[New Wave] When Increasing Patient Accessibility in Clinical Trials

Published 20 Jul.2020 10:59(KST)

The most important stage in developing a new drug is clinical trials. Clinical trials are conducted in three phases, and based on the results, an application for new drug approval is submitted to the authorities, which then decide whether to grant marketing authorization. During the clinical trial phase, the new drug candidate must demonstrate superiority in safety and efficacy compared to existing drugs, known as control drugs (standard treatments). For anticancer drugs and others, this process can cost from hundreds of millions to several billion Korean won, depending on the target.

Since clinical trials involve human subjects, they inevitably require rigorous procedures and thorough verification. Recently, with the activation of startups, most bio ventures are focusing significant effort and resources on overcoming the clinical phase. However, the majority of companies ultimately give up development or focus on technology transfer during the "valley of death" in Phase 1 or Phase 2 clinical trials.

The government is making efforts to strengthen the coverage of health insurance. Although this acts as a financial burden on health insurance, it is socially welcomed and being promoted. Alongside this, to enhance new drug development capabilities, tax reductions on clinical trials have been extended through Phase 3 to encourage voluntary corporate investment. Additionally, for investigator-initiated clinical trials conducted for public interest purposes, insurance coverage is applied during clinical trials after undergoing regulated procedural reviews, limited to infectious diseases, rare and intractable diseases, etc.

Looking at other countries, such as the United States, Japan, and the United Kingdom, health insurance coverage is mainly provided in clinical trials to offer new treatment opportunities to patients who urgently need treatment or for whom participation in clinical research is the last chance for therapy.

In this way, Korea applies insurance coverage for clinical trials more restrictively than other countries. Globally, innovative new drugs expected to have excellent therapeutic effects face cost burdens when conducting clinical trials in Korea compared to other countries. This may lead to Korea being excluded. This could weaken patients' access to new innovative treatments. The launch in Korea may be relatively delayed compared to countries where clinical trials are conducted, causing patients to miss the appropriate treatment window.

From the patient's perspective, the areas where clinical trial burdens are most significant are concentrated on high-cost drugs such as anticancer agents, which are linked to new drug development. Unlike other diseases, anticancer drugs are applied to patients starting from Phase 1 clinical trials. Patients need to receive coverage through health insurance, but they are excluded from insurance coverage simply because they participate in clinical trials. The costs must be borne by bio ventures or pharmaceutical companies. Given this, there is a need to flexibly expand the scope of insurance coverage for control drugs used in clinical trials to at least the level of advanced foreign countries. This aligns with the government's policy goal of expanding coverage and requires policy consideration that strengthens both the patient's position and new drug development capabilities.

The government continues to expand R&D support for companies, but this can act as a financial burden. Therefore, to achieve the best policy goals, it is important to effectively allocate limited resources and devise ways to achieve various policy effects.

Applying insurance coverage for control drugs during clinical trials can increase patients' access to innovative treatments and provide companies with opportunities to focus on national research, thereby strengthening new drug development capabilities.