Copy the Cancer Drugs Fund: pay for uncertain drugs while collecting the data
England funds promising cancer drugs at a discount for two or three years while real-world data are collected, then decides for good; other systems could use the same managed-access deal instead of a yes-or-no at launch.
Overview
Since July 2016 England's Cancer Drugs Fund has operated as a managed-access scheme: NICE identifies drugs with plausible but uncertain benefit, NHS England pays a confidential discounted price under a fixed budget with an expenditure-control mechanism, and Public Health England collects outcome data; NICE then reappraises. Most drugs that entered have since been recommended for routine use. The model gives patients early access and gives the payer leverage and evidence. Germany's AMNOG, Canada's time-limited recommendations and Medicare's coverage with evidence development are partial versions.
- 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.
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
Pages like this
not linked directly; found by shared links- IdeaGood practice standards and inspection for real-world data sources
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaOne international registry, not one per country, for conditional approvals
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaRequire post-approval evidence in patients over 75 and update labels accordingly
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- InstitutionISPOR – The Professional Society for Health Economics and Outcomes Research
Shares Pharmaceutical Benefits Advisory Committee, Gemeinsamer Bundesausschuss / IQWiG, National Institute for Health and Care Excellence, Weak real-world evidence and registries.
- IdeaEvery patient on an accelerated-approval drug enrolled in a registry until confirmation
Shares Weak real-world evidence and registries, Real-world evidence, Regulatory divergence between regions.
- IdeaPayers fund cancer drugs conditionally on a registry with a pre-specified analysis
Shares Weak real-world evidence and registries, Real-world evidence, Prices and value.
- IdeaReassess cancer drug prices at three years using real-world outcomes
Shares Weak real-world evidence and registries, Real-world evidence, Prices and value.
- IdeaOne evidence plan agreed by regulator and payer before the pivotal trial
Shares Regulatory divergence between regions, Prices and value.