OnCo
ideasIdea

Use food effects to cut the dose and cost of oral drugs that absorb better with meals

Some cancer pills are absorbed several times better with food, but the label says take them fasting at a high dose. Taking a quarter of the dose with breakfast can give the same drug levels at a quarter of the price.

Randomised PK and non-inferiority trials of low-dose-with-food versus standard fasting dosing for oral agents with large positive food effects (abiraterone is the established example; others include several kinase inhibitors), followed by label changes and guideline adoption. Regulators accept PK-bridged non-inferiority; payers fund the trials because savings are immediate.

Hypothesis
Low-dose-with-food regimens will show equivalent exposure and non-inferior efficacy for most agents with a fourfold or greater food effect, cutting drug cost by 50-75 percent.
Rationale
Fasting dosing was chosen to reduce variability, not to maximise benefit; for drugs whose absorption is limited fasting, feeding is a cheap way to increase exposure, and the variability concern can be tested directly.
What would test it
Identify candidates from label PK data; run PK-bridged randomised non-inferiority trials for the two with the largest spend, with a pre-agreed pathway to label change.
Maturity
early clinical
Who has to act
research
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
  • Wrong doses · Most drug doses were chosen as the highest a person can tolerate, which is often more than they need.
  • Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.

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