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- 2025-12-22 01:01:47
- Policy
- MFDS, approval of Vadadustat for anemia tx of renal disease
- by Lee, Hye-Kyung Mar 15, 2023 05:56am
- Vadadustat, which is used to treat anemia in patients with chronic kidney disease, has received domestic product approval. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 13th that it had approved two doses (150 and 300mg) of Vadadustat from Mitsubishi Tanabe Pharma Korea Co., Ltd., a new drug for the treatment of anemia in patients with chronic kidney disease. Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis. Vadadustat is a treatment for anemia in adult patients with chronic kidney disease undergoing hemodialysis. The drug promotes red blood cell production by inhibiting proline hydroxylase, which breaks down hypoxia-inducible factor (HIF). Sufficient iron stores should be ensured when Vadadustat treatment is initiated, and transferrin saturation (TSAT) and ferritin concentrations should be checked. If not previously treated with erythropoiesis-stimulating agents (ESAs), the criterion for initiation of this drug is a hemoglobin (Hb) concentration of less than 10 g/dL. Patients receiving erythropoiesis-stimulating agents (ESAs) may be switched to this drug. As Vadadustat, 300mg once a day is orally administered as a starting dose, and after the start of treatment, the dose is appropriately increased or decreased according to the patient's condition. The highest dose can be up to 600 mg once daily. If looking at the precautions for use, there is a risk of death due to serious thromboembolic events such as stroke, cerebral infarction, myocardial infarction, deep vein thrombosis, and pulmonary embolism during the administration of this drug. Since the administration of this drug may cause liver dysfunction, liver function tests should be performed regularly. The Ministry of Food and Drug Safety said, "We will continue to do our best to expand treatment opportunities for patients by promptly supplying treatments whose safety and effectiveness have been sufficiently confirmed based on regulatory scientific expertise."
- Policy
- MOHW provides real-time confirmation service
- by Lee, Jeong-Hwan Mar 15, 2023 05:56am
- When the government requests pharmaceutical companies to expand drug reimbursement standards, the government plans to use the information system to provide administrative services to check the progress of evaluation tasks at each stage. Drugs with clear efficacy for survival-threatening diseases will strengthen patient accessibility by implementing a pilot project that simultaneously proceeds with permission from the Ministry of Food and Drug Safety, benefits evaluation by the Health Insurance Review and Assessment Service, and drug price negotiations with the National Health Insurance Corporation. It also announced a plan to legalize public late-night pharmacies that provide pharmacist services to provide counseling for patients with mild symptoms and guarantee access to medicines. On the 9th, the Ministry of Health and Welfare announced a plan to promote health and welfare regulatory reform in 2023. This year, the Ministry of Health and Welfare will promote regulatory improvement in seven key areas, focusing on the regulatory innovation plan for the new health industry. They are innovative medical devices, innovative and essential medicines, digital healthcare, advanced regenerative medicine and advanced biopharmaceuticals, genetic testing, BMI, and infrastructure. In addition, we will continue to discover regulatory improvement tasks such as rapid registration of new drugs. In the health and welfare sector, regulations are improved to allow new industries to enter the market by supporting innovation in the private sector, as population aging and increased demand for health care are expected. Although leasing was prohibited after the sale of land to companies in the high-tech medical complex, various forms of occupancy opportunities were provided, such as allowing leasing only to resident companies in need of leasing, such as conducting joint research with a common goal. We plan to revitalize the complex and improve space utilization. When a pharmaceutical company requests an expansion of reimbursement standards for pharmaceuticals, the process of reviewing reimbursement standards is made transparent and predictability is increased by enabling the information system to check the progress of each evaluation task. When evaluating drugs that are life-threatening and have sufficient improvement effects, a policy to promptly list new drugs is also implemented. A pilot project will be conducted to strengthen patient accessibility by concurrently proceeding with permission from the Ministry of Food and Drug Safety, benefits evaluation by the Health Insurance Review and Assessment Service, and drug price negotiations with the National Health Insurance Corporation. By legalizing public late-night pharmacies that provide counseling for patients with mild symptoms that occur at night and provide pharmacist services to ensure access to medicines, the public health blind spot is eliminated by providing medication counseling and drug use guidance to patients with mild symptoms during night time. Despite changes in the environment of the pharmaceutical industry, the innovative pharmaceutical company certification system maintains its original form when introduced (2012). Minister of Health and Welfare Cho Kyu-hong said, "In accordance with the strong regulatory innovation direction of the Yoon Seok-yeol government, we will continue to create results of regulatory innovation in the health and welfare sector to revitalize new industries and resolve difficulties and public inconvenience while putting top priority on the lives and safety of the people." revealed
- Policy
- SGLT2 + DPP4 combi benefit expansion has increased
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- As the insurance authorities decided to expand the combined coverage of major diabetes drugs from April, applications for reimbursement for related complex drugs are continuing. MSD Stegluzan's application for benefits was recently confirmed, and Dong-A ST Sugadapa, which was approved on the 13th, plans to apply for benefits this month. Accordingly, it is understood that a total of five items will be applied for benefits within this month. According to the industry on the 13th, two-dose items of MSD Stegluzan were applied for and the HIRA was calculated. Stegluzan is a combination of the SGLT-2 inhibitory ingredient Ertugliflozin L-pyroglutamic acid and DPP-4 inhibitory ingredient Sitagliptin Phosphate Hydrate. For Ertugliflozin, the original single drug product is Steglatro, and the ingredient Sitagliptin is Januvia. All of these items are owned by MSD and are listed on the list. Stegluzan will be calculated based on the upper limit of Steglatro and Januvia. Prior to this, Boehringer Ingelheim Esglito and AstraZeneca Qtern were also known to have applied for benefits. Since the company that owns the original single drug is launching it on the market as a combination product that combines the single drug, there is no possibility that the market launch will be delayed due to patents. LG Chem is also said to have applied for Zemidapa benefits. Gemigliptin is a DPP-4 inhibitory ingredient developed by LG Chem, and its brand name is Zemiglo. Accordingly, among the SGLT-2+DPP-4 combination drugs, 3 items from foreign companies and 2 items from domestic companies are expected to be reimbursed within the first half of the year. Since the upper limit of the single system is voluntarily lowered according to the April benefit expansion, the upper limit of the combined system is set based on this. LG Chem and Dong-A ST's combination drugs are paying close attention to the voluntary reduction rate of the original Forxiga because Dapagliflozin is combined. Meanwhile, the insurance authorities plan to expand reimbursement for the combined use of drugs between classes, such as Metformin + DPP-4 + SGLT-2, from April.
- Policy
- Voluntary withdrawal of reimbursement for Tepmeko
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- It was found that Tepmeko, a MET mutated anti-cancer drug that failed to set reimbursement standards, recently voluntarily withdrew its application for reimbursement. Tepmeko has not been recognized as valid as a result of discussing the reimbursement standard in HIRA. According to the industry on the 10th, Merck announced its intention to voluntarily withdraw Tepmeko's application for drug reimbursement decision to HIRA. Tepmeko is a treatment for locally advanced or metastatic non-small cell lung cancer with confirmed MET exon 14 deletion. In Korea, in November 2021, it was approved simultaneously with Tabrecta, a drug in the same family, and has been undergoing a full-scale reimbursement review since last year. Metastatic non-small cell lung cancer patients with MET mutations, which Tepmeko is targeting, appear in about 3-4% of all non-small cell lung cancer patients. Although the number of patients is small, the prognosis is poor, so a cure is desperately needed. According to a presentation by Prof. Han Ji-yeon, Department of Oncology, Lung Cancer Center, National Cancer Center, at the International Conference of the Korean Lung Cancer Society last year, an analysis of 79 Asian patients who participated in the Tepmeko VISION clinical trial showed a significantly high objective response rate of 66.7%, and the second-line treatment group The response rate was 48.1%. Despite this effectiveness, the non-insured prescription price of Tepmeko in the US reaches 25 million won per month in Korean money. For this reason, patients are eagerly waiting for the application for reimbursement. Tabrecta has also failed to set reimbursement standards, so it will take more time to apply for the benefits. It is not known whether Tepmeko will reorganize its data and apply for benefits. However, since the previous application for benefits was withdrawn, even if you apply again, it will take longer than before to apply for health insurance. Assuming the worst-case scenario, if Tepmeko gives up on the domestic market, there is a possibility that Tabrecta will also be affected. In this case, only the patients are expected to suffer.
- Policy
- Innovative plans for domestic vaccines/txs to face post-pand
- by Lee, Jeong-Hwan Mar 13, 2023 05:53am
- Lim Sook-young, leader The government will promptly import vaccines and treatments for new infectious diseases that will occur in Korea after Corona 19 and improve laws and systems so that domestic products can be produced quickly. For now, only the big direction has been set, and the government plans to announce a comprehensive plan in May after consultations with related ministries and experts to prepare specific countermeasures. Attention is focused on whether government support measures can be prepared to speed up the development of domestic vaccines and treatments. On the 8th, Lim Sook-young, head of the Central Disease Control Headquarters, said at a regular Corona 19 briefing, “The government is establishing a mid-to-long-term plan to prepare for a new infectious disease pandemic that will occur in the future.” Based on the COVID-19 response evaluation over the past three years, Director Lim's will is to establish a mid-to-long-term plan to expand quarantine and medical response capabilities so that vaccines and treatments can be quickly secured and large-scale long-term epidemics can be stably managed. It plans to consult with related ministries in each field, including new infectious disease monitoring, initial response, large-scale epidemic management, daily recovery, research and development of treatments and vaccines, and improvement of laws and systems. She said, "Prevention of new infectious diseases is important first. That is why it is necessary to strengthen the surveillance system." he explained. She added, "When the scale of the epidemic increases, it is necessary to be fully prepared for hospital beds and medical response," adding, "We also need to review the compatibility of social distancing measures and various compensation issues." In particular, he said, "In the next pandemic, we need to develop vaccines and treatments more quickly and respond to infectious diseases with our own vaccines and treatments." She emphasized, “We will discover improvement tasks for each area and announce a comprehensive plan after consulting with related ministries and experts.”
- Policy
- Pfizer’s Cibinqo to undergo NHIS negotiations for reimb
- by Lee, Tak-Sun Mar 13, 2023 05:53am
- (From top to bottom) Dupixent Prefilled Inj., Rinvoq ER Tab., and Cibinqo Tab attempts reimb to treat pediatric and adolescent AD Pfizer has accepted the conditions set by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee for the reimbursement of its Cibinqo Tab (abrocitinib) in Korea. The drug received conditional approval at the DREC meeting that was held on March 2. The committee deemed Cibinqo’s reimbursement will be adequate if the company accepts a price less than the assessed amount. According to industry sources on the 12th, Pfizer accepted DREC’s conditions and is moving on to the pricing negotiation stage with HIRA. DREC’s proposed assessment price is expected to be set at the same level or below the weighted average price of its alternatives. Other JAK inhibitors that are currently available in the market include Olumiant Tab (baricitinib, Lilly) and Rinvoq ER (upadacitinib, Abbvie), therefore, Cibinqo’s price is expected to be set below the weighted average price of these drugs. After the Ministry of Health and Welfare orders pricing negotiations, Pfizer will be conducting negotiations with the NHIS for Cibinqo’s reimbursement. Although the statutory period set for NHIS negotiations is 60 days, if Pfizer accepts a price less than the upper limit set and receives negotiation exclusions, the company can further reduce the NHIS negotiation period to 30 days. If negotiations are completed in a short period of time, the industry expects Cibinqo may be listed for reimbursement in May at the earliest. Currently, Dupixent (dupilumab, Sanofi), Cibinqo, and Rinvoq are undergoing the reimbursement listing process as a treatment for pediatric·adolescent patients with atopic dermatitis. Among the three drugs, Dupixent has been making the most rapid progress. The drug entered negotiations last month and is expected to be listed for reimbursement next month at the earliest. Rinvoq ER, which is already listed as a treatment for atopic dermatitis in adult patients, is also attempting to extend its reimbursement as a treatment for adolescent patients aged 12 years or older with moderate-to-severe atopic dermatitis. Rinvoq ER’s reimbursement to the indication has passed HIRA review by applying the scope of use expansion formula and is set to receive NHIS negotiations soon. As Rinvoq and Cibinqo are both oral JAK inhibitors aiming to receive reimbursement as a pediatric atopic dermatitis treatment, their pricing negotiations will likely be conducted at the same time and be listed at a similar period.
- Policy
- Industry unsatisfied with the proposed PVA improvements
- by Lee, Tak-Sun Mar 10, 2023 05:50am
- Companies that have released new drugs in Korea have expressed discontent over the measures to improve the price-volume agreement (PVA) system that had been recently disclosed by the National Health Insurance Service. The new measure will put drugs that undergo PVA Type A negotiations at a relative disadvantage. According to the measures for the improvement of the PVA system that were disclosed at a roundtable meeting with the press corp, the improvement contained measures to change the ‘drugs whose claims have increased by 30% or more’ condition for PVA Type A negotiations to ‘drugs whose claims have increased by 10% or more or have claims amount that exceeds KRW 5 billion.’ PVA Type A had currently only been applied to drugs whose annual claims amount increased by 30% or more from the expected claims amount during the 3 years after reimbursement listing. Each company agrees to a certain amount during negotiations with the NHIS. However, if the NHIS applies the additional measures to the system, even drugs whose claims amount had increased by only 10% will be subject to PVA if the total amount exceeds KRW 5 billion. Regarding the measure, an industry official said, “If the KRW5 billion and 10% increase condition is added to PVA Type A, this will come as a burden to companies that develop new drugs in Korea. Adding more price discount mechanisms to homegrown new drugs may discourage the local pharmaceutical companies from developing new drugs.” The official added, “The measure to vary the drug price discount rate according to the claims amount is nothing new as this was previously announced by the NHIS, but the conditions that are being added to PVA Type A require some thought. The NHIS’s improvement plan contains measures to differentiate the price cut rate into three categories according to the magnitude of the claims amount and proposes calculating the maximum discount rate based on a reference formula. In other words, the NHIS plans to differentiate the discount rate according to the claim size. On the other hand, small and mid-sized pharmaceutical companies seem to be looking forward to NHIS’s additional measures. This is because the plan offers measures that raise the annual claims amount of drugs subject to PVA negotiations from KRW 2 billion to KRW 3-5 billion. If this exclusion criteria is applied to products with an annual claims amount of KRW 5 billion as well, most products by small and mid-sized pharmaceutical companies will be excluded from receiving price discounts. Another industry official said, “The research service results that contain HIRA’s proposals have not been disclosed yet, and a working group to promote the system is scheduled to commence in May, so we are not at the stage to guess how the final plan will come about. We will have to internally discuss and weigh the advantages and disadvantages of the proposed measures.”
- Policy
- Dupixent, Cibinqo, Rinvoq to be reimb for pediatric AD in 1H
- by Lee, Tak-Sun Mar 10, 2023 05:49am
- The three drugs that are attempting to receive reimbursement as a treatment for pediatric·adolescent patients with atopic dermatitis - Dupixent (dupilumab), Cibinqo (abrocitinib), and Rinvoq (upadacitinib) – are expected to be approved for reimbursement within the first half of the year. With all 3 drugs passing the Health Insurance Review and Assessment Service’s deliberations, only the pricing negotiation process with NHIS remains for the three drugs. This is why analysts believe the drugs will be listed for reimbursement within June this year. In the case of Sanofi’s Dupxient Prefilled Inj (200·300mg), the drug’s reimbursement adequacy was accepted by HIRA’s Drug Reimbursement Evaluation Committee on January 12 and has been going through the drug price negotiation process with the NHIS from February. As Dupxient will be reimbursed through the risk-sharing agreement (RSA) system, there is a high possibility that negotiations with the NHIS will focus on the required financial expenditures and the pharmaceutical company’s contribution amount If the negotiations end this month, reimbursement may be applied as early as April and May. Pfizer’s Cibinqo (50·100·200mg) received conditional approval from DREC on March 2. The drug’s reimbursement was deemed adequate when the company accepts a price less than the assessment amount, and the industry expects that it is highly likely that Pfizer will accept the said conditions. This is because another JAK inhibitor and competitor, Abbvie’s Rinvoq ER, is also speeding up its reimbursement process. The company is attempting to expand Rinvoq ER’s reimbursement to its pediatric and adolescent indication and will be carrying out negotiations with the NHIS through the drug price discount formula that is used with the scope of use expansions. Rinvoq ER tab is listed at KRW 21,085 per tablet, and when applied the scope expansion formula, its price may be reduced by up to 5%. Industry analysis is that Cibinqo will likely be listed for reimbursement at Rinvoq’s price as well. The two drugs are both attempting to receive reimbursement as a treatment for patients aged 12 years or older with moderate-to-severe atopic dermatitis. The industry expects that all three drugs may likely be reimbursed within the first half of the year. An industry official said, “In the case of Dupixent, pricing negotiations will be made within the scope of its RSA contract, and pricing negotiations for Cinvinqo and Rinvoq will be conducted together and be applied the same reimbursement standards.”
- Policy
- Multiple myeloma CAR-T therapeutic agent CARVYKTI, imminent
- by Lee, Hye-Kyung Mar 09, 2023 06:00am
- CARVYKTI compares self -hematopoietic stem cell transplantation (ASCT) after administration of Daratumumab, Bortezomib, Lenalidomide, and DVRD in December last year. The clinical trial was conducted. According to the industry on the 8th, the Ministry of Food and Drug Safety recently completed the safety and validation of Carvykti. If the Efficacy & Safety screening is completed without any problems, product permission will be made soon. CARVYKTI is a T -cell immunotherapy that is derived from BCMA targeted genetic variant. The US FDA has previously been allowed to treat reissue or rebel-resistant multiple myeloma adult patients with four or more treatments, including proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies. The European Executive Committee (EMA) has granted CARVYKTI a conditional sale of at least three treatments, including immunomodulators, protease inhibitors, and CD38 monoclonal antibodies. Japan has no experience in receiving BCMA target CAR positive T cell injection treatment and has approved Carvykti as a treatment for recurrent or rebellious adult patients with three or more treatments. Korea is also likely to be permitted as a patient treatment that has performed ASCT after the administration of DARATUMUMAB, BORTEZOMIB, Lenalidomide, and DVRD. CAR-T therapeutic drugs that challenge hematopoietic stem cell transplantation include BMS's Breyanzi and Gilead's YESCARTA.
- Policy
- Gov expands SGLT-2 diabetes drug combi benefit from April
- by Lee, Jeong-Hwan Mar 08, 2023 05:53am
- The Ministry of Health and Welfare will be the first to recognize the 3-drug combination benefit for diabetes treatment with SGLT-2 inhibition mechanism from April and expand the scope of the 2-drug combination benefit compared to the previous one. Specifically, 'Metformin + SGLT-2 inhibitor + DPP-4 inhibitor' and 'Metformin + SGLT-2 inhibitor + TZD-type drugs' are covered by health insurance benefits when 3 drugs are prescribed together, and sulfonylurea (SU)-type drugs and When using SGLT-2 inhibitors together, the number of covered drugs will be increased from the current one to four. In the case of insulin injection and SGLT-2 inhibitor combination therapy, the number of covered drugs will be expanded from the current two to four. On the 5th, Director Oh Chang-hyeon of the Insurance Pharmaceutical Division of the Ministry of Health and Welfare met with the Ministry of Health and Welfare Professional Correspondents Association and announced the plan to expand the SGLT-2 inhibitor combination benefit. If the health insurance benefit is revised as announced by the Ministry of Health and Welfare, all three-drug and second-drug combination benefits for all SGLT-2 inhibitory diabetes drugs currently approved for marketing in Korea will be recognized. AstraZeneca Forxiga, Boehringer Ingelheim Jardiance, Astellas Suglat, and MSD Steglatro Korea are a total of four SGLT-2 single-drug original diabetes drugs prescribed under domestic approval. There are a total of seven therapies for which the Ministry of Health and Welfare announced the expansion of SGLT-2 combination benefits, including generics that are identical to the original ingredients, from next month. There are 2 oral 3-drug therapies, 3 oral 2-drug therapies, and 2 insulin-oral combination therapies. First of all, the health insurance benefits for the oral triple therapy are 'metformin + SGLT-2 inhibitor + DPP-4 inhibitor' and 'metformin + SGLT-2 inhibitor + TZD-type drugs'. Oral double-drug therapy is a combination of a SU-type drug and an SGLT-2 inhibitor. Currently, dapagliflozin is the only SGLT-2 diabetes drug that is approved for concurrent benefit with SU. Ministry of Health and Welfare from next month following Dapagliflozin, Empagliflozin, Ertugliflozin, and Ipragliflozin will be approved for SU concomitant benefit. The combination therapy of insulin and oral medication will be expanded compared to the current one. Currently, two drugs, Dapagliflozin and Empagliflozin, are approved for reimbursement when insulin and SGLT-2 diabetes drugs are prescribed together. The Ministry of Health and Welfare will expand insulin combination benefits to Ertugliflozin and Ipragliflozin starting next month. Oh Chang-hyun said, "We plan to implement 7 therapies in April that will expand the 3-drug and 2-drug combination benefits for diabetes drugs with SGLT-2 inhibitory mechanisms." explained.
