Association of Launch Price and Clinical Value With Reimbursement Decisions for Anticancer Drugs in China

Document Type : Original Article


1 HEOA Group, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China

2 Institute for Healthy Cities and West China Research Center for Rural Health Development, Sichuan University, Chengdu, China

3 School of Public Health, Imperial College London, London, UK

4 School of Public Administration, Sichuan University, Chengdu, China


The potential role played by launch price and clinical value in reimbursement decisions has not been sufficiently established in China. This study aimed to investigate the association of launch price and clinical value with reimbursement decisions for anticancer drugs after the implementation of reimbursement-linked price negotiation in China.
Anticancer drugs approved by the National Medical Products Administration (NMPA) of China from January 2017 to June 2022 were eligible for inclusion. Approval and reimbursement dates of included drug indications were retrieved from publicly available resources. We collected measures of clinical value, including survival, quality of life (QoL), and overall response rate from pivotal clinical trials and calculated treatment price at launch. Univariate and multivariate Cox proportional hazards models were employed to estimate the association between launch price, clinical value, and reimbursement decisions of anticancer drugs in China.
The median reimbursement lag was 579 days (interquartile range [IQR]: 402–936) for 93 indications supported by randomized controlled trials and 637 days (IQR: 373–858) for 42 indications supported by single-arm clinical trials. Reimbursement was granted to 60 (65%) and 23 (55%) indications supported by randomized controlled and single-arm clinical trials, respectively. The launch price of anticancer drugs was not associated with reimbursement decisions in multivariate regression analyses. Indications supported by randomized controlled trials with higher clinical value were more likely to be reimbursed (hazard ratio [HR] for survival = 1.07, 95% CI: 1.00–1.15, P = .037), while the overall response rate of indications supported by single-arm clinical trials was not associated with the likelihood of being reimbursed (HR = 2.09, 95% CI: 0.14–32.28, P = .595).
The launch price of anticancer drugs may not have a significant impact on reimbursement decisions, while the implementation of reimbursement-linked price negotiation in China has prioritized anticancer drugs with higher clinical value, but only for indications supported by randomized controlled trials. Efforts are needed to prioritize indications supported by single-arm clinical trials that have higher value during the process of price negotiation. 


  1. Zhang Y, Wagner AK, Guan X. Newly approved cancer drugs in China - innovation and clinical benefit. Nat Rev Clin Oncol. 2023;20(3):135-136. doi:1038/s41571-023-00728-3
  2. Liu Y, Zhang N, Xie C, et al. Evolution of drug regulations and regulatory innovation for anticancer drugs in China. Acta Pharm Sin B. 2022;12(12):4365-4377. doi:1016/j.apsb.2022.08.004
  3. Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015;351:h4633. doi:1136/bmj.h4633
  4. Zhang Y, Naci H, Wagner AK, et al. Overall survival benefits of cancer drugs approved in China from 2005 to 2020. JAMA Netw Open. 2022;5(8):e2225973. doi:1001/jamanetworkopen.2022.25973
  5. Zhu X, Liu B. Launch delay of new drugs in China and effect on patients' health. Clin Ther. 2020;42(9):1750-1761.e7. doi:1016/j.clinthera.2020.06.023
  6. Eichler HG, Bloechl-Daum B, Abadie E, Barnett D, König F, Pearson S. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov. 2010;9(4):277-291. doi:1038/nrd3079
  7. Shih YR, Liao KH, Chen YH, Lin FJ, Hsiao FY. Reimbursement lag of new drugs under Taiwan's national health insurance system compared with United Kingdom, Canada, Australia, Japan, and South Korea. Clin Transl Sci. 2020;13(5):916-922. doi:1111/cts.12778
  8. Zannad F, de Los Angeles Alonso Garcia M, Borer JS, et al. Role of payers in the development of cardiovascular therapeutics: misalignment between approval and reimbursement. J Am Coll Cardiol. 2017;70(22):2822-2830. doi:1016/j.jacc.2017.10.027
  9. Liu GG, Wu J, He X, Jiang Y. Policy updates on access to and affordability of innovative medicines in China. Value Health Reg Issues. 2022;30:59-66. doi:1016/j.vhri.2021.12.003
  10. Li H, Liu GG, Wu J, Wu JH, Dong CH, Hu SL. Recent pricing negotiations on innovative medicines pilot in China: experiences, implications, and suggestions. Value Health Reg Issues. 2018;15:133-137. doi:1016/j.vhri.2018.01.009
  11. Zhou J, Lan T, Lu H, Pan J. Price negotiation and pricing of anticancer drugs in China: an observational study. PLoS Med. 2024;21(1):e1004332. doi:1371/journal.pmed.1004332
  12. Zhang Y, Wushouer H, Han S, et al. The impacts of government reimbursement negotiation on targeted anticancer medication price, volume and spending in China. BMJ Glob Health. 2021;6(7):e006196. doi:1136/bmjgh-2021-006196
  13. Vogler S, Paris V, Panteli D. Ensuring Access to Medicines: How to Redesign Pricing, Reimbursement and Procurement? WHO Regional Office for Europe; 2018.
  14. Wen J, Li M, Jiang Y. Cost effectiveness of innovative anti-cancer drugs and reimbursement decisions in China. Health Policy Technol. 2023;12(2):100742. doi:1016/j.hlpt.2023.100742
  15. Ling K, Qin H, Feng Y, Che H, Ding J, Li W. Correlation between clinical trial endpoints of marketed cancer drugs and reimbursement decisions in China. Front Public Health. 2022;10:1062736. doi:3389/fpubh.2022.1062736
  16. Salek S, Lussier Hoskyn S, Johns JR, Allen N, Sehgal C. Factors influencing delays in patient access to new medicines in Canada: a retrospective study of reimbursement processes in public drug plans. Front Pharmacol. 2019;10:196. doi:3389/fphar.2019.00196
  17. National Medical Products Administration. 2021 Drug Review Report. 2022. Accessed March 24, 2023.
  18. Center for Drug Evaluation of NMPA. Information on Listed Drugs.
  19. Mills M, Michaeli D, Miracolo A, Kanavos P. Launch sequencing of pharmaceuticals with multiple therapeutic indications: evidence from seven countries. BMC Health Serv Res. 2023;23(1):150. doi:1186/s12913-023-09095-2
  20. Michaeli DT, Michaeli T. Cancer drug prices in the United States: efficacy, innovation, clinical trial evidence, and epidemiology. Value Health. 2023;26(11):1590-1600. doi:1016/j.jval.2023.06.020
  21. National Healthcare Security Administration. Policy and Regulation. Accessed April 4, 2023.
  22. Rational Administration. Accessed March 24, 2023.
  23. Vokinger KN, Hwang TJ, Grischott T, et al. Prices and clinical benefit of cancer drugs in the USA and Europe: a cost-benefit analysis. Lancet Oncol. 2020;21(5):664-670. doi:1016/s1470-2045(20)30139-x
  24. Salas-Vega S, Iliopoulos O, Mossialos E. Assessment of overall survival, quality of life, and safety benefits associated with new cancer medicines. JAMA Oncol. 2017;3(3):382-390. doi:1001/jamaoncol.2016.4166
  25. Zhang Y, Wei Y, Li H, et al. Prices and clinical benefit of national price-negotiated anticancer medicines in China. Pharmacoeconomics. 2022;40(7):715-724. doi:1007/s40273-022-01161-7
  26. Kovic B, Jin X, Kennedy SA, et al. Evaluating progression-free survival as a surrogate outcome for health-related quality of life in oncology: a systematic review and quantitative analysis. JAMA Intern Med. 2018;178(12):1586-1596. doi:1001/jamainternmed.2018.4710
  27. Howard DH, Bach PB, Berndt ER, Conti RM. Pricing in the market for anticancer drugs. J Econ Perspect. 2015;29(1):139-162. doi:1257/jep.29.1.139
  28. Lauenroth VD, Kesselheim AS, Sarpatwari A, Stern AD. Lessons from the impact of price regulation on the pricing of anticancer drugs in Germany. Health Aff (Millwood). 2020;39(7):1185-1193. doi:1377/hlthaff.2019.01122
  29. Information of Drug Winning Bid. 2022.
  30. Salas-Vega S, Shearer E, Mossialos E. Relationship between costs and clinical benefits of new cancer medicines in Australia, France, the UK, and the US. Soc Sci Med. 2020;258:113042. doi:1016/j.socscimed.2020.113042
  31. Lunghi C, Moisan J, Grégoire JP, Guénette L. The association between depression and medication nonpersistence in new users of antidiabetic drugs. Value Health. 2017;20(6):728-735. doi:1016/j.jval.2016.09.2399
  32. Hernán MA, Cole SR, Margolick J, Cohen M, Robins JM. Structural accelerated failure time models for survival analysis in studies with time-varying treatments. Pharmacoepidemiol Drug Saf. 2005;14(7):477-491. doi:1002/pds.1064
  33. Leinwand B, Sollano J, Doherty JP, et al. PCN402 the clinical and economic consequences of delays in reimbursement for select novel cancer therapeutics in Canada, Italy, and Australia. Value in Health. 2019;22(Suppl 3):S514. doi:1016/j.jval.2019.09.597
  34. Technology Development Center of Chinese Pharmaceutical Association. Blue Book on the Progress and Achievements of China's Medical Insurance Drug Management Reform. 2021.
  35. EFPIA Patients W.A.I.T. Indicator 2022 Survey.
  36. Drummond M. Twenty years of using economic evaluations for drug reimbursement decisions: what has been achieved? J Health Polit Policy Law. 2013;38(6):1081-1102. doi:1215/03616878-2373148
  37. Gong JR, Lee D, Lim KM, Bae S. Are recently evaluated drugs more likely to receive positive reimbursement recommendations in South Korea? 11-year experience of the South Korean positive list system. Clin Ther. 2020;42(7):1222-1233. doi:1016/j.clinthera.2020.05.006
  38. Malinowski KP, Kawalec P, Trąbka W. Impact of patient outcomes and cost aspects on reimbursement recommendations in Poland in 2012-2014. Health Policy. 2016;120(11):1249-1255. doi:1016/j.healthpol.2016.09.016
  39. China National Health Development Research Center. Notice of the National Center for Comprehensive Evaluation of Drugs and Health Technology on the Release of Technical Guidelines for Clinical Comprehensive Evaluation of Cardiovascular Diseases, Anticancer, and Pediatric Drugs.
  40. Kim ES, Kim JA, Lee EK. National reimbursement listing determinants of new cancer drugs: a retrospective analysis of 58 cancer treatment appraisals in 2007-2016 in South Korea. Expert Rev Pharmacoecon Outcomes Res. 2017;17(4):401-409. doi:1080/14737167.2017.1276828
  41. Thomson S, Everest L, Witzke N, et al. Examining the association between oncology drug clinical benefit and the time to public reimbursement. Cancer Med. 2022;11(2):380-391. doi:1002/cam4.4455
  42. Ferrario A. Time to entry for new cancer medicines: from European Union-wide marketing authorization to patient access in Belgium, Estonia, Scotland, and Sweden. Value Health. 2018;21(7):809-821. doi:1016/j.jval.2018.01.003
  43. Wieseler B, McGauran N, Kaiser T. New drugs: where did we go wrong and what can we do better? BMJ. 2019;366:l4340. doi:1136/bmj.l4340
  44. Michaeli DT, Michaeli T. Overall survival, progression-free survival, and tumor response benefit supporting initial US food and drug administration approval and indication extension of new cancer drugs, 2003-2021. J Clin Oncol. 2022;40(35):4095-4106. doi:1200/jco.22.00535
  45. Janzic U, Knez L, Janzic A, Cufer T. Time to access to novel anticancer drugs and the correlation with ESMO-Magnitude of Clinical Benefit Scale in Slovenia. Expert Rev Pharmacoecon Outcomes Res. 2019;19(6):717-723. doi:1080/14737167.2019.1702879
  46. Jommi C, Armeni P, Costa F, Bertolani A, Otto M. Implementation of value-based pricing for medicines. Clin Ther. 2020;42(1):15-24. doi:1016/j.clinthera.2019.11.006
  47. Sussex J, Towse A, Devlin N. Operationalizing value-based pricing of medicines: a taxonomy of approaches. Pharmacoeconomics. 2013;31(1):1-10. doi:1007/s40273-012-0001-x
  48. Huang Y, Xiong W, Zhao J, Li W, Ma L, Wu H. Early phase clinical trial played a critical role in the Food and Drug Administration-approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021. J Clin Epidemiol. 2023;157:74-82. doi:1016/j.jclinepi.2023.03.006
  49. Hilal T, Gonzalez-Velez M, Prasad V. Limitations in clinical trials leading to anticancer drug approvals by the US Food and Drug Administration. JAMA Intern Med. 2020;180(8):1108-1115. doi:1001/jamainternmed.2020.2250
  50. Schnog JB, Samson MJ, Gans ROB, Duits AJ. An urgent call to raise the bar in oncology. Br J Cancer. 2021;125(11):1477-1485. doi:1038/s41416-021-01495-7
  51. Seruga B, Templeton AJ, Badillo FE, Ocana A, Amir E, Tannock IF. Under-reporting of harm in clinical trials. Lancet Oncol. 2016;17(5):e209-e219. doi:1016/s1470-2045(16)00152-2
  52. Marandino L, La Salvia A, Sonetto C, et al. Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016. Ann Oncol. 2018;29(12):2288-2295. doi:1093/annonc/mdy449
  53. Saleh RR, Meti N, Ribnikar D, et al. Associations between safety, tolerability, and toxicity and the reporting of health-related quality of life in phase III randomized trials in common solid tumors. Cancer Med. 2020;9(21):7888-7895. doi:1002/cam4.3390

Articles in Press, Corrected Proof
Available Online from 17 March 2024
  • Receive Date: 05 June 2023
  • Revise Date: 08 February 2024
  • Accept Date: 16 March 2024
  • First Publish Date: 17 March 2024