핵심 개념
The monthly cost of treating breast cancer is not associated with improved overall survival or progression-free survival for patients.
초록
This study analyzed 26 new breast cancer drugs approved by the FDA between 2000 and 2023. The researchers focused on the development, benefits, trials, and prices of these new therapies, collecting data from FDA labels, Medicare, Medicaid, and clinicaltrials.gov.
Key findings:
- The new drugs had a median overall survival (OS) improvement of 2.8 months and a median progression-free survival (PFS) improvement of 4.4 months.
- 60% of the treatments had a "high-value" ESMO-MCBS score, and 14% demonstrated improvements in quality of life (QoL).
- The average monthly cost of the new drugs was $16,013 in 2023.
- There was no significant association between the new drugs' clinical benefit (OS, PFS, or ESMO-MCBS) and their prices.
- The researchers concluded that there is a misalignment between the value and price of new cancer drugs, and value frameworks like the ESMO-MCBS could help identify high-value treatments.
The study also discussed the challenges of using PFS as a surrogate endpoint for OS, and the importance of evaluating both OS and QoL in clinical trials.
통계
The new drugs had a median OS improvement of 2.8 months (interquartile range [IQR], 1.8-5.8) and a median PFS improvement of 4.4 months (IQR, 2.2-7.1).
In single-arm trials, the objective response rate was 31% (95% CI, 10-53%).
The median value per life year gained was $62,419 (IQR, 25,840-86,062) for OS.
인용구
"Our analysis shows that the monthly treatment costs of new breast cancer drugs were not associated with their OS or PFS benefit."
"This suggests that, in the US, we do not pay higher prices for drugs that provide a greater benefit to patients, but conversely, it also suggests that we could (maybe should) pay lower prices for drugs with only a marginal benefit."