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- 2026-05-18 18:57:48
- Policy
- Regulation of COVID-19 vaccines is imminent
- by Lee, Jeong-Hwan Aug 27, 2021 05:59am
- As the "Special Act on the Development of Public Health Crisis Response Medical Products and the Emergency Supply" sub-enforcement decree passed the Regulation Reform Committee preliminary review, regulations and management such as COVID vaccines will be strengthened. The MFDS plans to conduct a follow-up investigation of the public health crisis-response vaccine announced in April, report methods of abnormal cases, emergency production and import orders, and establish regulations on distribution improvement measures. On the 25th, the Regulation Reform Committee judged all four regulatory provisions as "non-critical regulations" as a result of the MFDS' preliminary review of the Enforcement Decree of the Special Act on Public Health Crisis Response. If non-critical regulations are determined in the Regulation Reform Committee preliminary review, the relevant ministries can proceed with enactment or revision of the regulation reform committee without submitting, deliberating, or deciding on the regulation reform committee's main review. When classifying important regulations, the regulation reform committee or the main committee's review must be passed before the legislation and revision of the relevant ministries can be made. Critical regulatory standards include the cost of more than ₩10 billion a year to be borne by regulated groups and citizens, or excessive levels of regulation in light of international standards. The Enforcement Decree of the Special Act on Medical Products for Public Health Crisis Response determined by the Regulation Reform Committee as a non-critical regulation is a regulation established by ▲ tracking investigation and reporting methods ▲ registration of medical products subject to tracking investigation ▲ emergency production and import order and ▲ distribution. Specifically, the method of tracking investigation and reporting abnormal cases is applied when it is recognized that it is necessary to check whether abnormal cases occur for a certain period of time. Based on the special law, the method of tracking investigation reporting and the method of reporting abnormal cases may be specified in detail. Statistics can be aggregated as abnormal cases and side effects can be reported through follow-up investigations after permission to market and treatments. The registration of medical product details subject to follow-up investigation is a provision that allows the identification of the occurrence of abnormal cases when conditional item permission is obtained as a crisis-response medical product. Conditional licensed products can be designated and managed as targets for follow-up investigation, so sales and supply details can be specifically determined from administration and registration. The emergency production and import order procedure stipulates the contents of an emergency production and import order to secure the quantity of medical products necessary for responding to public health crisis. The regulation allows those notified of emergency production and import orders to establish a production and import plan, submit it to the director of the MFDS, and report the results. The distribution improvement measures procedure stipulates necessary measures for each person when determined to be subject to distribution improvement measures to respond to public health crises. The MFDS is expected to take steps to enact enforcement ordinances that have been judged non-critically by the regulatory reform committee. Regarding the need to introduce the regulations, the MFDS said, "It is urgent to introduce a supply system to manage the manufacture, import, and distribution of medical products necessary for the spread of COVID-19." The MFDS added, "The government should intervene to support the rapid development and emergency supply of medical products such as vaccines, treatments, masks, hand sanitizers, diagnostic kits, and artificial disposal."
- Opinion
- [Reporter’s View]Reimbursement of antidiabetic combos
- by Eo, Yun-Ho Aug 27, 2021 05:59am
- After 3 long years, discussions on extending reimbursement of SGLT-2 inhibitor combos are expected to begin. In September, the Health Insurance Review and Assessment Service will hold an expert meeting to discuss approving reimbursement for combination use of the two classes of oral antidiabetics: DPP-4 inhibitors and SGLT-2inhibitors. ‘Recognizing the expected efficacy of two drugs with the same MOA.’ Acknowledging this class effect has been a long-discussed dilemma in the industry. The opinion has been divided among the HCPs, and the interest of individual pharmaceutical companies also differ. The conclusion was to take on the agenda ‘case by case.’ It is not necessarily a question that requires a fixed answer. The decision made by the prescribing doctor based on his or her experience and medical knowledge is, of course, most important. However, for the SGLT-2 inhibitor issue, the problem lay in the consistency of the decisions. For some classes, the class effect was recognized regardless of the drug’s indications and applied the same reimbursement standards, while reimbursement for other classes was approved for different scopes by each product. In 2013, the Korean Diabetes Association had played a leading role in extending reimbursement to cover the combined use of DPP-4 inhibitors and Thiazolidinedione (TZD) class drugs, insisting on the justification and necessity of its reimbursement. Clinical experience and expert judgment were emphasized rather than the fiscal impact, and the government accepted the reimbursement extension based on the disease characteristics and drug use experience. What has changed since then? In 2018, the academic community had mixed opinions regarding SGLT-2 inhibitors, which put discussions on reimbursing the combined use of the drug on hold. Many drugs were at stake, as this not only affected SGLT-2 inhibitors like ‘Jardiance(empagliflozin),’ ‘Forxiga(empagliflozin),’ ‘Suglat (ipragliflozin), ‘Steglatro (ertugliflozin),’ but also the many DPP-4 inhibitors including ‘Januvia (sitagliptin), ‘Galvus (vildagliptin),’ ‘Tradjenta (linagliptin),’ ‘Gemiglo(gemigliptin),’ etc. However, the changes that followed were encouraging. In April last year, the academic society saw consensus and submitted the opinion that expanding reimbursement is necessary. In August last year, the Ministry of Health and Welfare announced that it will simplify the indication listing method of antidiabetic drugs from by substance to ▲monotherapy or ▲combination therapy. Now the baton is in the hands of the insurance authorities. Time has already passed, and dissatisfaction still does exist around primary medical institutions. As it is a prescription drug, it is also true that the issue should be considered carefully, and a cautious approach is needed. However, if the class effect is to be finally acknowledged, this could be the perfect opportunity for the stakeholders to reach a consensus on ‘the time or amount of prescription required to accumulate sufficient prescription experience.’
- Company
- Shingles vaccine market overwhelmed by COVID-19… drops 60%
- by An, Kyung-Jin Aug 27, 2021 05:59am
- The domestic market for shingles is shrinking at a fast pace. With vaccinations for COVID-19 ongoing in earnest from earlier this year and the new ‘Delta variant’ intensifying the resurgence of COVID-19 cases, sales of the two shingles vaccines have dropped together. According to the pharmaceutical research institution IQVIA on the 26th, the shingles vaccine market in Q2 this year was ₩9.2 billion, a 59.1% YOY decrease from the ₩22.6 billion in the same period of the previous year. Sales had decreased 53.0% compared to the ₩19.6 billion in Q2 2019. Cumulative sales in 1H of this year have also decreased 42.2% from the previous year to record ₩20.1 billion. The shingles vaccine market in Korea consists of two products – MSD’s ‘Zostavax’ and SK Bioscience’s ‘SKYZoster.’ Its market had grown rapidly with the introduction of ‘SKYZoster’ in 2017 that broke the monopoly held by ‘Zostavax.' The local vaccine ‘SKYZoster’ had gradually increased its influence in the market, to rise and record ₩27.9 billion in Q4 2019. However, this shingles vaccine market that was once on a roll, is riding a rollercoaster of ups and downs after the COVID-19 pandemic. In Q1 last year, when COVID-19 started to spread, the market sales had halved to ₩12.2 billion. In Q2 of the same year, the market showed some signs of recovery, recording ₩22.6 billion, but then started falling again to ₩20.3 billion in Q3 and ₩17.3. billion in Q4. Entering this year, the drop became steeper, to record the lowest-ever sales since the two-drug competition structure was established in the market. The industry pointed out that the shingles vaccine market and other vaccine markets are more vulnerable to external factors such as pandemics, etc. than the chronic disease treatment market. Such vaccines are used to prevent a disease rather than be used in emergencies, therefore, the spreading reluctance to visit medical institutions naturally leads to a reduced vaccination rate. Full-scale inoculations with COVID-19 vaccines developed by multinational pharmaceutical companies including Pfizer and BioNTech, AstraZeneca, and Janssen have started earlier this year and have affected the decrease in the number of people receiving other vaccines. According to the Korea Disease Control and Prevention Agency, as of midnight on the 25th, a total of 26,701,704 people have received their first dose of a COVID-19 vaccine. This is around 52.0% of the total population in Korea. With the social atmosphere prioritizing COVID-19 vaccinations, Most of the vaccine market for adults, including the one for the shingles vaccine, is experiencing a slump. The two types of shingles vaccines -‘Zostavax’ and ‘SKYZoster’ – have shown a similar trend in their distribution of quarterly sales since last year. ‘Zostavax’ sold ₩5.4 billion in Q2 last year, which is a 57.9% YOY decrease from the same period of the previous year. This is also a 17.0% drop from the previous quarter, during which ‘Zostavax’ sold ₩6.5 billion. This year's cumulative sales in 1H were ₩11.9 billion, a 40.8% decrease from the previous year. Starting this year, MSD’s ‘Zostavzx’ has been marketed and sold by HK Inno.N in Korea. SKYZoster’s sales dropped 60.8% YOY to record ₩3.8 billion in Q2 this year. This is the lowest ever performance shown for the product other than in Q4 of 2017, immediately after its release. Cumulative sales of the first half of this year were ₩8.2 billion, a 44.2% decrease from the previous year. Not only in sales but SKYZoster’s market influence, which had skyrocketed ever since its release, has also decreased due to the pandemic. Based on cumulative sales of 1H, SKYZoster’s share in the market has decreased 1.4%p YOY from 42.2% to 40.8%. SK Bioscience expected sales of SKYZoster to recover in 2H with the increase of people who completed COVID-19 vaccinations and the start of the flu vaccination season.’ Also, another competitor is soon to be introduced to the domestic shingles vaccine market, forewarning more changes to come. Earlier this year, GSK has applied for the marketing authorization of its shingles vaccine, ‘Shingrix,’ to the Ministry of Food and Drug Safety. ‘Shingrix’ has been approved and is being sold in major countries around the world since 2017, when it was first approved by the U.S. Food and Drug Administration. Due to its high demand, the vaccine has been met with shortages in stock abroad. If sold in Korea, GSK’s ‘Shingrix’ in Korea may intensify competition and become a game-changer in the market.
- Policy
- RSA refund should be differentiated by income
- by Kim, Jung-Ju Aug 27, 2021 05:59am
- Currently, it has been suggested that Korea should apply RSA's refund flexibly by differentiating it according to income. It is suggested that the government should reduce the refund of high-income earners according to the income distribution and strengthen the guarantee of high-weakness by operating the refund of low-income earners in the form of a pre-deductible system. Ahn Jung-hoon, a professor of health convergence at Ewha Womans University, made the announcement at a policy forum hosted by Kang Sun-woo today (the 25th) under the theme of "the performance of strengthening health insurance policies and task-improving drug guarantees for seriously ill patients." In Korea, 20 to 30 anticancer drugs and rare diseases are listed on the list of drug benefits every year. Anti-cancer drugs are also expanding their benefit standards for around 20 drugs each year. Claims for serious diseases in 2019 amounted to ₩2.2 trillion, accounting for 11.7% of total drug costs. It has been increasing by 18.5% annually since 2015. Among them, anti-cancer drugs increased by 16% and drugs for rare diseases increased by 28.1%. Professor Ahn said that in order to develop a policy to strengthen guarantee, an evaluation based on the basis of medical non-reimbursement is necessary. It is also necessary to induce reasonable medical use by strengthening the role of medical staff and giving incentives, not by the current HIRA's billing reduction system. Professor Ahn suggests that expanding RSA is the right way to strengthen the guarantee of high-priced drugs. He said, "Unlike other countries, the NHIS receives the drug refund amount under RSA and refunds the patient's compensation as a refund rate, but the upper limit of the health insurance premium is applied." The upper limit is applied differently depending on the income quintile, but it is also worth considering reducing the burden of low-income people and reducing the RSA refund for high-income people, Ahn suggested. He said, "To reduce the burden of high-priced drugs on low-income patients, the drug that has become an RSA on the total amount should also be considered by the NHIS to prepay a certain percentage of drug claims by low-income people as collateral."
- Company
- Korea Pharma has signed a contract to supply Accrufer
- by Aug 27, 2021 05:59am
- Korea Pharma announced on Monday that it has signed an exclusive contract with Shield Theapeutics to supply the anaemic drug Accrufer in Korea. Anemia is very common in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Poor treatment of anemia increases the morbidity and morbidity of cardiovascular disease. According to Korea Pharma, existing oral anemia treatments have severe side effects such as gastrointestinal disorders and constipation. Since intravenous iron tablets require visiting hospitals once to three times a week, it takes time and is economically burdensome. Accrufer is an ideal alternative because it does not cause side effects such as gastrointestinal disorders and constipation, and absorbs as much iron as the body needs. Accrufer is a formulation that can replace the main used iron in the AEGIS-H2H study published in March 2019. Accrufer is expected to reduce the economic burden of intravenous iron preparations and improve patient conformity. Accrufer is approved by the FDA and EMA and is sold in Europe and the United States. It is the only oral anemia treatment in Korea that has been recognized for its excellent efficacy and safety with FDA approval. "Korea Pharma is a successful pharmaceutical company with outstanding performance in product development and commercial success," CEO Greg Madison said. "Iron deficiency is a global problem, and through this agreement, more iron deficiency patients in Korea will be able to use Accrufer in the near future," he said. Park Eun-hee, CEO of Korea Pharma, expects that the company will be able to provide iron deficiency treatment to Korea through Accrufer. Korea Pharma signed the world's first one-liter PEG bowel cleansing Plenvu exclusive contract with Norgine in December 2018, and this time it has expanded to IBD and CKD through Accrufer exclusive contract.
- Policy
- Clinical trials of Jardiance have been approved
- by Lee, Tak-Sun Aug 26, 2021 05:58am
- The SGLT-2 diabetes treatment has expanded its indication to other treatments for diseases such as heart failure. In Korea, AstraZeneca's Forxiga (Dapagliflozin Propanediol Hydrate) has also been recognized for its efficacy and effect on chronic heart failure and chronic kidney disease. And Boehringer Ingelheim's "Jardiance (Empagliflozin)" is also expanding his indication. EMPACT-MI, which is currently undergoing multinational clinical research, is also a test to seek other treatments for diseases. The MFDS approved the EMPACT-MI (clinical phase 3) for domestic subjects on the 24th. This test is for patients with acute myocardial infarction for hospitalization and death due to heart failure. A test to evaluate the effectiveness of Empagliflozin verifies placebo control superiority. The total number of test subjects for EMPACT-MI is 3,312. Among them, 35 subjects were selected in Korea. The test will be conducted at Busan National University Hospital, Bundang Seoul National University Hospital, Wonju Severance Christian Hospital, Chonnam National University Hospital and Chungbuk National University Hospital. Through the EMPOWER clinical program, Jardiance is seeking treatment in a wide range of areas, including heart, kidney and metabolic diseases. EMPACT-MI is also being carried out as part of EMPOWER. In June, Jardiance was also approved by the EU Commission as a treatment for chronic heart failure in adults with reduced heart rate. However, it was not approved as a treatment other than adult type 2 diabetes in Korea. Compared to competitive drug Forxiga's completion of chronic heart failure and chronic kidney disease, it is slow. Forxiga will also be used in Korea on the 12th for chronic kidney disease. At AstraZeneca's request, the MFDS has decided to add Forxiga's "chronic kidney disease" effect. Forxiga is effective in continuous reduction of estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease, reaching terminal kidney disease, and reducing risk of death and kidney-related death from cardiovascular disease. On December 22 last year, Forxiga acquired chronic heart failure. As a result, it can be used to treat patients with chronic heart failure whose left ventricular contraction function has been reduced by 18 years of age or older. Forxiga's successive addition of indicative symptoms proves the transformation of SGLT-2-based treatments into other treatments other than diabetes. The SGLT-2 series of treatments has a mechanism to control blood sugar by preventing reabsorption of glucose filtered from the kidneys and releasing it. This inhibits the transport "SGLT-2", which simultaneously carries NaCl and glucose. In particular, it is known to have a beneficial effect on heart remodeling and preserve new functions by exhibiting diuretic effects while simultaneously reducing volume overload and reducing blood pressure.
- Company
- Who will head Novartis Korea after Joshi Venugopal?
- by Eo, Yun-Ho Aug 26, 2021 05:58am
- The president of Novartis Korea is expected to change soon. According to industry sources, Joshi Venugopal, who had led Novartis Korea since September 2018, has completed his term at the end of last month and made a promotional transfer to become the Global Head of New Products at Novartis headquarters. Novartis Korea’s Chief Finance Officer, Kim Skafte Mortensen, has been running the company as the acting head since Joshi Venugopal’s resignation. Novartis is currently seeking a new head for its Korean subsidiary that will officially be appointed in coming October. Regarding the new appointment, some industry officials are cautiously mentioning internal rumors of a Korean national being appointed. Although Novartis has been operating its oncology and pharmaceutical division independently as a separate division, with reimbursement discussions for the CAR-T therapy ‘Kymriah (tisagenlecleucel)’ and SMA treatment ‘Zolgensma’ in progress, who will be appointed the new head is attracting much attention. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Gladsen in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015.
- Policy
- Ppl willing to pay max ₩13.52 mil. for one-shot therap
- by Kim, Jung-Ju Aug 26, 2021 05:58am
- Over 75% of the public responded that high-priced innovative new drugs, or so-called ‘one-shot treatments,’ should be covered by the National Health Insurance. As to the maximum price the public was willing to pay for such treatments, the average price was ₩13.52 million, and the most amount of respondents - 33.3% - agreed to the price. The Korean Organization for Rare Disease recently announced the results of a public survey on reimbursing innovative new drugs, which was commissioned to Gallup and sponsored by National Assembly Health and Welfare Committee member Sun-woo Kang of the Democratic Party of Korea. The survey was conducted online on 1,018 adults between the age of 19 to 65. Results showed that the general public tended to agree that applying health insurance on high-priced innovative new drugs even if it goes against equity and agreed on bearing additional insurance premiums or taking measures such as reducing coverage of mild diseases, etc. In particular, 52.6% of the respondents, which was twice more than the 22% that responded that covering high-priced new drugs that treat a small number of patients with specific diseases may be against the principle of equity of the National Health Insurance System. However, 75.2% of the respondents also agreed that health insurance coverage should be applied to recently-approved innovative new drugs, which was overwhelmingly higher than the 6.6% who opposed coverage. Also, the consent rate in general was higher for taking measures necessary to ensure the financial stability of the health insurance while covering innovative new drugs. On the question of whether it would be okay to slightly increase one’s insurance premium to cover high-priced new drugs, the majority, 55.7% of the respondents agreed, which was three times higher than the 19% that opposed. 42.2% of the respondents agreed on partially reducing the medical level of coverage provided for mild disease and medical treatments, which is a lower rate of agreement than for other questions, but still higher than the 32% that opposed. In addition, 51.1% of the respondents answered that innovative new drugs that were developed recently and have not verified their efficacy and safety for over 10 years, in the long-term, should be reimbursed, a 3 times higher rate than the 17.7% that opposed. On supporting the treatment cost of severe rare diseases and cancer with a separate source other than the NHI finances to address the issue of equity, the majority -79.6% - of the respondents agreed, and 72.8% agreed that Korea’s healthcare policy should prioritize enhancing accessibility and coverage of new drugs with an innovative MOA and therapeutic effect despite its high price. In particular, the respondents were willing to pay on average of ₩13.52 million for rare disease drugs that require 100% copayment, and the respondent who was willing to pay the most said that he or she is willing to pay up to ₩2.5 billion. Among those who responded that they will pay, the most amount of respondents, 33.3%, responded that they will pay at most ‘between ₩1,000,000-5,000,000,’ followed by 23.4% that responded ‘between ₩100,000-500,000,’ and then 13.6% that responded ‘between ₩10,000,000-50,000,000’ Tae-young Lee, President of the Korean Organization for Rare Disease said, “The survey showed that not only the patients, but the general public also have consensus on enhancing coverage for high-priced innovative new drugs. The government should reflect public opinion and make efforts to promptly incorporate high-priced drugs into our healthcare system using various policy alternatives.” The KORD president also said the organization will work closely with the government to support such efforts.
- Company
- GSK will supply Fluarix Tetra through Kwang Dong
- by Aug 26, 2021 05:58am
- GSK has signed a contract with Kwang Dong, which has disrupted discussions between SK Bioscience and Fluarix Tetra. GSK announced on the 24th that it has advertised and signed a joint sales contract with the flu vaccine Fluarix Tetra as a new partner. Initially, GSK discussed co-sale of Fluarix Tetra with SK Bioscience, which decided not to produce the flu vaccine "SKY Cellflu" this year. It seemed that the contract in the form of SK Bioscience sales marketing and receiving inquiries from hospitals and clinics in the consumer counseling office was almost finalized, but it was not contracted. GSK signed a contract with Kwang Dong. Kwang Dong decided to supply only a small amount of Fluarix Tetra to some hospitals, but it also decided to take charge of all the supplies SK Bioscience was planning to take. Kwang Dong will be responsible for the sale of Fluarix Tetra in all areas, including internal medicine, family medicine, orthopedic surgery, pediatrics and gynecology. GSK is expected to strengthen its expertise in distribution of influenza vaccines through the signing of this partnership. Yoon Je-young, brand manager of GSK's vaccine marketing department, said, "I think this contract will serve as an opportunity for Fluarix Tetra to be supplied and distributed more appropriately to the market."
- Policy
- Drugs caught in rebates for 2 years can be replaced by fines
- by Kim, Jung-Ju Aug 26, 2021 05:58am
- Among the insurance drugs caught as rebates, drugs that have been claimed for two consecutive years based on the date of disposal are expected to be replaced by fines. It belongs to cases that may cause inconvenience in patient care, not to harm public welfare. In the case of fines on these drugs, the rate will be increased by varying the upper limit of imposition according to the third and fourth violations. The MOHW announced a partial revision of the Enforcement Decree of the National Health Insurance Act and launched an opinion inquiry. The effective date is 9 December. According to the amendment, the reason for the suspension of rebate drug benefits could first be replaced by fines if it could cause inconvenience to right patients, i.e. when it is expected to interfere with public welfare. The reason is "drugs that were charged with medical care benefits in the year in which the disposal date belongs and the previous year." The rate of fines on the drug was also raised and set. Based on the existing cap amount, the rate of imposition will be set at 3.3 times for the third violation and 3.5 times for the fourth violation or higher. The MOHW has decided to conduct the amendment on December 9th if there is nothing special after consulting opinions by October 5th
