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- 2025-12-24 06:42:03
- Policy
- Prevymis and Rekovelle PFS were newly listed
- by Kim, Jung-Ju Aug 26, 2020 06:23am
- Xarelto 2.5mg’s benefit standard will be expanded. Prevymis (Letemovir), a vaccine for preventing MSD virus from Korea, and Rekovelle (Follitropin Delta), a follicle-stimulating hormone injection by Ferring Pharmaceutical Korea, are newly applied next month, and a new reimbursement standard will be established. Pharmaceutical Reimbursement Listing Standard and Method The MOHW is pursuing the notification of 'Pharmaceutical Reimbursement Listing Standard and Method' with the aim of applying this on September 1. Benefits will be expanded to 'multivascular coronary artery patients aged 65 or older who have exceeded one year since recent myocardial infarction' and 'multivascular coronary artery patients with both coronary artery disease and peripheral artery disease'.with Xarelto 2.5mg and Aspirin combination therapy. The MOHW and the HIRA newly established and added reimbursement standards by referring to domestic and international permits, textbooks, clinical practice guidelines, clinical research literature and opinions of the society. Specifically, It is intended for adult patients with coronary artery disease or symptomatic peripheral arterial disease at a high risk of ischemic events, and is prohibited for patients with high risk of bleeding, stroke onset within 1 month, ischemic or stroke history. As Prevymis 240mg and 480mg listed, a new reimbursement standard is also established. This drug is a prophylactic treatment for cytomegalovirus infection that occurs after allogeneic hematopoietic stem cell transplantation. Subjects to be administered are cytomegalovirus (CMV)-serum positive [R+] adults who have undergone allogeneic hematopoietic stem cell transplantation (HSCT), and are patients who have been confirmed negative by serum CMV tests (both PCR and antigen) within 5 days before the start of administration. .The administration method begins on the day of transplantation and within 28 days after transplantation, and administration is possible up to 100 days after transplantation .However, if CMV disease occurs or preemptive therapy is required, the administration should be stopped .In human-derived cell lines that stimulate follicles to induce hyperovulation, Rekovelle (Follitropin Delta), a recombinant follicle-stimulating hormone injection, is scheduled to be listed next month and is newly included in the reimbursement standard .As with other follicle-stimulating hormone (FSH) injections, this drug is recognized for medical benefits within the range of 'assisted reproductive surgery benefits', but co-administration with hMG (menotrophin) cannot be recognized .The MOHW decided to apply the reimbursement standard as of the 1st of next month if there are no specific matters after checking opinions on the amendment by 6 pm on the 26th .
- Policy
- Jardiance follow-on drugs seek approval to launch in 5 years
- by Lee, Tak-Sun Aug 25, 2020 06:14am
- A promising antidiabetic treatment, sodium-glucose co-transporter-2 (SGLT2) inhibitors are seeing their follow-on drugs emerging for an early market release after winning approval from the South Korean health authority. Due to the extended patent term, however, the new follow-on drugs’ release would have to for another two years at least. According to pharmaceutical industry sources on Aug. 24, follow-on drugs of Boehringer Ingelheim Korea’s SGLT-2 inhibiting antidiabetic treatment Jardiance (empagliflozin) has submitted an application for approval as of Aug. 12. One shares the same substance empagliflozin, and another one is empagliflozin L-proline with an extra solvate attached. SGLT-2 inhibitor impedes reabsorption of glucose in kidney, but excretes the excessive glucose through urine to prevent the spike in glucose level in blood. The medicine is known for showing low-risk in causing hypoglycemia and helping body weight control. Already over 40 Korean pharmaceutical companies have evaded Jardiance’ crystalline form patent and they are well under way to prepare an early release. But as the substance patent would be expired on Oct. 23, 2025, five more years are left until the release. Previously, Dong-A ST has failed in its attempt to nullify Jardiance’ substance patent. The latest item approval seems to be targeting the title of a first generic, as Jardiance’ post-marketing surveillance (PMS) period has ended on Aug. 11. A first generic to apply for an item approval can expect to receive preferential sales rights as well. Another SGLT-2 inhibitor, Forxiga, already has over 50 follow-on drugs approved with different solvate. They can be released to the market after Apr. 7, 2023, when the first substance patent expires. Nonetheless, Dong-A ST’s pro-drug has successfully evaded the first substance patent, and it would be launched in the market earlier than any other drugs when it gets the approval. According to pharmaceutical market research firm UBIST, the SGLT-2 inhibitor market volume in last year has reached approximately 90 billion won with a 39-percent surge from the year before. Jardiance has raised 28.2 billion won, whereas Forxiga generated 31.1 billion won in the same year.
- Policy
- Started to develop the generic for Norspan Patch
- by Lee, Tak-Sun Aug 25, 2020 06:11am
- The development of generic drug for 'Nospan Patch', a narcotic pain reliever that has been growing recently, has begun. Samyang Biopharm has received approval for the bioequivalence test from the Ministry of Food and Drug Safety. Northpan patch has no patents on the PMS and patent list, but there is no same active ingredient so far. On the 20th, the Ministry of Food and Drug Safety approved the bioequivalence test of Samyang Biopharm's tentatively named 'Noprepatch 10ug/h'. The test is conducted with healthy adults for bioequivalence evaluation with Norspan patch 10ug/h' of Mundipharma. It is the second time Samyang Biopharm is conducting a bioequivalence test on this formulation. The bioequivalence test was also approved in August 2019. It is interpreted that the previous test did not satisfy the validity data required for the generic license. Some analyzes indicate that it is difficult to prove bioequivalence due to the nature of the patch. Norspan patch is a pain reliever patch containing a narcotic ingredient called Buprenorphine. In Korea, the product was approved in November 2004, but the launch was conducted in April 2012 due to insurance benefits. At the time of launch, there were many views that it was not enough to target the market dominated by Janssen Korea's Durogesic D-trans patch. Durogesic D-trans patch (Fentanyl) was widely used, and The weakness is that Northpan cannot be used for cancer pains. Norspan patch is used for moderate to severe chronic pain relief that does not respond to non-narcotic analgesics. Transtec patch (Buprenorphine), which was licensed in 2017, is used to relieve cancer pain. Transtec patch has a higher content than Norspan patch. Myungmoon’s Buprein Patch, generic for Transtech Patch was approved in 2018. Although Norspan patch has no indication for cancer pain, its indication with Tramadol has expanded, and sales are now higher than Durogesic D-trans patch. As of last year's IQVIA, Norspan recorded ₩13.6 billion, and Durogesic D-trans patch recorded ₩8.4 billion. The rising trend of Norspan Patch is that Mundipharma is making progress in targeting specialized hospitals such as orthopedic clinics as well as large hospitals through joint promotions with Samil Pharmaceutical in 2017. Moreover, the lack of competing drugs for the same ingredient is an analysis that the uptrend will continue in the future. If Samyang Biopharm succeeds in developing drugs for the second generation, it is expected that high sales as a first generic will be expected.
- Policy
- Followup of drug price agreement, possible by electronically
- by Kim, Jung-Ju Aug 25, 2020 06:11am
- When the NHIS concludes a drug price negotiation with a pharmaceutical company, a legal basis will be prepared for notifying the company in writing or electronically of the details of the subsequent proceedings. The purpose of this is to increase administrative convenience so that insurance benefits work more efficiently. The MOHW announced the legislation today (21st) of a partial amendment to the 'Rules on the Standards for Medical Care Benefits of National Health Insurance' based on these contents. This revised bill was created to provide a basis for notifying applicants in writing or electronically of the matters to be reviewed by the Health Insurance Policy Deliberative Committee and the expected date and effective date of notification when a drug price negotiation is concluded to enhance the transparency of the drug price decision system. Looking at the contents, the latter part was newly established to the regulation that the drug for which the agreement was reached should be deliberated by the deliberation committee within 30 days, and whether to be eligible for medical care benefits and the maximum amount of the drug must be determined and announced. It is possible to notify the applicant in writing or electronically of the expected date of notification and the effective date of the notification." The government plans to go through an opinion inquiry for groups or individuals with opinions by October 5, and it will be applied and implemented immediately if there is no specific matter.
- Policy
- Forsteo reduced pricing effective from Aug. 25
- by Kim, Jung-Ju Aug 25, 2020 06:10am
- As the South Korean court ruled against Lilly Korea’s litigation claiming unfair pricing reduction on its osteoporosis treatment Forsteo (teriparatide), the government would execute the order as planned initially. The insured pricing reduction would be enforced on Aug. 25, but it could be suspended again if the company decides to take the case to the High Court. Which means the pricing change may not be applied in the healthcare institutes depending on the court registration schedule. On Aug. 20, Ministry of Health and Welfare (MOHW) announced the pricing reduction on Forsteo would be authorized according to the original plan, as the Seoul Administrative Court has recently dismissed Lilly’s litigation. MOHW applies ‘half-price drug’ regulation, or 53.55 percent of the original pricing, when a first generic is listed. But the health authority applies weighted pricing of 70 percent on the first-in-class drug for a year from the point of the first generic listing. And the weighted pricing is maintained until there are more than four companies supplying the same-substance drug, regardless of passing the one year point. Due to the government’s decision to authorize pricing reduction on Forsteo, the company filed a lawsuit against MOHW to revoke the maximum price adjustment. The Ministry was planning to bring down the pricing of Forsteo by 30 percent from 326,353 won a pen to 228,451 won. The decision was made as Daewon Pharmaceutical’s biosimilar Terosa was categorized as a same substance drug. The multinational company, however, argued the two medications are not the same. Nevertheless, the Administrative Court ruled in favor of MOHW’s decision. According to the court’s ruling, MOHW stated the authorized pricing reduction, initially planned from last March, would lower the drug’s pricing by 30 percent from Aug. 25. Unless the company takes another legal action before the regulation is enforced, the respective healthcare institutes would have to sell medication by the lowered pricing from Aug. 25. But if the company, again, request to halt the pricing reduction as it brings the case to the High Court for an appeal, the drug’s pricing in healthcare institutes may remain unchanged.
- Policy
- Democratic Party submits 5 bills to curb spiking COVID-19
- by Lee, Jeong-Hwan Aug 24, 2020 06:19am
- The ruling party readies for a full-on quarantine measures by introducing a series of bills to curb COVID-19 resurging in South Korea centering a far-right church in Seoul metropolitan area. On Aug. 20 and 21, the Democratic Party submitted five bills to the National Assembly (NA) to strengthen the existing regulations to contain the rapid spread of the novel virus. The bills would clarify standards of imprisonment or fine, in case of disrupting a COVID-19 epidemiological investigation or violating the ban on assembly like protesting at the Gwanghwamun Plaza, and seek indemnification for the damae of an individual willfully spreading the infection. The five bills on preventing resurgence of COVID-19 outbreak were registered on the NA Bill Information System website as of Aug. 23 that reinforce restriction against misconduct affecting the virus infection like the 8/15 Gwanghwamun Protest or relevant participants. The ruling Democratic Party is highlighting the close relationship between the United Future Party and the controversial Sarang Jeil Church’s pastor, Jun Kwang-hoon, as they introduced the bills. Ultimately, the new spike of COVID-19 cases has broken out right in the middle of political strife between the ruling and the opposition parties. First, the Democratic Party Lawmaker Jung Chung-rae proposed a revision bill in ‘Framework Act on the Management of Disasters and Safety,’ and reprimanded Sarang Jeil Church’s Rev. Jun and the followers being the catalyst to the major outbreak of COVID-19 in Seoul. Regarding the current law stipulating the restricted or prohibited use of a facility or site to prevent a severe disaster threatening the public safety and the submission of private information of related event participants, Lawmaker Jung pointed out the existing law, lacking a clear punishment for violators, is impractical. Therefore, the lawmaker submitted a bill to levy penalty on an individual disobeying the restricted or banned use of high-risk facility or site, mandated evacuation, or requested provision of personal information. Other lawmakers from the party—Kim Sung-joo (a ruling party adviser to NA Health and Welfare Committee), Lee Wonwook, Oh Young-hwan and Jeon Yonggi—have also introduced bills to amend ‘Infectious Disease Control and Prevention Act.’ (From left) Democratic Party Lawmaker Jung Chung-rae, Kim Sung-joo, Lee Wonwook, Oh Young-hwan and Jeon Yonggi. Lawmaker Kim Sung-joo’s bill stipulates a tightened penalty on a violator of the infectious disease control measures, and a regulation to claim damage compensation. The revision bill would legally allow the government or regional government body to claim damage compensation in case an infectious disease spreads or the risk of outbreak grows due to a third-party’s intentional conduct or major fault. Also the amended law would levy a severe penalty on a certain group or a leader or member of an organization refusing or disrupting the epidemiological investigation, or intentionally omitting or covering facts to impede relevant investigation. Moreover, the high-level penalty would be imposed on an individual intentionally refusing to be quarantined or hospitalized, or leaving the quarantined site and infecting others. Lawmaker Lee Wonwook criticized the existing law as it only imposes comparatively light criminal penalty on an infected patient refusing to receive in-patient treatment or hospitalization and treatment. In particular, the lawmaker rebuked the absence of penalty regulation on an individual that not only refuses the treatment, but also actively infects other individuals recklessly, and difficulties the law enforcements face when acquiring the location of an individual accused of committing the said misconduct. Accordingly, Lawmaker Lee’s bill would newly add penalty clauses for an individual infecting other people, and stipulate three years or less of imprisonment and arrest without warrant during an emergency. Meanwhile, Lawmaker Oh Young-hwan’s bill tightened the penalty on temporary prohibition order on gatherings like a protest. The existing law stipulates the Minister of Health and Welfare to prohibit protest to calm the spreading of infectious disease, and levies fine of less than 3 million won for violating the order. But the lawmaker argues such weak penalty has allowed the 8/15 Protest to boost the COVID-19 outbreak. Lawmaker Oh’s bill would make the penalty significantly stringent by tightening the current penalty of a fine less than 3 million won to five years or less of imprisonment or 50 million or less of fine. Lawmaker Jeon Yonggi also aims to reinforce the penalty when violating the restriction on an assembly like protesting. Referring to the ‘Assembly and Demonstration Act,’ his bill would elevate the penalty to imprisoning and warranting exemplary damages on an infected individual violating the health authority’s restriction on gathering. The NA plans to review and deliberate the submitted bills during the September provisional session.
- Policy
- Tagrisso and Eliquis pricing lowered 4% through PVA
- by Kim, Jung-Ju Aug 24, 2020 06:18am
- The insured pricing of AstroZeneca Korea’s Tagrisso tablet (osimertinib mesylate) and Bristol-Myers Squibb’s (BMS) Eliquis tablet (apixaban) would be lowered by approximately 4 percent from next month due to pricing-volume agreement (PVA). According to the pharmaceutical industry sources, South Korea’s Ministry of Health and Welfare (MOHW) is in process of revising the ‘List of Reimbursed Drugs and Upper Limit Pricing.’ The finalized version would come in effect from Sept. 1. Under the Type ‘Ga (가)’ PVA, National Health Insurance Service (NHIS) and pharmaceutical companies negotiated over lowering the pricing of AstraZeneca’s Tagrisso and Celgene’s Pomalyst each in different doses. The Type Ga is applied to a new drug listed through pricing negotiation that marked over 30 percent surge in claimed reimbursement against the projected amount of the claim. The item’s claimed amount is calculated from the claims made under the same supplier, administration method, active ingredient and form of the item. The reimbursed pricing would reduced by 4.2 percent on 40 mg and 80 mg Tagrisso tablets from 121,686 won to 116,563 won, and from 227,312 won to 217,782 won, respectively. The pricing on Celgene’s Pomalyst would be brought down from 377,979 won to 367,774 won (2.7 percent) in 1 mg tablet, from 377,829 won to 368,633 won (2.4 percent) in 2 mg, from 382,629 won to 373,215 won (2.5 percent) in 3 mg, and from 386,537 won to 376,364 won (2.6 percent) in 4 mg. The pricing on three items would also fall under the Type Na (나) PVA. The case applies to an item that has been listed for over four years, without pricing adjustment by Type Ga PVA, but its total amount of claim exceeded by 30 percent from the amount projected at the point of listing. For such items, NHIS negotiates with the supplier depending if the claimed amount has surpassed 60 percent more than the previous year’s amount, or the increased amount has surpassed over 10 percent and adds up to over 5 billion won. The new pricing on Lilly Korea’s Trulicity 1.5 mg, effective from next month, would be brought down by 0.2 percent from 34,289 won to 34,213 won. Also the pricing on BMS’ Eliquis 2.5 mg tablet and 5 mg tablet would be lowered by 4.5 percent from 1,185 won to 1,132 won. Meanwhile, some drugs’ reimbursed pricing is lowered even further after the PVA negotiation, as relevant company voluntarily reduce the pricing. Lilly Korea’s Trulicity 1.5 mg/ 0.5 ml (dulaglutide) single-dose pen would be priced at 32,129 won from next month, dropping from the existing pricing at 34,213 won. On the contrary, some companies request a raise in the upper limit pricing of an item, and the government accepts the new pricing after a negotiation. Saehan Industry’s Techne DMSA kit Injection (dimrcaptosuccinic acid) was the case. The item was approved with radioactive medicine dimrcaptosuccinic acid (99mTc) dispensed in an injection. Although the item was not designated as an essential drug, other foreign supplier raised the cost and disrupted the supply in Korea. The foreign company’s decision ultimately made the product an orphan drug with an irreplaceable option and no further prospective production plan. The company underwent a new pricing negotiation with NHIS and agreed to raise the pricing by 62.6 percent. Effective from next month, the injection in two doses—1.4 mg and 1.2 mg—would be priced at 20,700 won, brought up from the current price at 12,728 won.
- Policy
- Promote legislation to include the shingles vaccine in NIP
- by Lee, Jeong-Hwan Aug 21, 2020 06:26am
- A bill is being promoted to include the shingles vaccine, which is classified as a premium vaccine, in the National Immunization Program,(NIP). On the 19th, Yoo Sang-beom, a member of the United Future Party announced that it had proposed a bill with the same content. He explained that the onset of shingles markedly lowers the quality of life of the patient due to complications along with acute and chronic pain. In addition, he pointed out that the number of patients in Korea is increasing from about 660,000 as of 2015 to about 740,000 in 2019, which induces the burden of disease socially and economically. Currently, the KCDC is recommending vaccination of the shingles vaccine for the elderly aged 60 and over, but the inoculation rate is only 10% for those in their 50s or older at a cost of about ₩150,000 to ₩200,000. He said, "The shingles vaccination has great disease prevention effect and a great reduction in cost compared to the cost of an outbreak, so it is subject to national vaccination in the UK, Germany, Canada, and Australia, and Korea should also be included to reduce the burden of national medical expenses."
- Policy
- Global companies expand business in expensive orphan drugs
- by Lee, Tak-Sun Aug 20, 2020 06:24am
- Vyndaql approved for the Korean market in 2015. Shares the same substance with Vyndmax but indicated for different disease. As global pharmaceutical companies are on to expanding businesses in drugs for rare diseases, the companies are now winning item approvals in South Korean markets. Rare diseases have limited patient size and insufficient treatment options, but the drugs are expensive enough for the companies to seek for profit. On Aug. 19, Ministry of Food and Drug Safety (MFDS) approved Pfizer Pharmaceutical Korea’s Vyndamax 61 mg capsule (tafamidis). The medicine is indicated to treat cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Although the patient size is small, the disease is known to develop a heart failure and have a high risk of death. Prior to the drug, no other treatment option was approved. Previously, Pfizer has received approval on another drug with the same substance—Vyndaqel 20 mg capsule (tafamidis meglumine). However, its salt base, substance amount and indication are different. Vyndqel is also indicated to treat a rare disease, transthyretin familial amyloid polyneuropathy (TTR-FAP). In October 2018, Vyndqel was listed for healthcare reimbursement and priced at 141,900 won per capsule. A yearly drug expense would add up to 51.79 million won. According to IQVIA, Vyndaqel earned approximately 1 billion won last year. Considering the high upper limit pricing of Vyndaqel, Vyndamax would also be another ultra high-cost drug. When the U.S. Food and Drug Administration (FDA) approved of the drug in May last year, Pfizer put forth a yearly expense of USD 225,000, or approximately 266 million won, for the listed price. The company also announced they are in a negotiation with insurers. A growing number of global pharmaceutical companies launching ultra high-cost drugs for rare diseases is seemingly making the Korean health insurance authority anxious. Early this year, Novartis submitted an official approval application for a spinal muscular atrophy (SMA) treatment Zolgensma with yearly expense proposed at 2.5 billion won. Currently designated as an orphan drug, Zolgensma is in process of getting approved with expanded user age group in Korea.
- Policy
- Drug Approval system under direct control of the MFDS
- by Lee, Tak-Sun Aug 20, 2020 06:23am
- #Drug Approval System, which was in charge of the National Institute of Food and Drug Safety Evaluation, will be carried out at the headquarters of the MFDS. The 'Convergence Innovation Product Support Group', a temporary organization that has been in charge of licensing affairs since last year, is formally incorporated into a department under the direct control of the Deputy General Manager. The MFDS (Minister Eui-kyung Lee) and the Ministry of the Interior and Safety (Minister Chin Young) reinforce the expertise of medical product approval and review, and to ensure the right to life for the people and strengthen the international competitiveness of companies through rapid productization support. It was announced on the 18th that the system will be reorganized. With the reorganization of the medical product approval/examination system, the approval task that had been carried out by the National Institute of Food and Drug Safety Evaluation will be carried out by the vice-minister of the MFDS, and the review will continue to be carried out by the National Institute of Food and Drug Safety Evaluation. Specifically, for medical product licensing, two new divisions are established and operated, the 'licensing general manager' and the 'high-tech product licensing manager' under the deputy of the headquarters. The NIFDS continues to carry out the evaluation work, and two new divisions are established and operated under the director, the 'pre-counseling department' and the 'expedited examination department'. First of all, among the two divisions of the headquarters, the licensing general manager generalizes the approval of medicines (including herbal medicines) and the improvement of the approval/examination system for all medical products, while the high-tech product licensing manager is responsible for converging medical products and biologics and medical device approval. In addition, the pre-counseling department conducts preliminary consultation on the application for approval of clinical trial plans and product approval of pharmaceuticals, medical devices, and new drugs subject to rapid review, and the expedited examination department designates rapid review of drugs, medical devices and new drugs. Review data on the application. Targets for rapid review are products that contribute innovatively to responding to public health crises or treating diseases such as life-threatening diseases, new infectious diseases, and digital-based medical devices, and categorized into crisis response drugs, innovative new drugs, and innovative medical devices. Since last year, the MFDS has formed a temporary organization called the 'Convergence Innovation Product Support Group' within the NIFDS and has been carrying out the licensing work. Instead, the person in charge of the approval work of the NIFDS-related department was dispatched to the Convergence Innovation Product Support Team. This time, it has become a formal office through reorganization. In addition, in accordance with the recently enacted 'Advanced Renewable Bio Act' and 'Medical Device Act', advanced biopharmaceuticals and innovative medical devices (software) permits and reviews, advanced regenerative medicine high-risk clinical research plans, etc. expand technical experts and introduce and operate a customized screening system. With this reorganization, the government is expected to establish a dedicated review system for high-quality rapid review of new concept medical products in accordance with the 4th industrial revolution and biohealth trends by strengthening policy linkage under comprehensive review of permits and screenings in a rapidly changing era. Through the reorganization of the medical product approval/examination system, the Ministry of the Interior and Safety added rational policy judgment on the basis of scientific basis for approval, and consulted in advance from the R&D stage for the review, while conducting a rapid review for innovative treatments. By shortening the productization period, such as, the opportunity for patient treatment will expand, and it will greatly contribute to rapid response to public health crises. The MFDS has reinforced the policy functions of the headquarters of the license and maintained the evaluation expertise of the NIFDS through the reorganization of the approval/examination system. By shortening it, it has made efforts to strengthen the global market competitiveness of the pharmaceutical industry while putting the life and safety of the people first. The MFDS plans to complete the revision of the 'The MFDS and the Directive Enforcement Regulations of its affiliated organizations' with the goal of the 25th. However, the procedure for passing through the Ministry of Public Administration and Security, which is the main ministry related to the organization, remains. related personnel are expected to proceed in line with the revision.
