토토 카지노

Since passing the Severe Cancer Disease Review Committee last November, the reimbursement listing process for Trodelvy (ingredient: sacituzumab govitecan) has made little progress. The primary issue appears to be the incremental cost-effectiveness ratio (토토 카지노) threshold for insurance coverage.

토토 카지노 is an antibody-drug conjugate (ADC) targeting the Trop-2 protein. In May 2023, the Ministry of Food and Drug Safety (MFDS) approved it in South Korea as a second-line treatment for metastatic triple-negative breast cancer (TNBC) patients, excluding cytotoxic chemotherapy, regardless of genetic mutations or biomarkers.

During the November review meeting, reimbursement criteria were set for "adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic treatments, with at least one for metastatic disease." Following this decision, public petitions urging reimbursement were submitted in December and April, each garnering over 50,000 signatures.

However, the prolonged delay in securing reimbursement has placed a heavy financial burden on patients. Industry insiders attribute the delay primarily to the high 토토 카지노 value in the economic evaluation.

Trodelvy, similar to Enhertu, is awaiting a flexible 토토 카지노 application. The 토토 카지노 is a standard tool for assessing the economic value of new drugs with enhanced efficacy, measuring the additional cost per unit of health benefit compared to existing alternatives. Drugs are considered cost-effective if their 토토 카지노 falls below a specified threshold.

Trodelvy meets all the criteria for flexible 토토 카지노 application under the government’s favorable conditions for innovative drugs. These criteria include: (1) the absence of alternative or equivalent therapeutic options, (2) clinically significant improvements such as substantial survival extension, and (3) approval through expedited review by the Ministry of Food and Drug Safety (MFDS) or receiving breakthrough therapy designation (BTD) from the U.S. FDA or PRIME status from the European EMA.

Nevertheless, Trodelvy’s 토토 카지노 reportedly stands around ,000, posing significant challenges for reimbursement listing. Although South Korea has no officially fixed 토토 카지노 threshold, data from economic evaluations between 2007 and 2021 show median 토토 카지노 values of ,000 for general drugs, ,000 for cancer treatments, and ,000 for orphan drugs. Enhertu, another breast cancer treatment listed for reimbursement in April, had an 토토 카지노 in the ,000 range.

A Gilead Sciences representative commented, "While we cannot disclose specific details, we are engaged in discussions with health authorities to improve patient access through 토토 카지노’s reimbursement."

Meanwhile, the Health Insurance Review and Assessment Service (HIRA) has announced plans to revise the drug pricing system to enhance patient access through appropriate compensation for innovative drugs. Their focus is on refining the definition of "innovation," a critical factor in determining the 토토 카지노 threshold.