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- 2026-04-20 05:00:52
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- Policy
- Ginkgo biloba ·calcium dobesilate ·silymarin set for reimb re-eval this month
- by Jung, Heung-Jun Apr 17, 2026 09:03am
- Ginkgo biloba extract, calcium dobesilate hydrate, and silymarin are set to be discussed for the re-evaluation of reimbursement appropriateness during this month’s Health Insurance Policy Deliberation Committee (HIDC) meeting.Three ingredients, including the two reviewed by the Pharmaceutical Reimbursement Evaluation Committee (PREC) in January and silymarin (added this month), are expected to be considered. The HIDC's final decision process, which had been somewhat delayed following the drug pricing system reform, is anticipated to be finalized this month.According to industry sources on the 15th, the ingredients for this year's reimbursement re-evaluation are highly likely to pass through the HIDC subcommittee today (the 16th) and be presented at the plenary session on the 23rd.The list of ingredients for re-evaluation differs slightly from those discussed in last year's HIDC subcommittee. At that time, seven ingredients were under discussion, including kallidinogenase, meglumine gadoterate, diacerein, afloqualone, and octylonium bromide, as well as ginkgo biloba and calcium dobesilate.However, as the drug pricing system reform plan, which included a new set of criteria for appropriateness re-evaluation, passed the HIDC last November, re-discussions were held this year based on these updated standards.The requirements for claim amounts and registration in specific countries have been removed. The selection criteria have been changed tov include ▲ingredients for which health authorities in A8 countries have initiated clinical or reimbursement appropriateness re-evaluations ▲cases where data or clinical evidence contradicting previously reported efficacy has been published ▲drugs for which academic societies or experts have recommended a re-evaluation.Accordingly, ginkgo biloba and calcium dobesilate were reviewed as re-evaluation targets by the PREC in January. Typically, these should have been finalized at the January HIDC meeting following PREC approval, but the HIDC consideration was delayed alongside the postponement of the drug pricing reform.In the meantime, silymarin was added to the list of targets for review at this month's PREC meeting. Although a court had previously ruled to cancel the notification of silymarin's removal from the reimbursement list following an administrative lawsuit by pharmaceutical companies, the ruling was limited to procedural issues, leaving re-evaluation likely.The Health Insurance Review and Assessment Service (HIRA) plans to proceed with the re-evaluation again, this time acknowledging the literature previously pointed out by the court. Consequently, silymarin, which underwent reimbursement re-evaluation in 2021, will return to the evaluation table alongside ginkgo biloba and calcium dobesilate.Due to the government's reform of the drug pricing system, the follow-up measures following a reimbursement re-evaluation have been simplified to either exclusion from reimbursement or selective reimbursement. The bypass that allowed companies to maintain reimbursement by voluntarily lowering drug prices to demonstrate cost-effectiveness relative to alternative drugs has effectively been blocked.
- Policy
- New reimb criteria established for growth hormone Sogroya
- by Jung, Heung-Jun Apr 17, 2026 09:03am
- The government is establishing new reimbursement criteria following the new listing of growth hormone treatments. Additionally, self-injectable formulations of severe asthma treatments have been newly added to the list, allowing for switching between formulations.On the 16th, the Ministry of Health and Welfare issued an administrative notice regarding the amendment to the “Detailed Provisions on the Application Criteria and Methods for Medical Care Benefits.” The amendment is scheduled to take effect on May 1.Novo Nordisk’s Sogroya prefilled pen (somapacitan) will have new reimbursement criteria established for growth hormone deficiency in both pediatric and adult patients.The drug is administered at a maximum of 8 mg per week in accordance with the approved indications, and patients must bear the full cost if they exceed specific height criteria (153 cm for females, 165 cm for males). Coverage may be extended if growth hormone deficiency is confirmed after 3 years of treatment. Self-injection prescriptions are also permitted.Reimbursement criteria have also been newly established for emergency imported drugs supplied through the Korea Orphan & Essential Drug Center. The skeletal muscle relaxant Takeda Lysthenon Inj is now covered for use during general anesthesia to alleviate spasms associated with endotracheal intubation or electroconvulsive therapy (ECT).For the anti-atherosclerotic agent Epic Cholestyramine Powder for Susp, coverage criteria have been established solely for the purpose of 'Reducing serum cholesterol levels’ within the scope of approval by the Ministry of Food and Drug Safety. However, patients must bear the full cost when the drug is administered for other purposes, such as treating pruritus.Reimbursement criteria have been established for the vasodilator Viatris Isoptin Inj for the treatment of angina and arrhythmia, and Centa 5-HT-P Cap is now covered for the treatment of patients with BH4-deficient phenylketonuria. For GSK’s severe asthma treatment Nucala, the self-injectable autoinjector formulation Nucala Autoinjector was added, allowing switching with the existing formulation.Additionally, for Nucala Autoinjector, long-term prescriptions of up to 24 weeks are permitted for patients who have shown stable disease activity and no side effects 6 months after the initial dose.’With the listing of new combination drugs for diabetes and hypertension/dyslipidemia, general reimbursement principles have been partially revised. The empagliflozin + linagliptin combination has been added for diabetes with the new listing of K-Glito Tab, and the fimasartan + atorvastatin + ezetimibe combination has also been added for hypertension and hyperlipidemia with the new listing of Kanarbzet Tab.Gliptide Tab, which failed to demonstrate usefulness during the Ministry of Food and Drug Safety’s clinical reevaluations, will be removed from the reimbursement list.
- Opinion
- [Reporter's View] NHI "red light", societal consensus needed
- by Lee, Jeong-Hwan Apr 17, 2026 09:03am
- South Korea’s National Health Insurance (NHI) finances are expected to enter a deficit in 2026. While the fund was in surplus for five consecutive years since 2021, the end of the COVID-19 pandemic, the transition to endemic status, and the onset of a super-aged society have led to a sharp increase in medical expenditures, causing the surplus to plummet annually.The government has established and implemented various policies to ensure the soundness and sustainability of NHI finances. One example is the reduction of pharmaceutical costs through generic drug price cuts, which recently sparked a conflict with the domestic pharmaceutical industry.However, health insurance experts argue that the government must resolve larger fundamental issues rather than focusing on administrative measures to create fiscal room through drug price cuts.While the increase in medical utilization and benefit expenditures due to a super-aged population is an unavoidable natural growth factor, experts criticize that the failure to aggressively resolve distortions in the medical delivery system or the lack of measures to eradicate excessive medical care ("medical shopping") is a man-made disaster that exacerbates the problem through inadequate administration despite being preventable.Furthermore, health insurance experts view the solutions for securing the soundness of NHI finances as having been consistently discussed as an agenda for over a decade, and the correct answers are already somewhat determined.Ultimately, this means that procedures must be established for the government, medical providers (doctors), and medical consumers (patients and the public) to form a consensus and agree on a policy direction that boldly lowers or suspends the benefit coverage rate for excessive medical care and overhauls the payment system centered on the fee-for-service model from its roots.Of course, there is a high probability that opinions will differ regarding the priorities for allocating NHI finances. However, before coordinating such detailed disagreements, the government should take the lead in establishing societal consensus.The etymology of "consensus" originates from the Latin words con- (together) and sentire (to feel). It refers to members of society sharing common feelings and thoughts.NHI finances are a social insurance system operated by the state with public consent, and the key lies in how to create, maintain, and distribute limited public resources. Ultimately, it means that the NHI can be operated without conflict only when it is based on consensus.At this crossroads, where NHI finances are being depleted and the deficit is set to increase significantly, the Ministry of Health and Welfare (MOHW), the ministry in charge, must engage in bold, active administration. This is necessary so that the entire public and medical providers can share the common view that NHI sustainability must be significantly strengthened before social conflict is triggered by fiscal deterioration.This implies that the Ministry of Health and Welfare (MOHW) should take the lead in improving the perception that a "red light" has been turned on for NHI finances and that all members of our society must share some of the burden to solve the problem.
- Policy
- Free HPV vaccination for 12-year-old boys to begin in May
- by Lee, Jeong-Hwan Apr 17, 2026 09:03am
- Starting this May, 12-year-old boys will also be eligible for free human papillomavirus (HPV) vaccinations.The Korea Disease Control and Prevention Agency announced on the 16th that it will launch a new national HPV vaccination support program targeting 12-year-old male adolescents (born in 2014) starting May 6.With this change, the existing HPV free vaccination program for female adolescents aged 12–17 and low-income women aged 18–26 will now include male adolescents, who will receive two HPV vaccine doses at six-month intervals.Starting with those born in 2014 this year, those born in 2015 will be newly supported next year. Even if those born in 2014 do not complete both doses this year, they will still be eligible for free vaccination next year.The KDCA plans to expand the program gradually, broadening the target group by one age group each year.HPV vaccination is included in national immunization programs in 147 countries worldwide, including 37 of the 38 member nations of the Organization for Economic Cooperation and Development (OECD).According to the U.S. Centers for Disease Control and Prevention (CDC), 90% of cervical cancers and 70% of anogenital and oropharyngeal cancers are caused by HPV infection. The KDCA believes that expanding free HPV vaccination will help prevent related diseases such as cervical cancer, anal cancer, genital warts, and anal intraepithelial neoplasia.The KDCA maintains that since HPV can infect not only women but also men, and since the HPV vaccine’s efficacy in preventing related diseases has been confirmed in men as well, vaccination can reduce future infections and the incidence of related diseases.The Advisory Committee on Immunization also determined that HPV vaccination is effective in preventing diseases such as genital warts and anal cancer in men. Based on domestic and international research and vaccination experience, which have confirmed the safety and efficacy of the HPV vaccine, the agency recommended expanding support for HPV vaccination among male adolescents.Eligible individuals can visit a nearby designated medical institution or public health center to receive the HPV vaccine (quadrivalent HPV vaccine) free of charge. The KDCA plans to provide information on medical institutions through the Vaccination Assistant website and support vaccination history tracking and management.Commissioner Seung-Kwan Lim stated, “HPV vaccination is an effective means of preventing future cancers and related diseases. We hope that this expansion of the target group will enable more adolescents to receive the vaccination in a timely manner.”
- Policy
- GLP-1 obesity drugs designated as medicines at risk of misuse
- by Lee, Tak-Sun Apr 16, 2026 02:26pm
- Eun-hee Moon, Director of the Pharmaceutical Management Division at the Ministry of Food and Drug Safety, explains the details of the plan to designate GLP-1 obesity drugs as drugs at risk of misuse or abuse to reporters on the 14th.The Ministry of Food and Drug Safety (MFDS) has officially stated that its proposal to designate GLP-1 class obesity treatments as drugs at risk of misuse or abuse passed the Central Pharmaceutical Affairs Council review on the 8th, and that implementation may begin within as little as 2 to 3 months.According to the MFDS, all participating members of the Central Pharmaceutical Affairs Council agreed to the designation of GLP-1 obesity treatment drugs as being at risk of misuse or abuse. However, it was noted that no representatives from obesity societies or specialists attended the committee meeting.Eun-hee Moon, Director of the Pharmaceutical Management Division at the MFDS, made the announcement during a briefing for specialized media reporters held at the MFDS headquarters in Osong on the 14th.Director Moon explained that prior to the council meeting, the MFDS had consulted with the Ministry of Health and Welfare to designate GLP-1 obesity treatments as drugs at risk for misuse or abuse, and proceeded with the designation process by collecting data on usage and distribution patterns for relevant products.The target ingredients are liraglutide, semaglutide, and tirzepatide formulations indicated for obesity treatment. At present, that means Saxenda, Wegovy, and Mounjaro are included. However, because Mounjaro has indications for both diabetes and obesity, the misuse-risk warning is expected to appear on the packaging of the diabetes treatment product as well.Once designated as drugs at risk for misuse or abuse, these products may be sold in pharmacies located in areas exempt from the separation of prescribing and dispensing, and only with a doctor’s prescription.In addition, pharmaceutical companies will be required to display the phrase “drug at risk of misuse and abuse” on containers, packaging, and package inserts.Director Moon stated, “We expect that labeling GLP-1 obesity treatments as ‘drug at risk of misuse and abuse’ will serve as a reminder to patients and healthcare professionals, ensuring the drugs are used only by those who truly need them.” Moon added that the agency plans to continuously provide guidelines and information materials to promote appropriate use.She explained that the decision to designate these GLP-1 obesity treatments as drugs at risk of misuse and abuse was based on surveys regarding Koreans’ perceptions of obesity. Moon said, “We took into account many of the social phenomena highlighted by the media following the launch of Wegovy in 2024. In particular, we referred extensively to survey data on obesity rates and public perceptions.”She explained, “According to a survey by the Korea Disease Control and Prevention Agency, while Korea’s obesity rate is lower than the OECD average, the proportion of citizens who perceive themselves as obese is relatively high. Although only about one-third of the population exceeds the BMI threshold for obesity, the subjective perception of being obese stands at 54%,” noting that these factors served as the basis for designating GLP-1 obesity drugs as misuse-risk medicines.The reason only GLP-1 obesity treatments were selected for designation was that the authorities took into account the broader social issue of misuse and abuse, along with increasing trends in usage and import volume. Consequently, other obesity treatments besides GLP-1 agonists and psychotropic drugs were excluded from this designation.Regarding concerns that the designation could lead to counterfeit drugs entering through illegal distribution routes, Moon said the ministry plans to communicate with manufacturers, continue monitoring overseas cases, and urge the public to exercise caution.Moon emphasized, “The Central Pharmaceutical Affairs Council discussed all controversies, including the use of these drugs for pediatric obesity that may require treatment. The members focused on the fact that there are cases in which patients are able to obtain prescriptions too easily, including online, and all agreed that GLP-1 obesity drugs should be designated as misuse-risk medicines.”In response to a reporter’s question, Moon also clarified that no representatives from obesity academic societies or obesity specialists had attended the committee meeting.Moon stated, “We will proceed with the ‘Regulations on the Designation at Risk of Misuse and Abuse’ (MFDS Notification) to designate GLP-1-based obesity treatments accordingly. Following regulatory review and consultation, we expect to complete the revision of the notice and implement it within two to three months at the earliest.”
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