Domestic CAR-T Limcato speeds toward reimbursement

Selected for parallel Approval–Evaluation–Negotiation track… Reimbursement expected in H2

Post-management and risk-sharing conditions key rather than price

Domestic manufacturing seen as supply advantage vs. Kymriah and Yescarta

With Korea’s first domestically developed CAR-T therapy Limcato (anbalcabtagene-autoleuce) receiving regulatory approval, attention is now focused on the timing of its reimbursement.

Curocell expects to accelerate market entry through the pilot program that allows parrallel operation of approval, reimbursement evaluation, and price negotiation. With the fast-track system in place, commercialization may be possible as early as the second half of the year.

However, some observers note that it remains to be seen whether the reimbursement listing will proceed strictly according to schedule. While Limcato holds symbolic significance as the first domestically developed CAR-T therapy, it is still an ultra-high-cost, one-time treatment costing hundreds of millions of won.

This implies that factors such as risk-sharing, performance-based post-marketing management, and reimbursement conditions, in addition to the drug price, could serve as variables in the negotiation process.

Ultimately, the key focus regarding Limcato’s reimbursement is shifting from “whether it will be reimbursed” to “under what conditions and how quickly it will be listed.”

While the likelihood of reimbursement itself is viewed relatively positively, analysis suggests that the actual speed of commercialization may vary depending on the terms of the negotiations.

Reimbursement prospects are optimistic… Speed expected to rise via parallel track

Limcato is an autologous CD19-targeted CAR-T therapy developed by Curocell. Its approved indications are for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma following two or more prior line of systemic therapy.

The Ministry of Food and Drug Safety (MFDS) granted marketing authorization for Limcato on the 29th of last month. This marks the first instance of a CAR-T therapy developed by a domestic company receiving approval.

Previously, the MFDS designated the drug as a “Bio-Challenger” candidate and the 33rd entry in the “Global Innovative Product on Fast-Track (GIFT)” system, providing tailored consultation and expedited review from the early stages of development.

The outlook for reimbursement is quite promising. Limcato has been selected as a drug for the Ministry of Health and Welfare’s “Pilot Project for Parallel Application for Approval, Reimbursement Evaluation, and Drug Price Negotiation.”

Previously, the process could take over 300 days, including 120 days for MFDS approval, 150 days for HIRA reimbursement evaluation, and 60 days for NHIS drug price negotiations, but the pilot project aims to shorten this timeline.

The company also maintains a positive outlook. Regarding drug price negotiations, the company has mentioned the possibility of an adjustment to a level that is the same as or slightly lower than the prices of existing CAR-T therapies, and therefore does not view the drug price itself as a factor that will cause significant delays.

In Korea, Novartis’ Kymriah has already established a precedent for CAR-T reimbursement, making this scenario more feasible.

Last January, the National Health Insurance Review and Assessment Service (HIRA) established reimbursement criteria for Gilead Sciences’ Yescarta for the indication of “treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) following two or more prior systemic therapies.”

Although Limcato is a late entrant, it benefits from accumulated experience in prior CAR-T evaluations and negotiations.

However, the industry notes that reimbursement likelihood and negotiation difficulty are separate issues. Even if the likelihood of entering the reimbursement system is high, given the nature of ultra-high-cost one-time treatments, there may be significant debate surrounding the conditions for listing.

Conditions, not price, may be the key variable… focus on risk-sharing discussions

Pricing is an important starting point for Limcato. Since Kymriah is already reimbursed, the CAR-T therapy’s price is expected to serve as a benchmark.

If Limcato adopts a relatively lower pricing strategy, this could strengthen its case for reimbursement. Its domestic manufacturing base also adds positive policy value.

However, industry experts suggest that risk-sharing and post-management conditions may be more critical than price itself.

CAR-T is an ultra-high-cost therapy that is expected to produce therapeutic effects with a single administration. If a sufficient response does not occur after administration, or if relapse or death occurs within a certain period, it will be crucial to determine how to link the financial burden on the national health insurance system to treatment outcomes.

According to Market Access (MA) experts, the likelihood of Limcato being covered by insurance is considered relatively high. This is because there are precedents for the coverage of existing CAR-T therapies, and if the company proposes a price that is equal to or lower than that of existing treatments, there is a strong possibility that the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) will positively consider the necessity of listing the drug.

However, the pharmaceutical industry views that, given the high likelihood of Limcato being discussed within the category of ultra-high-cost one-shot therapies, conditions such as performance-based reimbursement, patient-specific tracking, efficacy evaluation over a set period, and submission of post-treatment management data may be attached.

This is assessed not so much as a factor that makes reimbursement itself difficult, but rather as a variable that influences the duration of negotiations and the burden of actual commercialization preparations.

In particular, Limcato is the first domestically developed CAR-T therapy to be commercialized directly by a Korean biotech company. Compared to multinational pharmaceutical companies, the organizational burden may be relatively greater in areas such as managing risk-sharing agreements, establishing collateral, managing refunds, responding to hospitals, the National Health Insurance Service (NHIS), and the Health Insurance Review and Assessment Service (HIRA), and managing long-term follow-up data.

The industry is considering two scenarios regarding this point.

The first scenario is if the company accepts the drug price and post-marketing management conditions relatively quickly. In this case, leveraging the intent of the pilot program, which combines approval, evaluation, and negotiation, it appears possible to secure reimbursement listing and achieve commercialization in the second half of the year.

If Limcato secures price competitiveness compared to existing CAR-T therapies and negotiations proceed without major disagreements regarding post-marketing management conditions, the speed of market entry could accelerate.

The second scenario is if negotiations over risk-sharing conditions drag on. Even if the drug price can be adjusted relative to existing treatments, discussions regarding reimbursement conditions, long-term follow-up criteria, and performance evaluation methods could take a long time.

In this case, rather than the reimbursement listing itself falling through, it is more likely that the timing of the listing and the actual pace of prescription expansion will be delayed.

The initial key point to watch is the timing of the submission to the Cancer Drug Deliberation Committee. Even if the drug enters the parallel approval, evaluation, and negotiation track, it must still undergo deliberation by the Cancer Drug Deliberation Committee. The industry is closely watching whether it will be submitted in May.

Some observers believe there will be no Cancer Drug Deliberation Committee meeting scheduled for June, so the outline of the reimbursement schedule for the second half of the year is expected to become clearer depending on the timing of the agenda’s submission.

Limcato clinical results (Excerpt from Curocell IR Materials) Anbal-cel demonstrates superior treatmnet effect and lower side effect compared with 3 FDA-approved marketed CAR-T therapies

Supply speed is a strength… Differentiation through domestic manufacturing infrastructure

In the commercialization phase following reimbursement, Limcato’s supply competitiveness is expected to emerge as a key differentiator.

Existing CAR-T therapies followed a structure where patient cells were collected, sent to overseas manufacturing facilities, and the finished product was then imported back into the country.

In this process, manufacturing, logistics, and customs clearance procedures overlapped, requiring a certain amount of time before treatment could begin. Particularly for patients with rapidly progressing terminal blood cancers, the waiting period itself has been cited as a barrier to treatment accessibility.

In contrast, Curocell has established a system for domestic manufacturing and supply based on its CAR-T-dedicated GMP production facility in Daejeon. In fact, the company highlights the ability of Limcato to reduce waiting times through this domestic production and supply system as a key strength.

Curocell has also established “CuroLink,” an integrated solution for commercial operations. CuroLink is a cell therapy supply management solution that links information in real time between hospitals, manufacturing sites, and logistics providers. It is structured to track and manage patient-specific information from prescription through leukocyte collection, cell manufacturing, shipment, and administration.

Curocell also believes that its domestic production base will help expand patient access.

A Curocell official stated, “Since Limcato is manufactured at domestic GMP facilities, we can promptly respond to supply requests even from regional hospitals. Once a hospital decides to prescribe the drug after it is listed for reimbursement, the product supply process can be carried out through the system prepared by the company.”