Amgen's Blincyto moves closer to 1st-line reimbursement for ALL after PREC review

Amgen’s Blincyto (blinatumomab) has passed the Pharmaceutical Reimbursement Evaluation Committee (PREC), moving closer to first-line reimbursement for acute lymphoblastic leukemia (ALL) in Korea.

At the fourth PREC meeting held Thursday, the Health Insurance Review and Assessment Service (HIRA) determined that reimbursement was appropriate for Blincyto as a first-line induction therapy for Philadelphia chromosome-negative precursor B-cell ALL in adults and children.

Blincyto must still undergo price negotiations with the National Health Insurance Service (NHIS), followed by final approval from the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee. Industry observers expect a final decision later this year.

Amgen’s acute lymphoblastic leukemia treatment, Blincyto (Courtesy of Amgen)

Passed key review stages without re-evaluation

Since its review by the Cancer Disease Review Committee (CDRC) in July 2025, Blincyto has passed the Cost-Effectiveness Evaluation Subcommittee and the PREC without requiring re-evaluation.

A full cost-effectiveness assessment was conducted as part of the expanded indication review, despite the drug previously being listed as an orphan drug under an exemption.

As an orphan drug, Blincyto was initially listed in 2016 under a special exemption from cost-effectiveness evaluation, with its price set based on the lowest level among reference A7 countries (the U.S., the U.K., France, Germany, Italy, Switzerland, and Japan); it has since undergone multiple price reductions.

This pricing history may be considered during NHIS negotiations, though the outcome remains to be determined.

Clinical data supporting Blincyto include the E1910 study in adults, where the addition of blinatumomab to chemotherapy reduced the risk of death at three years by 59 percent compared to chemotherapy alone (P=0.002).

In the AALL1731 study in pediatric patients, disease-free survival was 96 percent, compared to 87.9 percent with chemotherapy alone (P<0.001).

These findings have contributed to its inclusion in treatment guidelines and its use in certain clinical settings.

In Korea, however, use of Blincyto has been limited due to reimbursement restrictions. Current coverage does not include first-line induction therapy, despite broader use in some international guidelines.

The recent PREC decision may support efforts to align reimbursement with clinical practice, depending on the outcome of the remaining review steps.

Reimbursement expansion could broaden treatment options

Blincyto is a bispecific T-cell engager (BiTE) immunotherapy that targets both T cells and cancer cells, offering an alternative mechanism of action to conventional chemotherapy.

Recent treatment strategies for ALL increasingly incorporate approaches based on minimal residual disease (MRD), including the use of targeted or immunotherapies in certain settings.

If reimbursement is finalized, clinicians would have an additional option for first-line treatment, though its uptake will depend on pricing and clinical considerations.

The remaining steps include NHIS negotiations and final approval by the Health Insurance Policy Deliberation Committee. The timeline and final reimbursement conditions have not yet been determined.