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- 2026-05-14 01:01:08
- Policy
- Empagliflozin's permission changes
- by Lee, Hye-Kyung Sep 19, 2022 05:56am
- Epilepsy neurosurgery is added to the abnormal reaction of a formulation containing Empagliflozin, an SGLT-2 inhibitor used to treat type 2 diabetes. The Ministry of Food and Drug Safety announced a change in permits based on the results of a review of safety information on Empagliflozin-containing drugs by EC and EMA. The drugs that announce the change of permits are 104 items such as Jardiance, an Empagliflozin-based drug of Beringer Ingelheim Korea, 106 items such as Jardiance Duo, an Empagliflozin and Metformin complex, and SGLT-2, an Empagliflozin and Linaglipin complex. As a result of a review by the Ministry of Food and Drug Safety, "interstitial neurosurgery" is added to the abnormal response term for both Empagliflozin and complex drugs. Serum Li concentrations should be observed more frequently after administration and dose change of Empagliflozin, and patient care should be referred to the doctor who prescribed Li for observation of serum lithium concentrations. The review opinion inquiry on the change of permission (proposal) will be held until the 30th. Meanwhile, SGLT-2 inhibitors, which started as type 2 diabetes treatment, are expanding their scope to heart failure. Last year, SGLT-2 inhibitors were recommended as a major drug for chronic heart failure treatment in domestic heart failure treatment guidelines.
- Company
- Breast cancer drug Nerlynx can be prescribed
- by Eo, Yun-Ho Sep 19, 2022 05:56am
- Breast cancer drug Nerlynx can be prescribed in general hospitals. According to related industries, the oral tyrosine kinase inhibitor Nerlynx, which inhibits Bixink Therapy's HER2 protein, passed the Drug Committee (DC) of the Big 5 Advanced General Hospital, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. However, as it is still a non-reimbursed drug, it is expected to take some time until the prescription is reimbursed. This drug was submitted to the Health Insurance Review and Assessment Service in February, but it was judged that the benefit standard was not set. Bixink Therapetics plans to submit it again in the second half of this year. HER2-positive early breast cancer has a 1.89 times higher tendency of brain metastasis than HER2-negative breast cancer. The high incidence of brain metastasis is interpreted to mean that it directly affects the survival rate. When comparing the 5-year survival rate of metastatic breast cancer in Korea, the 5-year survival rate of patients with cerebral metastasis is only 10.7%, which is a significant difference compared to the 34% of patients with metastatic breast cancer. Compared to the past, a number of HER2-positive early breast cancer target treatments have been developed. However, in the case of current standard therapy treatments, drugs that prevent brain metastasis or prove treatment effects are still insufficient. In a five-year long-term follow-up study, Nerlynx reduced the risk of recurrence or death in HER2-positive early breast cancer women by 42% and reduced the risk of developing or dying of brain metastasis by more than 59%. Nerlynx was originally a drug developed by Puma Biotechnology in the U.S., and was first approved by the U.S. FDA as an extended adjuvant therapy for early HER2 positive breast cancer patients in July 2017. In February 2020, the indication for the treatment of metastatic HER2 positive breast cancer was expanded. Bixink introduced Nerlynx in Korea in October last year, and the current indication is "extension adjuvant therapy for early breast cancer patients who are HER2 positive and hormone receptor positive within one year of the completion of Herceptin-based treatment after surgery."
- Policy
- Drug price negotiation completed 307 drugs in 2022
- by Lee, Tak-Sun Sep 16, 2022 05:53am
- The number of drugs that completed drug price negotiations between the NHIS and pharmaceutical companies increased significantly from 15 years ago. As drug price negotiations began in earnest in 2007, the expansion of PVA negotiations is believed to be the cause. According to the NHIS' recent list of drugs that completed drug negotiations, the number of drugs that completed drug negotiations exploded from only 10 in 2007 to 307 in 2020. Drug price negotiations began in May 2006 with the introduction of a "plan to optimize drug costs" to stabilize health insurance finances. At the end of that year, guidelines for drug price negotiations were enacted, PVA negotiations as well as new drug drug negotiations, and later RSA were introduced. Looking at the number of drugs that have completed annual drug price negotiations, the number exceeded 100 for the first time in 2009 and surpassed 200 in 2011. 2020 is the only drug that has completed more than 300 negotiations. Last year, 238 drugs completed drug price negotiations, and 273 drugs have already completed drug price negotiations by August this year. As 172 items completed negotiations in the PVA multi-type negotiations in August, the number of drugs that completed drug negotiations has already exceeded last year. This year, Lutathera, Vitrakvi , Rozlytrek, Lorviqua, Zolgensma, Fexuclue, Donerion patch, Zerbaxa also successfully completed drug price negotiations. However, the number of drug price negotiations completed is increasing, but there are also disappointing opinions in the pharmaceutical industry. In particular, there are many calls for quick registration of salaries by shortening the duration of drug price negotiations. The corporation recently revised the guidelines for drug price negotiations, predicting that drug price negotiations will be shortened from 60 days to 30 days for treatments for severe and rare diseases without alternative drugs.
- Policy
- “GOV to prove causal relationship of vaccine side effects"
- by Lee, Jeong-Hwan Sep 16, 2022 05:53am
- The ruling party has set out to enact a Special Act to obligate the nation to compensate for damages caused by COVID-19 vaccinations. The Special Act was proposed because the compensation for damages caused by COVID-19 vaccinations currently implemented by the government is too passive in recognizing the causal relationship between vaccination and its side effects. To address this, the new law strengthened the government’s duty of post-vaccination management by obliging the Commissioner of the Korea Disease Control and Prevention Agency to bear the burden of proof when a dispute related to side effects, such as diseases caused by vaccination, arises. On the 14th, People Power Party member Gi-yun Kang submitted a bill to enact a ‘Special Act on Compensation for Damages from COVID-19 Vaccinations’ as a representative. Currently, vaccinations are being conducted and the damage compensated by the state under the “Infectious Disease Control and Prevention Act” to prevent the spread of infectious diseases and to promote public health. NA Rep. Kang pointed out that the current national compensation system is very passive in recognizing the causality between adverse reactions from vaccinations and vaccine’s side effects. To address this, Kang proposed a bill that can provide compensation to victims by including the adverse events and side effects from vaccinations as damages caused by vaccinations. If passed, the bill will prioritize compensation for damages arising from vaccinations above other laws. Also, for damages caused by vaccination, the state will pay national compensation after deliberation and resolution by the Vaccination Committee. In particular, in resolving disputes about damage caused by vaccination, the burden of proof will be borne by the Commissioner of the Korea Disease Control and Prevention Agency. Also, the Special Act included a provision to establish a Vaccination Committee that can check the causal relationship between vaccination and arising diseases to raise the public’s credibility.
- Opinion
- [Reporter’s View] Evrysdi awaits reimb review for over 1 yr
- by Eo, Yun-Ho Sep 16, 2022 05:53am
- One year has passed since the company applied for insurance reimbursement but to no avail. No progress has been made on the matter, not even the frequent news of the agenda being rejected by the Drug Reimbursement Evaluation Committee has been heard on the matter. Although the reimbursement application for the spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ had been submitted in July last year after its approval in November 2020, the agenda has not been listed for deliberation on any of the lists disclosed by the Health Insurance Review and Assessment Service. There is a deadline for each stage of HIRA’s reimbursement assessment. The current overall reimbursement review period is 150 days, and the government had announced a systemic reform to reduce the period to 120 days. However, this period is often not kept. This is why the industry was not so enthusiastic about the reform plan. In the case of Evrysdi, its review period had already exceeded 150 days earlier this year, as the company had once failed to pass the Drug Reimbursement Standard Subcommittee and reapplied for reimbursement after supplementing data. On this, the Solidarity Against Disability Discrimination issued a statement last month when Zolgensma started being reimbursed, asking HIRA to abolish the reimbursement discontinuation standards set for another SMA treatment, ‘Spinraza (nusinersen),’ and the prompt reimbursement discussion to be made for Evrysdi. SADD had pointed out that SMA patients are being left unattended in the blind spot because HIRA is postponing discussions on Evrysdi just to discuss it in line with the adjustment made for Spinraza’s reimbursement criteria. So Evrysdi, which has applied for and is awaiting review, is still waiting in line after a year without even a single discussion made for its reimbursement and remains a ‘pie in the sky' for the patients. The importance of providing a clear explanation of an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a system, which raises more questions than an introduction or abolition of a system. However, the government has never provided an explanation on drugs that were extended their drug pricing negotiation period after passing the set deadlines. And more and more drugs receiving reviews for reimbursement listing or standard extensions or are being left without news. In the current “high-priced drug era,” plenty of very effective but expensive drugs are being introduced to the market. Therefore, it can be difficult for the government and the pharmaceutical company to reach an agreement within the set ’60-day’ period. In particular, the area of SMA treatments had been an ongoing issue due to their high price. However still, the emphasis needs to be laid on the word, deadline. Deadline is a promise. Also, the NHIS has described the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. In other words, the period is set for the final negotiation period to speed up listing and allow others to estimate the time to listing or rejection. Also, the people need to know why the negotiation fell through so that they could criticize the faulty party and find a compromise.
- Policy
- The introduction of Moderna COVID-19 vaccine has begun
- by Kim, Jung-Ju Sep 16, 2022 05:53am
- Moderna's omicron mutation (BA.1) bivalent vaccine of 1.611 million doses will be introduced in Korea sequentially from today (15th). According to the Korea Centers for Disease Control and Prevention, 805,000 doses will arrive at Incheon International Airport on the 15th and 806,000 doses on the 17th, respectively, and will be used for winter vaccinations in October after the Ministry of Food and Drug Safety approves the lot release. The vaccine to be introduced this time is a divalent vaccine containing two antigens (the virus and omicron mutation BA.1), and was approved by the Ministry of Food and Drug Safety on the 8th. The detailed implementation plan for winter vaccinations using divalent vaccines will be announced at the end of September when divalent vaccines are prepared. The government will continue to closely consult with pharmaceutical companies for a stable supply of vaccines, and will promptly guide the additional supply schedule as soon as it is set. The authorities have contributed to the international community through overseas donations along with related ministries such as the Ministry of Foreign Affairs, and have donated a total of 4.86 million doses to nine countries since last year. In addition, 4.83 million doses of the AZ vaccine, which was distributed through COVAX, were also provided to COVAX without introduction in Korea.
- Product
- Benefit standards are the key to the migraine market
- by Whang, byung-woo Sep 16, 2022 05:52am
- Treatment options are also changing at clinical sites as CGRP (calcitonin gene-related peptide)-based migraine treatments are entering or about to enter the benefit range. However, given that the standard is high, it is expected that patients who receive actual benefits will be limited, so it is evaluated that the task to expand accessibility remains. CGRP-based drugs are attracting attention in migraine treatment because they target CGRP pain-causing substances in the migraine market, which has not had a suitable treatment. This is why existing drugs are relatively free from side effects in that they have a mechanism to target only CGRP if they generally suppress pain-causing substances. This is already being paid attention not only abroad but also in Korea. The Korean Headache Society also recommended the use of CGRP treatment as a preventive drug for adult chronic migraine patients in the revised medical guidelines. (Criteria level: I, Recommended level: Strong for). Currently, CGRP target antibody treatments in Korea have entered the market with Lilly's Emgality first, and Handok Teva released Ajovy last year. With high prices still acting as a hurdle, the number of prescription options has also increased as Emgality entered the benefit range on the 1st. In addition, Ajovy, a competitive drug, is also expected to enter the benefit range soon as it is set to negotiate drug prices after passing the 9th Drug Benefit Evaluation Committee review. Experts are also paying attention to the reduction in drug prices due to the entry of benefits. According to the announcement by the Ministry of Health and Welfare, the burden of patient costs has been reduced from about 3.8 million won to 1.15 million won due to the application of Emgality's benefit. Cho Soo-jin, chairman of The Korean Headach Society, said, "The migraine itself has been used at a cost burden in that it hinders the quality of life and reduces work efficiency," adding, "The fact that migraine treatment has been paid is important in that it is the beginning to expand into areas where migraine is recognized as essential." It is good news that many patients hesitated to receive treatment due to high costs. Lee Won-gu, a professor of neurology at Kosin University Hospital, said, "It has been difficult for medical staff to recommend treatment to patients due to price barriers." He said, "As we have entered the salary, accessibility will improve from the perspective of medical staff and patients." However, some say that there may be fewer patients than expected as Emgality's benefit standards are difficult. According to the Ministry of Health and Welfare, Emgality's detailed criteria for health insurance benefits are preventive measures for chronic migraine patients aged 18 or older that meet the International Headache Classification (ICHD-3) diagnostic criteria. A response evaluation (headache period, MIDAS, etc.) should be conducted every three months before administration begins (within the last month) and after administration, and the administration period is applied for up to 12 months, patients who have a history of migraine for at least one year, have a monthly headache for at least six months before administration for at least 15 days, and have migraine headaches for at least eight days a month, and patients who have failed to treat three or more types of migraine prevention drugs within the last year (with the maximum dose of each drug, the number of migraine days per month does not decrease by 50% or cannot be used as side effects or taboos even after at least 8 weeks), if looking at the details. Professor Lee said, "There was a discussion among experts that there was a risk of cutting if the standards were not used well for patients who needed to be used," and explained, "As we need to prove the records, history of treatment, and headache period, we think the prescription may be limited at primary clinics or general hospitals." If the use of the treatment is recognized for up to one year or if the treatment effect is not proven every three months, the elimination is also expected to be a task in the future. Cho said, "If CGRP-based treatments are recognized as a single drug, they are recognized for up to one year, but in some cases, 18 months or more may help patients." He said, "Even if Ajovy enters the benefit, it is currently stipulated that the drug cannot be changed, so it remains to be seen how to evaluate this part in the future."
- Company
- Companies are ending a series of phase 3 of core R&D
- by Lee, Seok-Jun Sep 15, 2022 05:55am
- Samchundang ends phase 3 of Eylea biosimilar. Top line of Ildong's Zochova will be unveiled around November. Pharmaceutical companies' core R&D phase 3 is ending one after another. Corporate value is expected to change depending on the results. Some companies are seeking foreign permission using phase 3 data. DAE HWA recently completed an application for permission for Liporaxel, a gastric cancer drug containing Paclitaxel. The application for permission is based on Liporaxel efficacy and safety data. The clinical trial compared the efficacy and safety of Liporaxel and Paclitaxel injections Taxol as a secondary treatment for patients with advanced gastric cancer. Liporaxel, which was licensed in Korea in 2016, is the world's first PO Paclitaxel. Currently, Paclitaxel is being used as a single drug recommended by CSCO in China for secondary treatment of advanced gastric cancer. Samchundang also recently ended phase 3 of the Eylea biosimilar (SCD411). Phase 3 of SCD411 was conducted on 576 patients with macular degeneration in 15 countries, including the United States and Japan, starting with the first patient administration in September 2020. Comparative studies such as effectiveness and safety between SCD411 and Eylea were conducted. Samchundang expects to receive the final phase 3 clinical report of SCD411 in January 2024. The company is also pushing for partner contracts along with producing phase 3 results. Negotiating partners conducted a final due diligence in July this year to evaluate the production and quality management eligibility of SCD411. At the end of August, Ildong completed a phase 2/3 in Korea of Zochova (S-217622), a candidate for oral COVID-19 treatment. Topline results are expected to be produced around November. Ildong is co-developing Zochova with Shionogi, Japan. Ildong has been conducting phase 2b and phase 3 of Zochova for patients infected with mild, moderate, and asymptomatic COVID-19 in Korea. The size is 204. CTC Bio ended the administration of CDFR0812 phase 3 clinical trial patients at the end of April. Phase 3 of CDFR0812, which has been held since 2019, was conducted with 795 people. It is currently under statistical analysis and the results are expected to be released within this year. The substance is non-reimbursed and can be released immediately upon approval by the Ministry of Food and Drug Safety. CTC Bio has signed a business partnership with Dongkoo Pharmaceutical Co. for CDFR0812. Dongkoo owns about 5% of CTC Bio. A market official said, "As phase 3 of core R&D materials of pharmaceutical companies are terminated one after another, results are expected to be drawn soon. "Company value will fluctuate depending on when and when the data results are released," he analyzed.
- Company
- NSCLC drug Rybrevant can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 15, 2022 05:55am
- Janssen’s new lung cancer drug Rybrevant can now be prescribed at general hospitals in Korea. According to industry sources, the anticancer drug Rybrevant (amivantamab), which is used to treat EGFR exon 20 insertion non-small-cell lung cancer (NSCLC) that is insensitive to currently available EGFR tyrosine kinase inhibitors (TKIs), has passed the review of drug committees tertiary hospitals in Korea including the Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other institutions nationwide, such as Konyang University Hospital, Kyungpook National University Hospital, Seoul National University Bundang Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. However, Rybrevant’s still non-reimbursed in Korea. Janssen Korea applied for reimbursement but was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The company is known to be preparing to reapply for reimbursement. EGFR exon 20 insertion mutation in NSCLC is so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to expenditure cuts. Although lung cancer in itself is not rare, NSCLC with EGFR exon 20 insertion mutation can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. Rybrevant, which is well known for its use in combination with ‘lasertinib (Leclaza),’ was the first targeted therapy approved in Korea for the treatment of NSCLC with EGFR exon 20 insertion mutations in February this year. The approval for the drug was based on the results from the CHRYSALIS study, where the drug demonstrated an overall response rate (ORR) of 40% and a 4% complete response (CR), 36% partial response (PR) rate in with Rybrevant use as monotherapy. The US Food and Drug Administration (FDA) granted accelerated approval based on Phase I trial results in recognition of its value as a treatment for a rare type of cancer. Following approval in the US, the drug also was designated for expedited review and approved in Korea as well. However, the issue lies in whether its value will be accepted during reimbursement review. As the drug was approved based on data from a single-arm clinical trial without a control group, Rybrevant needs to take the pharmacoeconomic evaluation exemption track for reimbursement. Therefore, the key is whether Rybrevant’s value as a treatment for rare cancer, not just lung cancer, will be acknowledged during the reimbursement review. Byoung-Chul Cho, Chief of the Lung Cancer Center at Yonsei Cancer Center, said “EGFR exon 20 insertion presents in various subtypes, and the sub-analysis of the CHRYSALIS study showed that Rybrevant showed an even response rate across rate in several subtypes. In addition to its target inhibition effect, Rybrevant shows more promise due to its immune cell-directing activity.”
- Company
- JW Pharm sells ₩10 bil with Actemra in 1H 2022
- by Chon, Seung-Hyun Sep 15, 2022 05:55am
- Actemra, JW Pharmaceutical’s rheumatoid arthritis treatment, rose and settled as the company’s flagship product, exceeding KRW 10 billion in sales in 1H this year. The product's increase in sales was fueled by the increase in its prescription as a rheumatoid arthritis treatment and its increased use as a COVID-19 treatment. According to the market research institution IQVIA on the 14th, Actemra recorded KRW 11.4 billion in sales 1H this year, a 39.7% YoY increase from the same period last year. The drug had raised KRW 6.2 billion in Q1 this year, which was a 59.9% YoY increase from the previous quarter, and then raised KRW 5.2 billion in Q2, marking a 21.2% increase. Although its growth slowed down in Q2 compared to Q1, the product still continued on its high growth. Quarterly sales of Actemra (Unit: KRW 1 million, Source: IQVIA) Actemra was approved in Korea in 2012 as a treatment for rheumatoid arthritis and other autoimmune diseases. The drug inhibits the binding of ‘Interleukin-6,’ the protein that causes inflammation in the body, and its receptor, in the body. JW Pharmaceutical introduced this new biologic drug after entering into a license agreement with Chugai Pharmaceutical, a subsidiary of Roche, for the co-development and exclusive marketing right of Actemra in Korea. The new drug candidate was developed by Chugai Pharmaceutical, based on which JW Pharmaceutical conducted clinical trials at major large hospitals in Korea including the Seoul National University Hospital, and received domestic approval. It is indicated for the treatment of adult patients with rheumatoid arthritis and children with juvenile idiopathic arthritis. Actemra did not exert much presence in the early stages of its release. The drug exceeded KRW 10 billion in annual sales for the first time in 2018. Actemra’s sales rose steeply since last year. After recording KRW 3.8 billion in sales in Q4 2020, it broke its own sales record for 5 consecutive quarters until Q1 this year. It is evaluated that the reliability of Actemra in the field has risen with its accumulated prescription experience in rheumatoid arthritis. Actemra has also attracted further attention as it had shown excellent therapeutic effects in patients who do not respond to TNF-alpha inhibitors like Humira, Seretide, and Enbrel. Recently, its sales growth has increased further with its rising demand for COVID-19 treatment purposes. Since last year, Actemra has been used off-label in more than 60 hospitals nationwide for the treatment of severely ill patients with COVID-19. Off-label use refers to the use of existing drugs on the market for purposes other than what it was approved to treat after receiving approval from each institution’s institutional review board (IRB). Demand for Actemra increased significantly in the domestic field after the U.S. Food and Drug Administration (FDA) and the European Commission (EC) authorized emergency use of Actemra as a treatment for severely ill patients in need of artificial respiration due to COVID-19 infection in June and December last year, respectively. The demand for Actemra, therefore, had surged last year to cause a shortage in its supply one time. Actemra’s scope of reimbursement was extended to COVID-19 treatment in March this year. The Ministry of Food and Drug Safety granted emergency approval for Actemra in March for use in severely ill COVID-19 patients over the age of 2. Actemra's high growth has led to improved company performance. JW Pharmaceutical’s operating profit rose 173.7% YoY to record KRW 10.3 billion in Q2, and sales rose 12.4% to record KRW 163 billion.
