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- 2026-05-11 10:19:25
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- One step left to Dupixent’s reimb in pediatric patients
- by Eo, Yun-Ho Feb 10, 2023 05:53am
- The atopic dermatitis treatment ‘Dupixent’ has entered the last phase of extending its reimbursement coverage to children and adolescents. According to industry sources, Sanofi-Aventis Korea is conducting drug pricing negotiations for the low-dose formulation (200mg) of Dupixent (dupilumbab) with the National Health Insurance Service. The reimbursement agenda has made smooth progress after passing deliberation by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service on the 12th of last month. When considering the set negotiation period, the results are expected to come out by March. Being an RSA (Risk Sharing Agreement) drug and the addition of the separate 200mg dose, the drug had to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service to receive reimbursement. If the drug successfully completes drug pricing negotiations, Dupixent will finally be able to see results two years after applying for the reimbursement extension in April 2021. The journey had not been so easy for the drug. IT first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were only set in May last year. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent. The two drugs were both listed for reimbursement in May last year and Rinvoq is also attempting to extend its reimbursement to pediatric adolescent patients. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
- Policy
- MOHW opposes legislating premium pricing for KIPC drugs
- by Lee, Jeong-Hwan Feb 10, 2023 05:53am
- The Ministry of Health and Welfare virtually opposed the bill that legislates preferential treatment for drugs manufactured by accredited Korea Innovative Pharmaceutical Companies. The MOHW’s position is that drugs manufactured by Korea Innovative Pharmaceutical Companies already receive preferential treatment, such as premiums provided on insurance price ceilings as well as other support such as additional points for R&D, levy discounts, etc.” On the 9th, the MOHW submitted the opinion above regarding the bill for the ‘Partial Amendment of the Special Act to Foster and Support for the Pharmaceutical Industry’ that was submitted by NA Rep. Jung-sook Suh of the People Power Party. Suh’s bill contains a clause that changes the official name of the Pharmaceutical-Bio Industry Innovation Committee and upgrades its status, as well as a clause that obligates the provision of preferential treatment on drugs manufactured by Korea Innovative Pharmaceutical Companies. Pharmaceutical companies have shown interest in the bill as the bill seeks to obligate the existing arbitrary regulation on preferential treatments for drugs manufactured by Korea Innovative Pharmaceutical Companies, including those that provide premiums on price ceilings set for reimbursement, etc. The industry is also in favor of upgrading the status of the Pharmaceutical-Bio Industry Innovation Committee to an agency directly operated by the Prime Minister. However, the MOHW expressed caution in reviewing the two provisions. Although the ministry agreed on the need to systematically support and foster the pharmaceutical and bio-industry, it opposed the provision of preferential drug pricing. The MOHW said, “Drugs manufactured by Korea Innovative Pharmaceutical Companies are already receiving preferential treatment with premiums provided on the reimbursed price ceilings of their drugs. Also, additional points for R&D, and payment discounts are also provided as support." Regarding upgrading the status of the committee, the MOHW explained, “The government plans to discuss the establishment of a pan-ministerial governance body that not only covers the pharmaceutical industry but also medical devices and digital healthcare. During legislative discussions for that agenda, it will be necessary to review the scope of jurisdiction of each committee, as well as their function, system, and operation method.” However, the Health and Welfare Expert Committee deemed it necessary to revise the mandatory regulations on preferential drug prices for Korea Innovative Pharmaceutical Companies. Article 17-2 of the current Act that stipulates preferential treatment such as providing a premium to the ceiling price of reimbursed drugs was newly established in December 2018 and is an arbitrary rule that provides preferential treatment for drugs manufactured by Korea Innovative Pharmaceutical Companies. However, due to the lack of follow-up legislation, it has been criticized that no preferential treatment other than the price ceiling is being provided under the clause. In other words, the committee believes the optional regulation alone is not enough for the preferential system to be properly applied to drugs manufactured by Korea Innovative Pharmaceutical Companies. The Health and Welfare Expert Committee said, “Effective support measures for drugs manufactured by Korea Innovative Pharmaceutical Companies are needed to increase incentives to attract investment into R&D in the pharmaceutical industry. Therefore measure to provide preferential treatment to benefiting companies and drugs should be specified and stipulated as legislations through discussion with the public-private consultative body.”
- Company
- Botulinum Xeomin can be stored at room temperature
- by Jung, Sae-Im Feb 10, 2023 05:52am
- Professor Heo Chang-hoon presenting at the Merz Xeomin press conference"Improving toxin quality and strengthening management change perceptions Merz's botulinum toxin Xeomin has been upgraded to room-temperature storage. It emphasized quality as the only room-temperature storage product with the highest purity among botulinum toxin drugs on the market in Korea. Merz held a press conference at the Grand InterContinental Seoul Parnas Hotel in Gangnam-gu, Seoul on the 9th to commemorate the Xeomin room temperature storage (1 to 25 degrees Celsius). Launched in 2011, Xeomin has recently changed its license for storage temperatures. Unlike other botulinum toxin preparations that require refrigeration at 2 to 8 degrees, Xeomin can be stored at 9 to 25 degrees Celsius. It is the only toxin product on the domestic market that is stored at room temperature. In order for biological agents such as botulinum toxin to be licensed for upper marriage storage, consistent effectiveness, and stability must be demonstrated at 1 to 25 degrees. As a result of the experiment, Xeomin confirmed that biological activity and human serum albumin content remained constant for 36 months under conditions of 25 degrees Celsius and 60% humidity. Director Park Je-young (Oracle Dermatology in Apgujeong), who served as the speaker of the meeting, said, "Xeomin has already been allowed to be stored at room temperature in the U.S. and Europe. This means that there is a low risk of decomposition and deterioration of products that may occur due to temperature changes during transportation or distribution," he explained. As a result, Xeomin is the only botulinum toxin preparation that removes complex proteins and can be stored at room temperature at the same time. It minimized the risk of developing resistance by leaving only neurotoxin, an active substance, and proved high stability by storing it at room temperature. Heo Chang-hoon, a dermatologist at Seoul National University Bundang Hospital, said, "Botulinum toxin is determined based on ▲ the purity of neurotoxin ▲ consistency of effect expression ▲ stability during distribution and storage." In particular, toxin preparations are often not consistently refrigerated in storage and movement, and Xeomin has achieved the desire of all medical staff and pharmaceutical companies to store them at room temperature, he added. Yoo Soo-yeon, CEO of Merz, said, "This permit can save the use of energy essential for refrigeration, which is in line with the ESG management pursued by Merz."
- Policy
- Drugs subject to 2nd evaluations may submit data by Oct
- by Lee, Tak-Sun Feb 09, 2023 05:50am
- Drugs that were to receive the 2nd series of reevaluations by HIRA and were required to submit data by July will also be deemed to have met their requirements even if they exceed their submission deadline and submit the Ministry of Food and Drug Safety review completion notice by the end of the objection period. This will allow companies an additional 3 months of time, until October, to submit data. The measure has been made in consideration of the unavoidable circumstances, just as the first series of drugs that were subject to receive evaluations this year. According to the Health Insurance Review and Assessment Service on the 7th, oral and sterile preparations that were subject to receive evaluations in the second review were required to submit data by July 31 will be deemed to have satisfied their requirements if they submit their MFDS review completion notice within the objection period in consideration of the delay in MFDS review. A total of 5,905 oral and sterile preparations that were expanded and designated to conduct bioequivalence tests were set to receive the second set of evaluations. Some of the items have not even started bioequivalence tests , being unable to designate reference drugs. The authorities had previously announced that it will register priority review requests from drugs subject to receive the first set of evaluations and need to submit their data by February, and deem those companies that submit MFDS review completion notice within the objection period to have satisfied standard requirements. Therefore, relevant companies will first submit review requests to the MFDS by February, then submit their review completion notice by May. The data submission deadline had been extended in consideration of the COVID-19 situation, and HIRA explained that the same consideration will be provided to drugs subject to the second series of evaluations. Therefore, drugs subject to receive the second series of evaluations will be allowed to first submit review requests by July and submit the review completion notice by October to satisfy the standard requirements. HIRA believes that the 3-month addition to the deadline of the drugs subject to receive the second series of evaluations will allow drugs whose bioequivalence tests have been delayed due to reasons including non-announcement of reference drugs or difference in the sorbitol additive with its reference drug, to fully conduct reevaluations. A HIRA official explained, “Although discussions will still need to be made with the MFDS, we believe most drugs will be able to submit data within the evaluation period." Meanwhile, HIRA will hold a briefing session on its reevaluation of standard requirements on reimbursed ceiling price of listed drugs at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association office from 3:30 p.m. on the 10th and provide guidance on frequently asked questions in a Q&A format. Afterward, after collecting the opinions of the pharmaceutical industry on the series of evaluation subjects that will follow, the final list of drugs subject to evaluation will be released on HIRA’s webpage once again.
- Policy
- Enhertu's referral to the National Petition Welfare Committe
- by Lee, Jeong-Hwan Feb 09, 2023 05:49am
- It was referred to the National Assembly's Health and Welfare Committee as the number of people's consent to the application of breast cancer treatment Enhertu's health insurance reached 50,000. Enhertu is an antibody-drug conjugate that obtained a domestic marketing license last year due to the petition of the National Assembly. The petition for the approval of Enhertu Health Insurance rose on the 30th of last month, and 50,000 people agreed on the 3rd of this month, five days later. The petitioner pointed out that Enhertu is a high-priced drug that costs 5 million won per injection, and expressed the need to strengthen the accessibility of breast cancer patients. In June and August last year, Enhertu also filed a petition calling for approval of health insurance. In particular, Enhertu was designated as a subject of rapid permission in June 2021, but it was not approved for more than a year, so it was approved due to the influence of the national petition. Both Enhertu developers Daiichi Sankyo Korea and AstraZeneca Korea completed submitting a salary application for the approved indication in November last year and are currently waiting for the HIRA to review it. The public is paying keen attention to whether the government will respond quickly. The petition review subcommittee of the Welfare Committee is expected to review the petition calling for Enhertu health insurance approval according to the procedure.
- Company
- 80 billion won worth of Anticonvulsant Market
- by Nho, Byung Chul Feb 09, 2023 05:49am
- In the 80 billion Anticonvulsant market, Topiramate-based treatments form 30 billion units, leading the market. The epilepsy drug consists of about 10 components, including Topiramate, Lamotrigine, sodium Valproate, Oxcarbazepine, and Perampanel. According to the drug distribution performance data, as of last year, the performance of Lamotrigine, sodium valproate, Oxcarbazepine, and Perampanel drugs was 14.9 billion won, 10.4 billion won, 7.6 billion won, and 4.5 billion won, respectively. It is also notable that the rest of the formulations, excluding topiramate, show an annual growth rate of around 100 million won to 300 million won. About 10 products of Topiramate formulations have been released, forming the largest number of epilepsy drugs. Total sales in 2018, 2019, and 2020 were 23.2 billion won, 25.7 billion won, and 28.9 billion won, with the highest growth rate. The leading product of topiramate ingredients was the Janssen Topamax Sprinkle capsule, which generated about 10 billion won in sales last year. SK Chemicals Qudexy and Huons Ceti followed with 2.2 billion won and 2.1 billion won. GSK Lamicta, the No. 1 product of Lamotrigine ingredients, maintained its appearance of 11.9 billion won in 2021. It has the highest performance based on a single product of epilepsy drugs. Lamostal and Bukwang Lamotigine ranked second and third in the same ingredient, which recorded 800 million won 600 million won in performance. Myungin Camazepine and Novartis Tegretol Korea form an appearance of 2.9 billion won and 2.4 billion won. Perampanel-based product Eisai Korea Fycompa's 2021 performance is 4.5 billion won, while Handok Sentil is moving within 900-1 billion won for five years. According to academia, the prevalence of epilepsy is about 4 to 10 per 1,000 people, and it is known that 20 to 70 people per 100,000 people occur newly every year, especially in childhood (under 9) and old age (over 60). Genetic defects cannot be excluded as the cause of epilepsy, but it is a general classification criterion to classify it into structure, metabolism, and unknown cause. It is a case of seizures due to acquired diseases such as stroke, brain damage, and infection due to structural and metabolic causes, and can come from brain nerve cell stimulation due to hypoglycemia, uremia, withdrawal of alcohol, and sleep deprivation. Most likely causes include cerebrovascular disease, encephalitis, hippocampus sclerosis, cerebral palsy, brain tumors, vascular deformities, and degenerative diseases, but more than half of the causes are unknown. Looking at the guidelines for treatments of the Korean Epidemiology Association, epilepsy can be improved with drug treatment, and 60-70% of patients can control seizures with treatments. Since drug treatment should be maintained for a long period of at least two years, it is important to choose a drug that suits each patient's condition.
- 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.
