Pharma 2021 (formerly eyeforpharma Barcelona)

Oct 12, 2021 - Oct 22, 2021, Digital Conference, Exhibition & Networking

Meet decision-makers from across the entire value chain, with 2000+ leaders from commercial, marketing, digital, patient engagement and advocacy, clinical development, medical affairs, market access, RWE and more. You can’t miss it.

Keeping it real: How data is driving healthcare reform in China 

China’s healthcare market is ripe for those capable of helping it capture the vast potential of real-world data

China’s pharma market is booming and full of innovation. Already set to become the world’s most lucrative, COVID-19 has accelerated the drive towards improving healthcare outcomes. 

Not surprisingly, the major pharmaceutical companies are already testing their digital commercial engagement models in a $232-bn market, which is expected to soar to $574-bn by 2022, according to the New Jersey-based international fund group PGIM Investments. 

As China’s government continues to restructure the industry with its Healthy China 2030 programme, it is now accelerating efforts to apply real-world data (RWD) and real-world evidence (RWE) to outcomes-based reimbursement. 

Amy Wang, a China and Asia-Pacific regional expert at EY Life Sciences Commercial Access practice, explains why: “Globally, the use of real-world data to inform various aspects of drug development and policy decisions are well established. However, in China to date, there has been a lack of practical experience using RWD to support pricing and reimbursement decisions.” 

What this has meant, according to consultancy L.E.K., is that historically innovative medicines have struggled to make the list of drugs that China’s government is willing to reimburse for. However, applying RWD and RWE will offer pharma companies operating in China “new resources to complement their internal data and other traditional datasets, and [they] will be able to design pricing strategies for product launch and market access”. 

With the emphasis on improving patient access to innovative medicines in general, companies could begin to develop RWE strategies earlier in the clinical development phase. “Not only can RWD support regulatory submissions and label expansion in China, but also aid patient assistance programmes post-launch, and subsequent reimbursement and pricing discussions,” Wang says. 

She adds: “Because RWD helps to predict drug use rates for the duration of a disease, it can confirm the clinical value as well as demonstrating cost and resource-saving potential.” 

The Chinese state is set to launch a large-scale, post-market, re-evaluation system using RWD and evidence to support more post-market research of domestic drugs and RWD is expected to become integral in reimbursement systems and decisions on resource allocation.

2020: A remarkable year for RWE 
First attracting widespread attention in 2010 with research into traditional Chinese medicine, the Chinese research community has since increasingly embraced RWE, adopting broadly the same definition as its international counterparts. 

As outlined in a 2018 British Medical Journal review - Real World Evidence: experience and lessons from China  study designs are “generally classified into three categories: pragmatic clinical trials, which may or may not be randomised; observational studies involving prospective collection of data; and observational studies using retrospective administrative databases. Real-world evidence can be used for developing medical products and informing healthcare practice and policymaking.” 

However, the year 2020, says Wang, was “a remarkable one” in China’s RWE development. While government was grappling with the COVID-19 crisis, China’s National Medical Products Administration issued multiple technical guidelines, cementing the Chinese government’s “strong willingness” to clarify the definitions of RWD and RWE. The guidelines also listed common sources, and situations where they could be applied in clinical evaluation, as well as access and regulatory decision-making processes. 

At a time when China’s government is demanding affordable prices for drugs, and significant cuts from the launch price, it has become clear that more than ever before pharma companies need good data. As L.E.K. points out: “Using RWD, companies can develop a more precise view on the price-adoption relationship to decide on acceptable ranges for launch price and/or reimbursement price, as well as how hard they should be pursuing national reimbursement.”

The NPMA’s official sources of accepted RWD now include:  

  • Hospital information systems (HIS) such as electronic medical records and electronic health records, laboratory information management systems, medical image archiving, and more. 
  • Medical insurance: Data gathered from both basic insurance systems established by government and healthcare institutions, such as patient information, prescription records, payment settlements, as well as claims’ data from private commercial companies.  
  • Patient registries / observational studies: Used mainly to evaluate a product’s safety, efficacy, cost-effectiveness and patient compliance.
  • Natural population cohort data
  • Omics data, which relates to precision outcomes and refers to branches of science that include genomics to proteomics and metabolomics
  • Data gathered through national or regional drug safety monitoring networks, death registries, mobile devices and patient reported outcomes.    

Cooperation and collaboration 
While the government was establishing technical guidelines, on the tropical island of Hainan, two new RWE centres have been established: 

  • In 2020, the Bo’ao Lecheng Real World Data Research and Innovation Centre will develop a framework for RWE generation and carry out RWD collections and evaluation
  • In 2021, the Laboratory of RWD Research and Evaluation was also established to build a real-world data platform to facilitate central government’s approval and post-marketing surveillance of innovative drugs and medical devices.

Cooperation and common activity is already underway in Hainan’s medical pilot zone, which was first established in 2013. Stakeholders such as the NMPA, Hainan Provincial Medical Product Administration and key opinion leaders (KOL) are working to develop RWE research protocols and evaluate the feasibility of different types of studies. These will later be trialled with local hospitals. 

Collaboration to combine the results of overseas clinical trials with local RWE collection is also happening, enabling the assessment of ethnic differences to treatment. “Not only is this accelerating patient access,” says Wang, “it also allows cost-savings for manufacturers which would otherwise need to conduct clinical bridging trials.” 

Meanwhile, ChinaREAL, a national RWE consortium, is being established to bring together doctors, researchers, scientists and policymakers to optimise RWE generation and use in China.

A burgeoning market 
Described by consultant Deloitte as “the world’s largest digital transformation sandbox”, China’s pharma market is well worth the effort. 

Among other elements which make China conducive to the testing of new healthcare products and new digitally reimagined commercial engagement models, is that it is one of the leading countries on digitalisation in all aspects of life – from e-commerce to mobile payments and telemedicine. The country is spending to transform its digital ecosystem, committing to being the leader in 5G development and application. 

Traditionally, Chinese pharma companies relied on reps to drive sales and collect market information, and unsurprisingly, says Deloitte, this resulted in a lack of targeted engagement and a low marketing return on investment. As the number of approvals of their drugs rose, the companies came under pressure to cover costs and up profits.  

Following the example of the US and of China’s own dynamic retail industry, they are now partnering with tech companies to leverage big data – the use of RWE and RWD has been introduced in a major way for designing pricing strategies, for product launches and market access.

The edge of possibility
Cancer is a prime focus for Chinese biotech research since the country accounts for half the world’s incidence of the disease. Here China’s growing RWE experience comes into play. Its massive quantities of data, and the greater willingness of Chinese consumers to share it online compared to the West, underpin China’s biotech potential, the Wall Street Journal quotes Lachlan Towart, global healthcare analyst at international investment bank UBS, as saying. 

An exciting area is in the emerging field of precision medicine, Towart states in the report, in which genetic, biological and lifestyle data are analysed by algorithms to create bespoke healthcare plans for users: “Through online apps, companies such as Shenzhen-based iCarbonX can send users precise daily instructions on everything from what to eat based on genomic data, to how to ward off a hereditary risk of cancer. 

“China’s exploding prowess in Artificial Intelligence – as it pursues a state-driven mission to be the global AI leader by 2030 – will fuel the precision-medicine transformation, which relies on crunching vast amounts of genomic data to offer tailor-made medical solutions.” Helping in this field is the fact that top Chinese research talent is returning home, he adds. 

There are also opportunities to make use of RWE in the ancient market for traditional Chinese medicine (TCM), says Adelaide University Professor Mark Hutchinson, the entrepreneurial president-elect of the industry body Science Technology Australia. 

It was Hutchinson’s research fields, at the interface of neuroscience, immunology and pharmacology that led him to work with the TCM division of a Chinese state company. He explains why: “In and around the fundamental science of brain immunology, there is a lot of evidence to suggest that various traditional Chinese medicines and their theoretically active components may act via the immune system to deliver benefits.”

The company was looking to scale its ‘natural’ products to Western markets through a process of standardisation. This required numerous inter-related and circular steps - everything from identifying the active constituents to verifying the clinical efficacy of the preparation and the synthesis of novel small chemical entities that act in the same fashion as the TCM to allow for safeguarding and broader registration of the product and its indication. 

This is where RWE could help. “Just being able to align modern, small chemical entities or biologics with TCM actions or indications would provide some highly valuable real-world evidence that would open market access,” Hutchinson says. 

Although the jury is still out, Hutchinson believes there is a “huge opportunity” for Western pharma to apply real-world evidence to the ancient practice of traditional medicine, which accounted for 40% of the pharmaceutical market in China in 2019, according business intelligence firm InsightSLICE. To succeed, however, will need to understand some of cultural subtleties. As the Australian scientist puts it: “They will need to enter with their IP plus a layer of IQ and EQ”. 

Challenges, of course, remain considerable for a programme as ambitious as Healthy China 2030. Even with China’s huge data and digital advances, there are, says Wang, other hurdles to overcome. Among these:

  • Misconceptions around ‘big data’: Not everybody has bought into the validity of real-world evidence, and common misconceptions include: it is just ‘big data’, it is universally observational, studies do not require ethical review, and it is nothing more than a regulatory requirement. 
  • Immature infrastructure: Medical data in China are from fragmented sources, and top-quality, standardised electronic medical systems are not yet widely implemented in China. 
  • Poor data quality and limited research capabilities. 
  • Data privacy and protection: China is still catching up in terms of data privacy legislation. 
  • But where there are limitations there are also opportunities for big pharma – from educational activities for RWD use with relevant stakeholders and collaborative investments that meet the need for multisource databases, registries and data analytics technologies to lessons in data protection and privacy. 

However, these resources are steadily improving and China, says Deloitte, “is becoming a major growth engine for multinational companies”, increasingly seeking to infuse the business models developed there, into other markets. Crucial to that step is the “development of a market engagement framework to allow co-ordinated exchanges between China and other markets”.

Pharma 2021 (formerly eyeforpharma Barcelona)

Oct 12, 2021 - Oct 22, 2021, Digital Conference, Exhibition & Networking

Meet decision-makers from across the entire value chain, with 2000+ leaders from commercial, marketing, digital, patient engagement and advocacy, clinical development, medical affairs, market access, RWE and more. You can’t miss it.