In a recent issue of Rinsho Hifuka (Clinical Dermatology), Dr. Tomoo Fukuda of Saitama Medical University contributed an article entitled “Appropriate Use of Recently Introduced High-Cost Drugs.”
This is an important issue that carries implications not only for dermatology but also for the future of Japan’s healthcare system and public finances. I would like to summarize the main points of his article and add some personal thoughts.
1. Escalating Healthcare Expenditures
Japan’s national healthcare expenditure increased dramatically from 18 trillion yen in 1987 to 44.4 trillion yen in 2019. The average annual healthcare cost per person is approximately 300,000 yen, but this rises to 750,000 yen for people aged 75 and to 900,000 yen for those aged 80.
There is little doubt that population aging is a major driver of these rising costs. However, the growing number of expensive new drugs has further accelerated the trend. In dermatology, biologic agents and immune checkpoint inhibitors have become increasingly common.
2. Biologic Therapies
Biologics are antibody-based drugs produced through biotechnology and designed to target specific molecular pathways. Because they act precisely on disease-related molecules, they can achieve remarkable therapeutic effects. However, their manufacturing processes are complex and require large-scale facilities, making them extremely expensive.
In dermatology, biologics are widely used for psoriasis, atopic dermatitis, chronic urticaria, and other conditions.
For psoriasis, eleven biologic agents have currently been approved in Japan. Their use is restricted to patients whose disease cannot be adequately controlled with conventional treatments, and prescribing physicians and institutions must meet criteria established by the Japanese Dermatological Association.
For atopic dermatitis, dupilumab, which targets Type 2 cytokine pathways, as well as three oral JAK inhibitors, have been introduced. Although there is no approval system identical to that used for psoriasis, comparable standards for appropriate use are expected.
For chronic urticaria, omalizumab, a humanized anti-IgE monoclonal antibody, has become available. Unlike some other biologics, however, its indications are not defined by particularly strict eligibility criteria.
3. Cancer Therapies Including Immune Checkpoint Inhibitors
In 2014, Japan became the first country in the world to approve nivolumab (Opdivo), an anti-PD-1 antibody and immune checkpoint inhibitor, for the treatment of malignant melanoma.
Subsequently, ipilimumab and pembrolizumab were introduced. In addition, BRAF inhibitors and MEK inhibitors became available. Combination therapies using these agents have significantly improved survival outcomes for patients with malignant melanoma.
However, nivolumab was initially associated with an annual drug cost of approximately 30 million yen per patient, making it one of the most expensive therapies ever introduced. Drug prices have since been substantially reduced.
4. Therapies for Rare Diseases
Hereditary angioedema is a rare disease, but severe attacks can be life-threatening. A number of injectable and oral treatments have been developed in recent years.
As is often the case with therapies for rare diseases, these drugs tend to command very high prices because the costs of development must be recovered from a relatively small patient population.
5. Concluding Remarks
The term “unmet medical needs” refers to medical conditions for which effective treatments have not yet been established. These needs include not only serious illnesses such as cancer and dementia but also conditions that significantly affect quality of life, including insomnia and migraine.
The development of innovative therapies cannot and should not be stopped. However, unless a system is established to keep drug prices under control, Japan’s healthcare economy may eventually become unsustainable.
From a physician’s perspective, one practical contribution is to avoid unnecessary prescribing and to ensure that these expensive treatments are reserved for patients who genuinely need them.
Personally, I find myself torn on this issue.
If I were diagnosed with cancer or another serious illness, I would certainly want access to the most effective treatments available. The remarkable advances achieved by modern medicine over the past decade have improved and extended countless lives, and few would wish to slow that progress.
At the same time, every healthcare system operates with finite resources. Even in countries with public insurance systems, the cost of expensive therapies is ultimately borne by society through taxes, insurance premiums, or other forms of collective funding.
The fundamental question, therefore, is not whether medical innovation should continue—it unquestionably should—but how its benefits can be made sustainable and accessible.
Why have new therapies become so expensive? Part of the answer undoubtedly lies in the enormous costs and risks associated with drug development. Many promising projects fail, and successful medicines must bear the burden of those failures. Yet it is also difficult to ignore the fact that a relatively small number of multinational pharmaceutical companies dominate the market for innovative therapies and generate substantial profits.
This raises broader questions about equity. If life-changing treatments are available only to wealthy individuals or wealthy nations, can we truly say that medical progress is benefiting humanity as a whole?
These are not challenges unique to Japan. As populations age and biomedical innovation accelerates, healthcare systems around the world will face similar dilemmas. Society must find ways to encourage innovation while maintaining affordability and fairness.
I do not pretend to know the answer. However, it seems increasingly clear that the long-term success of modern medicine will depend not only on scientific breakthroughs, but also on our ability to develop sustainable models for delivering them to patients.