2025.4.14

Technology Focus Series: Comprehensive Genomic Panel Test Market Access

In June 2019, Japan’s main reimbursement advisory committee, the Central Social Insurance Medical Council (Chuikyo), recommended the reimbursement of the first comprehensive genomic profiling (CGP) tests in Japan – Chugai’s FoundationOne® CDx Cancer Genomic Profile and Sysmex's OncoGuide NCC Oncopanel System. Since then, five other CGPs have been listed in Japan including, more recently, Otsuka’s HemeSight, which is the first gene panel test for hematological malignancies developed through a collaboration between Otsuka, Ilumina, and the National Cancer Center of Japan. HemeSight’s listing is described in the FY2024 new listings here.

The term CGP is typically reserved for gene panel tests that test for 100 or more different genes / gene mutations. The table below shows the CGPs that are currently reimbursed in Japan as well as some other reimbursed gene panel tests. All the CGP tests and other gene panel tests reimbursed to date in Japan have not received reimbursement for the test kit / system itself, but rather a new technical fee has been established for their use.

For most CGPs, hospitals receive a specific technical fee when they are used to determine treatment after standard of care (SoC) has been completed (or is expected to be completed) or when patients are ineligible for SoC. In that situation, facilities are reimbursed JPY 440,000 (approx. USD 3,064) when administering the test and then JPY 120,000 (USD 836) after an expert panel has convened and the patient is explained the results of the test. The patients would typically pay 20-30% of all costs out-of-pocket. Also, there is typically a rule that patients can only undergo a CGP once.

Most CGPs and other gene panel tests can also be reimbursed as a companion diagnostic (Dx) to determine whether a treatment can be prescribed or not, like other single gene tests. For example, among other things, Chugai’s FoundationOne® CDx CGP can be used to test for an EGFR mutation, the ALK fusion gene, or a BRAF gene mutation to prescribe Giotrif (afatinib), Zykadia (ceritinib), or Zelboraf (vemurafenib), respectively. When the test is used as a CDx, however, a lower reimbursement price applies depending on the number of items being tested for, which ranges from JPY 25,000 (approx. USD 174) to JPY 202,000 (USD 1,407). This is similar to how the reimbursement of other gene panel tests is handled. Again, the patients would typically pay 20-30% of those costs out-of-pocket. Interestingly, it seems that even if the CGP is used as a CDx to determine initial treatment, the difference in the CDx reimbursement (JPY 25,000 to JPY 202,000) and the CGP reimbursement (JPY 560,000) can be claimed by hospitals if they convene an expert panel after initial treatment has been completed and explain the test results to patients.

Exact Science’s Oncotype DX Breast Recurrence Score® Test, which is used to assess the likelihood of breast cancer recurrence in patients with early-stage, hormone receptor-positive, HER2-negative breast cancer and to determine optimal treatment, has a different fee associated with it that is slightly less than the testing fee for other CGPs. Also, the reimbursement price for GenMineTOP CGP system and HemeSight when used as a CDx was not found (It may be that kind of use is not permitted for those tests yet.)

Concerning other CGP manufacturers, it seems that Illumina’s TruSight Oncology CGP system has not been approved or reimbursed in Japan yet, but that Illumina submitted for manufacturing and marketing approval for it in May 2022. SB Tempus also recently agreed to acquire all shares of Konica Minolta Real, which markets the GenMineTop CGP in Japan. Activities of other CGP companies in Japan like Caris Life Sciences could not be confimed, but it seems like some companies such as Natera are collaborating with partners in Japan to develop evidence for personalized gene testing.

Establishment of reimbursement of gene panel testing in Japan in June 2019 was also tied to the establishment of a genome information management and usage system. Under this system, the results of gene panel tests must also be submitted to the Center for Cancer Genomics and Advanced Therapeutics (C-CAT), a division of the National Cancer Center. At present there are 13 “core” hospitals that participate in the C-CAT system that play a central role in the C-CAT – in addition to be able to convene an expert panel. Then there are also 32 “base” hospitals that can also convene expert panels and collaborate with core hospitals for research. Lastly, there are about 235 “collaborative” hospitals that are able to provide CGP testing in Japan.

According to the C-CAT site (and other MHLW materials), as of 28 February 2025, 97,965 test results had been submitted to the C-CAT system. It seems that over two-thirds of the test results submitted to date have been for Chugai’s FoundationOne® CDx CGP, but recently the percentage of submissions that comprises other tests has been increasing - including Chugai’s FoundationOne® Liquid CDx CGP. The tumor types the tests were conducted for vary a lot, but it seems like most have been submitted for pancreatic, liver, and gall bladder cancers (34%), digestive tract cancers (22%), breast cancer (7%), and lung cancer (6%). It seems, however, that only about 45% of submissions have led to a treatment option being presented by an expert panel and among those about 70% have been for the use of an approved / reimburse treatment regiment, while the remaining have been for treatment administered through a clinical trial or for compassion use, for example.

Patients who undergo cancer gene panel testing are also asked whether they agree to their data registered in C-CAT being provided to third parties for the purposes of academic research and drug development (i.e., secondary use) and it seems that nearly 100% of patients have agreed to that kind of usage which is used by the C-CAT and its affiliates for research on treatment.

Closing thoughts:

Japan was quick to establish the C-CAT to allow for secondary use of data as part of reimbursement which is no doubt a valuable resource for considering optimal treatment. In fact, it seems that about 70 research groups and around 10+ manufacturers have used the data (click here). In terms of reimbursement, it is unclear how reimbursement of CGPs in Japan “stacks up” to reimbursement in other developed countries like the US, UK, Germany, and France. However, there is a clear pathway for the reimbursement of CGP for usage after initial treatment and an option for usage as a CDx for determining initial treatment as well. Findings from Matsubara et al. (2023) suggest that “CGP testing before SoC for patients with advanced solid tumors may be clinically beneficial to guide the subsequent anticancer therapies”. Moreover Tang et al. (2023) suggest that CGP testing before SoC in Japan “may improve patient outcomes in various cancer types with a limited and controllable increase in medical costs”. So there seems to be a good case for using CGP tests earlier than later. Nevertheless, continual evidence to support that kind of use is probably needed – especially since CGPs cover a wide range of tumor types. Please contact us if you are interested in developing evidence on the benefit, utility, cost-effectiveness of CGPs and other gene panel tests for Japan.

Comprehensive Genomic Profiling (CGP) and Other Gene Panel Tests Reimbursed in Japan (as of April 2025)

*CGP reimbursement (other than OncoType DX) includes reimbursement for the test (D006-19) and the test results fee (B011-5). CDx reimbursement depends number of items being tested for in relation to the the treatment being considered.
**CRC: colorectal cancer, NSCLC: non-small lung cancer, BCa: breast cancer, PCa: prostate cancer, Mel: melanoma, TCa: thyroid cancer, CCA: (gall bladder cancer), OCa: ovarian cancer, Hem: hematologic cancers including lymphoma, leukemia, and multiple myeloma.

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