OBJECTIVES:

China has been implementing price negotiation to control the high prices of innovative drugs annually since 2016. With the increasing importance of value-based pricing, we aimed to assess whether the price negotiation has led to drug pricing being more aligned with clinical value on top of price reduction in China.

METHODS:

Therapeutic indications of anticancer drugs that were negotiated successfully between 2016 and 2021 were eligible for inclusion. We collected measures of clinical value on safety, survival, quality of life, and overall response rate from pivotal clinical trials and calculated treatment costs over expected treatment durations of included therapeutic indications. Regression analyses were used to test the association of clinical value with treatment costs before and after negotiation, and whether the price negotiation has impacted the relationship between drug prices and clinical value.

RESULTS:

93 therapeutic indications for 65 anticancer drugs were included in our analysis including 71 indications supported by randomized clinical trials and 22 indications supported by single-arm clinical trials. The median treatment costs over the entire sample have been reduced from CNY217,800 to CNY80,600 after price negotiation. Greater survival life-months gained for therapeutic indications supported by randomized clinical trials, and higher overall response rates for therapeutic indications supported by single-arm clinical trials were positively associated with higher treatment costs both before and after negotiation. We did not find evidence supporting greater alignment of drug prices with clinical value on top of price reduction with the implementation of price negotiation in China.

CONCLUSIONS:

Price negotiation has not led to drug pricing being more aligned with clinical value on top of price reduction in China. Decision-makers should re-examine the pricing strategy in China to enable finite resources to be further tilted towards treatments that offer patients greater clinical benefits rather than being wasted on low-value treatments.