What manufacturers should know about companion diagnostics access pathways in the Asia-Pacific region

Written by Sudha Sundaram

Recommendations for optimizing access to a drug’s corresponding companion diagnostics (CDx) in Australia, Japan, South Korea, Singapore, Taiwan, and China.  

In the Asia-Pacific (APAC) region, evaluating a CDx for reimbursement remains a relatively new concept in terms of market access, as payers are developing their understanding of drug-CDx pairings and deciding on how best to evaluate them existing health technology assessment (HTA) and reimbursement, or how best to modify them as needed.

To ensure that a CDx required prior to prescribing a drug does not become an obstacle to the access and adoption of the drug, a clear understanding of the market access dynamics for these drug-test pairings is needed.

To enable this and optimize CDx access in the APAC region, the following 4 activities may be key:

  1. Monitor the evolving CDx reimbursement restrictions
  2. Undertake early consultations with relevant local authorities
  3. Partner with local companies in APAC markets
  4. Generate local evidence to increase payer acceptance of CDx testing

Key points to consider for CDx access pathways

From our work in the region, focusing on Australia, Japan, South Korea, Singapore, Taiwan, and China, we have identified the following key points regarding CDx access pathways.

  • Most APAC markets are yet to develop dedicated regulatory and reimbursement pathways for CDx. This means that manufacturers may need to refer to regulations for medical devices or in vitro diagnostics (IVDs) to understand the pathways and evidence requirements for bringing new CDx technologies to market.

    • As exceptions to the above, the regulatory agencies for Japan and Australia – the PMDA and TGA, respectively – have released well-defined regulatory guidelines dedicated to CDx evaluation. In fact, Japan has one of the shortest CDx approval and reimbursement timelines in the APAC region, making it a promising market to prioritize when expanding access for a drug-CDx pairing into APAC.

  • In many markets, regulatory and reimbursement evaluations for the drug and the CDx test are not explicitly linked, and reviews are conducted based on separate submissions (Australia allows exceptions via its “integrated co-dependent submission” pathway, which enables joint drug-CDx evaluations). However, if the drug and CDx submissions are made simultaneously, there are opportunities in most APAC markets for the submissions to undergo parallel regulatory and reimbursement evaluations. Parallel evaluation is recommended by regulators as well as payers, and collaboration between drug and CDx manufacturers can expedite such evaluations.

    • China is currently an outlier, as drugs undergo centralized reimbursement evaluation by the NHSA (China’s reimbursement agency), while CDx are evaluated provincially, even when the corresponding drug that requires CDx has already been listed on the NRDL (China’s national reimbursed drug list). Therefore, coverage for CDx across provinces can vary, based on the comparative clinical benefit of the CDx over existing products and provincial budgets, resulting in heterogeneous levels of CDx access across China.

  • In most APAC markets, drug manufacturers can apply for the reimbursement of a CDx test that is co-dependently with their drug. This allows room for drug manufacturers to influence CDx access alongside or even in the absence of the CDx manufacturer’s involvement in the process (if the drug and the CDx test are manufactured by different entities). However, in Taiwan and Singapore, only key opinion leaders (KOLs), medical societies, or healthcare institutions – but not drug or CDx manufacturers – can apply for reimbursement of CDx. Where public reimbursement is not applied for, the CDx test can still be made available in the market via self-pay or other funding channels once the relevant market authorizations are obtained.

  • Working closely with clinical KOLs is crucial to ensure optimal CDx access and uptake, as KOLs play a key role in regulatory and reimbursement processes for CDx in APAC. Not only are KOLs actively consulted during both regulatory and reimbursement evaluations for CDx, but they can also initiate CDx reimbursement applications in most APAC markets.

  • Reimbursement for CDx in APAC markets is often restricted to a specific utilization of the biomarker test, such as using a test to identify patients who will benefit the most from a targeted therapy for a specific indication. However, in most cases, there are no restrictions on specific brands of kit or methodologies (although exceptions to this have been reported in China).

  • Based on findings from global data, when a drug-CDx pairing undergoes pricing and reimbursement evaluation, the specific data requirements for CDx may be less stringent if the CDx test is co-developed alongside the drug. This is because the clinical utility of the CDx is considered to have been demonstrated within the clinical trial if testing methodologies in the trial and clinical practice are aligned. This has been reported to be the case in Japan and is expected to also apply to other markets in the APAC region.


In APAC markets, national regulatory and reimbursement pathways for CDx are still evolving. While some markets (e.g., Australia and Japan) have consolidated drug and CDx regulatory pathways, in others, CDx reimbursement mechanisms remain unstructured.

ACE, Agency for Care Effectiveness; APAC, Asia Pacific; CSIMC, Central Social Insurance Medical Council (Chuikyo); C2H, Center for Outcomes Research and Economic Evaluation for Health; IVD, In-vitro diagnostic; HIRA, Health Insurance and Review Assessment; CDx, Companion diagnostics; HTA, Health Technology Assessment; MFDS, Ministry of Food and Drug Safety; MHLW, Ministry of Health, Labour and Welfare; MSAC, Medical Services Advisory Committee; NECA, National Evidence-based Healthcare Collaborating Agency; NHIA, National Health Insurance Administration; PMDA, Pharmaceuticals and Medical Devices Agency; TFDA, Taiwan Food and Drug Administration; TGA, Therapeutic Goods Administration

4 activities to optimize CDx access pathways in the Asia-Pacific region 

With the above key takeaways in mind, PRMA Consulting recommends the 4 following activities to optimize access in APAC markets:

  1. Monitor the evolving CDx reimbursement restrictions by tracking published guidelines and recent CDx reimbursement decisions in each market (ideally in the relevant therapy areas) to help understand how drug-CDx pairings can be best positioned for commercial success

  2. Undertake early consultations with relevant local authorities, especially where clinical development of a drug and its CDx has been synchronized; this can help in realizing opportunities to co-ordinate launch as well as reimbursement of drug-CDx pairings

  3. Partner with local companies in APAC markets, for example with local CDx manufacturers, testing service providers, and commercial laboratories, to maximize and expedite the likelihood of access and adoption

  4. Generate local evidence to increase payer acceptance of CDx testing in the targeted population, for example by utilizing clinical trial or real-world registry data to build epidemiological datasets on testing rates and CDx efficiency as well as on clinical outcomes.

As policies and guidelines specific to CDx continue to emerge and evolve in the APAC region, they will require input from all stakeholders to steer their development, and their impact on the access of drug-CDx pairings need to be closely watched.

Supporting your policy, access, value, and evidence needs in the APAC region

As manufacturers seek to maintain value in established markets, and focus grows on emerging markets, the strategic importance of Policy, Access, Value, and Evidence in the APAC region is increasing – and the need for an integrated 360 approach is becoming ever clearer. Our dedicated APAC experts can help you explore current trends and challenges in the region and understand how you can optimize access for your assets in these markets.

Please get in touch for a confidential conversation.

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