Keytruda to be reimbursed as first-line treatment for NSCLC

5 years since the drug was approved for the indication… first-ever cancer immunotherapy reimbursed for NSCLC

Reimbursement standard for acute myeloid leukemia (AML) treatment ‘Xospata’ newly established

A new category will be added to reimburse MSD’s NSCLC treatment ‘Keytruda’ as a first-line treatment.

 

This is the first anticancer immunotherapy released in Korea to be reimbursed for NSCLC, five years into its approval as a first-line treatment for non-small-cell lung cancer in Korea.

 

The drug passed deliberations by the Health Insurance Reimbursement and Assessment’s Drug Reimbursement Evaluation Committee, which decided to extend the national health insurance coverage for Keytruda as first-line treatment for NSCLC.

 

HIRA announced the results above while collecting opinions on the 'revisions on the announcement made for drugs prescribed and administered to cancer patients' on the 18th.

 

The revisions showed that a new reimbursement category has been added for Keytruda as first-line therapy and will take effect from March.

 

Keytruda is a cancer immunotherapy drug that specifically binds to PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 proteins existing on the surface of tumor cells and induces T cells to attack the tumor cells.

 

Therefore, the drug can be used in various cancer patients with PD-L1 expression and was approved as a first-line treatment in Korea in March 2017 for the treatment of metastatic NSCLC.

 

However, its reimbursement did not gain momentum until last year, when the agenda passed HIRA’s Cancer Disease Review Committee and then passed DREC review in January this year.

 

In the proposed revision, Keytruda can now be reimbursed as ▲first-line treatment for PD-L1 positive (Tumor Proportion Score (TPS)≥50%), advanced NSCLC (Stage IV) patients with no EGFR or ALK mutation, ▲ first-line treatment of metastatic nonsquamous NSCLC patients with no EGFR or ALK mutation in combination with pemetrexed platinum-based chemotherapy, ▲ first-line treatment of metastatic squamous NSCLC patients in combination with pemetrexed or paclitaxel (or albumin-bound paclitaxel), ▲as monotherapy for the treatment of adult patients and pediatric patients aged 2 years or older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have relapsed after at least two types of therapy or failed or is ineligible for allogeneic hematopoietic stem cell transplantation (HSCT).

 

This is the first time a cancer immunotherapy is reimbursed as a first-line treatment for NSCLC.

 

A clinical trial conducted on NSCLC patients as monotherapy for the reimbursed indication showed that its median OS was 30 months and median PFS 10.3 months, both better than the control group (14.2 months, 6.0 months), raising expectations on the treatment effect the drug will bring to the field.

 

The ORR in the Keytruda-treated group was 69%, higher than the 42% of the control group.

 

A qualitative improvement is expected in the field of NSCLC treatment in general with the increased treatment options and the improved patient access to new options.

 

Meanwhile, the revision also added a new reimbursement standard for the acute myeloid leukemia (AML) treatment ‘Xospata (Astellas, gilteritinib).’ A new reimbursement standard will be added for the second-line or higher use of Xospata as monotherapy in patients with FLT3 mutation-positive relapsed or refractory AML.