Opdivo reimb as first-line therapy in gastric cancer in KOR

...Imbruvica’s reimb extended to G-CSF

HIRA collects opinions on the amendment of the anticancer drug reimb standards... to be implemented on September 1st

The immuno-oncology drug Opdivo will be available for use as a first-line treatment, and the administration subjects for Imbruvica and G-CSF injections will be expanded.

 

The Health Insurance Review and Assessment Service started collecting opinions on the amendment of the reimbursement standards that contain the changes above from the 24th.

 

The adjusted reimbursement standards will be implemented on September 1st.

 

Like the NCCN guidelines, Opdivo will be reimbursed as first-line treatment for HER 2-negative, unresectable, locally advanced, or metastatic gastric cancer.

 

Reimbursement will be approved for the combination treatment (first-line, palliative therapy) 'nivolumab(ingredient name Opdivo) + capecitabine + oxaliplatin,’ and combination treatment (first-line, palliative therapy) 'nivolumab + oxaliplatin + leucovorin + fluorouracil.’ More specifically, patients with PD-L1 expression positive (expression rate≥5) HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma are allowed reimbursement, and HER2-positive patients are excluded.

 

In addition, patients whose disease recurred 6 months after completing neoadjuvant chemotherapy, adjuvant treatment, and curative anticancer chemoradiation therapy are also allowed reimbursement.

 

Imbruvica Cap 140mg is approved as first-line monotherapy for patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who are aged 65 years or older with comorbidities.

 

More specifically, patients over 65 years of age with previously untreated active CLL or SLL, whose ▲(CIRS) score >6, or a ▲Creatinine Clearance < 70 mL/min, With the reimbursement extension, Janssen’s Imbruvica will voluntarily lower its insurance ceiling from KRW 58,555 to KRW 48,015.

 

The reimbursement for G-CSF injections will also be extended.

 

It is used to treat pancreatic cancer, and the 'adjuvant FOLFIRINOX(oxaliplatin + irinotecan + leucovorin + 5-FU)' combination will be additionally approved.

 

The G-CSF injections approved are pegfilgrastim (Neulasta Prefilled Syringe Inj), pegteograstim (Neulapeg Prefilled Syringe Inj), tripegfilgrastim (Dulastin Prefilled Syinrge Inj), lipegfilgrastim (Lonquex Prefilled Inj), and eflapegrastim (Rolontis Prefilled Syringe Inj).

 

Among these, Kyowa Kirin Korea’s Neulasta Prefilled Syringe Inj and GC Biopharma’s Neulapeg Prefilled Syringe Inj will be voluntarily lowering their insurance price ceiling.

 

As a result, Neulasta’s price will be lowered from KRW 778,334 to KRW 764,324, and Neulapeg from KRW 567,086 to KRW 565,952.

 

Also, the 'oxaliplatin + capecitabine' combination therapy will be reimbursed for patients with colorectal who have received neoadjuvant or adjuvant chemotherapy.