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- 2026-06-28 06:18:50
- Company
- Supreme Court dismissed again
- by Chon, Seung-Hyun Apr 13, 2023 05:44am
- Pharmaceutical companies won a complete victory in the 2nd round suspension of execution of the lawsuit to cancel the reduction of benefits for the brain function improving Choline alfoscerate. Following Daewoong Bio Group, Chong Kun Dang Group also issued a ruling in the Supreme Court to suspend the implementation of wage reduction until the main lawsuit in the second trial is over. According to the industry on the 7th, the 3rd Special Division of the Supreme Court dismissed the decision of the Ministry of Health and Welfare to suspend the enforcement of choline drug benefit reduction. It is a decision to suspend the effect until the 30th day from the date of adjudication of the cancellation case of the ‘Announcement of Partial Revision of Details on the Application Criteria and Methods of Medical Care Benefit’, which contains the reduction of health insurance benefits for choline preparations. This means that 26 pharmaceutical companies including Chong Kun Dang and 8 individuals will not be able to reduce benefits until the end of the second trial in progress with the Ministry of Health and Welfare to cancel benefit reduction for choline drugs. This means that the benefit reduction will not be implemented until the end of the second trial of the ongoing lawsuit against the Ministry of Health and Welfare between 24 pharmaceutical companies such as Daewoong Bio and one individual to cancel the benefit reduction of choline drugs. In August 2020, the Ministry of Health and Welfare issued a partial revision notice of ‘Details on the Application Criteria and Methods of Medical Care Benefits’, which contains the content of reducing the scope of benefits for choline preparations. It is content that increases the cost burden rate from 30% to 80% when patients who have not been diagnosed with dementia use cholinergic drugs. After the Ministry of Health and Welfare issued a notice, a lawsuit began all at once. Pharmaceutical companies filed a lawsuit to cancel the notice of reduction in benefits. The lawsuit was filed in two groups according to the legal representative. Law firm Shin & Kim filed a lawsuit on behalf of 39 companies, including Chong Kun Dang, and eight individuals, while Lee & Ko, a law firm, took on the lawsuit for 39 companies, including Daewoong Bio, and one person. However, the Chong Kun Dang Group lost in July of last year, and Daewoong Bio also received a ruling in November of last year. The pharmaceutical companies filed an appeal and also requested a suspension of execution of the reduction in benefits. The suspension of execution requested by Daewoong Bio Group was cited in December of last year. The Ministry of Health and Welfare requested an appeal for suspension of execution, but the Supreme Court also sided with the pharmaceutical companies last month. The Chong Kun Dang Group’s request for suspension of execution also received a ruling in November of last year, “Suspend the enforcement of the public notice until the 30th day from the date of the second trial judge.” Pharmaceutical companies have all led to the suspension of execution in the first trial of the lawsuit for cancellation of benefit reduction. Pharmaceutical companies filed a lawsuit to cancel the reduction in benefits in 2020 and requested suspension of execution to suspend the implementation of the reduction notice until the main lawsuit. The lawsuit for suspension of execution was also filed in two groups according to the legal representative. The suspension of payroll reduction enforcement requested by Chong Kun Dang and others was completed until the Supreme Court ruling in April 2021. In September 2020, the Seoul Administrative Court made a decision to suspend execution, and in the appeal trial in December of the same year, the court sided with the pharmaceutical companies. The Supreme Court upheld the decision of the lower court even in the appeal of the suspension of execution. The suspension of execution of choline drugs, which was raised by Daewoong Bio and others, was cited in October 2020, and nine months after the Ministry of Health and Welfare appealed, the second trial also issued a decision citing the suspension of execution. In October of last year, a ruling was dismissed in an appeal filed by the Ministry of Health and Welfare. From the pharmaceutical company's point of view, it means that they have won all 10 cases of suspension of execution of choline drug benefit reduction. Looking at the ruling in the case of suspension of execution, the court judged that "there is no reason to admit that there is a concern that the suspension of choline drugs may have a significant impact on public welfare." The court pointed out that due to the reduced reimbursement for cholinergic drugs, patients may find themselves in a situation where they have to continue to be prescribed the drug or give up taking it while bearing a considerably higher co-payment than before. The court judged that if benefits were reduced because the clinical usefulness of choline preparations was not proven, the trust and reputation of choline preparations and the reputation of pharmaceutical companies could be damaged, and the related market could suffer a major blow.
- Company
- SK Bioscience declares its vision
- by Kim, Jin-Gu Apr 13, 2023 05:43am
- SK Bioscience announced on the 12th that it held a vision proclamation ceremony at Andong L House on the 11th and pledged to become a 'global bio hub' through 'One Goal, One Team'. About 450 executives and employees attended the vision proclamation ceremony, including Ahn Jae-yong, CEO of SK Bioscience, Kim Hoon, CEO of Global R&BD, and Lee Sang-gyun, plant manager (vice president) of L House. The vision proclamation ceremony consists of a time to look back on the achievements and major milestones that L House has achieved during the COVID-19 pandemic and to share future strategies and goals at the time of transition to the endemic era. SK Bioscience shared the future strategy of 'SKBS 3.0', which consists of specific action tasks and action plans to grow into a global company in the endemic era, and a 'digital establishment plan'. In addition, to achieve the One Goal of 'Global Innovative Partner of Vaccine and Biotech', the members of L House were asked to join forces as one team in the future. In particular, the acquisition of cGMP (Current Good Manufacturing Practice) from the U.S. Food and Drug Administration (FDA) was selected as a key task for L House to achieve SK Bioscience's vision. Along with this, SK Bioscience plans to solidify its position as a global vaccine production hub by expanding facilities of about 1,067,616 sqft in L House. In addition, it plans to build a global top-tier R&D network through the 325.7 billion won Global R&PD Center being established in Songdo, Incheon with the goal of completion in 2025. Ahn Jae-yong, CEO of SK Bioscience, said, "Today's vision proclamation ceremony is a place where the members of House L announce their will to achieve 'One Goal' by gathering strength through the 'One Team' culture." We will secure a vaccine portfolio and promote sustainable growth.” Lee Sang-gyun, Plant Manager, said, “SK bioscience has been able to stand at the center of the response to the COVID-19 pandemic over the past three years because of the valuable efforts of L House members.” I am grateful to the staff," he said.
- InterView
- Samsung Bio, investing in Swiss ADC bio company
- by Hwang, Jin-joon Apr 13, 2023 05:43am
- Panoramic view of Samsung Biologics. (Photo Samsung Biologics) Samsung Biologics announced on the 12th that it invested in Araris Biotech AG through the 'Samsung Life Science Fund' along with Samsung C&T. This investment was conducted exclusively by Samsung as a strategic investor (SI) prior to Araris Biotech AG's Series A phase. The investment is expected to be used for the further development of antibody-drug conjugate (ADC) candidates by Araris Biotech AG. ADC is a drug that combines a drug with an antibody and is one of the next-generation treatments. Araris Biotech AG is a company established in 2019 through the Federal Institute of Technology in Zurich, Switzerland. It has next-generation ADC linker technology. Araris Biotech AG's next-generation ADC linker technology has the advantage of attaching drugs to off-the-shelf antibodies without the need to redesign the antibody. This can reduce the time and cost required for drug development. Samsung plans to cooperate with Araris Biotech AG in the field of ADC treatment production and development. Previously, in July 2021, Samsung created a life science fund worth 150 billion won to discover new businesses in the biofield.
- Company
- LSK's contracts for early-phase clinical trials increase
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- After analyzing Korea’s clinical trial trend through the number of its contracted research, LSK Global Pharma Services Co., Ltd. (LSK Global PS) announced that the number of early-phase clinical trials increased significantly recently. As of March 2023, the company’s number of contracted clinical research was 1,503, including 164 global clinical trials and 1,339 domestic clinical trials. Since its establishment in 2000, the company’s number of contracted research cases reached 1,000 in 2018 and then increased by 50% in 5 years thereafter. By research type, the number of Phase III clinical trials was the highest at 372 cases, and the rate of increase or decrease in the trials compared to 2018 showed that early phase trials such as Phase II clinical trials (▲ 62%) and Phase I clinical trials (▲ 49%) increased the most. A similar trend can be observed when dividing the domestic clinical trial approval status by phases. In the past, late-stage clinical trials were more actively conducted than early-stage clinical trials in Korea. However, with various domestic clinical trials being conducted by CROs and accumulated experience, early clinical trials are now being actively conducted, and related infrastructure has also been established. To accommodate the increase in demand, in 2021, LSK Global PS explained that it has been providing differentiated services by operating a team dedicated to early-phase trials to respond to the increasing demand for early-phase clinical trials. This also aligns with the global drug development trend. Anticancer drugs are still the most actively researched area in new drug development due to high unmet demand, and 10 to 20 new drugs are approved by the US FDA every year in the area. In Korea, R&D investment and recruitment of research personnel in the field of anticancer drugs is being actively carried out recently. Young-Jack Lee, CEO of LSK Global PS, said, “Unlike treatments for other diseases that are highly prevalent, there are many factors to consider when developing an anti-cancer drug, such as disease complexity, tumor heterogeneity, toxicity, and resistance, and require huge time and monetary investments. LSK Global PS offers medical consulting throughout clinical trials for anticancer drugs from setting target patient groups, study design, and efficacy endpoint suggestions to help establish and conduct strategic clinical trials.” A total of 129 clinical trials (54 global, 75 domestic) related to Investigational New Drug Applications (IND) that are conducted to receive approval from regulatory authorities were found to be in progress. By clinical stage, Phase I and Phase II clinical trials, and by disease group, anticancer drugs increased the most, showing a similar trend with the change in the total number of contracted clinical research. In addition to the continuous rise in the number of contracted clinical research related to new drug development, marked growth has also been observed in the fields of digital therapeutics and medical devices. Compared to 2018, the number of contract clinical research cases for medical devices had increased around threefold, 10 of which trials are related to digital therapeutics. LSK Global PS newly established a medical device clinical team in January of last year to provide more specialized services.
- Policy
- The results of the PVA improvement plan study were disclosed
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- The NHIS, which is promoting PVA improvement, disclosed the results of service research conducted last year and announced plans to seek improvement measures with the private sector in May. In this improvement plan, it is expected that items with a 10% billing amount and more than 5 billion won will be added to the Ka-type negotiation target, which is a new drug, and a plan to raise the standard for exclusion from negotiation to 3 billion won to 5 billion won a year will be pursued. According to industry sources on the 11th, the NHIS released last year's 'PVA Performance Evaluation and Improvement Study,' in which Bae Seung-jin, professor of pharmacy at Ewha Womans University, participated as the research director. This seems to be a measure to secure transparency of the improvement plan by disclosing the research results internally and externally prior to the working group in May. The results of the study mainly suggest ways to relax the existing standards in terms of financial savings. In the case of Type Ka, it is currently included in the negotiation only if the billing amount increases by more than 30%, but like Types Na and Da, a plan to include items with a billing amount of 10% & 5 billion won or more were included. If items with an increase of 10% & 5 billion won or more in the ka type are included in the negotiation target, the amount of savings will increase by about 4.4 billion won (22.4 billion → 26.8 billion won) as of 2022. In addition, as a short-term improvement plan, it was proposed to increase the efficiency of negotiations and system acceptance by raising the exclusion standard from the current claim amount of 2 billion won to 3 to 5 billion won. Some of the research results were also disclosed at the meeting of Sang-Il Lee, executive director on salary, with the Korea Special Press Association on the 7th. The NHIS plans to make a booklet of the research results and distribute them to pharmaceutical organizations such as KRPIA, and to hold a meeting at the end of April prior to the operation of the working group in May. The working group runs from May to August and aims to implement improvement measures next year by revising related regulations in the second half of the year.
- Policy
- 16% of PVA-applied products cut more than 2 times
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- The items with the highest cumulative reduction rate fell 25.2% in total with three cuts. It was found that about 16% of the total products had the upper limit price lowered twice or more with PVA. The remaining 84% of products were cut once. Compared to the pharmaceutical industry's complaints about repeated cuts, the number of products with repeated cuts did not appear high. According to the 'PVA Performance Evaluation and Improvement Study report recently published by the NHIS, 62 product groups (16%) out of 380 identical product groups in which the usage-drug price interlocking system was applied from 2012 to 2021 had an upper limit twice or more. the amount has been reduced. 318 products (84%) of the same product group were cut only once. There were 36 product lines cut twice (19 domestic, 17 multinationals), 15 product lines cut three times (4 domestic, 11 multinationals), and 9 products cut four times (3 domestic, 6 multinational). The maximum number of iteration cuts reaches 6 times. For one product group, the upper limit was lowered six times due to the usage-drug price linkage system. The price of this product in 2012 was reduced by a total of 13.9% due to the application of the system six times. There was also one 5-time cut product line. The research team explained, “Among the products that were repeated less than three times, there were 9 products from domestic pharmaceutical companies and 17 products from multinational pharmaceutical companies. In addition, the product with the highest cumulative reduction rate was cut three times, a total of 25.2%. This investigation stemmed from the complaints of pharmaceutical companies over repeated cuts. Statistically, however, the repeated cut was not so large. The research team said, “About 16% of the total product groups were subject to repeated application twice or more, and when applied three or more times, they were generally blockbusters. At 14%, it was relatively low compared to the increase in finances.”
- Company
- PharmaEssentia attempts to reimb its first new drug BESREMi
- by Eo, Yun-Ho Apr 12, 2023 05:53am
- The Taiwanese pharmaceutical company PharmaEssentia is attempting to list its first new drug ‘Besremi’ for reimbursement. According to industry sources, PharmaEssentia submitted an application for the reimbursement of its polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) on March 28th. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be reimbursed is gaining attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The response rates at 72 months were high at 80.4% and 65.3% in low-risk and high-risk patients, respectively, and showed high hematologic and molecular responses. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in terms of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment options available for use and had no option but to wait for their condition to progress further. He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera by the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
- Policy
- The alternative drug pricing system will be improved
- by Nho, Byung Chul Apr 12, 2023 05:53am
- It is expected that the specific direction of the public-private consultative body for rational drug price calculation of domestically developed innovative new drugs will be set, and system improvements will be promoted from May at the earliest. According to the industry, the public-private consultative body for improving the drug pricing system, composed of officials from the Ministry of Health and Welfare, KPBMA, and KRPIA, has held five rounds of discussions since last December and is expected to give positive incentives to new drugs. The drug price system improvement classification plan that the health authorities and the industry have formed a consensus on ▲innovative value for new drugs, ▲recognition of appropriate value for natural medicines (formerly new natural medicines), ▲derived system improvement for raw material self-sufficiency, and ▲stabilization of pharmaceutical supply maintenance of the period of accrual of the amount, etc. This proposal is a point of convergence in the larger framework, and the specific calculation method needs to be narrowed down through a general meeting of the public-private consultative body around the middle of this month. The most noteworthy part is the method of assigning value to new drugs and IMDs, and it is expected to be able to receive up to 10% higher drug prices than existing ones. If the alternative drug was reduced to 53.55% due to patent expiration, an additional 86.8% (100% 53.55%) is requested. IMD is expected to be recognized for up to 110% of development target products, including drugs for which the Ministry of Food and Drug Safety has approved data submission, as well as new usage and dosage. It is also eye-catching to prepare measures to strengthen its status as the originator of oriental medicine and to promote herbal medicine and herbal preparations. In the case of herbal medicines with improved clinical usefulness, it is likely to apply an additional 110% of the highest price of alternative medicines. For drugs using domestically produced drug substances, the additional period will be extended from 1 year to 5 years, and an exception to the follow-up management system will be applied. It is expected that the system will be improved so that if the number of companies for administration routes and products of the same dosage form is two or less, the addition of already-listed products will be maintained until there are three or more.
- Policy
- Leukemia Scemblix·Onureg passed the Evaluation Committee
- by Lee, Tak-Sun Apr 11, 2023 06:11am
- Leukemia treatments Scemblix and Onureg are recognized for their suitability for reimbursement and will move on to drug price negotiations with the NHIS. The HIRA held the 4th Pharmaceutical Reimbursement Evaluation Committee and reviewed the appropriateness of reimbursement for the six drugs for which the decision was applied. As a result of the deliberation, two out of six items passed, one item conditionally passed, two items failed, and one item decided to be re-discussed. The items that passed the committee first were Scemblix and Onureg. Scemblix 20, 40 mg is indicated for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) previously treated with 2 or more TKIs. At the beginning of the year, the Cancer Disease Review Committee succeeded in setting the reimbursement standard. Onureg 200, 300 mg is used for maintenance therapy after induction therapy in adult patients with AML. The item that passed conditionally was Nephoxil 500mg (ferric citrate monohydrate) from Kyowa Kirin Korea. This drug is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Tabrecta 150 and 200mg and Vyndamax 61mg are items that have not passed the committee due to non-reimbursement decisions. Tabrecta is a drug used for locally advanced or metastatic non-small cell lung cancer in which MET exon 14 skippings have been confirmed, and Vyndamax is a rare disease treatment used for ATTR-CM. Meanwhile, Lilly's RET-targeted anti-cancer drug Retevmo 40, 80mg will be discussed again. This drug has efficacy and effectiveness in RET fusion-positive non-small cell lung cancer, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer.
- Company
- Luxturna, a one-shot retinal disease treatment
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- Luxturna, a one-shot retinal disease treatment, is once again aiming to enter insurance coverage. As a result of the coverage, Novartis Korea recently resubmitted a reimbursement application for Luxturna, a treatment for Inherited Retinal Dystrophy. This is a quick resumption of the process after the HIRA's non-reimbursed decision last month. As the company's will to be listed on the salary is firm, it remains to be seen whether this re-challenge will be successful. This drug submitted an application for reimbursement in September 2021, but there was no progress in the listing process so far, and it was first introduced this year. Although it is expensive one-shot gene therapy, it seemed difficult to register because the disease is not directly related to life. Luxturna restores the function of the defective or defective RPE65 gene, one of the causes of IRD, by replacing it with a normal gene with just one administration. This means that the fundamental treatment of the disease is possible. Therefore, the key is how much Luxturna can achieve the value of preventing blindness. This drug was designated by the US FDA as Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained expedited approval in 2017. IRD is a rare and intractable disease in which vision loss occurs due to mutations in the gene responsible for the structure and function of retinal photoreceptors. It includes more than 20 different eye diseases, and there are about 300 causative genes. IRD caused by RPE65 gene mutation causes an abnormality in the visual cycle in the retina, which converts visual information entering the eye into nerve signals and transmits them to the brain. RPE65 gene mutation reduces the RPE65 protein, which is essential for visual circuitry, and destroys retinal cells, gradually narrowing the field of vision and eventually leading to blindness. Luxturna proved its effectiveness through a phase 3 clinical trial targeting patients with hereditary retinal diseases in which a biallelic mutation in the RPE65 gene was confirmed. As a clinical result, the functional vision of patients treated with Luxturna improved statistically significantly compared to the control group who did not receive treatment at 1 year of treatment. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT), which evaluates the ability to pass through an obstacle course of various heights in various levels of illumination by recreating a daily walking environment, as the primary evaluation variable at 1 year of treatment, Luxturna treatment group The score change of was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.
