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- 2026-04-11 09:37:17
- Policy
- CDDC blindly opposes applying RSA to Tabrecta and Rybrevant
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- The National Assembly criticized how the Cancer Disease Deliberation Committee has been undermining the purpose of the Risk-Sharing Agreement system that waives submission of PE evaluation data and disapproved reimbursement of anticancer drugs and rare disease treatments. The committee has not allowed reimbursement of these drugs that have already been granted marketing authorization from the Ministry of Food and Drug Safety for lacking Phase III trial data, although the drugs cannot conduct Phase III trials. On the 13th, Rep. Ki-Yoon Kang of the People Power Party claimed so while referring to the data submitted by the National Health Insurance Service. According to the minutes of the CDDC meeting from 2018-2020, HIRA opposed reimbursing Tabrecta tab., which is used to treat patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. HIRA also rejected reimbursement of Rybrevant, a rare NSCLC treatment present in only 2% of all NSLCL patients with EGFR mutations in Korea. As conducting a placebo-controlled Phase III trial on the small number of end-stage cancer patients that are eligible for the drug was impossible due to ethical reasons, the companies of the two drugs demonstrated the clinical efficacy and safety of their drugs through a single-arm Phase II trial, received MFDS approval, then applied for reimbursement to HIRA after satisfying the RSA requirements. Rep. Kang criticized how the CDDC blindly opposed their reimbursement for being unable to evaluate the drug’s efficacy with only Phase II trials without considering the circumstances. According to Article 6-2 of the ‘Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits,’ the RSA Pharmacoeconomic evaluation exemption regulation was established to reinforce patient access to severe and rare disease treatments, and 2-a of the same clause allows PE exemption for drugs that were approved by the MFDS with single-arm clinical trial data that does not have a control group. Anticancer drugs like Tabrecta or Rybrevant that treat life-threatening conditions have already been recognized for their clinical efficacy by the Ministry of Food and Drug Safety through a single-arm Phase II trial, but it is ethically impossible to set up a control group that consists of severe cancer patients who have less than a year of expected survival period left. This is why there is criticism that the CDDC’s disallowance of reimbursement of these drugs under the pretext of the absence of Phase III clinical trial data undermines the purpose of the PE Waiver System which works to reinforce patients' access to treatments for severe rare diseases. In addition, Rep. Kang also criticized the CDDC's decision for violating the function of the MFDS itself, which evaluates and approves the efficacy and safety of drugs. Rep. Kang said, “The CDDC’s non-allowance of reimbursement of drugs that have no alternatives and cannot conduct Phase III trials completely contradicts the national task of increasing patient access to treatments by rapidly listing drugs that treat life-threatening conditions. CDDC should review reimbursement of anticancer drugs and rare disease treatments that are directly related to the survival of patients in accordance with regulations.” He added, “The CDDC requesting Phase III clinical data for drugs that meet the requirements of the PE exemption system is excessive administration, and the committee needs to focus on reviewing the clinical necessity in line with its original function to allow patients to receive reimbursement as soon as possible.”
- Company
- PARP anticancer drugs raise expectations of ovarian cancer
- by Oct 14, 2022 05:53am
- Lee Taek-sang, professor of obstetrics and gynecology at Boramae Hospital, Seoul Metropolitan Government As benefits are applied to the primary maintenance therapy of PARP inhibitors in ovarian cancer treatment in Korea, the treatment site is rapidly changing. Above all, a specialist evaluates that the use of PARP inhibitors for early treatment has significantly improved the patient's prognosis. However, the expansion of benefits and commercialization of HRd diagnosis in BRCA negative patients are considered tasks to be improved. ◆ Improved prognosis with recurrent ovarian cancer and PARP inhibitors Unlike other solid cancers, ovarian cancer has less remote metastasis and excellent sensitivity to anticancer drugs. Therefore, regardless of the stage of ovarian cancer, surgery and chemotherapy are considered the first-line treatment. However, the initial symptoms were insignificant, so cancer was often diagnosed after progression, and eight out of 10 patients suffered recurrence after the first treatment, making treatment difficult. PARP inhibitors have made new changes in the treatment of ovarian cancer. In the past, in addition to cytotoxic anticancer drugs, vascular endothelial growth factor (VEGF) inhibitors have appeared, but they were far from customized treatments due to specific biomarkers. PARP inhibitors were able to perform customized treatment according to biomarkers such as BRCA and homologous recombination deficiency (HRd). In an interview with Dailypharm, Lee Taek-sang, a professor of obstetrics and gynecology at Boramae Hospital, said, "PARP inhibitors have improved ovarian cancer prognosis and changed the treatment paradigm with survival rate. The PARP inhibitors used in Korea are Takeda's Zejula and AstraZeneca's Lynparza. Recently, PARP inhibitors in the U.S. have withdrawn their indications for the fourth or higher treatment of ovarian cancer, but the impact is expected to be minimal as both drugs are used in early treatment such as primary maintenance therapy. ◆ Same but different Zejula Lynparza Zejula and Lynparza show some differences in primary maintenance therapy. Basically, both drugs are used as maintenance therapy in platinum-sensitive patients, while Zejula can be used regardless of BRCA or HRd, while Lynparza can be used alone in BRCA-positive and in combination with Avastin in HRd-positive patients. Professor Lee said, "Lynparza is also likely to be effective in patients without BRCA or HRd mutations, but there is no indication because it was only for patients with BRCA mutations in the clinical trial on the basis of permission." Zejula added that through large-scale phase 3 clinical trials, consistent data are also available in BRCA-negative and HRp (homologous recombinant negative) patients. Health insurance benefits apply only to BRCA-positive patients on both drugs. In addition, when Lynparza is used as primary maintenance therapy, the benefit is applied only up to two years after initial administration, while Zejula can be used continuously until recurrence. This is because the follow-up period was only up to two years in clinical trials on which Lynparza permits were based. In addition, the two drugs also show differences in the number, dose, and safety profile of the drug. This difference is the standard for selecting drugs in the clinical field. Professor Lee said, "Lynparza is taken twice a day, but Zejula is taken only once a day. In addition, Zejula has data that shows consistent treatment effects even with adaptive doses, he said. "The more worrisome part is the benefit recognition period, and patients taking Lynparza are converted to non-reimursement two years after the benefit is applied," he said. ◆What is the direction of ovarian cancer treatment? The disappointing part of the benefit standard is the BRCA-negative patient. Zejula also demonstrated consistent benefits in BRCA-negative patients but was not recognized for benefit adequacy in the group. Professor Lee said, "It is certain that Zejula is helpful in this patient group, but the patient has to make a difficult decision because the drug has to be used as a non-payment." For HRd biomarkers, improving the diagnostic environment is a priority. Unlike the BRCA test, the HRd test method has not yet been commercialized, so it is limited to some institutions on a trial basis. The cost of the test also amounts to 5 million won. It is judged that more patients will be able to benefit from PARP inhibitors only when an environment where HRd tests can be freely used at the medical site is created. Professor Lee said, "If the results show that PARP inhibitor + Avastin combination therapy is more meaningful, the treatment pattern and paradigm can be changed again. In this case, the drug will be selected in consideration of the side effects and cost problems caused by Avastin, he said. "If the non-inferiority results show that there is no significant difference between the two treatments, it is expected to be a landslide victory for PARP inhibitor alone."
- Company
- The release of a flu vaccine exclusively for the elderly
- by Oct 13, 2022 06:09am
- The development of domestic companies is still far away. In order to prevent influenza (flu) infection in the elderly, a high-performance vaccine with improved preventive effects will appear in Korea. One of the two representative products has been approved in Korea, and the other is likely to be introduced. According to the pharmaceutical industry on the 13th, CSL Seqirus's tetravalent flu vaccine Fluad, which contains immunostimulants for the elderly aged 65 or older, has completed domestic approval and is preparing for its introduction. Due to the schedule, it is difficult to sell in the 2022-2023 season, but it is expected to be released next year during the flu season. Sanofi is also considering introducing a high-dose flu vaccine in Korea for those aged 65 or older. In the United States, it has been sold under the name Fluzone since it was approved in 2019. ◆ Influenza vaccines that have increased effectiveness for the elderly with reduced immunity appear Older people aged 65 or older are considered high-risk groups for flu, so active prevention is recommended with vaccination. Korea provides free flu vaccinations to senior citizens aged 65 or older through NIP. However, with conventional vaccines, the preventive effect tends to be somewhat reduced in the elderly with a reduced immune system. Accordingly, flu vaccine developers have started to develop new vaccines to increase preventive effects. Fluad, developed by CSL Seqirus, can improve the immune response by adding an immune enhancer called MF59. MF59 is an immune enhancer made using squalene ingredients produced in the liver. MF59 induces a cellular immune response to promote antigen absorption by antigen-presenting cells, thereby increasing the immune response through the activation of T cells and B cells. Even with a small amount, it can exert a strong antibody effect. MF59 was also used during the swine flu epidemic in 2009. According to a study by CSL Seqirus comparing the difference in disease burden according to the type of vaccine for senior citizens aged 65 or older in Korea, it is predicted that the burden of flu-related diseases will be significantly reduced when switching from the existing flu vaccine to a vaccine containing immune enhancers. Vaccines containing immunostimulants are expected to prevent 35,390 cases of flu, 1,602 cases of flu-related complications, 709 cases of hospitalization, and 145 cases of deaths per year compared to existing vaccines. Fluzone, developed by Sanofi, is a product that increases the number of antigens, unlike Fluad, which has added immune enhancers. It is known to have four times more antigens than existing doses. It was first approved in the U.S. in 2019 and is considering introducing in Korea. It is predicted that vaccinations with high doses will reduce the burden of diseases similar to vaccines containing immunostimulants. ◆ Vaccination for the elderly being reorganized with high-performance In the United States, flu vaccines for the elderly are changing mainly to high-performance products. This is because the analysis of studies in recent years has proved that high-performance vaccines are more advantageous in reducing the risk of hospitalization and death in the elderly over 65. In terms of safety, side effects such as pain at the injection site were reported more frequently after high-performance vaccination, but they were resolved naturally over time. Based on this, the U.S. ACIP revised its flu vaccination guidelines and recommended that senior citizens aged 65 or older receive a high-dose flu vaccine (Fluzone) or a flu vaccine containing immunostimulants. On top of that, only recombinant vaccines containing three times more antigens than existing vaccines were additionally included in the recommendation list for vaccination for the elderly. When the domestic high-performance flu vaccine market opens, multinational pharmaceutical companies are expected to dominate the market for a while. This is because only one domestic company is developing a high-performance flu vaccine, and even this has been slow to develop. GC Pharma has started developing GC3114, the first high-capacity flu vaccine in Korea. In 2018, the phase 2 clinical trial plan of GC3114 was approved and the clinical trial was completed the following year, but it was found to be in a holding state for three years. It is estimated that it will take more than five years to commercialize it as it has not yet entered phase III and has not set a specific schedule.
- Company
- How about collaboration?
- by Kim, Jin-Gu Oct 13, 2022 06:09am
- 4th largest population in the world, the advantage of clinical performance. Indonesia is emerging as a new market for the Korean pharmaceutical bio industry. In addition to the potential of being the world's fourth-largest population, the pharmaceutical market seems to be expanding rapidly as national income has recently increased overall. In line with this trend, the Indonesian government is strengthening benefits for locally produced drugs. Analysts say that for Korean pharmaceutical bio companies seeking to enter Indonesia, establishing local subsidiaries or collaborating with Indonesian companies will be an effective strategy rather than directly exporting. ◆ Indonesian government emphasizes local production On the 12th, "Global Bio & Pharma Plaza 2022" was held at Lotte Hotel World in Songpa-gu, Seoul, hosted by the Ministry of Trade, Industry and Energy. Dr. Banun attended the "Pharmaceutical Overseas Advancement Strategy Briefing" held together on the same day at the Indonesian Ministry of Health to explain the recent changes in Indonesia's policy to foster the pharmaceutical industry. According to him, the Indonesian Ministry of Health has been planning to foster the pharmaceutical and medical device industries with a 10-year long-term plan since 2016. The key is to encourage the production of medicines, raw materials for medicines, and medical devices in Indonesia. Tinkat Komponen Dalam Negeri (TKDN) was specified, and for raw material drugs, the proportion of domestic production was increased to 65%. Through this, the Indonesian government's goal is to reduce the high dependence on imports of raw materials and drugs. Dr. Banun said, "By 2024, we will make efforts to develop the pharmaceutical industry at the national level." He said, "In particular, we are focusing on the domestic manufacturing and production of medicines. "We will spare no financial support for the domestic production of major drugs," he explained. "Whether it's raw material or finished product, it's giving a lot of benefits to companies that produce medicines in Indonesia," he said. He said, "We are attracting overseas pharmaceutical companies by establishing free economic zones along with special tax cuts. "If Korean pharmaceutical companies collaborate with Indonesia, we expect good results," he stressed. ◆"Daewoong and Chong Kun Dang's cooperation with local companies, best practices for entering Indonesia" Dr. Banun cited Daewoong Pharmaceutical and Chong Kun Dang's entry into Indonesia as an exemplary example. Among Korean pharmaceutical companies, Daewoong Pharmaceutical entered Indonesia in 2012 and Chong Kun Dang in 2015 through joint ventures with local companies. Daewoong Pharmaceutical completed the construction of a pharmaceutical plant in Surabaya in cooperation with local pharmaceutical company Infion. This factory is certified halal for medicine. Currently, it ranks first in the anemia treatment (EPO) market in Indonesia. Chong Kun Dang entered the local market through a joint venture with another local pharmaceutical company, OTTO. In 2018, it completed the first halal-certified anticancer drug plant in Indonesia. Dr. Banun emphasized the "halal certification" received by the two pharmaceutical companies. Halal certification is essential in addition to its own GMP certification to enter Indonesia, he explained. "Daewoong Pharmaceutical and Chong Kun Dang have successfully established themselves as halal-certified pharmaceutical companies," Dr. Banun said. "It is a successful case of cooperation between Korean and Indonesian companies." Dr. Banun said, "In Indonesia, Halal certification is required. If there is a Korean company entering Indonesia, (the Ministry of Health of Indonesia) will help with quick certification, he said. "If we get halal certification here, it will be easy to enter the Middle East or other Southeast Asian countries that need the same certification." ◆ Interested in cooperation with Korean pharmaceutical companies in drug and health product development" In the case of Genexine, a joint venture named Kalbe and KGBIO is being established and developing immuno-cancer drugs GX-17 and new anemia drug GX-E4. "In the case of Indonesia, it has the advantage of conducting clinical trials as the world's fourth-largest population," said the CEO. "In recent years, interest in health products has also been heating up." "We are interested in developing cooperative relationships with Korean pharmaceutical companies that have excellent health products," he said.
- Company
- Dupixent's child benefit expands after over 1 1/2 yrs
- by Eo, Yun-Ho Oct 13, 2022 06:08am
- Discussions on expanding insurance benefits for children and adolescents of Dupixent, a treatment for atopic dermatitis, have been slow. According to related industries, Sanofi-Aventis Korea's Dupixent 200mg passed the Drug Benefit Standards Subcommittee in May, but has yet to be submitted to the Drug Benefit Evaluation Committee. The drug was applied for benefit expansion in March last year, but it is still in the early stages of the registration process. Earlier, Dupixent spent seven months until the expert opinion inquiry began last year. As it is an expensive new drug and it was not easy to register for the first time, it is believed that difficulties are also being followed in the discussion of expansion. Although detailed indications are different, there is a clear difference in speed compared to JAK inhibitors such as Lilly Oluminant and Abbvie Rinvoq, which belatedly submitted applications for expansion of atopic benefits. JAK inhibitors are also relatively inexpensive. Both drugs have been reimbursed since May. Since it is a risk-sharing agreement drug and a separate dose of 200mg has been added, it has to go through negotiations with the NHIS as well as HIRA's cost-effectiveness review process in the future. It remains to be seen whether Dupixent will be able to reach an agreement with the government and expand child benefits. Dupixent's health insurance coverage criteria are both 23 or higher EASI (Extremely severe eczema) even if symptoms are not controlled and systemic immunosuppressants are administered for more than 3 months, or if Dupixent is not available due to side effects. This corresponds to 300 mg.
- Company
- Status of antidiabetic SGLT-2 inhibitors rise with use in HF
- by Oct 13, 2022 06:08am
- SGLT-2 inhibitors that were initially released as a diabetes treatment have expanded their scope and risen as a representative heart drug. In addition to Heart Failure with reduced EF (HFrEF) and Heart Failure with mildly reduced EF (HFmrEF), SGLT-2 inhibitors have also demonstrated an effect in Heart Failure with Preserved Ejection Fraction (HFpEF), transforming heart failure guidelines in Korea and abroad. The heart failure treatment effect of SGLT-2 inhibitors, which was first demonstrated with Jardiance (empagliflozin), was confirmed with Forxiga (dapagliflozin). In the EMPEROR-Preserved clinical trial on HFpEF patients, Jardiance succeeded in reaching the primary efficacy endpoint. Then, Forxiga demonstrated its effect in HFrEF and HFpEF patients in the DELIVER trial. Based on such grounds, the Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of heart failure including HFrEF, HFmrEF, and HFpEF. The US has also recommended SGLT-2 inhibitors as the main drug in the guidelines for the treatment of heart failure. Some have compared the SGLT-2 inhibitor to a '21st-century statin' and predicted that it will become a standard of care in heart failure. Dailypharm met with professor Javed Butler from the University of Mississippi Medical Center in Jackson and Professor Seok-Min Kang from the Yonsei University College of Medicine (Chair of KSHF) to highlight the changes SGLT-2 inhibitors brought to the heart failure treatment paradigm. -Among SGLT-2 inhibitors, Jardiance was the first to present data demonstrating an effect on all heart failures including HFpEF. What significance does this hold and how was Jardiance able to become the first SGLT-2 inhibitor to demonstrate such data? ? Prof. Butler: Jardiance marked two milestones in the history of heart failure treatments. First, the drug was the first to demonstrate a reduction in cardiovascular deaths in diabetes patients in 2015 through the EMPA-REG OUTCOME trial. Also, the drug holds significance for being the first to demonstrate clinical efficacy in HFpEF, an area where no treatment option exists, through the EMPEROR-Preserved trial. In patients with HFpEF, Jardiance reduced the relative risk of hospitalization from HF or cardiovascular deaths by 21% and reduced the relative risk of all hospitalization from HF by 27%. This is significant because it can be felt in the field while treating patients, beyond being simply statistical figures. Although the cardiac ejection fraction rate will continue to serve as a key indicator in determining the type of heart failure and the according treatment method, it will not hold much meaning in determining the use of SGLT-2 inhibitors. Furthermore, when discussing treating heart failures, we usually discuss treatment in the spectrum of HFrEF to HFpEF. However, as SGLT-2 inhibitors have also demonstrated a relative risk reduction in the development of new heart failure events in patients with Type 2 diabetes, I would like to expand the spectrum and discuss extending its use to prevention as well. For patients with diabetes or chronic kidney disease (CKD), the best time for them to start treatment with SGLT-2 inhibitors is at the ‘pre-heart failure’ stage. -When comparing the two representative SGLT-2 inhibitors Jardiance and Forxiga, Jardiance showed a slight reduction in effect in the patient group with an ejection fraction rate of 65% or higher, but recent data on Forxiga showed that its effect remained constant in these patients. How should we interpret this difference? Professor Javed Butler Prof. Butler: It would be difficult to say that the results signify any difference between the two drugs. Based on the primary efficacy endpoint, it is difficult to say that the drugs show different efficacy in different ranges of ejection fraction rate. Only in the secondary efficacy endpoint does Jardiance show a slight reduction in effect in the group with an ejection fraction between 65-70%. However, as the drug’s efficacy rises again in the group with an ejection fraction rate of 70% or higher, the measure in the EF of 65-70% group has to be considered a noise that arose in the process of conducting the subgroup analysis. Even when taking into account the biological mechanism and principle of action of SGLT-2 inhibitors, it is difficult to provide a reasonable explanation on why its effect decreases in the EF of 65-70% group and rises again in the EF of 70% or higher group. When looking at the trend lines of clinical trials conducted on Forxiga and Jardiance, although the two may seem contrasting, it is difficult to see the difference as a clear signal indicating a significant difference when comprehensively analyzing the overall data. Also, a comprehensive meta-analysis of these data shows a fairly consistent effect across the entire cardiac ejection fraction rate spectrum. -Then, rather than discuss which drug is better, should we understand that SLGT-2 inhibitors have a class effect? Prof. Butler: It is too soon to consider it a class effect. Of course, the clinical trials of the two drugs that were conducted on patients with HFrEF and HFpEF showed consistent results. However, as we saw in various cases where the results were different after expecting such a class effect in the past, it is hard to prescribe SGLT-2 inhibitors while expecting a class effect. In other words, it would be difficult to put other SGLT-2 inhibitors on the same line other than the two drugs that have proven their treatment effect in heart failure. -The 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure gave a Class 2A recommendation for SGLT-2 inhibitors to treat HFpeF. How was the recommendation for the guideline determined at that level? Prof. Butler: There had been no other treatment option recommended in HFpEF before then. We used diuretics to treat congestion or were at the level of dealing with comorbidities. The US was the first to revise the major practice guidelines for heart failure in HFpEF after the Jardiance trial results were presented. The recommendations were changed based on the convincing trial results. However, the US guidelines require at least 2 related studies to recommend a treatment as Class 1 when revising guidelines. At the time of the revision, only one study - EMPEROR-Preserved – existed for SGLT-2 inhibitors, which was why it was not given a Class 1 recommendation. In Korea, SGLT-2 inhibitors have a Class 1 recommendation in HFpEF. I believe this is a more reasonable and advanced decision than the one made in the Us guidelines. With more relevant data being presented, I believe the US and European guidelines will also be revised to follow Korea’s guidelines. -Until now, the Korean practice guidelines mostly followed those in Europe and the US. What enabled your society to make such a bold decision this time? Prof. Kang: Korea lacks the conditions to conduct large-scale randomized clinical studies like Europe or the United States. This is why Korea commonly sets guidelines by adopting or accepting results from foreign clinical studies. We underwent various voting and debates to determine the level of evidence for several drugs before releasing our heart failure guidelines on July 22nd. Also, the DELIVER trial on Forxiga was scheduled to be presented at the European Society of Cardiology (ESC) Congress 2022 in August. We already knew the top-line results and were able to analyze the results to some extent. Considering how the prevalence of heart failure in Korea will continue to increase rapidly, the prevailing opinion was that it is reasonable to defiantly recommend a good treatment option as soon as possible. -You also mentioned SGLT-2 inhibitors should be used for prevention as well. At what scope are SGLT-2 inhibitors being prescribed in the US? Prof. Butler: As SGLT-2 inhibitors were first introduced to treat diabetes, it was mainly used by primary care doctors or endocrinologists that commonly treat diabetes. In cardiology, there is still a perception that SGLT-2 inhibitors are used to treat diabetes. Therefore, several heart failure-related societies are making efforts to raise awareness of SGLT-2 inhibitors as a treatment that can reduce cardiovascular risk, regardless of the patient’s diabetic status SGLT-2 inhibitors are being moderately used as a treatment for heart failure. However, compared to ARNis, its usage is increasing relatively quickly. -In Korea, the drugs would need to also receive reimbursement in the indication, but setting the reimbursement standards for SGLT-2 inhibitors may also be a difficult task. Even when basing the standards on the cardiac ejection fraction rate, it would be difficult to apply for reimbursement benefits according to the specific ejection rate. Prof. Kang: I cannot say what would be the clear standard for reimbursement, and this area would need to be considered further. When using the level of ejection fraction as a standard, we could set an arbitrary level and reimburse all substandard drugs for other class drugs, but for SGLT-2 inhibitors, we would need to contemplate what should be considered a normal ejection fraction rate. - So SGLT-2 inhibitors are now set in the forefront of heart failure treatment. Are there any tasks we need to solve to select patients that will benefit more from the use of SGLT-2 inhibitors or any precautions that need to be taken? Prof. Butler: SGLT-2 inhibitors are more of a supplement than a replacement of existing drugs. We need to first focus on starting drug treatment as soon as possible, and take into consideration the patient's condition, including blood pressure, cardiac and kidney condition, to start administration of drugs in the appropriate order so that patients can receive all 4 drugs within 3-4 weeks of initial administration. In most cases, we can add SGLT-2 inhibitors without regulating the use of the existing drugs, however, patients who are old, have hypotension, or dehydration may need to reduce their diuretic dose, etc. Prof. Kang: As there are many phenotypes of HFpEF, more follow-up studies on the use of SGLT-2 inhibitors in these various patients would be needed. Some may oppose the prospect that SGLT-2 inhibitors may be beneficial across the entire cardiac ejection fraction rate spectrum. Therefore, data supporting how effective SGLT-2 inhibitors are for the various characteristics of heart failure is needed.
- Policy
- National lot release for Moderna's bivalent COVID-19 vaccine
- by Lee, Hye-Kyung Oct 13, 2022 06:08am
- The 1.57 million courses of the bivalent vaccine manufactured by Samsung Biologics have been approved for national lot release. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the national lot release for 1.57 million courses of Moderna Korea’s domestically manufactured mRNA bivalent COVID-19 vaccine, ‘Spikevax 2’ on the 11th. The national lot release system was implemented to reaffirm the quality of a vaccine through a comprehensive evaluation of the state’s national test and the manufacture and test results of the manufacturer for each manufacturing unit (lot) before they are distributed on the market. Spikevax-2 is manufactured in Korea (by Samsung Biologics) through fill-finish processes after being supplied the API of the same Spikevax-2 vaccine that has been approved for import on September 8th from overseas. The MFDS expects the national lot release approval of the bivalent COVID-19 vaccine will contribute to the prevention of COVID-19 and will continue efforts to ensure a stable supply of quality vaccines through thorough and swift verification of COVID-19 vaccines to come.
- Policy
- The loss of health insurance is close to 200 billion won
- by Lee, Jeong-Hwan Oct 13, 2022 06:08am
- Rep. Nam In-soon said, "The Legislation and Judiciary Committee's pending bill to recover the reduction will be dealt with." Over the past decade, health insurance benefit losses amounted to 19.7 billion won for 17 cases in which pharmaceutical companies lost lawsuits related to weak cuts and re-evaluation. Critics point out that the revision of the Health Insurance Act, which calls for the recovery and refund system of drug prices, should be handled as soon as possible to prevent pharmaceutical companies from suing lawsuits to cancel drug prices. On the 6th, Rep. Nam In-soon of the Democratic Party of Korea said, "We should pass the National Assembly's Health and Welfare Committee and deal with the revision of the Health Insurance Act pending at the Legislation and Judiciary Committee as soon as possible to minimize the loss of health insurance finances and achieve pharmaceutical rights." Regarding the claim that some pharmaceutical companies are concerned that the regulation on redemption within the revision of the Health Insurance Act may neutralize the effect of suspension of execution, a principle of litigation law, Rep. Nam insisted that "it is not persuasive." Considering the ongoing administrative litigation of pharmaceutical companies, administrative trials, and applications for suspension of execution for the drug reduction, and accumulated financial losses on health insurance, she believes the National Assembly should wrap up the legislation as soon as possible. She said, "The provisions for the redemption and refund of the amendment do not limit the application for administrative litigation or suspension of execution itself." She emphasized, "It is a system operated on the premise of filing administrative litigation and administrative trial, and the purpose is to post-calculate losses incurred in the NHIS or pharmaceutical companies during the suspension period according to the characteristics of the profitable health insurance drug price system." Rep. Nam said, "If legality is recognized after the decision to suspend execution, it is similar to the purpose of the Supreme Court ruling in September 2020, which judged that the administration should take active measures the same as if there was no decision to suspend execution," adding, "It is expected to minimize health insurance financial losses and protect pharmaceutical companies' rights." "The loss of health insurance benefits for 17 cases lost by the plaintiff pharmaceutical company out of 49 administrative lawsuits is estimated to be 19.7 billion won, but the financial loss of health insurance due to the difference in drug prices before and after the decision to suspend execution of 49 administrative lawsuits," she added.
- Company
- The third PD-1 immuno-cancer drug is about to enter Korea
- by Eo, Yun-Ho Oct 12, 2022 05:50am
- It is predicted that additional immuno-cancer drugs with PD-1 inhibitory mechanisms will enter the domestic market. According to related industries, the Ministry of Food and Drug Safety is reviewing the final approval of PD-1 inhibitor Jemperli, which GSK Korea submitted an application for permission in March. Approval is possible as early as this year. If Jemperli is approved, it will be the third PD-1 inhibitor after Opdivo and Keytruda. Unlike the two drugs that took the first indication as a treatment for melanoma, this drug was first approved in the United States in April last year as a treatment for "reoccurring or progressive endometrial cancer" indicating a defect in platinum-based therapy or subsequent inconsistency recovery. Jemperli demonstrated its validity through a multi-cohort clinical trial GARNET study involving patients with recurrent or progressive dMMR/MSI-H endometrial cancer that progressed during or after platinum-based chemotherapy. As a result, RR was 43.5% and DCR was 55.6% after Jemperli treatment. The duration of the reaction has not yet reached the median value, and the rates at which the reaction lasted for 6 months and 12 months were 97.9% and 90.9%, respectively. In addition, in August of the same year, Jemperli obtained additional approval for recurrent or progressive solid cancers of adult replication error recovery defects (dMMRs) that did not reach satisfactory results with existing treatment. Jemperli recently confirmed its efficacy in non-small cell lung cancer. GSK announced positive headline results on the 5th that it met the primary evaluation variables RECIST and ORR goals in a phase 2 PERLA clinical study. The study compared Jemperli and chemotherapy combinations and Keytruda and chemotherapy combinations in primary care patients with NSCLC.
- Policy
- 99 items were granted generic exclusivity, none reimbursed
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- ▲ Boehringer Ingelheim diabetes combo drug Although 99 items were granted generic exclusivity, none of the items were granted reimbursement during the period. This was what happened to generics of Boehringer Ingelheim’s Jardiance Duo (empagliflozin+metformin hcl). Although a large number of products were approved and even obtained generic exclusivity, the drugs were unsellable in the market, and the exclusive rights granted for the products became obsolete. According to industry sources on the 11th, the generic exclusivity granted to 99 Jardiance Duo generics ended on August 15th. However, none of the items were listed for reimbursement and sold in the market during the period. This was not unexpected. Although the Jardiance Duo generics succeeded in avoiding subsequent patents and obtained generic exclusivity, they were unable to release their drugs to the market due to a substance patent that was not registered with the Ministry of Food and Drug Safety. The MFDS patent list serves as the standard for granting generic exclusivity. A substance patent for the single ingredient Jardiance is currently listed, but none is listed for Jardiance Duo. Based on the patent list, companies that manufacture Jardiance Duo generics were allowed to release their drugs after approval as they have overcome all of the registered patents by avoiding subsequent patents that are terminated after the substance patent. Thus, all Jardiance Duo latecomers that were approved from November last year to April this year were allowed to be marketed upon approval under the drug approval-patent linkage system, and their generic exclusivity period was also set based on the approval date. The end date was set until August 15th based on the products that were approved in November last year. However, substance patents need to be observed due to the risk of a dispute with the patentee regardless of whether or not it is registered on the MFDS patent list. The substance patent for Jardiance Duo is set to expire on October 23rd, 2025. Ironically, the generic exclusivity of the single-ingredient Jardiance is set to start on October 24th, 2025. In other words, generics of the combination drug Jardiance Duo were unable to be sold in the market even with the generic exclusivity. Then how were 99 items allowed to receive this obsolete generic exclusivity? This is because the restrictions set for the 1+3 consigned bioequivalence tests were implemented in July last year. Pharmaceutical companies that conducted bioequivalence tests after July 2012 could only consign manufacture of same-ingredient drugs for up to 3 pharmaceutical companies. As a result, pharmaceutical companies had entered into consignment agreements before the enforcement of this law and rushed the development of their generics, which resulted in the manufacture of such large number of Jardiance Duo generics. According to the MFDS, Dongkoo Bio&Pharma is currently manufacturing empagliflozin+metformin hcl products on consignment for 24 pharmaceutical companies (71 items in total). Such large-scale consignment manufacture was possible because the generic was developed before the enforcement of the consigned bioequivalence test restriction law. As the approved items may only be sold after 4 years from now, it seems inevitable that all of the test products manufactured for approval will have to bd discarded. This means that much social cost was wasted due to the new regulations. Couldn't the generics rather be regulated through drug prices? The Ministry of Health and Welfare had announced a drug pricing system in July 2020, one year before the enforcement of the consigned bioequivalence test restriction law. The system focused on reinforcing the standard requirements for self-bioequivalence tests and a stepped drug pricing system. Under the new system, generics are required to conduct self-bioequivalence tests and be listed within the 20th in the reimbursement list to maintain its base price, which is 53.55% of the insurance ceiling price of the original drug. However, the system could be bypassed as many items that apply for reimbursement at the same time are listed at the same time and considered a single group, and not discounted their price even if the number exceeds 20. Jardiance Duo generics will also be able to avoid the stepped pricing system by applying for the insurance price at the same time before patent expiry. However, such waste from large-scale approvals will not be made for items that were developed after the bioequivalence restrictions were set last year, as only 4 companies at most will be approved at once.
