NSCLC in China and South Korea presents a huge challenge for healthcare providers and a considerable opportunity for drug manufacturers. Incidence in China is the second highest of the major emerging markets and is expected to reach levels comparable to the West in the next decade.
As the molecular pathogenesis of NSCLC is further elucidated, treatment of advanced disease in China and South Korea is increasingly influenced by tumor molecular characteristics predictive of response to premium-priced targeted agents. In both markets, EGFR tyrosine kinase inhibitors (TKIs) Iressa (AstraZeneca; gefitinib) and Tarceva (Roche; erlotinib) are approved for EGFR mutation-positive NSCLC, while in China, Zhejiang Beta Pharma’s Conmana (icotinib) is also available. Recently published meta-analyses suggest that this disease subtype occurs in as many as 47% of Chinese patients, although the incidence in South Korea appears to be closer to the levels seen in Western nations. More recently, Pfizer’s Xalkori (crizotinib) has been approved in both countries for the treatment of the small proportion of patients whose tumors express the EML4-ALK fusion protein; this agent launched in South Korea in January 2012, with rollout in China taking place from mid-2013. While biomarker-driven prescribing enables treatment with these expensive drugs to be channeled toward the patients most likely to respond, the associated cost of molecular testing (borne largely by patients in both countries) adds to the market access challenges for each agent.
Furthermore, the costly targeted treatment options approved for NSCLC also include VEGF inhibitors Avastin (bevacizumab) and Endostar (SD. Simcere Medgenn's endostatinin) in South Korea and China, respectively. With novel agents such as irreversible EGFR inhibitors Gilotrif (Boehringer Ingelheim; afatinib) and dacomitinib (Pfizer; PF-00299804) and c-Met inhibitor MetMab (Roche/Genentech; onartuzumab) waiting in the wings, NSCLC undoubtedly represents an increasingly costly healthcare challenge for payers and prescribers in these markets.
This report covers the prescribing and coverage/reimbursement environment for these drugs and drug classes in China and South Korea and assesses how the NSCLC market access landscape will evolve in the next several years as new therapies expand the treatment armamentarium.
Questions Answered in This Report:
Understand the access and reimbursement environment for high-cost targeted NSCLC brands in China and South Korea: - China:
How are targeted agents for NSCLC reimbursed in China? Why are none listed on the NRDL? Which targeted agents have achieved inclusion on regional formularies (PRDLs), and to what extent? What are payers’ and prescribers’ expectations for inclusion of current and emerging brands in the next NRDL and PRDLs? What market development strategies have been adopted? How has prescription of targeted agents been encouraged at the municipal level? - South Korea:
How are targeted agents for NSCLC reimbursed in South Korea? What restrictions do HIRA’s national guidelines apply? To what extent has South Korea’s notoriously lengthy pricing negotiations impacted admission to reimbursement for current targeted NSCLC therapies, and what are payers’ and prescribers’ expectations for admission of emerging agents? What is the likely impact of implementation of the Four Major Diseases Security Guarantee Plan on the treatment of NSCLC?
Understand the impact of pricing and reimbursement on the use of currently available targeted NSCLC agents.
What are prescriber perceptions of Western-branded agents versus homegrown brands and generics? What does an analysis of prescribing patterns reveal about the real-life impact of payer policies on prescribing? How does access vary between agents? How do reimbursement/coverage constraints rank against other market access hurdles? What has been the impact of tumor biomarker testing on targeted agent prescribing? What are prescriber expectations for biomarker testing by the end of 2016? What are the key drivers for the prescribing of specific EGFR TKIs? In several discount scenarios, how much power would price discounts have to shift prescribing?
Explore physician and payer perspectives on emerging brands.
What are the market access hurdles emerging brands will need to overcome in these markets? How do physicians expect to prescribe the agents? How important will companion biomarker tests be in encouraging/supporting use? How will payer policies in these markets impact uptake of emerging brands over currently approved drugs? What clinical and commercial factors would most likely convince payers to grant emerging brands coverage or advantaged positioning? How will inclusion in government formularies/drug lists impact the uptake of emerging therapies?
This Emerging Markets Physician & Payer Forum report explores the market access hurdles and levers that affect NSCLC market dynamics in China and South Korea. The report is based on a survey of 100 prescribers (oncologists) mostly located in tier III hospitals in China and in both public and private general and high-level general hospitals in South Korea, plus interviews with 7 payers who have an influence at a national or regional level and include the following:
- China: Senior officials at the Qingdao and Zhejiang Provinces Human Resources and Social Security Bureaus; Researcher at the National Institute of Human Social Security Research, Beijing.
- South Korea: Section Chief, Healthcare Benefit Standard Team, HIRA; Head of Department, DRG Management Department, HIRA; Section Chief, Department of Insurance Benefits, NHI; Head, Health Care Policy Institute, Private Sector.