Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan
Abstract
:1. Introduction
2. Materials and Methods
2.1. Selection of Therapeutic Drugs
2.2. Data Collection
2.3. Data Analysis
- Improvement OS (%) = (median OS (days) in experimental treatment arm)/(median OS (days) in control treatment arm);
- Improvement PFS (%) = (median PFS (days)in experimental treatment arm)/(median PFS (days) in control treatment arm);
- ΔOS (days) = (median OS [days] in experimental treatment arm) − (median OS (days) in control treatment arm);
- ΔPFS (days) = (median PFS [days] in experimental treatment arm) − (median PFS (days) in control treatment arm);
- The incremental drug costs of all anticancer drugs until disease progression or death in the experimental treatment arm were defined as the Cost Index (CI), as follows:
- CIpfs (Yen) = drug price/ΔPFS;
- CIos (Yen)= drug price/ΔOS.
2.4. Statistical Methods
3. Results
3.1. Background of Approved Drugs
3.2. Rates of Increase in OS and PFS Extension and Incremental Drug Costs
3.3. Correlation between Improvement Rate of OS and Incremental Drug Costs
4. Discussion
Future Issues and Definitions Based on the Present Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristic | Number | Percentage | |
---|---|---|---|
Compound type | Molecular-targeted drug | 43 | 53.8% |
Antibody | 15 | 18.8% | |
Cytotoxic drug | 11 | 13.8% | |
Hormonal drug | 6 | 7.5% | |
Immunotherapy drug | 5 | 6.3% | |
Other | 0 | 0.0% | |
Indication | Hematologic tumor | 30 | 37.5% |
Solid tumor | 50 | 62.5% | |
Dosage form | Oral | 43 | 53.8% |
Injection | 37 | 46.3% | |
Review period (days) | Average (±SD) | 73.1 (±44.4) | |
Median (interquartile) | 21,694 (4855.0–93,396.8) | ||
Maximum | 289 | ||
Minimum | 21 | ||
Primary endpoint support approval | OS | 18 | 22.5% |
PFS | 28 | 35.0% | |
Response rate | 13 | 16.3% | |
Time to Progression | 3 | 3.8% | |
Others | 18 | 22.5% | |
NHI drug price | Average (±SD; Yen) | 88,416.2 (±148,974.7) | |
Median (interquartile) (Yen) | 21,694 (4855.0–93,396.8) | ||
<JPY 1000 | 2 | 2.5% | |
<JPY 10,000 | 34 | 42.5% | |
<JPY 100,000 | 25 | 31.3% | |
<JPY 1,000,000 | 19 | 23.8% | |
>JPY 1,000,000 | 0 | 0.0% | |
Calculation system for NHI price standard | Cost accounting method | 24 | 30.0% |
Similar efficacy comparison method (I) | 51 | 63.8% | |
Similar efficacy comparison method (II) | 3 | 3.8% | |
Inter-specification adjustment | 2 | 2.5% | |
Corrective premium rate | With premium rate | 56 | 70.0% |
None | 24 | 30.0% | |
Type of pharmaceutical company | Japanese domestic company | 31 | 38.8% |
Foreign company | 49 | 61.3% |
Overall Survival (n = 16) | Progression Free Survival (n = 28) | p Value | |
---|---|---|---|
Drug Price (Yen) | 208,877 | 1,372,417 | 0.0223 |
Cost Index (Yen) | 205,431 | 64,540 | 0.2297 |
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Okabe, A.; Hayashi, H.; Maeda, H. Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan. Curr. Oncol. 2023, 30, 1776-1783. https://doi.org/10.3390/curroncol30020137
Okabe A, Hayashi H, Maeda H. Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan. Current Oncology. 2023; 30(2):1776-1783. https://doi.org/10.3390/curroncol30020137
Chicago/Turabian StyleOkabe, Ayano, Haruto Hayashi, and Hideki Maeda. 2023. "Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan" Current Oncology 30, no. 2: 1776-1783. https://doi.org/10.3390/curroncol30020137
APA StyleOkabe, A., Hayashi, H., & Maeda, H. (2023). Correlation of Anticancer Drug Prices with Outcomes of Overall Survival and Progression-Free Survival in Clinical Trials in Japan. Current Oncology, 30(2), 1776-1783. https://doi.org/10.3390/curroncol30020137