A new program from MHLW to allow patients access to new technology on their own cost but yet cover the standard cost through social insurance system

1. Patient Driven Treatment Option
A new program by MHLW
Keisuke Med Tech Consulting, LLC.

2. Overview
 Starts from April 2016
 Patient requests for non-insured and/or non-approved treatment to
designated hospital
 Designated hospital applies to MHLW on behalf of patient within 2 wks, if
determined to be clinically feasible
 Designated Committee will evaluate safety and efficacy within 6 wks
 If approved, social insurance covers standard costs similar to ATP, delta is
paid by patient
 MHLW will post the treatments and offering hospitals to public
 More details will be made public in March 2016

3. Objective
 Provide patient access to non-insured and/or non-approved
drugs and devices for those patients without alternative
choice – compassionate use
 Non-insured are non-approved indication
 Non-approved are non-approved new technology

4. Designated Hospitals
 Designated First in Man Clinical Research Center
 5 hospitals
 Designated Clinical Research Center of Excellence
 10 hospitals
 Advance Treatment Hospital, as research collaborator
 Joint research with Designated CR Center of Excellence
 84 hospitals, mainly university teaching hospitals
 Satellite Hospital, as supportive hospital
 If determined to be adequate to administer treatment

5. Proposed Process (subject to change)
1. Patient requests
2. Designated hospital will apply to MHLW on behalf of requesting patient
 Clinical evidences for safety and efficacy, proposed treatment protocol, informed consent,
pathway to approval and reimbursement
 Collaborate and satellite hospital must be determined at the time of application
3. Designated committee evaluates submitted package
 Collaborate with Drug Lag and Device Lag committees
4. If approved, designated hospital will administer treatment

6. First in Man Hospital
 National Cancer Research Hospital
 Cancer drugs
 Osaka University
 Cerebral and cardio vascular drugs
 National Cardiovascular Research Hospital
 Cerebral and cardio vascular devices
 Tokyo University
 Neurology drugs
 Keio University
 Immunology drugs

7. Clinical Research Center of Excellence
 Hokkaido University
 Tohoku University
 Chiba University
 Gunma University
 Nagoya University
 National Center for Children Health & Development
 Nagoya National Medical Center
 Kyoto University
 Okayama University
 Kyushu University

8. Advance Therapy Program
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9. Overview -1
• Clinical usage of unapproved devices or drugs are allowed with
Physician License, at his or her own risk.
• HOWEVER, Reimbursement from social insurance system is not
possible, thus FULL fees are out of pocket
• This program basically allows for none direct fees (regular
diagnostics, tests, drugs, hospitalization fees) to be covered by
social insurance system.
• The fees associated specifically to the usage of unapproved
device or drug are not covered
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10. Overview -2
• Two programs available
• A: New therapy without use of unapproved device or drug
• B: New therapy with use of unapproved device or drug, or expansion of their
indications
• Application is per hospital basis, not industry
• Committee evaluate the appropriateness and the protocol, and if
determined to be appropriate, recommend to MHLW to allow usage of
social insurance system
• Recently, the result from this study are accepted to be used for regulatory
submission purposes
• Usually device are donated in exchange for access to the study result
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