The 10th Cancer Disease Review Committee (CDRC), under the Health Insurance Review and Assessment Service (HIRA), held its first meeting with newly reconstituted members on Wednesday, during which it discussed nine new and expanded reimbursement proposals.

However, most drugs did not pass the review, except for some chemotherapy drugs, government and business officials said.

Aside from the failures of the targeted anticancer drugs of Tepmetco, Pemazyre, and Verzenio, which made their second attempts, the initial attempt by immunotherapyTevimbra in esophageal cancer, a barren area for new drug reimbursement, also ended up unsuccessful.

HIRA released the results of the deliberations on the reimbursement standards for drugs used for cancer patients at the CDRC meeting.

HIRA recently released the roster of the 10th CDRC, which consists of 40 members. The committee, led by Chairman Lim Ho-young of the Department of Hematology/Oncology at Samsung Medical Center, an expert in digestive cancers, will serve a two-year term from Feb. 16, 2024, to Feb. 15, 2026. The new committee members held their first meeting on Wednesday and deliberated on nine new and expanded reimbursement proposals.

Merck's Tepmetco (tepotinib), Handok's Pemazyre (pemigatinib), and BeiGene’s Tevimbra (tislelizumab) were tabled for new reimbursement but all were rejected.

Merck tried again to reimburse Tepmetco for "locally advanced or metastatic non-small cell lung cancer with confirmed MET exon 14 skipping" but was not approved for reimbursement.

Tepmetco, a MET inhibitor approved by the Ministry of Food and Drug Safety (MFDS) in November 2021, failed to get coverage in its first attempt at the CDRC meeting in February last year. With the latest failure, Tepmetco will remain an uncovered drug for over two years after its approval.

Pemazyre is a targeted antitumor drug approved by the MFDS in April last year for treating “FGFR2 fusion or rearrangement locally progressive or metastatic cholangiocarcinoma that has received at least one systemic therapy." Handok challenged its reimbursement simultaneously with the approval of Pemazyre but received a "re-discussion” decision at the CDRC meeting last November.

There are no other targeted therapy options available in Korea for patients with previously unsuccessful cholangiocarcinoma. Still, Pemazyre failed to meet the reimbursement threshold due to the re-discussion.

Tevimbra, an anti-PD-1 immuno-oncology drug approved by the MFDS in late November last year for treating "unresectable, recurrent, locally progressive or metastatic esophageal squamous cell carcinoma unable to continue prior platinum-based chemotherapy treatment or has recurred or progressed since its administration," was also unsuccessful in its coverage challenge.

Currently, immunotherapies with the same mechanism of action, such as Keytruda (pembrolizumab) and Opdivo (nivolumab), are indicated for the first and second-line treatment of esophageal cancer, but there are no reimbursed options. Tevimbra was the only immuno-oncology drug to apply for coverage for "second-line treatment of advanced esophageal cancer," but failed to set the reimbursement criteria.

Other immunotherapies sought to expand their reimbursement at Wednesday’s meeting. They included pemetrexed drugs, such as Teva Handok's Lonquex (ripegfilgrastim), Sanofi's Taxotere 1 (docetaxel), and Boryung's Alimta, as well as Clinigen's Erwinase (L-asparaginase), Pfizer's Zavedos (idarubicin), and Eli Lilly's Verzenio (abemaciclib) were tabled but only Alimta and Erwinase were successful in expanding coverage.

Not only did the relatively new targeted anticancer drug Verzenio but also chemotherapy drugs used in Korea for nearly 10 to 20 years failed to pass the review.

Lonquex, which was approved in July 2015 for "reducing the duration of severe neutropenia in patients receiving cytotoxic chemotherapy for solid tumors and malignant lymphomas," was unsuccessful in its bid to expand coverage to "children two years of age and older" in addition to adults.

Sanofi unsuccessfully sought a benefit expansion for Taxotere in combination with oxaliplatin and S-1 (tegafur/gimeracil/oterasil potassium) in the preoperative adjuvant treatment of resectable locally advanced gastric cancer.

Zavedos attempted to expand coverage as monotherapy for transcatheter arterial chemoembolization (TACE) in liver cancer but failed (but was approved for 5/100 co-pay as off-label therapy).

CDK4/6 inhibitor Verzenio failed to gain coverage as an adjuvant treatment in combination with endocrine therapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-), lymph node-positive early breast cancer at high risk of recurrence.

Eli Lilly also sought coverage for Verzenio in the same regimen last year, which failed to pass CDRC in May last year.

Globally, only two CDK4/6 inhibitors are available for adjuvant therapy in patients with early-stage breast cancer – Verzenio and Novartis' Kisqali (ribociclib). However, adjuvant treatment with Kisqali has not yet been approved in the U.S., leaving Verzenio as the only option.

Meanwhile, pemetrexed, which is covered for "first-line treatment of metastatic non-squamous non-small cell lung cancer without EGFR or ALK mutations in combination with Keytruda and platinum chemotherapy," was removed from the maximum two-year benefit period.

Besides, Erwinase, which is covered for "combination therapy with other chemotherapeutic agents in patients with acute lymphocytic leukemia (ALL) who are hypersensitive to E. coli-derived asparaginase, in combination with other chemotherapeutic agents," has been changed from a Tier 3 to a Tier 2 status.