Cost-Effectiveness Analysis of Evolocumab or Inclisiran in Combination with Statins Versus Statin Monotherapy Among Patients with ASCVD in China

Background and objective Several innovative proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have been approved for combination lipid-lowering therapy in China. Compared with their high initial launch prices, some PCSK9 inhibitors have been subjected to the National Drug Price Negotiation (NDPN) policy with substantial price reductions, such as a 78.14% reduction for evolocumab (EVO). Others, such as inclisiran (INC), have not been included in this policy and maintain high prices. This study aimed to: (1) assess the cost-effectiveness of representative PCSK9 inhibitors (EVO and INC) in combination with statins versus statin monotherapy for Chinese patients with atherosclerotic cardiovascular disease (ASCVD), and (2) evaluate the influence of the NDPN policy on cost-effectiveness. Methods A Markov model was developed from the Chinese healthcare system perspective. Atorvastatin monotherapy was used as the standard of care (SOC), and the combinations of EVO or INC with SOC were employed as the intervention regimens. The transition probabilities and treatment effects were based on the Asian subgroup of the FOURIER trial and pooled analysis of the ORION-8, -9, and -10 trials, or calculated with results from a meta-analysis. Costs and utilities were derived from published literature or calculated with methods from literature and assumptions. Sensitivity and scenario analyses were conducted to evaluate the robustness of the model and the influence of the NDPN policy. Finally, the cost threshold analyses were conducted to estimate the annual costs required for EVO and INC to achieve a 75% probability of cost-effectiveness. Results The base-case incremental cost-effectiveness ratios (ICERs) of EVO + SOC and INC + SOC were 168,066 Chinese yuan (CNY) [23,652 US dollars (USD)] and 586,119 CNY (82,485 USD) per quality-adjusted life year (QALY), respectively. At WTP thresholds of three and one times GDP per capita (268,200 CNY [37,744 USD] and 89,400 CNY [12,581 USD]) per QALY gained, the probabilities that the intervention regimens were cost-effective would be 89.86% and 0.30% for EVO + SOC and 0.54% and 0% for INC + SOC, respectively. To achieve a 75% probability of cost-effectiveness, the required annual costs would be 9851 CNY (1386 USD) and 3434 CNY (483 USD) for EVO and 6554 CNY (922 USD) and 2096 CNY (295 USD) for INC, respectively. When the price reduction caused by the NDPN policy was removed from EVO and added to INC (assuming that the price of INC also reduces by 78.14%), the ICERs were 782,954 CNY (110,185 USD) and 130,877 CNY (18,418 USD) per QALY, respectively. Conclusions With the intervention of the NDPN policy, EVO + SOC has been a cost-effective option for Chinese patients with ASCVD at the WTP threshold of three times GDP per capita. However, INC + SOC is not a cost-effective regimen at the current price, and the NDPN policy may be an appropriate intervention measure.