OBJECTIVES: In current China’s National Reimbursement Drug List (NRDL) negotiation, when submitting cost-effectiveness analysis evidence, Volume-based Procurement (VBP) price is referenced for comparator if comparator is off-patent drug with generics. Our study aims to explore whether it is reasonable to reference VBP price of comparator in innovative drugs NRDL negotiation.

METHODS: A partitioned survival model was constructed for innovative drug X in treatment of metastatic castration-resistant prostate cancer (mCRPC). Lifetime horizon and healthcare payer perspective were adopted. We utilized published literature for cost and utility inputs. The hypothetical drug X’s efficacy and safety data is combined from two innovative mCRPC drugs. Abiraterone was selected as comparator as it is widely used among mCRPC patients in China. Then we compared the negotiation prices of drug X at given willingness-to-pay threshold using branded price (before VBP) and VBP price of Abiraterone. Finally, we estimated the trend of market growth and overall sales forecast for drug X to evaluate its long-term return.

RESULTS: Drug X achieved 0.323 QALY gain compared with Abiraterone. Assuming a willingness-to-pay threshold of 0.8 times GDP per capita (CNY 64,781), the simulated negotiation prices of drug X were CNY 24,590 and CNY 4,071 respectively, using branded price and VBP price of Abiraterone. The price difference of inverting innovative drugs is more than 6 times. CNY 4,071 is 75% lower than branded Abiraterone before VBP (CNY 16,231) and is close to abiraterone VBP price (CNY 4,009). In the long-term sale forecast simulation, the estimated sales peak and 5-year sales revenue of innovative drug X would be 80% lower than average level of other prostate cancer drugs listed in NRDL.

CONCLUSIONS: To promote innovation and ensure long-term efficiency in healthcare industry, VBP price of comparator should not be recommended as reference for innovative drugs in NRDL negotiation.