'Trodelvy' approved for prescription at general hospitals

Reimbursement review has been delayed for 9 months

Lands in 'Big 5' tertiary general hospitals and 34 medical centers

Can be prescribed at all medical centers…still awaiting consideration for DREC review in September

Product photo of Gilead Science Korea

'Trodelvy,' still not covered by reimbursement, has now been quickly approved for prescription in general hospitals.

 

Sources said that Gilead Science Korea's Trodelvy (sacituzumab govitecan), a treatment for triple-negative breast cancer (TNBC), has cleared drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, Seoul Asan Medical Center, and Severance Hospital in Sinchon, and 34 medical centers nationwide.

 

Although not covered by reimbursement, it has been approved for prescription at all medical centers with a prescription code issued.

 

More prescriptions are anticipated if it succeeds in listing for insurance reimbursement.

 

However, the reimbursement process for Trodelvy has not progressed since clearing the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) in November last year.

 

It was expected that Trodelvy would be considered for the Drug Reimbursement Evaluation Committee (DREC) review this month, but it was not.

 

The upcoming DREC review is scheduled to be on September 5th.

 

It is to be watched whether the first Trop-2 targeting Antibody-Drug Conjugate (ADC), Trodelvy, is to be considered for reimbursement listing.

 

Triple-negative breast cancer is an aggressive form among breast cancer types that is more likely to recur and metastasize.

 

Patients with triple-negative breast cancer who have progressed metastasis despite undergoing chemotherapy have a life expectancy of several months.

 

However, chemotherapy has been used as the standard therapy for a long time because an effective method to target cancer cells has not been discovered.

 

The current guidelines in the United States and Europe recommend Trodelvy as a priority treatment for patients with metastatic triple-negative breast cancer who have a treatment history.

 

According to the Phase 3 study, patients treated with Trodelvy had an overall survival of 11.8 months, close to a year, whereas patients undergoing chemotherapy had 6.9 months.

 

Furthermore, Trodelvy has been shown to be effective in regulating symptoms and pains associated with cancer and improving overall well-being, thereby improving patients' quality of life.

 

Trodelvy received the highest score of 5 on the ESMO-MCBS, a value-evaluation tool for anticancer medicines rated by the European Society for Medical Oncology (ESMO).

 

Drugs with Score of 5 are indicated to not only extend patient survival but also be effective in improving quality of life.

 

Trodelvy is the only drug to receive a Score of 5 among triple-negative breast cancer treatments.

 

In South Korea, several petitions requesting reimbursement listing of Trodelvy were posted on the website, and over 100,000 people agreed to the petition.

 

However, despite these efforts by patients and caretakers, the petition was ended due to the session ending of the 21st National Assembly.

 

Accordingly, the Korea Alliance of Patients Organization has submitted a statement to the Ministry of Health and Welfare (MOHW) requesting reimbursement review to be made quickly for drugs with high patient demand, such as Trodelvy, in May.

 

Meanwhile, in the United Kingdom, Trodelvy was granted a preferential status on a cost-effectiveness analysis based on extending survival of the patient group, a population less than rare disease, who have a life expectancy of less than two years.

 

As a result, it was approved for reimbursement after receiving a twofold higher incremental cost-effectiveness ratio (ICER) than other drugs.