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- 2025-12-21 05:14:25
- Policy
- AZ renews orphan drug Strensiq’s risk-sharing agreement
- by Lee, Tak-Sun May 09, 2024 05:52am
- The risk-sharing agreement (RSA) for Strensiq Inj (asfotase alfa, AZ), a treatment for hypophosphatasia, has been successfully renewed in Korea. The drug was last covered under the RSA scheme in June 2020, when it was listed for reimbursement in Korea under the Expenditure Cap Type and Refund Type RSA. According to the National Health Insurance Service on the 8th, AstraZeneca and NHIS recently completed negotiations to renew the risk-sharing arrangement for 5 Strensiq Inj items. Both sides reportedly settled on appropriate terms for the agreement. The 4-year RSA term for Strensiq Inj was set to expire on May 31, but with the renewal, the drug will continue to be reimbursed for 5 years thereafter. The drug’s prior authorization requirement was also removed recently. Previously, if a patient with perinatal/infantile- and juvenile-onset hypophosphatasia wished to use Strensiq as a long-term enzyme replacement therapy to treat bone symptoms, he or she had to be reviewed on an individual basis by the Heath Insurance Review and Assessment Service’s review panel. After 4 years of prior authorizations, Strensiq’s reimbursement status has been converted to post-approvals due to its high prior authorization rate and lack of fluctuation in the number of patients. When it was first introduced, Strensiq was distributed domestically by Handok but has been supplied by AstraZeneca Korea since last year. The exclusion of the prior authorization requirement and RSA renewal are expected to improve patient access to Strensiq in Korea.
- Policy
- MSD’s Cancidas will retain premium pricing for up to 5 yrs
- by Lee, Tak-Sun May 08, 2024 05:48am
- MSD's antifungal injection Cancidas’s premium pricing will be maintained for 5 years after generic entry. Originally, the price should have been adjusted to 53.55% of the highest price, but for various reasons, its price has remained at the level of 70% of the highest price. According to the industry sources on the 6th, Cancidas’s drug pricing premium was supposed to end on the 1st of this month, but the pricing premium was extended for another year according to the opinion of the Drug Reimbursement Evaluation Committee. As a result, the price of Cancidas 50mg will remain at KRW 215,977 and Cancidas 70mg at KRW 275,989. Sam Chung Dang Pharm’s Casfun Inj, the only generic version of Cancidas, also maintained its markup, and its price ceiling will remain at KRW 188,198 for Casfun Inj 50mg and at KRW 238,253 for Casfun Inj 70mg for another year. In principle, after the entry of generics, the price of the original drug drops to 70% of the highest price through ex officio adjustment, and after 1 year, it becomes the same price as its generic, set at 53.55% of the highest price. However, the price of Cancidas remains at the 70% level for 5 years. In the meantime, the principle of equal pricing for generic drugs has been broken. In June 2020, the price of Cancidas was adjusted to its current price following generic entry. The adjustment was temporary and set to last until May 2021. However, a year later, the number of generic companies remained below three, so the markup was maintained for 2 more years. Then, in April of last year, the 3-year premium pricing period passed, but the company wanted to extend the period for reasons such as ensuring a stable supply of the product, and DREC accepted the request and decided to maintain the premium pricing for one more year. This year, despite the expiration of the premium pricing period (3+1year), the premium pricing period was extended another year until May 2025 on the basis that if a drug manufacturer, contract manufacturer, distributor, or importer wants to extend the premium pricing period for reasons such as ensuring a stable supply of products, the period can be extended following DREC opinion. In January 2021, the Ministry of Health and Welfare reorganized the premium pricing system to allow up to 5 years of premium pricing through 1+2+2, including 1 year of markup upon initial registration, up to 2 years of premium pricing maintenance for drugs with 3 or fewer manufacturers, and 2 years of additional premium pricing granted after DREC deliberation when the pharmaceutical company wishes to extend the premium pricing. Cancidas’s premium pricing is being maintained for up to 5 years through the new system. Cancidas’s sales in Korea had been KRW 8 billion in 2022 (IQVIA). The drug is used for ▲ Empirical therapy for presumed fungal infections in febrile, neutropenic patients; ▲treatment of Candidemia and Other Candida Infections; ▲ treatment of esophageal candidiasis; and ▲ treatment of invasive aspergillosis. Sam Chung Dang Pharm was the only Korean pharmaceutical company to launch a generic version of Cancidas in May 2020. Since then, Sam Chung Dang Pharm ‘Casfun Inj ‘ has been the only generic version that entered the market.
- Policy
- Will oral anemia drugs for dialysis patients be reimbursed?
- by Lee, Tak-Sun May 07, 2024 05:50am
- AstraZeneca recently withdrew Evrenzo, an oral treatment for anemia in chronic kidney disease, from the Korean market Industry interest in rising on whether oral treatments used to treat anemia in dialysis patients will be covered by health insurance in Korea. The drugs have long been approved in Korea since 2020, but one of the products recently withdrew its license. The other two have yet to be reviewed for reimbursement, raising interest. According to industry sources on the 3rd, AstraZeneca dropped the license for its Evrenzo Tab (Roxadustat, AstraZeneca), which is used to treat symptomatic anemia in patients with chronic kidney disease, on April 30. The market withdrawal comes more than 3 years after its approval in July 2021. The drug was praised for improving the convenience of anemia treatment for patients with kidney disease who previously had to depend on injections by switching to oral medication. Historically, patients with chronic kidney disease have been given injections to stimulate red blood cell production called erythropoietin (EPO) or erythropoiesis-stimulating agents (ESA) to treat anemia, a common complication of chronic kidney disease. However, Evrenzo was developed as an oral formulation that works by activating hypoxia-inducible factor (HIF), a gene involved in erythropoiesis that regulates gene expression and raised expectations on improving the convenience of treatment for the patients. After Evrenzo, JW Pharmaceuticals received approval for Enaroy in November 2022, and Mitsubishi Tanabe Pharma Korea received approval for Vadanem in March last year. Both are reportedly working to list their respective drugs for reimbursement. Under these circumstances, Evrenzo's market withdrawal has raised concerns that the authorities may have a negative stance toward the reimbursement of oral anemia drugs for chronic kidney disease. The reimbursement of these drugs also rose as an issue at the National Assembly audit held in October last year. At the time, Democratic Party lawmaker Sun-woo Kang questioned the denial of reimbursement, to which the HIRA responded that the drugs had not been reviewed for reimbursement in key reference countries and lacked clinical evidence. In a written QA, the HIRA said, "Although the drugs are oral formulations unlike existing ESA preparations that are injectables, additional advantages such as the convenience of dosing in hemodialysis patients, which is the target patient group for approval, are unclear. Although it may be potentially useful in some patient groups such as cancer patients for whom ESA administration increases the risk of tumor progression and recurrence and patients with adverse reactions or poor response to high-dose ESA therapy, it lacks direct clinical evidence of effectiveness and safety in these patient groups.” HIRA added that it would review any additional evidence of their therapeutic benefit in future reapplications or supplemental data submitted, as well as the results of overseas assessments, but was not deliberated by the Drug Reimbursement Evaluation Committee on reimbursement adequacy thereafter. However, as Vadanem received US FDA approval in March and reapplied for reimbursement, it remains of interest whether HIRA will start a reimbursement review for the drug soon.
- Policy
- Handok’s imported PNH drug Empaveli is approved in Korea
- by Lee, Hye-Kyung May 03, 2024 05:53am
- The Ministry of Food and Drug Safety (MFDS) announced on the 29th that it has approved Handok's imported new drug Empaveli Inj (pegcetacoplan). Empaveli binds to complement proteins C3a and C3b and inhibits the complement chain reaction, inhibiting intravascular and extravascular hemolysis. The drug is expected to help expand treatment options for adult patients with paroxysmal nocturnal hemoglobinuria**. The complement system is a part of the body’s innate immune system and helps the body fight off pathogens such as bacteria and viruses. It comprises a large number of different proteins (comprised of C1 through C9) that work together to promote immunity and inflammatory responses. PNH is caused by a somatic mutation in the X-chromosome that makes red blood cells sensitive to the complement response, leading to intravascular and extravascular hemolysis extravasation. Clinically, it manifests as aplastic anemia with decreased hematopoietic stem cells. Symptoms include fatigue, jaundice due to chronic hemolysis, hepatosplenomegaly, hemolytic anemia, hematopoietic deficiency, and venous thrombosis. The MFDS said, "We will continue to make our best efforts to ensure that treatments with sufficiently verified safety and efficacy are promptly supplied based on regulatory science so that patients can gain access to expanded treatment opportunities.”
- Policy
- AZ wins nod for new breast cancer drug 'Tiroo Cap Tab'
- by Lee, Hye-Kyung May 03, 2024 05:53am
- The Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety (MFDS; Minister, Yu-Kyoung Oh) stated that it has granted AstraZeneca Korea’s new breast cancer drug 'Tiroo Cap Tab (capivasertib)' on April 29th. Capivasertib inhibits the activation of AKT protein, a serine·threonine kinase. Thus, it blocks the intracellular signaling pathway, preventing the survival and proliferation of tumor cells. This drug can be used in combination with fulvestrant in adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced, or metastatic breast cancer who have one or more mutations in PIK3CA/AKT1/PTEN genes during an endocrine therapy or when the disease progresses after completion, or when relapse occurs within 12 months after adjuvant therapy. The MFDS anticipates that this drug will provide a new treatment opportunity for patients with HR-positive, HER2-negative, advanced breast cancer who cannot be treated with existing treatments. The MFDS stated that with their specialty in regulatory science, they are committed to ensuring that treatments with proven safety and effectiveness are promptly distributed to expand patients’ treatment opportunities.
- Policy
- 1488 drugs approved last year…30% diabetes drugs
- by Lee, Hye-Kyung May 02, 2024 05:52am
- A total of 1488 drugs were found to be approved by the Ministry of Food and Drug Safety last year. The MFDS said on the 30th that it published the Drug Approval Report that contains the approval, certification, and report status of drugs, quasi-drugs, and medical devices in 2023. In the case of pharmaceuticals, a total of 1,488 items were approved, including 1,300 finished drugs, 49 APIs, and 139 herbal medicine ingredients. Of the approved finished drugs, 884 (68%) were ETC drugs and 416 were OTC drugs. Also, the number of orphan drug approvals increased continuously, and diabetes drugs accounted for the largest number of approvals among all finished drugs. However, the number of generic drug approvals has steadily decreased after the ‘1+3 system’ was implemented. In terms of the total number of finished drug approvals, diabetes drugs accounted for the largest number of approvals, totaling at 462. This is more than 30% of all finished drugs. This was followed by antipyretic, analgesic, and anti-inflammatory drugs (120 items), other vitamins (87 items), and blood pressure-lowering drugs (77 items). In terms of synthetic drugs approved last year by type, 29 were new drugs, 22 orphan drugs, 390 data submission drugs (including 15 incrementally modified drugs), and 2 APIs. The number of new drug approvals increased by about 50% compared to 2022 to 29 (5 manufactured and 24 imported), and the top efficacy categories by the number of approved items were nervous system drugs (7), diabetes drugs, and antineoplastic agents (6 each), circulatory system drugs and blood and body fluid agents, respiratory system drugs and allergy drugs (3 each). In the case of orphan drugs, a total of 37 products that contain 26 ingredients were approved last year, an increase of 4 ingredients and 7 products from the previous year. This is a threefold increase from 2019 (9 ingredients), which is likely due to increased industry investment and active government support for orphan drug development. Of the 375 new data submission drugs, 50.4% (189) were submitted for new salts or isomers, followed by 24.5% (92) for new compositions, and 13.3% (50) for new dosage forms (with the same route of administration). Looking at the types of incrementally modified drugs developed and approved in recent years, in 2016-2017, the development of combination drugs (drugs containing two or more active ingredients in a single product) with new active ingredient compositions was popular, and in 2018, 6 sustained-release drugs with improved dosing and dosage by reducing the number of required doses were approved. Last year, a total of 15 products were approved, including 14 combination drugs with new active ingredient compositions and 1 product that improved utility by developing a product with different efficacy and effectiveness. Last year, a total of 802 generic drugs were approved and reported. Other drugs accounted for the largest share of generic drugs. Also, 15 of the synthetic drugs among data submission drugs were recognized as incrementally modified new drugs. Since July 2021, the number of applications for generic approvals decreased sharply until 2022 due to the implementation of the '1+3' system, which limits the use of the same clinical trial data to 3 times. The number of applications in 2023 is on par with those in 2022. A total of 929 quasi-drugs were approved and reported. This was mainly due to the eased mandatory requirement and decreased wearing of masks, as well as the active development of quasi-drugs related to daily life, such as sanitary napkins, band-aids, and toothpaste due to the growing interest in health. A total of 7065 medical devices were approved, certified, and reported, with an increase in ▲high-tech medical devices such as artificial intelligence-based medical devices and surgical rehabilitation robots. Also, ▲ medical device software items are on the increase, and ▲digital treatment devices and heavy-ion particle therapy devices were introduced as new means of treatment.
- Policy
- 32 med schools in KOR confirm their admission quota
- by Lee, Jeong-Hwan May 02, 2024 05:52am
- Prime Minister Han Duck-soo. The 32 medical schools that were assigned increased medical admission quota from the government confirmed their final medical admission quota for the 2025 academic year. After withdrawing the initial announcement of increasing the medical school admission quota to 2,000 students, the government allowed universities to adjust their intake autonomously. As a result, the expansion of the 32 medical schools is anticipated to be around 1,550 students. The Korean Council for University Education (KCUE) plans to review changes to next year's college admissions process, including medical school admission quotas submitted by each university. It will notify the universities of the decisions by the end of this month. On May 1st, Prime Minister Han Duck-soo chaired the "Central Disaster and Safety Countermeasures Headquarters Meeting regarding the doctors' collective" at the Government Complex Seoul. During the meeting, he stated, "The 32 medical schools across the country that have increased their quotas have determined the admission quotas for the 2025 academic year and submitted them to the KCUE." The nine regional national universities have decided to reduce 50% of the previously allocated expansion quotas and recruit accordingly. Most private universities have decided to fully utilize the expansion quotas or reduce them slightly by 10 to 20 students. If Soonchunhyang University, Dankook University, Konyang University, and Cha University, which have not disclosed the exact expansion size, decide to recruit 100% of the allocated expansion quotas, the total number of medical school admissions for next year is estimated to be around 1550. According to Han, the KCUE is scheduled to disclose the results of each university’s medical school admission quota on May 2nd. "The President and the main opposition party leader had a long conversation on Monday regarding national affairs. They discussed the medical school expansion and healthcare reform in particular," Han said. "This reflects the support and desire for healthcare reform." "The government will continue communicating effectively with the National Assembly throughout the healthcare reform process," Han added. "We strongly encourage the medical community to engage in dialogue with the government actively." "If the medical community brings forward a scientific and rational single proposal, the discussion on the expansion scale beyond the 2026 academic year is possible," Han said. "However, it is regrettable that another group of hospital professors plans to go on strike this Friday," he added. “While patients feel anxious, some professors say they are to leave their side,” Han said. “I urge medical school professors to continue to stay by the patient's side as they have done so far, and residents and medical students should also return now,” Han emphasized. The Prime Minister also suggested that they plan to discuss allowing doctors to hold additional positions at 119 emergency centers and metropolitan emergency medical situation rooms to respond to emergency patients. Han explained, "We are working to immediately improve regulations in the medical field to allow general practitioners to treat patients in emergency rooms of other medical institutions and permit trauma center specialists to provide emergency room and inpatient care outside their centers." "Today at the Central Disaster and Safety Countermeasures Headquarters meeting, We will discuss ways to facilitate cooperation between universities and hospitals to ensure swift approval for doctors who wish to work in 119 emergency centers and metropolitan emergency medical situation rooms, thereby enhancing emergency patient response capabilities," Han added.
- Policy
- Gov’t will announce preferential pricing measures by June
- by Lee, Jeong-Hwan May 02, 2024 05:52am
- The government plans to prepare and announce the standards for providing preferential drug prices to pharmaceutical companies that have led healthcare innovation through R&D investment, supply of essential medicines, and job creation by June at the latest. The government will also provide preferential drug pricing for drugs that use domestic APIs and establish a procedure to promptly raise drug prices of drugs experiencing supply instability due to rising costs by June. Also, for efficient health insurance drug expenditures, the MOHW will devise a mid-to-long-term strategy to integrate the currently fragmented mechanisms for adjusting the upper limit of insured drug prices, while also promoting clinical reevaluation of listed drugs and rationalization of the price-volume agreement (PVA) system. The MOHW made the announcement through the '2024 Implementation Plan for the 2nd Comprehensive National Health Insurance Plan' on the 30th. The MOHW plans to prepare a preferential treatment system for innovative new drugs, establish a stable supply support system for essential medicines, and promote efficient drug price expenditures through the detailed plan for the 2nd Comprehensive National Health Insurance Plan. ▲Advancing the preferential treatment system for innovative new drugs=The MOHW will strengthen compensation for innovative growth efforts, including fostering a virtuous cycle for new drug development through R&D investment, etc. This is to support the creation of a sustainable pharmaceutical and biotechnology innovation ecosystem. To this end, the evaluation criteria and procedure regulations for medical care benefits of medicines will be revised by the first half of this year. Specifically, the government will ease the standard for cost-effectiveness evaluations of new drugs that meet the innovation evaluation criteria, such as those that demonstrate clinical superiority. Preferential pricing will be applied to companies that lead healthcare innovation, including companies that invest in R&D, supply essential drugs, create jobs, and ensure stable supply. The detailed action plan will specify how the innovativeness of new drugs should be defined to apply a flexible scope for acceptance during cost-effectiveness evaluations. The plan will apply preferential pricing for new drugs made by pharmaceutical companies with a high R&D ratio and expand subjects for the risk-sharing agreement (RSA) scheme. It will allow RSA to be applied to life-threatening or chronically debilitating diseases that do not qualify for the current special exception of calculations. The MOHW estimates the budget for the program to be around KRW 81.9 billion. ▲Strengthening the support System for a stable supply of essential medicines=To ensure the stable supply of essential medicines in terms of health security, prices of essential drugs will receive preferential treatment upon listing, and drugs with low profitability will be protected. The MOHW has decided to give generics of designated ingredients of national essential drugs a higher drug price than other generics if they are newly registered using domestic ingredients. The preferential rate is 68% of the original drug price, which is higher than the 59.5% granted to first listed generics. In the case of generic drugs, the upper limit will be raised if a listed generic drug designated as a national essential medicine changes its API from foreign to domestic. Also, the government will establish a procedure to quickly raise the price of drugs that have become difficult to produce due to unstable drug supply and rising costs after COVID-19. The government plans to shorten the period required to raise drug prices from '210 days or more' to '30 days or more' by streamlining the review process for the Health Insurance Review and Assessment Service's upper limit increase adjustment criteria and simultaneously negotiating drug prices with the National Health Insurance Service. It will also strengthen the adequacy of compensation for drugs that fall under the drug shortage prevention program by reflecting the manufacturing cost and adjusting the upper limit for herbal medicines covered by Korean medicine insurance. To this end, the MOHW will revise the standards used for determining and adjusting medicines that fall under the MOHW's notification by the first half of this year. Its expected budget is around KRW 75.6 billion. Efficient management of drug expenditures= The government will also maintain rational expenditure management and financial sustainability of Korea’s national health insurance through drug price reevaluations and ensure both drug quality and reasonable cost. As a mid-to-long-term strategy, the government plans to integrate the currently fragmented drug price ceiling adjustment mechanism. The government plans to order a policy research service in May to establish an integrated drug price adjustment mechanism that can accommodate for the authorities’ plans above. More specifically, the research will analyze the current status of the drug price follow-up system as a whole, compare its performance with overseas cases, and prepare a system improvement plan tailored to domestic conditions. Drugs that have been listed for a long time but lack clinical utility will be selected and reevaluated based on current standards. If they fail to prove clinical utility, reimbursement of those drugs will be restricted. Also, the government will maintain a rational follow-up system by adjusting the reimbursement range and drug price through the reevaluation of reimbursement adequacy and reevaluation through comparison with foreign drug prices. The government will also rationalize the PVA system. For example, the government plans to increase the price discount rate for drugs with high claims amounts, such as those whose claims exceed KRW 30 billion. It will also expand the exclusion criteria for the PVA system. The government explained that the PVA system will be improved by expanding the current standard of less than KRW 2 billion to less than KRW 3 billion. Losses incurred during the stay of execution of rebate drug price cuts will be collected afterward to minimize financial losses. To solidify these plans, the MOHW will revise the standards used for determining and adjusting medicines within the first half of this year. The MOHW has estimated the drug cost savings incurred by the administrative action to be around KRW 242.8 billion.
- Policy
- Industry fumes over government's drug price reeval plan
- by Lee, Tak-Sun Apr 30, 2024 05:50am
- The pharmaceutical industry continues to criticize the government's plan to reevaluate Korea’s drug prices based on foreign drug prices. Not only is the industry unconvinced about the purpose of the reevaluation itself, but the industry believes that the government's proposal has been designed to disadvantage the pharmaceutical industry while disregarding existing evidence. As a result, the industry is reluctant to accept the government's proposal this time as final. However, what they worry is that the government will proceed with the reevaluations using the ‘A8 average price excluding the highest and lowest price’ standard nevertheless. The government’s foreign drug price reevaluation plan seeks to adjust Korea’s insurance ceiling price of off-patent drugs by comparing it with the highest price of the same drug in A8 countries. According to industry sources on the 29th, the government proposed the average price of the A8 countries (Japan, France, Germany, Italy, Switzerland, the United Kingdom, and Canada), excluding the highest and lowest prices, as the adjustment standard for the pricing reevaluations at the 8th meeting for the foreign drug price comparison reassessment that was held on the 26th. This news has sparked outrage from many in the pharmaceutical industry. The industry’s position is that the reevaluation using foreign drug prices is a redundant follow-up mechanism and that the government should conduct a research service or pilot project to evaluate its effect before commencing the project in earnest. Some argue that if it is inevitable to implement the program, the adjustment standard should be set as the 'A8 adjusted average price.’ An industry official said, "The A8 adjusted average price is the most reasonable option, as it has been used as a standard in the comparative reevaluation using foreign drug prices in the past and is also being used for new drug listings.” The A8 adjusted average price had been 1 of the 4 options originally proposed by the government. The industry has simulated the 4 adjustment standards proposed by the government and found that the 'A8 adjusted lowest price' will bring the most price reduction, followed by the 'A8 adjusted average price excluding the highest and lowest', then the 'A8 adjusted median price', and finally the 'A8 adjusted average price'. In other words, the government's proposal is the second worst. Another industry official said, "The impact of excluding the lowest price is minimal because there is not much price difference between the countries, but if the highest price is excluded, the price reduction rate will become immense." On the other hand, if the A8 adjusted average price is used as the standard, the price reduction effect is said to be slight. In the industry, there is talk that the government clearly intends to reduce the price of off-patent drugs to save health insurance finances through the measure. An industry official said, “Using the A8 adjusted average price that excludes the maximum and minimum prices has not been used for reevaluations or new drug registrations, and has an equity issue to continuously use the mechanism for the follow-up management of drug prices in the future. The government seems to be trying to refer to that standard without reason, as the effect of drug price cuts is small with existing methods,” expressing discontent. The government plans to hold additional meetings to gather industry opinions regarding its proposal. However, there are those in the industry who believe that even if the government receives more opinions, it will be difficult to change the evaluation standard already set out by the government. An official from a domestic pharmaceutical company said, "This is the first proposal presented by the government after 8 meetings, so it will be difficult to overturn it again. However, industry opinions on subjects for exclusion, detailed criteria, and reduction rates may likely be reflected.” However, despite the government's proposal, it is still unclear whether the reevaluations will be conducted within the year. As the supply and demand of drugs continue to be unstable after the COVID-19 pandemic, the government would be conscious of public opinion that the reevaluation should be postponed as a sharp reduction in drug prices could worsen the supply shortage.
- Policy
- Cancellation of Forxiga approval, HK inno.N gets indication
- by Lee, Tak-Sun Apr 30, 2024 05:50am
- Forxiga (left), canceled its approval in South Korea, and Dapa N (right), inherited Forxiga’s indication. AstraZeneca Korea voluntarily canceled its Korean approval for ‘Forxiga (dapagliflozin propanediol hydrate), an oral diabetes treatment, valued at KRW 50 billion. As reimbursement will be canceled soon, Forxiga’s exit from the Korean market is imminent. After the approval cancellation, Forxiga indication was transferred to HK inno.N’s generic ‘Dapa N tab.’ Meanwhile, attention is gathered to the outcome of ongoing negotiations for a price-volume agreement (PVA). As the reimbursement cancellation has been scheduled, the variable would be whether the ceiling price will be reduced or maintained. AstraZeneca has been trying to retain the drug price as other countries selling Forxiga might reference the Korean pricing. According to industry sources on the 29th, the approval for Forxiga tab was voluntarily canceled on April 25. From now on, domestic distribution under the name of Forxiga is no longer possible. Following the cancellation of the approval, it is expected to be deleted from the reimbursement listing. Reimbursement deletion is anticipated on June 1st, but insurance coverage will be provided for a certain duration as a matter of custom. Along with the cancellation of Forxiga’s approval, its indication has been transferred to the company’s partnering company HK inno.N’s generic ‘Dapa N tab 10 mg.’ While the generics launched in April of last year only have indications for diabetes due to patent issues, AstraZeneca transferred the indication to its partnering company HK inno.N through granting approval documents. Consequently, Dapa N 10 mg currently has indications for diabetes, chronic heart failure, and chronic kidney disease, and its reimbursement critieria include diabetes and heart failure. What matters from now is whether Forxiga will be able to maintain its current ceiling price of KRW 734. AstraZeneca’s Forxiga successfully defended its price even during customary drug pricing reduction after generics launched last year, through the court’s suspension of execution. However, PVA negotiations became the variable. The National Health Insurance Service (NHIS) tried to negotiate a drug pricing reduction last year for Forxiga, which had increased usage (claimed amount). The first negotiation did not meet an agreement, and the NHIS and AstraZeneca Korea are currently in the final negotiation until May 20th. As Forxiga is expected to be no longer reimbursed starting June 1st, whether the PVA negotiations-reflected ceiling price will be adjusted before Forxiga leaves the Korean market is a matter of interest. The industry expects that AstraZeneca will put all efforts into maintaining the current ceiling price in consideration of other countries that sell Forxiga.
