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- 2026-05-02 20:13:48
- Policy
- Insurance price ceiling reeval results to be notified soon
- by Lee, Tak-Sun May 09, 2023 05:38am
- The Health Insurance Review and Assessment Service completed its first review on drugs subject to primary pricing ceiling reevaluations and will be notifying companies of the results soon. A 30-day objection period will follow HIRA’s result notification. According to HIRA on the 8th, HIRA’s Drug Reimbursement Evaluation Committee completed its first review of drugs subject to pricing ceiling reevaluations and will notify companies of the results within the week. About 14,000 items from about 200 companies were subject to primary evaluations. According to the original schedule, HIRA was supposed to complete the first evaluation and DREC review in April, but the period was delayed by a month due to the large amount of data the companies submitted in February, the last month of the data submission deadline. As a result, the plan for the results to be applied to the reimbursement list in July after negotiations is also likely to be delayed by a month. The re-evaluation of the upper limit amount of drugs includes the decision of whether to maintain or lower the upper limit after examining whether listed drugs met the self-bioequivalence testing and DMF listing requirements. Drugs that satisfy both the self-bioequivalence testing and DMF listing requirements are allowed to maintain their previous upper limit, and the price ceiling for drugs that satisfy only one of the two requirements is reduced to 85%, and those that satisfy none are reduced to 72.25%. In July 2020, the government applied the differentiated drug pricing system based on the standard requirements such as self-bioequivalence testing and DMF to new drugs and then started to reevaluate existing drugs (items listed as of August 1, 2020) after a grace period. The reevaluations were conducted in two groups in consideration of the pharmaceutical companies’ schedules. Companies that were subject to submit bioequivalence test results last year for their items (5,905 items) submitted data by July 31, and for other drugs, the standard requirements data were submitted from October of last year to February of this year. The items that will be notified of the first results are those whose data has been submitted by February. Once the first results are notified to each pharmaceutical company, a 30-day objection period will be available for the companies’ appeal. After the appeal process is concluded, the final result will be announced through DREC’s second review. According to the current schedule, it is highly likely that the final evaluation results will be deliberated at the second DREC meeting held at the end of June. Then, the results are expected to be reflected in the reimbursement list in August after the companies undergo main negotiations with the NHIS in July. The NHIS is currently forging preliminary discussions with pharmaceutical companies to complete the main negotiations in one month.
- Policy
- Retevmo passes DREC review and undergoes negotiations
- by Lee, Tak-Sun May 08, 2023 05:41am
- The anticancer drug ‘Retevmo Cap (selpercatinib, Lilly Korea)’ has passed redeliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC). Therefore, the drug is expected to be smoothly listed for reimbursement if it passes drug pricing negotiations with the National Health Insurance Service. On the 4th, HIRA announced that it had recognized the reimbursement adequacy of Retevmo Cap after deliberations at the 5th 2023 DREC meeting. Although the agenda had been discussed at the 4th DREC meeting held in April, a conclusion had not been made for Retevmo Cap, and was set to be rediscussed at a further meeting. Retevmo is indicated for ▲RET fusion-positive non-small cell lung cancer (NSCLC); ▲ RET-mutated medullary thyroid cancer; ▲ RET-fusion benign thyroid cancer. Although the number of patients is small, it is used in the RET mutation patient group with poor prognosis Along with Retevmo Cap the chronic kidney disease treatment ‘Verquvo Tab’ was also determined to be adequate for reimbursement. On the other hand, the Breztri Aerosphere inhaler and the Hemophilia A treatment Jivi Injection were determined to have reimbursement adequacy if they accept a price lower than DREC’s assessed amount. In other words, the two drugs will be able to pass DREC review and proceed further to receive pricing negotiations with the NHIS only if they accept the price presented by DREC.
- Policy
- First reimbursement of Yuhan Pregabalin 75mg CR
- by Lee, Tak-Sun May 08, 2023 05:41am
- Yuhan Pregabalin SR 300mgYuhan Corporation became the first company in Korea to list Pregabalin 75mg SR tablets for benefit. This drug is used as an initial dose for patients with moderate renal impairment. According to the industry on the 6th, Yuhan Pregabalin SR 75mg has been listed at 513 won per tab since May. Various doses of Pregabalin, such as 25 mg, 50 mg, 150 mg, and 300 mg, as well as 75 mg for neuropathic pain, were registered for reimbursement. Pregabalin is usually administered at a starting dose of 150 mg per day for neuropathic pain. However, in patients with renal impairment, lower doses are used first. Pregabalin 75 mg is used as a starting dose for patients with moderate renal impairment. In the meantime, only 150mg and 300mg, which are the main doses, have been developed for SR. Pregabalin 75mg extended-release tablet is the first time for Yuhan. This drug is intended for use in low doses in patients with moderate renal impairment. As it is SR, it is taken once a day. Considering that the existing 75mg fast-acting tablet was taken 2-3 times a day, it is expected that the convenience of taking it will increase for patients. Although there is no 75mg sustained-release tablet, Original Viatris is offering Lyrica CR extended-release 82.5mg for patients with moderate renal dysfunction. It is analyzed that Pregabalin 75mg was developed targeting Lyrica CR 82.5mg. In terms of price, Pregabalin 75mg is cheaper than Lyrica CR 82.5mg. Yuhan products are priced at 513 won, while Viatris products are priced at 732 won, which is more than 200 won higher. Lyrica is a blockbuster product that recorded 69 billion won in outpatient prescriptions (UBIST) last year. However, the SR market is small. Lyrica CR's outpatient prescriptions last year were only 900 million won. As such, the extended-release tablet market, which is highly convenient to take, has great potential for growth, and generics are also launching products one after another targeting this. Yuhan was the first to receive approval and is evaluated as having established an unrivaled area in the domestic Pregabalin 75mg market. Yuhan is already rolling out Pregabalin 50mg and 300mg SR through reimbursement. In the pregabalin market, in the Pregabalin market, attention is focused on whether Yuhan's efforts to develop SR will bear fruit.
- Policy
- The expansion of MPOX vaccination
- by Lee, Jeong-Hwan May 03, 2023 05:38am
- 17 million adult males aged 20 to 64, 170,000, about 1%, the high-risk group estimated As the number of MPOX cumulative confirmed cases in Korea increased to 49, concerns about community infection grew, and domestic quarantine authorities decided to expand the target of third-generation MPOX vaccine to 'high-risk subjects of infection', drawing attention. Currently, the quarantine authorities are implementing the MPOX 3rd generation vaccine by dividing it into 'pre-exposure vaccination' for medical staff and 'post-exposure vaccination' for contacts. The plan is to add people at high risk of infection among the general public. The high-risk target for infection is estimated to be 17 million adult male sexual minorities between the ages of 20 and 64, and the quarantine authorities plan to more actively recommend and publicize the third-generation vaccine for them. On the 2nd, the Korea Centers for Disease Control and Prevention (KCDC) responded to a written inquiry related to the MPOX epidemic in the community by In-soon Nam, a member of the Democratic Party of Korea. Rep. Nam In-soon closely inquired about the possibility of an outbreak in the MPOX community, the vaccination of medical staff, the current status of high-risk groups, and plans for siege vaccination. According to the Agency for Disease Control and Prevention, as of the 27th of last month, 109 people have been vaccinated, including medical staff in treatment beds to treat MPOX patients, and 165 people have received the first vaccination. The second dose of Jynneos, a third-generation MPOX vaccine, should be administered 28 days after the first dose. The Agency for Disease Control and Prevention announced through an official document the implementation of vaccination for those who wish to be pre-vaccinated with the Mpox 3rd generation vaccine in 17 cities and provinces to improve vaccination, such as treatment bed medical staff, diagnostic test laboratory personnel, and epidemiological investigators. The hospital for the confirmed patient was informed by phone to the hospital and actively encouraged vaccination in advance. Going further here, the Agency for Disease Control and Prevention plans to implement the 3rd generation vaccination administration. This is to prevent infection in the MPOX community in advance. Specifically, the target of third-generation vaccination before MPOX exposure is not limited to medical staff, but is expanded to 'high-risk subjects of infection'. The Agency for Disease Control and Prevention estimated that about 170,000 LGBT people are the high-risk group, based on UNAIDS, an AIDS task force under the United Nations, at about 1% of the 17 million adult male population aged 20 to 64 in Korea. MPOX 3rd generation vaccine The Agency for Disease Control and Prevention said, “We are currently conducting pre-exposure vaccination for medical staff and post-exposure vaccination for contacts.” We will expand it to those at high risk of infection.” The Agency for Disease Control and Prevention predicted that sporadic MPOX infections would continue for the time being, but diagnosed that it was not at a level to worry about a pandemic at the level of Corona-19. Unlike respiratory infectious diseases such as COVID-19 and MERS, where droplets are the main route of infection, MPOX is mainly spread through the skin and sexual contact with symptomatic infected people, and it was presented on the basis that the risk of transmission is low on the general population other than the high-risk group. The Agency for Disease Control and Prevention said, "Recently, MPOX patients have been steadily occurring in the region, and are not limited to a specific region and are distributed across the country, so sporadic cases in the community will continue." The prevailing opinion is that it is not at the level of concern about the same pandemic.” The Agency for Disease Control and Prevention added, “MPOX, which is transmitted through skin and sexual contact, has a relatively low risk of transmission in the general population of Korea, not in the high-risk group.” Meanwhile, on August 11 last year, the Korean government introduced 10,000 doses for 5,000 Jynneos, the third-generation Mpox vaccine produced by Bavarian Nordic A/S, a foreign pharmaceutical company. The third-generation smallpox vaccine, Jynneos, has been approved by the FDA and EMA for being effective against both human and monkeypox.
- Policy
- Pemazyre received domestic product approval
- by Lee, Hye-Kyung May 02, 2023 03:40pm
- Handok's locally advanced or metastatic cholangiocarcinoma treatment Pemazyre received domestic product approval on the 25th. The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced that it had approved three doses (4.5mg, 9mg, 13.5mg) of Pemazyre, an orphan drug. Pemazyre is an oral FGFR inhibitor that inhibits the proliferation of cancer cells caused by the fusion or rearrangement of fibroblast growth factor receptor 2 (FGFR2), which is involved in cell growth and differentiation. It is expected to provide a new treatment opportunity for adult patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement who have received one or more systemic treatments. Pemazyre is approved in the United States, Europe, and Japan for the treatment of adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy. In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment for life-threatening or serious diseases since December. Previously, the US FDA designated Pemazyre as a breakthrough therapy for the treatment of previously treated patients with advanced, metastatic, or unresectable FGFR2 translocation cholangiocarcinoma, and designated it as an orphan drug, conducting an expedited review through a priority review program. Cholangiocarcinoma is a rare type of cancer and is classified according to its anatomical origin as iCCA and extrahepatic cholangiocarcinoma arising from the bile duct outside the liver. Cholangiocarcinoma is often diagnosed at an advanced or advanced stage with a poor prognosis. FGFR2 fusions or rearrangements are found in 10-16% of patients with intrahepatic cholangiocarcinoma. FGFRs play important roles in the proliferation, survival, migration, and angiogenesis of tumor cells. FGFR fusion, rearrangement, translocation, and gene amplification activities are closely related to the development of various cancers. Pemazyre is an oral FGFR inhibitor and is the first and only treatment approved by the FDA for this indication.
- Policy
- Dual punishment for CSO rebate excluded from review
- by Lee, Jeong-Hwan Apr 28, 2023 05:49am
- An amendment to the Medical Service Act that applies a dual punishment system when doctors receive rebates paid by pharmaceutical contract sales organizations (CSOs) and an amendment to the Pharmaceutical Affairs Act to prohibit potential hospital/pharmacy owners and brokers from exchanging illegal hospital subsidies in exchange for prescriptions has been omitted as an agenda of the plenary meeting of the National Assembly’s Legislation and Judiciary Committee that was set to be held in the afternoon (27th) However, the amendment to the Pharmaceutical Affairs Act, which legislates the factual survey of illegally opened and operated pharmacies and publicly announces the results of illegally confirmed pharmacies, and the Narcotics Control Act, which grants pharmacies the right to refuse prescriptions of insolvent drugs that are suspected of forgery or missing some of the mandatory information, will be reviewed by the Legislation and Judiciary Committee. The bill for the illegal pharmacy factual survey and their public disclosure and refusal to dispense poor drug prescriptions are expected to be reviewed at the NA’s plenary session scheduled for tomorrow (27th) if they pass the Legislation and Judiciary Committee review. If the two bills pass the plenary session, pharmacies that have not gone through proper procedures, such as face-to-face pharmacies, will be regularly managed and regulated through factual surveys, and punitive public announcements will be possible. If passed, the difficulties front-line pharmacies have dispensing prescriptions for drugs that are suspected of being counterfeit or poor drug prescriptions issued by medical institutions without essential information such as the patient's resident registration number, will be improved. However, the bills to ban CSO rebates and illegal hospital subsidies for doctors and pharmacists will not be passed at the plenary session held this month due to the delay in their Legislation and Judiciary Committee review. In particular, the exclusion of the bill to ban CSO rebates for doctors from the Legislation and Judiciary Committee review leaves room for regret. This is because the CSO reporting system passed the plenary session of the National Assembly last month, and regulatory synergies were expected in the future when the National Assembly passed the CSO rebate ban bill this month. Legislation of the bill to ban collusion activity between pharmacies and medical institutions for prescriptions was supposed to add 'a person who intends to open an institution’ and the bill to eradicate illegal hospital subsidies and punish brokers who mediate collusions has also been delayed with the exclusion of their review by the Legislation and Judiciary Committee. In addition, a partial amendment to the National Health Insurance Act, which will enable stable financial support for health insurance by extending the effective period of state treasury support for the National Health Insurance Service to 'December 31, 2027' will also be proposed for review by the Legislation and Judiciary Committee today.
- Policy
- JW Pharma Hemlibra will be reimbursed starting in May
- by Lee, Tak-Sun Apr 25, 2023 05:56am
- JW Pharma's Hemlibra will also be covered for patients with severe non-antibody hemophilia A from May. Previously, this drug was covered only for hemophilia A patients with antibodies. This increase in coverage is expected to greatly contribute to the quality of life of patients with severe non-antibody hemophilia A, especially pediatric patients. According to the industry on the 21st, Hemlibra has been used as a daily prophylaxis to reduce or prevent bleeding frequency in patients with severe hemophilia A (congenital factor VIII deficiency) who do not have factor VIII inhibitors since May. Even if you use it, the salary will be applied. In other words, severe hemophilia A patients without antibodies can receive health insurance benefits when using Hemlibra. In the meantime, non-antibody hemophilia patients have been using intravenous treatment two to three times a week. Hemlibra is expected to be more convenient than existing intravenous treatments because the preventive effect lasts with subcutaneous injections from once a week to once every 4 weeks. In particular, it is analyzed that it will help improve the quality of life of pediatric patients. In the parliamentary audit last year, the rapid payment of Hemlibra for pediatric patients with non-antibody hemophilia was also an issue. According to the 2019 Hemophilia Foundation White Paper, among a total of 1,746 patients with hemophilia A in Korea, 78 were antibody patients and 1589 non-antibody patients were resistant to the existing treatment (factor 8 drug). Among them, severely ill patients accounted for 1259 (72.1%). Hemlibra is a treatment for hemophilia A developed by Chugai, a subsidiary of Roche, in Japan. This time, Hemlibra's drug price will be reduced as reimbursement increases. The 30mg/1mL product is adjusted to 2.28 million won per bottle, 60mg/0.4mL to 4.56 million won, 90mg/0.6mL to 6.84 million won, 0.105g/0.7mL to 7.98 million won, and 0.15g/1mL to 11.4 million won. From May, Chinese pharmaceutical company BeiGene's anti-cancer drug 'Brukinsa 80mg' will be covered. This drug is reimbursed for the treatment of Waldenstrom's macroglobulinemia (WM). Waldenstrom's macroglobulinemia (WM) is a rare blood cancer in which the bone marrow produces large numbers of abnormal white blood cells that crowd out healthy blood cells. The US FDA approved Brukinsa as a treatment for WM in September 2021. In Korea, it is attracting attention as it is the first case in which a Chinese new drug entered the right to benefit. Brukinsa is priced at 34,100 won per capsule. Expenditure cap RSA is applied to this drug.
- Policy
- Original Concor voluntarily reduced the price
- by Lee, Tak-Sun Apr 25, 2023 05:56am
- Concor (Bisoprolol fumarate), the original β-blocker antihypertensive drug, voluntarily lowered its drug price, gaining recognition and price competitiveness. Many generic drugs are more expensive than original drugs, so marketing activities are expected to be difficult. According to the industry on the 24th, the price of Concor 5mg will go down from next month from 222 won to 200 won. The price of Concor 2.5mg will be reduced from 132 won to 120 won. The company lowered the price itself. Concor is a second-generation β-blocker that has been sold in Korea since 2001 and has established itself as a treatment for hypertension, angina pectoris, and chronic heart failure. In particular, as the awareness of original products increases, there is a big gap with generic products. As of last year, Concor's outpatient prescriptions amounted to 18.6 billion won. Since 2020, Daewoong Pharmaceutical has exclusively sold the drug in Korea. As the company's performance is sound and the market share of generic drugs is low, the market is also showing a skeptical response to the voluntary lowering of the drug price this time. The fact that Elyson's lowest-priced generics continued to increase their market share was a potential cause for concern. Bisoprolol fumarate 5mg has eight products, including Concor and Elyson Conbloc. Previously, Concor and six generics were priced the same at 222 won, and only Conbloc 5mg was listed at 198 won. For Bisoprolol fumarate 2.5mg, Elyson Conbloc 2.5mg was 124 won and Concor tablet 2.5mg was 132 won. With this price cut, Concor narrowed the gap with Conbloc by 2 won in the 5mg product and became 4 won cheaper in the 2.5mg market. Currently, in the generic market, all but Elyson are producing less than 1 billion won a year. On the other hand, Conbloc, which boasts drug price competitiveness, is increasing every year to KRW 3.6 billion last year according to UBIST. Conbloc is drawing an upward trend with 1.1 billion won in 2017, 1.8 billion won in 2018, 2.3 billion won in 2019, 2.9 billion won in 2020, 3.5 billion won in 2021, and 3.6 billion won in 2022. Compared to Concor's performance of 18.6 billion won in 2022, there is still a gap. However, Concor's 2022 performance is down 3% from the previous year. If this trend continues, Conbloc's market share may increase and Concor's market share may decrease. This drug price cut is interpreted as the intention of Concor to gain an absolute advantage in generic competition. It is expected that the six generic companies, which had the same drug price as Concor, could suffer damage. Previously, these six companies only produced less than 1 billion won per year, but it is expected that their market competitiveness will further weaken as the original drug price cut overlaps. There is also a way to lower the price of the drug depending on the original, but in this case, it seems that it will worry about whether to continue the business because it comes back to the cost burden. Elyson, which has put forward a low price, is expected to become a burden on marketing activities as the price becomes similar to the original. It remains to be seen what effect the original drug's voluntary price cut will have on the market.
- Policy
- Price of Eliquis reduced by 3.5%... Kanarb by 1.7% each
- by Kim, Jung-Ju Apr 24, 2023 05:52am
- Merck's Mavenclad tab. (cladribine), which is used to treat relapsing-remitting multiple sclerosis, has become subject to price cuts under the price-volume agreement and will be sold at a 6.9% lower price starting next month. The price of Boryung’s flagship hypertension drug, Kanarb (fimasartan potassium trihydrate), will be reduced by 1.7% for each dose, and the price of BMS Korea Eliquis will also be reduced by 3.5% for each dose. According to industry sources on the 21st, the Ministry of Health and Welfare is planning to revise the 'Drug Reimbursement List and Reimbursement Ceiling Amount Table' and apply it on the 1st of next month. A total of 6 products will be applied PVA price cuts. One is subject to ‘PVA Type A’ and the other 5 are subject to ‘PVA Type B’ and the subject drugs have been conducting negotiations with the National Health Insurance Service until now. ◆PVA Type A = Price of only 1 drug classified as 'type A' will be reduced after completing negotiations with the government. Among new drugs listed as negotiable after the introduction of the drug price negotiation system, the government applies PVA A type to drugs whose claims amount in the same product category exceeds the expected claims amount by over 30%. By same product category, drugs that have the same company name, route of administration, ingredient, and formulation are classified as drugs of the same product category. The drug subject to ‘Type A’ price reduction is Merck’s Mavenclad Tab. Its price is set to be reduced by 6.9%, and the price cut will be applied starting on the 1st of next month. ◆PVA Type B = Also, 5 drugs that were classified as Type B will receive price discounts this time. The government applies PVA Type B and reduces the price of drugs ▲whose price ceiling had been already adjusted according to Type A, ▲ whose claims amount increased by over 60% from the previous year without undergoing Type A negotiations, or 4 years after receiving Type A negotiations, or ▲ has increased by over 10% but the increased amount exceeds KRW 5 billion and does not fall under PVA Type A. By each item, the price of 60mg and 120mg doses of Boryung’s Kanab Tab. will be reduced by 1.7%, respectively. The price of its 30mg dose product will be reduced by 1.8%. Eliquis's insurance drug prices will fall by 3.5% each for both the 2.5mg and 5mg doses.
- Policy
- The price of Envlo is 611 won & Qtern is 833 won per tab
- by Lee, Tak-Sun Apr 23, 2023 09:42pm
- Leading diabetes treatments such as Daewoong Pharmaceutical's new SGLT2i diabetes drug Envlo and AstroGeneca's SGLT2i+DPP4i complex Qtern will be poured out at once in May. In line with the expansion of the Forxiga patent expiration and diabetes drug combined salary standards this month, the application of new product benefits was concentrated in May. According to the industry on the 20th, Daewoong Pharmaceutical's salary will be applied to 611 won per table of 0.3mg per table on the 1st of next month. Envlo is known to have been determined at less than 90% of the price of existing SGLT2i drugs. It is lower than the existing SGLTi treatment Jardiance 10mg 660 won, Sugar 50mg 685 won, and Steglatro 5mg 666 won. The price of Envlo is higher than that of Forxiga, because at the time of calculating the Envlo price, Forxiga was before the patent expired. Forxiga 10mg will be reduced from 734 won to 514 won from May. Hanall Biopharma, an affiliate of Daewoong Pharmaceutical Co., Ltd. with Envlo, Eaglex and Daewoong Bio Benavo's price is the same. The SGLT2i+DPP4i compound will be reimbursed for the first time. Korea's AstraZeneca Qtern 5/10mg, Korea's Beringer Ingelheim's Esglito 10/5mg, Korea's MSD's "Stegluzan 5/100mg" and LG Chem's Zemidapa will be on the list in May. Qtern costs 833 won per tablet, Esglito costs 755 won for 10/5mg, Stgluzan costs 846 won, and Zemidapa costs 940 won per tablet. Chong Kun Dang Exiglu-S will also be on the list in May. It will be four months ahead of the expiration of the Sitagliptin material patent (September 1), drawing keen attention to Chong Kun Dang's strategy. The Dapagliflozin+Sitagliptin combination licensed by domestic companies is expected to be listed after September. These SGLT2i+DPP4i combination are only eligible for benefits in the third system combined with metformin according to the standard. It is on the list for 677 won per tablet, with Hutecs Korea Pharmaceutical's "Gluxiga 10/4mg," Jinyang Pharmaceutical's "Dapagreen-G 10/4mg," Kyungdong Pharmaceutical's "Dapamepi 10/4mg," and Mothers Pharm's Pharmaceutical's "Xig Double M 10/4mg."
