- LOGIN
- MemberShip
- 2026-04-10 18:48:20
- Company
- Olumiant may land to treat alopecia areata in KOR this year
- by Eo, Yun-Ho Feb 09, 2023 05:49am
- The JAK inhibitor ‘Olumiant’ may be prescribed to treat hair loss in Korea within the year. According to industry sources, the Ministry of Food and Drug Safety is conducting a review on expanding the indication of Lilly Korea’s JAK inhibitor Olumiant (baricitinib) to severe alopecia areata in Korea. The company may receive the final marketing authorization for the indication in the first half of the year at the earliest. Olumiant was approved for the alopecia areata indication in the US and Japan in June last year and received a recommendation for its use in the EU as well. With the approvals, the drug is quickly making its way into the global market. Olumiant selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and demonstrates an overall anti-inflammatory effect. It was first approved as a treatment for rheumatoid arthritis, then expanded its indication to atopic dermatitis in some countries including Korea. In the US, Olumiant is also prescribed to treat hospitalized COVID-19 patients. Alopecia areata is also an autoimmune disorder that causes the body to attack its hair follicles, resulting in hair falling out. In addition to scalp hair, eyebrows, and eyelashes can also fall out. The efficacy of Olumiant was demonstrated through the BRAVE-AA1 and BRAVE-AA2 trials that were conducted on patients with severe alopecia areata. The two trials evaluated the safety and efficacy of Olumiant in 1,300 patients compared with the placebo. In the AA1 trial, 22% of the 184 patients in the Olumiant 2mg arm and 35% of the 281 patients in the Olumiant 4mg arm showed an appropriate level of scalp hair coverage and achieved a Severity of Alopecia Tool (SALT) score of 20 or less. The rate was only 5.3% in the placebo arm. The higher the SALT score, the more severe the degree of hair loss is considered to be. 31% and 35% improvements in eyebrow and eyelash coverage were also observed in the Olumiant 2mg and 4mg arm, respectively. In the AA2 trial, 17% of the Olumiant 2mg arm and 32% of the Olumiang 4mg arm achieved a SALT score of 20 or less, which was a significantly higher proportion than the 2.6% in the placebo arm. Reimbursement for Olumiant was extended to atopic dermatitis in May last year after being first listed for rheumatoid arthritis in 2018.
- Company
- Entresto’s sales exceeded KRW 40 billion last year
- by Feb 08, 2023 05:53am
- Pic of Entresto Sales of Novartis Korea’s chronic heart failure treatment ‘Entresto’ has exceeded KRW 40 billion 6 years into its release. According to market research institution UBIST on the 7th, Entresto’s outpatient prescription sales had recorded KRW 40.6 billion last year. This is a 26% increase from the KRW 32.3 billion it had recorded the previous year. Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that combines the angiotensin receptor blocker (ARB) 'valsartan' and neprilysin inhibitor 'sacubitril.' The drug may be used as an alternative to an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor in patients with left ventricular (LV) dysfunction as an alternative to other heart failure treatments. Entresto received marketing authorization in April 2016 and the drug was officially launched with reimbursement in October 2017. Although the drug recorded KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then exceeded KRW 30 billion and recorded KRW 32.3 billion in 2021. Data: UBIST The drug’s quarterly sales first exceeded KRW 10 billion for the first time last year. Last year, Entresto raised sales of KRW 9.1 billion in Q1, then KRW 9.6 billion in Q2, then KRW 10.5 billion in Q3. In Q4, its sales continued to rise to record KRW 11.4 billion in Q4 last year. Entresto made explosive growth demonstrating its superior efficacy in heart failure with reduced ejection fraction (HFrEF). Entresto replaced the ACE or ARB inhibitors that had been mainly used in these patients. In HFpEF, no suitable treatment exists other than Entresto. Entresto may be used in patients with a left ventricular ejection fraction of 40% or higher to 60% (below normal level). Based on the evidence, the Korean Society of Heart Failure (KSHF) recommended Entresto as a priority treatment in HFrEF, and as a Class IIa, Level of Evidence B in heart failure with mildly reduced EF and heart failure with preserved ejection fraction in the newly revised clinical practice guidelines last year. Recently, Novartis released large-scale real-world trial data on Entresto that was conducted on Korean patients, increasing evidence on the efficacy and safety of the drug. Results of the study that was conducted on a total of 600 patients from 2017 to 2019 showed that patients first started treatment with the initial 50-100 mg bid dose and maintained or stably increased the dose for 12 and reached target dose. The trial results addressed the concerns on how the target dose of Entresto was difficult to administer due to concerns over hypotension. Of the total patients, about 40% maintained their dose of Entresto, and 42% stably increased their dose. SGLT-2 inhibitors, which were previously used as diabetes drugs, had expanded their scope to treating heart failure. Although new drugs with new mechanisms of action have also been introduced to the market, Entresto's growth is expected to continue for the time being as newly introduced drugs have a different mechanism of action, and various attempts at its combined use with other class drugs are expected to be made. Domestic companies have been continuing their attempts to challenge Entresto that had emerged as a blockbuster drug. Domestic pharmaceutical companies, starting with Hanmi Pharmaceutical, followed by Chong Kun Dang, Samjin Pharm, Hana Pharm, and Ahn-Gook Pharmaceutical, filed suits to avoid all four patents related on Entresto. Last year, Hanmi Pharmaceutical was the first to succeed in avoiding all 4 patents related to Entresto. Since then, 9 more companies have succeeded in avoiding the patents. In other words, the generic companies have all won the first trial. Novartis appealed to the results of the first trial, and the second trial is currently in progress.
- Policy
- Legislation of health functional foods
- by Lee, Jeong-Hwan Feb 08, 2023 05:53am
- A bill to make drug preferential treatment for drugs developed by innovative pharmaceutical companies mandatory by law and a bill to institutionalize customized health functional foods will be presented to the plenary session of the National Assembly's Health and Welfare Committee on the 9th. A bill to strengthen regulations on specialized human drugs distributed from pharmacies to animal hospitals and a bill to allow the application of "e-labels" to government-designated specialty drugs were also listed on the agenda. On the 7th, the Health and Welfare Committee confirmed the list of the plenary session on 146 laws under its jurisdiction. Looking at the major bills, a bill to change the name of the Pharmaceutical Industry Promotion and Support Committee to the Pharmaceutical Bio-Industrial Innovation Committee and raise its status to an organization under the Prime Minister will be held at the plenary session. It is a revision to the Special Act on the Promotion and Support of the Pharmaceutical Industry, which was proposed by Rep. Seo Jung-sook of the People's Power. The bill included a provision to revise provisions such as drug preferential treatment for drugs made by innovative pharmaceutical companies into mandatory regulations. A revision to the Health Functional Food Act, which provides a legal basis for the pilot project of "Sales of Personalized Health Functional Food," which is currently temporarily operated as a regulatory sandbox, will also be proposed at a plenary session. The bill, proposed by Kang Ki-yoon, a lawmaker of the People's Power, introduces the concept of customized health-functional foods, establishes customized health-functional food sales, and subscribes to liability insurance to relieve consumer damage. It also included regulations that prohibit the introduction of customized health functional food managers and the sale of non-report customized health functional foods. A bill that mandates pharmacists to report sales details to the General Center for Drug Management when distributing and selling Rx drugs to animal hospitals was also on the agenda. Seo Young-seok of the Democratic Party of Korea proposed a bill to make the Rx drug distribution network used in animal hospitals transparent. A bill to allow Rx e-labeling, which was proposed by Rep. Seo Young-seok and Baek Jong-heon's power, will also be proposed. The content allows electronic information such as barcodes and QR codes, not paper manuals or text messages, to be provided to Rx drug containers and packaging designated by the Minister of Food and Drug Safety. Six amendments to the medical law to be held at the plenary session were decided, including the Democratic Party of Korea lawmaker Han Jung-ae's bill, which provided the basis for considering ESG management indicators in the designation of advanced general hospitals and certification of medical institutions. A revision to the Medical Law to strengthen punishment for drug offenders of medical personnel is also proposed. The bill, proposed by Jang Dong-hyuk, the people's power, calls for medical personnel to cancel their licenses for five years if they are addicted to drugs and reduce the ratio of internal doctors on the license issuance review committee. The eight amendments to the National Health Insurance Act included in the agenda included a bill that would fund the national health insurance finances so that they would be subject to the National Finance Act and subject to parliamentary review.
- Company
- Huonslab is speeding up the development of Prolia biosimilar
- by Lee, Seok-Jun Feb 08, 2023 05:53am
- Huonslab announced on the 7th that it has confirmed that the HLB3-013 biosimilar under development is equally effective in non-clinical animal efficacy tests compared to the original Prolia. This is the result of an osteoporosis-causing model mouse at an overseas CRO institution (BioMedCore, Greece). When the original and HLB3-013 were treated equally, the effect of inhibiting osteoporosis symptoms was confirmed in various factors (average volume, density, separation, and external bone thickness of the femur). The same effect was shown at the same concentration of the test group compared to Prolia (3 mg/kg, 10 mg/kg). Prolia's mechanism of action is a drug that prevents bone destruction by binding to RANKL, an essential protein for bone-destroying osteoblasts, to suppress the formation, function, and survival of osteoblasts. Prolia is a biopharmaceutical product with improved convenience and persistence that lasts for six months with the first dose. With this effect, it is used in treatment for increasing bone density in osteoporosis patients. The patent is about to expire in 2025. Prolia's global sales in 2022 recorded about 4.55 trillion won (about $3.6 billion) and domestic sales about 100 billion won. Yoon Sung-tae, CEO of Huonslab, said, "As we have confirmed the same effect in animals, we will launch the Prolia biosimilar by conducting follow-up studies on non-clinical toxicity and clinical trials." Huonslab is a company that develops new biological drugs and biosimilars. It is developing Prolia biosimilar for the third time in Korea.
- Company
- Prescription of Celltrion’s Takeda drugs fall for 2 yrs
- by Kim, Jin-Gu Feb 08, 2023 05:53am
- Prescription performance of the 3 major chronic disease treatments that Celltrion Pharm acquired from Takeda Pharmaceutical had fallen for 2 consecutive years since their acquisition. The ‘Nesina’ series, which account for the most proportion of sales among the acquired products, recorded KRW 28.2 billion in sales last year, recording a downward trend for 3 consecutive years since 2020. Sales of the other diabetes treatment ‘Actos’ series and the hypertension treatment ‘Edarbi’ series have also shown sluggish sales in terms of prescription performance over the past 2 years. According to the market research institution UBIST on the 8th, the total prescription amount of the 3 major chronic disease treatments that Celltrion acquired from Takeda Pharmaceutical was KRW 65.4 billion last year. This is a 5% decrease from the KRW 68.9 billion recorded by the same drugs in 2021. In June 2020, Celltrion signed an agreement with Takeda Pharmaceutical to acquire the rights of 18 prescription drugs and OTCs sold by Takeda’s Primary Care Business Unit in the Asia Pacific region for a total of USD 278.3 million (KRW 307.4 billion). Under the deal, the company acquired the diabetes treatment Nesina Actos, the hypertension treatment Edarbi, and OTCs Whituben, Albothyl, etc. The acquisition process was completed in December of the same year, and work to switch the domestic marketing authorization license had been ongoing until January last year. The products are now being sold by Celltrion in Korea. The decrease in sales was most significant in the sales of the Nesina series, the DPP-4 inhibitor class diabetes treatments. Total sales of Nesina, Nesina Met, and Nesina Act recorded KRW 28.2 billion last year. Ever since their sales peaked at KRW 35.9 billion in 2019, sales steadily declined to KRW 33.4 billion in 2020, then KRW 31.4 billion in 2021. In particular, sales fell below KRW 30 billion for the first time in 6 years since 2016 last year. In the case of the Nesina series, their prescriptions have been on a decline even before the drug was acquired by Celltrion due to fierce competition in the DPP-4 inhibitor class diabetes treatment market. In addition, the release of generic versions of its competitor Galvus and Tenelia further decreased the influence of Nesina in the market. The TZD class antidiabetic Actos series and the ARB class hypertension treatment Edarbi series had also shown a slowdown in sales recently. The total prescription amount of Actos, Actos Med, and ActosRyl was KRW 25.9 billion, which was a 3% increase from KRW 25.2 billion in 2020. However, the amount had decreased by 2% from KRW 26.6. billion in 2021. Total prescriptions of Edarbi and Edarbi klo had increased by 3% in the past 2 years from KRW 10.8 billion in 2020 to KRW 11.2 billion last year. The combined prescription amount of the three product groups rose steadily from KRW 62.9 billion in 2018 to KRW 69.5 billion in 2020. However, sales then fell to KRW 68.9 billion in 2021, then to KRW 65.4 billion last year. After Celltrion acquired the products, sales performance of the Edarbi and Actos series had improved slightly, but as the performance of the Nesina series, which accounted for the largest portion of sales among the acquired products decreased significantly, this is analyzed to have led to the decrease in the total prescription amount. In the case of the OTCs Whituben and Albothyl, their sales data has not been compiled yet. However, in the case of Whituben, sales are said to have increased twofold compared to the previous year due to the increase in demand for cold medicines following the rapid increase in confirmed cases of COVID-19 last year. Sales of the Whituben series in 2021 had been KRW 2.5 billion.
- Company
- The first reverse growth of NOAC worth 230 billion won
- by Jung, Sae-Im Feb 08, 2023 05:53am
- Eliquis·Pradaxa·Xarelto·Eliquis The NOAC market, which is worth 230 billion won, fell for the first time last year. This is because the generic market for some items was opened and drug prices were cut. Generics, which competed with the original "Xarelto," secured a market worth 9 billion won last year. According to Ubist, a pharmaceutical market research firm on the 8th, the size of the outpatient prescription market in the NOAC market last year was 227.6 billion won, down 1.8% from 231.8 billion won the previous year. NOAC has attracted attention as a drug that has a lower risk of bleeding side effects than warfarin, a conventional anticoagulant, and has a great thromboembolic effect. A total of four original products are on sale. Since the early 2010s, they have replaced warfarin and gained influence in the prescription field. The NOAC market, which had been increasing every year, saw its annual prescription reverse growth for the first time in 2022. With the emergence of generics of some items, the original drug price cut was made, and it entered a downward phase. The representative one is Bayer's "Xarelto." Last year, Xarelto's outpatient prescription amount was 46.8 billion won, down 22% from 59.6 billion won the previous year. Since its launch, Xarelto prescription solutions, which have continued to grow, have turned downward since last year. The biggest blow is the original drug price due to the generic salary registration. As of August 22 last year, the Ministry of Health and Welfare cut the drug price of all doses of Xarelto (2.5·10·15·20mg) by 30%. This is because the Seoul High Court sided with the Ministry of Health and Welfare in a lawsuit filed by Bayer against the Ministry of Health and Welfare to cancel the Xarelto drug price cut. The Xarelto price was scheduled to be lowered in May 2021, when generic was first listed, but the execution was suspended until the original ruling because Bayer filed a lawsuit that the drug price cut was unfair, saying that Generic was released before the patent expired. The ruling was made after about a year and two months, and the drug price cut was finally confirmed. Xarelto's quarterly prescription, which was between 14 billion won and 15 billion won, fell sharply to 11 billion won in the third quarter. In the fourth quarter, it was 7.4 billion won, which is half the level before the drug price cut. Compared to 2020, Xarelto's prescription in the second half of last year lost 40%. The decline is expected to be steeper as additional Xarelto drug price cuts are expected this year. The government will add the original drug price to 53.55% for the first time when generic is listed, and 70% for one year after adjusting it to 53.55%. As a result, Xarelto, which was cut by only 30% last year, is expected to be cut by 23.5% to 23.6% this year. The influence of Xarelto generic is also growing. Last year, Xarelto generic products received 9 billion won in outpatient prescriptions, more than five times higher than the 1.6 billion won in the previous year. Chong Kun Dang (2.9 billion won), Hanmi Pharm (1.5 billion won), and Samjin Pharm (1 billion won) are driving the growth of the generic market. ◆Lixiana and Eliquis increase without generic penetration, 160 Billion-scale Lixiana, the No. 1 in this market, raised its prescription amount by 89 billion won last year. This is an increase of 5% compared to the previous year. Lixiana is the latest NOAC formulation to enter the market. There is a five-year difference from other drugs. Despite being generic, Lixiana succeeded in reversing in 2019 by accumulating data through direct comparative studies with other drugs. Analysts say that aggressive sales strategies with domestic companies also affected rapid growth. Lixiana, which was 4.8 billion won in 2016, expanded its size from 20.9 billion won in 2017 to 39.5 billion won in 2018, 61.9 billion won in 2019, 72.9 billion won in 2020, and 84.8 billion won in 2021. As of last year, Lixiana accounted for 41% of the original NOAC market. BMS's Eliquis ranked second in the NOAC market. Equis' prescription amount last year was 70.6 billion won, an 8% increase from the previous year. The recent increase in Eliquis' sales is largely due to the withdrawal of generics. Eliquis' growth slowed in June 2019 as it faced competition with generics. Generic companies, which won the case until the second trial, preemptively released generic, and annual prescriptions rose by nearly 10 billion won in 2020. During this period, Eliquis was 50.6 billion won in 2019 and 55 billion won in 2020. Eliquis growth, which increased by 10 billion won every year, slowed down. However, in April 2021, the Supreme Court reversed the previous ruling in the patent lawsuit and sided with BMS, taking a new turn. Immediately after the ruling, the generics withdrew from the market en masse. This is because BMS announced a claim for damages due to patent infringement. The Mayor of Eliquis generic, which was 1.2 billion won in 2019 and 9.4 billion won in 2020, shrank to 5.4 billion won in 2021, when the Supreme Court ruled. Last year, the prescription amount was 0 won as the generic benefit was deleted and all distribution inventory was exhausted. Along with this, Eliquis' prescription amount, which had slowed down, recovered to 65.2 billion won in 2021, expanding by 10 billion won again. Last year, it surpassed 70 billion won. Generics that lost the lawsuit can only sell their products after September next year. ◆Pradaxa's sales have been on the decline for 5 years Sales of another NOAC, Pradaxa of Beringer Ingelheim, have been on the decline for the fifth consecutive year. Pradaxa's prescription amount last year was 12.2 billion won, down 20% from 15.2 billion won in 2020. Unlike other formulations, Pradaxa, which expanded its size in 2017, failed to exceed 20 billion won and turned downward. Pradaxa's sales, which were 21.6 billion won in 2017, showed a clear decline to 19.6 billion won in 2018, 18.7 billion won in 2019, and 16.5 billion won in 2019. Pradaxa, which has been pushed back from the competition with NOAC Original, is also out of the interest of generics. According to the Ministry of Food and Drug Safety, 10 domestic companies were licensed for Pradaxa Generics in 2018, but none of them have been released on the market. It seems that it is meaningless to compete in the Pradaxa market, which is only 10 billion won.
- Company
- Dong-A Forxiga loses the patent dispute
- by Kim, Jin-Gu Feb 07, 2023 05:48am
- A new method of avoiding material patents virtually fails the 'prodrug' strategy, which was drawing attention. Dong-A ST lost the Forxiga patent dispute alone. Dong-A ST pushed ahead with the release of Forxiga's late drug, Dapapro, on the basis of its victory in the first trial, but the ruling put considerable pressure on sales. ◆ Dong-A ST loses patent dispute alone, Dapapro sales variable The Supreme Court's special second division ruled in the morning of the 2nd that Dong-A ST would dismiss the appeal in an appeal filed against AstraZeneca. Forxiga is protected by two substance patents. The first substance patent (10-0728085) expires on April 7, 2023, and the second substance patent (10-1021752) expires on January 8, 2024. Dong-A ST alone challenged the first substance patent, which expires first. In April 2018, Dong-A ST requested a passive judgment on the scope of rights for the first substance patent. In the first trial, Dong-A ST won. The Korean Intellectual Property Trial and Appeal Board made a trial decision on the establishment of the claim in August 2020. AstraZeneca objected, and the ruling was overturned in the second trial. The patent court ruled in favor of AstraZeneca. This time, Dong-A ST filed an appeal with the Supreme Court in protest. However, the Supreme Court finally sided with the original company. Dong-A ST has already released Posh's generic Dapapro exclusively based on the first trial victory trial in December last year. However, the Supreme Court ruling put a burden on Dapapro's sales. However, Dong-A ST won the nullification lawsuit for the second substance patent issued on the same day, so there is no problem with sales after April this year when the second substance patent expires. Patent infringement related to the forced sale of Dapapro is treated separately as a lawsuit. Currently, Dong-A ST is proceeding with a separate lawsuit against AstraZeneca and Prodrug and a patent infringement lawsuit. ◆New method of avoiding material patents The 'Prodrug' strategy, which was drawing attention, has virtually failed Dong-A ST's challenge to avoid material patents has received considerable attention from the pharmaceutical industry. This is because Dong-A ST has come up with a new material patent avoidance strategy called "Prodrug." A prodrug is a drug in the pro stage of the drug. Until just before taking the drug after it is produced, the chemical structure of the original drug is partially different in the substituent part. When you take a drug, it acts like an original drug in your body. In the pharmaceutical industry, if Dong-A ST wins, it is predicted that the challenge of material patents using the Prodrug strategy will continue. However, Dong-A ST's prodrug strategy has virtually failed to see the light as it lost consecutive second and third trials. "The strategy of avoiding material patents by Prodrug has been put on hold by the Supreme Court for now," a pharmaceutical industry official said. "However, we have to wait and see the results because Dong-A ST is filing a separate lawsuit using Prodrug."
- Policy
- MFDS prepares a list of pre-requisite data for inspections
- by Lee, Hye-Kyung Feb 07, 2023 05:47am
- The Ministry of Food and Drug Safety has prepared a list of pre-requisite data for local inspections of overseas pharmaceutical manufacturing plants. A total of seven data submission lists, including the list of drug manufacturing over the past three years, have been prepared to enhance the predictability and consistency of administration during field inspections of overseas manufacturing plants. This list of data is one of the suggestions submitted by the pharmaceutical industry through the first meeting of the regulatory innovation industry in the pharmaceutical sector held in July last year. At the time, the pharmaceutical industry requested that data should be prepared at the site of due diligence and submitted and reviewed during the due diligence process instead of submitting data in advance of the on-site inspection of overseas manufacturing plants. The on-site inspection of overseas manufacturing plants is conducted in accordance with Article 695 of the Pharmaceutical Affairs Act, and specific procedures and methods are stipulated through the Prime Minister's Decree, but a detailed list of pre-requisite data has never been released. In response, the Ministry of Food and Drug Safety decided to disclose a list of pre-required data by reflecting some of the pharmaceutical industry's suggestions instead of not submitting prior data. According to the list of required data, ▲ List of pharmaceutical products (including manufacturing date, manufacturing number, shipment status, export volume, etc.), ▲ List of document management regulations and standards (including approval date and revision number), ▲ Comprehensive Process Validation Plan and Report (badge filling test, filter validation included), ▲ Quality Assessment Report (P) ▲ Manufacturing Material Report (Recent) For the last three years, the list except for the manufacturing list of medicines and the manufacturer's general list must be submitted only for items subject to field inspection. The Ministry of Food and Drug Safety plans to finalize the list of pre-requisite data for overseas manufacturing plants in the future by collecting opinions from the pharmaceutical industry on the list.
- Policy
- Further proposals made for reimb of diabetes combos
- by Lee, Tak-Sun Feb 07, 2023 05:47am
- SGLT-2 inhibitor class diabetes drugs (from the left: Forxiga, Jardiance, Xigduo, Jardiance Duo) The health insurance authorities have once again started analysis on the fiscal impact of reimbursing diabetes combination drugs. In the latest financial impact analysis, a red light was turned on in reimbursing the combined use of diabetes drugs as the reimbursement amount exceeded the government’s range of expectations. Whether the newly submitted price cut proposals will satisfy the government's expectations and finally allow reimbursement to be made for diabetes combinations is gaining attention. According to industry sources on the 6th, the Ministry of Health and Welfare collected the voluntary price cut rates submitted by 11 pharmaceutical companies related to the reimbursement of combination drugs for diabetes until last Friday (3rd) and began analyzing their fiscal impact. Discussions on the reimbursement of combination drugs for diabetes had previously come to a halt after the MOHW determined the fiscal impact of the drugs that submitted voluntary discount rates in November last year exceed the expected range. Accordingly, the MOHW held another meeting on the 11th of last month with related pharmaceutical companies and requested the companies to submit the voluntary discount rates again within two weeks. If the fiscal impact falls within the expected range with the voluntary reduction rate that was submitted this time, discussions on the reimbursement of diabetes drug combos will gain momentum. The combinations being discussed are triple therapy combinations such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and the combination of some SGLT-2 drugs+sulfonylurea or insulin. The Korean Diabetes Association has been requesting reimbursement of the combined use of diabetes drugs since 2016. However, due to their large impact on finances, discussions on their reimbursement have only been made in earnest since 2021 and were sluggish before then. In the market, companies have also released fixed-dose combinations that were designed to increase treatment efficacy through the combined use of diabetes drugs. However, if the government turns down the reimbursement listing, these new drugs are likely to be abandoned without proper use. It is said that the government is determined to make the decision quickly as discussions on the reimbursement of the combined use of diabetes drugs had been ongoing for a long time. The key will be the discount rate submitted by companies that own large drugs such as Forxiga. An official from a related company said, “What discount rate the companies such as AstraZeneca that owns Forxiga submitted will greatly affect the reimbursement listing of combination drugs. If the additional proposal cuts the drug price by only a small amount from the previous proposal, the discussion itself will likely be discontinued. Therefore, this is virtually the last chance."
- Policy
- Non-face-to-face treatment included as key policy task
- by Kang, Shin-Kook Feb 07, 2023 05:47am
- The Korean government is expected to make systemic improvements in the field of healthcare this year, with non-face-to-face treatment included as a key social policy. The Ministry of Education (Deputy Prime Minister and Education Minister Ju-Ho Lee) held the first Ministerial Conference on Social Relations at the Government Complex-Seoul on the 6th to deliberate and decide on a plan for implementing key social policies in 2023. The 2023 Key Social Policy Implementation Plan that was jointly established by 15 social government ministries contained the vision, goals, and major policy tasks for social policies and areas that the ministries will focus and collaborate on this year. Key social policy tasks for 2023 During discussions, the institutionalization of non-face-to-face treatment was included as a healthcare policy task. The policy is aimed at introducing non-face-to-face treatment mainly in primary medical institutions for the health management of patients residing in islands and isolated areas, overseas residents, infectious disease patients, and chronic disease patients. Also, the plans also include measures to expand emergency medical centers and expand healthcare in public health centers. Measures to expand essential healthcare and improve accessibility were also included as social policy measures. The plan is the same as the one announced by the Ministry of Health and Welfare, which aims to expand essential medical services, especially for severe emergencies, childbirth, and pediatric care, and to improve and strengthen public medical infrastructure Major social policy tasks for 2023 Also, the development of manufacturing and quality control technology to localize essential national medicines and the establishment of a national supply chain for medical devices that are rare or require urgent introduction were included as key tasks. Ju-Ho Lee, Deputy Prime Minister and Minister of Education said, “We have prepared the Key Social Policy Implementation Plan this year to bring hope of making a Korea that realizes the value of freedom through solidarity. We have established a pan-ministerial cooperation system to promote this.” Prime Minister Lee added, “The plan consists of 9 major tasks and 27 detailed policy tasks to achieve the social policy goals of ▲leaping towards the future, ▲ solidarity together, and ▲ensuring safe daily life.”
