November 2022
Health and Global Policy Institute

Policy Recommendations: Furthering the Development of Precision Cancer Medicine—Proposals for Effective Policy Changes Based on Key Characteristics of Precision Medicine inCancer Treatment—

Summary
While remarkable progress has been made in cancer medicine in recent years, there are particularlyhigh expectations for precision medicine to play a critical role in cancer treatment in the future. This
field, sometimes referred to as precision cancer medicine, is a form of treatment tailored toindividuals based on the genetic mutations and other characteristics of their cancer.
To further develop precision cancer medicine, it will be necessary to overcome policy issues invarious areas including: (i) access to medical care, (ii) human resource development, (iii) researchand development, (iv) regulatory approval and health insurance coverage, and (v) patient support.
Although many of these issues are shared among various forms of cancer medicine, precision cancer
medicine has the following three key characteristics which further complicate efforts to address
them, namely: (a) the number of medical indications for its use are still quite limited; (b) it involves
the use of genetic information; and (c) the costs of testing and treatment are often expensive. As
such, attempts to address the policy issues mentioned above will be more effective if they have afirm basis in these key characteristics. Based on a recognition of this issue, Health and Global Policy
Institute (HGPI) offers the following recommendations to promote the development of precisioncancer medicine:
Recommendation I: To effectively allocate human resources and aggregate knowledge, a “hub-andspokes” network should be developed across all areas, including (i) healthcare delivery systems, (ii)human resources, (iii) research and clinical trials, and (iv) patient support measures. When doingso, proactive steps to adopt information and communication technology (ICT), including the use of
online services, should be taken to streamline the aggregation of information and medical
resources.
Recommendation II: While establishing data repositories for genetic information, legislationprohibiting discrimination based on genetic information should be enacted and public awarenessactivities should be conducted.
Recommendation III: Regulatory approval, health insurance coverage, and other conditions
governing the use of precision cancer medicine should be revised to be made more scientific andrational in a manner that complements the key characteristics of precision cancer medicine andpractical needs in clinical settings.
HGPI strongly hopes these recommendations will be utilized in future cancer control measures tofurther develop patient-centered healthcare.
1November 2022
Health and Global Policy Institute

Introduction
Remarkable progress has been made in cancer therapies in recent years, particularly in precisioncancer medicine, in which treatment is tailored to individuals based on the genetic mutations andother characteristics of their cancer.
While the devoted efforts of related parties have resulted in a steady increase in successfultreatments and other accomplishments for precision cancer medicine, like other areas of cancer
medicine, it faces various issues related to policy. Moving forward, it will be crucial to steadily
overcome these issues with particular attention on the voices of people who serve in healthcare
settings as well as those of patients. When doing so, adequate attention must be paid to the key
characteristics of precision cancer medicine, namely: (a) the number of medical indications for its use
are still quite limited; (b) it involves the use of genetic information; and (c) the costs of testing andtreatment are often expensive. It is desirable that proactive steps are taken to effectively address
policy issues while keeping these characteristics in mind.
In recognition of these issues, Health and Global Policy Institute (HGPI) kicked off an initiative called
the “Project for Considering the Future of Precision Medicine with Industry, Government, Academia,
and Civil Society” in FY2021. The recommendations offered in this document are based on repeateddiscussions we have held with various experts in this area as part of that initiative.
In this proposal, after (i) providing a simple explanation and overview of precision cancer medicine,including genomic cancer medicine, and their characteristics, we will (ii) arrange current policy issues
by key area and (iii) provide recommendations based on those issues and, under three pillars, outline
the policy actions we believe are most important to take now.
The fourth-term Basic Plan to Promote Cancer Control Programs will come into effect in 2023. HGPI
strongly hopes these recommendations will be utilized in future cancer control measures to further
develop patient-centered healthcare.

2November 2022
Health and Global Policy Institute

Table of Contents
Introduction ........................................................................................................................................... 2
1 An overview of precision cancer medicine .................................................................................... 4
1.1
What are precision cancer medicine and genomic cancer medicine?.................................... 4
1.2
Key characteristics of precision cancer medicine ................................................................... 8
2. Major policy issues facing precision cancer medicine.................................................................... 9
2.1
Summary ................................................................................................................................ 9
2.2
Policy issues by key area ......................................................................................................... 9A) Improving healthcare access and achieving equity in the healthcare provision system ........ 9B) Scope of health insurance coverage ..................................................................................... 12
C) Research and development (including clinical trials, effective data utilization, etc.) ........... 13
D) Regulatory approval and related topics ................................................................................ 14E) Ethical, Legal and Social Issues (ELSI).................................................................................... 17
F) Patient and Public Involvement (PPI).................................................................................... 18
3. Recommendations ....................................................................................................................... 20
3.1
Key points of our three recommendations ........................................................................... 20
3.2
Explanation of Recommendation I ....................................................................................... 21
1. Basic concept ........................................................................................................................ 21
2. Content of recommendation ................................................................................................ 21
3.3
Explanation of Recommendation II ...................................................................................... 24
1. Basic concept ........................................................................................................................ 24
2. Content of recommendation ................................................................................................ 24
3.4
Explanation of Recommendation III ..................................................................................... 25
1. Basic concept ........................................................................................................................ 25
2. Content of recommendation ................................................................................................ 26
Conclusion ........................................................................................................................................... 27
Acknowledgements ............................................................................................................................. 29

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November 2022
Health and Global Policy Institute1

An overview of precision cancer medicine
1.1

What are precision cancer medicine and genomic cancer medicine?

Precision cancer medicine refers to cancer treatment that is tailored to individuals. More specifically,
it is the administration of drug therapies that target the mutated sections of genes of each individual’s
cancer cells.1 (For more information, please refer to “Reference 1 – The Definition of Precision Cancer
Medicine.”)Another term that is often used alongside precision cancer medicine is genomic cancer medicine.
This document defines genomic cancer medicine as a field of precision cancer medicine, in which tests
focusing on the genome (all genetic information starting with genes) are conducted, and treatment
decisions are made according to test results (in which drug therapy is based on genomic information).2
In conventional cancer drug therapy, cancers are usually perceived in terms of the affected organ,and drugs are administered with the expectation they will be effective for that type of cancer. In
precision cancer medicine, the cancer cells of the individual patient receiving treatment are identified
as the section of the gene where mutations are occurring, and drugs that are particularly effective on
those mutated genes and molecules called molecularly targeted drugs3 are selected and administered.
In this manner, compared to conventional cancer drug therapy, more targeted therapies areadministered in precision cancer medicine, and this can reduce burdens on patients, increase response
rates, and achieve better outcomes.
Recently, applications of precision cancer medicine have been gradually expanding. For example, inclinical settings, when considering optimal treatments for certain forms of cancer, like lung or breast
cancer, it has become common practice to first conduct cancer gene tests to detect genetic mutations
that can be targeted by molecularly targeted drugs.
In general terms, however, precision cancer medicine is (1) a form of therapy that targets specificgenetic mutations for which the number of indications is still limited.4 Additionally, (2) conducting the1

Cancer cells are known to develop due to genetic mutations that generally occur because of factors like lifestyle and aging.

However, certain cancers (called “familial” or “hereditary” tumors) occur due to strong influence from the genes in normal
cells throughout the entire body (which cause “inborn” or “congenital” mutations).
2

The third-term Basic Plan to Promote Cancer Control Programs (which was enacted by Cabinet Decision on March 9, 2018)

defines genomic medicine as “providing medical treatment according an individual’s physical characteristics or symptoms
based on information, particularly individual genetic information, obtained using any form of omics-based testing.” (Page 16
footnote, https://www.mhlw.go.jp/file/06-Seisakujouhou-10900000-Kenkoukyoku/0000196975.pdf)
3

Even for two different types of cancer, one molecularly targeted drug may be effective for both if the mutated sections of

the gene are the same.
4

If all pathogenic mutations that may be targeted through precision cancer medicine are taken together, the number ofpatients is by no means small. However, the highly individualized nature of mutations means there is only a limited numberof patients with each pathogenic mutation. Furthermore, even if certain genetic mutations are detected, there are manycases in which drugs that are likely to effectively target that mutation have not yet been developed.
Because it is likely that the number of drugs and other therapies will increase as research advances, it is safe to say that the4November 2022
Health and Global Policy Institutegenetic testing required before precision cancer therapy can be provided requires advanced
technology and highly-trained specialists. Furthermore, because (3) certain tests and molecularly
targeted drugs are expensive, national health insurance coverage is limited.
(Reference 1) The definition of precision cancer medicine
While the definition of precision cancer medicine can vary depending on the source, in this document,
we use it to refer to all tests and treatments that (1) focus on the mutated sections of genes to (2)provide the optimal drugs for those mutations (Table 1).
In practice, definitive cancer diagnoses are usually reached by using a combination of multiple testing
methods, such as those listed in Table 1. For example, imaging studies may be combined withpathological examinations.
There are cases in which cancer gene tests or other such tests are conducted but molecularly targeteddrugs or similar treatments are not selected.5 We include such cases within the scope of “precisioncancer medicine,” since the testing phase focuses on genetic mutations.6

number of diseases for which precision therapy is indicated is still limited at this time.
5

When (1) drugs that can be expected to effectively target a genetic mutation have not yet been developed, or (2) genomic

cancer testing does not reveal specific genetic mutations that are targeted by existing molecularly targeted drugs, then it isassumed that existing molecularly targeted drugs will not be effective even if administered, and other treatment methods
are pursued.
6

There are also cases in which testing reveals the presence of inherited genetic mutations that are likely to result inhereditary tumors.

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November 2022
Health and Global Policy Institute
Table 1: Defining precision cancer medicine
Main test types

Main treatment methods

Imaging studies• Surgical operation• X-ray exam
• PET scan
• Echocardiography, etc.
Pathological exam

• Radiation therapy(examination of cells withmicroscope)• Cytological exam

Treatment
methoddeterminedaccordingto results• Bone marrow test, etc.
Biomarker testing(focusing on characteristics
of genes and proteins)• Chemotherapy(treatment with anticancer drugs)• Tumor marker test
• Molecularly targeteddrugs used

• Cancer gene test

Precision cancer
medicine(companion diagnosis)• Cancer gene panel
test (cancer genomic• Immunotherapy, etc.

profile)(Reference 2) Methods of conducting genetic testing for cancer
The two methods of genetic testing for cancer are (1) cancer gene testing (companion diagnostic
testing) and (2) cancer gene panel testing (genomic cancer testing or profiling). Summaries of testing
methods and their characteristics are provided below.
a. Cancer gene testing (companion diagnostic testing)
To determine if a certain drug (namely, a molecularly targeted drug) will be effective for the cancerof the patient in question, a single test is conducted to detect mutations in one or multiple genes. As
a general rule, these tests involve the use of diagnostic agents called companion diagnostics, or CDx.7
For certain types of cancer, such as lung cancer or breast cancer, these genetic tests are covered byinsurance and are currently used in clinical settings to provide precision cancer therapy.
b. Gene panel testing (genomic cancer testing or profiling)
These procedures use a single test to detect the presence or absence of mutations in many genes,
usually over 100. As the results of these tests can make it possible to more accurately grasp the7

The name “companion diagnostic” is derived from the fact that these diagnostic agents are administered before specificmolecularly targeted drugs as sets (companions), matched on a one-to-one basis.

6

November 2022
Health and Global Policy Institutecharacteristics of the cancer that is to be treated (namely, the types of mutations), expectations arehigh that they will contribute to therapies using advanced treatments. However, they are even more
expensive than option (1) above because they use specialized equipment to read vast amounts ofgenetic information at high speeds.
Due to the high cost of cancer gene panel testing (and subsequent genome information-based drug
therapy), the use of these treatments – known as genomic cancer therapy – is, in most cases, subject
to strict conditions. These include situations when no standard treatments are available or when
standard treatments have already been completed. As a result, their use is often limited to advanced
medical treatments and clinical trials.8
Furthermore, the genetic mutations detected by cancer gene panel tests are subject to review bycommittees that include multiple specialists called expert panels. This is another reason that precisioncancer therapy is considered an advanced medical treatment.

8

Certain tests are covered by insurance.

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Health and Global Policy Institute

1.2

Key characteristics of precision cancer medicine

As seen above, precision cancer medicine is a promising method of treating cancer. However, it
possesses three key characteristics: (a) the number of medical indications for its use are still limited;(b) it involves the use of genetic information;9 and (c) testing and treatment tend to be expensive(Table 2).
Table 2: Key characteristics of precision cancer medicine(a) The number of medical indications for its use are stillquite limited(b) It involves the use of genetic information.
(c) The costs of testing and treatment are often expensive.

In general, existing testing, examination, and treatment systems have been designed around thepremise of examining cancers by organ. In contrast, in precision cancer medicine, diseases are
examined with the focus on genetic mutations. Therefore, in order to fully incorporate and utilize
precision medicine within cancer treatment, a paradigm shift that encompasses all cancer testing,examination, and treatment systems (as well as R&D, regulatory approval, and patient support
systems) is needed. Furthermore, because it can be said that its development is still an ongoing processof this, many policy issues exist.
Given these circumstances, when addressing the various policy issues for precision cancer medicine,
it is necessary that effective actions are taken in a proactive manner and are firmly based on the key
characteristics of precision cancer medicine. (These actions will be described in a later section.)9

Not only is advanced technology required to conduct genetic testing, careful measures are also required to protect genetic

information, which is highly personal. (These measures will be described later.)8

November 2022
Health and Global Policy Institute

2. Major policy issues facing precision cancer medicine
2.1 Summary
On one hand, while precision medicine is an emerging form of cancer treatment, the many policy
issues it faces are s not uncommon within the realm of cancer treatment methods.
For example, it goes without saying that a key issue for all forms of cancer medicine is improving
access by establishing health systems that allow all patients and citizens in all regions to receive
treatment in an equitable manner.10
On the other hand, as previously discussed, precision cancer medicine (a) is still only indicated for alimited number of diseases, (b) involves the use of genetic information, and (c) tends to involve
expensive tests and treatments. Accordingly, (i) there are a number of policy issues unique to precisioncancer medicine, and (ii) even when the issues it faces are shared with other forms of cancer medicine,
there are times overcoming those issues in precision cancer medicine is more difficult.
For example, regarding healthcare access there is often a lack of trained specialists or facilities thathave been established to provide precision cancer medicine. This reflects the first two key
characteristics, ((a) the number of indications is still limited and (b) it involves the use of genetic
information). Such issues make it more difficult to achieve equitable access to care while still centering
care around existing core cancer hospitals.11
Taking these characteristics into account, current policy issues for precision cancer medicine in eachkey area have been summarized in the following section.
2.2 Policy issues by key areaA) Improving healthcare access and achieving equity in the healthcare provision system
As to healthcare access, policy issues on precision cancer medicine may be categorized as follows:10

For example, looking at the current number of core hospitals and other institutes providing general cancer treatments, inaddition to (i) the National Cancer Center, which serves as the central medical institution for cancer and has two locations,
there are also (ii) core hospitals for coordinated cancer care (including (a) 51 prefectural core hospitals for coordinated cancer
care and (b) 354 regional core hospitals for coordinated cancer care, with around one in each secondary care area). Efforts
to consolidate care and achieve nationwide care equity are currently underway, but disparities in progress among prefectures
still exist. (Listed numbers of institutions current as of April 1, 2022.)
11

In recent years, steady developments have been made in establishing systems for providing genomic cancer treatment.

For example, (i) data from genetic tests is now being gathered at a central location, the Center for Cancer Genomics andAdvanced Therapies, (ii) a system for designating healthcare institutions to provide genomic cancer care and to enable
collaboration among care facilities have been established, and (iii) expert panels have been established at core hospitals forgenomic cancer care and similar facilities for evaluating test results and proposing optimal approaches to treatment. As of
May 2022, there are currently (a) twelve central cancer hospitals for genomic cancer treatment, (b) 33 core cancer hospitals
for genomic cancer treatment, and (c) 188 core hospitals for coordinated genomic cancer treatment (which coordinate withthe facilities described in (a) and (b) to conduct cancer gene panel tests).

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November 2022
Health and Global Policy Institute(1) Need to establish care provision systems and similar systems centered around core hospitals
As discussed above, there are shared issues between precision cancer medicine and the field ofcancer medicine as a whole with respect to establishing care provision systems and similar systems
centered around core hospitals. Sufficient progress, however, has yet to be made in efforts to build
said systems for precision cancer medicine, due to one of its key characteristics: ((a) only indicated fora limited number of diseases) (Table 3-A: A-1).12(2) Shortages of specialists including physicians and nurses
Shortages of specialists, including physicians and nurses, is commonly seen in all types of cancer care
(Table 3-A: A-2). However, for precision cancer medicine, (a) the number of indications is still limitedand (b) it involves the use of genetic information, so educating and securing specialized humanresources (including pathologists, clinical laboratory technicians, genetic counselors, 13 and expert
panel members) presents a major challenge (Table 3-A: A-2 through A-4).

12

Similar circumstances can also be seen for rare diseases which affect relatively few patients, such as Parkinson’s disease

and ulcerative colitis.
13

Genetic counselors: Specialists who utilize their expertise in genetics to support patients (such as by providing them withpsychological care, counseling, or appropriate medical information).

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Health and Global Policy Institute
Table 3-A: Main policy issues for precision cancer medicine (Improving access to care, etc.)◎: Key characteristic of precision cancer medicine, etc. with arelatively strong relationship to an individual issue〇: Key characteristic of precision cancer medicine, etc. related to anindividual issue（A) Improving Access and Equal Distribution of Medical Care
Issues Related to Precision Cancer Medicine

Issue
A- 1

Explanation andCommon Issue

Supplementary Information

Medicine in

Disparities in Access to

Improvement from a hardware approach remains difficult

Medical Care Delivery

due to population decline and budget issues. Use of ICT can

Systems that are

be expected to improve access disparities from a software

Centered Around Corein Cancer
General(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

〇

◎

〇

〇

◎

◎

◎

◎

◎

◎

approach, but currently its use is limited.
Not all medical personnel possess knowledge andA- 2

Human Resource

experience related to precision cancer medicine, andShortages

training opportunities are limited. Development of human（physicians, nurses,

resources is especially difficult in rural areas. In thedevelopment of core hospitals for precision cancer medicine,pathologists, clinical

it is necessary to meet the requirements for human resource

technologists)

standards and medical treatment systems within eachfacility.
As genomic medicine continues to develop, the demand for

Human Resource

A- 3

Shortages（genetic counselors）

genetic counselors is expected to rise. Despite this need,certification is carried out only by academic societies.
Furthermore, the training of genetic counselors is also achallenge not only in terms of quantity, but in terms of
quality as well.
There is concern that widespread implementation of
precision cancer medicine and the associated tests andA- 4

Expert Panel Shortages

diagnosis that go with it will cause even large hospitals to
face difficulties in providing expert panels and other related
services.

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November 2022
Health and Global Policy InstituteB) Scope of health insurance coverage
Regarding health insurance coverage, it is not surprising to see that precision cancer medicine faces
significant limitations since (c) tests and treatments for precision cancer medicine tend to be
expensive. However, when looking at the current scope and conditions for health insurance coverage,
we see that they do not sufficiently reflect the latest scientific advances and needs in clinical settings.
In addition, when examining those conditions from a health economics perspective, we see that manyof them have become unreasonable.14
Policy issues on health insurance coverage of precision cancer medicine may be categorized into thefollowing:(1) Limited scope of health insurance coverage for testingFirst, when using companion diagnostics, even though it is not rare for measurements to fail becauseof factors like insufficient specimen volume or poor specimen quality, tests in which specimens havebeen resubmitted are not covered. This causes an unreasonable problem – namely, that retesting isvirtually impossible (Table 3-B: B-1).
Second, despite the fact that it is extremely important to monitor for gene mutations that may occur
over the course of treatment to enhance treatment outcomes, liquid biopsies,15 which provide that
information, are not covered by insurance (Table 3-B: B-2).
Third, despite the fact that conducting cancer gene panel tests16 at diagnosis has the potential toresult in better prognosis, at the present, these tests can only be performed after patients havecompleted standard treatments. Because of this, there have been very many cases in which a patient
can no longer undergo a treatment by the time they get their test results, which is a serious problem(Table 3-B: B-3).
(2) Limited scope of health insurance coverage for medical services
Despite being an essential part of genetic testing, genetic counselling is not usually covered by

14

If, when utilizing precision cancer medicine, (1) patients with genotypes that are eligible for new treatments are identified

in advance by screening with cancer gene panel tests and other such tests and (2) the majority of patients (those who do notpossess the genetic mutations that would make them eligible for targeted therapies) are provided with standard treatments,
it would not only be much more scientific, it would also be much more likely to achieve patient-centered healthcare. In fact,
it is safe to say this is already happening to a degree for certain types of cancers, such as lung cancer or breast cancer.
For other types of cancer treatment, however, owing to the fact that (c) testing and treatments tend to be expensive, anissue rooted in health economics, testing is currently treated as something that should only be conducted in a limited capacity.
Promising treatments are not being sufficiently provided nor is sufficient evidence being gathered, which results in negative
effects for “D. Regulatory Approval” (described in a later section).
15

An analysis of genes contained in bodily fluids samples (“liquid biopsy samples”) such as blood, urine, sputum,

cerebrospinal fluid, and stool.
16

Health insurance currently covers three cancer gene panel tests.

12November 2022
Health and Global Policy Instituteinsurance. This demonstrates an imbalance between what is covered and what is not (Table 3-B: B-4).
(3) Timing the start of genomic cancer therapy
Patients generally cannot begin genomic cancer therapy unless they have already completed
standard treatments. This means patients with conditions where prognosis is severe, like pancreaticcancer, face absurd situations in which they cannot receive what are likely to be optimal treatments atearly stages (Table 3-B: B-5).
Table 3-B: Main policy issues for precision cancer medicine (Scope of health insurance coverage)（B)Scope of Health Insurance Coverage
Issues Related to Precision Cancer Medicine

Issue

Explanation andCommon Issue

Supplementary Information

Medicine inin Cancer
General(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Limitations related to theB- 1

Number of Tests（companion diagnostics

Re-testing due to technical failures is not covered byinsurance. A significant number of such cases have been

〇

◎

〇

◎

〇

◎

〇

◎

〇

◎

observed, creating a barrier to optimal treatment.

(CDx)）

Limitations related to theB- 2

Number of Tests andTesting Period

Insurance does not cover the monitoring that is necessary to
examine dynamic genetic changes over the course oftreatment.

（liquid biopsies）

B- 3

Limitations related to the

If done at the time of diagnosis, cancer gene panel testing

Timing of Testing

has the potential to improve treatment prognosis. However,（cancer gene panel

it currently is not carried out until after standard cancer

test）
Limitations related toB- 4Target Services

treatment has finished.

Insurance does not cover much of the genetic counselingthat is required in conjunction with genetic testing.

（genetic counseling）
Limitations related to theB- 5Genomic therapies are only available after the completion

Timing of Treatment

ofstandard cancer treatment (or in the absence of possible（cancer genome

standard treatment), which prevents early access to optimal

medicine）

treatment.

C) Research and development (including clinical trials, effective data utilization, etc.)
With regards to research and development (including clinical trials, effective data utilization, etc.),
policy issues generally fall into one of three categories:(1) Reinforcing collaboration among researchers and health specialists or among organizations
Collaboration among researchers and health specialists or between organizations is a shared issue
for all forms of cancer medicine. Precision cancer medicine, however, faces additional issues because(a) the number of indications is still quite limited. In particular, (a) insufficient systems and humanresources have resulted in regional disparities in access to clinical trials; (b) it is difficult to gather
sufficient data for clinical trials and similar efforts because overall patient numbers are low in terms ofaffected organ or genetic mutation; and (c) it is difficult for hospitals to coordinate (Table 3-C: C-1 and
C-2).
13

November 2022
Health and Global Policy Institute(2) Building databases and making effective use of data
Another issue that is common across cancer medicine is building databases and making effective useof data. Particular care must be taken for precision cancer medicine, however, because (b) it involves
the use of genetic information (Table 3-C: C-3 and C-4).17(3) Providing feedback on the results of research to the patients and general public
Another policy issue shared among all cancer treatments is returning the results of research to thepatients and to general public. Once again, particular care is necessary with precision cancer medicine
because it (b) involves the use of genetic information. Regardless, efforts to establish systems to sharesuch information and return it to the public have been slow (Table 3-C: C-5).
Table 3-C: Main policy issues for precision cancer medicine (Research and development)（C）Research and Development（Clinical Testing, Data Use, etc.）
Issues Related to Precision Cancer Medicine

Issue

Explanation andCommon Issue

Supplementary Information

Medicine inin Cancer
General(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Although core hospitals are supposed to play a central roleC- 1

Lack of Collabortaion
between Core Hospitals

in promoting clinical trials, there are geographical disparities
in terms of access to clinical trials. In order to increase the

〇

◎

〇

〇

◎

〇

〇

◎

〇

〇

◎

number of participants in clinical trials, close collaboration
among core hospitals is necessary.

Lack of Collaboration

C- 2

Along with the commencement of the "Anti-Tumor Drug

between Industry,

Development Forum", efforts have been made to promote

Government, andcollaboration between industry, government, and academia.

Academia
Delay in the Construction

C- 3 of a Database for
Genomic Information

However, further efforts are needed.
Systems and methods for utilizing results from wholegenome analyses are being investigated as a part of theWhole Genome Analysis Action Plan. However, theconstruction of a large-scale Japanese whole genome
sequence data base has been delayed.

Delay in the Industrial

C- 4

Utilization of Data for
Secondary Uses, DrugDue to the protection of personal information andmaintenance of database construction, secondary uses ofregistry data from academic societies have not progressed.

Discovery, etc.
Insufficient Return of

C- 5 Research Results toPatients and the Public

The current system is not structured to provide prompt
feedback to patients when new treatments are developed asa result of research. The current structure also makes it〇◎

difficult for patients to understand the benefits ofparticipating in research.

D) Regulatory approval and related topics
Looking at how precision cancer medicine is handled during regulatory approval and similar processes,
there are certain aspects that do not line up with conditions in research and development or in clinical17

The “Basic Policy on Economic and Fiscal Management and Reform 2022” (approved by Cabinet Decision on June 7, 2022)

reads, “To promote drug discovery related to cancer and intractable diseases, we will build information infrastructure thatlinks and carries clinical information and such information as the results of whole genome analyses, and immediately lay
down the groundwork for its utilization.”(https://www5.cao.go.jp/keizai-shimon/kaigi/cabinet/2022/2022_basicpolicies_en.pdf, page 46)

14November 2022
Health and Global Policy Institutesettings, and that could be considered unreasonable.
Policy issues on regulatory approvals of precision cancer medicine may be categorized into two as
follows:(1) Regulatory approval for therapeutic agents
Simultaneous approval is required for the companion a diagnosis (that (b) involves the use of genetic
information) and the drug that is to be prescribed based on the results of the genetic test. Although,there is a certain degree of rationality to perceiving companion diagnostics and therapeutic agents asa single treatment set to be matched on a one-to-one basis, therefore requiring simultaneous approval,
this means that even when a proven therapeutic agent is already available, it will not receive approval
from regulatory bodies until approval is granted to the companion diagnostic to which it will be paired.
This contributes to what is known as a drug lag.
Furthermore, recent development in medical science have resulted in more complex methods ofdetecting the presence or absence of specific genetic mutations, making it less necessary for those
items to be matched as sets. As such, the time has come to review the practice of approving diagnostics
and therapeutic agents as a set (Table 3-D: D-1).18(2) Verifying the effectiveness of diagnostic and therapeutic agents
There are also major issues for verifying the effectiveness of diagnostic and therapeutic agents (using
cost-effectiveness calculations).
For example, for cancer gene panel tests, as discussed above in “B. Scope of health insurance
coverage,” (c) tests and treatments tend to be expensive. This means they face very restrictive
conditions for coverage, and despite the fact that their use at diagnosis could lead to better prognosis,
tests can currently only be performed after standard treatments are completed. It is safe to say thiscreates unreasonable obstacles for cancer gene panel tests and genomic cancer therapy during costeffectiveness assessment (Table 3-D: D-2).19
In addition, because (a) the number of indications for precision cancer medicine is still limited, it isdifficult to make regulatory approvals or pharmaceutical prices that are based on sufficient evidence.
It will be necessary to conduct a thorough review of the evidence assessment framework, while taking
into account the characteristics of precision cancer medicine (Table 3-D: D-3).

18

For example, examples of therapeutic agents being granted earlier approval with greater flexibility are starting to appear

in the U.S.
19

This could be considered an issue to address by reviewing the conditions for insurance coverage, which have been mademore restrictive because testing and treatments are costly.

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Health and Global Policy Institute
Table 3-D: Main policy issues for precision cancer medicine (Regulatory approval, etc.)（D）Regulatory Approval
Issues Related to Precision Cancer Medicine

Issue

Explanation andCommon Issue

Supplementary Information

Medicine inin Cancer
General(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Requirements for
Approval of Therapeutics（requirement that

Approval of therapeutic drugs is delayed in comparison toother countries (one of the causes of drug lag). Flexible

D- 1 therapeutics are approved measures such as pre-approval of therapeutics areat the same time as

〇

◎

〇

◎

〇

〇

necessary.

companion diagnostics(CDx)）
Cost-effectivenessD- 2Cancer gene panel testing is currently limited to after

Calculations

standard cancer treatment has finished. This inevitably（timing of cancer gene

reduces the cost-effectiveness of testing and cancer

panel testing）

genome therapy.

Cost-effectivenessCalculations

D- 3

At present, indications for the use of precision medcine is（need for evidence based limited, making it difficult to gather the necessary evidence
on the uniquecharacteristics offor approving and determining market-prices of therapeutic
drugs.

precision medicine）

16◎

November 2022
Health and Global Policy InstituteE) Ethical, Legal and Social Issues (ELSI)
Generally speaking, policy issues in the area of Ethical, Legal and Social Issues (ELSI)20 are shared
between precision cancer medicine and the field of cancer medicine as a whole, and should be
addressed in a comprehensive manner.
For example, learning the results of cancer gene panel tests places extreme psychological burdensand other burdens on patients.21 At the same time, this could be considered an issue that is sharedfor all forms of cancer medicine. In this case, it is likely that comprehensive measures that encompass
other forms of cancer medicine will be more effective for providing patient-centered responses (Table
3-E: E-1 to E-2).
When it comes to precision cancer medicine, however, there are some areas that require additional
consideration because it (b) involves the use of genetic information:(1) Social discrimination
Regarding social discrimination, one issue that is unique to precision cancer medicine is that (b) it
involves the use of genetic information. To prevent this from causing discrimination or other harm, it
will be important to implement broad allowances in terms of both legislation and social awareness(Table 3-E: E-3).
(2) Securing health-related data
As to securing health-related data, it is necessary to handle personal information related to precisioncancer medicine in an even more careful manner than when handling other private health and medical
data, because (b) genetic information can be considered the most private form of personal
information (Table 3-E: E-4).

20

ELSI is a concept that refers to all non-technical challenges that may arise during research, development, and theimplementation of new science and technology in society. In the area of precision cancer medicine, it encompasses multifaceted issues such as: (1) methods of managing genetic information, an extremely personal form of information; (2) methodsof communicating and providing psychological care to patients and their families when genetic diseases are detected in test
results; and (3) preventing or addressing discrimination or social disadvantages that may occur as a result of genetic diagnoses.
21

Because the results of genetic information analysis can detect a potential disease not only for the patient but also theirblood relatives, special consideration should be paid when providing said results.

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Health and Global Policy Institute
Table 3-E: Main policy issues for precision cancer medicine (Ethical, Legal and Social Issues (ELSI))（E）Ethical, Legal, and Social Implications（ELSIs）
Issues Related to Precision Cancer Medicine

Issue

Explanation andCommon Issue

Supplementary Information

Medicine inin Cancer
General(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Reducing theE-

1

Psychological Burden on

It is anticipated that there will be cases in which the results

Patients

of genetic analysis show that effective methods using（in the case thatprecision cancer medicine

precision cancer medicine may not be an option. Sufficient

◎

〇

◎

〇

〇

◎

〇

◎

communication with the patient and the family is required
beforehand regarding this possibility.

is not an option）
Reducing thePsychological Burden on
Patients

E-

2（in the case that apatient is found to have agenetic mutation that is

In cases where it is revealed that a patient has a genetic
mutation associated with hereditary cancer, it is possiblethat related family members carry the same mutation.
Sufficient communication with the patient and the family isrequired beforehand regarding this possibility.

associated with hereditarycancer）
Remediating Social

E-

3

Discrimination（in the case of certain

In addition to legislating the prohibition of genetic
discrimination, it is necessary to raise awareness, includingin school education, for a wide range of generations.

genetic mutations）

Protection of PersonalE-

4

The development of guidelines for the handling of genetic

Data related to Medical

information is in progress. As a prerequisite for the use ofCare and Genetic

this data, it is necessary to establish a system for the

Information

protection of personal information.

F) Patient and Public Involvement (PPI)On the topic of policy issues related to Patient and Public Involvement (PPI),22 just as with the Ethical,
Legal and Social Issues (ELSI) described above, we believe that there are many items that should be
addressed as shared issues for both precision cancer medicine and other forms of cancer medicine(Table 3-F: F-1).23
In general, it is difficult to establish and foster patient advocacy organizations for diseases where (a)the number of indications is limited. However, we may, consider educating and supporting patient
22

Patient and Public Involvement (PPI): The act of researchers utilizing the knowledge possessed by patients and citizens(including the family members of patients, former patients, and future patients) as reference throughout the processes of
medical research and clinical trials (AMED: Japan Agency for Medical Research and Development, AMED;
https://www.amed.go.jp/ppi/teiginado.html). In recent years, the concept of PPI has evolved, and it is now considerednecessary to not only involve patients and citizens in research, but in all aspects of health, including in health policy and indecision-making forums (Office of Pharmaceutical Industry Research, https://www.jpma.or.jp/opir/news/065/02.html).
23

For example, patient advocacy groups are currently participating in formulating guidelines for certain types of cancer. As

these sorts of activities expand to include other types of cancer, it will be necessary to establish a framework that enables
patient participation from the earliest stages of all policy discussions, including during asset development.

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November 2022
Health and Global Policy Instituteadvocacy organizations as a critical first step for promoting PPI in precision cancer medicine (Table 3F: F-2).24 25
Table 3-F: Main policy issues for precision cancer medicine (Patient and Public Involvement)(F) Patient and Public Involvement（PPI）
Issues Related to Precision Cancer Medicine

Issue

Explanation andCommon Issue

Supplementary Information

Medicine inin Cancer
General(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Involvement of PatientGroupsF-

1 （development of

Although PPI initiatives are underway, they are notsufficiently developed in the field of precision cancer
medicine.

◎guidelines, process ofregulatory approval, etc.）
In particular, it would be desierable to foster cultivatepatient groups that can be involved in policy making andF-

2

Supporting and Fostering other advocacy activities. The formation of patient groups isPatient Groups

considered to be difficult when the number of cases is〇◎small. Precision cancer medicine is considered to fall within
this category.

24“Rare cancers,” for example, are defined as tumors with fewer than 6 cases per 100,000 people, making them extremely

uncommon. This makes it difficult for affected parties to readily form connections with people with similar diseases who live
nearby to share problems and concerns.
25

Overseas, there are movements to establish patient advocacy groups that match people by “driver genes” which areclosely linked to the growth and spread of cancer cells.

19November 2022
Health and Global Policy Institute

3. Recommendations
3.1 Key points of our three recommendations
As discussed in the previous section (Section Two), precision cancer medicine faces various policy
issues across a wide range of areas, many of which are closely linked to its key characteristics: (a) the
number of indications is limited, (b) it involves the use of genetic information, and (c) the costs oftesting and treatment are often expensive.
Given these circumstances, we believe that thorough consideration of these characteristics willcontribute to more effective policy approaches. Specifically, it is desirable that multi-faceted policy
responses are taken under the pillars of the three recommendations described below (Table 4).
Table 4: Responding to policy issues of precision cancer medicine (key points)

Key characteristic ofThree recommendations

precision cancer
medicine(a) The number ofRec. I: To effectively allocate human resources and aggregate

indications isknowledge, a “hub-and-spokes” network should be developed across all

still quite

areas, including (i) healthcare delivery systems, (ii) human resources,

limited(iii) research and clinical trials, and (iv) patient support measures.
When doing so, proactive steps to adopt information andcommunication technology (ICT) including the use of online services,
should be taken to streamline the aggregation of information andmedical resources.

(b) It involves theuse of genetic
information

Rec. II: While establishing data repositories for genetic information,
legislation prohibiting discrimination based on genetic information
should be enacted and public awareness activities should be conducted.
Rec. III: Regulatory approval, health insurance coverage, and other(c) The costs ofconditions governing the use of precision cancer medicine should betesting andrevised to be made more scientific and rational in a manner thattreatment arecomplements the key characteristics of precision cancer medicine andoften expensive

practical needs in clinical settings.

It is our strong hope that urgent policy responses are taken with cooperation from related parties
along the three pillars described above.
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Health and Global Policy Institute

3.2 Explanation of Recommendation I
1. Basic concept
Because (a) the number of indications is still quite limited, precision cancer medicine faces difficult
issues not only in providing patients with access to care, but in various fields including securing
specialized human resources, gathering research and development-related information (clinical trialdata), and patient support.
A system that facilitates the aggregation of necessary health resources (including human resources,
supplies, data, and know-how) should be established as soon as possible. When doing so, it may be
useful for precision cancer medicine to adopt an approach that is similar to that of rare diseases
treatment, where nationwide “hub-and-spokes” networks have been established to make the best
possible use of human resources, equipment, data, and know-how. When implementing ICT, whileadvancing efforts to standardize data and to share knowledge, it is desirable that steps are taken to
help specialists respond to all patients, including those who are in remote areas, such as by providing
remote medical examinations using the internet.
2. Content of recommendation
Rec. I: To effectively allocate human resources and aggregate knowledge, a “hub-and-spokes”
network should be developed across all areas, including (i) healthcare delivery systems, (ii)human resources, (iii) research and clinical trials, and (iv) patient support measures.
When doing so, proactive steps to adopt information and communication technology (ICT)including the use of online services should be taken to streamline the aggregation of
information and medical resources.
Specific items to which Recommendation I apply are described below (Table 5-1).

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November 2022
Health and Global Policy Institute1) The healthcare provision system: Build and reinforce a “hub-and-spokes”
network centered around central cancer hospitals for genomic cancer
treatment to further enhance the healthcare system (related to Table 3-A: A1).26
2) Human resources: Utilizing the network described in (1) above to make it easierto aggregate the clinical knowledge and skills possessed by each specialist.
Furthermore, address human resource shortages and enhance human resource
quality through the proactive adoption of ICT including effective use of online
technologies (related to Table 3-A: A-2 to A-4).
3) Clinical trials: Building and reinforcing a “hub-and-spokes” network in research
will also promote decentralized clinical trials (DCTs) (related to Table 3-C: C-1).27
4) Establishing data repositories: Establish the data necessary for (1) and (3) above
in a centralized manner (related to Table 3-C: C2 to C-4). (For C-3 to C-4, pleaserefer to (1) under “Section 2 – Content of recommendation” under 3.
Explanation of Recommendation II below)
5) Patient support: When establishing the systems for (1) and (3) above, create anenvironment that enables information sharing and facilitates cooperation
among patients (related to Table 3-F: F-2).

26

The current system of genomic cancer treatment (see footnote 11) provides a collaborative network of healthcare

institutions, and discussions on conditions for designating each hospital based on their operational issues are being held at
the working group. However, those discussions are centered around the perspective of what human resources, equipment,
and systems will be needed to designate individual institutions, and satisfying those criteria presents high hurdles forhealthcare institutions.
27

Decentralized clinical trials (DCTs): A method of conducting clinical trials that does not require meeting in person by

utilizing smartphones, wearable devices, and other digital technologies. In traditional clinical trials, patients visit healthcare
institutions where all procedures are performed, including medical examinations, tests, and the administration ofpharmaceuticals. This requires them to visit healthcare institutions frequently. With DCT, however, test kits are sent to thepatients’ homes and physicians provide explanations on pharmaceuticals over the internet. This eliminates the need tocommute and lightens the burden on patients.

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Health and Global Policy Institute
Table 5-I: Responding to policy issues facing precision cancer medicine (Recommendation I)
Issues Related to Precision Cancer Medicine

Issue

Recommendation

Common Issue
in Cancer
Medicine inGeneralA- 1

Disparities in Access toFurther develop the medical system, centered around core

Medical Care Delivery

hospitals for precision cancer medicine.

Systems that are

following the "hub and spokes" model.

Centered Around Core

(2)Additionally, ICT should be actively used to promote online

hospitals

medical care and share medical information (PHR).

Human Resource
Shortages

A- 2(1)A network of medical institutions should be established(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

〇

◎

〇

〇

◎

◎

◎

◎

◎

◎

〇

◎

〇

〇

◎

(1)Utilize ICT based methods such as online medical care andtele-nursing in order to accumulate knowledge and utilize（physicians, nurses,

human resources.

pathologists, clinical(2)Share expert human resources within the network of coretechnologists)

hopsitals, rather than within each facility.

(1)Utilize ICT based methods such as online counseling in

Human ResourceA- 3order to accumulate knowledge and utilize human resources
across regions.

Shortages(2)Share expert human resources within the network of core（genetic counselors）

hopsitals, rather than within each facility.
(3)Promote human resource recruitment and education,
including the consideration of national qualifications.

A- 4Expert Panel Shortages

In the case that an expert panel is required, consider relaxing
requirements (e.g. introducing AI or other software algorithms)(1)A platform centered around the core hospitals for precisionC- 1

Lack of Collabortaion
between Core Hospitals

cancer medicin will have a collaborative function between
researchers in industry, government, and academia.
(2)Use the platform to promote "Decentralized Clinical Trials"(DCT).

Lack of Collaboration

C- 2

A detailed R&D consultation scheme between domestic andbetween Industry,

foreign companies and regulatory authorities should be

Government, andestablished to ensure competitive advantage in the Japanesemarket.

Academia
Cost-effectivenessCalculations

D- 3（need for evidence based Fundamentally re-examine methods of evidence evaluation◎

using real world evidence following the launch of a product.

on the unique〇〇characteristics ofprecision medicine）

F- 2

Supporting and Fostering While utilizing a network of medical institutions, support thePatient Groups

activities of patient groups on a national scale.

〇◎6) Regulatory approval: Thoroughly reexamine which evidence assessment
methods are best, such as conducting ex-post value assessment using postmarket evidence in clinical settings (related to Table 3-D: D-3).

23

November 2022
Health and Global Policy InstituteFor items related to regulatory approval, because (a) the number of indications for precisioncancer medicine is still limited, it will not be sufficient to only establish a “hub-and-spokes”
network and facilitate the collection of clinical trial data and other information. Instead, it will benecessary to be very flexible when thinking of topics such as how to make use of information
obtained post-market as evidence.
3.3 Explanation of Recommendation II
1. Basic concept
Because precision cancer medicine (b) involves the use of genetic information, which can beconsidered the most personal form of information, it requires more careful information management
and handling compared to other forms of health and medical information.
In addition, to ensure that individual patients and citizens do not face social discrimination due totheir genetic information, laws and regulations that prohibit discrimination based on said genetic
information must be established and efforts to raise awareness among all citizens must be taken.
2. Content of recommendation
Rec. II: While establishing data repositories for genetic information, legislation prohibiting
discrimination based on genetic information should be enacted and public awarenessactivities should be conducted.
Specific items to which Recommendation II applies are described below (Table 5-II).
1) Building genomic information databases: Build a (1) whole genome sequence
database and a (2) registry database containing prospective data gathered withuse in regulatory approval and similar processes in mind, and develop systems
and laws that aim to facilitate the effective use of these databases amongindustry, Government, and academia (related to Table 3-C: C-3 and C-4; Table 3E: E-4).
2) Returning research results to patients and the public: Establish a feedback
system for returning research results to patients and the general public (related
to Table 3-C: C-5).
3) Addressing social discrimination: Enact legislation prohibiting discrimination
based on genetic information and take steps to build awareness among all ages,
including during school education (related to Table 3-E: E-3).

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Health and Global Policy Institute
Table 5-II: Responding to policy issues facing precision cancer medicine (Recommendation II)
Issues Related to Precision Cancer Medicine

Issue

Recommendation

Common Issue
in Cancer
Medicine inGeneral(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Delay in the Construction

C- 3of a Database for

Promptly establish a "whole genome sequence database" thatcan be easily utilized by industry, government, and academia.

〇

〇

◎

〇

〇

◎

Genomic Information
Delay in the Industrial

C- 4

Establish systems and legislation for the construction andUtilization of Data for

utilization of a database that can be publicly integrated with

Secondary Uses, Drugregistry data currently owned by academic societies for the

Discovery, etc.

purpose of regulatory approval of pharmaceuticals.

Insufficient Return ofC- 5

Research Results toEstablish a feedback system for the return and disseminationof research results to patients and the public.

〇

◎

〇

◎

〇

◎

Patients and the Public(1)Promote the development of laws against societal

E- 3Remediating Social

disadvantages caused by genetic and genomic information

Discrimination

along with self-regulation by related companies. Furthermore,（in the case of certain
genetic mutations）

in order to design a system that addresses current issues,
promote open discussions with such companies.
2)Raise awareness among a wide range of generations (e.g.
through school education).

E- 4Protection of Personal(1)Promote the development of laws and guidelines for data

Data related to Medical

sharing.

Care and Genetic
Information(2)In particular, promote the development of laws based on thepremise of genomic medicine following the US "Genetic
Information Nondiscrimination Act."

3.4 Explanation of Recommendation III
1. Basic concept
Because (c) the costs of testing and treatment are often expensive in precision cancer medicine, it
faces extremely tight limitations regarding health insurance coverage and regulatory approval. It is
likely those limitations were reasonable from a health economics perspective when they were first
introduced.
However, given advances in science and technology, the accumulation of clinical examples, and othersuch developments that have taken place since then mean that those limitations are currently
preventing people from enjoying better outcomes. In addition, many of these limitations are no longer
reasonable from a health economics perspective, which was the reason they were established in thefirst place.
Moving forward, while listening to the voices of researchers and those who serve in clinical settings
and referring to recent responses taken abroad, urgent steps should be taken to revise these systems
to make them more reasonable from both treatment and health economics perspectives.

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Health and Global Policy Institute

2. Content of recommendation
Rec III: Regulatory approval, health insurance coverage, and other conditions governing theuse of precision cancer medicine should be revised to be made more scientific and rational ina manner that complements the key characteristics of precision cancer medicine and practicalneeds in clinical settings.
Specific items to which Recommendation III applies are described below (Table 5-II).
Conditions for health insurance coverage and related items
Each of the following items should be granted health insurance coverage.
1) Companion diagnostics: Tests in which specimens have been resubmitted(related to Table 3-B: B-1)
2) Liquid biopsies: Tests taken for monitoring (related to Table 3-B: B-2)
3) Cancer gene panel tests: Certain tests taken during examinations (related toTable 3-B: B-3)
4) Genetic counseling: Some of the counseling (related to Table 3-B: B-4)
5) Genomic cancer therapy: Certain treatments, when provided before standard
treatments begin (related to Table 3-B: B-5 and Table 3-D: D-2)
Regulatory approval
1) Therapeutics:

Certainregulations

surrounding

simultaneous

approvalrequirements for companion diagnostics and therapeutic agents should berelaxed (related to Table 3-D: D-1)

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Health and Global Policy Institute
Table 5-III: Responding to policy issues facing precision cancer medicine (Recommendation III)
Issues Related to Precision Cancer Medicine

Issue

Recommendation

Common Issue
in Cancer
Medicine inGeneral(a)Limited(b)Use of(c)High Cost of

MedicalGenetic

Testing andIndications

Information

Treatment

Limitations related to theB- 1

Number of Tests

Regarding tests that use companion diagnostics (CDx), review（companion diagnostics

the limitations on the number of re-tests covered by insurance.

〇

◎

〇

◎

〇

◎

〇

◎

〇

◎

〇

◎

〇

◎

(CDx)）
Limitations related to theB- 2

Number of Tests andRegarding liquid biopsies, review the limitations on the number

Testing Periodof tests covered by insurance for monitoring purposes.

（liquid biopsies）
Limitations related to theB- 3Timing of Testing（cancer gene panel

Review the limitations on insurance coverage so that gene panel
tests can be performed prior to the completion of standard
cancer treatment.

test）

B- 4

Limitations related to

Genetic counseling and related online medical services, which

Target Services

should be combined with genetic testing, should be covered by（genetic counseling）

insurance.

Limitations related to theB- 5Timing of Treatment（cancer genome

Review the limitations on insurance coverage so that gene panel
tests can be performed prior to the completion of standard
cancer treatment.

medicine）
Requirements for
Approval of Therapeutics（requirement that

D- 1

For therapeutics with proven efficacy, approval processes
should be flexible to allow for certain exceptions such as priortherapeutics are approved approval under the termporary provision of alternate tests forat the same time as

CDx (e.g. tests in clinical trials).

companion diagnostics(CDx)）
Cost-effectivenessD- 2

Calculations（timing of cancer gene

Review the limitations on insurance coverage so that gene panel
tests can be performed prior to the completion of standard
cancer treatment.

panel testing）

Conclusion
The people involved in precision cancer medicine are extremely diverse, and even if we narrow ourfocus on key areas, we see that this field faces a wide range of policy challenges.
Therefore, even if those involved have the shared central goal of “actively promoting precisioncancer medicine,” the issues that each person considers to be most important can vary greatly
depending on, for example, the field in which they are involved. Many of the discussions arecomplicated and efforts to mount policy responses tend to scatter.
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Health and Global Policy Institute

Given these circumstances, these recommendations attempt to provide a foundation and generalframework to enable shared understanding among related parties with various opinions as describedabove. We hope these recommendations can assist efforts to build shared recognition among relatedparties and encourage cooperation and collaboration among them to advance precision cancer
medicine.

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Health and Global Policy InstituteAcknowledgements
When formulating these recommendations, we held hearings with the specialists, including thoselisted below who served on our advisory board. We would like to express our deepest gratitude for
their participation.
These recommendations were compiled by the author, HGPI, in its capacity as an independent healthpolicy think-tank based on the hearings mentioned above. They should not be taken to represent theopinions of any advisory board member or related party, or of any organization to which they belong.
“The Project for Considering the Future of Precision Medicine with Industry, Government, Academia, andCivil Society”
Advisory board (honorific titles omitted; in Japanese syllabary order):Reiko Akizuki(Director, Oncology Department, Medical Affairs Division, Janssen Pharmaceutical
K.K.)

Kosuke Iijima(Head, Foundation Medicine Business Department, Chugai Pharmaceutical Co.,Ltd.)

Ataru Igarashi(Associate Professor, Unit of Public health and Preventive Medicine, Yokohama City
University School of Medicine)

Mitsuho Imai

(Project Assistant Professor, Shinanomachi Cancer Center, School of Medicine, Keio
University)

Hiroji Iwata(Vice Director and Chief, Department of Breast Oncology, Aichi Cancer Center
Hospital)

Sotaro Enatsu(General Manager, Oncology Business Unit, Research and Development andMedical Affairs, Eli Lilly Japan K.K.)

Atsushi Otsu

(Director, National Cancer Center Hospital East)

Tomohiro Kuroda(Professor, Division of Medical Information Technology and Administration
Planning, Kyoto University Hospital)

Shinji Kosugi(Professor, Medical Ethics and Medical Genetics, Department of Social Medicine,
Graduate School of Medicine and Faculty of Medicine, Kyoto University)

Naomi Sakurai(President, Cancer Solutions Co., Ltd)

Chizuko Sakashita (Project Assistant Professor, Hematology, Advanced Therapeutic Sciences, Medical
and Dental Sciences, Graduate School of Medical and Dental Sciences, Tokyo
Medical and Dental University)
Kuniko Sunami(Department of Laboratory Medicine, National Cancer Center Hospital)

Junpei Soeda(Head, Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical
Company Limited)

Yusuke Tsugawa(Associate Professor, David Geffen School of Medicine (Internal Medicine),
University of California, Los Angeles (UCLA); Associate Professor, Health Policy and29

November 2022
Health and Global Policy InstituteManagement; Faculty Associate, UCLA Center For Health Policy)
Mamoru Narukawa (Professor, Department of Clinical Medicine (Pharmaceutical Medicine), Kitasato
University School of Pharmacy)
Kazuo Hasegawa(Representative, NPO Lung Cancer Patient Network One Step)

Yoshiyuki Majima(Chairman, NPO PanCAN Japan)

Tetsuya Mitsudomi (Professor/Senior Staff, Division of Thoracic Surgery, School of Medicine, Kindai
University)
Kaori Muto

(Professor, Department of Public Policy, The Institute of Medical Science, The
University of Tokyo)

Takayuki Yoshino(Director, Department of Gastrointestinal Oncology, National Cancer Center
Hospital East)Sponsors (in Japanese syllabary order):Takeda Pharmaceutical Company Limited
Chugai Pharmaceutical Co., Ltd.
Eli Lilly Japan K.K.
Janssen Pharmaceutical K.K.
Co-authors (in no particular order)
Haruka Sakamoto (Senior Manager, HGPI)Shu Suzuki (Associate, HGPI)
Osamu Takemoto (Program specialist, HGPI)
Motoi Miura (Program specialist, HGPI)
Sayaka Honda (Program specialist, HGPI)
Kate Nakazato (Intern, HGPI)

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Health and Global Policy Institute

About Health and Global Policy Institute (HGPI)
Health and Global Policy Institute (HGPI) is a Tokyo-based independent and non-profit health policy
think tank, established in 2004. Since our establishment, HGPI has been working to help citizens
shape health policy by generating policy options and bringing together stakeholders as a nonpartisan think-tank. Our mission is to enhance the civic mind along with individuals’ well-being andto foster sustainable, healthy communities by shaping ideas and values, reaching out to global needs,
and catalyzing society for impact. We commit to activities that bring together relevant players fromvarious fields to deliver innovative and practical solutions and to help interested citizens understandavailable options and their benefits from broader, global, long-term perspectives. HGPI has again
ranked Second in the “Domestic Health Policy Think Tanks” category and third in the “Global Health
Policy Think Tanks” category within the 2020 Global Go To Think Tank Index Report released on
January 28, 2021, by the Think Tanks and Civil Societies Program (TTCSP) of the Lauder Institute at
the University of Pennsylvania

31