Harjit Gill is the CEO of APACMed(Asia Pacific Medical Technology Association)

Over the past decade, we have witnessed rapid growth in genomic research and its applications in healthcare, and Next Generation Sequencing(NGS) has emerged as a potential game-changer, providing unparalleled insights that are starting to make a big impact on patient lives. In particular, NGS can revolutionize cancer care, unlocking better patient outcomes and building efficient and effective health systems. The Asia-Pacific(APAC) region is poised to benefit from NGS as the region continues to witness the rising burden of cancer, imposing clinical, societal, and economic burden on the region encompassing 60% of the world’s population. Implementing NGS in cancer care to enable the delivery of personalized cancer care through tumor profiling of each patient can help policymakers and all stakeholders in the healthcare ecosystem achieve the shared goal of improving outcomes for cancer patients and reduce economic and societal burden of cancer for patients in the region.

Access to NGS-based tumor profiling is heterogenous across the APAC region due to diversity in healthcare infrastructure and access to policies, local practice guidelines, and patients’ socioeconomic status. South Korea is one the few countries that have made progress in reimbursing NGS-based tumor profiling to some extent, however, certain access barriers still exist. To overcome NGS access barriers for cancer patients in Korea, a fit-for-purpose Value Assessment Framework(VAF) for NGS-based tumor profiling is critical to comprehensively evaluate NGS. The Asia Pacific Medical Technology Association(APACMed), the only regional trade association and voice of the medical devices and in-vitro diagnostics industry has developed the first APAC policy paper titled, “Advancing Patient Access to NGS for Cancer in APAC: Key considerations and a value assessment framework” to propose a VAF as a practical tool to comprehensively assess the value of NGS-based tumor profiling while capturing perspectives from healthcare ecosystem stakeholders. This proposed VAF encompasses the benefits of NGS that extend beyond clinical domains, into economic and societal domains.

Burden of cancer in South Korea and the role of NGS to address these challenges

From 2004 to 2023, Korea observed a surging economic cost of cancer, with medical cost due to cancer increasing from US$ 1.2 billion to US$ 9.2 billion. In 2017, the Korean government began to provide selective health insurance coverage so that NGS could be used to diagnose ten common cancers. Since then, the scope of reimbursement has widened to all solid cancers. NGS tests have therefore become more affordable in Korea, however, making them a routine part of clinical practice remains a challenge due to the complex infrastructure and specialized expertise needed, and its relatively long turnaround times compared to conventional tests.

In 2021, Korea initiated its fourth National Cancer Control Plan(NCCP) for 2021-2025, and the national cancer screening rate(targeting stomach, liver, colorectum, breast, and cervix uteri cancers) has increased to around 50%. With some level of NGS reimbursement, Korea has a lower mortality-to-incidence (MIR) compared to territories in APAC without NGS reimbursement, and patients who opted for NGS testing experienced more favorable survival outcomes compared to those who did not. In Korea, NGS tumor profiling has reduced the cost per patient per year for advanced non-small cell lung cancer(NSCLC) and advanced colorectal cancer patients by 10% for those using NGS versus single gene tests. With economic benefits as such, full inclusion of NGS in cancer is much anticipated for.

Collaborating to advance access and the reimbursement landscape of NGS in South Korea

Across the APAC region, it is observed that access to NGS is hindered by fragmented regulatory, reimbursement, and clinical implementation policies. These individual bodies often function in siloes, resulting in a lack of coherence across approval, reimbursement, and implementation policies for NGS. In Korea, reimbursement for in-territory tests allow ‘pan-cancer’ indications but regulatory approval is still done on a ‘per indication’ basis. Additionally, no regulatory or reimbursement pathways exist for overseas tests. The National Evidence-based Healthcare Collaboration Agency(NECA) and the Health Insurance Review & Assessment(HIRA) are looking into ways to refine existing frameworks that enable access to NGS. However, recent decisions to reduce reimbursement for solid cancers from 50% to 20%(excluding NSCLC), underscore the repercussions of insufficient local evidence.

APACMed remains committed to work with our partners including KMDIA along with stakeholders in South Korea to engage and understand the current barriers to access NGS to help for the upcoming NCCP, through inclusion of NGS tumor testing in national health agendas, policies, and programs. For successful implementation, key stakeholders including clinicians and pathologists will be vital to advising payers on the full value of NGS.