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- 2025-12-20 23:44:31
- Policy
- Forxiga withdraws from the Korean mkt despite reimbursement
- by Lee, Tak-Sun Jan 22, 2024 05:48am
- The SGLT-2 inhibitor ‘Forxiga Tab,’ which its company plans to withdraw from the Korean market in the first half of the year, will now be reimbursed for chronic heart failure. However, the withdrawal of the drug from the market has put a damper on the reimbursement expansion. Even if it is reimbursed from next month, there will inevitably be a gap in the use of the treatment when stocks run out due to the discontinuation of its supply. Therefore, patients with heart failure in Korea are at risk of losing access to the treatment option of Forxiga despite the coverage expansion. The Ministry of Health and Welfare announced in a preliminary notice of revisions to the drug reimbursement standards that it will expand reimbursement for SGLT-2 inhibitors such as Forxiga and Jardiance to chronic heart failure from the 1st of next month. With the revision, Forxiga and Jardiance will be reimbursed for patients with chronic heart failure and a left ventricular ejection fraction of 40% or less who are receiving a stable dose of standard therapy. Here, standard therapy is defined as an ACE inhibitor or angiotensin Ⅱ receptor blocker (ARB) or sacubitril-valsartan in combination with a beta-blocker or aldosterone antagonist. Forxiga and Jardiance can also be used in combination with other standard therapies for heart failure. As a result, the treatment scope of Forxiga, which had mainly been used to treat patients with diabetes, was been extended to chronic heart failure. However, the reimbursement extension was overshadowed by the company's withdrawal from the domestic market in the first half of this year. AstraZeneca announced late last year that it would be withdrawing Forxiga from the domestic market in the first half of this year. Given the upcoming domestic supply disruption, patients with heart failure may be hesitant to use Foxiga even with the reimbursement extension. The patients will have to discontinue use of Forxiga the day the remaining stock runs out, On this, AstraZeneca Korea said, "We are in multi-faceted discussions with the health authorities on how to continue treatment for patients with chronic heart failure and chronic kidney disease who are using Forxiga. We currently have secured sufficient quantities for domestic supply for the year.” The problem is, other than Forxigna, none of the same-ingredient generics that have been released since April last year own the chronic heart failure indication. Upon Forxiga’s market withdrawal, generic versions of the same drug would have to be used, but this is difficult because the generic versions are not authorized or reimbursed for the chronic heart failure indication. This is because Forxiga’s patent for chronic heart failure does not expire until March 2040. Due to this, the reimbursement extension granted for SGLT-2 inhibitors is likely to benefit Boehringer Ingelheim Korea's Jardiance. Jardiance has yet to launch a generic, and other SGLT-2 inhibitor generic drugs do not have a chronic heart failure indication. Therefore, whether the health insurance authorities will find a way to maintain the use of dapagliflozin, Forxiga’s main ingredient, available for chronic heart failure, remains to be seen.
- Policy
- P3T for chin fat reduction injection ‘AYP-101’ approved
- by Lee, Hye-Kyung Jan 19, 2024 05:45am
- A Phase III trial for Amipharm's 'AYP-101', an injectable drug for submental fat reduction, will be conducted in Korea. On the 16th, the Ministry of Food and Drug Safety approved a Phase III clinical trial to ‘evaluate the efficacy and safety of AYP-101 in reducing submental fat in adults with moderate-to-severe convexity or fullness associated with submental fat. Amipharm had previously conducted a Phase II trial for the injection on 96 Koreans from August 2021 to June 2023 and will initiate the Phase III trial in Korea with the MFDS approval. AYP-101 is an injectable for submental fat reduction that selectively induces fat cell apoptosis and lipolysis. Its main ingredient is polyene phosphatidylcholine (PPC), a natural substance extracted from glycine max. merr (soybeans) at high purity. In 2018, Amipharm obtained a patent from the Korean Intellectual Property Office for "Composition and Manufacturing Method of Local Fat Reduction Injectable (AYP-101) without Pain, Edema and Side Effects. If commercialized, Amipharm expects AYP-101 will become the first new incrementally modified drug to be developed in Korea in the aesthetic field. AYP-101’s composition improves the disadvantages of existing PPC injections, which cause pain and swelling through a mechanism of action that brings about cell necrosis. PPC injections have previously been approved for cell membrane binding and regeneration in areas such as liver disease and dementia as ‘Lipobin Inj,’ but have been used off-label as lipolysis injections. Current treatment options for submental fat, also known as a double chin, are limited. Existing methods include off-label, mesotherapy cocktail injections performed under general or local anesthesia and surgical liposuction performed under general anesthesia. AYP-101 is expected to help expand the therapeutic area for the injection to patients who are interested in the non-surgical injectable method of localized fat reduction. Meanwhile, AMI Investment, an investment company established through a 6:4 joint venture between KPM Tech and Telcon, invested KRW 10 billion and acquired 810,000 shares (24.2% stake) of AmiPharm, and became the second largest shareholder. Amipharm holds a patent for 'Composition and Manufacturing Method for Injectable Drug Containing PPC without deoxycholic acid sodium’ that it obtained in Korea in 2014 and a patent for 'Composition and Manufacturing Method for Fat Decomposition Substance that contain PPC' in the United States in 2015.
- Policy
- Emerging candidate for Dir. of the Pharmaceutical Benefits
- by Lee, Jeong-Hwan Jan 19, 2024 05:45am
- Secretary Jung-min Yu (Left), Director Chang-Hyun Oh (Right). Chang-Hyun Oh (55/College of Pharmacy, Chung-Ang University), the incumbent director of the Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW), is expected to be succeeded by Jung-min Yu (passed the 51st civil service exam/Ewha Womans University), who is currently serving as Secretary in the Office of the Senior Secretary to the President for Social Policy while being transferred to the Presidential Secretariat. Oh is expected to rejoin the Ministry of Food and Drug Safety (MFDS) after his promotion. According to the sources in the pharmaceutical industry on the 17th, MOHW will make personnel changes for the position of Director of Pharmaceutical Benefits soon. The Division of Pharmaceutical Benefits is responsible for various aspects of domestic pharmaceutical reimbursements. Specifically, its responsibilities include conducting cost-effectiveness evaluations and setting the upper limit of healthcare benefits (insurance drug pricing) for pharmaceuticals seeking reimbursements, reassessing the drug prices of previously listed insured drugs, developing comprehensive plans for post-insurance management of insured drugs, and conducting research and investigations related to the insurance reimbursement system for pharmaceuticals. If Yu assumes the position of the Director of the Pharmaceutical Benefits, she will also oversee the practical implementation of the revised drug pricing system to ensure fair-value compensation for innovative new drugs, which was announced in December of last year, in addition to Yu’s responsibilities related to the division. Secretary Yu initially started her career in the MFDS, then moved to the Office for Governmental Policy Coordination, and later joined the MOHW. Subsequently, Yu was transferred from working as the Director of healthcare security management in May 2022 to take the position as Secretary in the Office of the Senior Secretary to the President for Social Policy and continued to work in that position. Yu has an extensive background in roles within the MOHW, including working in the Division of National Pension Policy, Committee on Low Birthrate, and the Division of Healthcare Policy. After serving as the Head of the Healthcare Delivery System Task Force, Yu was promoted to the position of Director of healthcare security management. In March 2021, while serving as Secretary at the MOHW, Yu was recognized from the Prime Minister for her proactive administration, which included implementing temporary telephone counseling and prescriptions to prevent the spread of Covid-19 outbreak in Korea. Director Oh is expected to rejoin the MFDS after his promotion. Oh, who graduated from Chung-Ang University, is a government official responsible for pharmaceutical matters. He previously transferred to the MOHW from the MFDS through a personnel exchange program.
- Policy
- Celltrion rebrands and sells self-manufactured drugs
- by Lee, Hye-Kyung Jan 19, 2024 05:44am
- Celltrion Pharm will discontinue importing the original diabetes and hypertension drugs that it has successfully self-manufactured after acquiring all the rights, including sales rights and patents, from Takeda Pharmaceutical. According to the list of supply discontinuation drugs reported to the Ministry of Food and Drug Safety, the soon-to-be-discontinued drugs include Celltrion's diabetes drug ‘Nesina Tab (alogliptin benzoate),’ 12. 5mg and 25mg; ’ as well as ‘Nesina Act Tab (pioglitazone hydrochloride-alogliptin benzoate)’ 25/30mg, 25/15mg; and the hypertension drug ‘Edarbi Tab (azilsartan medoxomil potassium)’ 40mg, 80mg; and Edarbyclor (chlorthalidone-azilsartan medoxomil potassium) 40/25mg. Also, the company will discontinue sales of ‘ActosRyl Tab (glimepiride- pioglitazone hydrochloride)’ 30/4mg and 30/2mg due to deteriorating product profitability from decreased sales volume. In December 2020, Celltrion acquired all rights, including sales and patents, of Takeda Pharmaceutical's 12 ETC drug brands including ‘Edarbi’ and 'Nesina,' as well as 6 OTC drugs such as ‘Whituben Q’ and ‘Albothyl’ in 9 Asia-Pacific countries for USD 278.3 million (approximately KRW 30.74 billion), and has been preparing to self-produce and sell these products to ensure stable product distribution. The diabetes drug Nesina that is being discontinued was rebranded to ‘Celltrion Alogliptin Met’ and Nesina Act to ‘Celltrion Alogliptin Benzoate.’ In addition, the hypertension treatments Edarbi Tab and Edarbyclo Tab were approved as 'Celltrion Azilsartan Medoxomi Tabl' and 'Celltrion Azilsartanclo Tab,’ and have been localized. Celltrion Pharmaceutical said, "We have discontinued imports due to self-production. We will supply our own products to the market before the stock of imported products is exhausted, and we will establish a manufacturing plan according to market needs." In the case of its diabetes drug ActosRyl, the company said that it would terminate its sales due to the decline in sales volume with prescriptions of around 100,000 tablets per year, and because there are many existing single-agent drugs that contain glimepiride and pioglitazone. Meanwhile, the Celltrion Group announced in January that it will separately sell the sales rights to ETCs in all of the Asia-Pacific region excluding Korea, and OTCs in the Asia-Pacific region, that it had acquired from Takeda Pharmaceutical in 2020. The business rights for the ETC in the Asia-Pacific region is about KRW 209.9 billion, and Celltrion Group is expected to make a significant return on the KRW 138 billion investment it had made at the time of acquisition. However, the items that reported discontinuation of original imports due to in-house conversion and self-manufacture were excluded from the sale and will continue to be sold in Korea by Celltrion Pharm. Celltrion Group excluded the Asia-Pacific rights for Nesina, Actos, and Edalbi from the list of products it will sell.
- Policy
- Moderna will only supply Spikevax Duo 2 in Korea
- by Lee, Hye-Kyung Jan 18, 2024 06:07am
- Moderna Korea has discontinued the supply of all other vaccines, leaving only its latest version, Spikevax Duo 2 (elasomeran, davesomeran) in circulation among the 5 COVID-19 vaccines it had received approval for in Korea. On the 17th, the Ministry of Food and Drug Safety (MFDS) received a report on Moderna’s supply discontinuation of ‘Moderna Spikevax Inj,’ ‘Moderna Spikevax 2 Inj,’ ‘Spikevax inj,’ and ‘Spikevax 2 Inj.’ Moderna stated that it is “producing, importing, and supplying a new updated vaccine in response to the emergence of new coronavirus variants," and that it has been “supplying the latest updated version of Spikevax Inj that protects against the latest variants since October 2023.’ Moderna’s most recently updated version is called ‘Spikevax Duo 2 Inj', and its entire domestic supply is contract manufactured by Samsung Biologics. Spikevax Duo 2 Inj was granted Emergency Use Approval by the MFDS on September 27th last year for adolescents and adults aged 12 years and older against the XBB.1.5 subvariant of the SARS-CoV-2 virus. In preparation for the winter vaccination season, national regulatory agencies and international public health organizations have recommended countries update their COVID-19 vaccines to monovalent vaccines that include protection against the XBB.1.5 variant. Moderna has published clinical data confirming that its XBB.1.5 targeted monovalent vaccine provides neutralizing antibody responses to the variants BA.2.86, EG.5, and FL.1.5.1 in addition to XBB subvariants XBB.1.5, XBB.1.16 and XBB.2.3.2. The most common local adverse reaction following the use of Spikevax Duo 2 was injection site pain. The most common systemic adverse reactions were headache, fatigue, myalgia, and chills. Its safety profile was consistent with what is known for the original Spikevax vaccine. Meanwhile, Moderna has been ranked as the No. 1 domestic pharmaceutical company in terms of production volume in 2022 with its COVID-19 vaccine alone. According to the '2023 Food and Drug Statistics Yearbook', Moderna's production volume amounted to KRW 1.2756 trillion in 2022, driven by the production of 2 dosage forms of its Spikevax Inj vaccine.
- Policy
- Drug price cuts will be applied in bulk next month
- by Lee, Tak-Sun Jan 18, 2024 06:07am
- A number of products are expected to receive price cuts next month as a result of the second round of reevaluations the government conducted on the insurance price ceiling of listed drugs. The drug price adjustments, which were initially set to be applied in January, were pushed back to February. Also, in consideration of the returns and difference settlements that need to be made by pharmacies, sufficient time is expected to be given between the announcement and the effective date of the pricing adjustments. According to industry sources on the 17th, the second round of negotiations after reevaluation of the insurance price ceiling of listed drugs will be completed this month and be reported to the Health Insurance Policy Deliberation Committee (HIPDC). About 3,220 products were subject to the second round of negotiations. As this includes all of the evaluated items, some that are not subject to pricing adjustments are also included in the negotiations. Therefore, it is expected that the actual number of products that receive price cuts will be fewer than this. In the first round of reevaluations that were conducted in September last year, 12,800 items were subject to negotiations, but 7,400 items were applied pricing adjustments. The second round of price ceiling reassessment will cover some specialty oral drugs and aseptic drugs that were included in the bioequivalence demonstration by the Ministry of Food and Drug Safety in 2020. The second round of reevaluations included some prescribed oral drugs and aseptic drugs that were required to demonstrate bioequivalence by the MFDS in 2020. Initially, the Ministry of Health and Welfare had planned to apply the drug price adjustments in January after reporting the results to HPIDC in December last year. However, it was postponed in February due to concerns about the burden borne by pharmacies. Also, drug price ceiling adjustments following the investigation into actual transaction prices had been set to be applied in January at the time. However, this was also postponed thereafter. Therefore, the adjustment period will likely be further delayed to after March, as the results were not reported to HIPDC’s meeting this time. The pricing adjustment date for the second round of price ceiling reevaluations is also expected to be a few days after the first of next month, just as it had been in the first round of price ceiling reevaluations. In the first round, the adjustments were announced on Aug. 23 last year, notifying its implementation on Sept. 1, but the actual implementations were made on Sept. 5 to account for return and settlement confusion among pharmacies. Meanwhile, the reevaluation of the price ceiling of listed drugs is being conducted to maintain or reduce the price of listed drugs depending on whether the drug meets the requirements of self-bioequivalence testing and DMF listing. If the listed drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met.
- Policy
- Stability data requirement eased for metformin approvals
- by Lee, Hye-Kyung Jan 17, 2024 05:29am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) will change and ease the stability test submission data requirements for approvals (and changes) of metformin-containing preparation that had been strengthened following the detection of an impurity (N-nitrosodimethylamine (NDMA, NDMA). Metformin is used for the treatment of Type 2 diabetes and has been approved for 120 single-agent and 1,227 combination drug products. The government’s action follows a scientific analysis of NDMA-related stability test data that have been submitted to the MFDS to date and the conclusion that the changed data requirements are sufficient to ensure the quality of the drugs within their expiration date. The MFDS had strengthened the data submission requirements since July 2020 after NDMA was detected in metformin products to strictly control the impurity level to be lower than the standard. The stability test data required for product approval (and changes) has been strengthened to the level of new drugs. As a result, companies had to submit 12 months of long-term storage stability test data when applying for new approvals or changes to their metformin products. However, in the future, the companies will again only need to submit 6 months of long-term storage test data. The MFDS expects this improvement to help ensure the rapid development and launch of metformin products and access to treatment for patients and will continue to make the best efforts to operate Korea’s drug approval system flexibly and reasonably based on its expertise in regulatory science.
- Policy
- High-priced drugs receive reimb in the new year
- by Lee, Tak-Sun Jan 17, 2024 05:29am
- Ultra-high-priced drugs whose costs exceed KRW 100 million are being listed for reimbursement one after another in the new year. Following Koselugo’s reimbursement this month, Luxturna, which will cost KRW 1 billion, is expected to be reimbursed next month. With such ultra-high-priced drugs being listed one after another, voices have been rising on the need to strengthen post-listing management to efficiently manage the financial expenditures of Korea’s national health insurance. According to industry sources on the 16th, ‘Luxturna Inj,' an ultra-expensive drug that costs KRW 950 million, has completed drug pricing negotiations with the NHIS and is set to be reported to the Health Insurance Policy Deliberation Committee this month. The drug is a ‘one-shot treatment’ that shows an effect after a single dose, similar to previously listed drugs like Kymriah and Zolgensma. Luxturna is indicated for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. It is estimated that there are about 50 patients who are eligible to receive LUXTERNA in Korea. The issue is its high price. The drug costs about USD 710,000 per single dose in the US, which roughly translates to KRW 950 million in Korean won. Feeling burdened by the high price, patients have been awaiting the drug’s reimbursement listing since it was approved by the Ministry of Food and Drug Safety in September 2021. However, a sense of anxiety filled the air when Luxturna’s pricing negotiations, which began in September, failed to finish within the set deadline and extended the deadline. Fortunately, the two sides quickly reached an agreement during the extended negotiation period. The company and the government reportedly shared the price burden at a reasonable level through the risk-sharing agreement system. Since this drug is an ultra-high-priced one-shot treatment like Kymriah and Zolgensma, it is likely to raise follow-up management issues even after listing. Ultra-high-priced KRW 950 million Luxturna awaiting to be reimbursed in Korea The neurofibromatosis treatment Koselugo Cap (selumetinib, AstraZeneca) has been reimbursed from the 1st of this month. The drug has succeeded in receiving reimbursement listing for 2 years and 6 after filing an application in June 2021. The expanded scope of subjects eligible for waiving submission of pharmacoeconomic evaluation data (PE exemption drugs) that was implemented in January last year played a decisive role in its reimbursement listing. The company agreed upon three risk-sharing types of RSA – the refund type, expenditure cap type, and initial treatment cost refund type – with the NHIS reducing the burden of health expenditures on the government’s part. With the reimbursement listing, patients only need to a copayment rate of 10% of the annual cost of KRW 200 million required for its use, reducing the burden to a KRW 10 million range. The cost of new drugs being listed recently is well over KRW 100 million. Zolgensma, which was listed for reimbursement in 2022, is currently the most expensive drug on the reimbursement list, at a price of KRW 1.98173 billion per kit. With these high-price drugs increasing healthcare expenditures, health authorities are also focusing on the post-listing management of these high-priced drugs. With the introduction of Kymriah and Zolgensma, a performance evaluation system that applies reimbursement through post-evaluations has been introduced. HIRA is seeking to broaden the scope of the system to manage PE exemption drugs and has been also promoting the reevaluation of existing drugs. From this year, it also established the 'Pharmaceutical Performance Evaluation Department, which will be responsible for the post-listing management of listed high-priced drugs. The NHIS plans to secure the financial soundness of its system by advancing the risk-sharing agreement system. To this end, it plans to minimize financial uncertainties by applying a performance-based risk-sharing system at the patient level and strengthening follow-up management of drugs using systems including the price-volume agreement system. The government’s plan for managing high-priced drugs is also expected to be included in the 2nd Comprehensive National Health Insurance Plan that is expected to be announced this month.
- Policy
- Caution required for use of ADHD drug methylphenidate
- by Lee, Hye-Kyung Jan 16, 2024 06:09am
- The warnings and precaution section of the attention deficit hyperactivity disorder (ADHD) treatment ‘methylphenidate’ is expected to add warnings for increased intraocular pressure and glaucoma. The Ministry of Food and Drug Safety (MFDS) prepared a change to the label of drugs that contain methylphenidate based on a review of the safety information on methylphenidate products by the U.S. Food and Drug Administration (FDA) and is conducting an opinion inquiry until the 26th. 14 methylphenidate products are currently approved in Korea, including Janssen Korea’s ‘Concerta OROS Er Tab,’ Whan In Pharm’s ‘Penid Tab,’ and Myung-In Pharm’s ‘Perospin Tab.’ The labeling change will be made separately, for ‘delayed release capsule’ products ‘film-coated extended-release tablets,’ and ‘uncoated immediate release tablets.’ The updated general warnings and precautions for delayed-release capsule products will include increased intraocular pressure and glaucoma. Due to reports of increased intraocular pressure (IOP) associated with methylphenidate treatment, the warning and precautions section will be changed to state that patients with abnormally elevated IOP should only be prescribed treatment if the benefits outweigh the risks. Patients with a history of abnormal IOP elevation or open-angle glaucoma should have their IOP monitored closely during treatment. For the extended-release film-coated tablets, ‘very rare motor and verbal tics’ will be added to the post-marketing surveillance data as an adverse event, and the general warnings and precautions will specify that patients should be monitored periodically for the onset and worsening of tics during methylphenidate therapy in addition to conditions such as IOP elevation and glaucoma and that treatment should be discontinued when clinically appropriate. The general warnings and precautions section for uncoated immediate-release tablets will include ‘Clinical evaluation of tics should be performed prior to use as well as family history,’ in addition to IOP elevation and glaucoma. During treatment with methylphenidate, patients should be regularly monitored for the onset and worsening of tics or Tourette syndrome, and treatment should be discontinued when clinically appropriate.’ Meanwhile, the treatment efficacy of methylphenidate ADHD has been demonstrated in clinical trials in children and adolescents aged 6 to 17 years of age and adult ADHD patients aged 18 to 65 years who meet the who meet the DSM-IV criteria.
- Policy
- AHA drug Obizur to soon receive reimb in Korea
- by Lee, Tak-Sun Jan 12, 2024 07:06am
- Takeda Pharmaceuticals Korea’s hemophilia drug Obizur is expected to soon be reimbursed in Korea. The company was found to have completed pricing negotiations with the National Health Insurance Service recently. The drug received conditional approval from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in October last year. According to industry sources on the 11th, Takeda Pharmaceuticals Korea recently completed negotiations with the NHIS on Obizur’s reimbursement and is set to be reported to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare soon. Obizur can be reimbursed in Korea in the month following the HIPDC report. Obizur is used to treat bleeding in adult patients with acquired hemophilia A. At the DREC meeting that was held in October, the committee determined Obizur’s reimbursement was adequate at a price below the appraised value. The importer, Pharmaceuticals Korea, is understood to have accepted this condition. The company also accepted a price less than 100% of the weighted average price of its substitute, thus omitting negotiations on its insurance ceiling price. Therefore, the company only needed to negotiate the estimated claims amount with the NHIS. If reimbursed, Obizur’s reimbursement process will be complete in one year since its marketing authorization in March last year, serving as a good example of expedited reimbursement. Unlike existing bypassing agents, Obizur replaces blood coagulation Factor VIII with AHA indications. Its unique mechanism of action allows Obizur to become the only AHA drug that can stably monitor patients’ blood factor VIII levels using standard assays, enabling individually tailored dosing. In a prospective, non-randomized, open-label Phase II/III study of 28 patients with AHA that evaluated the safety and efficacy of Obizur, all patients that were treated with Obizur had a positive response to treatment at 24 hours after initial dosing. A positive response was one where bleeding had stopped or was reduced, with clinical improvement or with factor VIII activity above a pre-specified target. Takeda Pharmaceuticals Korea said, “Obizur is a gene recombinant therapy that was produced by deleting the B-domain from a porcine factor VIII that is comparable to human Factor VIII. Therefore, the inhibitory antibodies in the human body do not readily recognize the treatment, allowing Obizur to replace the inactivated human coagulation factor VIII to help blood clotting and control bleeding.
