Improving Access to new Oncology Drugs in the China Market: Shortentime-To-Market and Improve Affordability

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planned economy to a market economy with Chinese characteristics, reform has been implemented on state-owned enterprises in last two decades, while the SOEHs also experience various kinds of reform. The objective of this study is to provide a preliminary evaluation on the reform of SOEHs and raise applicable suggestions for further reform.  Methods: We conducted a survey on SOEHs in all 31 provinces in China, collecting information on status of reform, the form of restructure, the size of hospital, the workforce, financial statement and so on. For comparison, we collected statistical data on Health Sector Affiliated Hospitals (HSH) from China Health Year Book.  Results: We received feedback from 1,290 SOEHs totally. In 2012, there were 3,619 SOEHs accounting for 16% of all the hospitals in China. Most SOEHs (79.5%) were identified as small hospitals with less than 100 beds, a much higher percentage than all hospitals in China (59.6%). In our survey samples, there were 300 SOEHs (23.2%) being reformed, and 29 SOEHs had undergone a second reform due to previous unsuccessful reformation. Regarding performance, the operational efficiency in SOEHs was lower with the bed usage ratio of 60.7% in 2012 versus 96.9% of HSHs. Additionally, the average length of stay in SOEHs of 10.86 days was longer than the 10 days in HSHs. From 2008 to 2011, the SOEHs experienced increases in both outpatient visits and inpatient visits, but were less than HSHs.  Conclusions: The recent performance of SOEHs is worse than HSHs. This indicates more analysis of diversified forms of SOEH restructuring, such as cooperating with social capital, and similar policy support as HSHs from the government would be needed to revitalize SOEHs. PHP64 Assessment of Criteria Influences on Judicious Selection of New Drug for Future Coverage Policy in Iran: An Analysis with Structural Equation Modeling Viyanchi A, Niasti F, Rabani T Hamadan University of medical sciences, Hamadan, Iran

Objectives: To analyze hypotheses underlying the assumption that more criteria about clinical, managerial, and economic assessment have a positive impact on the judicious decisions of new drug coverage in public health insurance.  Methods: I developed a structural equation model in which the process components were considered latent constructs and operationalized by a set of proposed criterions. The dependent variable ‘’judicious decision’’ was defined by the relevance of clinical, economic, and other managerial criteria in new drug appraisal for reimbursement (as opposed to appraisal based on stakeholder lobbying). We conducted a direct and email survey among individuals familiar with coverage decisions of third-party payers in Iran health system in 2013. Partial least squares path modeling (PLS-PM) was used, which allows analyzing small sample sizes without distributional assumptions. Data on 14 decisions criteria from 8 locations and 202 experts in Iran health system were used for model estimation.  Results: Managerial criteria (regression coefficient [RC] = 0.235; P < 0.001) and clinical criteria (RC =  0.424; P < 0.001) had a significant influence on the construct of judicious decision. The path from economic criteria to judicious decision was not significant (RC =  0.103; P =  0.182). For the judicious decision construct, a considerable share of the variance was explained (R2 =  0.35). Biases from missing data and nesting effects were assessed through sensitivity analyses.  Conclusions: Clinical assessment and intense managerial criteria appeared effective in promoting judicious decision making, whereas the influence of economic criteria was not significant. PHP65 Consolidation of China’s Two Basic Medical Insurance Programs: Understanding New Opportunities for Access MI M1, Suponcic S2, LIU Y1 1Navigant Life Sciences, Shanghai, China, 2Navigant Life Sciences, Lawrenceville, NJ, USA

Objectives: On Feb 12, 2016, the State Council of China launched a new initiative to consolidate the two basic medical insurance programs: New Rural Cooperative Medical System (NRCMS) and Urban Residents’ Basic Medical Insurance (URBMI). NRCMS currently covers approximately 790 million citizens and has a reimbursed drug list of less than 1000 products in general while URBMI covers approximately 315 million and has a reimbursed drug list of nearly 2400 products. The initiative seeks to set the same standards in six key areas for the former two insurance schemes: 1) coverage policy (i.e., align coverage to URBMI standard for all) , 2) source of funds, 3) reimbursement rate, 4) reimbursement list, including drugs and services, 5) management of audit, and 6) management of funds. Understanding how reimbursement and price will be determined under this new initiative, given the pressure to centralize decision making and establish value, will be essential to achieving market access success.  Methods: Secondary research reviewed the data of centralized drug procurement and BMI premium income and expenditure at both national and regional level to estimate the market increment of NRCMS. Primary research was conducted with drug procurement officials, and national and regional payers to assess the use of value-based decision making.  Results: The consolidation of the two schemes brings a significant increase in the drug budget and expenditures. The introduction of new policies to assist with centralized procurement of drugs such as therapeutic class reference will mean that companies need to consider even more the tradeoff between lower prices and much broader patient access and use. To widen adoption of appropriate use, companies also will need to optimize availability and access to innovative medicines in the true center of care and prescribing.  Conclusions: The new policies changes bring opportunities for companies to align product value to patient and reimbursement system requirements. PHP66 Is the Lack of Inclusion on the National Drug Reimbursement List the end of the World for Access? MI M1, Suponcic S2, LIU Y3 1Navigant Life Science, Shanghai, China, 2Navigant Life Sciences, Lawrenceville, NJ, USA, 3Navigant Life Sciences, Shanghai, China

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Objectives: China further expanded universal health insurance in 2014 with 1,387 million citizens now eligible for Basic Medical Insurance (BMI) and a coverage rate of over 97%. The patients covered by BMI have access to drugs listed on the NDRL (National Drug Reimbursement List). However, inclusion criteria for listing on the NDRL are very strict and the list has not been revised since 2009. Therefore, understanding alternative strategies and approaches for increasing the probability of Provincial Drug Reimbursement List (PDRL) inclusion is essential.  Methods: This analysis includes a review of secondary data of PDRL inclusion in 6 key provinces in China: Zhejiang, Jiangsu, Fujian, Shandong, Anhui and Jiangxi and is supplemented with primary research with regional payers and payer advising KOLs to assess the PDRL inclusion criteria as an alternative market access strategy to the NDRL.  Results: In contrast to the NDRL, the PDRLs are revised on a more regular basis and have less restrictive inclusion criteria. Important criteria for assessment are aligned with substantiating and communicating product value in the areas of efficacy, effectiveness, safety and not surprisingly, price. Interviews with stakeholders identify the importance of real world data and pharmaco-economic (PE) studies in decision making with the priority of identifying cost offsets and cost effective use of insurance funding.  Conclusions: Given the current environment, healthcare stakeholders are eager for PE studies that support and lend credibility to value-based decisionmaking. While NDRL remains an elusive goal for access, PDRL inclusion may be a more realistic alternative with the probability for success enhanced by providing locally-relevant pharmaco-economic studies completed in conjunction with local authorities and KOLs. PHP67 Improving Access to new Oncology Drugs in the China Market: Shortentime-To-Market and Improve Affordability LIU Y1, Suponcic S2, MI M1 1Navigant Life Sciences, Shanghai, China, 2Navigant Life Sciences, Lawrenceville, NJ, USA

Objectives: Based on strong growth underpinned by a host of macro-economic drivers, the pharmaceutical market in China is now the world’s second largest. At the same time, market access for new pharmaceutical products still represents one of the most salient challenges especially for MNCs. Examining how oncology drugs have gained access to the Chinese market over the last decade, this research explores the essential elements that must be considered in order to reach the most patients who can benefit.  Methods: This analysis is based on a review of secondary data from the introduction of new oncology drugs launched by MNCs into China in the last decade. Primary research also was conducted with commercial and private insurers and national, regional and local decision-makers to assess affordability pathways in the presence of access and registration barriers.  Results: Successful market access strategies for new oncology agents in China must address two critical challenges: time to market and affordability to patients and other stakeholders. Time to market can be shortened by partnering locally to further accelerate clinical trials and increase the awareness of regional/local key opinion leaders who inform the regulatory approval and reimbursement processes. Additionally, four approaches can be utilized to help to increase affordability for patients: listing on the Provincial Drug Reimbursement List prior to the listing of National Drug Reimbursement List, utilizing the Serious Illness Insurance Program, gaining coverage by Commercial insurance and providing a Patient Assistant Program. Data showed patient access to new oncology drugs was improved dramatically with the adoption of those approaches.  Conclusions: Access to new oncology drugs is significantly improved with initiatives to shorten the time-to-market and improve affordability in China. PHP68 Patient Access to High-Cost and High-Value Specialty Products in China: Review of Decisions From Zhejiang, Neimenggu, Shandong and Jiangxi Gambari J, Chowdhury CA, Duttagupta S, Yang M CBPartners, New York, NY, USA

Objectives: Due to KOL advocacy and patient groups, several provinces in China, such as ZheJiang, JiangXi, ShanDong and NeiMengGu, have initiated an access negotiation mechanism to expand drug coverage under the “Severe Diseases Insurance” and improve patient access to “life-saving” high-cost and high-value drugs. The objective of this analysis was to understand which types of products and which manufactures are most likely to benefit today and in the future from this negotiation mechanism.  Methods: The list of products for access negotiation based on KOL recommendations in the last 5 years for ZheJiang, NeiMengGu, ShanDong and JiangXi provinces were extracted and reviewed towards the end of 2015.  Results: The ZheJiang Province Human Resources and Social Security (HRSS) has selected a list of 31 products for inclusion in the access negotiation mechanism based on KOL recommendations. 21 of the manufacturers invited were multinational pharmaceutical companies, with only 10 local manufacturers being part of the process. Out of the 31 initially selected products, 15 have made it to the final list and areexpected to be covered under the “Severe Diseases Insurance” (SDI). Under the SDI, the government will cover up to 70% of the drug cost dramatically decreasing OOP for patients. In the NeiMengGu province, 12 high-cost oncology products treating 8 malignant cancers, such as NSCLC, CRC and CML, were included in the SDI in 2015. Similarly, in the JiangXi province, 5 high-cost oncology products, including HERCEPTIN and GLEEVEC, gained access through the “Severe Diseases Insurance” after an access negotiation with the provincial HRSS.  Conclusions: Though only a few provinces in China have made significant progress, many more are trying to establish this negotiation mechanism. Future launches may have to benchmark against these prices for reimbursement coverage in China bringing about new challenges and opportunities for manufacturers of innovative molecules.