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- 2026-04-13 23:21:32
- Company
- Novartis starts reimbursement discussions for Zolgensma
- by Eo, Yun-Ho Aug 20, 2021 05:56am
- After ‘Kymriah,’ Novartis has now begun the reimbursement listing process for ‘Zolgensma.' According to industry sources, the application for the reimbursement of Novartis Korea’s Zolgensma (onasemnogene abeparvovec-xioi) that was submitted through the approval-benefit appraisal linkage system will be put on the agenda for deliberation by the Central Review Adjustment Committee in coming September. As a result, Novartis, which already has Kymriah (tisagenlecleucel) set for review by the Cancer Disease Review Committee (CDRC) on September 1st, will be working with the government to list two of its blockbuster drugs for reimbursement benefit in September. And the industry's eyes are focus on whether and how the two drugs will be listed for insurance benefits. Zolgensma is a treatment for Spinal Muscular Atrophy (SMA), like ‘Spinraza (nusinersen)’ that was approved in 2017, and is a gene therapy that contains a genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved Zolgensma as the second advanced biopharmaceutical after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of a single-shot of Zolgensma costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to this high price, the reimbursement approval process for Zolgensma in Korea is also not going to be easy. However, expectations on the drug's efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was recently presented had received much attention to that effect. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copy (Cohort 1) that were treated pre-symptomatically survived without requiring ventilatory or nutritional assistance, and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. Zolgensma is indicated in Korea for the treatment of pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) who ▲ have been clinically diagnosed with SMA Type 1 or ▲ has up to 3 copies of the SMN2 gene.
- Policy
- The current health insurance premium increase rate is 2.91%
- by Lee, Hye-Kyung Aug 20, 2021 05:56am
- Health authorities have refuted allegations that health insurance premiums have been raised for the success of health insurance policies. The MOHW and the NHIS recently released a statement by the Korea Enterprises Federation (KEF) explaining that "reorganization, including a cap on health insurance premiums, is a reasonable and fair result of social consensus." The KEF said in a report that Japan and Taiwan, which have similar systems to Korea, have a higher upper limit on domestic health insurance premiums than other countries, with a gap of about 24 times and 12 times, respectively. The NHIS explained, "Health insurance is based on the principle of social solidarity, a social insurance system in which subscribers premiums, and anyone, regardless of income level, receives medical benefits as needed." The NHIS explained, "In Korea, as a single national health insurance, the insurance upper limit is institutionalized as income redistribution and social solidarity are emphasized, and the insurance upper limit is the result of social consensus that reflects the history of the national system and people's perception." In France, the health insurance premium rate reaches 13% (full copayment of patient), but the higher the wage level due to the lack of an upper limit, the greater the user's health insurance premium. The upper limit of insurance premiums is part of a reform of the health insurance premium system, and discussions have begun to cope with the heavy burden on low-income local subscribers. "It is based on years of social discussion and the agreement between the ruling and opposition parties to increase the equity of insurance premiums," the NHIS said. "It is planned to reorganize the imposition system of Step 1 in July 2018 and revise the effect of Step 1 in July 2022. In the process of promoting Moon Jae-In Care, the health insurance premium rate is 2.91%, which is lower than the average of 3.20% over the past decade (2007-2016), and the NHIS said, "As of 2021, the health insurance premium rate is 6.86%, France (13%), Germany (14.6%), and Japan (9.21-10.0%)." The NHIS said, "The health insurance premium rate for next year has not been determined, and it will be decided through social consensus after sufficient discussion by the Health Insurance Policy Committee, which includes all members, suppliers, and public interest members."
- Policy
- Seven companies are supplying flu vaccines this year
- by Lee, Tak-Sun Aug 20, 2021 05:55am
- SK Bioscience will focus on COVID vaccine after consulting with the KDCA. The market share of the GC Pharma is likely to increase. Two imported vaccines including Sanofi and GSK Flu vaccines, which will be distributed and sold in Korea this year, are nine items from seven companies, down three from the previous year. SK Bioscience, which had the highest sales performance of flu vaccines last year, will not supply them this year due to the production of COVID-19 vaccine, and Dong-A ST and LG Chem have also been excluded from the market. According to the MFDS on the 17th, domestic manufacturers that distribute flu vaccines this year are Boryung Bio (2 items), Boryung, GC Pharma (2 items), Il Yang (2 items), and the importers are Sanofi Pasteur and GlaxoSmithKline. Compared to last year, SK Bioscience, Dong-A ST, and LG Chem were excluded. SK Bioscience has been unable to distribute flu vaccines in Korea this year due to the production of COVID vaccine. SK Bioscience is commissioning and producing AZ and Novavax vaccine and is also developing its own products. A company official said, "The existing production line of the flu vaccine at Andong plant is producing COVID vaccines, in consultation with the KDCA, we decided not to supply flu vaccines this year." SK Bioscience recorded the highest performance in Korea last year, with production of only 4-valent flu vaccine worth ₩164.7 billion. As SK Bioscience is out this year, only two companies that produce raw material to finished products in Korea will remain: GC Pharma and Il Yang. The share of GC Pharma, which recorded the second highest production performance of ₩82.9 billion after SK Bioscience last year, is expected to increase significantly. In the case of Dong-A ST, the company received the original amount from Sanofi and manufactured and supplied the finished product, but due to the expiration of the contract, Vaxiflu Tetra Injection Solution Prefilled Syringe was revoked in January. LG Chem, which receives products from GC Pharma, is not selling flu vaccines this year. Like last year, Sanofi Pasteur and Glaxosmithkline distribute imported vaccines. However, Sanofi Pasteur participates in NIP for children and pregnant women under the age of 13. It is explained that the mandatory vaccination for national procurement aged 65 or older was not available because it was difficult to meet the supply schedule suggested by the KDCA. It is known that importers such as GSK do not actively participate due to the same low cost of the national mandatory vaccination project as last year. The MFDS predicts that about 28.8 million flu vaccines will be distributed this year. Among them, 14.6 million people were involved in the NIP project. Last year, National lot releases for 29 million people were distributed. As of the 13th, the national lot release for 3.66 million people was received.
- Policy
- Hanmi's Suvast 2.5mg has been approved
- by Lee, Tak-Sun Aug 19, 2021 06:03am
- There was no Rosuvastatin 2.5 mg available.Hanmi has started to create a new market by pushing for the approval of combination drug. The MFDS approved Hanmi's Suvast 2.5mg on the 17th. It is Rosuvastatin 2.5mg, which is not released in Korea. It is used in primary hypercholesterol and complex hyperlipidemia. Ministry of Health, Labour and Welfare of Japan recommends Rosuvastatin 2.5mg to Asians with smaller body types. According to indications of Suvast 2.5 mg, the recommended initial dose is 2.5 mg or 5 mg because of increased systemic exposure to Asian patients. Previously, if Rosuvastatin 5mg was used for initial dose, the drug choice that can be used with 2.5mg was increased. Hanmi is known to be planning to market Rosuvastatin 2.5mg strategically. Hanmi is also pushing for the approval of combination drug containing Ezetimibe. It is said that in April, it applied to the MFDS for approval of Rosuzet 10/2.5 mg (Rosuvastatin 2.5mg / Ezetimibe 10mg). Rosuzet posted ₩99.1 billion in outpatient prescription sales last year alone. It is expected to focus on Suvast 2.5mg, and drugs containing Rosuvastatin 2.5mg in Korea. As a result, it is expected that it will emphasize that the amount of Rosuvastatin 2.5mg is more suitable for Koreans with its initial dose. Hanmi conducted phase 3 of Ezetimibe/Rosuvastatin 10-2.5 mg dose group (N=68), this drug (Rosuvastatin 2.5 mg) dose group (N=67), Ezetimibe 10 mg dose group (N=70), and Rosuvastatin 5 mg dose group (N=70) for 8 weeks in 275 patients with primary hypercholesterol. In the primary validation, the LDL-C change rate (%) in this drug (Rosuvastatin 2.5 mg) administration group decreased statistically significantly compared to the Ezetimibe 10 mg administration group, and the average LDL-C change rate (%) in Ezetimibe / Rosuvastatin 10/2.5 mg administration group decreased by 2.5 mg. Through clinical trials, the complex has already been announced
- Policy
- PPIs benefit from ranitidine’s market removal
- by Lee, Jeong-Hwan Aug 19, 2021 06:03am
- MFDS notice regarding ban on ranitidine drugs With proton pump inhibitors (PPI) enjoying reflective interest in sales from the market removal of ranitidine, which was banned due to detection of the potentially carcinogenic substance NDMA(N-Nitrosodimethylamine), criticism is rising that national health insurance finances are being unnecessarily wasted. The point is that PPIs cost on average twice to three times more than tidine-class H2 receptor blockers, and the increased use of the PPIs not only increases NHI expenditures but also increases the financial burden borne by the patients. On the 17th, the pharmaceutical industry was been busy analyzing the changes in the peptic ulcer treatment market brought on by the banned sales of ranitidine drugs after the rise of its NDMA impurity issue in 2019. After ranitidine was removed from the market due to the detection of NDMA impurities, a significant amount of prescriptions have moved from H2 receptor blockers to PPIs. Annual prescription sales from 2018 to 2020 also show that prescription sales of PPIs have increased from ₩454.9 billion in 2018 to ₩523.4 billion in 2019, and ₩633.5 billion last year. On the other hand, prescription of H2 receptor blockers decreased from ₩346.5 billion in 2018 to ₩296 billion in 2019 when NDMA impurities were detected and relevant products were banned from the market, then fell to ₩132.5 billion last year, to be reduced to 1/3 in just 3 years. Numbers show that the size of the peptic ulcer prescription market has rather grown compared to 2018 due to an increase in PPI prescriptions despite the removal of the ranitidine ingredient. The growth of the prescription market was influenced by the increased use of PPIs that cost on average twice to three time more than H2 receptor blockers. More specifically, H2 blockers cost ₩276 to ₩360 a day at an average of ₩314/day, whereas PPIs cost from ₩527 to ₩1,300 at an average of ₩314/day. Due to this, some have criticized that replacing ranitidine prescriptions with the high-priced PPIs that are of a different class when other lower-priced H2 blockers in the same class as ranitidine with no NDMA detected are available increases waste of NHI finances. Their position is that changing prescriptions to higher-priced drugs not only increases NHI expenditures but also increases the financial burden borne by patients in the long term. To resolve the issue, industry experts had suggested that the authorities should provide same-class drug prescription recommendations in the event inevitable recalls and substitution of drugs arise due to safety issues as in the NDMA case, Industry experts believe efforts such as introducing pop-up windows in the DUR system that show same-class drug recommendations when HCPs select and prescribe drugs should be made to prevent an unnecessary increase in NHI expenditures. An official from a domestic pharmaceutical company said, “I am positive about the government’s decision to promptly recall and discontinue sales of the potentially harmful ranitidine substance, but it is unfortunate that there were no specific guidelines on its replacement and that it caused an increase in NHI expenditures. It is a waste of NHI finances as well as an increased financial burden on the patients to substitute ranitidine to high-priced PPIs when there are other, lower-priced drugs available in the same class with the same indications.” He continued, “The replacement process for hazardous drugs should be further improved and advanced using the DUR system, etc. It is the doctor’s responsibility to select or switch drugs due to their lack of effect in the treatment process, however, the use of same-class low-priced drugs should be prioritized for substitutions due to external factors."
- Company
- The Supreme Court again rejected α-GPC suspension
- by Chon, Seung-Hyun Aug 19, 2021 06:02am
- The Supreme Court again rejected α-GPC suspension to negotiate the withdrawal of Choline alfoscerate. Pharmaceutical companies finally lost the withdrawal negotiations. According to an industry on the 17th, the Supreme Court's special department 2 decided to reject discontinuance of trials in negotiations on the recovery of the Choline alfoscerate system filed by 27 companies including Chong Kun Dang on the 12th. Discontinuance of trials is a system that does not accept appeals if it is judged that there is no specific reason. At the end of last year, the MOHW ordered the NHIS to sign a medical care contract for the system. It means that if the clinical trial fails, the MFDS should proceed with a recovery negotiation to return the entire amount of the health insurance prescription to the NHIS from the date of submission of the clinical plan to the date of deletion. It means that if the clinical re-evaluation of the Choline alfosculate system, which is being pursued by the MFDS, fails, pharmaceutical companies will have to return the prescription results to the NHIS from the date of submission of the clinical plan to the date of cancellation of the permit. Pharmaceutical companies filed an administrative litigation and suspension of execution against the MOHW's order to negotiate the recovery. The lawsuit was divided into 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang. The suspension of execution, which was raised by the Chong Kun Dang and others, was rejected in May after the ruling was rejected in January. Chong Kun Dang and others filed for a re-appeal, but it was rejected again. Following the first and second trials, the Supreme Court ruled in July that Daewoong Bio and others rejected discontinuance of trials. The suspension of execution, which was requested by pharmaceutical companies, was finally rejected. Pharmaceutical companies have also claimed suspension of execution for re-ordering the recapture negotiations. When the MOHW ordered renegotiation in June, 26 companies, including Chong Kun Dang, and 26 companies, including Daewoong Bio, were divided into an action for nullity and suspension of execution. On the 6th of last month, Daewoong Bio's request for suspension of execution was dismissed, and on the 8th of last month, the decision was made to dismiss the suspension of execution, which was raised by Chong Kun Dang and others. Chong Kun Dang and others have filed another appeal for suspension of execution.
- Policy
- It plans to expand its supply of Moderna vaccines in Aug/Sep
- by Kim, Jung-Ju Aug 19, 2021 06:02am
- It plans to expand its supply of Moderna vaccines in August and September. Samsung Biologics' distribution in Korea is still pending. A government delegation to the U.S. announced the results after visiting Moderna The government received an apology from Moderna for the disruption in the domestic supply of COVID vaccines and announced that it will receive more domestic supplies this month and next month and move up the supply schedule early next month. However, the government avoided giving a definite answer as there are many obstacles such as contracts between companies regarding supplying models or products that Samsung Biologics is consigned to Korea first. At the COVID-19 Central Disaster and Safety Counters Headquarters, video conference held today (the 17th), the delegation consisting of Kang Do-tae, the second vice minister, and Ryu Geun-hyuk, the presidential secretary for social policy, reported last week's visit to the U.S. Moderna headquarters, and the company's recent discussion on vaccine supply disruption and supply stabilization. According to the MOHW and Central Disaster and Safety Counters Headquaters, during the visit, Moderna apologized for the government and people's difficulties caused by sudden supply disruptions, and explained that the manufacturing laboratory problems at cooperative manufacturers are now being resolved and gradually released in July. The government asked the company to provide supplies that could not be supplied from August to early September, and to inform the schedule by this week, and Moderna said it would do its best to supply supplies and notify the government of its supply plan. In particular, the government has not received a clear answer on how it can supply production volume of Samsung Biologics, which is consigned to produce Moderna vaccines, to South Korea. In an answer to a regular briefing question, Vice Minister Kang Do-tae said, "It is desirable that domestic consignment production supplies are supplied to Korea in terms of securing safety in the supply of vaccines and streamlining the distribution process. He added, "There is a need for continuous consultation on the contractual relationship between Samsung Biologics and Modena, and the interrelationship between companies and domestic administrative procedures" According to the government, there will be no significant disruption to the age-specific vaccination plan and achievement of the target.
- Company
- Will AML drug Xospata be reimbursed through PE exemption?
- by Eo, Yun-Ho Aug 18, 2021 05:52am
- Whether the new leukemia drug Xospata that is attempting reimbursement through the PE exemption track will be able to be listed for insurance benefit in Korea is receiving attention. According to industry sources, Astellas Korea’s acute myeloid leukemia (AML) treatment Xospata (gilteritinib), which applied for reimbursement through the PE exemption track, passed the Health Insurance Review and Assessment Service’s RSA subcommittee last June. However, after passing the subcommittee, the drug’s reimbursement was no put on as an agenda of the Pharmaceutical Benefit Assessment Committee in July or August, therefore making no progress in its discussions. Accordingly, speculation is rising that ‘applying 80% of the A7-adjusted lowest price for PE exempted drugs', which has recently emerged as a hot topic in the industry, may be the cause of the delay. Xospata is the first FLT3-targeted anticancer therapy to be approved by the Ministry of Food and Drug Safety in Korea to treat FLT3 mutation-positive (FLT3mut+) relapsed or refractory AML. The drug targets both FLT3-ITD and FLT3-TKD of the FLT3 mutations and may be self-administered orally once daily as monotherapy at home without frequent hospital visits. Also, the drug demonstrated better efficacy and safety compared to chemotherapy. Xospata has received the highest - ‘Category 1’ - recommendation in the NCCN Clinical Practice Guidelines for treating patients with relapsed or refractory (R/R) AML with an FLT3 mutation. Interest in Xospata is high as a treatment option that had never existed before. In fact, the Korea Alliance of Patients Organization had delivered their opinion requesting prompt reimbursement of new drugs including Xospata at a roundtable with the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits in May. Healthcare professionals have also shown high expectations for the drug. Hee-Je Kim, Professor of Hematology at the Catholic University of Korea’s Seoul St. Mary’s Hospital said, “The approval of Xospata in Korea has resolved the specific concern of patients having to endure the condition without a proper treatment option. Of course, the cost remains a problem, however, if the drug is listed for the insurance benefit, I believe it will quickly settle as the standard of care in for its indication." Kim added, “FLT3mut+ R/R AML patients need to promptly receive adequate treatment as they have a poor prognosis and are at risk of rapid disease progression. This is why Xospata is being continuously being prescribed even without reimbursement.”
- Company
- Hanmi & Organon maintain ₩70 billion worth contract
- by Kim, Jin-Gu Aug 18, 2021 05:52am
- Hanmi has maintained a copromotion contract with Organon, which is separated from MSD. According to the Financial Supervisory Service on the 18th, Hanmi signed a domestic copromotion contract with Organon in the second quarter. The contract is due at the end of this year. The items include hair loss treatment Propecia, prostate hypertrophy treatment Proscar, and osteoporosis treatment Fosamax. The total amount of prescriptions last year amounted to ₩67.7 billion. Propsia's prescription amount is ₩41.3 billion, Prosca's prescription amount is ₩14.3 billion, and Fosamax's prescription amount is ₩12.2 billion. Hanmi had already signed a contract with MSD to promote its products. However, the contract was changed as Oganon spun off the MSD earlier this year. In the end, Hanmi and Organon signed a new contract with the same contents. Hanmi has signed contracts with MSD and Organon for more than 10 years. The renewal of the contract is also due to the contract made in 2014. At that time, the two companies drew attention by signing a two-way contract to mutually promote products from each company, rather than a one-way contract for domestic companies to promote items from multinational companies. Hanmi has decided to jointly sell MSD's Propecia, Proscar, Fosamax, Andriol, Livial, Cosopt-S, Emend, Invanz, and Ezetrol. MSD has decided to co-promote Hanmi (such as PalPal and Tamsulosin). Earlier in 2009, MSD signed an overseas export contract with Amosartan, a hypertension combination drug of Hanmi. It was the first time a multinational pharmaceutical company sold a drug developed by a domestic company. It is currently sold in more than 50 countries under the name Cozaar XQ. Last year, MSD signed a license agreement with Hanmi to develop, manufacture, and commercialize dual agonist for non-alcoholic fatty hepatitis (NASH) treatments, which was canceled due to the return of Janssen's rights. In March this year, Hanmi's hyperlipidemia combination drug Rosuzet was released in Mexico under the name of NAXZALLA, and Organon is in charge of local marketing. Hanmi signed an export contract with MSD in 2017 to 23 countries, but the contract was recently changed following the establishment of Organon.
- Policy
- Indication extensions filed by Abilify generics increase
- by Lee, Tak-Sun Aug 18, 2021 05:51am
- Otsuka After Yungjin Pharm finally succeeded in invalidating the use patent of Abilify (aripiprazole·Korea Otsuka Pharmaceutical) after 6 years of patent dispute, other generics products of Abilify are now seeking to extend its indications. The use patent that was in dispute had protected Abilify’s ‘bipolar disorder’ indication, due to which generic companies other than Yungjin Pharm were unable to include the indication in their Abilify generics. According to the Ministry of Food and Drug Safety on the 16th, applications containing the 'treatment of acute manic and mixed episodes related to bipolar disorder' indication are being continuously filed for Abilify generics. Bipolar disorder, commonly known as 'manic-depressive disorder,’ causes extreme mood swings that include a pattern of emotional highs (mania or hypomania) and lows (depression). Abilify is a representative central nervous system (CNS) drug that has many indications, including schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autism, and Tourette syndrome, etc. However, Otsuka had registered use patents for each indication at the time of indication expansion, restricting the use of generics for such indications. As a result, most domestic companies with Abilify generics had released their product in the market with only 1 to 2 indications, such as schizophrenia and Tourette syndrome. On the other hand, Yungjin filed an invalidation suit on the use patent registered for Abilify’s bipolar disorder and received approval for the said indication. The patent suit continued for 5 years from March 2015 when the invalidation claim was first filed. In the first trial, the Intellectual Property Trial and Appeal Board turned down Yungjin’s claim and ruled in favor of Otsuka. However, in the second trial, the Patent Court of Korea overturned the first trial decision and rule in favor of Yungjin Pharm. Last April, the Supreme Court ruled the use patent invalid, ending the fierce dispute in Yungjin Pharm’s victory. For Yungjin, the trial could have ended in immense claims for damages from patent infringement. Moreover, when the Patent Trial and Appeal Board rejected the claim, reducing the possibility of patent invalidation, other generic companies had taken a step back, withdrawing their claims and deleting their indications. After twists and turns, Yungjin, the only company to continued the suit, succeeded in invalidating the use patent. The win came with less than a year left until patent expiry, as the patent was scheduled to expire on January 29 of next year. Yungjin’s win has affected indications filed by other generic companies as well. Daewoong Pharmaceuticals and Pharvis Korea had already received approval for the bipolar disorder indication for their generics. The companies’ products are produced by Yungjin Pharma under a CMO agreement. Other companies have also recently applied for approval of their generics that contain the bipolar disorder indication. As the patent had expired due to patent invalidation, and the number of generics with the bipolar disorder indication is expected to continue to increase in the future. Abilify is a blockbuster drug that posted 45.4 billion won in sales last year. Even after its substance patent expired and generics were introduced to the market, the drug maintained its high market share with its use patents. However, the continued patent challenges filed by generic companies are expected to continue to challenge Abilify's throne in the market.
