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?
AI-driven prediction of achieving "Major Added Benefit" ratings across different indications.
Prioritize indications where HTA evidence requirements align naturally with regulatory endpoints.
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.
Lost Revenue Potential: Billions of Dollars
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