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- 2026-05-03 21:33:02
- Policy
- Erleada applied for health insurance in April
- by Lee, Tak-Sun Mar 20, 2023 05:51am
- As this drug is an upgraded version of prostate cancer treatment, which is increasing every year, many patients are expected to benefit if health insurance benefits are applied. On the 16th, the HIRA foretold the reimbursement standards for anticancer drugs, which include the establishment of new reimbursements for ADT and combination therapy for Erleada's hormone-responsive metastatic prostate cancer (mHSPC) patients. The effective date is the 1st of the following month. According to the announced reimbursement criteria, Erleada is covered as first-line therapy, block therapy (ADT), and combination therapy for mHSPC patients. ADT is an androgen deprivation therapy, limited to orchiectomy, LHRH agonist + 1st generation anti-androgen, and LHRH antagonist. In addition, LHRH agonist + 1st generation anti-androgen among ADT therapy will not be recognized when administered in combination with new hormone therapy drugs. The HIRA is a drug that Erleada has approved for use in combination with ADT for the treatment of patients with hormone-responsive metastatic prostate cancer (mHSPC). As a result of reviewing with reference to textbooks, guidelines, and clinical papers, the therapy is mentioned in textbooks, and the NCCN Guide It is stated that it is recommended as category 1 in the line, [Ⅰ, A] in the ESMO guidelines, and ESMO-MCBS score 4. In phase 3 clinical trial (TITAN study) for patients with hormone-responsive metastatic prostate cancer (mHSPC), as a result of comparing the therapy with the control ADT monotherapy, median overall survival (mOS) NR vs. mPFS2 NR vs. 52.2 months, confirmed by PSA progression, etc. He explained the justification for reimbursement, saying that clinical usefulness was confirmed at 44 months. Erleada passed the HIRA in February last year and the committee in December and has been negotiating with the NHIS since January.
- Policy
- Lansoprazole+antacid combo awaits entry into market
- by Lee, Tak-Sun Mar 20, 2023 05:51am
- A new combination is awaiting entry into the Proton pump inhibitor (PPI)+ antacids combination market. This time, the new entrant is a combination of lansoprazole and precipitated calcium carbonate. Ever since Chong Kun Dang achieved outstanding results in the market, new combinations have been pouring out every year in the market. With already over 70 products in the market, whether the newly released product may settle in the market is gaining attention. According to industry sources on the 19th, the lansoprazole 30mg + precipitated calcium carbonate 600mg combination that was approved in Korea in January is expected to be listed for reimbursement in April. 6 companies including Guju Pharm, Myungmoon Pharm, Yu & Life Science, Hana Pharm, and Union Korea Pharm had received approval for related products. The drugs are being manufactured by Yu & Life Science. Four PPI ingredients are now available for use in combination with antacids - omeprazole, esomeprazole, rabeprazole, and lansoprazole. The antacids used with the PPIs are sodium hydrogen carbonate, precipitated calcium carbonate, and magnesium hydroxide. PPI+antacids are characterized by the shorter time required to take effect. The drugs combine antacids with PPI, which is weak against stomach acid, to complement the shortcoming and provide a rapid effect. Chong Kun Dang’s Eso Duo is a representative product in the market. Based on UBIST, Eso Duo recorded outpatient prescription sales of KRW 16.3 billion last year, which was a 10% YoY decrease from the previous year. This is analyzed to be due to the immense inflow of PPI+antacids in the market. 25 esomeprazole+ sodium hydrogen carbonate products are currently available in the market, and over 70 PPI+antacids are approved in the market. In this context, attention is focused on whether the latecomer lansoprazole+precipitated calcium carbonate will be able to overcome the fierce competition and settle in the market. However, in terms of price, the new entrant is expected to have competitivity over previous combination drugs due to its relatively cheaper price. The combination drug awaiting entry contains the high-strength lansoprazole (30mg, ceiling price KRW 877), and the ingredient’s price is relatively lower than the high-strength esomeprazole (40mg, ceiling price KRW 1,078), or the high-strength rabeprazole (20mg, ceiling price KRW 1,069). The price of the combination drugs is calculated based on the price of the single ingredient, the ceiling price for lansoprazole+precipitated calcium carbonate is expected to be lower than those set for other high-strength PPI combination drugs. However, whether a lower price will lead to an increase in market prescriptions remain unknown. There is also an analysis that the low price may instead become a burden on the profitability of the pharmaceutical companies.
- Policy
- Marketing authorization imminent for Obizur in Korea
- by Lee, Hye-Kyung Mar 17, 2023 05:46am
- Marketing authorization for Takeda Pharmaceuticals Korea’s ‘Obizur Inj (susoctocog alfa)’ is imminent in Korea. Obizur Inj is a treatment for bleeding episodes in adults with acquired hemophilia A. The drug has been used as a treatment for hemophilia A in Korea after receiving an orphan drug designation in July 2021. According to the industry on the 16th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Obizur. If the MFDS completed the safety and efficacy review without issues, the drug’s marketing authorization is expected to be underway soon. Hemophilia is a congenital bleeding disorder caused by a congenital deficiency of a blood clotting factor and is estimated to have an incidence of 1 per 10,000 births. Depending on the deficient blood clotting factor, hemophilia is divided into two types – hemophilia A and hemophilia B – and hemophilia A accounts for 80% of all hemophilia and hemophilia B for the other 20%. Unlike general hemophilia, acquired hemophilia A is a very rare condition caused by the development of autoantibodies directed against factor VIII, which leads to bleeding episodes like those experienced by hemophilia patients. According to domestic research, 55 patients are reported to have acquired hemophilia in Korea, and the prevalence rate is 0.2-1.48 per 1,000,000 people. Unlike congenital hemophilia, which almost always occurs in boys, acquired hemophilia mostly affects men and women over the age of 65. Orphan drugs are treatments used for diseases that affect 20,000 or fewer patients (prevalence population) in Korea, and are used for diseases for which no appropriate treatment method or drug has been developed, or drugs whose safety or efficacy have been significantly improved compared to existing alternatives.
- Policy
- Upper limit re-evaluation of drugs in the negotiation stage
- by Lee, Tak-Sun Mar 16, 2023 05:45am
- The re-evaluation of the drug cap amount according to the standard requirement has now moved to the negotiation stage with the NHIS. Pharmaceutical companies that submitted their primary drugs to the HIRA by last February will proceed with prior consultation with the NHIS in March. After that, the main negotiations will be completed and the final drug price adjustment results will be announced in July. The NHIS announced on the 15th that it will hold prior consultations with pharmaceutical companies from this month in accordance with the re-evaluation of the standard requirements for the maximum amount of drugs. Accordingly, the NHIS plans to hold a briefing on the reevaluation negotiations on the 27th. An official from the corporation said, "We recently shared matters related to negotiations on standard requirements through a meeting with pharmaceutical organizations." About 15,000 drugs will be targeted for the first round, and prior consultations will be held until May. During the preliminary consultation period, the items to be negotiated will be checked and an agreement will be sought, so it is expected that the agreement will be concluded during the main negotiations in June. Based on this, the contents of the final drug price adjustment will be announced in July after going through the review committee in June. Negotiations are underway for the second target drug. The secondary target drugs are about 5,000, and if data are submitted to the HIRA by July, negotiations will proceed with the NHIS again. Negotiations will be conducted by the NHIS Pharmaceutical Control Office's Generic Management Division. An official from the generic management department explained, "Based on our experience over the past two years, we are thoroughly preparing to complete the negotiations within the deadline." The re-evaluation of the upper limit amount is being carried out by maintaining or lowering the upper limit amount depending on whether the company's own BA test and DMF registration criteria are met. If both of the BA and DMF requirements are met, the upper limit is maintained, and if one is met, the price is reduced to 85% of the adjusted standard price, and if both are not met, the price is reduced to 72.25%.
- 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.
