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But now, that model is collapsing under its own weight.
Biologics that pass those narrow metrics often fail within a
year. They’re neutralized by anti-drug antibodies. They’re
switched out for newer agents. They disappear from
formularies as their cost-to-value ratio deteriorates. And the
patient starts over—again.

This isn’t just a medical failure. It’s a policy failure. And
policy is where reform must begin.

What Needs to Change:

Immune-informed endpoints:
The gold standard can no longer be “response at 12 weeks.”
Trials must report metrics like:

o Time to secondary loss of response
(SLOR)
o ADA formation rates
o Biologic drug survival curves at 12, 24,
and 36 months
These aren’t optional extras. They must
become central to trial design and approval.

Durability-based reimbursement:
Payers shouldn’t fund failure. A biologic that works for six
months and fails in the seventh should not command the
same pricing as one that lasts three to five years.
Contracts should:

o Incentivize long-term immune harmony.
o Penalize escalation and switching.
o Shift toward value-based pricing models tied
to patient stability over time.

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