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- 2026-05-05 04:40:47
- Policy
- Pfizer Corona vaccine passed a verification advisory group
- by Lee, Hye-Kyung Oct 05, 2022 06:10am
- The Ministry of Food and Drug Safety (Director Oh Yoo-Kyung) announced on the 30th that Pfizer Pharmaceutical's COVID-19 vaccine "Comirnaty 2 0.1mg/mLP (Initial Virus of COVID-19, Omicron (BA.1)") passed the COVID-19 vaccine safety and effectiveness verification advisory group. The advisory group held a meeting on the 29th and proved its effectiveness in comparing the immune response of the neutralizing antibody with the existing vaccine after inoculating "Comirnaty 2 0.1 mg/mL", and judged safety to be similar to the existing vaccine. Seven people, including infectious medicine specialists and vaccine and pharmaceutical experts, attended the meeting of the verification advisory group. The Ministry of Food and Drug Safety will refer to the results of vaccine experts' consultation on the safety and effectiveness of the vaccine, including infectious medicine specialists, and quickly and closely review the submitted clinical, nonclinical, quality, and GMP data to decide whether to approve it. The Ministry of Food and Drug Safety said, "We will continue to do our best to supply safe and effective vaccines to our people."
- Policy
- Post-marketing surveillance of breast cancer drug Kadcyla
- by Lee, Hye-Kyung Oct 04, 2022 06:07am
- A total of 31 serious adverse reactions (ADRs) whose causal relationship cannot be ruled out had been reported as results of the 8-year post-marketing surveillance (PMS) on Roche Korea’s second-line breast cancer treatment ‘Kadcyla (trastuzumab emtansine).’ With 163 additional cases of unexpected ADRs whose causal relationship cannot be ruled out also being reported in the same period, Kadcyla’s label will be changed. The Ministry of Food and Drug Safety announced it will change the label for Kadcyla inj. 100mg and 160mg according to the reevaluation results as of December 28th. Kadcyla received domestic marketing authorization in January 2014 to treat patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who had previously received trastuzumab and a taxane (separately or in combination). The drug has been approved for reimbursement since August 2017 in Korea. Also, the drug was also additionally approved by the MFDS as an adjuvant monotherapy for patients with early HER2-positive breast cancer who had residual invasive disease after completing neoadjuvant therapy containing trastuzumab and taxane in August 2019 and was listed for reimbursement in July this year. At the time of the Health Insurance Review and Assessment Service’s reimbursement evaluations, the committee deemed Kadcyla’s pharmacoeconomic evaluation results to be at an acceptable level compared to its competitor Herceptin and acknowledged that the drug was listed in all A7 countries. Through drug pricing negotiations with the National Health Insurance Service this year, the company agreed with the authorities on adopting the utilization cap type of the Risk Sharing Agreement and set the price at KRW 1,956,328 per vial for the 10mg dose and at KRW 2,930,920 per vial for the 160mg dose. Results of the post-marketing surveillance that was conducted on 520 patients over the past 8 years showed that the incidence rate of adverse events were 74.63% (338/520 patients, 1590 cases) regardless of causal relationships. Serious adverse events were reported in 12.69% (66/520 patients, 90 cases) of the patients. As a result of the 6-year post-marketing surveillance conducted in 307 patients for the reevaluation, pleural effusion will be deleted and erythema and infection in the catheter area, bacterial arthritis, COVID-19, infectious spondylitis, and mastitis added as serious adverse events. Among these, 4.23% were serious adverse drug reactions (22/520 patients, 31 cases), based on which vomiting, shortness of breath, and pulmonary edema will be added to the label. The MFDS said, “We plan to change the label according to the Pharmaceutical Affairs Act and the Regulation on Safety of Drugs, etc. We ask hospitals, clinics, and pharmacies to ensure proper use of the drug.”
- Policy
- The price of Zerbaxa is listed at 60,098 won
- by Kim, Jung-Ju Oct 04, 2022 06:07am
- Zerbaxa, called the next-generation antibiotic for MSD Korea, will be listed at 60,098 won per vial as of the 1st of next month. Yuhan Corporation's allergic rhinitis treatment Ryaltris nasal spray 18ml is listed at 6,197 won and Ryaltris nasal spray 31ml is listed at12,396 won, respectively. The Ministry of Health and Welfare held a health insurance policy review committee today (29th) and announced that it was approved for the revision of the "drug benefit list and upper limit table" for a total of three new drugs. These drugs will be listed on the drug benefit list as of October 1 and sold at insurance prices. ◆Zerbaxa = This drug is an antibacterial agent used to treat complex intra-abdominal infections and complex urinary tract infections and was approved by the Ministry of Food and Drug Safety as of April 7, 2017. The company applied for insurance registration in early November last year and applied for insurance registration with the HIRA in November of the same year. The HIRA submitted it to the Drug Benefit Evaluation Committee in June this year for deliberation. At the time, the committee confirmed that clinical usefulness was inferior to that of the control group, and judged that the company's price was more cost-effective than the Japanese drug price, which is the lowest A7. Among the A7 countries, it was listed in the U.S., Japan, Italy, and the U.K., and the average adjustment price was 108,383 won per bottle. Since then, the Ministry of Health and Welfare has negotiated drug prices with the NHIS from June to August this year and decided on the expected amount of claims. The NHIS and the company signed an Expenditure cap RSA contract to refund the amount to the NHIS if it exceeds a certain amount (cap). The price was agreed to be 60,098 won per bottle, down 6.44% from the price passed by the evaluation committee, considering the number of patients who are eligible for more PE drugs such as anticancer drugs and rare disease treatments. ◆Ryaltris nasal spray = This drug, a treatment for seasonal allergic rhinitis, was approved by the Ministry of Food and Drug Safety as of June 22, 2020. The company applied for the HIRA insurance registration more than a year later on July 30, 2021. The HIRA introduced the drug and conducted deliberation on January 13 this year. At the time, the evaluation committee judged that it was more effective in relieving symptoms than a single drug in terms of clinical needs and that it was cost-effective as the company accepted less than 90% of the weighted average price of alternative drugs. It is listed in the UK and Italy among the A7 countries, and the adjusted average price is 16,308 won per 240 doses. In February, the company moved to the industrial complex to negotiate the expected amount of claims. Initially, the two sides conducted and completed negotiations for two months, but the application for registration was made after confirming the possibility of normal supply due to delayed imports due to COVID-19. It predicted that no additional finances would be required because alternative drugs such as Motesone plus Nasal Spray or Dylastine existed. The insurance price is 6,197 won for Ryaltris 18mL and 12,396 won for Ryaltris 31mL.
- Policy
- Strengthen the guarantee of 21 new drug by the third quarter
- by Kim, Jung-Ju Sep 30, 2022 05:53am
- From January to the third quarter of this year, a total of 21 new drugs were newly listed on the drug benefit list or improved access to use due to expanded insurance benefit standards. Among them, two new drugs were newly listed on the drug benefit list this month. The number of domestic patients estimated to benefit or suffer from the government's policy to strengthen the guarantee of new drugs this year is 1,323,065, and the cost of drugs is 451.75 billion won. In particular, with the emergence of ultra-high-priced drugs that focus on the minority, the government's drug guarantee and accessibility policy are becoming more flexible according to social trends and needs. A total of 21 drugs (based on the representative content) have been strengthened due to the expansion of standards among new drugs and registered drugs that succeeded in listing new drug pay lists from January to this month. On a monthly basis, Vyzulta and Skilarence were newly registered in February, and Besponsa's standards expanded, and the coverage began to be strengthened. In March, Xospata 40mg and five new osteoarthritis treatments, including Lutathera, Keytruda, Vitrakvi Rozlytrek, newly registered ultra-high-priced treatment kymriah in April, and Tecentriq in May. Looking at the recent drug coverage, the coverage of Kadcyla, a breast cancer treatment, expanded in the third quarter, starting with the new registration of Fexuclu, a treatment for erosive gastritis. In August, Zolgensma, a new drug for spinal muscular dystrophy, which was called an ultra-high-priced new drug and attracted social attention for a long time, was newly registered, widening the scope of drug coverage. Zolgensma's estimated number of patients in Korea is only seven but expected demand The cost of drugs reached 13.87 billion won, making it difficult to guarantee for a long time. Nevertheless, the fact that this drug was able to be paid can be said to be the result of our society's flexible expansion of coverage by recognizing the social importance, even if the number of patients is small. Subsequently, Sonazoid, radiation drugs for PET, Doppa check, Donerion and Dongesive, which are used for Alzheimer's-type dementia, were newly listed, and the standards for prostate cancer treatment Xtandi and urinary tract epithelial cancer treatment Keytruda, which had high patient needs, were expanded. This month, Pfizer Lorviqua and the chronic migraine drug Emgality succeeded in paying, allowing 350 and 2,344 patients, respectively, to receive benefits. The annual fiscal requirement estimated here is an absolute financial forecast. Among them, since RSA-applied drugs are calculated based on the indicated price, it is estimated that the actual amount required will be less than this considering the refund rate. In addition, the contents of the contract between the insurer and the company, such as the substitute drug and the sharing of required costs, were not reflected.
- Policy
- Reevaluation deadline for listed drugs extended 5 months...
- by Kim, Jung-Ju Sep 30, 2022 05:53am
- The government finalized its plan to extend the deadline for reimbursed price reevaluations of listed drugs that are subject to conduct bioequivalence tests and made a final report to the top legislative organization for the national health insurance. The finalized plan will extend the data submission period of listed drugs that are subject to reevaluations by 5 months, and companies that submit review results during the objection period for the Drug Reimbursement Evaluation Committee’s review after exceeding the submission deadline will also be accepted. The objection period on the Drug Reimbursement Evaluation Committee’s judgment will be around the end of May, and the final announcement period for the drug price cuts is scheduled for December next year. The Ministry of Health and Welfare held a Health Insurance Policy Deliberation Committee meeting on the 29th and reported the ‘Changes regarding the reevaluation of the upper limit (standards) set for pharmaceuticals.’ The reevaluation of listed drugs was made as a follow-up measure after the introduction of the stepped new drug pricing system that links approvals with drug price to ensure the quality of generic drugs and countermeasures against the flood of generics in the wake of the detection of impurities in valsartan-containing drugs in 2018. Since July 2020, all new generics introduced are applied a stepped pricing system under the new drug pricing system when determining its insurance price. The essence of the standard is to prove the results after conducting in-house bioequivalence tests. However, due to the spread of COVID-19, the bioequivalence tests that were to be conducted by the companies were not progressable due to difficulty recruiting subjects and the increase of confirmed COVID-19 cases among subjects which led to discontinuation or delays in trials and disrupted system implementation. Industry voices on the need for deadline extensions and deferred evaluations increased further due to the time taken in designating reference drugs necessary to demonstrate the bioequivalence of sterile drug products. Accordingly, the MOHW and the Ministry of Food and Drug Safety discussed flexibly adjusting the reevaluation procedure and schedule to facilitate smoother operations since May. In comprehensive consideration of the special circumstances that include preserving the consistency in insurance finances and the drug pricing system, equity with new products, and the prolonged COVID-19 outbreak, the MOHW decided to partially modify the data submission deadline and evaluation period, but with the goal of completing the schedule within 2023. According to the HIPDC report, the data submission deadline for existing items had been extended with a condition in consideration of the COVID-19 situation. The extension will be applied to 10,000 tablet preparations among oral prescription drugs and suppositories that are subject to bioequivalence tests. Among these drugs, if their bioequivalence tests have been delayed due to COVID-19, etc., the company may submit the test result report to the MFDS by February next year or submit the review results by end of May to HIRA within the planned objection period on HIRA’s Drug Reimbursement Evaluation Committee review, will be deemed to have met the final requirements. If the companies are unable to demonstrate bioequivalence within the set period, their drug’s price will be reduced as of July 1st next year. Authorities plan to identify progress made for bioequivalence tests by company and month within the second half of the year so that submission of bioequivalence test reports will not be concentrated in a specific period, and encourage prompt data submission to the MFDS upon completion. Adjustments to the reevaluation period will also follow. The government will also adjust HIRA's reevaluation period in consideration of the current designation status of reference drugs and MFDS's review schedule. The data submission deadline to HIRA is by July next year, and HIRA's evaluation period will be adjusted from July next year to November. With the changes, the drug price reduction announced for unproven products will be made around December next year. The MOHW will continue to monitor the progress of bioequivalence tests and the designation status of reference drugs and consult with MFDS and other related associations on issues to guide companies to disperse the submission of their reports.
- Policy
- Research service for re-evaluation of listed drug benefits
- by Lee, Tak-Sun Sep 30, 2022 05:53am
- The HIRA will conduct a study on the re-evaluation of drug benefit adequacy with the aim of ending in February next year. Through this, it will be used as a policy to promote re-evaluation projects. The HIRA announced on the 27th that it would bid for a research service to rationalize the evaluation of drug benefit adequacy. Ticketing is scheduled to take place on October 5. The research period is four months from the date of signing the contract, and the goal is to end in February next year. The budget was allocated 60 million won. The HIRA explained that through this study, it will come up with a reasonable target selection and evaluation standard improvement plan to stably establish a benefit adequacy re-evaluation system, operate an effective system, enhance predictability of stakeholders, and prevent unnecessary issues. Re-evaluation of drug benefit adequacy is being conducted by the first comprehensive health insurance plan (2019-2023). Therefore, the relevant grounds will be lost next year. This year, The HIRA has prepared criteria for selecting the grand prize, but there is no research to support this. In the first half of last year, the HIRA set the criteria for the long-standing registration year when selecting the subject for re-evaluation, and decided to evaluate the clinical usefulness first, considering cost-effectiveness and social demands if necessary. This is why this study is necessary because the re-evaluation does not achieve the purpose of reducing insurance finances immediately. The HIRA is suspended from administrative litigation and execution by pharmaceutical companies in all three components and Choline alfoscerate in 2020. The committee pointed out that the achievement of the purpose of the system is insufficient and that the reduction of insurance finances is being delayed. Accordingly, this study plans to conduct policy proposals for selecting targets for re-evaluation and improving evaluation criteria and methods through analysis of domestic and foreign reimbursed drugs, and adequacy re-evaluation system. The main contents of the study are policy suggestions for analyzing the current status and revaluation (post-management) system in Korea, analyzing the overseas revaluation (post-management) system and status, and re-evaluating the rational drug benefit appropriateness (spending efficiency). The HIRA expected that this service study will be used as a policy for selecting targets related to the promotion of drug benefit adequacy re-evaluation projects and managing reimbursed drugs.
- Policy
- Withdrawal of Hanmi's Olita permit, cancellation of benefit
- by Lee, Tak-Sun Sep 29, 2022 05:50am
- The benefit of Olita, a new domestic drug, will be canceled following the withdrawal. It has been six years since it was approved as the new domestic drug No. 27 in May 2016. Since Hanmi Pharmaceutical already announced the suspension of development in April 2018, the withdrawal of the license and cancellation of the benefit were scheduled, but it withdrew from the market due to global competitive drugs. According to the industry on the 28th, Hanmi Pharmaceutical's non-small cell lung cancer treatment drugs Olita 200mg and Olita 400mg will be removed as of the 1st of next month. It is a procedure following the withdrawal of permission. Olita has maintained permits for existing patients permission was withdrawn on 12 August. Hanmi Pharmaceutical, which received phase 3 from the Ministry of Food and Drug Safety, decided to suspend Olita's development in April 2018. This is because it was expected that it would be difficult to recruit phase 3 clinical patients as a competitive drug called Tagrisso quickly entered the market.The return of Olmutinib rights by Beringer Ingelheim and its Chinese partner Zai Lab affected the suspension of development. Tagrisso of AstraZeneca, a competitive drug, started selling around the world and received benefits in Korea, making it difficult to recruit patients necessary for phase 3 progression. Although Olita's domestic application was November 15, 2017, a month earlier than Tagrisso's (December 15, 2017), Tagrisso's benefit is a problem for Olita's domestic development because it had to proceed with a phase 3 clinical trial, which is a condition of permission. However, while the development was suspended, the permission was maintained for patients taking Olita at the time, but the permission and cancellation were a matter of timing because they did not meet the conditions of the permission, phase 3.
- Policy
- Boryung Zepzelca, conditional approval with phase 2 data
- by Lee, Hye-Kyung Sep 29, 2022 05:49am
- It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data. Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affairs Act has clarified the criteria for conditional approval only with phase 2 data. The HIRA benefit evaluation will be available if the company applies for conditional approval. If the adequacy is evaluated in the HIRA, it can be converted into a reimbursed drug through drug price negotiations with the NHIS. Until the benefit is applied, patients will be able to receive Zepzelca on a nonreimbursed basis only for permits. On July 6, the Central Pharmaceutical Affairs Review Committee, which was unveiled by the Ministry of Food and Drug Safety on the 27th, discussed the efficacy of Zepzelca's conditional approval. According to the minutes, the Ministry of Food and Drug Safety judged that the number of patients was reasonable because the phase 3 clinical trial proposed by Boryung was a multinational clinical trial. In addition, Zepzelca submitted a risk management plan as a rare drug, and added that it focused on hematological toxicity and hepatotoxicity in safety items. At the meeting, Boryung said, "We plan to proceed only with global clinical trials at the moment, and if we believe that domestic clinical trials are necessary, we will decide after discussing with developers." "In the United States, discussions have been held with the FDA several times since the phase 2 clinical trial, and conditional items have been approved and are currently on the market," he explained. Phase 3 clinical trials are currently underway, and plans to submit phase 3 clinical data as soon as clinical trials are completed in the future. Boryung announced its plan to launch Zepzelca in the first half of next year, which is an indication of "metastatic small cell lung cancer that failed primary platinum-based chemotherapy." Zepzelca is a new anti-cancer drug developed by Spanish pharmaceutical company PharmaMar S.A., and Boryung has exclusive rights to develop and sell in Korea since 2017. After being designated as a rare drug by the U.S. Food and Drug Administration (FDA) in 2018, it was released in July of the same year with conditional rapid approval and priority screening approval in June 2020. In the United States, only small cell lung cancer is allowed. Boryung said, "Although it was a phase 2 result, it showed effectiveness compared to existing treatments, and showed a low tendency in hematological adverse reactions in terms of safety," and expected, "If it is marketed, patients' choice opportunities will be expanded."
- Policy
- Janssen's Talquetamab, approved for Phase 3 in Korea
- by Lee, Hye-Kyung Sep 28, 2022 06:05am
- While Janssen's Talquetamab is undergoing phase 3 clinical trials around the world, phase 3 approval has been granted to 44 patients in Korea. On the 26th, the Ministry of Food and Drug Safety approved the Talquetamab subcutaneous injection and Daratumumab subcutaneous injection (Tal-DP) or Daratumumab subcutaneous injection and Daratumumab subcutaneous injection (Dalatum-3) in clinical trial subjects with at least 1st prior therapy. Currently, multinational clinical trials are underway for patients with recurrent or refractory multiple myeloma, and the total number of clinical trials is 810. In Korea, clinical trials will be conducted at Severance Hospital, Samsung Medical Center, Hwasun Chonnam National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, Seoul National Cancer Center, Gil Hospital, Chonbuk National University Hospital, and Dong-A University Hospital. A double antibody is an antibody that simultaneously recognizes two different antigens. Treatments are characterized by targeting both factors that cause disease. For example, it can act on immune cells and cancer cells at the same time to catch two rabbits, strengthening immunity and attacking cancer cells. Representative double-antibody anticancer drugs include Amgen's acute leukemia treatment BLINCYTO (Blinatumomab) and Roche's hemophilia type A treatment HEMLIBRA (Emishzumab). Talquetamab targets both GPRC5D and CD3 of T cells, a new multiple myeloma target, with off the shelf T cell-redirecting double antibody. According to data released by ASCO last year by Janssen, subcutaneous administration of phase 2 recommended doses in 30 patients with recurrent or refractory multiple myeloma with a median value of 6 months or more was 70%, and 60% of patients achieved VGPR (very good partial response). Subjects of clinical trials previously received the sixth treatment at a median value, and 87% did not respond to the last treatment. Reactions were observed in 70% of patients, including 65% of patients who were non-responsive to three drugs and 83% of patients who were non-responsive to five drugs, and during the 6.3 months of the follow-up period, patients have not yet reached the median of the response period.
- Policy
- Generic for Acelex will be released
- by Lee, Tak-Sun Sep 27, 2022 05:51am
- A new domestic anti-inflammatory drug developed by Crystal Life Science Generic drugs of the domestic anti-inflammatory drug Acelex developed by Crystal Life Science will be on the market from next month. It has been seven years since Acelex was licensed in Korea, and attention is being paid to whether generic, like the original, will be able to expand its market. This is because Celecoxib has high market dominance among coxib families. According to industries on the 26th, eight Acelex generics will be listed on the 1st of next month. Generic companies are Daewoong Pharmaceutical, Hutecs, Ilhwa, CrystalLife Science, Kuhil, Edenpharma, CMG Pharma, and Hana. Except for Daewoong Pharmaceutical, seven items will receive an additional amount of 522 won for one year, including first generics, and will be adjusted to 470 won on October 1 next year. Daewoong will be listed at 597 won, but will also be adjusted to 470 won on October 1 next year. Generic is in competition with original, but Acelex generic is in partnership with original. This is because Crystal Life Science, an affiliate of Crystal Genomics, produces products like the original company. Therefore, the original company's production performance will expand only when generic sales increase. Original and generic market expansion, by having common goals. Cerebrex 400 billion won in annual performance record. 2016, patent expiration as a generic is reimbursed. Acelex is properly lost the use of force and with earnings of less than 10 billion won per year. The sluggishness of Arcoxia and Acelex is due to the fact that the indication is limited to osteoarthritis and that the marketing ability was not great to destroy Cebrex's position. Since large companies such as Daewoong Pharmaceutical are included in Acelex generics this time, generics are expected to expand the overall market size, allowing both original and generics to create synergy.
