- LOGIN
- MemberShip
- 2025-12-21 11:27:15
- Policy
- MOHW ‘is discussing expanding non-face-to-face treatment’
- by Lee, Jeong-Hwan Sep 01, 2023 05:44am
- The Ministry of Health and Welfare formalized the expansion of the scope of its non-face-to-face medical treatment pilot project, and announced plans to expand the scope of first-time examinations, ease the standards for re-examination, and increase the ‘within 30 days of initial treatment’ term allowed for reexamination of acute conditions. In the case of first visit criteria, the authorities will focus on reviewing the need to improve medical access in areas that lack medical institutions at night, on public holidays, and during holidays. For re-examinations, the authorities will discuss ways to improve convenience for patients and medical institutions by addressing the complex eligibility standards and expanding the 30-day term for re-examinations. On the 31st, MOHW announced that it would begin discussing improvements with the advisory group ahead of the end of the guidance period for the non-face-to-face medical treatment pilot project. The MOHW referred to Minister Kyoo-Hong Cho’s statement on how the ministry "will periodically evaluate the performance of the pilot project supplement and develop shortcomings, to prepare a stable institutionalization plan’ on the day of implementation of the pilot project. In other words, the MOHW plans to fully utilize the test bed and prepare supplementary plans, and collect opinions fit for the purpose of the pilot project. As such, the MOHW plans to focus on improving the pilot project model by discussing setting appropriate criteria for first and repeat visits based on time and region and ensuring both the safety of non-face-to-face treatment and medical accessibility. The Ministry of Health and Welfare announced that after the end of the guidance period, it will continue to monitor illegal cases, such as the prescription of drugs that are not permitted in non-face-to-face treatment, such as narcotics and medicines that can be misused or abused. Second Vice Minister Minsoo Park said, "As this pilot project prepares for the institutionalization of non-face-to-face medical treatment, we need to make various attempts and reflect the demand in the field. We plan to collect public opinion through advisory group discussions and holding public hearings and use the results in improving the pilot project model."
- Policy
- The 1st results of the pharmaceutical benefit re-evaluation
- by Lee, Tak-Sun Sep 01, 2023 05:43am
- The HIRA does not plan to disclose the first results of the benefit re-evaluation reviewed by the committee on this day. After notifying the pharmaceutical company of the results, we plan to receive objections and then disclose the results during the second review. According to HIRA and the pharmaceutical industry on the 31st, the results of this year's salary adequacy reevaluation review will be discussed as an agenda item at the committee meeting held on the 6th. The ingredients subject to re-evaluation this year are Hyaluronic acid eye drops; Rebamipide, Limaprost Alfadex, Loxoprofen Sodium Hydrate, Levosulpiride, and Epinastine, etc. Among these, the market size of Hyaluronic acid eye drops, which are used for artificial tears, is the largest at approximately 200 billion won, drawing high interest from the industry. As there is great interest in Hyaluronic acid eye drops, the results are also unpredictable. However, in the pharmaceutical industry, as there is strong opposition from medical staff and there are opinions that benefits should be maintained for elderly patients, it is expected that benefits will be maintained after social discussion. An industry insider declined to comment, saying, “There is sufficient evidence for the effectiveness of Hyaluronic acid eye drops, but I don’t know how to judge it.” There are many predictions that other re-evaluation targets will not be deleted altogether even if there are reimbursement restrictions for some indications. In the case of Rebamipide, which is used for gastritis and gastric ulcers, there are many papers on its efficacy against gastric ulcers, so it is expected that reimbursement will not be maintained. The analysis also shows that there is sufficient clinical evidence for one of the two indications for Limaprost Alfadex, represented by Opalmon. The HIRA plans not to disclose the results of the first deliberation of this committee, but to notify only pharmaceutical companies. We plan to receive objections, reconsider them, and then make the results public. Last year, after the appeal, the committee deliberation was made public in October.
- Policy
- Cold medicine bills increased by 90% due to the coronavirus
- by Lee, Tak-Sun Aug 31, 2023 05:25am
- Jeong Hae-min, head of the NHIS Pharmaceutical Management Department, is answering questions at the Professional Journalists Due to the increase in confirmed cases of COVID-19 last year, cold medicine bills alone increased by 90% compared to the previous year. Based on the past five years, claims for COVID-19-related drugs were the highest in 2022. The NHIS conducted negotiations on linking usage and drug price reduction for 36 items related to COVID-19 and agreed on a reduction rate by applying a correction plan. The NHIS Pharmaceutical Management Office announced this at a meeting with the Professional Journalists Council on the 29th. According to NHIS, as a result of analyzing the billing amount for 2,637 cold medicine and antibiotic items last year, cold medicine billing amounted to 664.5 billion won and antibiotic billing amounted to 1.0575 trillion won. This is an increase of 90.1% and 24.0%, respectively, compared to the previous year. When looking at trends over the past five years, the number of pharmaceutical bills related to COVID-19, which was approximately 1.5 trillion won from 2018 to 2019, decreased to 1.2 trillion won from 2020 to 2021 but recovered to 1.7 trillion won last year. The NHIS also applied this COVID-19 drug while conducting PVA ‘Type C’ negotiations this year. Jeong Hae-min, head of the Pharmaceutical Management Department, explained, "Starting in June, we have supported a stable supply of cold medicines by easing the reduction rate of cold medicines and antibiotics monitored by the Ministry of Food and Drug Safety through the COVID-19 medicine correction plan derived through consultation with the Pharmaceutical Association." As a result of the negotiations, 'multi-type' negotiations were conducted on 36 items related to COVID-19 (18 pharmaceutical companies, 22 same product groups), and an overall agreement was reached. The NHIS plans to prepare guidelines for coordination and negotiation in response to the situation in which some essential medicines have become unprofitable due to the rise in raw material prices after the coronavirus outbreak, preventing smooth supply and repeatedly being sold out. It has been pointed out that the data submitted for mediation negotiations is based on HIRA's withdrawal prevention drug application data, so the amount of data is large and complex, putting a large burden on the company. Accordingly, the NHIS explains that it has been forming a consultative body with the Pharmaceutical Association since March to discuss and collect opinions from companies, simplify submitted data, and determine the ratio of general management costs and profits to be reflected in cost analysis. The 7th council discussion was held until August, and the plan is to compile the collected opinions establish mediation negotiation guidelines around October, and hold a company briefing session.
- Policy
- NHIS may cover high-priced new drugs with refund-type RSA
- by Lee, Tak-Sun Aug 31, 2023 05:25am
- The National Health Insurance Service is planning to improve the Risk Sharing Agreement (RSA) Scheme and is also discussing measures to improve the Price-Volume Agreement (PVA) system to reflect rewards for the innovative value of new drugs. The Department of Drug Management at NHIS said so at a press conference with correspondents on the 29th. Hae Min Jung, Director of the Department of Drug Management at NHIS, said “We are reflecting the results of the research service that was conducted to improve the RSA system, and advancing the system to achieve both the rapid listing of high-priced drugs and financial soundness of NHI finances. The demand for expansion of RSA subjects has been increasing, so we are planning to expand the drugs eligible to apply for performance-based refund-type RSA from one-shot treatments to high-priced drugs. We are also considering improving related systems, such as by new types of financial sharing plans.” Jung also added that discussions are underway with relevant organizations and the industry to come up with measures to reduce the administrative burden. Also, additional projects will be carried out for the post-marketing control of drugs that waived the submission of pharmacoeconomic evaluation data, which HIRA is seeking to improve. Jung said, “One of the results of the research service suggested the need for post-marketing management and system improvement for drugs were exempted from the submission of pharmacoeconomic evaluation data. Therefore, we plan to refer to the results of the research service on ‘Preparing measures to improve the PE exemption system’ that has been carried out by HIRA this year and come up with additional improvement tasks.” Since December 2013, when RSA was first implemented, to August 1, 2023, 68 drugs and 123 items have received reimbursement in Korea through the RSA system, and the RSA contract for 18 drugs and 26 items has been terminated. The amount refunded by pharmaceutical companies under the RSA system amounted to KRW 328.1 billion in 2022, and the refund amount has been increasing in line with the rise in the number of RSA contracts signed over the past five years. Hae Min Jung, Director of the Department of Drug Management at NHIS, is answering questions at a press conference held on the 29th The NHIS is seeking to improve the RSA system to manage high-priced drugs. As of 2022, 14 high-priced drugs costing more than KRW 300 million per person a year had filed claims of KRW 179.3 billion, which is around KRW 420 million per patient. This accounts for around 0.8% of total drug expenditures (KRW 22.9 trillion) spent by the NHIS. 37 drugs cost more than KRW 100 million per person a year, and the claims amount of the drugs amounts to KRW 348 billion. Due to these high-priced drugs, drug expenditures in health insurance finances have been increasing by more than KRW 1 trillion every year and reached KRW 22.9 trillion in 2022. This is why NHIS is seeking ways to share the financial risks through the RSA system when listing high-priced drugs, and to minimize the increase in drug costs by reducing prices of drugs that showed a rapid increase in usage through PVA negotiations. The government is also discussing measures for applying preferential treatment to innovative new drugs when applying PVA. This part is being carried out as part of the 'Measures to Improve the Insurance Drug Price System for Appropriate Compensation for the Innovative Value of New Drugs' that is being carried out by the Ministry of Health and Welfare. Jung said, “Improvement plans, such as appropriate compensation for the innovative value of new drugs, may be announced through the Health Insurance Policy Deliberation Committee meeting at the end of September at the earliest. The plan also includes the PVA part, which includes the pharmaceutical companies’ request that new drugs that meet the innovativeness requirements should be exempt from negotiations when they are subject to PVA 3 times in a row. Whether the requests were accepted will be clear when the final plan is disclosed at the end of September.”
- Policy
- Opdivo reimb as first-line therapy in gastric cancer in KOR
- by Lee, Tak-Sun Aug 29, 2023 05:28am
- The immuno-oncology drug Opdivo will be available for use as a first-line treatment, and the administration subjects for Imbruvica and G-CSF injections will be expanded. The Health Insurance Review and Assessment Service started collecting opinions on the amendment of the reimbursement standards that contain the changes above from the 24th. The adjusted reimbursement standards will be implemented on September 1st. Like the NCCN guidelines, Opdivo will be reimbursed as first-line treatment for HER 2-negative, unresectable, locally advanced, or metastatic gastric cancer. Reimbursement will be approved for the combination treatment (first-line, palliative therapy) 'nivolumab(ingredient name Opdivo) + capecitabine + oxaliplatin,’ and combination treatment (first-line, palliative therapy) 'nivolumab + oxaliplatin + leucovorin + fluorouracil.’ More specifically, patients with PD-L1 expression positive (expression rate≥5) HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma are allowed reimbursement, and HER2-positive patients are excluded. In addition, patients whose disease recurred 6 months after completing neoadjuvant chemotherapy, adjuvant treatment, and curative anticancer chemoradiation therapy are also allowed reimbursement. Imbruvica Cap 140mg is approved as first-line monotherapy for patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who are aged 65 years or older with comorbidities. More specifically, patients over 65 years of age with previously untreated active CLL or SLL, whose ▲(CIRS) score >6, or a ▲Creatinine Clearance < 70 mL/min, With the reimbursement extension, Janssen’s Imbruvica will voluntarily lower its insurance ceiling from KRW 58,555 to KRW 48,015. The reimbursement for G-CSF injections will also be extended. It is used to treat pancreatic cancer, and the 'adjuvant FOLFIRINOX(oxaliplatin + irinotecan + leucovorin + 5-FU)' combination will be additionally approved. The G-CSF injections approved are pegfilgrastim (Neulasta Prefilled Syringe Inj), pegteograstim (Neulapeg Prefilled Syringe Inj), tripegfilgrastim (Dulastin Prefilled Syinrge Inj), lipegfilgrastim (Lonquex Prefilled Inj), and eflapegrastim (Rolontis Prefilled Syringe Inj). Among these, Kyowa Kirin Korea’s Neulasta Prefilled Syringe Inj and GC Biopharma’s Neulapeg Prefilled Syringe Inj will be voluntarily lowering their insurance price ceiling. As a result, Neulasta’s price will be lowered from KRW 778,334 to KRW 764,324, and Neulapeg from KRW 567,086 to KRW 565,952. Also, the 'oxaliplatin + capecitabine' combination therapy will be reimbursed for patients with colorectal who have received neoadjuvant or adjuvant chemotherapy.
- Policy
- Hyundai Pharm's Hypejil 3mg
- by Lee, Tak-Sun Aug 29, 2023 05:28am
- 현대약품 치매증상치료제 하이페질정 5mg, 10mg. 9월부터 3mg도 출시된다.A 3mg low-dose product is listed for the first time in a Donepezil tablet used to treat Alzheimer's. The main character is Hyundai Pharm's 'Hypejil Tablet 3mg'. This drug will be paid from September to 486 won for the party according to the calculation criteria. According to the industry on the 25th, 3 mg of Donepezil is the first time that Donepezil 3mg is paid in Korea. There have only been 5mg, 10mg, and 23mg of Donepezil tablets so far. Donepezil 3 mg a day is not an effective dose, so in principle, it is not used for more than 1 to 2 weeks. Normally, rine sedatives require caution as they can increase stomach acid or increase the motility of the digestive system due to choline esterase inhibitors. Therefore, gastrointestinal medicine is often prescribed along with Donepezil at the site. Donepezil 3mg is used as an initial dose for the purpose of reducing these gastrointestinal side effects. Since it is only used as an initial dose, the market size is small, so domestic pharmaceutical companies have not made 3 mg. But 3 mg of donepezil is sold overseas. Hypezil tablet 3mg is the upper limit of the closest product among its products, and the content is calculated at 486 won by applying the content formula. The content formula is calculated at x150% if the content of the applied product is twice the content of the compared product. Hyphenic tablet 3mg and the proximity content product is Hypejil tablet 5mg, and this product is 646 won for the party. It is actually calculated at x133% because 5 mg of Hypejil tablets is less than twice as 3mg of Hypejil tablets. Since the current 3mg low content is the only product, it is likely to maintain its monopoly until a latecomer appears. It is noteworthy whether the 3mg market of Donepezil, which is used for initial treatment for the purpose of reducing side effects, will be newly formed with the appearance of this product.
- Policy
- MOHW-Roche have difficulty discussing resupply of Madopar
- by Lee, Jeong-Hwan Aug 28, 2023 05:21am
- The Ministry of Health and Welfare seems to be having difficulty bringing in Madopar, a Parkinson's disease drug that had withdrawn from the domestic market, back to Korea. The MOHW had previously announced that it would make efforts to resupply Madopar in Korea. Roche Korea is known to have refused to supply Madopar Tab to Korea, citing how additional administrative procedures are required to resupply Madopar and that significant expenses are required to produce quantities for export to Korea. On the 25th, the MOHW responded, "We will find a way to solve the patient's difficulties, including resupply," to a written inquiry submitted by Rep Eun-mi Kang, a member of the Justice Party and the National Assembly's Health and Welfare Committee regarding the supply of Madopar. According to MOHW, the authorities had listened to the patient's difficulties through an interview with the Korean Parkinson's Disease Association. At the same time, the Ministry of Health and Welfare also listened to the company's difficulties through a meeting with Roche Korea and suggested measures for Madopar’s resupply, such as guidance on drug price increase procedures. However, Roche Korea’s position is that it is difficult to resupply the drug in Korea because the company has to obtain documents necessary for new domestic approval from its Italian manufacturing plant and the manufacturing facility has been demanding a considerable price as the cost for restoring manufacturing facilities to produce the quantities for export. As a result, Myung-In Pharm's Myungdopar Tab, a generic version of Madopar, is being used instead of Madopar in the field. The MOHW said, "To address the need for Madopar in Korea, we will hold in-depth discussions with the pharmaceutical company the Ministry of Food and Drug Safety, and the Korean Parkinson's Disease Association to seek a way to resolve the difficulties of patients, including whether to resupply."
- Policy
- Are there any countermeasures against Rx of hair loss pills?
- by Lee, Jeong-Hwan Aug 25, 2023 06:06am
- The Health and Welfare Committee of the National Assembly will start reviewing legislation to institutionalize non-face-to-face treatment, excluding the prescription restriction bill for high-risk non-insured drugs such as hair loss treatment, which is being prepared by Rep. Jeon Hye-sook, and the public e-prescription legislation proposed by Rep. However, in the process of institutionalizing non-face-to-face treatment, the issue of prescription of high-risk non-reimbursed drugs and the need for regulatory and management measures for electronic prescriptions to be issued after non-face-to-face treatment are expected to be discussed together. Whether the Ministry of Health and Welfare can clearly come up with measures to solve the problem of abnormal prescriptions and dispensing that can be mass-produced when non-face-to-face treatment is enacted, or the collapse of the healthcare ecosystem such as hospitals, clinics, and pharmacies, will determine the legislative success or failure. On the 24th, the Welfare Committee began reviewing five previously proposed amendments to the Medical Act related to the institutionalization of non-face-to-face treatment and the implementation plan submitted by the Ministry of Health and Welfare. The screening, which began at 9:30 a.m., is expected to continue until lunchtime. The non-face-to-face treatment bill submitted by the Ministry of Health and Welfare is the main point of the pilot project currently being implemented. It is a content that allows non-face-to-face treatment mainly for returning patients and clinics and allows first visits only in special cases such as residents of medically underserved areas, people with mobility difficulties, and people with disabilities. Prescription drug delivery is allowed only in special cases by designating it as a home recipient, and basically, it is required to visit a pharmacy and receive face-to-face medication instruction. However, the Ministry of Health and Welfare submitted an improved opinion on the regulation of non-face-to-face treatment platforms such as Dr. Now. First of all, platforms that want to run a non-face-to-face treatment brokerage business must go through a reporting process that requires government repairs. In the case of non-reporting or false reporting, a fine of not more than 3 million won was imposed. According to the Ministry of Health and Welfare, a report requiring repair is a report system operated with a relaxed permit. It is not simply a report that meets formal requirements, but it must meet practical requirements such as human standards and material standards. The report review by the Ministry of Health and Welfare also includes not only a formal review but also a substantive review on whether or not the statutory requirements or legislative purpose are met. The view of multiple welfare committee members is that the key to reviewing the non-face-to-face treatment bill will be whether the Ministry of Health and Welfare has prepared specific countermeasures for the side effects that occurred during the pilot project. The purpose is that legislation may be difficult if it is not clear how to manage the ratio of non-face-to-face treatment, which is focused on prescriptions for non-insured high-risk drugs such as hair loss treatments, morning-after pills, and acne medications. In addition, it is expected that the Ministry of Health and Welfare will have to come up with solutions for electronic prescriptions issued after non-face-to-face treatment, such as managing sensitive patient information and preventing concerns about forgery. In particular, the range of non-face-to-face treatment patients allowed in the pilot project stage is also a legislative issue. The current pilot project permits all diseases other than those requiring a prescription for narcotic drugs or medicines concerned with misuse or abuse during non-face-to-face treatment other than first visits. For this reason, there are criticisms that the side effects of non-face-to-face treatment, such as hair loss pills, morning-after pills, and acne medicine, are accelerating, such as the concentration of prescriptions in some treatment categories or disease groups. Some welfare committee members are expressing the opinion that legislating such a pilot project as it is is too broad. It is the opinion that non-face-to-face treatment should be allowed locally only for residents of medically vulnerable areas where non-face-to-face treatment is unavoidable due to poor mobility or lack of medical institutions and pharmacies in the living radius. Cho Won-joon, the senior expert on the matter, said, "We examine the non-face-to-face treatment bill submitted by the Ministry of Health and Welfare, but how to manage non-consensual and irrational non-face-to-face treatment prescription behavior, such as non-insured hair loss prescriptions that have not yet been proposed or are omitted from the agenda, and how to manage e-prescriptions. The position of the Ministry of Health and Welfare will determine the success or failure of the legislation,” he explained. Commissioner Cho Won-joon explained, "The Ministry of Health and Welfare must clearly present a policy to operate the system so that non-face-to-face treatment does not produce side effects that threaten the safety of the public and patients and destroy the health care ecosystem."
- Policy
- Bayer completes pricing negotiations for Jivi Inj in KOR
- by Lee, Tak-Sun Aug 25, 2023 06:06am
- Bayer’s hemophilia A treatment Bayer’s s hemophilia A treatment ‘Jivi Inj (damoctocog alfa pegol)’ has come one step near to receiving reimbursement in Korea. On the other hand, reimbursement discussions for Lilly Korea’s ‘Retevmo (selpercatinib)’ have returned to square one after the company failed to complete pricing negotiations for its RET targeted anticancer drug with the NHIS. In addition, Teva-Handok started pricing negotiations for its antibody drug for asthma, ‘Cinqair (reslizumab)’ with the NHIS. According to the industry on the 24th, the NHIS had updated the drug pricing negotiation status of new drugs on its webpage recently. The drug pricing negotiations for Jivi Inj were found to have been completed. In May, the drug was approved for reimbursement under the condition that it accepts a price below the amount evaluated by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service. Jivi Inj then initiated and completed drug pricing negotiations with the NHIS. However, due to the timing of the agreement, the drug will be listed for reimbursement the month after the next, rather than next month. Jivi Inj is indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) as an on-demand treatment and control of bleeding episodes, for the perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Another drug, Lilly’s Retevmo Cap, had failed to reach an agreement after completing pricing negotiations. Retevmo passed the DREC review in May but was unable to close the gap in opinion with the NHIS during pricing negotiations without extending the negotiation period. As such, the company would need to restart the reimbursement application process from scratch for reimbursement in Korea. Retevmo is indicated for the treatment of ▲RET-mutated medullary thyroid cancer and ▲ RET fusion benign thyroid cancer. Although the number of patients is small, the drug is used in RET-mutated patients with poor prognosis. No drug for RET mutation has been approved for reimbursement in Korea yet. Teva-Handok newly started pricing negotiations for the reimbursement of its antibody drug for asthma, ‘Cinqair Inj.’ Cinqair passed DREC review in July. The drug is used to treat severe eosinophilic asthma. As an interleukin-5 (IL-5) inhibitor, it has a new mechanism of action that reduces the levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. Roche failed to reach an agreement within the deadline for its spinal muscular atrophy (SMA) treatment 'Everysdi Dry Syrup (risdiplam)', which has been under negotiations since last June and extended its negotiation period.
- Policy
- Reduction in the scope of platform regulation & re-examinati
- by Lee, Jeong-Hwan Aug 25, 2023 06:06am
- Following the decision to postpone the non-face-to-face treatment institutionalization bill again by the National Assembly Health and Welfare Committee on the 24th, it is evaluated that the number of issues to be resolved for legislation has increased. At the same time, the need to reduce the scope of non-face-to-face treatment patients compared to the current pilot project was raised, and criticism followed that there was no mechanism to regulate illegal and expedient actions by mediation platform companies. Furthermore, as a result of the pilot project that has been in effect since last June, it is still difficult to punish without distinguishing first-time and returning patients in non-face-to-face treatment, and it is a shame for violations of the law that exceeds 30% of non-face-to-face treatment and dispensing rates allowed by medical institutions and pharmacies. Members of the National Assembly’s subcommittee point out that there is not even a countermeasure against losing. On this day, the non-face-to-face treatment legislative review was in the direction of a collision between the Ministry of Health and Welfare's request to regulate expedients on some platforms through prompt institutionalization and the National Assembly's criticism of the Ministry of Health and Welfare's countermeasures against many side effects that may occur in the enactment of non-face-to-face treatment legislation. It is said that it has been done. Opposition members of the welfare committee who participated in the review are of the opinion that the Ministry of Health and Welfare has not come up with a proper legislative bill to address problems that threaten public health and cause confusion in the health and medical ecosystem. Although the Ministry of Health and Welfare submitted a government bill to the National Assembly that went through the process of amending and improving the provisions with the Welfare Committee expert committee, criticism continued that it failed to come up with legal provisions to solve even the problems that occurred during the pilot project. The basics of the welfare committee members are that there are no measures on how to classify first-time and returning patients when institutionalizing, what punishments to be imposed in case of violation, and how to regulate the problem of implementing non-face-to-face treatment exceeding the allowable rate (up to 30% for pilot projects). negative opinion.
