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- 2026-03-14 22:26:26
- Policy
- Reduced drug price by expanding the scope of Abraxane
- by Kim, Jung-Ju Mar 25, 2021 05:58am
- Celgene's anticancer drug Abraxane (Paclitaxel) is expected to cut the drug price by 3.6% next month as the scope of use is expanded. Janssen Korea's prostate cancer treatment Zytiga 500mg (Abiraterone Acetate) is subject to a 5% cut rate due to an additional indication, and advance drug price cuts are being promoted. Takeda Pharmaceutical Korea's lymphoma treatment Adcetris (Brentuximab Vedotin) and metastatic non-small cell lung cancer treatment Alunbrig (Brigatinib) dropped 1.4% and 1.5%, respectively. The MOHW is promoting the revision of the drug reimbursement list as of April 1. ◆Preliminary drug price reduction due to expansion of the scope of use = The government will lower the drug price in advance, taking into account the expected additional billing amount and the rate of increase in billing amount for drugs that expand the range of use by adding indications. In the case of the estimated additional charge of ￦7.5 billion or more and less than ￦10 billion, the amount will be reduced from 3.6% to 5%, depending on the increase rate of the claim. A total of two items to be promoted for this advance drug price cut are Celgene's anticancer drug Abraxane and Janssen Korea's prostate cancer drug Zytiga 500mg. First, Abraxane has been previously approved by the government and has been used as Paclitaxel+Carboplatin+RT for esophageal cancer prior chemotherapy, although limited. It will be converted to next month's benefit, and the drug price has been cut in advance in consideration of an increase in the amount charged. The price is expected to be set at ￦260,960, down 3.6% from the current ￦27,705. In the case of Zytiga 500mg, Docetaxel + ADT combination therapy and Zytiga + Prednisolone + ADT combination therapy are also recognized as benefits for metastatic hormone-sensitive prostate cancer, and advance drug price reduction is promoted. However, the patient's copayment is a selective benefit for 30/100 for Zytiga. The price is expected to be reduced by 5% from the current ￦20,090 to ￦19,086. ◆Voluntary price reduction by companies = The government adjusts the insurance drug price by calculating the item with that amount when a company applies for a reduction at a price lower than the upper limit of the listed drugs. There are a total of six items scheduled for voluntary price reduction. Takeda Korea’s Adcetris drops by 1.4% and Alunbrig (Brigatinib) 30mg/90mg/180mg products drop by 1.5%. Intro Bio Pharma's Icept 5mg (Donepezil HCl) will be reduced by 71.8% and Icept (Donepezil HCl) 10mg will be reduced by 64.6%.
- Policy
- MOHW announces list of premium pricing benefit decision
- by Kim, Jung-Ju Mar 25, 2021 05:58am
- The South Korean health authority is to authorize 30-percent reimbursed pricing reduction in every dose of Eisai Korea’s Symbenda injection (bendamustine hydrochloride). After a year, the injection’s pricing would be brought down again by 23.5 percent due to the expired weighted pricing benefit. Novartis Korea’s Afinitor (everolimus) is to maintain the weighted pricing benefit on each dose for two years, and they would be also reduced by 23.5 percent after the benefit expiration. South Korea’s Ministry of Health and Welfare (MOHW) is to revise and enforce the List of Reimbursed Drugs and Upper Limit Pricing with the said details as of Apr. 1. ◆Weighted pricing benefit expires: For a first generic, the South Korean government grants pricing of 59.5 percent of the original for a year from the date of listing. The pricing goes up to 68 percent for generics by an Innovative Pharmaceutical Company, however, when the benefit ends the pricing goes back to the original pricing (benefit expiration). As for a latecomer generic listed within a year the first generic is listed, the same premium pricing would be granted for a year from the point of the first generic listing. But if the number of generic supplying companies is three or under, the weighted pricing would be maintained until another company launches the generic. From coming June 1, total four items are to lose the premium pricing benefit. The pricing for every dose of Yungjin Zopiclone tablet (eszopiclone), 1mg, 2 mg and 3 mg, would be dropped by 4.1 percent, 5.4 percent and 6 percent, respectively. The pricing for Korea United Pharm’s Atmeg Combigel soft capsule (atorvastatin calcium hydrate) would be reduced by 21.2 percent from Apr. 1, 2022. ◆Weighted pricing benefit maintained or expired: Total five items would get to keep their premium pricing benefit. Regardless of a year of pricing benefit ending, the government lets the drugs to maintain the premium if the number of generic suppliers is three or lower. Every dose of Novartis Korea’s Afinitor tablet, Tai Guk Pharm’s Hyrosone cream (hydrocortisone) and Inist Bio Pharmaceutical’s Hydrocortisone ointment (hydrocortisone) are to maintain their pricing benefit. Their premium pricing benefit would expire two years later as of Apr. 1, 2023. The initial weighted pricing would remain unchanged for two additional years, until the fourth same-substance generic supplier comes along. All doses of Afinitor tablet would respectively get 23.5-percent pricing cut, whereas Hyrosone cream and Hydrocortisone ointment would get 5.6-percent and 23.5-percent pricing cut, respectively. ◆Authorized pricing adjustment and benefit expiration: The government authorized the pricing reduction on two items. The government-authorized pricing reduction is applied to first-in-class drugs and products with same administration route, substance and formula, when a generic is listed. Although, a first-in-class drug’s pricing is brought down to 53.55 percent when the first generic is listed, the premium pricing benefit at 70 percent of the initial pricing is granted for a year. Eisai Korea’s Symbenda injection is expected get authorized pricing reduction of 30 percent on both 25 mg and 0.1 g. And after a year, as of Mar. 1, 2022, the pricing would be reduced by 23.5 percent again as the premium pricing benefit is to end by then.
- Policy
- CMOs tense up for a full day MFDS investigation
- by Lee, Tak-Sun Mar 23, 2021 06:24am
- Set off by the Binex incident, South Korea’s Ministry of Food and Drug Safety (MFDS) has started a full investigation on pharmaceutical contract manufacturing organizations (CMOs). Although it was a day-long investigation, the companies noted it was pressuring. According to the relevant industry sources on Mar. 22, two to three regional MFDS branch officers in a group are investigating a single CMO a day. Compared against a regular Good Manufacturing Practice (GMP) inspection running three to four days, the special investigation was only a full day long. But all the investigated companies commented they felt the heavy pressure. Especially because the Criminal Investigations Office started digging into Binex and Vivozone accused of manufacturing products different from the approved label, which could not only lead to sales ban or recall order but also a judicial action, the investigated companies were apparently extremely tensed up. A medium-sized company associate said, “The staffs felt heavily pressured as the investigators knocked on the door unannounced. Even though the investigation was for a day only, we were worried of them finding some sort of an issue.” Regardless, there is no news of finding a new case. Some argue the investigation size is limited and finding the error based on document is extremely difficult. Another company associate said, “Apparently, the investigator chose one mass produced item and closely followed the manufacturing process. Generally, such investigation compares active pharmaceutical ingredient (API) inventory documents and the approved label to seek a possible difference. But it would be quite difficult to spot an issue within a company without a proper ERP management only based on the given papers.” However, the pharmaceutical companies are still keeping their guard up. They are concerned if any company among the 30 investigation subjects is found even with a miniscule problem, the investigation could open up to the entire pharmaceutical industry. The previous pharmaceutical company associate added, “Considering the negative public perception on the issue, MFDS could expand the investigation to target the whole of industry. The relevant companies would be greatly stressed to undergo the regular inspection and the special investigation.” On Mar. 12, Binex followed by Vivozone were found to have used different API from the approved manufacturing ingredient list, and MFDS began looking into 30 CMOs. Considering the inspection outcome, MFDS plans to revise the relevant system comprehensively to expand the inspection subject to include all pharmaceutical manufacturers and prevent the same violation.
- Policy
- New benefits for Epidiolex will be established from April
- by Lee, Jeong-Hwan Mar 23, 2021 06:23am
- New standard for Epidiolex (a drug for refractory childhood epilepsy) will be established. Democratic Party of Korea Rep. Nam In-soon and others strongly pointed out the validity of health insurance benefits at last year's national audit. Epidiolex costs about ₩1.64 million per bottle, and up to ₩40 million per year. On the 17th, the MOHW announced an administrative notice of the amendment to the notification of details on the application standards and methods of medical care benefits. It is scheduled to be implemented from April 1 after collecting opinions by the 24th. In the revised bill, first, a new reimbursement standard for Cannabidiol (Epidiolex, CDB oil), a seizure treatment drug related to Lenox-Gasto Syndrome or Dravet Syndrome, will be established. Administration methods, administration targets, and evaluation methods are prepared within the scope of the approval of the MFDS. These patients were administered at a dose but did not show seizure reduction by more than 50% compared to the time of initial antiepileptic drug administration. It is administered in combination with Clobazam, and if it cannot be administered due to contraindications or side effects to Clobazam, it can be administered alone. Epidiolex is subject to the deliberation and resolution of the reimbursement list and benefit upper limit amount table of the Health Insurance Policy Deliberation Committee to be held in late March. Epidiolex is a drug that Democratic Party of Korea Rep. Nam In-soon repeatedly emphasized the validity and urgency of the benefit. At last year's inspection of the state administration, she said, "Epidiolex, which is a rare among pediatric epilepsy patients, is effective for patients with Travet syndrome or Lennox-Gasto syndrome, and is a drug that burdens children and parents because it is expensive." She pointed out that "there is a need for rapid promotion of health insurance coverage." In addition to Epidiolex, as Atorvastatin, a treatment for dyslipidemia, and Atmeg Combigel, a combination of omega-3, are scheduled to be listed, a new reimbursement standard will be established by referring to differences in license requirements from existing drugs. Atmeg Combigel is administered to complex dyslipidemia in which low-density lipoprotein cholesterol (LDL-C) levels are properly controlled with a single treatment of Atorvastatin 40 mg, but triglyceride (TG) levels are not controlled despite proper diet. The triglyceride level is 1 when side effects are expected when using an existing similar alternative drug (Fibrate or Niacin series) when blood TG≥500 mg/dL, risk factors or diabetes, blood TG≥200 mg/dL. 4 capsules per day are accepted. In addition, as the new vascular (wet) age-related macular degeneration drug Beovu Prefilled Syringe is scheduled to be listed, new standards such as administration targets and evaluation methods will be established. According to the newly established standards, the subjects of administration are patients with submacular choroidal neovascularization due to age-related macular degeneration, and cases of scarring or severe atrophy are excluded from administration. As for the administration method, if the treatment effect is not observed even after the initial three doses, subsequent administration is not recognized. In the case of using only one of Eylea and Lucentis, if there is no therapeutic effect after 3 times of administration after replacing with Beovu, subsequent administration will not be recognized as a benefit. From the 5th dose, if the corrected visual acuity is less than 0.1, no benefit is recognized. Concomitant administration with Visudyne (Vertporfin) is not recognized. The newly listed rheumatoid arthritis treatment Xeljanz XR Tab. 11mg (Tofacitinib) is admitted in accordance with the notification of the comparative drug reimbursement standard, but is revised in consideration of the difference in authorization.
- Policy
- “Regular COVID-19 vaccination like flu vaccination"
- by Kim, Jung-Ju Mar 23, 2021 06:23am
- The South Korean health authority says the COVID-19 vaccination could be periodically provided in the future, similar to an influenza vaccination, due to the pandemic still spreading strong around the world. It also means the health authority would have to successfully develop an mRNA vaccine platform, in which the government plans to soon announce an mRNA vaccine development support roadmap. At a regular COVID-19 briefing session convened on Mar. 19, Deputy Director Kwon Joon-wook of the Central Disease Control Headquarters talked about the plan. Deputy Director Kwon opened his statement saying, “As a part of the health authority and a president of Korea National Institute of Health (NIH), I feel the grave desperation to ensure South Korea to successfully develop a COVID-19 vaccine. And for a long-term purpose, the country has to develop an mRNA vaccine platform.” The deputy director elaborated, “The virus variant and antibody duration have to reviewed, but for now, the government sees that, like the annual influenza vaccination, the COVID-19 vaccination could be highly likely to be inoculated, although it may not be annually provided.” But the health authority faces a mountain of challenges to seek the vaccine. Besides the actual development of vaccine, the authority is burdened with unpredictable clinical trial execution, investment and virus variant, while it has not had sufficient experience in developing a vaccine. Deputy Director Kwon stated, “Regardless of all difficulties, currently, vaccine developing companies, researchers, experts, clinical institutes and all government bodies are combining focused effort to develop the vaccine. We may be struggling with a late start, slow speed, rough challenges and numerous variables, but we do not doubt that we would ultimately develop a South Korean-made vaccine or a better mRNA vaccine platform. To achieve the goal, the government would soon prepare and explain about the detailed support plan including an enterprise organization and a roadmap.”
- Policy
- The HIRA's reimbursed standards for chemotherapy are changed
- by Lee, Hye-Kyung Mar 23, 2021 06:23am
- The HIRA has changed the chemotherapy benefit standard, four criteria are changed and three criteria are deleted in relation to pancreatic cancer chemotherapy. Changes are made in a total of 25 criteria. The HIRA recently prepared an amendment to 'Details on the Standards and Methods of Applying Medical Care Benefits to Drugs Prescribed and Administered to Cancer Patients.' As a result, the standard for chemotherapy was improved sequentially, and the standard for chemotherapy related to small cell lung cancer, esophageal cancer, thyroid cancer, hepatobiliary cancer, and head and neck cancer was changed. The chemotherapy for which the reimbursement standard is changed this time is for pancreatic cancer, and the HIRA will conduct an opinion inquiry on the announcement (draft) of the drugs prescribed and administered to cancer patients by the 25th. The effective date is April 1. According to the announcement, the reimbursed standard was changed to 4 items and 13 therapies ▲location of group 1 anticancer drugs (3 therapy) ▲1. Change the phrase of the administration target for the postoperative adjuvant therapy no.1 (1 therapy) ▲2. Palliative therapy a. Administration stage: 'Gemcitabine + Paclitaxel (Albumin-bound)' combination therapy at the first stage 2. Palliative therapy b. Administration stage: Change the administration stage to 1st or more (1 therapy) ▲ 2. Palliative therapy b. At least one of the first steps in the administration phase, changes are made to the target phrases (8 therapy) from 1 to 8 times in a row. The elimination of the reimbursed standard is 3 items and 12 therapies ▲ Classification of group 1 and 2 anticancer drugs and deletion of the table of group 1 anticancer therapy (9 therapy) ▲ 2. Palliative therapy b. Administration stage: at least 1st (3 therapy) ▲2. Palliative therapy b. Dosing step: The first or more week 1 is deleted. The HIRA enacted the anticancer drug reimbursement standard in 2006, allowing clinicians to properly judge and administer Group 1 anticancer drugs within the general principles of approval and anticancer therapy announcements. They were classified as group anticancer drugs and used within the range of the reimbursed standard for each drug. However, opinions have been raised that reclassification of Group 2 anticancer drugs is necessary due to changes in drug prices, registration of generic drugs, and new listing of many high-priced anticancer drugs after the initial enactment. In addition, as clinical evidence is added every year due to the development of new drugs with new mechanisms, the necessity to check old public health therapies has emerged. Accordingly, the HIRA's subcommittee on Cancer Drugs Benefit Appraisal Committee has prepared a reorganization (draft) of reimbursed standards for related fields, and is preparing a new chemotherapy standard by removing the classification of group 1 and group 2 anticancer drugs through the process of collecting opinions from related conferences.
- Policy
- Pitavastatin-Ezetimibe by JW Pharmaceutical was applied
- by Lee, Tak-Sun Mar 22, 2021 06:18am
- JW Pharmaceutical is participating in the Statin-Ezetimibe hyperlipidemia complex market, which has more than 600 products in Korea. It is a combination of Livalo (Pitavastatin) and Ezetimibe. According to industry sources on the 21st, JW Pharmaceutical recently applied for permission for Pitavastatin-Ezetimibe to the MFDS. It was known as Livalozet. It will be the third Livaro series if approved. Livalo is a product jointly developed by Japan's Kowa and Nissan Chemical, and is being introduced and sold in Korea by JW Pharmaceutical. It received the first product approval in 2005, and since its launch in Korea, it has recorded high performance as an original Statin formulation. The amount of outpatient prescriptions based on UBIST last year amounted to ₩73.4 billion. Following Livalo's success, JW Pharmaceutical received approval in 2015 for the hyperlipidemia-hypertensive combination drug Livaro V, which combines Pitavastatin and Valsartan. Livaro V recorded an outpatient prescription of ₩8.2 billion last year. The most recent hyperlipidemia treatments include MSD's Vytorin (Simvastatin-Ezetimibe), Atozet (Atorvastatin-Ezetimibe), and Rosuzet (Rosuvastatin-Ezetimibe). Many generics for Atozet have been released,except for JW Pharmaceutical. While other pharmaceutical companies have focused on introducing Statin combinations, including Ezetimibe. However, JW Pharmaceutical has focused on Livalo (Pitavastatin). Clinical trials for the combination of Pitavastatin-Ezetimibe by JW Pharmaceutical began in 2017, and clinical trials have now been completed. Pitavastatin is known to have a lower risk of side effects of blood sugar compared to other Statins. Accordingly, it is attracting attention from the medical community in that it has a low risk of diabetes and shows excellent cardiovascular disease prevention effects. Because of these advantages of Pitavastatin, it is expected that the combination drug combined with Ezetimibe will be competitive if it comes to the market. There may be difficulties in settling the market as there are more than 600 Statin-Ezetimibe products on the market. It is noteworthy whether JW Pharmaceutical will be able to create a new cash cow item that succeeds Livalo's reputation.
- Policy
- New standard for Adcetris combination has been established
- by Lee, Hye-Kyung Mar 22, 2021 06:17am
- Takeda's antibody-drug conjugate (ADC) and Adcetris (Brentuximab) are now available in combination with chemotherapy during the first-line administration of patients with non-Hodgkin lymphoma and Hodgkin lymphoma. The HIRA announced on the 17th that the revised bill 'Details on the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients' was released and that opinion inquiry will be conducted by the 25th. The scheduled enforcement date is April 1. The revised bill of this announcement contains the new and changed reimbursement standards for combination therapy including Adcetris, a lymphoma treatment. ◆Non-Hodgkin's lymphoma= It is recognized when Adcetris and chemotherapy drugs (Cyclophosphamide, Doxorubicin, Prednisone) are administered in combination with CD30-positive peripheral T-cell lymphoma that have not been treated before (sALCL). In the case of ALK-positive sALCL, it is possible by limiting to 'IPI (international prognostic index) ≥ 2 points' included in the clinical literature. As a result of reviewing textbooks, there is a mention of a clinical study of Adcetris combination therapy for sALCL, and NCCN recommends ALK-positive sALCL as a preferred regimen category 1A and other peripheral T-cell lymphoma as category 2A. In a randomized phase 3 clinical trial, it was confirmed that progression-free survival was increased as a result of comparison with CHOP (Cyclophosphamide, Doxorubicin, Vinblastine, Prednisone), an alternative therapy. ◆Hodgkin's lymphoma= Adcetris and chemotherapy drugs (Doxorubicin, Vinblastine, Dacarbazine) in combination therapy for stage 3 or 4 Hodgkin lymphoma that have not been treated before are recommended for NCCN. Reflecting the expert opinion that it is difficult to establish objective standards and prove relevance as symptomatic improvement, it was decided to be reimbursed only for 'IPS (international prognostic score) ≥ 4 points'. In the case of non-Hodgkin's lymphoma and Hodgkin's lymphoma combination therapy, it was decided to classify it as a therapy with a risk of febrile neutropenia exceeding 20%, reflecting the NCCN guidelines, related clinical trials (ECHELON-2), and expert opinions.
- Policy
- AZ vaccine plan can be updated after reviewing EMA's results
- by Lee, Jeong-Hwan Mar 19, 2021 06:28am
- Commissioner Jeong Eun Kyeong (left) & Rep. Jong-heon Paik KCDA Commissioner Jeong Eun Kyeong said that after reviewing the results of the analysis of side effects such as blood clots of the AstraZeneca COVID-19 vaccine of the EMA, follow-up measures such as discontinuation of vaccination in Korea will be decided. On the 17th, Commissioner Jeong responded to inquiries from the People Power Party of the National Assembly's Health and Welfare Committee, Rep. Paik Jong-heon. Rep. Paik Jong-heon explained that 16 people have died after vaccination against AstraZeneca in Korea. Commissioner Jeong Eun Kyeong, "The domestic case will also be reviewed and decided through an expert deliberation committee" Rep. Paik Jong-heon said, "Since there are 16 deaths after vaccination, we have to start causal analysis directly." KCDA Commissioner Jeong Eun Kyeong said that after reviewing the analysis results of side effects such as blood clots from the European Medicines Regulatory Authority (EMA) they will decide on follow-up measures such as discontinuation of vaccination in Korea. On the 17th, Commissioner Jeong responded to inquiries from the People Power Party of the National Assembly's Health and Welfare Committee, and Rep. Paik Jong-heon. Rep. Paik Jong-heon explained that 16 people have died after AstraZeneca vaccination in Korea. He said that Korea should also initiate a safety test for vaccines or drugs that have been discontinued overseas based on the rules on safety of drugs. He requested that the health authorities do not repeatedly say that the deaths after vaccination with AZ vaccination were simply a non-causal result of worsening the underlying disease, and he asked for a direct investigation of causality. He added, "If The EMA announces that there is a problem with the AstraZeneca vaccination, whether Korea will stop vaccination and initiate an investigation, the domestic drug safety standards are suspended by overseas governments, but if the corresponding measures are taken, the pharmaceutical companies will take measures in the domestic market. The pharmaceutical company should report its domestic action plan to the MFDS." He said, "If the EMA investigation reveals that AZ vaccine is associated with side effects, Korea should also immediately evaluate its safety. Rather than rushing to reveal that there is no problem between the vaccine and the side effects of death, people's trust must be strengthened based on accurate information and standards.," Commissioner Jeong Eun Kyeong said that she would review the analysis results of the EMA and the WHO along with domestic cases, and reflect them in the domestic vaccination plan after going through an expert deliberation committee. She said, "We are aware of the domestic regulations that must be reported to the MFDS in the event of an action taken by a foreign government. We will also review domestic cases and make decisions after reviewing the results of the EMA, the WHO and expert deliberation committee."
- Policy
- AZ and Pfizer COVID-19 vaccines to arrive on Mar. 24
- by Kim, Jung-Ju Mar 19, 2021 06:27am
- The detailed arrival schedule for the COVID-19 vaccines to be supplied this month has been finalized. When the vaccines arrive to South Korea, they would be distributed to 22 inoculation centers around the country, where the vaccines would be used to inoculate elderly citizens aged over 75, and elderly care center occupants and workers from Apr. 1. On Mar. 17, the COVID-19 Vaccination Task Force Team, led by the Korea Disease Control and Prevention Agency (KDCA) Director Jeong Eun-kyeong, has announced the vaccines by AstraZeneca and Pfizer to be used from the second quarter would be dispatched soon from Europe. The 500,000 doses of Pfizer vaccines, the South Korean health authority directly negotiated for, would arrive on Mar. 24. The vaccine has already been approved by the Ministry of Food and Drug Safety (MFDS), and it would be used for inoculation immediately after the fast-track lot release inspection. The outstanding 500,000 doses would be supplied in the last week of March. KDCA official said the vaccines are expected to be supplied to the country in April through May, but more specified dates have not been confirmed. Regarding the batch of AstraZeneca vaccines purchased through COVAX, the UNICEF told the 690,000 doses and 1.41 million doses would be dispatched on Mar. 31 and Apr. 22, respectively, from the Netherlands. Considering the customs processing in Europe and shipping take at least two to three days, the first batch would arrive early April and the latter batch would arrive late April. The COVAX-AstraZeneca vaccines are manufactured at SK Bioscience plant in Andong, South Korea, which was listed for an emergency use drug list by the WHO on Feb. 15. To distribute them consistently, the vaccines would be sent to Europe and supplied back to South Korea. The AstraZeneca vaccine has been authorized MFDS as of last Feb. 10, and the batch arriving soon would be used on occupants of nursing facility aged 65 and over, and the facility workers. Director Jeong Eun-kyeong commented, “To initiate the second-quarter inoculation plan promptly and safely, the government would put utmost care in distribution, storing and preparation for the vaccines coming to South Korea.”
