Coverage expanded for Roche's HER2-positive breast cancer drugs to include lymph node-positive patients

Roche Korea said Monday that effective Dec. 1, the health insurance coverage for upfront chemotherapy (preoperative adjuvant therapy) for its HER2-positive breast cancer drugs Perjeta (pertuzumab) and Phesgo (trastuzumab/pertuzumab) has been expanded to include lymph node-positive patients based on a notification from the Ministry of Health and Welfare.

Perjeta was previously covered at a 30 percent copayment for patients with locally advanced, inflammatory, or early-stage (>2 cm in diameter) HER2-positive breast cancer as upfront chemotherapy for early-stage breast cancer. In addition, lymph node-positive patients are now eligible for coverage, further broadening the range of those eligible for upfront chemotherapy. These criteria also apply to Phesgo, a subcutaneous formulation that combines Perjeta and Herceptin (trastuzumab).

Roche Korea said the reimbursement expansion is a unique example of academic input and aligns with the recommendations of the latest global guidelines, including those from the U.S. National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO).

Current global guidelines, including the NCCN and ESMO, recommend the combination of pertuzumab and trastuzumab as first-line chemotherapy for patients with HER2-positive early breast cancer. Notably, the NCCN guidelines recommend the combination of pertuzumab and trastuzumab as Category 1 for lymph node-positive patients regardless of hormone receptor status at the time of prior chemotherapy.

ESMO guidelines also strongly recommend the combination of pertuzumab and trastuzumab as Category I-A for patients with HER2-positive early breast cancer with tumor size greater than 2 cm (T≥2 (cT2) cm) or positive lymph node metastases (cN+), regardless of hormone receptor status, according to Roche Korea.

“This coverage expansion is a significant step forward in expanding patient access to the standard of care recommended by global guidelines, especially in HER2-positive early breast cancer with lymph node metastases,” Roche Korea General Manager Ezat Azem said. “Roche Korea will continue to support patients and healthcare providers to achieve better treatment outcomes.”