Academia requests reimb expansion for Perjeta, Verzenio

HIRA will collect industry opinions on the cancer drugs’ reimbursement standards...reimbursement expansion effective from December

Lymph node-positive patients will now be reimbursed for their use of the breast cancer drug Perjeta inj (pertuzumab, Roche).  The reimbursement extension was requested by the relevant medical societies and will take effect in December.

 

It is interesting to note that the new criteria for reimbursement of anticancer drugs were established based on the opinions of academic societies rather than pharmaceutical companies.  The Health Insurance Review and Assessment Service recently issued a notice for the opinion inquiry on the amendment to the 'Details on the Application Criteria and Methods of Medical Reimbursement Benefits for Drugs Prescribed and Administered to Cancer Patients' notice.

 

The amendment is set to take effect on December 1.

 

The most notable change in the amendment is that the expansion of reimbursement benefits was being made at the request of academic societies rather than pharmaceutical companies.

 

One such example is the breast cancer drug ‘Perjeta inj.’ Currently, the Perjeta-based combination as neoadjuvant combination therapy is being reimbursed for “locally advanced, inflammatory, or early-stage (>2 cm in diameter) HER2-positive breast cancer.

 

However, in other countries, its use is also covered for lymph node-positive patients.

 

In other countries such as the United States (FDA) and Australia (TGA), lymph node-positive patients are included in the indication, and the NCCN guideline recommends the regimen subject to the application as category 2A for cN1 or higher, and ESMO recommends the regimen as [I,A] for lymph node-positive patients.  As a result, HIRA decided to set the reimbursement standard to include lymph node-positive patients because HER2-positive lymph node-positive breast cancer patients are at high risk of recurrence and need to improve survival with neoadjuvant chemotherapy, and pertuzumab-based neoadjuvant chemotherapy for lymph node-positive patients is a therapy with proven clinical benefit, being recommended in major guidelines such as NCCN and ESMO.  The application for this reimbursement expansion was made at the request of the relevant academic societies.  Perjeta is not the only drug to benefit from reimbursement expansions at the request of a medical society this time.

 

Verzenio Tab will also be added reimbursement standards for use in combination with endocrine therapy.

 

It, in combination with endocrine therapy, will be approved as adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, early-stage breast cancer at high risk of recurrence.  This regimen was mentioned in the textbook as an effective agent for hormone receptor-positive, HER2-negative, lymph node-positive, high-risk recurrent early breast cancer and is recommended as category 1 in the NCCN guidelines (2024.

 

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As the combination demonstrated a significant difference in IDFS (invasive disease-free survival) compared to the group that received an alternative, endocrine monotherapy, HIRA set its reimbursement standard to grant 'Anastrozole, Letrozole, Exemestane, Tamoxifen ± LHRH agonist' partial co-insurance (5/100) and ‘Verzenio’ no co-insurance (100/100, full out-of-pocket cost) within the scope of Verzenio’s indication..

 

In addition, the new drugs ‘Qarziba Inj’ and ‘Vyxeos liposomal Inj’ have been added to the reimbursement list among anticancer drugs.

 

In addition, a benefit expansion for ‘Trisenox Inj’ (induction of remission and consolidation in patients with newly diagnosed low-risk (white blood cell count ≤10×109/L) acute promyelocytic leukemia) was added.

 

In addition, for the ‘Braftovi+Erbitux’ combination therapy, reimbursement was additionally approved as a biweekly treatment for previously untreated patients with BRAF V600E-mutant metastatic colorectal cancer.

 

Currently, only the weekly regimen was granted reimbursement.