Will Trodelvy be deliberated for reimb by DREC in August?

Failed to receive deliberation at the Drug Reimbursement Evaluation Committee’s July meeting

UK recognizes the drug’s value in small, late-stage patient population

Drug demonstrates survival benefit as only option in second-line or higher triple-negative breast cancer

The road to reimbursement for the new ADC breast cancer drug Troldelvy remains a bumpy one.

 

The agenda remains pending for 8 months now.

 

Gilead Sciences' triple-negative breast cancer (TNBC) drug Troldelvy, whose reimbursement request received 100,000 consents in a public petition, was not presented for deliberation to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in July.

 

The drug’s application has remained without progress since its reimbursement standard was set by the Cancer Disease Review Committee in November last year.

 

Therefore, attention is now focused on whether the drug will be submitted to DREC in August.

 

Trodelvy is already listed in about 30 countries around the world.

 

Taiwan, which has a single-payer healthcare system similar to South Korea's, began reimbursing Trodelvy in February this year.

 

The global rush to improve patient access to Trodelvy has been driven by the poor treatment environment for metastatic triple-negative breast cancer and the clinical value of Trodelvy.

 

Triple-negative breast cancer is an aggressive form of breast cancer that recurs and metastasizes rapidly.

 

Patients with metastatic triple-negative breast cancer who have metastasized despite treatment have a life expectancy of only a few months even with chemotherapy.

 

However, chemotherapy has long been the standard of care due to the lack of targets that can effectively kill cancer cells.

 

Trodelvy, the first Trop-2-targeted antibody-drug conjugate (ADC), is the only treatment for metastatic triple-negative breast cancer in the second-line or higher setting that has been shown to prolong survival compared to chemotherapy and has settled as the global standard of care since its introduction.

 

Currently, major guidelines in the U.S.

 

and Europe specify Troldelvy as the preferred agent for patients with previously treated metastatic triple-negative breast cancer.

 

In a Phase III study, the overall survival of the chemotherapy arm was 6.9 months, compared to a nearly one-year survival.

 

(11.8 months) in the Troldelvy arm, In addition, Troldelvy demonstrated an effect in controlling symptoms and pain caused by cancer and an improvement in patients' quality of life by improving their overall health status.

 

Trodelvy was awarded the highest possible score of 5 points on ESMO-MCBS, the European Society for Medical Oncology's (ESMO) scale used to rate the value of anticancer drugs.

 

A score of 5 indicates that a drug is effective not only in prolonging patient survival but also in improving quality of life, and Troldelviy is the only treatment for metastatic triple-negative breast cancer to receive a score of 5 on  ESMO-MCBS.

 

In fact, the U.K.

 

has detailed the rationale behind its assessment, stating that the state’s reimbursement decision was based on the severity of metastatic triple-negative breast cancer and the survival benefit of Troldelvy.

 

Similar to Korea, the U.K.

 

uses the incremental cost-effectiveness ratio (ICER) to evaluate new drugs for health insurance coverage.

 

While the UK has one of the highest reimbursement barriers for new drugs, it applies flexible pharmacoeconomic evaluation criteria for innovative drugs used for serious conditions to improve patient access.

 

In the UK, Troldelvy was granted preferential economic evaluation because it prolonged survival in terminally ill patients with less than 2 years of life expectancy, whose population is even smaller than those of rare diseases.

 

As a result, Trodelvy gained access with an ICER threshold that was approximately twice higher than that of general drugs.

 

Meanwhile, Troldelvy has been the subject of a series of petitions this year, gathering more than 100,000 consents online.

 

Since the petition system’s inception, Trodelvy is the only drug to be referred to the National Assembly for garnering more than 50,000 signatures.

 

The Korean Alliance of Patients' Organizations also responded to the desperate pleas of patients and their caregivers when the petition was abandoned due to the expiration of the 21st National Assembly's term.

 

In May, the organization submitted a letter directly to the Ministry of Health and Welfare requesting a prompt review of the reimbursement of drugs with high patient demand, including Trodelvy.