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- 2026-03-12 04:51:04
- Policy
- Pres. Yoon urges swift legislation for remote treatment
- by Kang, Shin-Kook Jul 06, 2023 05:39am
- President Yoon Suk-yeol has instructed the Ministry of Health and Welfare to make every effort to pass the amendment of the Medical Service Act for the introduction of non-face-to-face treatment, which is currently under discussion in the National Assembly, raising hopes for its rapid legislation. President Yoon made these remarks on the 4th while leading the 18th Emergency Meeting on Economic Affairs on the direction of economic policies for the second half of 2023 at the Yeongbingwan in Cheong Wa Dae. President Yoon stated, "Many bills aimed at improving the economic constitution and ensuring stable public welfare - such as the National Finance Act for the introduction of fiscal rules, the Housing Act for easing residency obligations, and the Medical Service Act for establishing the basis for non-face-to-face treatments - are being impeded by the National Assembly, disappointing many citizens." To this, President Yoon urged, "Ministers of each department should focus solely on the people and make every effort to ensure the swift passage of essential economic and public welfare bills." As President Yoon personally directed the amendment of the Medical Service Act, it is anticipated that the government will expedite the legislation for the non-face-to-face treatment system. Currently, the amendment of the Medical Service Act related to non-face-to-face treatment is pending in the Legislative Review Subcommittee of the NA’s Health and Welfare Committee. The direction of the legislation has taken shape to closely align with the current pilot project for non-face-to-face treatment. The legislative direction being discussed and promoted by the government in cooperation with the National Assembly is as follows: Allowing non-face-to-face treatment only for follow-up visits, with initial consultations primarily in clinic-level medical institutions as exceptions. If patients are not eligible for home-delivered medication, the patient (or their representative) may obtain the prescribed medication directly from a pharmacy after receiving face-to-face medication counseling from a pharmacist. While the method of delivering medication is still an issue, the matter will not be a major point of contention during the National Assembly discussions, as the aspect falls under the amendment of the Pharmaceutical Affairs Act and not the Medical Service Act.
- Policy
- Roche Korea, "No decision has been made to resupply Madopar
- by Lee, Tak-Sun Jul 06, 2023 05:39am
- Roche Korea recently announced that it has no plans to resupply Madopar, a Parkinson's disease treatment for which the grace period for the deletion of benefits was recently extended. It is explained that the headquarters did not make a decision to resupply, and that no agreement was signed with any organization for resupply. The extension of the grace period for deletion of benefits was carried out in consultation with the Ministry of Health and Welfare, and it is explained that there is no plan to resupply Madopar during that period. An official from Roche Korea said in a phone call on the 4th. announced its withdrawal from the country in January by voluntarily withdrawing Madopar's license. Patients with Parkinson's disease are urging the resupply of Madopar, urging Myungdopar, which is the only generic drug with the same drug, to have significant side effects. The Ministry of Health and Welfare has also opened the door to resupply, saying that it is possible to negotiate a price increase through the upper limit adjustment system, and some have reported that the Parkinson's Association and Roche Korea have agreed to resupply Madopar. Roche Korea said that the agreement for Madopar was not true. A company official explained, "The head office has not made any decision regarding the resupply of Madopar." However, he explained that the reason why the grace period for deleting benefits was extended was because there was a consultation with the Ministry of Health and Welfare. The official explained, "After checking the Madopar inventory, we found that there was still a lot left, and in consultation with the Ministry of Health and Welfare, we extended the grace period for the deletion of benefits to prevent patients from suffering economic damage." The grace period for deleting Madopar benefits was extended by 4 months to a total of 10 months. Normally, the grace period for deleting benefits is up to six months, but it was extended by four months under the authority of the Ministry of Health and Welfare. As a grace period was granted, some said that the Ministry of Health and Welfare and Roche had confirmed the resupply of Madopar and extended the grace period. There is criticism that it is giving preferential treatment to original drugs that have voluntarily withdrawn from the market. In addition, the generic industry argues that if the government follows the issue of resupplying the original, the reliability of generics will decrease.
- Policy
- Will AZ/Kolon succeed in challenging COPD combi benefit?
- by Lee, Tak-Sun Jul 05, 2023 05:45am
- Two COPD 3 drugs combi inhalers that are competing for reimbursement are not easily able to get out of the HIRA stage. AstraZeneca's 'Breztri Aerosphere' also requested a re-evaluation of the committee's results, while Kolon Pharmaceutical's 'Trimbow Inhaler' took on a re-challenge for reimbursement despite the drug evaluation committee's conditional decision. According to the industry on the 4th, Breztri Aerosphere, which was notified of the conditional determination of the adequacy of benefits when accepting less than the appraised amount at the 5th committee last May, recently applied for re-evaluation. According to the drug reimbursement evaluation regulations, drug manufacturers, etc. may apply for re-evaluation within 30 days of being notified of the evaluation results. It is interpreted that AstraZeneca's action is based on the judgment that it is difficult to accept less than the appraised amount. If the re-evaluation results remain unchanged, AstraZeneca is likely to consider whether to reapply for benefits. Similar to Breztri Aerosphere, Kolon Pharmaceuticals Trimbow, which received a conditional judgment that benefits are appropriate when accepted below the appraisal amount, has not accepted the committee's decision and is currently reapplying for benefits. Currently, it is known that the second supplementary data submission has been completed and the society's opinions are being listened to. The reason why these drugs are having difficulty receiving reimbursement seems to be that GSK's 3-dose combination COPD inhaler Trelegy Ellipta, which was listed first, was listed at a relatively low price. Trelegy Ellipta, which was listed as a benefit in 2021, costs 45,602 won for a 30-day supply, similar to the price of a two-drug combination drug. Given that alternative drugs are cheap, there seems to be a large gap between the HIRA valuation and the management's expectations. The 3 drugs combination is expected as an alternative treatment for COPD patients who do not respond well to the existing ICS-LABA and LABA-LAMA combination therapy. While GSK products are currently listed, it is noteworthy whether AstraZeneca and Kolon Pharmaceuticals will be able to find a solution to the insurance coverage.
- Policy
- AZ Capivasertib, designated GIFT No. 8
- by Lee, Hye-Kyung Jul 05, 2023 05:45am
- On the 4th, the Ministry of Food and Drug Safety designated AstraZeneca Korea's breast cancer treatment Capivasertib as the 8th "Global Innovation Product Rapid Review (GIFT)." Starting with Lunsumio, a lymphoma treatment in Roche Korea, which was designated as GIFT No. 1 in November last year, it has been designated up to No. 8 recently, but none of the items have been officially approved yet. In this regard, Park Jae-hyun, head of the rapid review division of the Ministry of Food and Drug Safety, said in a briefing for reporters on the 4th, "Even if it is designated as GIFT, it may not apply for permission for each item." However, since a total of eight items have been designated starting with Lunsumio, the GIFT No. 1, Park explained that GIFT designated items are expected to be linked to permits in the second half of this year. Since the establishment of the GIFT system, a total of 13 items have been applied for rapid review, and eight of them have been designated as targets. In the end, it means that the designation rate is not as high as 61%. This is because GITF items are limited to ▲ drugs aimed at treating serious or rare diseases such as life-threatening cancer, ▲ drugs aimed at preventing or treating infectious diseases such as bioterrorism or infectious diseases, ▲ new drugs developed by innovative pharmaceutical companies designated by the Ministry of Welfare, ▲ rapid screening, and medical devices or ▲ if there is no existing treatment or if there is a clinically significant improvement in effectiveness compared to the existing treatment Park said, "When I meet with the pharmaceutical industry, I receive many suggestions to expand the scope of rapid review." "Among them, we are sometimes asked to include improved new drugs in the rapid review, and although it is difficult due to a lack of manpower, we plan to review them in the mid- to long-term," he said. The hurdles are high, but if designated as GITF targets, ▲ the screening period will be reduced by at least 25% (e.g., 120 working days→90 working days), ▲ close communication between reviewers and developers, such as item briefings and supplementary briefings, or ▲ regulatory-related consulting. The GIFT system is a branding of the rapid review program that has been operated since the establishment of the rapid review and has been in full force since September last year to revitalize the two-year rapid review and strengthen support for rapid commercialization of innovative products. Starting with frequent screening of COVID-19 vaccines and treatments, the rapid screening of drugs is Daewoong Pharmaceutical's Envlo 0.3mg and AstraZeneca's Koselugo 25mg. With the introduction of rapid screening in Korea, items such as the COVID-19 treatment Regkirona, COVID-19 AstraZeneca vaccine, Pfizer vaccine, Janssen vaccine, Moderna vaccine, etc. were approved in 2021. Manager Park explained, "Since the rapid examination department was established in August 2020 and the rapid examination began, a total of 33 items have been designated for rapid examination, and 28 items have been approved, and about 85% have been approved." "Over the past three years, the average number of days required for rapid review of designated items has been 65 working days, and in the case of the COVID-19 vaccine, 28.7 working days, less than 30 days on average," he explained. Among them, Daewoong Pharmaceutical's Envlo reduced the screening period by 59% compared to 120 working days, and reduced the screening period by more than 100 days compared to the average new drug screening period from 353 days, including the data supplement period. Manager Park said, "GIFT designated items aim to be reduced to 75% of the general screening period, and it is difficult to calculate and answer the entire screening date because there are no items that have been approved yet." "For reference, you can refer to the overall average screening date of items subject to rapid screening over the past three years by the rapid screening department," he said. Regarding the criticism that the GIFT system seems to have focused only on foreign pharmaceutical companies, Park explained, "When the Pharmaceutical Affairs Act is revised for rapid review, the law has been revised to support the development of the domestic pharmaceutical industry." "Since February, we have been operating GIFT Kiwoom, a 1:1 consultative body with developers, focusing on domestic innovative pharmaceutical companies to support commercialization such as item permits," he said. Currently, there are 48 innovative pharmaceutical companies certified by the Ministry of Health and Welfare, of which 46 are domestic pharmaceutical companies, so it is expected to help designate new drugs developed by domestic pharmaceutical companies as GIFT.
- Policy
- Mounjaro, a weight loss effect for DM pts, has been approved
- by Lee, Hye-Kyung Jul 03, 2023 05:47am
- Eli Lilly's 'Mounjaro PFS', known overseas as a game changer for obesity treatment, has been approved in Korea. In Korea, it has been approved as a treatment for diabetes. Mounjaro is a synthetic peptide with a mechanism that can selectively bind to both the GIP and GLP-1 receptors for the first time in Korea. The Ministry of Food and Drug Safety (Ministry of Food and Drug Safety, Minister Oh Yu-Kyoung) has tested the content of 6 Mounjaro (2.5, 5, 7.5, 10, 12.5, 15mg/0.5ml) used as an adjuvant for diet and exercise therapy to control blood sugar in adult type 2 diabetic patients. It was confirmed on the 28th. This drug selectively binds to the GIP receptor and the GLP-1 receptor to induce insulin secretion promotion, insulin resistance improvement, and glucagon secretion reduction, thereby causing pre- and postprandial blood glucose reduction. GLP-1 agonists act on GLP-1, a hormone that makes you feel full by acting on the brain's hypothalamus, activates incretin, an intestinal hormone, and promotes insulin production to lower blood sugar levels. It slows down the movement of food from the stomach to the small intestine, increases satiety, and has proven its effectiveness, becoming a very popular obesity treatment in the United States. Mounjaro is a successor to Lilly's blockbuster diabetes treatment Trulicity and was approved by the US FDA in May of last year as a dietary and exercise supplement to improve blood sugar control in patients with type 2 diabetes. It can be used as a monotherapy or as a combination therapy with Metformin, SGLT2 inhibitor, Sulfonylurea, and Insulin glargine. The Ministry of Food and Drug Safety said, “We will continue to do our best to expand treatment opportunities for patients by making efforts to promptly supply treatments whose safety and effectiveness are sufficiently confirmed based on regulatory science expertise.”
- Policy
- Drug price negotiations such as Roche Evrysdi begin
- by Lee, Tak-Sun Jul 03, 2023 05:47am
- Roche's 5q spinal muscular dystrophy treatment Evrysdi Dry Syrup began negotiations with the NHIS as soon as it passed the Drug Benefit Evaluation Committee of the HIRA. Ace Pharma and H&O Pharm's multiple myeloma treatments Megval Inj. and Melpspal Inj. have also entered negotiations. The NHIS added oEvrysdi Dry Syrup 0.75 mg/mL, Melpspal Inj. 50 mg and Megval Inj. 50 mg to the negotiation list for new drug prices on the 30th. As a result, six items are currently under negotiation, including these three items, Lilly Retevmo Cap, Bayer Verquvo, and BMS Onureg. When the drug price negotiations are concluded, the benefits will be applied through a report by the Health Insurance Policy Review Committee of the Ministry of Health and Welfare. Evrysdi Dry Syrup, Megval Inj., and Melpspal Inj. were recognized for their adequacy of benefit at the Drug Benefit Evaluation Committee of the HIRA on June 1 and moved on to the negotiation stage of the industrial complex. Usually, when the MOHW orders the negotiation, the NHIS sets up a negotiation team to conduct full-fledged negotiations on the upper limit and expected usage. Evrysdi Dry Syrup is a liquid formulation that is taken PO QD and is characterized by being applicable to patients who have difficulty in treating spinal cord cavities. Motor function improvement and safety profiles were confirmed in patients of a wide range of diseases, including patients of a wide age range from 2.2 to 25 months old and patients with experience in scoliosis-related surgery. Since self-administration is possible at home, it is expected to reduce insurance financial and socioeconomic burdens by reducing the burden of indirect medical expenses such as academic, workplace interruption, transportation, and nursing. Megval and Melpspal are forms of injections with Melphalan as the main active ingredient and are national essential drugs. In Korea, Samil Pharmaceutical's Alkeran has been reported, but currently, the KODC has stopped importing and only the KODC supplies inventory as unlicensed drugs in Korea. Accordingly, Megval and Melpspal are expected to have much better accessibility to patients with multiple myeloma if they are paid.
- Policy
- Eval period for HCV treatment shortened to 12 weeks from 24
- by Lee, Hye-Kyung Jun 30, 2023 06:01am
- The evaluation period used to determine the efficacy of chronic hepatitis C treatments has been reduced in Korea. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) revised the 'Clinical Trial Evaluation Guidelines for Chronic Hepatitis C Treatments' on June 29 to align Korea’s clinical trial efficacy evaluation standards with the international standards and reflect the standard treatment method for chronic hepatitis C treatments. The main revisions included ▲changing the evaluation period of major efficacy evaluation indices, ▲setting toxicity test exemption standards for combination drugs, and ▲reflecting the latest chronic hepatitis C standard of care to the guidelines. Through the revision, the sustained virologic response (SVR) period that was used to evaluate the efficacy of HCV treatments will be reduced from 24 weeks to 12 weeks. The authorities had analyzed the clinical trial results of approved drugs and confirmed a correlation (98-100%) between the 12- and 24-week treatment results, and also considered its coherence with those of health agencies abroad. Also, the guidelines presented a clear standard for companies developing combination drugs to waive toxicity tests. Companies can submit their non-clinical or clinical data of the individual composite drugs and be exempt from toxicity tests if no serious toxicological concerns are present in the submitted data of each ingredient. Since the standard treatment for HCV was changed from the use of peginterferon in combination with ribavirin to direct-acting antivirals, the information on the new standard of care was also reflected in the guideline. The MFDS said, “We hope that the revised guidelines will support the development of HCV treatments, and will continue to provide information to support the development of treatments based on our expertise in regulatory science.”
- Policy
- Tx for combi of dementia/hyperlipidemia have increased
- by Lee, Tak-Sun Jun 30, 2023 06:01am
- The amount of claims for dementia treatment and hyperlipidemia has increased by more than 50% in the past two years. In the case of dementia treatment, it seems to have increased significantly as the elderly patients' visits to medical institutions decreased in 2020 due to COVID-19. The hyperlipidemia complex is interpreted as the amount of charge has also increased as the post-drugs of statin + edetimive came out all at once. In the '2022 payroll drug claim status' disclosed by the Health Insurance Review and Assessment Service on the 26th, the claim status by ATC code was compared to 2020. The drug with the largest claim in the ACT Code is the treatment for peptic ulcer and gastroesophageal reflux disease, and 1.155.8 trillion won was charged in 2022. Compared to the past 2020, this is an increase of 25.1%. However, the number of listed items decreased by 170 from 1510 to 1340. This formulation is interpreted as a significant increase in claims due to the overlap of the emergence of domestic new drug K-cap, the growth of PPI+ sodium bicarbonate formulation, and the balloon effect after the expulsion of ranitidine. Of course, the decrease in medical use due to COVID-19 in 2020 is also a major increase.. In the case of dementia treatment, such a underlying effect was more prominent. Dementia treatment claims increased by a whopping 58.4% when compared to 2020 and 2022, reflecting the decline in visits to medical institutions for the elderly in 2020. In fact, 2019 before COVID-19 had higher dementia treatment claims than in 2020. As visits to medical institutions have gradually normalized since 2021, the demand for dementia treatment has turned to an increasing trend, surpassing 400 billion won last year. During this period, the number of subsympathetic nervous system, which contains choline-alpocerate formulation, increased by 17.4%. This ingredient formulation has been judged as a selection benefit due to salary re-evaluation, but the notice is being delayed due to the suspension of execution, and the marketing of pharmaceutical companies is strengthening, so it seems that the claim is ahead of the dementia treatment. However, the number of listed items has decreased by 109 in two years. The hyperlipidemia complex also increased claims by 56% as 323 items were added in two years. Atojet generics have been pouring out since 2021, and the sales of improved new drugs from domestic companies have grown to 1 trillion won last year. The 16 top ATC code classifications for claims have all grown compared to 2020. However, direct-acting antiviral drugs, which include hepatitis B treatment and hepatitis C treatment, grew only 0.8%, making a contrast. This is interpreted because there are drugs that have a high therapeutic effect, so the number of patients does not increase. In the second year, the number of listed items has also decreased by 199.
- Policy
- New oral ulcerative colitis drug Zeposia approved
- by Lee, Hye-Kyung Jun 28, 2023 05:53am
- BMS Korea’s new ulcerative colitis treatment ‘Zeposia Cap (ozanimod)’ seems to have been granted marketing authorization for its effectiveness in broadening the treatment option for patients with ulcerative colitis despite the small number of clinical trial subjects. The recent minutes of the Central Pharmaceutical Affairs Council that were recently disclosed by the Ministry of Food and Drug Safety revealed that the council had a discussion on the feasibility of applying the clinical trial results of an ulcerative colitis drug in Korea. The minutes also mentioned that the ulcerative colitis treatment discussed by the CPAC had the ‘advantage of being taken once a day orally,’ indicating that an advisory meeting had been held for Zeposia ahead of its approval in February. Zeposia is a sphingosine 1-phosphate receptor modulator used to suppress inflammation by preventing self-reactive lymphocytes from moving to the stomach in ulcerative colitis where immunomodulatory abnormalities are observed Zepocia is taken once a day and is indicated to treat moderate-to-severe active ulcerative colitis in ▲ patients who respond adequately to existing treatment or biological agents including corticosteroids, immunosuppressants, etc., or ▲ have no response, or ▲have resistance. However, whether to grant Zepocia’s approval was discussed due to the small number of Korean subjects available in the clinical trial results submitted by the company for approval. One committee member said, "Epidemiologically and statistically speaking, due to the small of Korean trial participants in the bridging data, the results of one or two patients can make a large difference in the results, rendering the judgment difficult.” The MFDS explained, “Population pharmacokinetics analysis data show that the drug’s pharmacokinetics in the total patient population and Koreans were similar.” Also, the MFDS explained that the US label shows that the AUC and Cmax increased in Japanese patients compared to Caucasians, but the difference was not clinically significant. Also, discussions were made on what is the best indicator that can be used to evaluate the effectiveness of the ulcerative colitis treatment as the number of Korean subjects in the trial was insufficient to conduct a sub-analysis. The members discussed whether clinical remission was the right indicator of clinical response efficacy, and whether to use any as secondary indicators in determining the efficacy of the discussed drug. In this regard, a member said, “In ulcerative colitis, drugs are administered for a short period of time to induce remission, and steroids and mesalazine are used as maintenance therapy after the patient reaches a response. When the condition progresses to a severe state, biological agents or immunomodulators are additionally used, then surgery if drug treatment is insufficient.” Since ulcerative colitis can be managed but not cured, there was also the opinion that inducing an initial remission only indicates that patients respond to the drug. Also, another member claimed that although the clinical remission results may not be enough to determine the efficacy of the drug due to the small number of subjects, the clinical response results are in favor of its use in Korea. A member said, “There are so many types of ulcerative colitis drugs with various mechanisms of action in the market because the treatment rate of the currently available treatments for the disease is low, and even this low response is often lost over time. Therefore, if an effect can be seen with a drug that has a different mechanism of action, its addition will increase the number of treatment options for the patients to choose from.” Another member also agreed that the drug can be useful in terms of providing additional drug selection opportunities.
- Policy
- The share of drug spending was about 23 trillion won
- by Lee, Tak-Sun Jun 28, 2023 05:53am
- Last year, the share of health insurance drug expenses was 23%, the lowest level in the past five years. Although drug costs themselves are steadily increasing, the rate of increase in total medical costs is much higher, indicating that the proportion of drug costs is continuously declining. According to the 'Current Status of Claims for Reimbursed Drugs in 2022' published by HIRA on the 26th, drug costs last year were 22,896.8 billion won, accounting for 23.34% of the total medical expenses of 98,121.2 billion won. 2022 is the only time in the last five years that the share of drug spending has fallen to the 23% level. It fell by 1.28%p from 24.62% in 2018. The decrease in the share of pharmaceutical expenditures is due to the greater increase in total medical expenditures. Total medical expenses increased by 11.32% compared to the previous year, far exceeding the 7.95% increase in drug expenses. Last year, there were 906 items on the list and 2,332 deleted items, a much larger number. As a result, the number of registered items also decreased by 1,404 from the previous year to 23,643. In 2019 and 2020, the number of listed items due to the reorganization of the drug pricing system approached 4,000, but after the implementation of the system, the number of deleted items gradually increased and the number of listed items decreased. In 2022, the number of claims for health insurance reimbursement drugs was 23.481 trillion won, hospitalized 2.8604 trillion won and outpatient 20.1877 trillion won. By type, the amount claimed for pharmacy-reimbursed drugs was 16,234.6 billion won, accounting for 70.4% of the total. This was followed by 13.2% (3.327 trillion won) of advanced general hospitals, 8.2% (1.8919 trillion won) of general hospitals, 4.3% (983.3 billion won) of clinics, and 3.8% (885.5 billion won) of hospitals. Claims for reimbursed drugs for those aged 65 and over accounted for 45.6% of the total at 10,505.8 billion won. This is an 8.4% increase from the previous year, and the share of reimbursed drugs for those aged 65 or older continues to increase.
