm cost structure.
The central question

"How do FDA approvals actually translate into real-world access?"

Across therapy areas, the pattern is consistent. Strong clinical data. Regulatory approval. And yet—access is restricted. That gap is not random. It's driven by how payers and HTA bodies evaluate uncertainty, comparator relevance, real-world performance, and budget impact.

Specifically, I help teams

Four ways I close the gap between approval and access.

01
De-risk launch by identifying access friction early
Using analog HTA decisions and payer behavior patterns, I identify where prior authorization intensity, step therapy requirements, and eligibility constraints are likely to create friction—before your launch strategy is locked. Access restrictions follow patterns established in prior decisions for structurally similar products. Those patterns are readable in advance.
Analog HTA AnalysisPrior Authorization MappingStep TherapyPre-Launch Planning
02
Pressure-test access strategy against real decision-maker precedents
I run your evidence strategy against actual ICER, NICE, and U.S. payer decisions to surface where it's vulnerable. The goal is to find what breaks before decision-makers do. This is precedent-based scrutiny of the specific evidence claims your strategy rests on, applied against the criteria that have driven restrictions in comparable situations.
ICER ReviewNICE PrecedentU.S. Payer PolicyEvidence Gap Analysis
03
Design RWE that directly moves coverage decisions
I design real-world evidence programs aligned to the specific uncertainties driving payer restrictions—not to publication objectives. RWE that doesn't map to a decision rarely changes one. This means scoping studies around the comparative effectiveness gaps, population generalizability questions, and long-term outcome uncertainties that payers have flagged in analog decisions.
RWE StrategyCoverage Decision AlignmentEvidence DesignPayer-Facing Studies
04
Close the gap between forecasted and actual uptake
I explicitly model access dynamics—not just clinical adoption curves. Forecasts that don't account for prior authorization rates, time-to-coverage, step therapy requirements, and evolving formulary placement consistently overestimate real-world uptake. I build those friction points into the forecast architecture so the gap between projected and actual doesn't surface at launch review.
Access-Adjusted ForecastingUptake ModelingPA / Formulary DynamicsLaunch Analytics
What I focus on

The questions Market Access Signals explores—and that shape every engagement.

Payer & HTA dynamics
  • How payer behavior diverges from regulatory approval—and why it's predictable
  • Why forecasts miss access friction: PA, step therapy, time-to-coverage
  • How ICER and NICE decisions signal what U.S. payers will do next
  • When budget impact drives formulary tier placement more than cost-effectiveness
Evidence & strategy
  • When RWE actually changes coverage decisions—and when it doesn't
  • How access evolves post-launch, not just at approval
  • Where comparator misalignment becomes a restriction driver
  • How to design evidence generation for payer decisions, not just regulatory endpoints
Fit

This engagement works well in some situations. Not all.

Being clear about fit saves time on both sides.

A strong fit when
  • You're 12–24 months from launch and access strategy is still being shaped
  • Your evidence strategy exists but hasn't been tested against real payer or HTA precedents
  • Your RWE program is in design and you want it aligned to coverage decisions, not just publications
  • Your uptake forecast is built on clinical adoption assumptions without access friction modeling
  • You need senior-level scientific input without a large-firm engagement structure
  • You're pressure-testing an existing strategy, not starting from zero
Less likely to be the right fit when
  • You need a large team executing a multi-year program under one roof
  • The strategy decision has already been made and the work is execution-only
  • The asset is early-stage (Phase I–II) and access questions aren't yet structurally defined
  • You need regulatory submission support (FDA, EMA) rather than payer/HTA-focused work
How we work together

A structured process, senior throughout.

Every engagement is led directly by me—not delegated. Fixed scope, defined outputs, no overhead.

01
Evidence Strategy Call
A focused 20-minute conversation to understand the decision context, timeline, and where the specific risk lies. No agenda other than determining whether and how I can be useful.
02
Fixed-Scope Proposal
Clear deliverables, defined timeline, transparent pricing. No ambiguity about what you're getting and when.
03
Execution & Iteration
Close collaboration with your internal team throughout. Structured checkpoints so direction can shift if the evidence or context shifts.
04
Decision-Ready Output
Deliverables built for a specific audience and decision—payer dossiers, HTA submissions, internal strategy reviews, or board-level access briefings.

If you're pressure-testing how payer and HTA dynamics could impact your launch, access, or forecasts—

I'm happy to compare notes. The 20-minute call is about your specific situation: where the access risk sits, what evidence you have, and whether the strategy holds up under the scrutiny it's going to face.

Schedule a 20-Minute Evidence Strategy Call
A focused conversation about your launch, your evidence, and where the payer or HTA risk actually lives. No sales pitch.
Schedule a Call
Or reach out directly: ochigbo@valoremscientific.com
Based in Dallas, TX · Operating globally
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