Don’t Just Design for Approval. Design for Access.
Bridge the gap between Regulatory success and HTA value. Optimize your protocol to satisfy Regulators and Payers simultaneously.
The Strategic Questions We Answer
Lead Indication Strategy
“Which indication offers the fastest route to high-value reimbursement?”
Success Probability—Predictive modeling of “Major Added Benefit” ratings across different indications.
Strategic Selection—Prioritize indications where HTA evidence requirements align naturally with regulatory endpoints.
Comparator Strategy
“How do we select a comparator that satisfies Regulators and Payers simultaneously?”
Acceptance Probability—Predict the likelihood of G-BA/HAS accepting your chosen ACT (Appropriate Comparator Therapy).
Superiority Modeling—Quantify the risk of missing statistical significance against a stronger, payer-preferred comparator.
Pricing Anchors—Benchmark against the cost of accepted comparators to forecast your pricing ceiling.
Endpoint Strategy
“Which clinical endpoints effectively bridge the gap between regulatory significance and reimbursable value?”
Payer Hierarchy—Distinguish between obligatory endpoints (Mortality/Morbidity) and “nice-to-haves” (QoL) that fail to drive price.
Objection Mitigation—Historical analysis of endpoint-related “red flags” and model-derived recommendations on how to mitigate them.
Joint ProbabilityP(C ∩ H)—Integrated modeling of Clinical Success (significance) vs. HTA Success (relevance).
Patient Subgroup Strategy
“How can we define patient subgroups to maximize the magnitude of the ‘Added Benefit’ rating?”
Benefit-Risk Optimization—Identify subgroups with the highest effect size to safeguard your “Added Benefit” rating.
Fragmentation Risk—Predict if HTA bodies will split your indication into sub-cohorts and align stratification to match.
Commercial Alignment—Ensure your clinical subgroups match the target commercial product profile (TPP).
Future Readiness (SoC Evolution)
“Will this study design still be relevant in the 5–7 years it takes to finish?”
SoC Forecasting—Predictive modeling of the Standard of Care landscape at the time of your submission, not just today.
Evidence Bridging—Identify necessary Indirect Cross-Trial Comparisons (ITC) early to prepare for a market where your comparator might become outdated.
The SGLT2 Inhibitor Withdrawal
The cost of misaligning clinical design with HTA requirements is measured in billions.
The Strategy
AstraZeneca and Janssen designed Phase III programs testing against placebo or DPP-4 inhibitors. This satisfied regulatory agencies.
The HTA Reality
The German G-BA designated a cheaper generic (sulfonylurea) as the appropriate comparator.
The Result
Because trials did not compare against the G-BA’s choice, both drugs received “no added benefit” ratings.
The Impact
Price negotiations failed. Both companies were forced to withdraw these major assets from the German market entirely.
Don’t Let This Happen to Your Asset.
Identify comparator mismatches, endpoint gaps, and population issues before you enroll patient #1.
Stress-Test My Protocol