Advancing Health Technology Assessment in China: Progress, Challenges, and Future Directions

Introduction

In China, the world’s second largest pharmaceutical market, the role of HTA has evolved significantly over the past few decades, transitioning from an academic exercise to a critical component of policy-making, particularly in the realm of drug reimbursement decisions. China's pharmaceutical market size is projected to reach $191.7 billion in 2024 with an expected cumulative annual growth rate (CAGR) of 7.50% from 2024 – 2032¹driven by increased healthcare spending, an aging population and investments in innovative drug development and biotechnology². This article explores the evolution, current applications, and future challenges of HTA in China, highlighting its growing influence on healthcare policy and its potential to shape the future of the country’s healthcare system.

The Evolution of HTA in China

The origins of HTA in China can be traced back to the 1980s, when Professor Chen Jie of Fudan University introduced the basic concepts of HTA to the country³.These early efforts laid the groundwork for more formal systems for evaluating health technologies. In 2008, the establishment of a dedicated HTA division at the China National Health Development Research Center (CNHDRC) marked a significant milestone³. This division became a key player in supporting health policy decisions, particularly through collaborations with international bodies such as the National Institute for Health and Care Excellence (NICE) International. This division became a key player in supporting health policy decisions, particularly through collaborations with international bodies such as the National Institute for Health and Care Excellence (NICE) International.

The 2010s saw expansion of HTA in China, particularly with the launch of the China Health Technology Assessment Network in 2016. This network, aimed to institutionalise HTA as a foundational tool for achieving national health goals, including the ambitious "Healthy China 2030" program⁴. By 2017, the network had grown to include 37 organisations across China, with HTA embedded as a formal procedure for decisions about drug listing, reflecting the widespread adoption of HTA as a crucial component of health policy.

HTA's Role in Drug Reimbursement Decisions

One of the most significant developments in the application of HTA in China has been its integration into the drug reimbursement process. The National Healthcare Security Administration (NHSA) employs a two-stage appraisal process to decide which drugs are included in the National Reimbursement Drug List (NRDL), which is published once a year⁵.The first stage involves a quick review from an advisory committee of price, efficacy, safety, innovation, and equity. A subset of drugs, mainly new and high-cost medicines, are chosen for full HTA appraisal and price negotiation[7].

This two-stage process, which began in 2017, has significantly impacted drug pricing and access in China. For instance, by 2021, HTA-informed price negotiations had resulted in substantial price reductions, with negotiated drug prices decreasing by an average of 44% to 62%⁵.This has made high-value, innovative drugs more accessible and affordable for the Chinese population, particularly for treatments targeting cancer and rare diseases.

Challenges and Areas for Improvement

Despite early successes, several key challenges and areas for improvement remain in China’s HTA system.

1. Poor Quality Submissions

Many HTA dossiers submitted by manufacturer slack robust design, sufficient local clinical data, or active comparators, leading to biased evaluations. For example, in 2021, over half of the dossiers for innovative drugs lacked clinical data from Chinese populations. Improving submission quality is critical for reliable assessments⁵.

2. Capacity Building

China faces a shortage of trained HTA professionals, with many experts having limited experience. Additionally, the absence of standardised guidelines creates inconsistencies in appraisals. Greater investment in training programs and clearer technical standards are essential to build expertise⁷.

3. Transparency

China's HTA process lacks transparency compared to countries like the UK and Canada, where stakeholders have greater access to appraisal methods and decisions. Currently, stakeholders—including manufacturers, patients, and the public—have limited access to the evidence and methodologies used in HTA appraisals leaving the process relatively opaque. In China, manufacturers often receive only oral feedback, limiting their ability to improve submissions or engage with the process⁵. Additionally, China’s HTA appraisal process is managed by experts designated by the National Healthcare Security Administration (NHSA), the country’s largest healthcare payer, rather than an independent HTA agency⁸.

4. Willingness-to-Pay Threshold

Current thresholds vary widely among key experts, ranging from 0.5 to 1.5 times the GDP per capita for most medicines, with elevated thresholds proposed for childhood diseases, rare diseases, and first-in-class (FIC) medicines. However, there is no consensus on what baseline thresholds should apply, leading to variability in decision-making. Aligning WTP thresholds with international practices while addressing local priorities, such as rare and innovative treatments, will require extensive dialogue and methodological standardisation⁷.

5. Multi-Indication Pricing

China's approach to multi-indication pricing in HTA is evolving. While initially a single pricing model was predominant, there is a growing trend towards more nuanced pricing strategies. The National Healthcare Security Administration (NHSA) is increasingly considering indication-specific pricing, allowing for prices that may vary based on the clinical value and economic impact of each indication⁹. This shift aims to better align drug prices with their therapeutic value across multiple indications, potentially leading to more efficient resource allocation. This is particularly relevant in fields such as oncology, where drugs may be repurposed or used in combination therapies⁸.

Looking Forward: Recommendations and Future Directions

To strengthen HTA in China, national policies must continue evolving to balance payer priorities with the needs of the pharmaceutical industry. For payers, the focus should be on maximizing value for healthcare spending while maintaining affordability. For manufacturers, clearer guidelines and predictable HTA frameworks will ensure efficient market entry and engagement.

Key priorities include refining the willingness-to-pay thresholds to address varying disease burdens and innovation incentives, adopting flexible pricing models for multi-indication medicines, and improving transparency to foster trust and collaboration among stakeholders. Investment in capacity building and international knowledge exchange will also be critical to modernising China's processes.

By aligning HTA practices with global best standards while addressing local challenges, China can ensure that both its healthcare system and pharmaceutical market continue to thrive.

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