OnCo
ideasIdea

Require head-to-head trials against the best in class for later entrants

Once two drugs of a kind exist, a third should have to prove itself against the best of them, not against an outdated comparison, so patients and payers learn which is actually better.

Regulators (or payers, through reimbursement rules) require that registration trials for the third and later entrants in an established mechanistic class use the best available in-class agent as the active comparator, or at minimum include a randomised head-to-head arm. Exceptions apply where the new agent addresses a population the incumbents do not. This makes me-too development more expensive and more informative at once: it either yields comparative evidence patients need or diverts capital to novel mechanisms.

Hypothesis
A head-to-head requirement reduces late-in-class registration filings by at least a quarter within five years and produces comparative effectiveness evidence for the majority of remaining in-class approvals, where today almost none exists.
Rationale
The EU and payers such as Germany's G-BA already prefer active comparators; the WHO and IQWiG have argued that placebo- or obsolete-comparator trials waste patients. Comparative trials among PD-1 antibodies and among TROP2 ADCs are essentially absent despite dozens of products.
What would test it
Implement through a payer coalition's reimbursement criteria (faster than legislation) and count filings and comparator choices in oncology over three years against a pre-period.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
5
Bottlenecks it attacks

Connected

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Pages like this

not linked directly; found by shared links

drugs

4
ApprovedADC
Datopotamab deruxtecan · Datroway
ApprovedMonoclonal antibody (anti-PD-1)
Nivolumab · Opdivo / Opdivo Qvantig (SC)
ApprovedMonoclonal antibody (anti-PD-1)
Pembrolizumab · Keytruda / Keytruda Qlex (SC)
ApprovedADC
Sacituzumab govitecan · Trodelvy

terms

1
Standard of care

ideas

3
A legal right to obtain marketed cancer drugs at cost for combination trialsAn abbreviated approval path for follow-on antibodies within a validated classShorter exclusivity for later-in-class drugs without added benefit

bottlenecks

2
Incentives reward me-too drugs and marginal gainsTrial design, endpoints and cost