Launch Delay of New Drugs in China and Effect on Patients' Health.

Purpose: Although the launch delay of new drugs in China has been a deep concern during the past few years, research on this topic is scarce. The effect of recent regulatory efforts, such as initiating fast review channels to improve access to medical innovations, remains unclear. In this work, we measure the launch delay in China and study whether the fast channels contribute to shorter delays. We also offer an examination of the effect of launch delay on patients' health.

Methods: We examined the launch delays of 40 new drugs engaged in the 3 national price negotiations in China. Launch delay was defined as the differences between the approval dates of the United States or the European Union and that of China and was measured according to approved indications of every specific drug. Thirty-four health impact models comparing the new drugs and their corresponding comparator therapies were populated with open data from published studies to assess the loss of health attributable to launch delay. The time horizon for each model was the specified delay time.

Findings: A total of 40 new drugs with 54 approvals were studied. The median delay was 44.40 months (range, 7.30-196.24 months). For the 20 approvals granted with the fast channels, the median delay was 38.14 months, which was shorter than the 68.25 months of those 34 approvals on the track of standard procedure (P = 0.0276). Moreover, among the 34 health models for 27 new drugs, the largest loss of health was 5.76 life-years and 4.14 quality-adjusted life-years per potential patient, whereas the least loss was 0.006 life-years per head and 0.0035 quality-adjusted life-years per head, respectively.

Implications: Access to new drugs is delayed significantly in China, which may undermine patient benefit by causing loss of life-years and quality of life. The fast review procedures in China have appeared to mitigate the launch delay.