Reimbursement criteria set for Padcev, Rybrevant

HIRA registers 14 new and 5 revised regimens... Effective as of Oct. 1

Tevimbra gains criteria for 7 regimens across lung, gastric and esophageal cancers

Vyloy, Rybrevant enters reimbursement...Keytruda’s reimbursement extends to gastric cancer

Reimbursement criteria are being established for major cancer drugs, including Padcev, Rybrevant and Tevimbra, ahead of their coverage under Korea’s national health insurance.

The Health Insurance Review and Assessment Service (HIRA) on Sept. 22 began seeking public comments on proposed revisions to its “Notice on Drugs Prescribed and Administered to Cancer Patients.”

The proposal includes revisions across 18 items. 14 anticancer regimens will be newly added, while 3 items will be revised, including through expanded reimbursement. The changes are scheduled to take effect on Oct. 1.

The new reimbursement criteria cover 5 regimens for non-small cell lung cancer (NSCLC), 4 for gastric cancer, 2 for esophageal cancer, 1 for thyroid cancer, and 1 for urothelial carcinoma.

Tevimbra gains reimbursement criteria for 7 regimens across lung, gastric and esophageal cancers

Tevimbra (tislelizumab) accounts for the largest number of newly added anticancer regimens under the proposal, with reimbursement criteria established for 7 regimens: 3 in NSCLC, 2 in gastric cancer and 2 in esophageal cancer.

In NSCLC, two first-line combination regimens and one second-line or later monotherapy regimen will be added.

First-line treatment with Tevimbra in combination with pemetrexed and platinum chemotherapy will be covered for patients with nonsquamous NSCLC without EGFR or ALK alterations whose tumors have PD-L1 expression of at least 50%.

For locally advanced or metastatic squamous NSCLC, reimbursement criteria will be established for first-line Tevimbra in combination with paclitaxel and carboplatin.

Tevimbra monotherapy will also be newly covered as second-line or later treatment for patients with NSCLC whose disease has progressed following platinum-based chemotherapy.

In gastric cancer, coverage will apply to patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression of TAP ≥5%. Reimbursement criteria will be established for first-line Tevimbra in combination with either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

For esophageal cancer, coverage will apply to patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma with PD-L1 expression of TAP ≥10%.

Eligible regimens include Tevimbra combined with fluorouracil or capecitabine plus platinum chemotherapy, and Tevimbra combined with paclitaxel plus platinum chemotherapy.

Padcev+Keytruda gains first-line coverage in urothelial carcinoma...Keytruda eligibility expands to gastric cancer

In urothelial carcinoma, Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) will be newly covered as first-line combination therapy.

Coverage will apply to patients with locally advanced or metastatic urothelial carcinoma, including those whose disease recurs more than 12 months after completion of neoadjuvant or adjuvant chemotherapy. Patients previously treated with a PD-1 or PD-L1 inhibitor will be excluded.

Eligibility for Keytruda in gastric cancer will also be expanded. Patients with HER2-negative gastric and gastroesophageal junction adenocarcinoma with mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) will be added to patients covered under the existing criteria.

Reimbursement criteria established for Vyloy, Rybrevant and Retevmo

Reimbursement criteria will also be established for several targeted cancer therapies ahead of their entry into national health insurance coverage. Vyloy (zolbetuximab) will be covered for patients with CLDN18.2-positive gastric cancer.

Specifically, coverage will apply to patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 expression of at least 75%.

Reimbursement criteria will be established for 2 first-line Vyloy regimens: combination with oxaliplatin, leucovorin and fluorouracil, and combination with capecitabine and oxaliplatin.

In NSCLC, reimbursement criteria will also be newly established for Rybrevant (amivantamab) and Retevmo (selpercatinib).

Rybrevant will be covered as second-line or later monotherapy for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed following platinum-based chemotherapy.

Retevmo will be covered as first-line or later monotherapy for patients with RET fusion-positive NSCLC. Eligible patients must have locally advanced or metastatic nonsquamous NSCLC with a confirmed RET fusion-positive solid tumor.

Reimbursement criteria for Retevmo will also be established in thyroid cancer. Coverage will apply to adults and children aged 12 years or older with advanced or metastatic RET-mutant medullary thyroid cancer.

First-line or later coverage will be available to patients whose disease has progressed within 14 months and who require systemic therapy. However, patients who receive vandetanib after treatment failure with Retevmo will be required to pay the full cost of vandetanib out of pocket.