The Chinese market for hepatocellular carcinoma (HCC) therapies represents an increasingly lucrative space for many pharmaceutical companies. Although the high prices demanded by targeted brands are a major access barrier for Chinese patients in both the rural and the more-affluent urban areas, targeted therapies from both multinational corporations (MNCs) and local Chinese pharmaceutical companies have achieved a foothold in the Chinese HCC market. Bayer’s Nexavar takes center stage, with a number of other targeted agents prescribed off-label. The prognostic outlook for patients with stage IV HCC is dismal, and enormous unmet need exists for agents that can prolong overall survival and increase progression-free survival in HCC patients. A number of targeted agents are in the development pipeline from both local firms and MNCs. Once-promising agents brivanib (Bristol-Myers Squibb’s BMS-582664) and linifanib (Abbott Laboratories’ ABT-869) recently fell short in Phase III head-to-head trials against Nexavar, a situation that may lead to a greater demand for more second/third-line treatments. Bayer/Onyx Pharmaceuticals’ Stivarga (regorafenib) and Medigen Biotechnology’s PI-88 are currently in Phase III trials and are well positioned to launch in China in the upcoming years. Understanding the access and reimbursement environment for HCC targeted therapies in China will be essential for positioning novel treatments and expanding penetration of brands.

Questions Answered in This Report:

  • Understand the access and reimbursement environment for high-cost targeted HCC brands in China: Which agents are included on the National Reimbursement Drug List (NRDL) or Provincial Reimbursement Drug Lists (PRDLs)? What are the restrictions to reimbursement of formulary-listed drugs? Which therapies do physicians and payers expect to be included in the new NRDL and/or PRDLs? What are the differences in reimbursement between Tier 1 and Tier 2/3 cities?  How might reimbursement of key HCC therapies change in the near future?

  • Understand the impact of pricing and reimbursement on the use of currently available targeted HCC agents: How do prescribing patterns for HCC differ among agents and among different tier cities? How may programs to increase patient access to targeted therapies enhance drug uptake? What does an analysis of prescribing patterns reveal about the real-life impact of payer policies on prescribing for HCC? What are the key drivers for the prescribing of a specific targeted therapy over others? How do oncologists expect their prescribing of currently marketed targeted therapies to evolve by the end of 2016?

  • Explore physician and payer perspectives on emerging brands: What hurdles will emerging therapies encounter in these markets? What are clinicians’ requirements of an emerging brand positioned for prescribing ahead of Nexavar? How are emerging brands Stivarga and PI-88 perceived? How will market access barriers evolve, and what challenges are companies likely to face in the future? What clinical and commercial factors would most likely convince payers to grant emerging agents coverage or advantaged positioning?

Scope:

This Emerging Markets Physician & Payer Forum report explores the prescribing and market access environment for HCC in China. The report will examine the prescribing barriers that premium-priced targeted therapies for HCC face in this market, and strategies to overcome those obstacles. We will explore clinician and payer attitudes and behaviors concerning currently marketed brands, as well as their expectations for emerging therapies, with a focus on Bayer/Onyx’s Stivarga (regorafenib), and Medigen Biotechnology’s PI-88. We will examine differences between Tier 1 and Tier 2/3 cities, to explore how market access strategies for HCC brands need to be tailored to these different markets. The report draws on insights from 76 surveyed medical oncologists and 3 interviewed payers who influence reimbursement at a national or regional level, which include the following:

- Member, Ministry of Human Resources and Social Security (MOHRSS) for updating of the NRDL, Jilin

- Senior staff, Province Human Resources and Social Security Bureau, Anhui

- Member, MOHRSS for updating of the NRDL, Ningxia

Author(s): Michelle Zhou, M.B.B.S., Ph.D.

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