[Reporter's View] Rising new drug prices, increased reimb challenges for mild diseases

When we think of 'high-priced new drugs,' we tend to think of anticancer agents or severe disease treatments. To date, discussions of patient access have centered on severe or rare diseases. 

However, recent changes in the global drug pricing landscape are broadening the group of patients that require such discussion. This is because new drugs are emerging one after another that offer better efficacy than existing treatments or more convenient administration for diseases that are not life-threatening but require long-term treatment. 

The United States’ Most-Favored-Nation (MFN) prescription drug pricing policy is one variable that could accelerate these changes. If the United States transitions to lower drug prices by referencing other countries' lower prices, global pharmaceutical companies would face a greater burden of accepting low prices in a particular country.

If South Korea adopts lower drug prices, it would not only affect the domestic market but also influence other countries’ drug-pricing decisions, including the United States.

The non-reimbursed pricing of several new drugs introduced in South Korea is rising to the point where patients cannot bear the burden of long-term treatment. Even the cost of a single treatment, or a particular duration of treatment, for pharmaceuticals that do not fall under severe and rare disease treatments is substantial. Therefore, concerns have been raised that decision to receive treatment is determined by a patient’s economic status rather than the need for treatment.

The bigger problem is that the pricing impact is beyond a temporary non-reimbursement burden. When the initial price is substantially high, the pricing range widens during the process of determining national health insurance reimbursement. Furthermore, both a pharmaceutical company and an insurance recipient would struggle to meet reimbursement standards for diseases with many existing treatments and large patient populations.

For anticancer agents, policy foundations are relatively established, and reimbursement can continue despite high prices if endpoints clearly show patient benefits, such as improved overall survival. For rare and severe diseases, different systems, such as special cases, risk-sharing agreements (RSA), and exemptions from economic evaluation, can improve patient access. 

However, for new drugs, if many existing treatments are available and patient numbers are high, high pricing is difficult to achieve, even with higher efficacy than existing treatments. The same applies when patient burdens are lowered, such as significantly reduced administration or extended therapeutic intervals. 

It is difficult to resolve this matter by limiting potential recipients of reimbursement.

In certain cancers, administration targets can be clearly identified based on specific genetic mutations, biomarkers, or treatment stages. In contrast, for most chronic diseases, it's difficult to pre-select patients who would benefit, such as dermatological diseases or allergies.

Patient groups can be divided by symptom severity or response to prior treatment; however, it is difficult to narrow reimbursement targets based on price alone. This is because symptom severity and impact on daily life differ among patients, even within the same disease.

This creates a situation where it is challenging to accept high pricing while also applying reimbursement restrictively by carefully screening patient groups.

In such cases, patients’ realistic choice is to stay on previous treatments. 

Even when a new drug shows superior efficacy or improved dosing convenience, treatment options in real-world clinical settings can remain limited because alternative therapies are already available. Furthermore, even if a new drug is approved, it may be accessible only to a select few patients who can afford its high cost.

If the gap between the domestic launch price and the price recognized during the national health insurance reimbursement process becomes excessively wide, pharmaceutical companies may face reduced incentives to pursue reimbursement while enduring massive price cuts. In particular, if the price is linked to pricing strategies in other markets, such as the United States, it becomes even harder for them to accept an isolated lower price solely in the domestic market.

The issue of patient access to high-priced new drugs cannot be viewed as confined exclusively to severe diseases. Even when disease severity is relatively low, some patients may not achieve sufficient efficacy with standard treatments or may be unable to access superior therapeutic options because of prohibitive costs.

Blind spots in patient access do not occur solely in life-threatening, severe diseases. We must also examine patient populations excluded from the clinical benefits of novel therapies because of high prices and institutional limitations, despite clear medical need.

As the global drug pricing landscape rapidly evolves, domestic drug pricing and reimbursement policies must also move beyond an approach centered heavily on severe and rare diseases and decide how to incorporate the clinical value of new drugs and patient access in a balanced manner.