[Reporter's View] Is reimb criteria restricting patient access?

The same question is asked whenever the reimbursement criteria for a new drug are unveiled. "Is regulation aligning with the disease treatment flow?"

Concerns are mounting about the reimbursement criteria for Ozempic, a GLP-1-based diabetes drug. Despite the goal of its criteria to suppress prescriptions for obesity, the criteria may narrow treatment access.

Professionals in clinical practice are continually raising issues. They assert that the government's goal in reducing unregulated prescriptions for obesity treatments can be acknowledged. Yet if this goal is applied too broadly, it could undermine effective diabetes treatments.

The government limited Ozempic reimbursement recipients by considering factors such as body mass index (BMI), blood sugar levels, and prior medication history. The problem is that the criteria were designed to focus on reducing the risk of abuse rather than reflecting patient condition variables.

According to the reimbursement criteria for Ozempic, the drug can be prescribed as part of a triple therapy including metformin and sulfonylurea (SU), or in combination with insulin to Type 2 diabetes patients whose glycated hemoglobin (HbA1C) levels remain at 7% or higher despite at least 2 to 4 months of combination drug therapy. Following the initial treatment, when patients experience substantial improvement in blood sugar levels, their treatment scheme can be switched to a dual combination therapy (metformin + Ozempic).

Additionally, reimbursement is applied to the combination therapy of Ozempic plus basal insulin (±metformin) if the glycated hemoglobin (HbA1c) level remains at 7% or higher even after administering basal insulin monotherapy or metformin combination for more than 2-4 months, or if the HbA1c remains at 7% or higher following the combination therapy of Ozempic and metformin (±SU).

In current clinical practice, combination therapies centered on DPP-4 inhibitors and SGLT-2 inhibitors are widely used, and there is a trend toward increasingly excluding SU due to the risk of hypoglycemia and specific patient characteristics.

Despite this, requiring patients to return to sulfonylureas and essentially forcing a "treatment failure" to meet reimbursement requirements feels less like a typical clinical pathway and more like a regulatory mandate that mandates failure.

Another concern is that even non-reimbursement prescriptions are not permitted for patients who fail to meet the reimbursement criteria. While the intent is to block use for obesity purposes, the result is the elimination of even the minimum leeway to adjust treatment strategies based on individual patient characteristics. This has resulted in backlash, with accusations that the government has arbitrarily and preemptively defined the therapeutic needs of patients.

A bigger problem is the high probability that these criteria will be applied identically to other GLP-1 class diabetes treatments to be released in the future. If the structure of the criteria is finalized, with even innovative new drugs having their reimbursement status judged through a single frame of BMI, blood sugar, and prior treatment conditions, the domestic reimbursement policy will inevitably tilt further toward regulation. This serves as a warning that South Korea's clinical practices may continue to diverge from international treatment guidelines.

In the case of migraine treatments, international and domestic guidelines recommend calcitonin gene-related peptide (CGRP) class agents as first-line medications.

However, because Korean insurance criteria are excessively stringent, there are cases where patients must wait until their pain worsens or repeat multiple medication failures to meet reimbursement requirements. Consequently, new drugs that were granted reimbursement to increase treatment accessibility have become even more out of reach for patients.

Everyone acknowledges that institutional mechanisms to prevent misuse and abuse are necessary. However, a structure in which regulations are created first without clear standards ultimately result in uncertainty and disadvantages patients.

If the purpose of regulation is to aid patient treatment, what is needed now is not simple control, but a sophisticated design that places the patient at the center.