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- 2026-05-11 15:31:14
- Company
- “Reimb standard for hemophilia should align with approvals"
- by Jung, Sae-Im Apr 14, 2023 05:49am
- Young-Sil Park, Treasurer of KSH The Korean Society of Hematology has set out to narrow the gap between the approved indication and reimbursement standards for hemophilia treatments. Through the amendment, KSH aims to apply the optimal dose and dosing schedule for each patient as personalized treatment strategies have settled as the standard for maintenance and prevention therapies. Therefore, whether the government will accept the new reimbursement standard plan proposed by the KSH remains the focus of attention. Young-Sil Park, Treasurer of KSH (Department of Pediatrics, Kyung Hee University School of Medicine), met with reporters on the 13th and said “We have submitted a proposal for the amendment of the reimbursement standards for hemophilia drugs in the Fall last year and is awaiting results. Although there are several steps left to final reimbursement extensions, I heard that HIRA has shown a positive response." The amendment to the reimbursement standards that KSH proposed can largely be divided into two parts. Increasing dose amount and frequency of administration. Currently, the reimbursement standard is set narrower than the approved maximum dose and number of administrations. For this reason, it has been pointed out that the treatment effect may be reduced due to insufficient single dosage amount depending on the patient. Therefore, KSH’s argument is that the maximum level in the reimbursement standard should be set at the same level as each drug’s indication. Drug reimbursement standard improvement plan, reconstituted by Dailypharm Specifically, KSH requested the dosage allowed for administration with each reimbursement to be increased from the current 20-25 (IU/kg) to a maximum of 50. The amendment would allow the dose to be increased flexibly according to the patient's condition, with the dose for standard half-life formulations to range from 20 to 40 (20 to 50 for children under 6 years of age) and extended half-life formulations to range from 40 to 50. These are the scope of dosages specified in the label for each formulation. The KSH also suggested the reimbursed number of monthly administrations allowed for patients should be expanded. According to the current reimbursement standard, patients can visit the hospital once or twice a month and receive a total of 10 doses of standard half-life treatments. Severely ill patients are allowed up to 12 doses. A total of 7 doses (8 doses for severely ill patients) are reimbursed for extended half-life drugs during the 1-2 visits per month. Drug reimbursement standard improvement plan, reconstituted by Dailypharm This means that standard half-life drugs can be administered three times a week for severe patients. However, experts pointed out that it is often necessary to adjust the frequency of administration depending on the patient's condition. Accordingly, the proposed amendment stipulates that 'if the trough concentration level cannot be maintained at 1% or higher 48 hours after setting and administering the maximum dose allowed according to the individual pharmacokinetic test result, administration of an additional dose up to the maximum dose permitted in the label may be accepted.’ Treasurer Park said, “Currently, patients are administered treatments three times every 7 days, on Day 2, Day 4, and Day 7. In some cases, almost no clotting factors remain in the body on the third day for some patients. Our proposed improvement to the plan offers an increased number of administrations so that the optimal effect can be achieved for those whose minimum coagulation factor level is not maintained on the second day.” The KSH is requesting another revision 4 years after the reimbursement standards for hemophilia treatment were revised because the hemophilia treatment has now been expanded to maintenance and preventive therapies. In the past, treatment of hemophilia was centered around ‘replacment therapy', in which clotting factors were administered when bleeding occurred. In recent years, the treatment paradigm has evolved to 'maintenance and prevention therapy', which prevents bleeding in advance by regularly administering clotting factors even without bleeding events. Furthermore, ‘personalized treatment', where a patient’s administration cycle and dose are customized in consideration of the patient's symptoms, living environment, and pharmacokinetics, has emerged as a trend. Currently, the treatment goals for patients with severe hemophilia consist of maintenance and prophylaxis therapies. Also, the introduction of drugs with extended half-life has reduced the required number of regular administrations, and an application that allows patients to determine their pharmacokinetic levels has been introduced, customized maintenance and prevention therapy have settled as the standard of care. However, the reimbursement standards that have been set in the past are narrower than the scope approved, which limits the realization of customized maintenance and prevention therapy. Park added, “The reimbursement standards for hemophilia have improved a lot compared to the past. I believe that a change in the reimbursement standard is necessary to achieve the optimal effect for patients in line with the changes made to the domestic treatment environment and the hemophilia treatment environment. I look forward to the government's positive decision that can allow personalized treatment for each individual in consideration of each patient’s factors."
- Company
- “Olumiant rises as a new option for alopecia areata”
- by Jung, Sae-Im Apr 13, 2023 05:46am
- A new treatment option has emerged in the field of severe alopecia, an area where no option other than local steroid therapy had existed until now. The drug gained attention from patients with severe circular hair loss due to its safe and high therapeutic effect. However, it remains unclear whether the indication for circular hair loss will be able to rise to the right to benefit. Lilly Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 12th and explained the meaning of expanding the indication for severe circular hair loss of the JAK inhibitor 'Olumiant (ingredient: baricitinib)'. Oh-sang Kwon, professor of Dermatology at Seoul National University Hospital, and Bark-Lynn Lew, Professor of dermatology at Kangdong Kyunghee University Hospital, explained the current state of alopecia areata in Korea, the disease burden, and the effects of Olumient. Professor Kwon served as the vice president of the Korean Hair Research Society and Professor Lew serves as the Academic Director of her academic society. Professor Oh-sang Kwon (left) Professor Bark-Lynn Lew (right) According to Professor Lew, as of 2021, about 170,000 patients visit the hospital with alopecia areata a year in Korea. Young patients in their 20s to 40s account for about 60% of the AA population. Unlike general hair loss caused by hormones, alopecia areata is classified as one of the symptoms of an autoimmune disease. The immune system mistakenly recognizes part of one’s hair as a foreign substance, and the hair falls out. Unlike general hair loss, in which the hair gradually thins, the forehead widens in the shape of an M, and the hair loss expands, in alopecia areata, one or several circular bald areas with clear boundaries occur on the scalp. Bald spots can occur not only on the scalp, but also anywhere on the hair, such as eyebrows, beard, armpit hair, and pubic hair. Professor Lew added, “Most hair loss is naturally cured and responds well to treatment, but about 40% of patients experience recurrence within a year, and in severe cases, all hair on one’s scalp or body falls out and progresses to widespread alopecia. Alopecia areata is a chronic autoimmune disease, which has a high risk of autoimmune disease complications such as atopic dermatitis at the same time and can have a significant impact on the quality of life of patients. Its lifetime prevalence of the psychiatric disorder is up to 74%." he explained.” Before Olumiant, there was no treatment approved for severe alopecia areata. Instead, topical steroids were used off-label for patients with mild symptoms. However, the efficacy evidence was limited on its use while the risk of side effects was high from long-term steroid use. The efficacy of Olumiant was demonstrated through the Phase III BRAVE-AA1 and BRAVE-AA2 trials that were conducted on a total of 1,200 patients with severe alopecia areata. Koreans participated in both studies. The trials’ primary efficacy endpoint was a SALT score of 20 or less. SALT stands for Severity of Alopecia Tool score. 41%, and 37% in the group treated with Olumiant for 52 weeks in AA1 and AA2, respectively, achieved the primary efficacy endpoint. At the time, improvements in eyebrow and eyelash coverage were also observed. The company plans to further confirm the effectiveness and safety of Olumiant treatment for up to 200 weeks. Professor Kwon said, "What is noteworthy in the 52-week extension study is that the regrowth effect of scalp, eyebrows, and eyelashes continued to improve for up to 52 weeks when treated with Olumient 4mg. This shows that long-term treatment may be required to achieve maximum benefit in AA patients." Patients’ responses were also positive. Professor Lew said, "Although it is reimbursed yet, about 60% of patients were willing to use Olumiant when it was recommended. This is twice more than my expectations, indicating the high willingness to treat among the patients.” However, it is expected that the AA indication will not be covered for the time being. Lilly Korea said, "It's only been a month since the indication was added, so nothing has been decided or progressed related to reimbursement yet. We will make efforts to expand access to Olumiant in AA patients with high unmet needs.”
- Policy
- Domestic approval of Pemazyre is imminent
- by Lee, Hye-Kyung Apr 13, 2023 05:45am
- Domestic approval of Pemazyre, a treatment for advanced or metastatic cholangiocarcinoma, is imminent. According to the pharmaceutical industry on the 13th, the Ministry of Food and Drug Safety recently completed a safety and efficacy review of Pemazyre. Completing the safety and efficacy means that sooner or later, the product approval process will begin. Pemazyre is approved in the United States, Europe, and Japan for treating adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy. In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment for life-threatening or serious diseases since December. Previously, the US FDA designated Pemazyre as a breakthrough therapy for the treatment of previously treated patients with advanced, metastatic, or unresectable FGFR2 translocation cholangiocarcinoma, and designated it as an orphan drug, conducting an expedited review through a priority review program. Cholangiocarcinoma is a rare type of cancer and is classified according to its anatomical origin into intrahepatic cholangiocarcinoma (iCCA) arising from the bile duct existing inside the liver and extrahepatic cholangiocarcinoma arising from the bile duct outside the liver. Cholangiocarcinoma is often diagnosed at an advanced or advanced stage with a poor prognosis. FGFR2 fusions or rearrangements are found in 10-16% of patients with intrahepatic cholangiocarcinoma. FGFRs play important roles in the proliferation, survival, migration, and angiogenesis of tumor cells. FGFR fusion, rearrangement, translocation, and gene amplification activities are closely related to the development of various cancers. Pemazyre is an oral FGFR inhibitor and is the first and only treatment approved by the FDA for this indication. After the domestic approval of Pemazyre, Handok will exclusively take charge of domestic distribution and supply.
- Policy
- Decreased commitment to production/sales/new generics
- by Lee, Jeong-Hwan Apr 13, 2023 05:45am
- "Financial expenses for health insurance drugs are calculated by multiplying volume and price. The government has been engrossed in finding reasons for reducing drug prices and establishing policies for decades while neglecting efforts to reduce usage." "(To the government), it seems that the price adjustment of generic drugs is always recognized as the easiest and easiest way. For pharmaceutical companies that are constantly striving to create new drugs, generics are the driving force. Only pharmaceutical companies that do not directly produce drugs or do research and development Please consider the hard way to regulate tweezers." Domestic pharmaceutical companies are becoming more concerned as the Ministry of Health and Welfare is preparing a policy for preferential drug prices for innovative pharmaceutical companies and moving to reduce the price of generic drugs at the same time. It is a reality that generic drugs are already cut as soon as they are cut and it is difficult to go down further, and they are playing a role as a cash generator for pharmaceutical companies that are keen on R&D. Appeals from pharmaceutical companies come out. In particular, as the 2nd Vice Minister of Health and Welfare Park Min-soo is personally leading the policy for this move to adjust generic drug prices, there are even burdensome observations that the price-cutting policy equivalent to the past batch drug price cuts and cascading drug price systems will be triggered. According to pharmaceutical industry sources on the 9th, the Ministry of Health and Welfare is in the midst of preparing and announcing a policy for price adjustment of generic drugs as well as a policy for giving preferential prices to medicines and essential medicines made by innovative pharmaceutical companies in the near future. The Ministry of Health and Welfare has held five public-private consultative body meetings since last February to reflect the appropriate value of innovative new drugs, which were completed last month. The Ministry of Health and Welfare is expected to disclose a policy proposal based on the results of the council meeting at the end of April at the earliest and begin collecting opinions from the pharmaceutical industry. In addition, the public-private consultative body to prepare measures to adjust or lower generic drug prices is expected to quickly begin seeking specific policies from this month, starting with a kick-off meeting at the end of last month, right after the innovative new drug consultative body meeting. The domestic pharmaceutical industry sees this move by the Ministry of Health and Welfare as a full-fledged commitment to the 'trade-off' drug price policy. It is the opinion that the Ministry of Health and Welfare chose the policy goal of sacrificing generics for preferential prices for innovative new drugs. Ironically, the Ministry of Health and Welfare's drug price trade-off was initiated by the National Assembly's request to resolve the fact that sub-statutes for preferential drug prices for innovative new drugs within the 'Special Act on Promotion and Support of the Pharmaceutical Industry' had not been made for several years. The National Assembly pressed the Ministry of Health and Welfare by repeatedly emphasizing the legitimacy and necessity of converting the sub-statute on preferential drug prices for innovative new drugs from the current voluntary regulation to mandatory regulation, and the Ministry of Health and Welfare promised to create a sub-statute as soon as possible instead of amending the law. At the same time, the Ministry of Health and Welfare made clear its will to "lower generic drug prices." On top of that, starting on the 8th, 170 generics for single and combination drugs of Forxiga, which have prescriptions exceeding 90 billion won per year, were released to the market all at once. As a result, the Ministry of Health and Welfare entered the process of materializing the willingness to cut drug prices, which was revealed in an inquiry about generic drug prices by Rep. Choi Jae-hyeong of People’s Power in a parliamentary audit in October last year. In response to this move by the Ministry of Health and Welfare, the domestic pharmaceutical industry is evaluating that it has chosen an easy way to secure health insurance finances by reducing generic drug prices. Some are criticizing that the drug price was cut from the two pillars of health insurance finance, 'Volume' and 'Drug Price', to secure financial soundness and secure financial resources for innovative new drugs. In particular, rather than blindly lowering the price of generic drugs, pharmaceutical companies should look closely at each company's management to make generics that contribute to health insurance finances or exclude companies that do not neglect R&D investment to discover new drugs from the reduction targets. They are also requesting consideration of delicate administration. “In order to create a preferential drug price system for innovative new drugs as soon as possible, we did not stop at operating a public-private consultative body to collect opinions from pharmaceutical companies, but also pulled out a generic drug price cut card,” said a drug price manager at domestic pharmaceutical company A. It is not true, but it is very regrettable that the Ministry of Health and Welfare blindly chooses an easy way to touch the price of generic drugs.” An official from Company A said, "Even if the price of generic drugs is reduced, we have to think about reducing the amount of usage together with drug prices, such as reducing unnecessary prescriptions by analyzing the prescription patterns of domestic drugs, but the Ministry of Health and Welfare shows no signs of doing so. There are many cases where prescriptions are not necessary or for a longer period of time than necessary. It is easy to price a drug with a pharmaceutical company, and it is difficult to adjust the prescription amount with a doctor. A person in charge of drug prices at domestic pharmaceutical company B also said, “Regulate pharmaceutical companies that are only making temporary money through CSO sales without having a production plant or new drug R&D efforts, and pharmaceutical companies that make and sell generics themselves and use them as cash cows for new drug development can lower drug prices. “I hope the government will think about a delicate policy that does not cut prices,” he said. A person in charge of company B said, "I don't expect much from the enactment of sub-statutes for drug price preferential treatment. Prior to preferential treatment, we need to select pharmaceutical companies that are making generics and new drugs properly, and create an environment in which the pharmaceutical company's drugs can be properly sold in the market."
- 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.”
