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Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer,
A Vivot1,2, J Jacot1,2, J-D Zeitoun1,3,4
1METHODS Team, UMR1153 Epidemiology and Statistics Sorbonne Paris Cité Research Center (CRESS), INSERM, Paris, France.
Background:
Prices of anti-cancer drugs are skyrocking. We aimed to assess the clinical benefit of new drugs for treating advanced solid tumors at the time of their approval by the US Food and Drug Administration (FDA) and to search for a relation between price and clinical benefit of drugs.
Materials And Methods:
We included all new molecular entities and new biologics for treating advanced solid cancer that were approved by the FDA between 2000 and 2015. The clinical benefit of drugs was graded based on FDA medical review of pivotal clinical trials using the 2016-updated of the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Characteristics of drugs and approvals were obtained from publicly available FDA documents and price was evaluated according to US Medicare, US Veterans Health Administration and United Kingdom market systems.
Results:
The FDA approved 51 new drugs for advanced solid cancer from 2000 to 2015; we could evaluate the value of 37 drugs (73%). By the ESMO-MCBS, five drugs (14%) were grade one (the lowest), nine (24%) grade two, 10 (27%) grade three, 11 (30%) grade four and two (5%) grade five (the highest). Thus, 13 drugs (35%) showed a meaningful clinical benefit (scale levels 4 and 5). By the ASCO-VF which had a range of 3.4-67, the median drug value was 37 (interquartile range 20-52). We found no relationship between clinical benefit and drug price (P = 0.9). No characteristic of drugs and of approval was significantly associated with clinical benefit.
Conclusion:
Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by current scales. We found no relation between the price of drugs and benefit to society and patients.
Insights
Many new anti-cancer drugs approved by the US Food and Drug Administration (FDA) offer limited clinical benefit. Despite rising prices, there is no correlation between drug cost and patient benefit.
Area of Science:
- Oncology
- Pharmacoeconomics
- Drug Approval Process
Background:
- Anti-cancer drug prices are increasing significantly.
- There is a need to evaluate the clinical benefit of newly approved cancer medications.
- Assessing the relationship between drug price and clinical benefit is crucial for patient access and healthcare sustainability.
Purpose of the Study:
- To assess the clinical benefit of new drugs for advanced solid tumors approved by the US Food and Drug Administration (FDA).
- To investigate the relationship between the price of these drugs and their clinical benefit.
Main Methods:
- Included new molecular entities and biologics approved by the FDA for advanced solid cancer (2000-2015).
- Clinical benefit was assessed using the American Society of Clinical Oncology Value Framework (ASCO-VF) and European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- Drug prices were evaluated using data from US Medicare, US Veterans Health Administration, and UK market systems.
Main Results:
- Of 51 approved drugs, 37 (73%) had their value assessed.
- Only 35% of drugs demonstrated meaningful clinical benefit (ESMO-MCBS levels 4-5).
- No significant relationship was found between clinical benefit and drug price (P=0.9), nor between drug characteristics and clinical benefit.
Conclusions:
- A substantial number of recently FDA-approved cancer drugs show limited clinical benefit based on current value scales.
- There is no discernible link between the price of these cancer drugs and their benefit to patients or society.
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