Korean patients with multidrug-resistant tuberculosis (TB) will likely get faster and better treatment than now.
The Korea Centers for Disease Control and Prevention (KCDC) said it has recently published the fourth edition of the TB treatment guidelines that focused on rapid diagnosis and broader use of new drugs. Along with the new instructions, the government will discuss reimbursement for new medicines, too.
The key of the newest treatment guidelines, prepared after a public hearing in September and the review of the TB expert committee, is to diagnose multidrug-resistant TB patients as soon as possible and allow them to use advanced drugs even in the early stage.
The guidelines recommend a rapid sensitivity test of isoniazid and rifampin for the first cultured strain or mycobacterial smear-positive sample of all TB patients, to reduce the delay in the diagnosis of multidrug-resistant TB.
If multidrug-resistant TB was confirmed, the guidelines recommended a rapid susceptibility test for quinolone-based drugs that could be additionally used. To raise the success rate of multidrug-resistant TB treatment, the guidelines also classified bedaquiline (new drug), linezolid, and quinolone-based drugs as essential medicines to be included in the initial treatment of multidrug-resistant TB.
Professor Shim Tae-Seon of the Pulmonology and Critical Care Medicine at Asan Medical Center, who also headed revising the TB treatment guidelines, said that the revised guidelines would not only provide a diagnosis and treatment direction for multidrug-resistant TB in Korea but also have a significant impact on the development of test methods and patient care.
Korea Biomedical Review has met with Shim to learn about the current status of the local multidrug-resistant TB treatment, what to improve, and the implication of the new treatment guidelines.
Question: Why did you update the guidelines for multidrug-resistant TB?
Answer: There have been many significant changes related to multidrug-resistant TB recently. Genetic testing made it possible to diagnose multidrug-resistant TB in two to three hours. Also, new drugs such as Sirturo (bedaquiline) and Deltyba (delamanid) appeared.
If you use new drugs properly, you can treat multidrug-resistant TB better. However, the problem is that these drugs are expensive. If you use a non-insured new drug for six months, it will cost about 30 million won ($24,479). Besides, these drugs were approved to be used for only six months (24 weeks). So, some patients have to discontinue treatment due to cost or limited period of use. For this reason, the WHO revised the guidelines in 2019 to recommend the use of new drugs for all patients with multidrug-resistant TB. To resolve this controversy in Korea, the guidelines were revised after a public hearing last year.
Q: The new guidelines have widened the scope of new drugs for multidrug-resistant TB, haven’t they?
A: Yes. All patients with multidrug-resistant TB can use new drugs from an early stage. But it doesn’t mean that the new drugs will be exempt from a preliminary review. The drugs require a review for use beyond 24 weeks or use in children, outside the approval conditions. However, it will be easier to use new medications because expert opinions allow extended use.
Q: Unlike the updated guidelines, the reimbursement is still limited in new drug use.
A: That’s right. The reason the announcement of the new guidelines was delayed for over seven months after the public hearing in September was that we had the issue of reimbursement for new drugs. Initially, we had planned to push for new guidelines and revised reimbursement simultaneously to prevent confusion in prescription. But the circumstances were not going well. As the KCDC and the Health Insurance Review and Assessment Service are aware of the need for expanded reimbursement, I think they will complete the reimbursement criteria in August or September.
Q: We heard that you are also heading a consortium to fight multidrug-resistant TB, prepared by the government.
A: The consortium will be a private-public partnership, operated by the Korea Academy of Tuberculosis and Respiratory Diseases. The most important task of the consortium is managing patients and training physicians. To do so, we’re planning to carry out projects such as nationwide multidrug-resistant TB patient management, consultation, regional analysis, and patient monitoring.
Q: According to the consortium’s plan, is it possible to build Korea’s multidrug-resistant TB cohort?
A: We are looking forward to the consortium’s projects. Multidrug-resistant TB requires intensive management because treatment is complicated and takes a long time. The goal is to build a system that tracks patients from diagnosis to the end of the treatment. If clinical information of domestic patients accumulates and their bacteria are secured, we expect that we could identify the drug resistance status and conduct epidemiological investigations through genome-sequencing analysis.
Source: Korea Biomedical Review