OnCo
ideasIdea

A structured registry for every off-label cancer drug use

Doctors often use cancer drugs outside their approved use based on a hunch or a small study. Record what happens every time so the hunches become evidence.

Off-label use is common in oncology, especially for rare tumours and molecularly matched therapy, and the outcomes are almost never captured. DRUP (Netherlands) and TAPUR (ASCO) showed that a pragmatic protocol can turn off-label use into evidence and even into reimbursement (DRUP's personalised reimbursement model). The proposal extends this to all off-label anticancer use: a light-touch registration with structured indication, biomarker and outcome capture as a condition of reimbursement.

Hypothesis
An off-label registry will generate evidence supporting reimbursement or label expansion for at least five drug-indication pairs within four years, and will identify at least as many with no benefit that should stop being used.
Rationale
DRUP identified active cohorts (for example, nivolumab in dMMR tumours) and led to conditional reimbursement; the model has worked but only for molecularly selected patients in a few countries.
What would test it
Implement registration-as-condition-of-reimbursement for off-label targeted and immune therapies in one national payer; report cohorts reaching the pre-specified efficacy threshold at 24 months.
Maturity
early clinical
Who has to act
payer
Cost to try
Medium ($1M to $50M)
Years to first evidence
3
Bottlenecks it attacks

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