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- 2025-12-25 13:58:17
- Policy
- 6 new drugs newly listed or expanded coverage in 2021 so far
- by Kim, Jung-Ju Mar 29, 2021 05:58am
- According to the next month’s update for the pharmaceutical reimbursement list, total five items would be newly listed and improve patient access. And one already-listed drug gets to expand coverage. It is a result of enhancing the coverage based on social importance and patient needs. The South Korean government projected total 60,196 patients in the country would benefit from those drugs, costing them about 51.4 billion won annually. From January through April this year, total six pharmaceutical products have been newly listed or expanded coverage standard. January had none, but from February, the coverage on a Parkinson’s disease treatment Equfina Film Coated Tablet, a glaucoma treatment Eybelis Eye Drops and an ovarian treatment Zejula capsule have been improved. The coverage on Equfina Film Coated Tablet would benefit 7,000 patients a year, while costing 5.6 billion won. The coverage on Eybelis Eye Drops is estimated at 4.9 billion won annually, which would benefit 45,000 patients. The expanded coverage on Zejula Capsule would annually cost 2.5 billion won to provide treatment opportunity to 146 patients. From this month, the patient access on a multiple myeloma treatment Ninlaro Capsule improved with newly listed reimbursement. The government would spend about 9.6 billion won annually. Also, a neuroendocrine tumor treatment Lutathera Injection was newly listed in the same month, costing 8.8 billion won to benefit 6,890 patients annually. From Apr. 1, 20 billion won a year would be injected to treat 500 patients with a neovascular (wet) age-related macular degeneration (AMD) treatment Beovu Prefilled Syringe with reimbursement. The fact that each new coverage enhancement is to benefit a range of patient size from 45,000 at most to 146 patients at least proves the South Korean government’s healthcare coverage focus is now shifting from patient size and finance to value of a drug with high demand for reimbursement. It can be also interpreted as flexible policy and general social maturity to accept and provide an expanded coverage on expensive drugs used for rare disease treatment.
- Policy
- KRW 2.85 tln for KDCA COVID-19 vaccine supplementary budget
- by Kim, Jung-Ju Mar 29, 2021 05:58am
- The Korea Disease Control and Prevention Agency (KDCA) has secured an additional budget of 2.35 trillion won for procuring COVID-19 vaccines from overseas. This reflects additional 2.30 trillion won from this year. On Mar. 25, KDCA announced that this increase was reflected as the first supplementary budget in the year 2021. The total cost of vaccine purchase for 79 million people the government has contracted for is 3.81 trillion won, of which the additional cost in 2021, excluding the already secured budget, is 2.35 trillion won. Specifically, COVAX Facility (10 million), AstraZeneca (10 million), Pfizer (13 million), Janssen (6 million), Moderna (20 million) and NovaVax (20 million) are to supply the vaccines. To the date, the government has been sequentially expanding pre-purchase contracts according to the COVID-19 vaccine procurement plan, and has prepared necessary financial resources such as for upfront payments. The government has so far secured total 1.21 trillion won, including 356.2 billion won from last year’s contingency budget plan and 857.1 billion won from this year’s budget plan. Moreover, KDCA explained the additional cost of final vaccine payment was reflected on the new supplementary budget plan as the detailed calculation of the payments can be finalized after the negotiation over vaccine type, unit price and volume is concluded. KDCA elaborated the vaccines with already-signed contracts have been rolling out since February, and the agency would continue to roll out further doses of vaccines without an issue. And the new supplementary budget plan also reflects 1.10 trillion won for additional reserve for specific purpose, such as response against extended outbreak of COVID-19 and vaccine inoculation and related infrastructure cost. Due to finalized supplementary budget plan, the total expenditure in 2021 by KDCA was increased from 991.7 billion won to 3.34 trillion won.
- Policy
- Drug price management office takes care of all drug prices
- by Lee, Hye-Kyung Mar 26, 2021 05:37am
- “Drug Price Management Office of the NHIS is in charge of practical work to apply the results of research services for full-cycle management of pharmaceuticals to the field. It reviews and tries to realize the improvement or reform of the system related to pharmaceuticals. " Kang Cheong-hee, the executive director of the NHIS’ benefit related dept., commented on the direction of the drug price management office, which was newly established on January 1 of this year, at a briefing at the Professional Reporters Council on the 23rd. The need for full-cycle management of medicines has emerged as social issues such as the supply shutdown of Lipiodol in 2018, the impurities of Valsartan in 2019, and the selective benefit of Choline alfoscerate in 2020 have been raised. Accordingly, the NHIS has established a Drug Price Management Office that oversees the Drug Price Planning Department, New Drug Management Department, Usage Management Department, Generic Management Department, and Drug Life Cycle Management Department (TF). Director Kang said, "According to the plan to strengthen negotiation management following the introduction of a comprehensive evaluation system for reimbursement drugs, stable supply and drug cost management through full-cycle management of drugs was necessary." "We will establish a new payment plan for ultra-high-priced drugs such as Kymriah, settle a generic negotiation system, and establish a negotiation strategy that takes into account the characteristics of each drug, such as advancement of contract management and monitoring." Full-cycle management of pharmaceuticals means systematic management of the entire cycle from product approval to the registration, distribution and supply, and follow-up management. The Ministry of Food and Drug Safety monitors the safety and effectiveness of the re-examination result, and strengthens contracts for retrieval of drugs subject to clinical re-evaluation and management. A management plan will be prepared. Currently, a research service is underway to prepare a post-evaluation plan for drugs exempted from economic evaluation. In addition, the Drug Price Management Office ▲ conducts research services to screen excellent drugs and reviews measures to improve self-sufficiency of domestically produced drugs through consultations with experts and related organizations so that high-quality drugs can be supplied to the public in a cheap and stable manner, ▲prepares improvement plans through investigation of overseas systems and operation cases, and advice from external experts for rational use of cost-effective drugs and financial expenditure management, and ▲develops a financial demand prediction model based on the analysis of the drug expenditure structure, analyzes the financial expenditure according to the characteristics of diseases (efficacies) and drugs (patent expiration, etc.) to prepare an efficient drug expenditure plan in the distribution and supply stages, purchase and use stages. Also, plans were made for follow-up management. Director Kang said, "The prerequisite for drug management at the NHIS is to ensure that the public can consume good drugs inexpensively and safely, and the Drug Price Management Office aims to improve the efficiency of drug expenditures and improve national health rights by improving the overall drug price system." Accordingly, the negotiation procedure, which was applied only to existing new drugs, has been made mandatory for the registration of drugs such as generics since October last year, and a negotiation procedure has been introduced for all registered drugs, and mandatory contracts are being signed such as supply and quality management of all benefit drugs. As for the overall status of drug price negotiations, 1,937 items were negotiated out of a total of 1,969 items that were negotiated until December of last year since the introduction of the negotiation system, of which 1798 items were agreed, and the average agreement rate reached 92.8%. It has negotiated for the first time since December last year for 230 items from 130 companies subject to clinical re-evaluation, excluding 108 items from 72 pharmaceutical companies that have been voluntarily withdrawn and negotiated. And, it is negotiating for 122 Choline alfoscerate products from 58 companies. Director Kang said, "When taking measures such as withdrawal of permission due to clinical reevaluation, it is inevitable to take it back. And, we plan to maintain stable supply and drug costs through full-cycle management of drugs, such as strengthening the bargaining power for the benefit of excellent therapeutic and economic drugs, and elaborating contract management to prevent supply and quality problems."
- Policy
- Lipilouzet, listed as the highest price for the same formula
- by Kim, Jung-Ju Mar 26, 2021 05:37am
- Lipilouzet, a combination drug of Chong Kun Dang's Atorvastatin Calcium + Ezetimibe, will be listed as the highest price for the same formulation of all combinations. Pfizer Korea's Xeljanz XR Tab 11mg (Tofacitinib Citrate) does not have the same formulation, so it is listed at the same price as the target product. The MOHW is promoting the revision of the drug reimbursement list as of April 1. First, it is known that a total of 7 drugs will be listed at the same price as the highest price from next month. The government calculates the highest price and the same price among the upper limit for the same product if the applied product satisfies all the standard requirements if it is listed with 19 products or less. The price of Prete Eye Drops by Korea Global Pharm is ￦5,138, Clione Eye Drops by Hana is ￦1,140, Cecora Syrup is ￦14, Cecora Syrup 15mL is ￦188, Ramset Prefilled Inj is ￦22,630, and Mucosta SR 150mg by Otsuka Korea is ￦170 and Nexpharm's Sebonin Inj at ￦13,745. Chong Kun Dang’s Lipilouzet has a total of 3 items by content. The insurance drug price is set equal to the highest price among the upper limits of the registered same drug if the applied product meets all the standard requirements. Lipilouzet 10mg is expected to be listed at ￦1,037, Lipilouzet 20mg at ￦1,315 and Lipilouzet 40mg at ￦1,415, respectively. Three drugs are listed at 85% of the highest price for the same drug. In addition to the applied product, when there are no more than 19 products listed, the government calculates and registers it as 85% of the highest price among the upper limit for the same product if the applied product meets only one of the standard requirements. As for the items, Korea Global Pharm's Levohi Eye Drop 1.5% is expected to be set at ￦6,246, and Dongkwang's Dongkwang Pitavastatin 4mg and Dongkook's Pitaron 4mg are estimated at ￦715, respectively. Pfizer Korea's Xeljanz XR Tab 11mg is classified as a drug that does not have the same formulation as the target product and is given an insurance price. The government sets the insurance drug price in the same way as the upper limit of the development target product for a product that is approved as a drug for the new use and dosage of data submitted when there is no same formulation as the target product for development in the drug reimbursement list. It is expected to be listed next month at ￦22,170.
- 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.
