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- 2026-05-18 18:57:48
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- Kymriah was virtually pending at the Committee
- by Eo, Yun-Ho Sep 02, 2021 05:59am
- It wasn't easy: the listing of the super expensive one-shot treatment 'Kymriah's insurance benefits was discussed but put on hold. According to related industries, Novartis Korea's world's first CAR-T treatment, Kymriah(Tisagenlecleucel), was virtually pending at the HIRA Cancer Drugs Benefit Appraisal Committee on the 1st. However, based on the amendments mentioned in the commission, it is said that the discussion will proceed quickly. Kymriah's indications are Diffuse Large B-Cell Lymphoma (DLBCL) and B-cell Acute Lymphocytic Leukaemia (ALL) in children and young adults. Both are subject to terminal patients who are not effective in treating more than one or who have recurred after re-occurrence or transplantation. The Cancer Drugs Benefit Appraisal Committee reportedly responded positively to ALL, especially to children with high life expectancy, and skeptical responses to lymphoma. Kymriah, which was licensed in March, quickly submitted the benefit using the "Medicine Approval-Patent Linkage System." However, the Korea Leukemia patients organization criticized the government and Novartis after the Cancer Drugs Benefit Appraisal Committee failed to be presented in July. However, it is hard to predict whether ALL indications will be registered. The drug costs about ₩500 million per dose, and variables such as the NHIS negotiation can occur. Yoo Chul-joo, a professor of pediatric blood oncology at Severance Hospital, said, "Although recurrence and non-responsiveness ALL patients in Korea are extremely rare, we expect similar cases in Korea as the government, pharmaceutical companies, and medical community work together to treat them quickly with Kymriah." If Kymriah is listed, it is likely to be linked quickly to actual prescriptions. Currently, Big 5 general hospitals such as Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital and Sinchon Severance Hospital are undergoing management procedures, including human cells, and Samsung Medical Center has already completed approval. In the case of Seoul National University Hospital, Kymriah passed the DC in April, and passed at SMC in May .
- Policy
- Eligibility for adjustment applications improved
- by Lee, Hye-Kyung Sep 02, 2021 05:59am
- The criteria for adjustment applications that affect drugs subject to pricing calculations will be improved. On the 2nd, the Health Insurance Review and Assessment Service (HIRA) will present the ‘proposal to improve the assessment criteria for drugs that apply for drug pricing adjustments’ as an agenda for deliberation for its Drug Reimbursement Evaluation Committee (DREC). For drugs whose price changes after listing, a pharmaceutical company can request adjustments, upon which HIRA’s Drug Pricing Calculation Department adjusts the price. However, the drugs that may request adjustments were limited to single-brand drugs that are medically essential and have no alternatives, etc. An official from HIRA said, “Until now, not many adjustment applications were filed, so we applied the criteria to DREC’s deliberation for operation. However, with the increase in applications for adjustments that will arise after the reassessment for premium-priced drugs are complete and the complaints from the industry, we presented the agenda on easing the criteria for adjustment applications for DREC’s deliberation.” Companies that have items subject to reassessments of premium pricing had written an agreement regarding their supply obligations etc. after negotiations with HIRA. Since the reassessments were announced, the companies have been ardently awaiting the day to apply for adjustments. In the process, the pharmaceutical industry had requested the government to expand the scope of eligibility for adjustment applications to single brand drugs or drugs that occupy over 90% of its market, national essential medicines or rare diseases, and drugs that are cheaper than other drugs of the same class or cheaper than other countries. A HIRA official said, “Not all the requests made by the pharmaceutical companies were reflected due to concerns over its fiscal impact or rise of other side effects, but we have sent the draft to a public-private consultative body and collected opinions.” If the measures to ease the adjustment criteria pass the DREC meeting, the authorities plan to apply the changes to applications for adjustments filed from September without collecting opinions from pharmaceutical companies. The official added, “The adjustment criteria are currently operated based on an undisclosed internal guideline applied on DREC’s deliberation cases. We plan to reorganize the existing standards to set as operation regulations, then disclose and revise them continuously. Unlike new drugs that undergo the reimbursement listing application process, incrementally modified drugs (IMDs), combination drugs, and generics are listed for reimbursement in 45-75 days after receiving pricing according to a set calculation criteria (a fixed rate of the original’s price) and evaluation for appropriateness of reimbursement. These drugs are subject to the drug premium system, which allows a drug to be sold with a premium at a specific rate for a specific period of time (unlike price increases) for the following purposes: to mitigate the shock of price cuts experienced by original products; to ensure a stable supply of generics (3 or fewer companies); to encourage the entry of generics while providing preferential treatment for technology development, among others. However, the premium pricing criteria was adjusted last year, faced with criticism the system has fallen to become a system that prevents drug price reductions (for originals) and raises drug prices (for generics), as well as the existence of so many products that have maintained their premium long-term. According to the adjusted criteria, the base premium period for all drugs regardless of whether it is a small molecule drug or a biologic is set at 1 year, with a 2-year extension approved for drugs produced with identical ingredients by 3 or fewer companies. Accordingly, 416 generics that exceeded the premium pricing period by over 3 years had undergone price cuts starting September 1st.
- Company
- First IV acetaminophen+ibuprofen combo lands in Korea
- by An, Kyung-Jin Sep 02, 2021 05:59am
- Product picture of Maxigesic IV being sold abroadAn acetaminophen+ibuprofen solution for infusion will soon be released in the Korean pharmaceutical market. Whether the introduction of a new combination therapy option in the single drug-oriented nonopioid analgesic infusion space is gaining attention. According to industry sources on the 1st, Kyongbo Pharmaceutical had received marketing authorization for ‘Maxigesic IV’ from the Ministry of Food and Drug Safety on the 30th of last month. ‘Maxigesic IV’ solution’ is a unique solution combining two nonopioid analgesics- 1000mg acetaminophen with 300mg ibuprofen - for intravenous infusion. Recently, a different pharmaceutical company had applied for an oral drug that contains the same ingredients as an OTD drug but failed. Maxigesic IV was first developed in a tablet form by AFT, a New Zealand pharmaceutical company, to be sold as an OTC, but had switched formulations to be used to manage moderate-to-severe post-operative pain. In November 2018, Kyongbo Pharmaceutical had signed an exclusive development and sales agreement for ‘Maxigesic’ with AFT. The company will be importing the finished product from AFT to sell domestically. The agreement is valid for 15 years from the date of the product release. The two ingredients contained in ‘Maxigesic' -acetaminophen and ibuprofen- are the most widely used antipyretic analgesics. A Phase III clinical trial conducted by AFP on 276 adult patients with at least moderate pain following bunion surgery demonstrated that Maxigesic IV significantly relieved pain within 10 minutes after IV infusion. As a combination solution for infusion, the drug offers higher pain relief than acetaminophen or ibuprofen alone and develops fewer cardiovascular or gastrointestinal side effects. The drug has been received as a potential option that may reduce the use of opioid analgesics that even may replace the market for such drugs. With those strengths, AFP has finished submitting applications for drug approval in 21 countries worldwide, including in major European countries and Australia. The Belgian pharmaceutical company Hyloris Pharmaceuticals, which signed a licensing agreement with AFP for ‘Maxigesic,’ has also been taking steps to receive approval for the drug by the U.S. FDA. Analgesic effect of Maxigesic IV solution(Source: AFP, Hyloris Pharmaceuticals) With the domestic approval, Kyongbo Pharmaceutical is planning to hasten the release of the first IV solution that combines acetaminophen and ibuprofen. An official from Kyongbo Pharmaceutical said, “With a high unmet need remaining in the nonopioid analgesic market, an IV solution that combines two of the most commonly used analgesic ingredients may have the potential to exert and expand its influence in the field of analgesics.
- Company
- Sputnik V's lot release is imminent
- by Kim, Jin-Gu Sep 02, 2021 05:59am
- The Russian COVID vaccine Sputnik V is about to be released, Korus Pharm said on Tuesday. According to Korus Pharm, local administrative procedures for Sputnik V's lot release are being finalized. The production of finished products with a capacity of 1000L has already been completed, and it is expected that the product will be released in earnest once the quality check is completed at the Gamaleya Institute in Russia. In late July, Korus Pharm completed quality verification of Sputnik V's validation badge from the Gamaleya Institute in Russia. Production of 1000L DS was completed in mid-August. Korus Pharm has maintained production of 4 million doz per share, and is expected to increase production to 6 million doz per share starting this month. If bio-reactor is added, it will have a production capacity of more than 10 million doz per week. In addition, Korus Pharm explained that Kirill Alexandrovich Dmitriev, CEO of Russia's RDEF, will visit Korea to commemorate the full-fledged lot release, and is currently discussing his visit to Korea. Kirill Alexandrovich Dmitriev will visit to discuss contracts for additional supplies under the lot release of commercial supplies. "As soon as Russia's local administrative procedures are completed, we will start mass production and establish a shipping process," "As soon as the Russian administrative process is completed, we will mass-produce and establish a shipping process," a Korus Pharm company official said. "We hope that more vaccines will be supplied around the world to help with collective immunity of COVID-19."
- Company
- SK Bioscience has started clinical trial of GBP510
- by Chon, Seung-Hyun Sep 02, 2021 05:59am
- Phase 3 of COVID vaccine developed in Korea have begun in earnest. SK Bioscience announced on the 30th that it has started administering the first subjects of phase 3 clinical trials of GBP510, jointly developed by the Institute for Protein Design (IPD) at the University of Washington. This is the first phase 3 clinical trial of a candidate substance for COVID vaccine developed in Korea. Previously, SK Bioscience received approval from the MFDS on the 10th for clinical trial of GBP510. Phase 3 of GBP510 will be held in 14 domestic institutions, including Korea University and Guro Hospital, and 4,000 domestic and foreign adults over the age of 18 in Europe and Southeast Asia. GBP510 is mixed with GSK's Pandemic Immunostimulator (Adjuvant) and is injected twice every 28 days. SK Bioscience, along with the International Vaccine Institute (IVI), a non-profit international organization in East Europe and Southeast Asia, is applying for approval of each country's Phase 3 clinical trial plan. It is planning to start clinical trials overseas as early as next month. SK Bioscience plans to secure interim data in the first half of next year by evaluating the immunogenicity and safety of GBP510 through Phase 3 clinical trial conducted at home and abroad. With prompt permission from Korean health authorities, it will also begin preparation for the WHO certification and acquisition of Emergency Use Authorization by each country. SK Bioscience confirmed that as a result of Phase 1/2, Phase 1 clinical trial conducted on 80 healthy adults, 100% of neutral antibodies that neutralize COVID were formed in the dosing group that administered both GBP510 and immune enhancer. This is measured through international standard substances and evaluation methods established by the WHO and the NIBSC. In terms of safety, no significant adverse event has occurred that is related to the administration of GBP510. SK Bioscience is also monitoring safety of 247 participants in the second stage, which includes senior citizens. No particular safety issues have occurred so far. The company predicted, "When the development of the GBP510 is completed, the difficulty of supply and demand of COVID vaccine in Korea, which relies on imports, will be resolved." If GBP510 successfully enters the commercialization stage, it can establish and supply its own production and supply plan as it is a vaccine for domestic development. In the long term, it is expected that it will contribute to securing vaccines as it can quickly cope with mutant viruses based on platform technology. The synthetic antigen vaccine platform applied to GBP510 can be stored under refrigeration conditions of 2 to 8°C, so it can be distributed using the existing vaccine logistics network and can be stored for a long time, so it can easily secure accessibility globally. GBP510 was selected as the first target of the Wave 2 project, which CEPI operated last year to support differentiated COVID vaccine candidates, and hundreds of millions of vaccinations will be supplied to the world including South Korea through the COVAX facility once the development is completed. SK Bioscience' vaccine factory in Andong has the capacity to produce hundreds of millions of commercial products a year immediately after developing the vaccine and manufacturing various types of vaccines simultaneously through independent spaces in nine areas of the plant. "With the rapid and systematic cooperation of health authorities and clinical institutions, we have successfully started to administer subjects. We will thoroughly verify safety and effectiveness through clinical trials."
- Company
- It is necessary to provide Kymriah treatment accessibility
- by Sep 02, 2021 05:59am
- Novartis Korea (CEO Kim Skafte Mortensen) announced on the 30th that the ICBMT released the results of a study that analyzed the treatment of DLBCL patients in Korea from August 26 at ICBMT. DLBCL is an aggressive lymphoma that accounts for about 40% of non-Hodgkin lymphoma. Although most standard treatments show abnormalities in part, it is known that 10 to 15% of patients do not respond to primary treatments and 20 to 35% experience recurrence. The study was conducted to identify the demographic characteristics and treatment patterns and prognosis of DLBCL patients in Korea. Led by Professor Park Mi-hye, College of Pharmacy, Sungkyunkwan University, a total of 4931 claims of the HIRA were analyzed from January 1, 2013 to July 31, 2019. The analysis found that the median of the overall survival of DLBCL patients who failed secondary treatment was 4.73 months. In addition, about 70% of patients who failed the second treatment were repeatedly undergoing salvage chemotherapy, and the duration of the second treatment to the third treatment was gradually shortened to 2.86 months (median) and 1.81 months (median) to the fourth treatment. "This study confirmed the poor treatment prognosis and limitations of current treatment of recurrence and non-responsiveness DLBCL patients in Korea," said Park Mi-hye, a professor at Sungkyunkwan University, who led the study. "There are no alternative treatments and poor prognosis. "This is the first study that has been analyzed for all patients in Korea using all data on claim data." She added, "In the end, the patients were repeating salvage chemotherapy, which is difficult to expect a life extension due to the absence of treatment options, and as the number of treatment increases, the length of failure will be shorter, so patients who are unable to expect further reactions need available treatment options." Poor prognosis and the need for effective treatment options in patients with recurrent and non-responsive DLBCL have already been confirmed through global research. According to the SCHOLAR-1 study, the first patient-level analysis result for non-responsive DLBCL patients, the complete response rate for non-responsive DLBCL patients was 7% and the median duration was only 6.3 months. Further analysis of the CORAL study, a multi-organ, randomized clinical trial, also showed that the expected survival rate for one or two years among patients with recurrent and non-responsive DLBCL, especially those who failed secondary relief chemotherapy, was 23% and 15.7%, respectively. "This analysis is encouraging in that we can see the treatment patterns or prognosis of most patients in the actual benefit care environment," said Yoon Duk-hyun, a professor of oncology at Asan Medical Center in Seoul who participated in clinical consultation and research on DLBCL disease and domestic treatment status. Professor Yoon said, "Even though patients with recurrent and non-responsive DLBCL use repeated salvage chemotherapy, the period until the next treatment period was very short, with a median of two to three months, showing very poor prognosis because there are no effective alternative treatments." The new option CAR-T treatment, Kymriah, was the only one in Korea in March to prove a high response rate and persistence in a single treatment in a recurrent and non-responsive DLBCL patient. "Fortunately, new targeted treatments and cell treatments, which are completely different from conventional anticancer drugs, are under development or approval," Professor Yoon said. "However, most new treatments require improvement due to the high cost of patients."
- Company
- ‘Somavert’ is reimbursed and starts landing in GHs
- by Eo, Yun-Ho Sep 01, 2021 05:57am
- The new acromegaly drug ‘Somavert’ was listed for insurance benefit and has begun landing in general hospitals. According to industry sources, Pfizer Korea’s Somavert (pegvisomant) has submitted landing applications to drug committees at major medical institutions including the Seoul National University Hospital, Severance Hospital, and Seoul National University Bundang Hospital. As the Severance Hospital at Sinchon treats the most amount of acromegaly patients in Korea, Somavert is expected to be prescribed as soon as it passes the DC review. Somavert’s reimbursement has been approved and will be applied from the next month in September. Somavert was approved in Korea in September last year to treat patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with Somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. The drug demonstrated its efficacy in the randomized, double-blind, pivotal study SEN-3614 that was conducted on 112 acromegaly patients for 12 weeks. The 112 patients were randomly assigned to administer 10mg, 15mg, 20mg of pegvisomant or placebo every day, and its primary efficacy endpoint was the percent change in serum IGF-I concentration from baseline to Week 12. Study results showed that in Week 12, the median serum IGF-I concentration reduction level was 16.8%, 26.7±27.9%, 50.1±26.7%, 62.5±21.3% for the placebo arm, and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant significantly reduced serum IGF-I concentrations in all three doses compared to placebo. The rate of patients whose serum IGF-I concentrations normalized compared to baseline were 10%, 54%, 81%, and 89% for the placebo arm and 10mg, 15mg, 20mg pegvisomant arm, respectively. Pegvisomant showed a significantly higher rate in all three doses compared to placebo. Also, pegvisomant significantly improved the overall sign and symptoms of acromegaly in all doses, and the incidence of adverse events was similar for all doses of the pegvisomant and placebo arm. Acromegaly is a rare condition characterized by the excessive secretion of growth hormones that causes abnormal, excessive secretion of IGF-I, and is most often caused by a benign tumor of the pituitary gland. Acromegaly is associated with clinical changes including reduced life expectancy, cardiovascular issues, enlargement of hands, feet and other organs, facial deformity, fatigue, joint pain, metabolic disorder, etc, and may be accompanied by and various secondary systemic complications including osteoarthritis, metabolic complications (insulin resistance, hyperglycemia, hyperlipidemia, etc), risk of neoplasms, hypopituitarism, vertebral fractures, and reduced quality of life. The annual incidence of acromegaly is estimated to be around 3.3 cases per 1 million population, and the worldwide prevalence is about 60 cases per 1 million. Retrospective analysis results that were announced in 2013 for Korea shows that around 1,350 acromegaly patients are registered in 74 secondary and tertiary medical institutions from January 2003 to December 2007, making the annual incidence rate in Korea to be 3.9 cases per 1 million, and prevalence to be 27.9 cases per 1 million in 2007.
- Policy
- The MOHW objected to improved benefit for Prolia
- by Lee, Jeong-Hwan Sep 01, 2021 05:57am
- The MOHW objected to the criticism that it should continue to apply health insurance benefits of advanced bio-new drug Prolia (Denosumab), which treats osteoporosis, regardless of bone density figures. The MOHW said patients who still have low bone density measurements in follow-up tests after administering osteoporosis treatments such as Prolia continue to recognize their benefits regardless of time. On the 31st, the MOHW responded to a written question about the benefit standards for osteoporosis drugs by Rep. Lee Jong-sung, People Power Party. Rep. Lee requested that the standard for osteoporosis treatments be changed to improve Prolia's benefit regardless of bone density levels. Improving the benefit standard for osteoporosis treatments has continued to be needed by domestic medical staff and medicine experts. The benefit standard is to stop paying for osteoporosis patients if their bone density levels, T-score, are improved to "2.5 or less" due to the use of treatments earned by them. Osteoporosis drugs, which have already earned salaries, are converted to non-salary based on patient bone density figures. Previously, bisphosphonate drugs, which are used once a day, were mainly prescribed for osteoporosis treatment, but recently, Prolia prescriptions, which are injected once a six-month period, are mainly used. Rep. Lee also agreed with the request and asked the MOHW about its willingness to improve it, but it gave a theoretical answer that it would review it in accordance with the principle of standards. In particular, if bone density levels are still low in patient follow-up tests, Prolia's benefit continues to be recognized regardless of the period of time. "Prolia has expanded its primary treatment pay in 2019," it said. The MOHW also said, "The duration of administration of osteoporosis drugs depends on the measurement of bone density and whether or not osteoporosis fractures occur. Patients with low measurements in follow-up tests continue to pay Prolia." "We have continuously expanded the benefit standards for osteoporosis drugs by referring to textbooks, guidelines, and academic opinions," it added. "We will consider the principles of insurance benefits such as clinical usefulness, cost effectiveness, and required finance."
- Policy
- Lucentis biosimilars have been applied to the MFDS
- by Lee, Tak-Sun Sep 01, 2021 05:57am
- Along with Chong Kun Dang, Samsung Bioepis also applied for permission to the MFDS for Lucentis biosimilar. Lucentis (Ranibizumab) is a treatment for ophthalmic diseases that treat macular degeneration and various eye damage, and it is a blockbuster with annual global sales reaching ￦4.6 trillion and sales of ￦37 billion in Korea as of last year. According to the MFDS on the 31st, Lucentis biosimilar, a candidate from Chong Kun Dang and Samsung Bioepis, has received an application for permission. Chong Kun Dang announced to the media that it applied for permission for items on the 28th of last month. The company explained that from September 2018 to March this year, 25 hospitals, including Seoul National University Hospital, conducted the clinical phase 3 of Lucentis biosimilar candidate "CKD-701" for 312 macular degeneration patients. Macular degeneration can lead to blindness if the macula, a tissue that accepts light from the retina, loses its function or becomes severe due to aging and inflammation. Chong Kun Dang said it confirmed that there were no statistically significant differences in drug efficacy and other pharmacokinetics, immunogenicity and safety in indicators of less than 15 letters of vision loss and improved vision, average changes in maximum calibration vision, and thickness of the central retina. Samsung Bioepis also completed its domestic clinical trial for Lucentis Biosimilar candidate "SB11 shares" and applied for permission from the MFDS. Samsung Bioepis proved its equivalence with the original drug in phase 3 of the multinational market for 705 people. From March 2018 to December 2019, clinical equivalence and validation criteria were met through comparative studies between SB11 and Lucentis in clinical trials of a total of 705 wet age-related macular degeneration (nAMD) patients. In August, the company received approval for the first Lucentis biosimilar product in Europe. In November last year, the U.S. FDA began reviewing permits. The Korean patent for Lucentis ended in April 2018. As a result, biosimilar can enter the market as soon as it is approved. If the two companies start selling their products around the same time, fierce competition is expected.
- Policy
- DREC to include patient and civic groups' recommendations
- by Lee, Hye-Kyung Sep 01, 2021 05:57am
- In addition to experts recommended by consumer groups, experts recommended by patients and civic groups will also be included in the 8th Drug Reimbursement Evaluation Committee (DREC) that will be commissioned next month. Also, detailed guidelines that did not exist before for DREC’s subcommittees were newly established to aid the organization and smooth operation of subcommittees. The National Health Insurance Review and Assessment Service (HIRA) had recently finalized the ‘partial amendment to the operating regulations for DREC’ that contained the abovementioned changes. The amendment was made to improve fairness, objectivity, and transparency in the operations of DREC and its subcommittees. The new and changed provisions include: ▲Adding civic groups as a recommending body for DREC members (Article 3-1), ▲New regulations on the organization and operation of subcommittees (Article 6-2), and ▲ Clarification of terms to be observed by DREC members including the obligation to report and avoid unfair solicitation (mandatory provision) (Article 16-1), etc. The provision that stipulated recommending bodies for DREC members to ‘consumer organizations (including patient groups)’ was specified to include consumer, patient, and civic groups. With the increased number of recommending bodies, the 8th DREC member pool increased from 99 to 102. New operation guidelines on the specific organization and operation were newly established for DREC’s subcommittees that were operated for the effective evaluation of eligibility for medical insurance benefits, etc (reimbursement standards, PE evaluations, RSA, fiscal impact assessment, herbal medicine, post-evaluation), to be consistent with the subcommittee guidelines set for similar committees such as the Professional Review Committee. DREC's subcommittees are composed of 6-7 members including one chairperson, one or more clinical experts recommended by medical and pharmaceutical societies, and one or more experts with expertise and experience in health insurance and drug benefit evaluations. Agendas in subcommittees are passed with attendance by a majority of members and a majority vote. Also, reports of solicitation, which was a voluntary provision, was amended to a mandatory provision. Also, the existing provision that stipulates that members can apply for evasion to the chairperson for reasons of unfair solicitation, has been changed to “must apply for evasion.” If the Committee chair (or director) who received the evasion application believe that the fairness, objectivity of the member cannot be trusted for an agenda, the chair may reject attendant or opinion of the member, and collect opinions from other members on the agenda to remove the agenda from the plate or withhold discussions for a period set by the committee.
