Page 87 - Binder2

Rarely is ADA testing standardized or mandated. Even
when available, the results may not lead to a clear clinical
action. Physicians are rewarded for moving quickly to the
next therapy, not for interrogating whether tolerization has
occurred—and why. Time constraints, reimbursement
models, and institutional inertia favor reactive care, not
root-cause analysis.

The result? Tolerization becomes embedded in clinical
practice as just another checkpoint in the treatment
algorithm—not a red flag that the system itself needs to
change.

Payers: Paying for Failure, But Not Measuring It

Insurance companies reimburse for drugs that meet
regulatory approval and have guideline support. If a
biologic fails and the patient is switched to another, the
new therapy is typically covered—as long as step therapy
protocols are followed. There is no requirement to
demonstrate why the drug failed. There is no standardized
reimbursement incentive for therapies that last longer or
provoke fewer immune responses.

And because payers don’t routinely require ADA testing or
immune compatibility metrics, they remain blind to the
real drivers of therapy churn. As long as each step
appears justifiable on paper, the cost of failure is absorbed
into the system—hidden within medical benefit claims,
hospitalization codes, and pharmacy rebates.

But as biosimilars exert pricing pressure, and as value-
based care gains traction, payers are beginning to ask
harder questions. When drugs fail early, costs spike. When

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