PCN307 IMPROVING PATIENT ACCESS TO PD-(L)1 THERAPIES IN CHINA: POLICY IMPLICATIONS FROM PREVIOUS NRDL NEGOTIATIONS

Abstract

China National Healthcare Security Administration (former MoHRSS, the Ministry of Human Resources and Social Security) has conducted two rounds of price negotiation of high-price innovative drugs for National Reimbursement Drug List (NRDL) admission (Short for NRDL negotiation). Upon the opening of 3rd NRDL negotiation in 2019, PD-(L)1s (pembrolizumab, nivolumab, Toripalimab, Sintilimab) are lined up for NRDL admission. This study analyzed the policy implications from previous NRDL negotiations and identified the different determinants for PD-(L)1s negotiation in 2019. Through secondary research, we’ve reviewed and analyzed historical policies and price cuts in previous NRDL negotiations to predict the upcoming admission requirements for PD-(L)1s. We’ve also conducted qualitative interviews with China’s Basic Medical Insurance (BMI) payers to gauge the review process and access barriers for PD-(L)1s in 2019. We identified four determinants for PD-(L)1s NRDL negotiation in 2019: 1) Price cut is compulsory as previous oncology products have cut 53% on average to win NRDL admission (46% in 2017 and 56% in 2018). Price cut will be closely related to PAP (Patient Assistance Programs) net price. 2) Price after negotiation is intended to be the lowest among comparable countries/regions. 3) Submission of pharmaco-economic evidence is increasingly important. Cost-effectiveness and budget impact are two major factors reviewed by BMI payers. 4) BMI budget constraint will drive payers to apply payment restrictions on PD-(L)1s. Performance-based reimbursement, patient subgroup restriction and payment capping on treatment duration or expense are potential factors for PD-(L)1s negotiation. In addition, alternative funding is required imminently to sustain the reimbursement of upcoming PD-(L)1s. An over 50% price reduction is anticipated for PD-(L)1s in 2019 NRDL negotiation. BMI payers might apply payment restrictions to maintain the balance between increasing drug access and ensuring funding sustainability. Need for alternative funding is imminent.