Medical diagnostics: Saving lives and reducing costs

It’s no secret that Japan’s healthcare system faces a future of challenges. An ageing population, combined with a shrinking number of working-aged people, is creating a growing number of patients needing care — with fewer people around to fund the system.

Japan’s health administrators are busy working on ways of dealing with the strain. One approach is the increased use of medical diagnostic products. The idea is to boost prevention and early detection. Regular and sophisticated testing can pinpoint diseases at an early stage, before they become full-blown. The result is reduced costs to the system, not to mention a lightened ordeal for the patient.

Japan’s medical authorities are starting to recognise the value of this approach, albeit slowly, according to Shuichi Hayashi, chairman of the EBC Medical Diagnostics Committee.

“It can be difficult to grasp this situation, but some people in the [health] ministry have started to understand that medical diagnostics can be a major tool with a lot of value for reducing total medical expenditure,” he says.

The committee, in concert with several other industry associations, has been urging the ministry to streamline and speed up the regulatory processes, so that the latest and most effective in vitro diagnostic (IVD) products can more easily enter the Japanese market.

A key issue is approval periods: the time from when product makers apply for approval to when it is granted.

The manufacturers have complained that the periods in Japan are unnecessarily long. “In the pharma and medical device fields, the situation has improved, but I’d say that for medical diagnostics it’s the same as before,” says Hayashi.

Still, the committee has reason for guarded optimism. Last year, it was part of an effort to get an agreement to make efforts to shorten the approval periods from the Pharmaceuticals and Medical Devices Agency — an independent administrative body that works with the Ministry of Health, Labour and Welfare (MHLW) to ensure safety and quality in the industry.

The agency drew up an agenda with a set of action items. “But, unfortunately, the implementation is slow, as happens in Japan,” points out the committee chairman.

One issue concerns the hiring of more reviewers, as labour shortages in labs have been blamed in the past for delaying the approval process. Although Hayashi has yet to see any staff increases, he says recruiting may start in April, when Japan’s fiscal year begins, he says. “But it will take time to train them.”

Hayashi believes that part of the overall problem can be explained by the esoteric nature of his industry. Medical diagnostic-related issues don’t get the level of attention that pharma or medical devices do, from either the public or healthcare officials. He believes many people simply don’t fully appreciate the potential of the methods and technologies available.

“Some older people, lab technicians or people in charge of medical diagnostics at hospitals may be interested in working [as reviewers] in such a field,” he says.

“MHLW people aren’t very familiar with medical diagnostics. In addition, every two years they are reassigned to different divisions.”

Awareness-raising is especially important for a new field called “companion diagnostics”. The revolutionary approach enables personalised treatment for patients. “Instead of providing the same treatment and medicine to all patients [suffering from the same disease], there is diagnosis beforehand to find out [which is] the best therapy or medicine for each individual patient,” Hayashi explains.

The committee and its partner associations are urging Japan to set up a framework to pave the way for full implementation.

Linked to the approval issue are reimbursements. Industry officials want Japan’s healthcare system to pay fees that truly reflect the clinical value of upgraded, new and innovative products. Japan’s authorities have maintained a cost-containment policy, as a way of keeping a lid on expenses that are expected to spiral ever higher in the coming years.

But industry officials argue that the latest products are in line with that goal, since over the long run they improve efficiency and enhance preventative care. Failing to offer reimbursements that recognise the added value, they stress, will discourage manufacturers from bringing their best offerings to the Japanese market in the future.

“This isn’t an issue only in Japan,” says Hayashi, referring to companion diagnostics. For the US Federal Drug Administration Agency and Europe, the discussions are also still under way.”

In Japan, all the approvals and reimbursement costs are handled by the MHLW. In the United States, by contrast, the costs of advanced treatment are often out-of-pocket expenses covered by the patient.

“But in Japan, approval and reimbursement are always linked,” adds Hayashi.

That means the authorities still need to clear the bureaucratic bottlenecks and look beyond the short term if the population is to remain healthy — at costs the nation can afford.

Key advocacy points

• Access to IVDs – The government should incorporate in vitro diagnostics in an expedited review programme already in use for medical devices.

• Reimbursement system – Updated and new products should be reimbursed to fully reflect their clinical value.

© Japan Today