With Asia Medical Market Expert Ames Gross, Pacific Bridge Medical
Q: What is a mixed medical treatment?
A: A mixed medical treatment combines 2 treatments. One of the treatments is a pharmaceutical or medical device that has been approved in Japan and is covered by health insurance. The other treatment is a drug or device that has not been approved in Japan and is not covered by insurance. For example, a mixed medical treatment could be a combination of one anti-cancer drug that has been approved for use in Japan with an anti-cancer drug that has not been approved.
Q: What is the current policy for these treatments in Japan?
A: Currently, a patient who wants a mixed medical treatment must pay the full cost of both treatments. That means that the patient is not reimbursed for the portion of the treatment that would, on its own, be covered by health insurance. Very few mixed medical treatments are allowed in Japan, and there are strict limitations on patients eligible, the number of treatments and the types of medical facilities that can give the treatments.
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Q: What are the policy changes?
A: After the reforms go into effect, Japanese patients can directly apply for approval to have mixed treatments. The time it takes to get an approval will also be reduced. In some cases, patients may be able to receive the treatment at their local hospital. And, the portion of the treatment that is already approved and eligible for reimbursement will be covered under a patient’s health insurance.
Q: What does this mean for Western medical companies?
A: It is likely that most requests – and approvals – for mixed treatments will be for drugs and devices currently sold in the U.S. or EU. So, reform of Japan’s mixed medical treatment policies should increase Japanese medical market access opportunities for Western companies. They will be able to sell their devices and drugs to Japanese patients without product approval in more situations than they currently can. Also, because some of the treatment will be covered by insurance, mixed treatments will be affordable for a much larger number of Japanese patients.
Q: When will these reforms go into effect?
A: Japan’s Cabinet approved a package of reforms – including mixed medical treatment reforms – this past June. The reform package is scheduled to be approved next year by the Japanese legislature. Therefore, it is likely that the reforms will become effective in 2016.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at [email protected].
