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- 2025-12-22 15:40:06
- Policy
- The incidence of adverse effects in Alecensa is 80%
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that cannot be excluded from causal relationships, respectively. The Ministry of Food and Drug Safety announced that it will prepare an order (proposal) to change the permission based on the results of the investigation after marketing Alecensa in Roche Korea and conduct an opinion inquiry until the 19th. Eisai Korea obtained an item license for Fycompa film coated tab on July 10, 2015. Alecensa received a domestic item license in October 2016 for the treatment of ALK-positive local progressive and metastatic non-small cell lung cancer patients who had been treated with Xalkori. After expanding the indication to primary treatment in 2018, Alecensa sales exceeded Xalkori, which is 20.3 billion won, from 10.4 billion won in 2018 to 22.1 billion won in 2019. Since then, it has expanded to 29.3 billion won in 2020 and 32.7 billion won in 2021. As a result of a five-year post-marketing survey of 345 people under the patient registration program in Korea, the expression rate of abnormal cases was reported to be 80.29% (277/345 cases, a total of 1012 cases), regardless of causality. Among them, 4.64% (16/345 people, 20 cases) of serious drug abnormalities were reported, including mouth inflammation, increased blood bilirubin, increased blood creatine phosphorylase, increased blood creatinine, peripheral edema, fever, and death. Unexpected drug abnormalities such as decreased red blood cell volume rate decreased red blood cell count, joint pain, muscle weakness, dizziness, and nephropathy were found to be 24.06% (83/345 cases, 122 cases). The Ministry of Food and Drug Safety plans to change the permit after hearing opinions on the change order.
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinical trials. The guideline was prepared to promote the preparation of a rapid clinical support platform to support the development of COVID-19 vaccines and treatments, which was part of the 100 Tasks for Food and Drug Regulatory Innovation that the MFDS had announced on August 11th. The guideline contains the additional new clinical outcome parameters required for clinical trials on mild-to-moderate COVID-19 patients and includes considerations that need to be made in selecting subjects, clinical treatment effect evaluation methods, efficacy evaluation, and in designing and performing clinical trials. The existing clinical outcome parameter was effective in preventing severe COVID-19, however, due to the decrease in severe COVID-19 patients, this parameter had made it difficult to perform clinical trials. Therefore, a new indicator had to be inevitably set in line with the COVID-19 situation, which is why the government added symptom improvement as a new parameter. The MFDS said, “the addition of the new clinical outcome parameter will aid rapid development of treatments by enabling easier progress of clinical trials, including faster recruitment of clinical trial subjects. We have improved the predictability and transparency of the trials by allowing companies to introduce an adaptive design in preparing clinical trial protocols so the number of test subjects can be appropriately changed based on the results of the interim analysis.” Also, if the company has received approval for a clinical trial plan in advance, the trial can be conducted without additional approval, which is also expected to help reduce the period. As the trial is conducted on infectious patients, the guideline also guides companies on the major considerations that require attention when conducting non-face-to-face clinical trials and case studies. More information can be accessed on the MFDS website (www.mfds.go.kr) > Legislative data > Resources > Guide/Guidelines.
- Policy
- Data for reevaluation to be submitted from the 24th
- by Lee, Tak-Sun Oct 05, 2022 06:11am
- The data submission system for reevaluation of listed drugs that was set to be operated as of the 1st of this month will be operated from the 24th. The authorities plan to receive data submitted before then through the Health Insurance Review and Assessment Service’s e-mail. With the data submission system not being initiated in time, the industry has repeatedly been pointing to the administration's lack of preparation. Voices are continuing to rise in the industry to postpone the reevaluation of listed drugs in consideration of the circumstances, including the COVID-19 situation. According to the industry on the 3rd, HIRA has been notifying through associations that the data submission system for reevaluation of listed drugs that was set to be serviced from the 1st will be serviced from the 24th. Data submission is important to prove as the drugs subject to evaluations need to meet the reevaluation requirements or receive discounted ceiling prices depending on their degree of satisfaction. The health authorities have been requiring companies to submit data proving that the standard requirements were met to HIRA from the 1st of this month to February 28th next year. The standard requirements that need to be submitted are self-bioequivalence test data or evidence of clinical trial performance; and documents proving the use of APIs registered in the Drug Master File (DMF). If the subject drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met. As most listed drugs satisfy the DMF requirement, the self-bioequivalence test data will become the determining factor for the price discounts. The Ministry of Health and Welfare first applied the requirements to drugs that were newly listed from July 2020, and provide a grace period of 3 years for previously listed drugs. Therefore, the price adjustments for the listed drugs are planned on July 2023. To meet the self-bioequivalence test requirement, companies have switched their consigned products to in-house production and conducted self-bioequivalence tests. However, the COVID-19 outbreak in 2020 rendered the progress of the tests difficult, raising the suggestion that the entire revaluation schedule should be postponed. However, the MOHW decided to conduct the reevaluation of listed drugs as scheduled with some exceptions, with the goal of making price adjustments in July next year at the Health Insurance Policy Deliberative Committee meeting that was held on the 29th. However, the Ministry of Food and Drug Safety extended the data submission deadline for some oral preparations and sterile preparations among prescription drugs that were designated and subject to bioequivalence tests by 5 months, and the reports will be accepted if they are submitted by the end of May. Data on all other items will have to be submitted to HIRA by February 28th next year, as initially scheduled. Data submissions started on October 1st, but the authorities will have to wait another 20 days before the electronic window opens. Of course, the companies may submit their data via e-mail, but complaints about the delay in the industry are fierce as they are already pressed for schedule. An industry official said, “The government seems to not be ready to conduct the reviews that they have hurried the companies to prepare. With the 20-day delay in the data submission system, I wonder whether HIRA will be able to complete the review within the set period for the NHIS to complete pricing negotiations.
- 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.
