Phesgo can be prescribed in Korea with reimbursement

Roche’s biobetter for breast cancer

Passed drug committees of SNUH, etc.

The drug was applied the risk-sharing agreement scheme despite a precalculation drug

Breast cancer biobetter ‘Phesgo’ can now be prescribed in general hospitals in Korea with insurance reimbursement.

 

According to industry sources, Phesgo (pertuzumab/trastuzumab), which is a subcutaneous injection combination of Roche's Perjeta and Herceptin, has passed drug committees (DC) reviews of tertiary hospitals in Korea, including Samsung Medical Center and Seoul National University Hospital.

 

As a biobetter drug, the drug has been reimbursed since August, being applied to the preferential drug pricing plan.

 

Phesgo is a combination of Herceptin and Perjeta, drugs that were previously administered intravenously, into a single subcutaneous injection.

 

The primary benefit of the change from an intravenous to a subcutaneous formulation is its reduced administration time.

 

When treating HER2-positive breast cancer, the existing intravenous regimen required a total of 270 minutes (4.5 hours) for a single dose administration and observation.

 

In the case of Phesgo, the treatment can be completed within 20 minutes as it requires 5 minutes of administration and 15 minutes of observation time, reducing the time by up to 90% compared to traditional therapy.

 

The coinsurance rate of Phesgo was set at the same as for Perjeta: ▲30% when administered in combination with chemotherapy as neo-adjuvant therapy for patients with locally advanced inflammatory or early-stage (>2 cm in diameter) HER2-positive breast cancer; ▲100% when administered in combination as adjuvant therapy for patients who are HER2-positive and have lymph node-positive breast cancer (up to 18 cycles of trastuzumab and pertuzumab combination therapy); and▲5% when administered in combination for patients with metastatic or unresectable locally advanced recurrent breast cancer who are HER2-positive and have not received prior HER2 therapy or chemotherapy.

 

In the Phase III FeDeriCa study that studied 500 patients with HER2-positive early-stage breast cancer, the Phesgo subcutaneous arm was found to be non-inferior to the trastuzumab and pertuzumab intravenous arms.

 

In general, because intravenous and subcutaneous injections have different routes of administration, their anticancer effect is identified based on the trough level and the probability of being cancer-free at the time of surgery.

 

In the case of Phesgo, there was no difference in the trough level according to the route of administration, and the anti-cancer effect and survival period of the two therapies were the same, offering added strength of convenience to the existing advantages.

 

“In the FeDeriCa study, Phesgo subcutaneous injection demonstrated equivalent trough levels as intravenous trastuzumab and pertuzumab,” said Seock-Ah Im, Professor of hematology-oncology at Seoul National University Hospital.

 

”It provides convenience to both patients and healthcare providers by reducing treatment time while maintaining the effectiveness and safety of intravenous trastuzumab and pertuzumab.” Meanwhile, the insurance authorities have also decided to reimburse Phesgo through the risk-sharing agreement scheme, to save health insurance finances.

 

This is because Phesgo’s development target product, Perjeta, is also currently covered by the risk-sharing agreement scheme.