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

Policy Issues in Various Areas
A. Healthcare Provision System
Disparities in Medical Care Access
Human Resource Shortages
Expert Panel Shortages
B: Scope of Health Insurance Coverage
Companion Diagnostics (Number of Tests)
Cancer Gene Panel Tests(Timing of Testing)Cancer Genome Medicine (Timing of Treatment)

Ｃ:Research & Developments
Lack of Coordination in R&Ds
Delay in:
Database Building
Feedback to Patients and Public

D:Regulatory Approval

Key Characteristics ofPrecision Cancer Medicine

Three Recommendations(a)Limited Medical Indications

RecommendationⅠ：Aggregate Medical/Human Resources

・Shortages of Specialists/Facilities
・Limited Number of Clinical Trials
・Difficulties in:・Evidence Accreditation
・Managing Patient Groups(1)Develop “Hub-and-spokes” Network Across All Areas(2) Utilize Information and Communication Technology (ICT) ,including the use of online services

RecommendationⅡ：Properly Manage Genetic Information(b)Use of Genetic Information
・Delay in Database Building(1) Maintain Data on Genetic Information

・Risk of Social Discrimination(2) Legislate a Genetic Nondiscrimination Actand Raise Public Awareness(c) High Cost In Testing/Treatment

Rigid Operation of:
Evidence Accreditation
Pharmaceutical Approvals

RecommendationⅢ：Review from Economic/Scientific Perspective

・Rigid Operation of:(1) Relax Insurance Coverage Conditions (ex. Diagnostic Pharmaceutical, Genetic Counseling)

Regulatory Approvals

E: Ethical, Legal and Social Issues (ELSI)October 2022
Health and Global Policy Institute(2) Review Pharmaceutical Approvals

Pharmaceutical Approvals(ex. Prior Approval of Therapeutics）

Social Discrimination
Psychological Burden on PatientsManage within the Context of Cancer Medicine as a Whole

Policy Issues Shared Among Cancer Medicine

Ｆ:Patient and Public Involvement (PPI)・Disparities in Medical Care AccessDifficulty in Managing Patient Groups
Delay in Patient Involvement

・Psychological Burden on Patients

Definition

Precision Cancer Medicine(Commonly used in clinical settings oflung/breast cancer）

Genomic Cancer Medicine（Part of Precision Cancer Medicine）

・Improve Access to Medical Care Delivery
・Reduce Psychological Burden on Patients・Promote Patient Involvement in Guideline Development

・Delay in Patient Involvement

Test conducted to detect mutations in one or multiple genes(Companion diagnostic testing)→Treatment tailored to mutated sections of genes of individuals（Molecularly targeted drugs)

Test conducted to detect mutations in many genes(Genomic Cancer Testing or Profiling)→

Advanced treatments/Clinical Trials (No standard cancer treatment)（Certain tests covered by insurance)etc.

《Key Points of Three Recommendations》
RecommendationⅠ：Aggregate Medical/Human Resources
Develop “Hub-andSpokes” Network

Eliminate Expert
Panel Shortages
Improve Access toClinical Trials

To effectively utilize human resources of specialists, and to close the access gap, (a) aggregate the clinical knowledge and skills tocentral/core cancer hospitals for genomic cancer treatment (“Hub”), and (b) work with other partnering hospitals (“Spokes”) to
provide quality-assured care to patients living in rural areas, while utilizing the use of online services.

In the case that an expert panel is required, consider relaxing requirements (e.g. introducing AI or other softwarealgorithms).
Promote DCT (Decentralized Clinical Trial) so that even patients living in rural areas can participate in clinical
trials conducted only at the center/core hospitals, while continuing treatment at other partnering hospitals.

RecommendationⅡ：Properly Manage Genetic Information
Establish database system and laws for data management that can be easily utilized by industry, academia, andEstablish
government, such as (a) by building a "whole genome sequence database" and (b) by integrating multiple registry
Databases
data owned by academic societies.
Return Research
Establish a feedback system for the return and dissemination of research results to patients and the public.
Results
Legislate a genetic nondiscrimination act, and raise public awareness for a wide range of generations, including
Correct Social
in school education.
Discrimination
Recommendation Ⅲ：Review from Economic/Scientific Perspective
Review the limitations of insurance coverage as to the number of tests using companion diagnostics and liquid
Number of Tests
biopsies, etc.
Review the restrictions on insurance coverage of cancer gene panel tests and cancer genome therapies so that
Timing ofthey can be performed even before completion of standard cancer treatment.
Tests/Treatment
Make genetic counseling, which should be provided in combination with genetic testing, covered by insurance,
GeneticCounselingincluding online medical care
Operate the approval processes in a more flexible manner, e.g. allow prior approval under the temporary provision
Diagnosticof alternate tests for CDx (e.g. tests in clinical trials).
PharmaceuticalAppendix: Defining 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
focus on the mutated sections of genes to provide theoptimal drugs for those mutations.

Main test types

Main treatment methods

Imaging studies• Surgical operation•

X-ray exam•

PET scan•

Echocardiography, etc.

Pathological exammicroscope)•Cytological exam

• Bone marrow test, etc.

Treatment
methoddetermined

Biomarker testingaccording(focusing on characteristics

to resultsof genes and proteins)

There are cases in which cancer gene tests or othersuch tests are conducted but molecularly targeteddrugs or similar treatments are not selected. We
include such cases within the scope of “precisioncancer medicine,” since the testing phase focuses on
genetic mutations.

• Radiation therapy(examination of cells with

In practice, definitive cancer diagnoses are usuallyreached by using a combination of multiple testing
methods, such as those listed in the right table. For
example, imaging studies may be combined withpathological examinations.

• Chemotherapy(treatment with anticancer drugs)• Tumor marker test•

Precision cancer
medicine

Cancer gene test(companion diagnosis)•• Molecularly targeteddrugs used

Cancer gene panel
test (cancer genomic• Immunotherapy, etc.

profile)(Note 1) Cancer gene testing (companion diagnostic testing)
To determine if a certain drug (namely, a molecularly targeted drug) will be effective for the cancer of the patient in question, a single test isconducted 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.
(Note 2) 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. In general, there is no standard
treatment for the results based on this test, and the therapeutic agents and policies are determined by the judgment of specialists.