- LOGIN
- MemberShip
- 2026-05-06 14:50:29
- Policy
- Imfinzi's 3-drug combo burden reduced despite nonreimb
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- An unprecedented decision was made at the Cancer Disease Review Committee meeting that was held on the 22nd. At the meeting, AstraZeneca failed to establish reimbursement standards for its Imfinzi Inj (durvalumab) as part of a three-drug combination therapy for biliary tract cancer, but the CDDC decided to grant reimbursement for the gemcitabine and cisplatin used in the combination. Accordingly, the economic burden of the non-reimbursed Imfinzi + gemcitabine + cisplatin combination as first-line treatment for biliary tract cancer will be reduced to some extent with partial reimbursement approval. A HIRA official explained, "The CDDC decided to recognize part of the patient's out-of-pocket cost spent on gemcitabine and cisplatin that is used in combination with durvalumab. We plan to weigh the cost-effectiveness and report the results to the Ministry of Health and Welfare." If the MOHW recognizes the cost-effectiveness, it will amend the anticancer drug reimbursement standards so that only 5% of the drug cost for gemcitabine and cisplatin will have to be borne by the patient when used in combination with durvalumab. Gemcitabine’s insurance price ceiling is set at KRW 200,000 per vial, and cisplatin is also not expensive, costing less than KRW 20,000 per vial, so it seems likely that the reimbursement standards will be revised without complicated procedures. However, because Imfinzi, which is priced at KRW 3.34 million per vial, is non-reimbursed, the burden borne by the patients has not been completely resolved. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. The approval was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment naïve patients with unresectable locally advanced or metastatic biliary tract cancer. The Phase III trial results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a survival rate in the Imfinzi arm was 24.9% compared with 10.4% in the placebo arm at 2 years. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to the 5.7 months in the placebo arm. Since obtaining the indication, the non-reimbursed three-drug regimen has been widely used in the field for the primary treatment of biliary tract cancer. AstraZeneca applied for extended reimbursement in August in consideration of the burden borne by the patients, but failed at the first gate to reimbursement, at the CDDC level. However, the CDDC accepted the reimbursement for the other two drugs used in the combination in consideration of the patient burden and the high frequency of their use. An AstraZeneca official said, “We would like to express our gratitude to the government for showing the will to ease the burden of treatment costs for patients with biliary tract cancer, who are relatively elderly, have a poor prognosis, and have a progressive disease. Regarding the CDDC results, we have been conducting internal discussions to devise a measure to extend Imfinzi’s reimbursement to patients suffering from biliary tract cancer and the medical staff who work tirelessly day and night for their treatment.” “Considering the many HCPs and patients waiting to use Imfinzi, the first new standard treatment option and immunotherapy for biliary tract cancer that was introduced in 12 years, the company will continue to work with health authorities to expand its reimbursement in the future.” AstraZeneca is now left to decide whether to be content with the results or to reorganize the data and apply for reimbursement again.
- Company
- Demand for ADC Enhertu rise despite nonreimbursement
- by Kim, Jin-Gu Nov 30, 2023 05:55am
- Cumulative sales of Daiichi Sankyo’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab-deruxtecan)’ have exceeded KRW 10 billion even without reimbursement. According to the market research institution IQVIA on the 27th, Enhertu's cumulative sales were KRW 13.8 billion by Q3 this year. Sales steadily increased from KRW 2.2 billion in Q1, to KRW 5.2 billion in Q2, then to 6.4 billion in Q3 this year. In other words, the drug has posted cumulative sales of more than KRW 10 billion without insurance reimbursement. The non-reimbursed administration cost of Enhertu is known to be around KRW 7 million for each cycle that consists of 3 doses. For patients who participate in the company's Patient Assistant Program (PAP), the price drops to the high KRW 5 million range, which still poses quite a burden to the patient. Sales show that quite a few patients are in need of the drug. Voices calling for Enhertu's reimbursement were even raised during the National Assembly audit. At the NA audit on the National Health Insurance Service and Health Insurance Review and Assessment Service, Rep. Ki-Yoon Kang of the People Power Party, said, “I do not understand why Enhertu, which is undergoing pharmacoeconomic evaluations, cannot be reimbursed even though its global clinical trials are complete. Please review its reimbursement so no patients are left to die due to a lack of treatment.” Enhertu is a treatment for HER2-positive breast cancer. It is an antibody-drug conjugate (ADC) that has recently attracted attention and was approved by the Ministry of Food and Drug Safety in September last year. It is indicated for ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment), and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen. It further expanded indications in December and can be used in patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. However, it has been making less progress in receiving insurance reimbursement. Although the agenda had passed HIRA’s Cancer Disease Deliberation Committee review after redeliberation in May, it remains pending without being presented for review at the Drug Reimbursement Evaluation Committee level. The company had recently submitted supplementary pharmacoeconomic evaluation data to HIRA and is again awaiting DREC review. However, the company and the government are having difficulty reaching a consensus regarding Enhertu’s pharmacoeconomic evaluation results. The industry analysis is that Enhertu's superior effect is hindering economic evaluations. For pharmacoeconomic evaluations, Enhertu’s cost-effectiveness is being compared to that of Kadcyla. Enhertu demonstrated an extension in median progression-free survival (mPFS) by more than 22 months compared to existing drugs. The prolonged survival leads to an increased administration period. However, the current economic evaluation system is known to have difficulty reflecting this. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The median PFS for patients in the Enhertu arm was 28.8 months compared with 6.8 months for the T-DM1 arm. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and a mPFS of 16.4 months.
- Policy
- External ref price reevals will be carried out as planned
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- The Health Insurance Review and Assessment Service decided to thoroughly discuss its external reference price reevaluation plan with the industry. Although the government’s original plan of preparing a final draft by December is also expected to be postponed somewhat due to the prolonged discussions, HIRA explained that there is no change to its policy in starting the reevaluations next year. According to industry sources on the 29th, at the 2nd meeting on the external reference price reevaluation held on the 24th, HIRA accepted the pharmaceutical industry's opinion to continue working-level discussions until February next year when the final plan is set. Due to prolonged discussions, the final plan is expected to be prepared after February next year. Initially, HIRA planned to prepare final guidelines by December after several discussions with the industry. An industry official said, "At the meeting, the industry raised the opinion that more time was needed, so we decided to continue discussions until February. Specific details will likely come out after further meetings are held." Although the preparation of the final plan has been delayed, the government has confirmed that its policy of starting reevaluations next year remains unchanged. A HIRA official explained, “If we prepare well while gathering industry opinion, there will likely be no problem in conducting the first evaluation next year even if the final reevaluation plan is released after February.” Starting next year, HIRA plans to sequentially conduct reevaluations on the price of listed off-patent drugs, mainly chronic disease drugs, based on their overseas drug price. The price adjustments made through the reevaluations are planned to be applied from January of the following year. At the first meeting, the government had only disclosed the principle of comparing the highest price of each drug in the A8 countries (USA, UK, Germany, France, Italy, Switzerland, Japan, Canada) with the highest price in Korea, and decided to discuss further details in further meetings. The HIRA official added, “We plan to decide on subject drugs for the first year and other specifics after discussing with the industry. Internally, HIRA has already prepared a plan.”
- Policy
- BeiGene applies for reimb of its 2nd new drug after Brukinsa
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Chinese new drug developer BeiGene is working to quickly receive reimbursement for its 2nd new drug, Tevimbra (tislelizumab) following its first new drug, Brukinsa (zanubrutinib). According to industry sources, the company had immediately applied for reimbursement listing of its Tevimbra upon its approval on the 20th. Tevimbra is a PD-1 class immuno-oncology drug that received marketing authorization from the Ministry of Food and Drug Safety on the 20th as monotherapy for the treatment of adult patients with unresectable, relapsed, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy. The drug was also approved by the European Commission in September for the same indication. BeiGene had previously received approval for its 1st new drug, ‘Brukinsa’ in February last year. Brukinsa is the first drug developed by a Chinese company that received US FDA approval based on clinical trials in conducted China in November 2019. Brukinsa is indicated ▲as monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and ▲as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. The company had taken rapid steps for its reimbursement upon approval and was granted reimbursement in May, a year and 2 months since approval, as a ‘monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy.’ It was the moment when a new drug developed by a Chinese pharmaceutical company first entered the Korean market. Its insurance price ceiling was set at KRW 34,100 per capsule and was applied to an expenditure cap type risk-sharing agreement (RSA). At HIRA’s Cancer Diseae Deliberation Committee meeting that was held on the 22nd, Brukinsa’s reimbursement standards were set as ▲monotherapy for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, ▲ monotherapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and ▲ monotherapy for adult patients 65 years and older or adult patients below 65 years of age with comorbidities with naïve CLL or SLL previously treated with at least one prior therapy. The three indications that passed the CDDC review will become eligible for reimbursement once they pass HIRA’s Drug Reimbursement Evaluation Committee and the NHIS’s drug pricing negotiations. BeiGene has long been preparing to enter the Korean market, establishing a Korean branch in October 2019. Its entry is raising expectations as its immune-oncology drug may be distributed at a lower price than those sold by existing multinational pharmaceutical companies. However, it remains to be seen whether the second new drug, Tevimbra, will also succeed in promptly receiving reimbursement.
- Company
- Samsung Biologics’ CMO orders exceed KRW 3 trillion this yr
- by Chon, Seung-Hyun Nov 29, 2023 05:50am
- Samsung Biologics Samsung Biologics announced on the 28th that its contract manufacturing organization (CMO) orders this year will exceed KRW 3 trillion. On the day, the company publicly announced that it signed 1 new and 4 expanded CMO deals. Samsung Biologics signed a CMO deal worth KRW 588.8 billion with Asian pharmaceutical companies. In addition, the CMO order amount increased by KRW 171.9 billion with the 4 expanded contracts, As a result, the company's cumulative annual CMO order amount has reached KRW 3.4867 trillion, surpassing KRW 3 trillion for the first time since its establishment. The company explained, “Based on the solid trust we have built with our customers, large multinational pharmacuetical companies. that have initially signed agreements with us have all expanded the contracted line of products or increased the production scale of previously contracted quantities, strengthening partnerships thereafter.” The company’s fourth plant, which began full operations in June, is the world's largest facility with a production capacity of 240,000 liters. The plant has been continuously recording a high utilization rate due to the increase in large-scale orders from large multinational pharmacuetical companies. Samsung Biologics is currently operating 4 biopharmaceutical manufacturing plants. The company further strengthened its CMO capacity by starting its fourth factory 23 months after construction in October last year, which has the world's largest production capacity (240,000 liters) for a single plant. Samsung Biologics has secured a total production capacity of 618,000 liters along with the existing 3 factories (Plant 1 30,000 liters, Plant 2 152,000 liters, Plant 3 180,000 liters). In order to preemptively respond to market demand, Samsung Biologics began construction of a fifth plant with a 180,000 capacity last April with the goal of completion in April 2025. When the fifth factory is completed, Samsung Biologics' total production capacity will be expanded to 784,000 liters.
- Policy
- HIRA starts preparing for RWE-based reimb reevaluations
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Health Insurance Review and Assessment Service are accelerating the establishment of a plan to reevaluate Korea’s reimbursed drugs based on RWD (Real World Data)/RWE (Real World Evidence). The idea of RWD/RWE-based reimbursement reevaluations took shape at the public hearing for the ‘Performance-based reimbursement management plan for drugs using RWD/RWE’ that was held on the 21st. The plan is to reevaluate high-priced drugs or those that did not undergo pharmacoeconomic evaluations using RWD/RWE data. According to the industry on the 28th, HIRA's working-level officials will go on a business trip to Taiwan early next month as part of establishing the plan for RWD/RWE-based reimbursement reevaluations in Korea. Taiwan has been conducting RWD/RWE-based reimbursement reevaluations. Therefore, HIRA’s working-level officials plan to visit Taiwan's Ministry of Health and Welfare and benchmark Taiwan's RWE-based reevaluation system. RWD refers to a patient’s actual clinical data that is collected after reimbursement, such as health insurance claims data, hospital medical records, surveys, and post-marketing surveillance data. The clinical evidence based on such data is referred to as RWE (Real-World Evidence). At a public hearing that was held on the 21st, Ji-Hye Byun, associate researcher at HIRA presented the ‘Use RWE: reimbursement listing to reevaluation.’ Byun said, “For high-cost drugs that have submitted pharmacoeconomic evaluation data but have great uncertainty in its cost-effectiveness evaluation results (ICER), or for drugs that did not or cannot submit pharmacoeconomic evaluation data, we can conduct reevaluations after listing the drugs with RWD.” Associate researcher Byun is also known to be participating in the Taiwan business trip. Insurance authorities believe that there is a rising need for RWE-based reimbursement management based on RWD analysis due to the rising number of reimbursed high-priced drugs that have unclear treatment effects. Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access. So this is now the time a post-listing measure needs to be implemented. Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, added, “Addressing the uncertainty that follows the listing of high-priced drugs reimbursed with PE exemption is a pending task for all. As a tool, I expect RWD to become a good way to cover the uncertainties that remain in the area,” and expressed a positive attitude towards the introduction. The number of drugs that are exempt from submitting pharmacoeconomic evaluation data has been on the rise ever since the system was implemented in 2015. Last year, 87.5% of anticancer drugs and rare disease treatments reimbursed as new drugs were drugs that were exempt from submitting pharmacoeconomic evaluation data. In this context, RWE is rising as an alternative and appropriate follow-up management tool to verify cost-effectiveness. As HIRA held public hearings and has set out to conduct field surveys, an RWE-based reevaluation system is expected to surface soon in Korea as well.
- Policy
- DPM Choo ‘will finalize telemedicine plans this year'
- by Kang, Shin-Kook Nov 28, 2023 05:42am
- The direction of the government's policy to institutionalize non-face-to-face treatment has been set to institutionalize non-face-to-face treatment for overseas Korean nationals and prepare an improvement plan for the domestic non-face-to-face treatment pilot project within the year. Deputy Prime Minister Kyung-Ho Choo presided over the Emergency Economy-related Ministers' Meeting and Export Investment Measures Meeting on the 27th and finalized the regulatory innovation measures for new industries. Deputy Prime Minister Kyung-Ho Choo presides over the Emergency Economy-related Ministers Among the projects, the 4 regulatory innovation tasks in the field of bio healthcare field are ▲clarification of non-medical standards to foster the healthcare service industry; ▲institutionalization of non-face-to-face treatment; ▲allowing joint establishment and use of living modified organism (LMO) research facilities; and ▲expansion of subjects for rapid processing of advanced regenerative biopharmaceuticals. ◆Non-face-to-face treatment = The government plans to institutionalize non-face-to-face treatment for overseas Korean residents and improve the domestic pilot project for non-face-to-face treatment within the year. The government has decided to promote revision of the Medical Service Act to include Korean nationals residing abroad into the scope of eligible patients. The bill to amend the Medical Service Act (presented by Rep. Jong-Seong Lee) is pending at the National Assembly’s Health and Welfare Legislative subcommittee level. Furthermore, to resolve public inconvenience and improve access to medical care, the ministers decided to supplement and promote the pilot project by comprehensively reflecting opinions from various sectors, through discussion with the pilot project advisory panel, public hearings, etc. The goal is to contribute to improving medical accessibility and public health by improving and institutionalizing the pilot project for non-face-to-face treatment. Deputy Prime Minister Kyung-Ho Choo said, "We will institutionalize non-face-to-face treatment for Korean residents residing above, whose safety has been verified through the regulatory sandbox, and will improve the domestic pilot project for non-face-to-face treatment within the year." ◆Healthcare service = Due to the diversification of healthcare services, the government saw the need to clarify the uncertainties as to whether each service constitutes a medical practice (can only be performed by medical personnel) under the Medical Service Act. Accordingly, the government decided to clearly define whether certain medical services should be included or excluded from medical practice and expand the scope so that various healthcare services using new digital devices can be launched in line with technological developments. The goal is to create a foundation for revitalizing the development of new services by resolving uncertainty among non-medical healthcare service companies. The government decided to revise the 'Non-medical healthcare service guidelines and casebook' next year after conducting a pilot demand survey and collecting opinions in Q1 next year. ◆ LMO research facility = Companies had been burdened with high facility construction costs because the establishment and use of living modified organism (LMO) research facilities were prohibited. It was decided that a bill to amend to the ‘LMO Act' will be presented next year to improve this and allow joint establishment and use of research facilities to develop and test LMOs. The government predicted that this would contribute to revitalizing research by alleviating the cost burden of establishing separate facilities for relevant companies. ◆Advanced regenerative biopharmaceuticals = An expedited processing system (that reduces the review period from 115 days to 90 days) is in place for the accelerated approval and review of advanced regenerative biopharmaceuticals, but its scope of application was limited. Accordingly, the government decided to expand the scope of interpretation for 'cases where there is no alternative treatment' subject to expedited review. In other words, the scope will then include everything from ‘cases where there are no domestically approved drugs’ to ‘cases where the drug demonstrated improved safety and efficacy over existing drugs.’ The goal is to reduce the burden of approval and review on advanced regenerative biopharmaceuticals by reducing the time required for approval and improving public access to drugs.
- Company
- Korean companies bid to break AZ’s monopoly with FcRN drug
- by Son, Hyung-Min Nov 28, 2023 05:42am
- With new FcRn antibody drugs secured by Korean pharmaceutical companies demonstrating efficacy in myasthenia gravis, these new FcRn antibody drugs are expected to rise as a competitor to C5 complement inhibitors such as AstraZeneca’s Ultromiris and Soliris that currently occupy the market in Korea. to industry sources on the 27th, Handok is preparing to apply for marketing authorization of its new FcRn antibody drug Vyvgart (efgartigimod). The company had signed an agreement with the Belgian company Argenx for the marketing authorization, reimbursement, and exclusive distribution of Vyvgart in Korea. Vyvgart is a human Immunoglobulin G1 (IgG1) antibody fragment that binds to the neonatal. Fc receptors (FcRn). The mechanism of action reduces and blocks the circulation of IgG antibodies that cause diseases. FcRn binds to IgG antibodies, preventing them from being destroyed in the lysosome. Vyvgart is currently approved as a treatment for adult patients with generalized myasthenia gravis in the U.S., Europe, the U.K., Israel, and China. In the Phase III ADAPT trial, a significant 68% of anti-AChR antibody-positive gMG patients responded to Vyvgart therapy, compared to 30% of patients on placebo on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale during the first treatment cycle. Furthermore, patients who were treated with Vyvgart showed an improvement over those who received a placebo on the Quantitative Myasthenia Gravis (QMG) scale. Also, Argenx received approval for the subcutaneous formulation of its Vyvgart from the US FDA. In clinical trials, the subcutaneous injection formulation of Vyvgart reduced average IgG by 66.4% on the 29th day, which was higher than the 62.2% achieved using the existing intravenous injection formulation of Vyvgart. On the 23rd, Mirae Asset researcher Seung-min Kim selected FcRn antibody treatment as the most promising candidate for immune and inflammatory diseases in his 2024 Pharmaceutical Bio Outlook Report. Researcher Kim said that the FcRn antibody drug Vyvgart has the potential to become a blockbuster and that HanAll Biopharma, which is developing a treatment in the same class, also deserves attention. HanAll in Phase III trial for batoclimab…achieved positive results in the Phase I IMVT-1402 trial HanAll Biopharma is also developing a subcutaneous injection dosage formulation of its GcRn antibody treatment candidate, batoclimab (HL161). Its licensed partner in China, Harbour BioMed, is conducting clinical trials on the candidate to confirm the potential of batoclimab as a treatment for various autoimmune diseases. HanAll Biopharma obtained positive Phase III trial results with batoclimab in China in March. The trial was conducted by its Chinese partner Harbour BioMed on 132 patients with myasthenia gravis. In the trial, patients were randomly assigned to two groups and evaluated the candidate’s symptom improvement effect and safety at each designated cycle. Results showed that batoclimab met its primary endpoint and demonstrated statistically significant improvement over placebo. Also, batoclimab achieved the key secondary endpoints. It showed consistent safety and tolerability with the previous Phase II trial, and there were no newly discovered adverse reactions. Also, HanAll Biopharma is setting out to receive US approval with its US partner Immunovant. In addition to batoclimab, which is currently in the later stage of clinical trials, a Phase I trial is underway for IMVT-1402, another new FcRn antibody drug candidate. According to the interim results of the Phase I trial that was released last September, IMVT-1402 decreased blood IgG concentration, the efficacy endpoint, by 63%, and no decrease in albumin, a safety indicator, was observed. The ongoing Phase I trial administered IMVT-1402 and placebo as a subcutaneous injection formulation to randomly assigned healthy adults, in increased dosages for each patient group with single or repeated administrations. HanAll Biopharma plans to develop IMVT-1402 to target various autoimmune diseases in addition to myasthenia gravis. No.1 drug for myasthenia gravis in Korea is Ultomiris IV When introduced, the FcRn antibody treatments are expected to compete fiercely with existing AstraZeneca treatments in the market. AstraZeneca had successfully acquired Alexion, a rare disease specialized company that developed the C5 complement inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab), which are treatments for myasthenia gravis. Currently, the domestic market is dominated by AstraZeneca's Ultomiris. The drug absorbed most of the market share that had been previously occupied by Soliris. According to the market research institution IQVIA, Ultomiris recorded KRW 43.2 billion in sales last year. This year, it raised KRW 37.8 billion by Q3. Soliris recorded sales of KRW 10.1 billion last year and KRW 6.5 billion through Q3 this year. Based on the performance, AstraZeneca is evaluated to have successfully made the switch from Soliris to Ultomiris. Soliris, which is indicated both for paroxysmal nocturnal hemoglobinuria (PNH) and myasthenia gravis, had maintained its first place in the market for a long time, but then, a change in the market was detected with the full-scale introduction of Ultomiris in 2021. Ultomiris succeeded in increasing the dosing interval while maintaining its effect compared with Soliris. The dosing interval for Ultomiris has been extended to once every 8 weeks compared to Soliris, which is administered intravenously once every 2 weeks. However, no subcutaneous injection formulation currently exists in the field, so the new FcRn antibody treatments are expected to have high marketability.
- Company
- Budesonide’s price will be increased by up to 19%
- by Chon, Seung-Hyun Nov 28, 2023 05:41am
- The insurance ceiling price for asthma treatments containing ‘budesonide’ will be increased by up to 18.5%. The annual prescription market is expected to increase by more than KRW 1.5 billion. Once the supply and demand imbalance is resolved, the scope of market expansion is expected to increase further. According to the Ministry of Health and Welfare on the 27th, the prices of Pulmican and Pulmicort will increase starting December 1. The price of Kuhnil Pharmaceutical's Pulmican will increase by 18.5% from KRW 946 to KRW 1,121. The price of AstraZeneca's Pulmicort will rise 12.5% from KRW 1,000 to KRW 1,125. Pulmican and Pulmicort contain budesonide and are used to treat bronchial asthma and acute laryngotracheobronchitis in infants and children. As supply shortages have frequently occurred due to a recent surge in demand, a decision was made to increase drug prices after discussing with health authorities and pharmaceutical companies to encourage increased production. Prescriptions for Pulmican and Pulmicort both surged with the COVID-19 endemic. According to the pharmaceutical research institution UBIST, the prescription amount for Pulmicort and Pulmican in Q3 this year was KRW 1.6 billion. The amount decreased by 0.2% from Q3 last year but is 155.8% in 2 years from the KRW 600 million in Q3 2021. In 2020, the prescription market for budesonide was only KRW 3.8 billion. The average quarterly prescription amount was less than KRW 1 billion. In 2021, prescription performance was less than KRW 1 billion from Q1 to Q3. Budesonide prescriptions increased 39.0% YoY to KRW 1.4 billion in Q4 2021, then soared to KRW 3 billion in Q4 last year. This year, sales of budesonide continued to increase, recording KRW 2.5 billion and KRW 2.8 billion in Q1 and Q2, respectively. The cumulative prescription amount for budesonide in Q3 this year was KRW 6.9 billion, approximately 3 times higher than the KRW 2.3 billion it had raised during the same period in 2021. The prescription market for budesonide increased significantly with the surge in the number of confirmed COVID-19 cases since the end of 2021. Recently, the demand for asthma drugs has increased due to the increase in not only confirmed cases of COVID-19 but also cold and flu patients, resulting in a supply-demand imbalance where supply cannot meet demand Prescriptions for Pulmican and Pulmicort both surged from the end of 2021. Pulmicort’s quarterly prescriptions from 2020 to Q3 2021 ranged around KRW 300 million to 500 million. It jumped 36.6% YoY to KRW 800 million in Q4 2021 and exceeded KRW 1 billion in Q4 last year. The cumulative prescription amount for Pulmicort in Q3 this year was KRW 3.4 billion, up 194.7% from the cumulative KRW 1.2 billion in Q3 2021. Pulmican’s quarterly prescriptions from Q1 2020 to Q3 last year fell below KRW 1 billion. However, sales surged to KRW 1.8 billion in Q4 last year, and recorded KRW 1.5 billion and KRW 1.4 billion in Q1 and Q2 this year, respectively. The cumulative prescription amount of Pulmican in Q3 this year was KRW 3.4 billion, a threefold increase from 2 years ago. The price hike for Pulmicort and Pulmican is expected to expand the prescription market for budesonide. However, since the market size is not large, its financial burden on Korea’s health insurance is expected to be minimal. Pulmican recorded prescriptions worth KRW 4.7 billion from Q4 last year to Q3 this year. If a drug price increase rate of 18.5% is applied, the annual prescription volume will increase by about KRW 900 million. Pulmicort has recorded prescriptions worth KRW 5.3 billion in the past year, and if its drug price increases by 12.5%, the annual increase is expected to be about KRW 700 million. When the cost structure of Pulmican and Pulmicort is improved and the supply and demand instability is resolved through increased production, the prescription volume is expected to increase further. The price hike of Pulmican and Pulmicort is the fourth drug price increase case. The Ministry of Health and Welfare raised the insurance price ceiling of 18 acetaminophen 650mg items by up to 76.5% in December last year. The insurance price limit for 650mg acetaminophen, which ranged between KRW 43 to 51 before then, was raised to KRW 90. The government made an unprecedented decision to raise the price of all acetaminophen together when pharmaceutical companies expressed reluctance to increase production due to the drug’s poor cost structure. However, it is a temporary increase that will be adjusted to KRW 70 from December this year. The MOHW has also raised the price of magnesium hydroxide-based laxatives since last June. The price of Magmil was raised by 27.8% from KRW 18 to KRW 23. Cho-A Pharmaceutical's Marogel was raised from KRW 15 to KRW 22, and Sinil Pharm’s M Tab Sinil was raised from KRW 16 to KRW 22. In October, the prices of the 4 types of pseudoephedrine single-agent drugs were increased by up to 45%. The insurance price of Sinil Pharm’s Pseudoephedrine Tab Sinil increased by 45% from KRW 20 to KRW 29. The price of Sam Il Pharmaceutical's Sudafed rose 39% from KRW 23 to KRW 32. The insurance drug price of Sama Pharm’s Schdafen and Kolon Pharmaceutical's Cosue was raised by more than 30% from KRW 23 to KRW 30 and KRW 31, respectively.
- Company
- Series of sales right transfers occur in KOR
- by Kim, Jin-Gu Nov 27, 2023 06:07am
- Competition between domestic pharmaceutical companies has been heating up for the rights to copromote vaccines by multinational pharmaceutical companies. With new products being released one after another in Korea, domestic companies are intent on becoming partners to secure these vaccines that generate stable cash flow. In fact, over the past 2 years, 6 domestic pharmaceutical companies were found to have been competing to copromote 15 vaccines by 2 multinational pharmaceutical companies. The joint sales partners are showing mixed responses depending on whether they have secured the domestic sales rights for the vaccines. Eight MSD vaccines will be jointly sold by Boryung Biopharma and Kwangdong Pharmaceutical, instead of HK Inno.N According to industry sources on the 24th, MSD’s partner in joint sales and distribution of its 7 vaccines will be changed from HK Inno.N to Boryung Biopharma and Kwangdong Pharmaceutical starting next year. In addition, Boryung Biopharma will copromote another new vaccine for MSD in addition to the existing vaccines. Boryung Biopharma will sell the shingles vaccine ‘Zostavax,’ the pneumococcal vaccine ‘Prodiax 23,’ the rotavirus vaccine ‘RotaTeq,’ and MSD’s newly approved pneumococcal vaccine, ‘Vaxneuvance’ Kwangdong Pharmaceutical will sell the HPV vaccines ‘Gardasil,’ and ‘Gardasil 9’ from next year. The copromotion partners for the hepatitis A vaccine ‘Vaqta’ and the measles/mumps/rubella vaccine 'MMR2' have not been determined yet. The pharmaceutical industry predicts that it is highly likely that MSD will sign an agreement with a third party other than Boryung Biopharma and Kwangdong Pharmaceutical for the two vaccines. MSD With the switch, MDS will part ways with HK inno.N, which it had previously jointly sold all 7 of its vaccines. HK inno.N had signed an agreement with MSD in November 2021. For the 2 years from then to this year, the company jointly sold the 7 MSD vaccines in Korea. At the time, the two parties were known to have signed a ‘2+1 contract.’ Under the contract, HK Inno.N was supposed to carry out joint sales for 2 years, and then choose whether to extend the contract for 1 year. After the predetermined 2 years had passed, MSD and HK Inno.N mutually agreed not to exercise the one-year extension option. Entangled copromotion agreements… 6 domestic pharmaceutical companies compete for 2 years HK Inno.N entered the vaccine market by signing a copromotion agreement with MSD in 2021. Before then, Zostavax, Gardasil, and Gardasil had been sold by GC Biopharma, RotaTeq, Prodiax 23, Vaqta, MMR2 by SK Bioscience. In that situation, HK Inno.N signed a copromotion agreement to jointly sell all 7 of MSD’s vaccines. In this process, a chain transfer of sales rights occurred among vaccines. After terminating the copromotion agreement for the 4 MSD vaccines, SK Bioscience won a new copromotion contract for 5 GSK vaccines. These included Boostrix, Menveo, Havrix, Priorix, and Cervarix, which had been previously sold by Yuhan Corp. At a similar period, the sales rights of GSK’s flu vaccine Fluarix Tetra, which was jointly sold by GC Biopharma, had been transferred to Kwangdong Pharmaceutical. Kwangdong Pharmaceutical has been jointly selling Fluarix Tetra with GSK since the winter season of 2021. As such, sales rights transfer for 15 new vaccines have been made between 6 domestic pharmaceutical companies. Regarding the reason for the change in partners by multinational pharmaceutical companies, industry analysts believe that this is the result of intensified competition among domestic pharmaceutical companies to secure distribution rights for vaccines by multinational pharmaceutical companies. Vaccines from multinational pharmaceutical companies generate stable cash flow as expensive ‘premium vaccines’ in the domestic market. In fact, in the case of Zostavax, it had raised over KRW 50 billion in sales before COVID-19. Even during the prolonged COVID-19, it has posted sales of over KRW 20 billion. Gardasil and Gardasil 9’s sales had also exceeded KRW 60 billion. Last year, its sales had increased to exceed KRW 140 billion. The reason why the copromotion agreement with HK Inno.N had not been extended despite the company’s significant contribution to the sales growth can also be interpreted along the same lines. Boryung Biopharma and Kwangdong Pharmaceutical, which became new partners, may have offered better contract terms. From MSD's perspective, the fact that it can focus more on the promotion of its new product, Vaxneuvance, is also cited as a reason for changing partners. Vaxneuvance is a 15-valent pneumococcal vaccine, which was approved in Korea for the first time in 13 years. Vaxneuvance is expected to compete directly with Pfizer's Prevenar 13. It is analyzed that the company chose to change its partner in order to focus on competition with Prevenar 13, which virtually dominated the domestic pneumococcal vaccine market with sales of KRW 40.9 billion last year. GSK signs 2 companies as partners for its single shingles vaccine ‘Shingrix’ Pic of ShingrixGSK’s shingles vaccine ‘Shingrix’ is also considered an example of intensifying competition among domestic pharmaceutical companies to secure co-promotion contracts. GSK signed a copromotion agreement for Shingrix with GC Biopharma and Kwangdong Pharmaceutical in October last year. Typically, co-promotion between multinational pharmaceutical companies and domestic pharmaceutical companies is made as 1:1 contracts. However, in the case of Shingrix, a 1:2 contract was signed. GC Biopharma will focus on internal medicine and family medicine, where active inoculations occur, while Kwangdong Pharmaceutical will focus on pediatrics, obstetrics and gynecology, and dermatology departments and clinics. Shingrix has received much attention even before entering the domestic market due to its superior preventive effect over existing vaccines. The prevailing view was that it would record unrivaled sales in the shingles vaccine market, which is worth KRW 40 billion per year. As a result, GC Biopharma and Kwangdong Pharmaceutical competed fiercely for the domestic partner position, and a contract was made in an unusual form called a 1:2 contract. Shingrix’s market share has been increasing rapidly after vaccinations began in earnest in December last year. Shingrix's market share surged from 29% in Q1 this year to 47% in Q2 and became the market lead. In Q3, its share increased to 51%, accounting for over half of the market. HK Inno.N to suffer a KRW 200 bil gap in sales… Boryun Biopharma and Kwangdong’s sales to increase Domestic pharmaceutical companies are expected to experience joys and sorrows with the change in partner companies. For HK Inno.N, a sales gap worth 200 billion won is inevitable. On the other hand, Boryung Biopharma and Kwangdong Pharmaceutical are expected to split the sales of KRW 200 billion, as of last year. Zostavax, RotaTeq, and Prodiax 23, sold by Boryung Biopharma, recorded sales of KRW 54.1 billion last year. Adding the sales of the new vaccine Vaxneuvance, annual sales will increase to exceed KRW 50 billion. Kwangdong Pharmaceutical is expected to benefit the most. Last year’s sales of Gardasil and Gardasil 9 amounted to KRW 143.7 billion. Kwangdong Pharmaceutical is also in charge of sales of Shingrix. Kwangdong Pharmaceutical recorded sales of KRW 41 billion in the vaccine sector alone by Q3 this year. When adding on the sales of Gardasil and Gardasil 9, which amount to around KRW 140 billion next year, the sales volume of its vaccine sector is expected to expand to reach nearly KRW 200 billion in annual sales.
