政策提言「がんゲノム医療」への患者アクセスの改善に向けて
日本医療政策機構（HGPI）

Policy Recommendations
Improving Patient Access to Genomic Cancer Medicine
HGPI

2023年 8月 10日（木）Thursday, August 10th, 2023

OVERVIEW
Genomic cancer medicine was viewed as an advanced form of medical treatment whenComprehensive Genomic Profiling (CGP; or cancer gene panel tests) was granted healthinsurance coverage in 2019. Since then, people serving in clinical settings haveaccumulated experience handling this form of treatment. We are now at a stage to makegenomic cancer medicine a form of technology from which anyone should be able tobenefit. To achieve this, we should improve patient access to deliver genomic cancer
medicine more broadly to the public.
From the perspective of patient access opportunities, policy challenges with respect todelivering genomic cancer medicine may be sorted into three categories:
A: Constraints related to human resources in medicine (shortages of specialized
personnel, etc.)
B: Constraints related to genetic testing (restrictions on the timing/frequency of CGP
that can be conducted)
C: Constraints related to geographic factors or information (lack of easy access to testing
facilities and clinical trials)
We must take wherever possible actions to address each issue one by one, and expand
opportunities for patients to access genomic cancer medicine.
Based on these understandings, Health and Global Policy Institute (HGPI) offers thefollowing recommendations:
RECOMMENDATION I: Streamline operations and secure human resources
In view of the further spread of genomic cancer medicine, streamline operations
thoroughly, and adopt systems to secure human resources commensurate withworkloads.
RECOMMENDATION II: Review genetic testing practices including how tests are
performed
Based on the accumulated clinical experiences, revise the genetic tests and related
practices to meet the needs of those serving in clinical settings, and to suit thecharacteristics of each type of cancer.
RECOMMENDATION III: Improve patient access to testing centers and clinical trials
While paying attention to the constraints and disparities related to geographic
factors/information, make drastic improvements to patient access to testing centersand clinical trials.
It is also important to take active steps to build public awareness toward genomic
cancer medicine, and to improve post-graduate education for physicians.
HGPI strongly hopes that these recommendations be utilized in developing further
policy measures for genomic cancer medicine, and patient-centered healthcare.
1

TABLE OF CONTENTS
0. INTRODUCTION

3

Column 1 – Overview of HGPI’s September 2022 policy recommendations for
precision cancer medicine

1. OVERVIEW: WHAT IS GENOMIC CANCER MEDICINE
1.1 What is genomic cancer medicine?

55Column 2 –Precision cancer medicine and genomic cancer medicine
Column 3 –Comprehensive Genomic Profiling (CGP; cancer gene panel tests)

1.2 Recent trends in genomic cancer medicine

7

1.3 Key policy issues of genomic cancer medicine (overview)

11

2. POLICY CHALLENGES
2.1 Summary

1212

2.2 Policy challenges by key area
A: Constraints related to human resources in medicine

14

Column 4 – Expert Panels (EPs) and related administrative workloads
Column 5 – Tasks related to genomic cancer medicine at cooperative
hospitals for genomic cancer medicine and other facilities
Column 6 – Certified genetic counselors (CGCs) : roles and shortages of staffs

B: Constraints related to genetic testing
C: Constraints related to geographic factors or information
2.3 Awareness levels toward genomic cancer medicine among patients,
their families, and attending physicians

24

Column 7 – A flowchart of challenges from testing to treatment

3. POLICY RECOMMENDATIONS
26
3.1 Key points of the three recommendations
26
3.2 Recommendation I: Streamline operations and secure human resources 28
Column 8 – An initiative to introduce online counseling

3.3 Recommendation II: Review genetic testing practices including how
tests are performed
3.4 Recommendation III: Improve patient access to testing centers andclinical trials

34
37

Column 9 – Conducting low-tech, low-cost Decentralized Clinical Trials (DCTs)

3.5 Actively raise public awareness, and expand education and training forcommunity hospitals
43
4. CONCLUSION44ACKNOWLEDGEMENTS

2

0. INTRODUCTION
When genomic cancer medicine was first introduced, it was viewed as a particularly
advanced form of medical treatment. However, several years have now passed sinceComprehensive Genomic Profiling (CGP; or cancer gene panel tests) was granted healthinsurance coverage in 2019, and those serving in clinical settings are starting to gain
experience with this form of medicine.
Given current circumstances, we believe it is now the time to make further
improvements to patient access to genomic cancer medicine so it can be delivered
more broadly to the public. It should be recognized as a form of technology from which
everyone should be able to benefit.
As we expand genomic cancer medicine, multiple policy issues must be overcome.
While proactively advancing R&D on pharmaceuticals that target genetic mutations1
and related efforts, it will be important to address issues preventing the disseminationof genomic cancer medicine one by one, from the perspective of expanding access
opportunities for patients.
As for precision cancer medicine, Health and Global Policy Institute (HGPI) launched
an initiative in FY2021 (“Project for Considering the Future of Precision Medicine with
Industry, Government, Academia, and Civil Society”), and has made expert hearingsand conducted surveys to examine the issue. Based on our findings, we offeredcomprehensive policy recommendations in September 20222 (see Column 1).
For the second phase of this project, we conducted additional, expansive surveys
and hearings with our focus on measures for better patient access to genomic cancer
medicine.
This report describes current circumstances and sorts issues for genomic cancer
medicine based on those surveys and hearings. After categorizing policy issues into
three key areas, we have also compiled recommendations from the perspective ofimproving access opportunities for patients.
We strongly hope these recommendations will further patient-centered healthcare
and be useful when mounting policy responses for genomic cancer medicine in the
future.

1

In addition to genetic mutations, this includes other changes such as amplifications, deletions,and fusions. (This document uses “genetic mutations, etc.” depending on the context.)
2[Policy Recommendations] Furthering the Development of Precision Cancer Medicine —Proposals
for Effective Policy Changes Based on Key Characteristics of Precision Medicine in Cancer
Treatment— (September 20, 2022) (https://hgpi.org/en/research/ncd-pm-20220920.html)
3Column 1 – Overview of HGPI’s September 2022 policy recommendations for
precision cancer medicine
Personalized cancer medicine (precision medicine), in which treatment is tailored
to individuals in accordance with the genetic mutations and other characteristics oftheir cancer, is expected to play an important role in the future. In order to further
develop this, it will be necessary to overcome policy issues in various areas including
healthcare access, human resource development, R&D, regulatory approval andinsurance coverage, and patient support.
To effectively address these issues, it will be vital to fully take into account thethree key characteristics of precision cancer medicine, namely (a) the number ofindications is still quite limited; (b) it involves the use of genetic information; and (c)testing and treatment tend to be expensive.
In recognition of these issues, HGPI offered the following recommendations in a
proposal presented in September 2022.
RECOMMENDATION I: Aggregate medical resources (human, equipment,
information)
To effectively allocate human resources and aggregate knowledge, a “hub-andspokes” network should be developed across all areas, including healthcare delivery
systems, human resources, research and clinical trials, and patient support
measures. When doing so, proactive steps to adopt information andcommunication technology (ICT) and to make effective use of online services should
be taken to streamline the aggregation of information and medical resources.
RECOMMENDATION II: Manage genetic information appropriately
While establishing data repositories for genetic information, legislation3
prohibiting discrimination based on genetic information should be enacted andpublic awareness activities should be conducted.
RECOMMENDATION III: Revise the use of precision cancer medicine from healtheconomics and scientific perspectives
Regulatory approval, health insurance coverage, and other conditions governing
the use of precision cancer medicine should be revised to be made more scientificand rational in a manner that complements the key characteristics of precisioncancer medicine and practical needs in clinical settings.

3

After these recommendations were presented, a bill to promote genomic cancer medicine (the“Bill on the Comprehensive and Systematic Promotion of Measures to Ensure the Public Can Access
High-Quality, Suitable Genomic Medicine with Peace of Mind”) was passed in June 2023.
4

1. OVERVIEW: WHAT IS GENOMIC CANCER MEDICINE
1.1 What is genomic cancer medicine?
Genomic cancer medicine is a form of cancer medicine—they examine cancer cellsof an individual undergoing treatment using Comprehensive Genomic Profiling (CGP;or “cancer gene panel tests”) to identify the sections of genes that are mutated, andselect and administer drugs that are particularly effective on those mutated genes
and molecules (“molecularly targeted drugs”). (For more details, please see Column
2 and Column 3.)
It is understood that cancer medicine cannot be clearly divided into genomic
cancer medicine and others—rather, it is a combination of various testing andtreatment options according to the patient’s condition. For the sake of convenience,
however, this document organizes policy challenges related to genomic cancer
medicine with a focus on conducting CGP followed by providing treatment that is
appropriate for the genetic mutations detected.
Column 2 – Precision cancer medicine and genomic cancer medicine
In addition to the three most common forms of treating cancer, namely (1) surgery,(2) radiation therapy, and (3) chemotherapy, treatment options have increased inrecent years to include items like (4) cancer immunotherapy, which is also known as
immuno-oncology.

In conventional cancer drug therapy, cancers are usually perceived in terms of theaffected organ, and drugs are administered with the expectation they will be effective
5

for that type of cancer. In contrast, precision cancer medicine focuses on genetic
mutations, etc. to narrow the focus of treatment to the level of the individual. It has
attracted a lot of attention in recent years.
Furthermore, generally speaking, genomic cancer medicine is often used to refer toa field of precision cancer medicine, particularly that in which CGPs are performed at
the testing stage.
Column 3 – Comprehensive Genomic Profiling (CGP; cancer gene panel tests)
Generally, cancer gene tests performed in precision cancer medicine aim todetect one or more genetic mutations that can be effectively targeted by aparticular molecularly-targeted drug (or, when said drugs will result in side effects).
Because these tests use diagnostic agents that are paired with the molecularlytargeted drugs, they are called companion diagnostics, or CDx. CDx are currently
being utilized in real-world clinical settings for certain types of lung or breast
cancer.
In contrast to this, in genomic cancer medicine, which aims to detect the genetic
mutations in a more comprehensive manner, Comprehensive Genomic Profilings(CGPs; or “cancer gene panel tests”) are conducted to analyze multiple (hundreds)of genes simultaneously. In addition to tissue from tumors, these panels can use
blood (liquid biopsies) to detect circulating tumor DNA (ctDNA), which is cancer cell
DNA that has leaked into the bloodstream due to causes like cell death. (See table.)
Test nameComprehensive Genomic
Profiling (CGP)

Genestargeted
124

Material
Names of tests with healthanalyzed
insurance coverage4
Tumor ・OncoGuide™ NCC Oncopanel
tissueSystem (NOP)

324

Tumor
tissueBlood[Reference]
Companion diagnostics
(CDx)

74

Blood

1 to manyTumortissue or
Blood・FoundationOne® CDx (F1CDx)
comprehensive genomic
profiling assay
・FoundationOne® Liquid CDx(F1LiquidCDx) comprehensive
genomic profiling assay
・Guardant 360(Various diagnostic agents5)

4

There are also a number of tests that have yet to receive insurance coverage such as Genmine
TOP (which has received regulatory approval), and Illumina TruSight Oncology 500 (which iscurrently undergoing review).
5

For examples, please refer to “Information regarding companion diagnostics and related items”(https://www.pmda.go.jp/review-services/drug-reviews/review-information/cd/0001.html). F1CDx
and F1LiquidCDx are also being used as companion diagnostics.
6

Furthermore, to ensure that people can access high-quality care throughout
Japan, hospitals specializing in genomic cancer medicine have been assigned one ofthree designations such as “designated core hospitals for genomic cancer medicine.”
Currently, a total of 251 facilities have received designations (see Figure 1).6,7
Figure 1: Types of hospitals providing genomic cancer treatment and number offacilities
Name

Main functions(1)

Designated core hospitals forgenomic cancer medicine(2)

Designated hospitals forgenomic cancer medicine(3)

Cooperative hospitals forgenomic cancer medicine

Leads the way in genomic cancer
medicine(Conducts expert panel reviews)
Makes independent decisions
regarding treatment strategies(Conducts expert panel reviews)
Provides treatment while coordinatingwith (1) and (2)Numberoffacilities
13

32

206

1.2 Recent trends in genomic cancer medicine
In June 2019, a CGP was granted insurance coverage in Japan for the first time,
and those serving in clinical settings are gradually building experience with genomic
cancer medicine. The fourth-term Basic Plan to Promote Cancer Control Programs(approved by the Cabinet on March 28, 2023) also states, “further promote genomic
cancer medicine.”8 (See Figure 2 for a history of events.)

6“Designated core hospitals for genomic cancer medicine, etc. in the genomic cancer treatment
provision system: List of facilities” from the MHLW. (as of August 1, 2023.
https://www.mhlw.go.jp/content/000928433.pdf.)
7

To treat cancer, there are 4 types of facilities classified as “core hospitals for coordinated cancercare” throughout Japan (456 facilities total). Details are provided below (as of April 1, 2023).
(1) Prefectural core hospitals for coordinated cancer care: 51 facilities(2) Regional core hospitals for coordinated cancer care: 357 facilities(3) Core hospital for coordinated cancer care for specific cancer type: 1 facility(4) Regional hospitals for cancer care: 47 facilities(MHLW. “What are core hospitals for coordinated cancer care?”https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/kenkou/gan/gan_byoin.html)
8

In addition, the "Basic Policies for Economic and Fiscal Management and Reform 2023" (approvedby the Cabinet on June 16, 2023) also states that they should promote cancer control measures,such as implementing cancer gene panel tests at appropriate times (https://www5.cao.go.jp/keizaishimon/kaigi/cabinet/honebuto/2023/decision0616.html).
7

Figure 2: History of the introduction and dissemination of genomic cancer
medicine (2017-Present)
Yr. Mo.
Item2017 3-6 Roundtable Consortium on
the Promotion of Cancer
Genomic Medicine (Fourmeetings held; reportpresented June 2017)

2018

6

Guidance for Cancer
Treatment Based on Gene
Panel Testing Using NextGeneration Sequencers (1stedition)2

Establishing DesignatedHospitals for Genomic Cancer
Medicine, etc. (Revised
several times since initialpresentation)
Center for Cancer Genomics
and Advanced Therapeutics(C-CAT) establishedCouncil for Consortium on
the Promotion of Cancer
Genomic Medicine (Fourmeetings held by March
2021)
CGP granted insurance
coverage for the first time

6

8

2019

6

2020

3

2022

3

9

2023

3

Key organizations
MHLW

Notes
Discussions to determine
basic policy direction

Japanese Society of
Medical Oncology,
Japanese Society ofClinical Oncology,
and the JapaneseCancer Association
MHLW

Provided rationale for the
principle of conducting
CGP tests “after standard
treatments”

National Cancer
Center Japan

This organization
aggregates and utilizes
genome test information

Established centers forgenomic cancer medicine

MHLW

MHLW

Guidance for Cancer
Treatment Based on Gene
Panel Testing Using NextGeneration Sequencers (2ndedition) (Edition 2.1 releasedin May)Regarding Conditions forConvening Expert Panels;
Details for Conditions forConvening Expert Panels
Action Plan for Whole
Genome Analysis 2022

Japanese Society of
Medical Oncology,
Japanese Society ofClinical Oncology,
and the JapaneseCancer Association
MHLW

Basic Plan to Promote

MHLW

MHLW

8

Genomic cancer
treatments begin in
earnestRecommended more
flexibility in the timing of
CGPs

Provided conditions for
simplified expert panels
As for genomic cancer
medicine, (i) targeted
patients with intractable
cancers, and (ii) provided
broad guidance on topics
like the roles of data
centers and testing
centers; ethical, legal, andsocial issues (ELSI); andpatient and public
involvement (PPI)
While further promotingCancer Control Programs(Fourth term) (in effect until
March 2029)

6“Bill on the Comprehensive Parliamentaryand Systematic Promotion of Association for
Measures to Ensure theGenomics9
Public Can Access HighQuality, Suitable Genomic
Medicine with Peace ofMind” passed

genomic cancer
medicine, it covers many
items like (i) establishinga healthcare provisionsystem and (ii) reviewing
existing systems,
including the timing of
CGP
Covers broad discussion
points including (i)establishing an R&D
system, (ii) bioethics
considerations (iii)
prohibiting unfair
discrimination, etc., andprovides for theformulation of basic
plans to promotemeasures

The number of CGPs being conducted is gradually increasing. From June 2019 toJune 2023, the total number of entries registered at the Center for Cancer Genomics
and Advanced Therapeutics (C-CAT)10 reached 57,000 (Figure 3).
Figure 3: Cancer gene panel tests (CGPs) registered at C-CAT (June 2019-June 2023)

Source: Center for Cancer Genomics and Advanced Therapeutics（C-CAT）”CGPs
registered at C-CAT (monthly data)”（https://for-patients.ccat.ncc.go.jp/registration_status/）
9

A parliamentary association for the development of a social environment to promote appropriate
genetic medicine.
10

An institution that aggregates, stores, and utilizes medical information and genome sequence
information gathered using cancer genome analyses from each patient. (https://for-patients.ccat.ncc.go.jp/)9However, genomic cancer medicine has yet to be sufficiently disseminated to reachall people with cancer and, depending on the cancer type, there are major differencesin how it is handled.
For example, among the 380,000 people who died of cancer in FY2021, over half ofthem were likely to have been candidates for genomic cancer medicine, but onlyaround 14,000 CGPs were conducted that year.11
Furthermore, in most cases where CGPs are performed, treatments that match
patients’ genetic mutations (e.g. the administration of approved drugs, joining clinical
trials) are not ultimately selected.12 Even when clear CGP results have been obtained,
the majority of patients continue to select standard therapies or other treatments.

11“The 113th HGPI Seminar – Current Circumstances and Issues in Precision (Genomic) Cancer
Medicine.” (March 2, 2023. Lecturer: Dr. Atsushi Otsu. https://hgpi.org/en/events/hs113-1.html.)
12

While the rate at which patients select a drug or other therapy applicable to their genetic
mutation after CGPs is gradually increasing, such cases still only account for around 9.4% of patients(based on the 30,822 cases of expert panels from June 2019 to June 2022).
10

1.3

Key policy issues of genomic cancer medicine (overview)

Viewed as an advanced form of treatment, genomic cancer medicine was utilized
in a limited manner when it was first introduced. Now that several years have passed
since it was granted insurance coverage, those serving in real-world clinical settings
have steadily built experience with this form of medicine. We are now at a stage tomake genomic cancer medicine a form of technology from which anyone should be
able to benefit. We should deliver genomic cancer medicine more broadly to the
public by improving patient access.
There are a wide range of policy issues that must be overcome in order to further
promote cancer genome medicine. While many of these issues are common to those
faced by cancer medicine in general, there are also many issues that are unique togenomic cancer medicine. For example, while various departments and healthcare
facilities are facing shortages of cancer treatment specialists in addition to general
shortages of specialized personnel, the field of genomic cancer medicine also faces
significant challenges in the form of expert panel workloads and shortages ofcertified genetic counselors (CGCs) (Figure 4).
Figure 4: Key policy issues of cancer medicine and genomic cancer medicine(Items in brackets are unique to genomic cancer medicine)Issues for cancer medicine
Issues for genomic cancer medicine

Cancer prevention and screening
Specialist personnel shortages (quantity)
Specialist personnel shortages (quality)

Delays in R&D and regulatory approval[Workloads of expert panel duties][Shortages of certified genetic
counselors (CGCs)][Insufficient knowledge regarding
genomic medicine among attending
physicians][Few laboratories have the capacity toproperly extract specimens for CGPs][Few drugs that match genetic
mutations]

Restrictions on testing methods, etc. due to the [Restrictions on timing/frequency of
medical service fee scheduleCGPs]
Low number of clinical trials
Access to clinical trial information (real time information is insufficient)
Limits on geographic access to clinical trials (particularly for rural areas)
Citizen/patient literacy[Insufficient knowledge regarding
genomic cancer medicine]
Ethical, legal, and social issues (ELSI)[Discrimination based on genetic
information][Effects on blood relatives and otherissues unique to genetic disorders]Patient and public involvement (PPI)11

2. POLICY CHALLENGES
2.1

Summary
As described in the previous section, the policy issues that must be resolved tofurther promote genomic cancer medicine span a broad variety of items, which we
can rearrange in three broad categories13 to focus on patient access opportunities
as follows (Figure 5).14
A: Constraints related to human resources in medicine
B: Constraints related to genetic testing
C: Constraints related to geographic factors or information

Figure 5: Issues facing genomic cancer medicine from the perspective of patient
access opportunities (Overview)

A: Constraints related to humanresources in medicine (shortagesof specialized personnel)
B: Constraints related to genetic

C: Constraints related totesting (restrictions on thegeographic factors or information

timing/frequency of CGP)

(lack of easy access to testing
facilities and clinical trials)

A: Constraints related to human resources in medicine (shortages of specialized
personnel, etc.)
Deploying genomic cancer medicine effectively requires expanding humanresources in terms of both quantity and quality. In addition to the current lack of
manpower, as genomic cancer medicine gradually becomes more common, thenumber of CGPs being conducted is increasing rapidly compared to when it was
first introduced. This is exacerbating the manpower shortage.
B: Constraints related to genetic testing (restrictions on the timing/frequency of CGP
that can be conducted)
13

There are situations in which certain policy issues appear to be related to more than one of thethree categories.
14

As the focus of this report is improving patient access opportunities, it will not explicitly addresscertain items included in “Key policy issues of cancer medicine and genomic cancer medicine” suchas “R&D,” “Ethical, legal, and social issues (ELSI),” and “Patient and public participation (PPI).” Itgoes without saying that it will be vital to resolve issues in these areas in a simultaneous manner inorder to achieve better genomic cancer medicine for cancer patients.
12

Right now, the medical service fee schedule only provides coverage for one CGP
per lifetime, and in principle only after standard treatments have been completed.
This means that in the clinic, it is not always possible to provide the necessary
tests at the necessary times. This is resulting in cases in which patients face more
limited options with regards to receiving genomic cancer treatment.
C: Constraints related to geographic factors or information (lack of easy access totesting facilities and clinical trials)
The presence of constraints related to both geography and information ishindering cancer patient access to testing facilities and clinical trials where they
can receive genomic cancer treatment. Voices sharing this opinion are particularly
strong from healthcare institutions in rural areas.
It will be necessary to resolve policy challenges such as those represented by A
through C above, starting from wherever possible, and expand patient access
opportunities to genomic cancer medicine.15
In the following sections, we will take a more detailed look into each area.

15

We must note that improving patient access and expanding genomic cancer medicine does notnecessarily lead to a rosy future for the patients. For example, CGPs may find that (i) a patient does
not possess genetic mutations that can be targeted for treatment with genomic cancer medicine, orthat there is no approved drug or other treatment that is suitable for them; or (ii) a patient has
genetic mutations that are inheritable (“genetic disorders”). In such cases, their blood relatives may
also be at risk, and this can be a source of great mental burden for the patient or their family
members. As such, patients and their families may also need to be provided with psychological careand other support at the same time.
13

2.2

Policy challenges by key area

A: Constraints related to human resources in medicine (shortages of specialized
personnel, etc.)
Due to the significant increase in the number of CGPs being conducted in recent
years, administrative workloads in the field of genomic cancer medicine have been
growing. Sufficient human resources for handling these workloads have not been
secured. This shortage is not only limited to healthcare professionals, but also
includes personnel who handle data entry and other office work.
(i) Expert panel (EP) workloads
Designated core hospitals and designated hospitals for genomic cancer medicine
are required to hold expert panels (EPs)16 on every case for which a CGP has been
conducted including those from partnered cooperative hospitals for genomic
cancer medicine.
At hospitals that perform many tests, these panels review dozens of cases eachweek. As the number of CGPs being performed continues to increase, theworkloads associated with EP operations have become enormous (see Column 4).
A number of initiatives aiming to streamline operations and reduce workloads
for EPs have made a certain degree of progress. They include (i) changing the rules
under which EPs are operated (by narrowing down the cases they must
examine);17 (ii) promoting the adoption of ICT;18 and (iii) simplifying the referencematerials that are created.19 However, these efforts have yet to sufficiently reduce

16

Expert panels (EPs): Review committees that make decisions on items such as treatments to berecommended to each patient based on CGP results.
17

It was deemed no longer necessary to convene EPs (in a manner in which attendees can discuss
in real time basis) when (i) genetic mutations have not been detected for the case in question orwhen (ii) evidence has already been established for treatment selection for all detected mutations,or in similar situations. (MHLW Health Service Bureau, “Regarding Conditions for Convening Expert
Panels,” “Details for Conditions for Convening Expert Panels.” March 3, 2023.
https://www.hgminkanhp.com/members/login/070307-2.pdf,
https://www.hgminkanhp.com/members/login/040307-3.pdf)
18

For example, together with 18 designated hospitals for genomic cancer medicine, Kyoto
University is developing cloud systems (such as OncoGuideTM NET) to enable collaboration on EPrelated duties. Such systems perform such tasks as (i) consolidating patients’ genomic test results,case summaries, and C-CAT reports for EPs to examine, (ii) coordinating EP schedules and (iii)
automating the creation of reports on EP results.
19

For cases with no recommended form of chemotherapy or for cases where the recommended
treatment is clear, some hospitals have introduced greatly simplified presentations and summaries
for use during EP review.
14the heavy workloads.20
Column 4 – Expert Panels (EPs) and related administrative workloads
Reviews of CGP results conducted at designated core hospitals for genomic
cancer medicine follow a four-step process that is centered around EPs. Eachstep is accompanied by a massive administrative workload, as shown below.21(1) Preliminary preparations (to confirm recommended treatments or thepresence of secondary findings; to prepare various documents, etc.)(2) Preliminary review (to hold preliminary “Pre-EPs,” confirm recommended
treatments, etc.)(3) Expert Panels (to determine recommended treatments, etc.)(4) Report results (to create and share reports)
For example, at designated core hospitals for genomic cancer medicine, it takes
an average of over 60 minutes to review a single case (or, if 20 cases are reviewed
in a week, it takes a total of 21 hours).22 In addition to this, each step of the review
process requires intervention from many specialists and other personnel in
addition to physicians, meaning a significant amount of manpower is also
necessary (see following chart).

20

For example, according to an estimate from the Japanese Society of Clinical Oncology Working
Group, reducing the number of cases reviewed by EPs in accordance with the aforementioned
MHLW’s Notification (see footnote 16) and other directives would result in a workload reduction of
about 7.5%.
21

Aside from these steps related to reviews of CGP results, there are a number of other affairs thatprecede or accompany performing CGPs or convening EPs and that also present heavy
administrative workloads. They include (i) case data entry; (ii) procedures to inspect items detected;
and (iii) transferring test reports, C-CAT investigation results, and other files onto the C-CAT portal.
(MHLW. Fourth Meeting of the Council for Consortium on the Promotion of Cancer Genomic
Medicine, Reference 6. “Designated Core Hospitals For Genomic Cancer Medicine Liaison
Conference, Medical Care Working Group Reference Materials.” March 5, 2021.
https://www.mhlw.go.jp/content/10901000/000748592.pdf)
22

Figures were calculated by HGPI, using weighted averages, etc. for the nine designated core
hospitals for genomic cancer medicine for which relevant data was available using counts provided
in the Second Expert Panel Manual WG Charts in Manual on the Efficient and Effective Operation ofExpert Panels in Genomic Cancer Medicine (First ed., July 4, 2022;
https://www.jsmo.or.jp/about/kanko.html#guideline) from the Japanese Society of Medical
Oncology (JSMO). We must note that weighted averages do not show factors such as variations intimes required to review cases. For example, even if many cases were swiftly reviewed, theweighted average may vary greatly due to the presence of a few very time-consuming cases.
15

(ii) Shortages of other specialized personnel (CGCs, etc.)
In addition to physicians specializing in genomic cancer medicine, a broad
variety of specialized human resources is necessary to provide genomic cancer
treatment. These include certified genetic counselors (CGCs), cancer genome
medical coordinators (CGMCs),23 and administrative personnel who handle tasks
23

Cancer genome medical coordinators (CGMCs) are mediators in genomic cancer medicine thatassist in explaining genomic cancer medicine and provide genetic counseling. Their main duties
include (1)(i) explaining to patients the content and process of testing before CGPs are conductedand (ii) making arrangements to refer patients to CGCs, clinical trials, and other support they may
need after CGPs are performed. They also (2) serve as hubs that connect genomic cancer medicine
with other departments (specialists in cancer pharmacotherapy, medical researchers, pathology
departments, patient support, etc.). (Genomic Cancer Medicine Professional Training Program
Secretariat, “Training cancer genome medical coordinators.”
http://www.jsmocgt.jp/coordinator.html)
A number of professionals such as nurses, pharmacists, and clinical laboratory technicians havecompleted CGMC training from the MHLW (specifically, the Genomic Cancer Medicine Professional
Training Program which began in FY2017) and are actively serving as CGMCs. Few hospitals havededicated CGMCs on staff. Rather, in many cases, these roles are fulfilled by people who have otherconcurrent positions, such as nurses.
16like data entry. Overall, the number of people assigned to these positions is
insufficient. Voices sharing this issue are particularly strong from cooperative
hospitals for genomic cancer medicine and other facilities in rural areas (seeColumn 5 and Column 6).24
Furthermore, the pressure being placed on staff continues to grow more severeas the number of CGPs they handle continues to increase.
Column 5 – Tasks related to genomic cancer medicine at cooperative hospitals
for genomic cancer medicine and other facilities
As discussed in Column 4, many personnel are involved in the process forreviewing CGP results. In addition to those duties, a number of administrative
tasks related to genomic cancer medicine are performed by various personnel atcooperative hospitals for genomic cancer medicine and other facilities.
For example, patients are provided with multiple interviews and counselingsessions including preliminary explanations of CGPs and explanations of test
results. There are also many liaison and coordination-related tasks related toproviding tests and convening EPs, which include coordinating schedules withdesignated core hospitals for genomic cancer medicine and other facilities. A
large variety of other tasks must also be performed with various otherdepartments, from investigations related to C-CAT reports to data entry (fordetails, see below).

24

For example, to provide patients with explanations, consultations, etc. on genetic disorders(within genetic cancer medicine, the duties that are expected to be mostly performed by CGCs), (i)outpatient physicians may be required to perform these duties, further increasing the workloads ofattending physicians; or (ii) patients may be required to travel long distances to designated core
hospitals or designated hospitals for genomic cancer medicine to receive genetic counseling. In thelatter scenario, geographic constraints may also be present. As such, there are cases in which
patients do not actually get to receive genetic counseling, so this is an obstacle to patient access to
care.
17

Column 6 – Certified genetic counselors (CGCs): roles and shortages of staffs25(1) The roles of CGCs in genomic cancer medicine
CGCs fill key roles in genomic cancer medicine. In addition to participating on
25“Certified genetic counselor (CGC)” is a type of specialist that is certified after obtaining a certain
amount of on-the-job training in genetic counseling who provides patients and their families withvarious forms of information as well as psychological and social support not limited to genomic
cancer medicine (“The Certified Genetic Counselor System – What are certified genetic
counselors?” https://plaza.umin.ac.jp/~GC/About.html).
18

EPs,26 CGCs also provide cancer patients and their families with (i) preparatory
explanations before CGPs and support after results are obtained and (ii)consultations when tests detect conditions like genetic mutations associated withhereditary tumors. Throughout these activities, they provide information on
genetic information, support systems, and similar topics, and provide a broad
range of support.
(2) The lack of personnel and their uneven distribution
The increase in the number of CGPs being conducted has led to even greater
demand for CGCs, but the nationwide personnel shortage is overwhelming – there
were approximately 350 CGCs as of April 2023. This shortage is particularly severein rural areas, with six prefectures having no CGCs at all (see map below).

As a result, physicians and other personnel are performing genomic cancer
medicine-related duties that would originally be performed by CGCs.

26

Expert panels convened at designated core and designated hospitals for genomic cancer
medicine are required to have one or more members who “possess specialized genetic counselingtechniques related to medical genetics.”
19

B: Constraints related to genetic testing (restrictions on the timing/frequency of CGPs
that can be conducted)(i) CGPs in principle can only be performed “after standard treatments have been
completed”
As a general rule, the medical service fee schedule only allows for CGPs to be
performed in principle “after standard treatments have been completed.”27 This
limitation also comes with mention of cases in which standard treatments are
expected to be completed, so there appears to be significant leeway for people
serving in clinical settings to exercise their own judgment.
When we talked to healthcare professionals in each region, many told us that
CGPs are performed extremely early (within the scope of what is covered byinsurance) according to cancer patients’ conditions and other factors, based on
the judgment of those serving on the clinical frontlines.
On the other hand, there are also a few health institutions that are extremely
cautious about performing CGPs at early stages. For example, some cooperative
hospitals for genomic cancer medicine in rural areas place the use of CGPs understrict control based on a strong awareness of medical service fee rules. There havealso been cases at community hospitals where the start of genomic cancer
treatment was delayed significantly because they waited until standard treatments
had been completed, before referring patients to cooperative hospitals forgenomic cancer medicine. Practices such as these may be a significant restriction
on patient access to genomic cancer medicine.
There are also cases in which current rules of the medical service fee schedule
related to advancing clinical trials seem to be in contradiction with each other. For
example, there are times when even if some therapeutic target gene mutation isfound when CGP is conducted, the patient cannot enter a clinical trial because of
the restriction such as "subjects (patients) must be untreated," and as a result, it
may not lead to a promising treatment. In the end, they are unable to accesspromising treatments.
Given these challenges, in recent years, academic societies and other groups
have said there are cases in which it is better to perform CGPs at earlier stages (formore details, please see 3.3 Recommendation II).
(ii) Each patient can only take one CGP per lifetime
It is medically known that depending on the type of cancer, it is possible forgenetic mutations, etc. to progress even during treatment, but the medical service
fee rules place a uniform limit on all patients of one CGP per lifetime in principle,
27

Specifically, “patients with solid tumors for which no standard treatment is available, or withlocal progression or metastasis for which standard treatment has been terminated (including thosefor whom termination is expected).”20

regardless of their condition.
It is common practice in clinical settings to test patients and flexibly selecttreatment methods based on their condition. In this respect, a one-time-only
restriction may limit the patient's treatment options—for example, if a test is
performed during the initial stage of the disease, the same type of test cannot be
performed at the time of recurrence or relapse.

21

C. Constraints related to geographic factors or information (lack of easy access totesting facilities and clinical trials)
Designated core hospitals, designated hospitals, and cooperative hospitals forgenomic cancer medicine have been named throughout Japan to give citizens equal
opportunities to undergo testing and receive treatment in genomic cancer medicine.
Looking at the actual situation, however, it cannot be said that sufficient access
opportunities have been secured, especially for patients living in rural areas.
(i) Constraints related to testing facilities
To begin, few clinics have laboratories with the capacity to properly handle
specimens for CGPs. Namely, when collecting CGP specimens,28 even greater carethan usual must be taken to prevent problems like contamination. This can make it
difficult to conduct CGPs at community hospitals or clinics.29 When this is thecase, depending on where a patient lives, they may have to spend several hours
traveling so specimens can be collected at a cooperative hospital for genomic
cancer medicine.
Furthermore, some cooperative hospitals for genomic cancer medicine in rural
areas have said that the persistent shortage of pathologists means specimen
extraction for CGP becomes delayed due to the weight of their normal workloads.
(ii) Constraints related to clinical trials
In genomic cancer medicine, drugs approved for genetic mutations are still few
in number. This means participating in clinical trials is the main method forpatients to access genomic cancer medicine.30
Given these circumstances, opportunities for patients who live in rural areas toparticipate in clinical trials are extremely limited. In addition to information-related
constraints, this is also due to economic, geographic, and physical reasons. In otherwords, for a patient living in a rural area, the fact that a clinical trial site is located
far away could be called the highest hurdle to clinical trial access.

28

Regarding tissue specimen extraction for CGPs, liquid biopsy is recommended only when tissue
cannot be collected.
29

In this document, “community hospital” refers to public or private health institutions that havenot been designated as “designated core hospitals, designated hospitals, or coordinating cancer
hospitals for genomic cancer medicine” and are central hospitals in their communities.
30

Among cases in which patients who underwent CGPs successfully arrived at pharmaceuticals,
treatments, etc. that were applicable to their genetic mutations, no more than one in three wereadministered drugs that had already been approved, while the remaining two-thirds wereregistered in clinical trials for investigational new drugs. (This data was derived from the 2,295
patients who underwent CGPs at designated core hospitals for genomic cancer medicine fromFebruary 2020 to January 2021.)
22

(a) Clinical trial information cannot be obtained easily
At health institutions, C-CAT reports are the main resource used to obtain
information on clinical trials for which patients who will receive genomic cancer
treatment may be eligible.31
C-CAT reports summarize the results of patients’ CGPs and list a broad rangeof candidate clinical trials that correspond to their genetic mutations. However,in practice, the information contained in those reports is not updated in realtime basis, so they may include many trials that have already completed
participant recruitment.
This means cooperative hospitals for genomic cancer medicine must contact
the trial sites one by one to check the status of each clinical trial, which poses aheavy administrative burden.32(b) Patients must sometimes visit distant clinical trial sites for screening
Furthermore, even when options have been narrowed down to clinical trial
candidates that match a patient’s genetic mutations, patients must undergo
screening (tests, etc.) to determine if they are actually eligible to participate.
This means the patient must visit the facility conducting the clinical trial.
Given the fact that the vast majority of clinical trials are conducted in theTokyo metropolitan or Kansai areas,33 participating in these screening
processes places a major burden on patients who live far from these regions.34(c) It is unrealistic for participants to continuously visit distant clinical trial sites
Finally, even if a patient who lives far away from a clinical trial is found to beeligible to participate, there are a few cases in which they have to give up on
doing so due to economic, geographic, or physical reasons.35
31

There are certain cases where attending physicians are directly acquainted with physicians
serving at institutions conducting clinical trials, or designated core hospitals for genomic cancer
medicine are proactively providing clinical data to coordinating hospitals. It is, however, generally
difficult for patients in rural areas to obtain adequate information on clinical trials.
32

Health institutions devote great amounts of time and effort searching for clinical trials thatpatients may be eligible for, but even when they find a trial, there is no system in place to provide
them with an economic return on administrative costs (such as referral fees).
33

Specifically, early phase clinical trials for genomic cancer medicine are only conducted at two
National Cancer Center (NCC) hospitals and at certain university hospitals and cancer centers in theTokyo metropolitan area and Kansai region.
34

Considering that there are many cancer patients who are deemed ineligible for a clinical trial
after the screening stage, it is extremely important to reduce the burdens, etc. placed onparticipants (candidates) during the preparatory stages for clinical trials.
35

For example, clinical trials may include conditions like, “Participants must be able to visit the23

2.3 Awareness levels toward genomic cancer medicine among patients, theirfamilies, and attending physicians
In addition to the issues described above, genomic cancer medicine is arelatively new form of healthcare and citizens do not yet possess adequateawareness of it. Even among cancer patients and their families, fewer than 40%
have heard of genomic cancer medicine.36 It is often the case that attending
physicians (especially when they do not work at designated core hospitals ordesignated hospitals) are also unfamiliar with genomic cancer medicine.
For this reason, when cancer patients are being treated at health institutions inrural areas, sufficient consideration is not given to genomic cancer medicine(testing, clinical trials) as an option.37 Factors like this also end up delaying patientreferrals to cooperative hospitals for genomic cancer medicine.

facility conducting the trial once per week.” This means the vast majority of patients who canparticipate in clinical trials are those who live in the Tokyo metropolitan or Kansai areas.
36

HGPI, “Results of Internet Survey on Genomic Cancer Medicine (Summary).” (May 11, 2023.
Conducted jointly with the Tokyo Women’s Medical University in March 2023. Subjects: A total of
1,000 men and women ages 20 years or older who had been diagnosed with cancer (or who had afamily member who had been diagnosed with cancer). https://hgpi.org/en/research/ncd20230511.html)
37

It is widely known that even when patients receive CGPs, success rates for genomic cancer
treatments are low. For physicians in communities, this makes it difficult to go so far as to place
heavy physical and mental burdens on patients by attempting to actively pursue genomic cancer
treatment.
24Column 7 – A flowchart of challenges from testing to treatment
Rearranging the issues discussed above in chronological order (as shown in thetable below) shows that improving patient access opportunities will require issues
to be addressed at each stage, from the time patients are first diagnosed withcancer to the time they begin receiving genomic cancer treatment (through use of
approved drugs or by participating in clinical trials).
Issue

Area

Key issues

Issue shared with A: Constraints incancer medicine human resources

Other issues

in healthcare

1

Awareness of

Insufficient knowledge

genomic

among citizens (patientscancerand their families)

treatment

at community healthcare

optionfacilities

C: Geographic or
information
constraints○

Emphasis of reimbursement

community healthcare

rules ("after standard

facilities

treatments are completed")

citizens orcommunity healthinstitutions◎◎

Insufficient certified

treatment◎

genetic counselors
receiving hospitals

Delays in specimen
extraction

Long distances toAccess to
CGPs

Insufficient specialized

testing centers

Insufficient pathologists

◎

〇

◎

〇

Few facilities can extract〇

specimens to submit for

Restrictions on the◎

Restrictions on the◎frequency of CGPs

Low frequency of Expert

4 testing totreatment

Panels◎CGPstiming of CGPs

Period from〇

Delayed responses at

staff (other)Workloads at central hospitals◎

for genomic cancer treatment
and other facilities

Long periods between
obtaining test results andproviding explanations to◎

Examining all cases at EPs

patients

Delays to conducting tests◎("after standard treatments

Low rate of patientsare completed")arriving at therapies
applicable to genetic

Issues facing R&D◎

Drug lag◎mutations

Access to5

Awareness among◎

Delays in referrals fromsearch formethods

3

genetic testing

medicine as a Insufficient knowledge

Refining
2

B: Constraints inapproved

Insufficient clinical trial

drugs andinformation

clinical trials

Patient access during

Insufficient information◎

contained in C-CAT
reports
Lack of knowledge concerning

the preparatory stages of clinical trial protocols among
clinical trials○◎

attending physicians
Uneven distribution of clinical
trial sites (mostly conductedLong distances toin Tokyo metropolitan or◎

Kansai areas)

clinical test sites
Delays in dissemination of
DCTs

25

◎

3. POLICY RECOMMENDATIONS
3.1

Key points of the three recommendations

As we saw in Section 2, policy issues related to opportunities for patients to accessgenomic cancer medicine span a broad range of items. Many of these issues can be
categorized into the following three areas:
A: Constraints related to human resources in medicine
B: Constraints related to genetic testing
C: Constraints related to geographic factors or information
As such, it is appropriate to examine policy responses from the following threeperspectives, which generally correspond to the three areas described above (Figure
6):
A’: Streamline operations and secure human resources
B’: Review genetic testing practices including how tests are performed
C’: Improve patient access to testing centers and clinical trials
Figure 6: Issues and policy responses for genomic cancer medicine when viewed
in terms of patient access

A: Constraints related to humanresources in medicine (shortagesof specialized personnel)
C: Constraints related to geographic
B: Constraints related to genetic
testing (restrictions on

factors or information (lack of easytiming/frequency of CGPs)

access to testing facilities andclinical trials)

A’: Streamline operations andsecure human resources
B’: Review genetic testingC’: Improve patient access topractices including how tests

testing centers and clinical trials

are performed

Specifically, it is desirable that solutions are steadily implemented to issues facing26

practical duties based on the pillars of the three recommendations described below(Figure 7).
Figure 7 – Responding to policy issues in genomic cancer medicine(Three recommendations)Issues
A: Constraints
related tohumanresources inmedicine

Recommendations
RECOMMENDATION I: Streamline operations and secure
human resources
In view of the further spread of genomic cancer
medicine, streamline operations thoroughly, and adopt
systems to secure human resources commensurate withworkloads.
(i) Refine the scope of cases reviewed at Expert Panels (EPs) to asignificant degree(ii) Implement online genetic counseling(iii) Review reimbursements provided to facilities and for personnel
involved in genomic cancer medicine

B: Constraints
related togenetic
testing

RECOMMENDATION II: Review genetic testing practices
including how tests are performed
Based on the accumulated clinical experiences, revise
the genetic tests and related practices to meet the needsof those serving in clinical settings, and to suit thecharacteristics of each type of cancer.
(i) Make reimbursement rules regarding the timing/frequency of CGPs
more flexible(ii) Create testing algorithms for each type of cancer, with theinitiative from academic societies(iii) Disseminate genetic tests for which the number of genes tested
has been narrowed down (as compared to CGPs)

C. Constraints
related togeographic
factors orinformation

RECOMMENDATION III: Improve patient access to testing
centers and clinical trials
While paying attention to the constraints anddisparities related to geographic factors/information,
make drastic improvements to patient access to testing
centers and clinical trials.
(i) Greatly expand testing opportunities, while utilizing liquid biopsies
and other tests(ii) Simplify access during the preparatory stages of clinical trials(iii) Disseminate low-cost decentralized clinical trials (DCTs) that utilize
low-tech methods
27

3.2 Recommendation I : Streamline operations and secure human resources[Basic concept]
It has been several years since genomic cancer medicine was first granted
insurance coverage, when it was considered an advanced form of medical treatment.
This means, many tasks related to genomic cancer medicine are to be performed
through cooperation among many highly-specialized, multidisciplinary personnel, ina manner that is careful and thorough. The expert panels involved in genomic cancer
medicine are representative of this concept. However, the workloads and expenses
associated with these duties are not adequately reflected in the medical service feeschedule.
Meanwhile, a dramatic rise in the number of cases being handled in recent years isincreasing workloads and exhausting those in the field. However, experiences
accumulated over the past several years have also made it abundantly clear thatlabor can be saved in various areas and that certain tasks should be simplified.
Given these circumstances, it is desirable that steps are taken to improve quality ingenomic cancer medicine by advancing efforts to thoroughly streamline overall
duties to open up options and make it possible to concentrate cases. In addition, arational review of the medical service fee schedule should be conducted so healthinstitutions can expand staff to keep pace with the growing workload.
[Content of Recommendation I]
Issue
A: Constraints
related tohumanresources inmedicine

Recommendation
RECOMMENDATION I: Streamline operations and secure
human resources
In view of the further spread of genomic cancer
medicine, streamline operations thoroughly, and adopt
systems to secure human resources commensurate withworkloads.
(i) Refine the scope of cases reviewed at Expert Panels (EPs) to asignificant degree(ii) Implement online genetic counseling(iii) Review reimbursements provided to facilities and for personnel
involved in genomic cancer medicine(i) Refine the scope of cases reviewed at Expert Panels (EPs) to a significant degree
Based on the concept that each CGP result must be given appropriate examinationfrom an expert’s point of view, all cases in genomic cancer medicine are reviewed byExpert Panels (EPs). However, in the past few years, outpatient departments that
attend patients have accumulated experience with this form of medicine, and acertain degree of consensus has been reached that, from a medical standpoint, it is28

not necessary to review all CGPs.
As discussed in Section 2.2 above, the MHLW and health institutions haveadvanced concrete efforts to review, simplify, and streamline EP operations.38
However, past measures have not gone so far as to revisit the basic concept that allcases must undergo EP review.
From now on, we should fundamentally change the role of EPs, and refine thescope of cases reviewed at EPs to a significant degree,39 while fully taking into
account the actual need for EP reviews in real-world clinical settings.
Specifically, (1) it is desirable that attending physicians submit the cases for EP
review only when it is difficult to determine a treatment strategy based on CGP
results, or in similar circumstances, based on the principle that the attending
outpatient department should determine a patient’s treatment strategy directly.40
In the past, when health professionals had less experience with CGPs, it was
somewhat rational to have all cases reviewed by EPs. Health professionals in every
region of Japan have now accumulated experience with interpreting CGP results. In
cases where a consensus can be reached on applicable treatments for a genetic
mutation, attending physicians should now be allowed to determine the treatment
strategy. Gradually adopting this and similar methods is also likely to help thoseserving at cooperative hospitals for genomic cancer medicine and other facilities gain
more experience making decisions regarding cases.41

38

Academic societies have also recommended conducting reviews on certain aspects of operations(The Japanese Society of Medical Oncology “Manual for Efficient and Effective Expert Panel
Operations,” July 2022; https://www.jsmo.or.jp/about/kanko.html).
39

It is important not to overlook that EP reviews have been, to a certain extent, vital for ensuring
the quality of genomic cancer treatments, especially at health institutions with limited medical
resources. Therefore, it will be necessary to pay sufficient care to ensure that medical institutions
that submit cases to EP can select cases to be submitted according to their actual conditions, sothat the treatment quality does not decrease by uniformly omitting EP reviews.
40

It is important to sharing the latest information on clinical trials among hospitals, since there aremany cases in which different EPs offer different recommendations for treatments when said
treatments are still in the research stages, such as clinical trials with little established evidence(“Disseminating the Latest Research Findings in Genomic Cancer Medicine from Japan to the World:
Recommendations for Addressing of Expert Panel-Related Issues Based on an Analysis of Current
Circumstances at Designated Core Hospitals for Genomic Cancer Medicine,” March 8, 2023,
National Cancer Center Japan;
https://www.ncc.go.jp/jp/information/pr_release/2023/0308/index.html).
41

To prevent such developments from resulting in excessive workloads for attending physicians, weshould improve the environment for decision-making support in clinical settings, such as (i) deriving
recommended treatments through partially-automated processes using AI and other tools for cases
where the genetic mutations detected in CGPs are typical, and (ii) making C-CAT reports and otherreports easier to read.
29

In addition, (2) for genetic diseases, it is desirable that separate opportunities are
established for physicians specializing in genetic diseases, CGCs, and other genetic
disease specialists to review only those cases which require specialist review.42
Doing so would streamline duties to a significant degree (see Figure 8).
Figure 8: Visual representation of refining the scope of cases reviewed at Expert
Panels (EPs) (related to Recommendation I)

All cases

Attendingphysiciandecision

Typical cases, etc.

(With AI support）

Determinerecommended

CGPs
Difficult-to-decide cases

Cases with genetic diseases

Submit toExpert Panels

treatment

Genetic disease specialist and CGC examine
multiple cases at a time

Using these methods to drastically reduce the number of cases handled by EPs is
also likely to help patients receive treatments earlier.
(ii) Implement online genetic counselingTo overcome the extreme shortage of CGCs, hospitals throughout Japan should
actively collaborate with each other and make effective use of online genetic
counseling in the future (see Column 8).43
Certain aspects of in-person counseling are superior to online counseling. For
42

From the perspectives of patients, a conclusion regarding how their tumors will be treated isreached as soon as possible is their top priority. Rather than attempting to determine if they havegenetic diseases during EP reviews (which are conducted to decide on the recommended treatment
for each patient), it is likely that sufficient responses can be mounted even if some time passes
before the presence of genetic diseases is considered. Doing so would also eliminate the need for
EPs to have genetic disease specialists (such as CGCs) in attendance, streamlining the process.
43

Insurance currently covers genetic counseling for patients and their families who have beentested for intractable diseases (totaling 190) and hereditary tumors (cancer). Among those diseases,
remote genetic counseling (online counseling) was already approved for genetic counseling related
to intractable diseases in the 2022 revision of the medical service fee schedule. Efforts to expand
online counseling for genetic diseases (outside of insurance coverage) have also been launched insome areas.
The current medical service fee schedule does not allow patients to access online counselingfrom home, so they must visit nearby health institutions to undergo counseling. However, it is still
highly beneficial for patients to be able to access online counseling from health institutions that areclose to where they live.
30

example, in-person counseling allows counselors to see patients’ facial expressions
and grasp their degree of understanding more accurately. However, making
conversation online has become quite common due to the COVID-19 pandemic, so
communication hurdles for patients and their families are likely to be low.
While it is reasonable to enable staff at each community hospital to handle caseswith genetic mutations that appear very frequently, it is still desirable for there to be
consultations with specialists (who are located at distant hospitals) for rare cases andother situations. This is another reason why it would be highly beneficial to makeonline genetic counseling a common practice.
Column 8 – An initiative to introduce online counseling
Here is an example how hospitals work together and cooperate to provide online
genetic counseling:
Genetic counseling is an essential part of subsequent cancer treatment and followups, and the CGC of Hospital A and the medical team of Hospital B are working
together to ensure these health services are provided (while Hospital A is located in theTokyo metropolitan area, Hospital B is located in a rural area).
The following provides details on a number of actions they are taking to ensureneeds for genetic counseling can be met to a reasonable degree and within existing
systems.
(1) Working conditions for the certified genetic counselor
Hospital A has permitted the full-time CGC on its staff to serve as a part-time
employee of Hospital B.44 The CGC spends two half-days per month providing online
genetic counseling to patients at Hospital B.
(2) Interactions with patients
At Hospital B, patients undergo genetic counseling via online tools like Zoom for
Healthcare with staff from Hospital B participating alongside them. Using such tools
means that they do not require any special online equipment for genetic counseling.
(3) Preliminary information sharing and preliminary meetings
The CGC does not have direct access to electronic medical records held at Hospital B
and the physical distance makes it difficult for the CGC to provide follow-ups later on.
Nurses at Hospital B help with this by providing patient record summaries and byhandling post-consultation follow-ups.
The CGC also participates remotely in related regular meetings at Hospital B, where
they share information. This allows the CGC to make effective use of his/her expertise,
44

Through a framework similar to the one that allows hospital staff members teach seminars
outside of the hospital that employs them, this cooperative system between the two hospitals
allows the CGC to serve part-time at Hospital B on their days off at Hospital A. Because the CGC
works as a part-time Hospital B employee, this addresses various issues between the hospitals suchas how reimbursements are distributed.
31

even while working on a part-time basis.
(iii) Review reimbursements provided to facilities and for personnel involved ingenomic cancer medicine(a) Review reimbursements for CGPs
While CGPs are indeed expensive, this is mostly due to the testing fee, which ispaid to the testing company. Some have said that even if a cooperative hospital for
genomic cancer medicine performs over 100 CGPs in one year, the income for thehospital would not even cover the salary of a single staff member involved inperforming the tests.45 Even though the number of CGPs they handle continues toincrease, this shortfall means that health facilities cannot hire more staff as one
might expect. Many people serving at those facilities are now exhausted.
While mismatches between reimbursements and workloads are not somethingthat only affects genomic cancer medicine, these circumstances must not go
overlooked in efforts to ensure sustainability in this area.
To ensure that designated and cooperative hospitals for genomic cancer medicine
can expand their staff to match the increased workload and continue to handle acertain number of CGPs in the future, this reimbursement should be revised to becommensurate with actual working conditions based on an objective analysis ofduties that accompany genomic cancer treatment.46(b) Introduce a rule requiring certified genetic counselors (CGCs) to be placed athealth institutions
While CGCs have key roles to play in the provision of genomic cancer medicine,
45

CGPs and related tests are reimbursed at a rate of 56,000 points (560,000 yen) per test (CGPs:
44,000 points; CGP evaluation provision premium 1: 12,000 points).
Cooperative hospitals for genomic cancer medicine pay part of this reimbursement to testing
companies for testing fees. In fact, most of the test evaluation and explanation premium is devoted
to testing fees. They also pay outsourcing fees to designated core hospitals (or designated hospitals)
for genomic cancer medicine for EPs. After these expenses, they are only left with several tens of
thousands of yen.
Furthermore, at designated core hospitals and designated hospitals for genomic cancer medicine,
EP outsourcing fees alone are not sufficient to cover the costs of labor for EP administration, which
consumes considerable amounts of time for specialized personnel and other staff members.
46

Academic societies have submitted written requests and opinions to the MHLW regarding theallocation of points for conducting and interpreting CGPs in the medical service fee schedule. They
asked for points to be allocated appropriately so reimbursements are sufficient to cover the actual
costs for test providers and health professionals. (These include the “Written Request Regarding
Issues for Insurance Coverage of Cancer Medicine” presented on December 27, 2021 by theJapanese Society of Medical Oncology, the Japan Society of Clinical Oncology, and the JapaneseCancer Association. https://www.jsco.or.jp/news/detail.html?itemid=96&dispmid=767).
32

there are no criteria regarding the number of CGCs that must be placed at eachhospital, and their compensation is not commensurate with the content of theirduties. These issues are partially due to the fact that their certification is notrecognized at the national level.
This factor is one reason for the absolute shortage in human resources, so
specialized human resources who have key roles to fulfill in providing genomic cancer
treatments should be designated as positions that hospitals are obligated to fill.
Furthermore, they should introduce institutional measures that secure humanresource development measures, as well as compensation that is commensuratewith those roles.47

47

Criteria regarding the placement of cancer genomic medicine coordinators (CGMCs), who facesimilar issues, should also be clearly stated, and steps should be taken to establish an educational
system for training these coordinators as well as to improve their compensation.
33

3.3 Recommendation II : Review genetic testing practices including how tests are
performed[Basic concept]
As to the medical service fee schedule, strict restrictions on the timing/frequencyof CGPs have been in place since they were first granted coverage. From a healtheconomics perspective, it is safe to say that these restrictions were somewhat
reasonable when they were first introduced.
However, many cases in genomic cancer medicine have accumulated over the past
few years. Because of this, we may now be able to significantly improve clinicaloutcomes by exercising more flexibility in terms of the timing/frequency of CGPs,
depending on the type of cancer. This point should also be given active considerationfrom a health economics perspective.
As such, it would be appropriate to review the medical service fee schedule rules
related to timing/frequency of CGPs for each cancer type while taking opinions fromacademic societies and the needs of those serving in clinical settings into account.48[Content of Recommendation II]
Issue
B: Constraints
related togenetic
testing

Recommendation
RECOMMENDATION II: Review genetic testing practices
including how tests are performed
Based on the accumulated clinical experiences, revise
the genetic tests and related practices to meet the needsof those serving in clinical settings, and to suit thecharacteristics of each type of cancer.
(i) Make reimbursement rules regarding the timing/frequency of CGPs
more flexible(ii) Create testing algorithms for each type of cancer, with theinitiative from academic societies(iii) Disseminate genetic tests for which the number of genes tested
has been narrowed down (as compared to CGPs)(i) Make reimbursement rules regarding the timing/frequency of CGPs more flexible
Depending on cancer type and a patient’s condition, there may be cases where
patients can receive treatments that match their genetic mutations by performing
48

The Japanese Society of Medical Oncology and other academic societies have stated that there islittle scientific basis for limiting CGP eligibility to those who have completed standard treatments(Japanese Society of Medical Oncology, the Japan Society of Clinical Oncology, and the JapaneseCancer Association. Clinical Practice Guidance for Next-Generation Sequencing in Cancer Diagnosis
and Treatment (May 15, 2020; Version 2.1), p89 (CQ6),
https://www.jsmo.or.jp/about/doc/20200310.pdf)
34

CGPs before standard treatments have been completed.49 In particular, it isextremely important to test early when treating highly-malignant types of cancer
that require treatment to be delivered quickly, like pancreatic cancer.
In addition, it may be possible to provide more precise treatments by (i) actively
utilizing liquid biopsies for CGPs and (ii) performing CGPs multiple times.
Thus, we should review the rules of the medical service fee schedule from both
medical/clinical and health economics perspectives and make them more flexible
as soon as possible, while taking into account cancer types and patient conditions.
(ii) Create testing algorithms for each type of cancer, with the initiative fromacademic societies
From both medical and health economics perspectives, a great amount ofknowledge regarding the most effective stages to perform CGPs has accumulated
over the past several years. It is also gradually becoming clearer that which testingalgorithms are optimal may vary by cancer type.50
Generally, CDx tests are taken to determine if there is an approved drug that is
applicable to the disease in question, but even when those tests show that there
are no genetic mutations with a compatible approved drug, CDx still carry a certain
degree of significance. Knowing that there is no approved drug available makes it
possible to make decisions regarding the next steps for testing and treatment earlyon, particularly whether to (i) follow up with a CGP to search for a path forward fortreatment or to (ii) perform standard treatments.
In the future, it is desirable that testing algorithms that are optimal frommedical and clinical perspectives are developed for each type of cancer and with
the initiative from related academic societies.51
49

For example, a recent clinical study reported that the ratio of patients receiving recommended
treatments after undergoing CGPs was about three times higher when CGPs were performed before
starting standard treatments (approximately 19.8%) than when they were performed after standard
treatments (which is currently a general pre-condition for insurance coverage). (“First-Line Genomic
Profiling in Previously Untreated Advanced Solid Tumors for Identification of Targeted Therapy
Opportunities,” July 17, 2023;
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2807341). Rates at which patientsarrive at applicable drugs is extremely low, which is currently a problem facing genomic cancer
medicine. Reviewing the timings at which CGPs are performed and applying more flexible testing
practices is likely to result in significant improvement for this issue.
50

For example, specialists for lung cancer and gastrointestinal cancer have different views on when
to use CGPs and when to use CDx tests, if it becomes possible to conduct CGPs during the initialstage of drug therapy, (“Opinions on CGPs During Initial Stages of Drug Therapy Differ by Cancer
Type,” The Nikkan Yakugyo, March 17, 2023, No. 16063).
51

It goes without saying that experts should hold discussions on testing algorithms which arerational from both clinical and health economics perspectives, and this is already being partially35

(iii) Disseminate genetic tests for which the number of targeted genes has been
narrowed down (as compared to CGPs)
Most CDx tests are performed under the assumption that a therapeutic which isapplicable to the identified gene mutation, etc. will be used later, but as seen in (ii)above, CDx tests also have a role to play when dividing cases according to testingalgorithms.
From this perspective, it will also be effective to make more active utilization of
CDx tests that can test multiple driver genes simultaneously (which we can refer toas “multi-CDx” tests). These multi-CDx tests can detect specific gene mutations
more rapidly and at less cost compared to CGPs, so utilizing them would be arational decision from both medical and health economic perspectives.
Given these circumstances, from medical and clinical points of view (and whileleading the way in creating testing algorithms that are optimized for each type ofcancer), it is desirable that each academic society actively recommends the use ofdiagnostics for which the number of targeted genes has been narrowed down.

practiced in real-world clinical settings at certain facilities. Fully aware of this, we would like tointroduce some ideas that might be helpful:
To begin, (i) in lung cancer, a number of existing approved drugs that are applicable for several
common genetic mutations have already been identified. As such, it could be considered rationalfrom both clinical and health economics perspectives to utilize “multi-CDx” tests to detect suchgenetic mutations. For example, they could be used to simultaneously test for around ten drivergenes (that are likely to show results in around one to two weeks (faster than CGPs can)) and then
CGPs could be performed only on the patients who test negative (meaning those with no obvious
treatment strategy at the time of testing).
(ii) Although 90% of patients with pancreatic cancer test positive for KRAS, there are no drugs
targeting KRAS which have received regulatory approval in the field of genomic cancer medicine.
However, given the severe prognosis of the disease, it is desirable that a treatment strategy isestablished as soon as possible. As such, one potential testing algorithm might include (a)performing KRAS testing immediately, even before standard treatments begin, (b) rapidly initiating
standard treatments for the approximately 90% of patients who test positive for KRAS, and (c)performing additional CGPs at early stages for the approximately 10% of patients who test negativefor KRAS and exploring genomic cancer treatment options, including clinical trials.
Conversely, (iii) for colorectal cancer, only around four genetic mutations can be detected by CDx
tests, so it may be more reasonable to start with CGP.
36

3.4 Recommendation III : Improve patient access to testing centers and clinical trials[Basic concept]
To ensure equitable access to genomic cancer medicine nationwide, hospitals
throughout Japan have been assigned the roles of designated core hospitals,
designated hospitals, and cooperative cancer hospitals for genomic cancer medicine,and these assignments are reviewed regularly.
However, only establishing networks of these hospitals will not be enough toensure access opportunities, especially for patients who live in rural areas.
This is especially true for clinical trials, which are mainly conducted at cancer
centers and certain university hospitals in the Tokyo metropolitan and Kansai regions.
For patients living outside these areas, the fact that these facilities are so far away is
the greatest constraint to healthcare access.52
Domestic stakeholders agree that more clinical trials should be conducted inJapan. However, among facilities conducting clinical trials and other stakeholders in
the Tokyo metropolitan/Kansai areas, there seems to be little awareness toward theissue of improving access for patients in rural areas.
Strongly recognizing that improving access for patients in rural areas is important,
we should take actions to correct information disparities and reduce geographic
hurdles, through the active utilization of various technologies including ICT.
[Content of Recommendation III]Issue
C: Constraints
related togeographic
factors orinformation

Recommendation
RECOMMENDATION III: Improve patient access to testing
centers and clinical trials
While paying attention to the constraints anddisparities related to geographic factors/information,
make drastic improvements to patient access to testing
centers and clinical trials.
(i) Greatly expand testing opportunities, while utilizing liquid biopsies
and other tests(ii) Simplify access during the preparatory stages of clinical trials(iii) Popularize low-budget decentralized clinical trials (DCTs) thatutilize low-tech methods(i) Greatly expand testing opportunities, while utilizing liquid biopsies and other tests

52

Further expanding the content of Patient-Proposed Healthcare Services will also help improveaccess.
37

(a) Expand the use of liquid biopsies
In addition to CGPs which use tissue samples, CGPs which use liquid biopsy has
become more common in recent years. This alternative method examines the DNA
from cancer cells that has entered the bloodstream.53
From the perspective of test sensitivity, tests that show tumor tissue DNA are
usually thought to be preferable for solid tumors.
Liquid biopsies, however, provide a number of significant benefits:
For example, since they are taken by blood tests, liquid biopsies place a relatively
small burden on patients in terms of specimen collection; it is also highly likely that
institutions like community hospitals in rural areas may handle them in a safe andreliable manner. Liquid biopsies also provide results more quickly than standard
CGPs.54
Therefore, while taking the conditions of each patient into account, liquid biopsies
should be clearly positioned as a regular part of initial testing in situations where
they can be expected to be have strong merits (such as for gastrointestinal cancers)
and be utilized more actively.55(b) Expand genomic cancer testing centers to include core hospitals for coordinatedcancer care
Currently, the collection of tumor specimens for use in CGPs is supposed to be
conducted at designated core hospitals, designated hospitals, and cooperativecancer hospitals for genomic cancer medicine. Visiting facilities far from home toundergo testing, however, can impose great physical and mental burdens on cancer
patients. 56 To improve patient access with regards to specimen collection, it is53

According to the current medical service fee schedule rules, liquid biopsy is only recommended
for certain cases, such as when specimen extraction is difficult. This may have caused liquid biopsies
to remain a low-priority testing option in clinical settings.
54

For example, when testing gastrointestinal cancer, histopathology takes about one month toobtain results while liquid biopsy takes about 10 days. Using liquid biopsies is likely to contribute toshorter turnaround times (TATs) and greatly improve clinical trial enrollment. (For example, see
National Cancer Center Japan, “Development of Precision Medicine for Gastrointestinal Cancers:
Utility of Liquid Biopsy in Genomic Analysis,”
https://www.ncc.go.jp/jp/information/pr_release/2020/1006/index.html.)
55

For example, SCRUM-Japan (an industry-academia collaborative project called the Cancer
Genome Screening Project for Individualized Medicine in Japan, http://www.scrumjapan.ncc.go.jp/) uses liquid biopsies as its main form of initial testing.
56

Specimen collection for CGPs is considered to be somewhat difficult because of the high numberof tumor specimens required and for other reasons. In addition to providing reimbursements in the
medical service fee schedule, it will be necessary to establish a system that ensures specimens canbe collected in a safe and reliable manner by actively providing education, training, and human38

desirable that centers where specimens are collected for CGPs are expanded toinclude core hospitals for coordinated cancer care.57(ii) Simplify access during the preparatory stages of clinical trials(a) Simplify information gathered during testing
As previously discussed, C-CAT reports are a topic discussed at EPs and a key
source of information that patients can use to learn about clinical trials they might
be able to join. In particular, health facilities in rural areas rely heavily on C-CAT
reports.
This means it will be important to first revise C-CAT reports to make them more
useful within the context of clinical practice. C-CAT reports should be revised tomore accurately reflect the perspectives of those in clinical settings. Specifically,
they should (i) provide information closer to real-time basis and (ii) adopt a systemthat allows attending physicians to easily sort through the large amounts of
information they contain according to patient condition and place of residence or(iii) direct the health facility staffs to where inquiries can be submitted, such as the
URL of the clinical trial site or the e-mail addresses of the principal investigator (PI)and clinical trial coordinator.58(b) Simplify participation in clinical trials during the preparatory stages
Steps must also be taken to alleviate the need for patients in rural areas to visit
clinical trial sites (which are often located in the Tokyo metropolitan/Kansai areas)
to undergo screening (genetic testing, etc.) during the preparatory stages of clinical
trials.
resources.
At the same time, tumor specimens needed for general cancer treatment are collected at core
hospitals for coordinated cancer care, and there is no practical difference in terms of the technicalaspects of collecting specimens. Because the technical capacity to collect tumor specimens for CGP
is in place, it is likely that core hospitals for coordinated cancer care can gradually develop thecapacity to gather specimens for CGP if an environment that fosters such practices is established.
57

In genomic cancer medicine, even when tests find a genetic mutation, the chances of finding
applicable treatments (approved drugs or clinical trials) are still low. (For reference, please see“Chronological improvement in precision oncology implementation in Japan,”https://pubmed.ncbi.nlm.nih.gov/35976133/.) Because of this, it is desirable that steps are taken tolighten the burdens on patients (for whom applicable genomic cancer treatments have not beenfound) by allowing them to learn their test results through online medical consultations withgenomic cancer centers.
58

The National Cancer Center Hospital East is currently leading efforts to build an organization
called the “Academic Assembly” which will enable physicians to share clinical trial-related
information in a more timely manner. (The 113th HGPI Seminar – Current Circumstances and Issues
in Precision (Genomic) Cancer Medicine (March 2, 2023); Lecturer: Atsushi Otsu;
https://hgpi.org/en/events/hs113-1.html)
39

Specifically, it will be important to partially adopt decentralized clinical trials(DCTs) (see item (iii) for further discussion) and institutionalize a system in which
patients can complete initial screenings at satellite clinics located closer to where
they live.
(iii) Popularize low-budget decentralized clinical trials (DCTs) that utilize low-techmethods
For patients living in rural areas, the need to commute to faraway clinical trialsites is the greatest constraint to clinical trial access.
Decentralized clinical trials (DCTs) are clinical trials in which patients canparticipate without the need to visit a clinical trial site, by using online medical
services with digital devices or by having pharmaceuticals delivered to theirhomes. Actively implementing DCTs may significantly reduce regional disparities inclinical trials in Japan.59,60
It had been perceived that implementing DCTs face a number of extremely highhurdles, such as high costs of developing new systems, increased workloads, thedelay in the adoption of ICT in healthcare settings, and the lack of complete
guidelines regarding methods of obtaining patient consent throughelectromagnetic means.61
However, the success of physician-led, fully remote DCT that began in March2022 at the Aichi Cancer Center provides one clear example that conducting DCTs
does not require special skills or vast financial resources (see Column 9).
Improving access to clinical trials for patients in rural areas should be one of the
top priorities for promoting cancer genomic medicine.62 It is desirable to ensurethat DCT-based elements are incorporated into every domestic clinical trial, while
actively sharing know-how on methods for conducting DCTs in a low-tech, low-costmanner.

59

During the COVID-19 pandemic, DCTs were disseminated rapidly in the U.S., since staying incontact with participants was difficult.
60

Since DCTs facilitates the enrollment of eligible patients in clinical trials, it is likely to shorten
clinical trial launch times while improving patient retention rates.
61

As guidance on electronic consent (e-Consent) was published recently, there are growing
expectations for it to be used as a gateway to DCTs (MHLW, “Items of Note Regarding the Use of
Electromagnetic Methods for Explanations and Consent in Clinical Trials and Postmarketing
Studies,” March 30, 2023, https://www.mhlw.go.jp/hourei/doc/tsuchi/T230331I0140.pdf).
62

It is not absolutely necessary to achieve fully remote DCTs. Even making clinical trials partiallyremote would increase treatment options for patients and greatly improve patient access.
40Column 9 - Conducting low-tech, low-cost Decentralized Clinical Trials (DCTs)
Decentralized clinical trials (DCTs) may well be conducted with extremely low
budgets and without the need to introduce large-scale systems and other such tools.
Starting in February 2022, Aichi Cancer Center has been conducting a fully remote
DCT, i.e., participants have not visited the trial site even once during the clinical trial.63
Taking a look at this initiative, we see that the Aichi Cancer Center has adopted anumber of sensible practices to reduce the physical and psychological burdens forparticipants and other related parties at both the trial site and at satellite facilities(hospitals that participants regularly visit). These practices are described below.
(1) Preparatory stages of the clinical trial (participant recruitment, etc.)
Efforts were made so clinical trial preparations could be completed in an extremely
short period (approximately 4 weeks): (i) local hospitals were able to rapidly submit
inquiries to the clinical trial site, based on information in C-CAT reports provided by theclinical trial site,64 and (ii) the outsourcing contracts to satellite sites were smoothconcluded, by adopting a template for the contract.
(2) Communication with patients
Patient consent (eConsent) was obtained and medical examinations were conducted
via Zoom for Healthcare using patients’ smartphones, with patients’ family doctors
present (D to P with D65). This eliminated the need for special online equipment orsimilar tools.
(3) Collection of test data and other information
As a general rule, patient tests and other examinations (vital signs, blood tests or CT
scans, etc.) were performed at satellite facilities. Test data and related information was
exchanged among hospitals using traditional methods like fax and mail. These practices
eliminated the need for special online systems or security measures.
(4) Delivery of pharmaceuticals
By using ordinary delivery services to send investigational drugs to patients’ homes,

63

https://cancer-c.pref.aichi.jp/uploaded/attachment/1206.pdf

64This clinical trial targeted rare diseases (namely, solid tumors harboring anaplastic lymphoma
kinase (ALK) fusion genes (excluding non-small cell lung cancer)). When Aichi Cancer Center
included the information of clinical trial site and its contact information to all C-CAT reports of thepatients who were ALK-positive, almost 100% of those patients’ family hospitals (including
cooperative hospitals for genomic cancer medicine) made contact.
65

Doctor to Patient with Doctor; online medical care that takes place while the attending physician
or other health care provider is next to the patient.
41

drug delivery costs were reduced to one-tenth of what they had been previously.66

Source: Aichi Cancer Center

As demonstrated by Aichi Cancer Center’s DCT, DCTs can be conducted with lowtechnology, low budget practices without the need to introduce particularly large-scale
systems. When conducting clinical trials, we should take active steps to adopt DCTs tofacilitate participation among patients in remote areas.67
The current rules for clinical trials allow DCTs to be conducted for medicines forinternal use. It is desirable that these rules be changed to allow therapeutics to beadministered (through intravenous infusions or injections) at satellite facilities.

66

After a thorough exchange of opinions with the Pharmaceuticals and Medical Devices Agency(PMDA; https://www.pmda.go.jp/index.html), it was agreed that there was no need to use services
specializing in the delivery of investigational drugs as long as quality could be ensured. (MHLW,“Questions and Answers (Q&A) on Ministerial Ordinance on Good Clinical Practice for Drugs (OfficeCommunication),” January 31, 2023,
https://www.mhlw.go.jp/web/t_doc?dataId=00tc7305&dataType=1&pageNo=1)
67

It is not necessary to have all trial participants participate in the clinical trials in a fully
decentralized manner. In the Aichi Cancer Center case, only a portion of clinical trial participants isparticipating remotely.
42

3.5 Actively raise public awareness, and expand education and training forcommunity hospitals
Genomic cancer medicine is a new area within the field of medicine, so it is desirable
that steps are taken to actively inform the public of its significance in information
resources and publications on general cancer medicine.
Furthermore, it will not be possible to connect family health institutions to core
hospitals and other such hospitals if understanding toward genomic medicine(including testing) among family doctors is not improved. Raising awareness at
community hospitals is the key element to establish a system that provides access togenomic cancer treatment to all patients regardless of where they live.
Cooperative hospitals for genomic cancer medicine in rural areas are currently
making efforts to notify, educate, and train their communities and local healthinstitutions on genomic cancer medicine, but they have to cover the costs of these
activities themselves.
Many community hospitals are short on staff to begin with, and their staff members
often do not possess sufficient understanding of genomic cancer medicine. It is often
the case that these hospitals turn down invitations to participate in publicity andtraining programs.
In order to extend the benefits of cancer genome medicine to the entire population,
it is necessary to enhance opportunities for the public and physicians to learn about
genomic cancer medicine by introducing a framework to subsidize these publicity,
education, and training programs.

43

4. CONCLUSION
As we have seen, improving patient access is the key factor in disseminating genomic
cancer medicine. If related parties gradually advance such efforts, more patients will beable to benefit from genomic cancer medicine.
Since know-how regarding genomic cancer medicine was insufficient when it was
first introduced, it was somewhat rational to handle it with great caution and only
allow it to be provided by those with high levels of expertise. However, there has beena significant increase in the number of CGPs being handled and this number is likely tocontinue increasing. We should be proactive about transitioning to a system designed
to handle a large number of cases nationwide, by adopting more flexible attitudes
toward a wide range of items, from specimen collection to the positioning of EPs andthe dissemination of DCTs.
At the same time, while cancer genome analysis is advancing, few driver genes(genetic mutations that drive the progression of cancer) have been discovered inrecent years. For this reason, in the U.S., only about 8% of patients who undergo CGPs
end up receiving genomic cancer treatment through an applicable drug or clinical trial.
R&D for therapeutics will continue to be important, but we see the limits of what canbe accomplished with therapeutics.
As such, from the broader perspective of cancer medicine, it goes without sayingthat efforts to promote R&D for other promising treatment methods should continue,68
while taking steps to actively promote genomic cancer medicine. Such treatments
should be combined in optimal manner to match the needs of individual patients.
Bearing this in mind, this report presents a number of practical ideas of policy
actions with respect to improving patient access in genomic cancer medicine. We hopethat this report will be of some help in promoting cancer care and further developmentof patient-oriented medicine through the cooperation and collaboration of all parties
concerned.

68

For example, in recent years, there has been a series of successes in drug discovery. This includes
the development of antibody-drug conjugates (ADCs), radiopharmaceuticals, and middle moleculedrugs. This emphasis on the drug discovery environment is driving a shift toward an approach inwhich therapeutic drug targets are identified by analyzing a broad range of information including
RNA and proteins (known as “multi-omics analysis”). (“The 113th HGPI Seminar – Current
Circumstances and Issues in Precision (Genomic) Cancer Medicine,” March 2, 2023. Lecturer:
Atsushi Otsu; https://hgpi.org/en/events/hs113-1.html)
44

ACKNOWLEDGEMENTS
We conducted hearings with healthcare professionals and patient groups in every
region of Japan (including some whose names withheld by request). We express our
deepest gratitude for their cooperation.
The recommendations in this document are based on surveys and hearings
conducted by HGPI and have been compiled in HGPI’s capacity as an independent
health policy think-tank. They do not, in any capacity, represent the opinions of any
party who participated in those hearings or the organizations to which they areaffiliated.
Collaborating parties (who participated in hearings, provided reference materials,etc.) (Titles omitted; In alphabetical order)
Cancer Genome Medical Coordinators
Kimi Fujiwara(Kochi Medical School Hospital)
Misa Hirosue(Kochi Medical School Hospital)
Miho Komatsu(Kochi Medical School Hospital)
Certified Genetic Counselors
Keika Kaneko(Clinical Genetic Medicine Department, Cancer Institute Hospital of
JFCR)
Noriko Tanabe(Genetic Medicine and Services, National Cancer Center Hospital)
Clinical laboratory testing company
SRL, Ltd.
Medical office workers
Etsuko Sato
(Medical Affairs Section, Nihonkai General Hospital)
Akari Yamaguchi (Medical Affairs Section, Nihonkai General Hospital)
Patient advocacy group representatives
Kazuo Hasegawa (NPO Lung Cancer Patient Network One Step)
Yoshiyuki Majima (NPO PanCAN Japan)
Naomi Sakurai(Cancer Solutions Co., Ltd.)
Pharmaceutical companies and pharmaceutical company representatives
Kosuke Iijima(Foundation Medicine Business Promotion Department, Chugai
Pharmaceutical Co., Ltd.)
Kiyoma Itabashi (EFPIA Japan; Clinical Department, Bayer Yakuhin, Ltd.)
Hiroyuki Kakiki(DCT Japan Co., Ltd.)MSD, K.K.
Takuya Sato
(Integrated Market Access Division, Janssen Pharmaceutical K.K.)
Daisuke Yasumizu (Integrated Market Access Division, Janssen Pharmaceutical K.K.)
Dianne A Ledesma (Market Access Division, Bayer Yakuhin, Ltd.)

45

Pharmacist
Kotone Matsuyama (Center for Strategic Research Initiative (CSRI), Nippon Medical
School)Physicians
Tatsuru Ikeda
Mitsuho Imai

(Genomic Cancer Medicine Center, Hakodate Goryoukaku Hospital)(Genetic Medicine Department/Division of Pharmaceutical Researchand Development, National Cancer Center Hospital East)

Yushi Kato
Junichi Kitazawa (Genomic Medicine Department, Aomori Prefectural Central
Hospital)
Shinji Kosugi(Genomic Medicine Course, Graduate School of Medicine andFaculty of Medicine, Kyoto University)
Kinya Matsuoka (Department of Breast and Endocrine Surgery, Ehime Prefectural
Central Hospital)
Tetsuya Mitsutomi(Division of Thoracic Surgery, Department of Surgery, Faculty of
Medicine, Kinki University)
Chigusa Morizane (Department of Hepatobiliary and Pancreatic Oncology, National
Cancer Center Hospital)
Manabu Muto
(Department of Therapeutic Oncology, Graduate School of Medicine,
Kyoto University)
Kazuto Nishio(Department of Genome Biology, Kinki University Faculty of
Medicine)
Atsushi Otsu
(Hospital Director, National Cancer Center Hospital East)
Shigehira Saji
(Department of Medical Oncology, School of Medicine, Fukushima
Medical University)
Miyako Satouchi (Genomic Medicine Clinical Trial Center, Hyogo Cancer Center)
Kentaro Sawada (Department of Oncology, Kushiro Rosai Hospital)
Toshio Shimizu(Third Lecture of Internal Medicine, School of Clinical Medicine,
Wakayama Medical University)
Kenki Sugimoto (Genomic Cancer Medicine Center, Kochi Medical School Hospital)
Kuniko Sumina(Clinical Laboratories, National Cancer Center Hospital)
Yu Sunakawa(Department of Clinical Oncology, St. Marianna University School of
Medicine)
Shuhei Suzuki(Department of Oncology, Faculty of Medicine, Yamagata University)
Hiroya Taniguchi (Department of Pharmacy, Aichi Cancer Center)
Arisa Ueki
(Genetic Clinical Medicine Department, Cancer Institute Hospital of
the Japanese Foundation For Cancer Research (JFCR))
Yasushi Yatabe(Division of Molecular Pathology, National Cancer Center Hospital)
Takayuki Yoshino (Department of Gastrointestinal Oncology, National Cancer Center
Hospital East)46

Project sponsors (In alphabetical order):Bayer Yakuhin, Ltd.
Chugai Pharmaceutical Co., Ltd.
Janssen Pharmaceutical K.K.
MSD K.K.
◆ About Health and Global Policy InstituteHealth and Global Policy Institute (HGPI) is a non-profit, independent, non-partisan healthpolicy think tank established in 2004.
In its capacity as a neutral think-tank, HGPI involves stakeholders from wide-ranging fields ofexpertise to provide policy options to the public to successfully create citizen-focusedhealthcare policies. Looking to the future, HGPI produces novel ideas and values from astandpoint that offers a wide perspective. It aims to realize a healthy and fair society while
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◆For inquiries, please contact:
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