- LOGIN
- MemberShip
- 2025-12-23 01:54:52
- Policy
- Reimb. suspension on rebate drugs unconstitutional
- by Lee, Tak-Sun Apr 18, 2022 05:58am
- 박성민 변호사 A claim that applying the reimbursement suspension system on illegal rebate drugs that had been abolished in 2018 to acts that had been made before the law was revised can be unconstitutional has been raised. Due to unreasonable aspects of applying the existing law, the claim is that it is more reasonable to retroactively apply the law revised in 2018. Lawyer Seong-min Park at HnL law firm explained so at the monthly academic conference of The Korean Society of Law and Medicine that was held on April 16th. At the virtual conference, Park reviewed the ‘unconstitutionality of the insurance reimbursement suspension disposition applied under the National Health Insurance Act,’ and announced that the decision to suspend reimbursement for rebates caught before September 2018 violates the principle of prohibition of penalty surcharges or the principle of equality presented under the Constitution. The reimbursement suspension dispositions on drugs caught with illegal rebates had been first made in May 2017 after the system was introduced in 2014. However, due to concerns over hindered patient accessibility and side effects that arise from substituting drugs for non-medical reasons, the government revised the law to impose price cut dispositions rather than reimbursement suspensions in 2018. However, the government has applied the old law and issued reimbursement dispositions to acts of rebates that arose before September 2018, raising controversy. Park said, “The National Health Insurance Act revised as of 2018 does not stipulate which law to apply for rebates made before September 2018, however, the administrative agency has been issuing reimbursement suspension dispositions.” He added, “The retroactive application of the law, in particular, retrospective application of administrative laws is generally against the rule of law and therefore is not accepted as it unfairly infringes upon individual rights and freedoms and threatens the stability of living by the law. However, retrospective application of laws and ordinances is permitted as an exception in cases where there is no direct relationship to the interests of the general public or when the interest is rather advanced or eliminates disadvantages or suffering.” This is in accordance with the Supreme Court precedent that was made in May 2005 (Ruling No: 2004다 8630). He said, “We can’t definitively conclude that reimbursement suspensions are more advantageous than drug price cuts for the pharmaceutical companies. If the company clearly states it prefers price cuts over reimbursement suspensions, the protection of trust on the company’s part is rendered unnecessary, and the retroactive application of price cuts is therefore allowed as it can advance the interests of patients, doctors, pharmacists, health insurance finances, and pharmaceutical companies." In other words, the retroactive application of the revised law is reasonable even for rebates that occurred before September 2018. If the upper limit of fines is applied under the old law, the company may request a 40% penalty for one year of its sales rather than a suspension of reimbursement, and the authorities may exercise discretion. Park added that even if the law that was revised last year is applied, the company may request to receive a large fine that is applied for third violations under the current law rather than a reimbursement suspension, on which the authorities can also exercise discretion. Park said, “By substituting reimbursement suspensions to fines for lowest-priced drugs, the company may be subject to monetary sanctions through fines. Also, the price of drugs that are not lowest-priced can be effectively reduced by inducing voluntary drug price cuts, which can effectively result as same as drug price cut dispositions.”
- Policy
- Utilizing RWD for Re-evaluation of Old Drugs
- by Lee, Hye-Kyung Apr 18, 2022 05:58am
- Discussions were conducted at the Central Pharmacist Review Committee on the criteria for clinical re-evaluation of items licensed on the basis of foreign drug formulas without efficacy evaluation. The drug was Hanall Biopharma's "Blistop (p-Aminomethyl Benzoic Acid)" and was approved on May 16, 2001, and its efficacy expired on April 1. At the time of approval, Blistop was awarded to the eight major foreign drug formularies, allowing item approval without clinical data. However, with the recent revision of the permit regulations, it is impossible to permit drug formalities alone, and efficacy evaluation standard of "old drugs" used in the field for decades without efficacy evaluation has become controversial. According to the minutes of the committee's "Advice on the adequacy of drug item renewal" held by the MFDS on the 29th of last month, it was very difficult to prove its effectiveness through clinical re-evaluation. The MFDS said, "The items licensed based on foreign formularies have already been used in clinical sites for decades, and what to do with efficiency evaluation is a problem in the renewal of Old Drugs." "In consideration of not only clinical re-evaluation but also the use of RWD, we will only recognize the efficacy that can prove its validity through protocol review and approval procedures," he explained. Currently, the company has submitted opinions on clinical re-evaluation, and the MFDS is considering various methods such as clinical trials as well as post-marketing clinical trials. In this regard, a member said, "In the situation where there are differences in permission for each drug used for hemostasis, Blistop is well used so far in clinical sites," adding, "Since there is no significant adverse reaction, it is reasonable to give opportunities according to the company's will." Another member suggested, "It is difficult to objectively judge the validity of all drugs approved in the past. The MFDS needs to ease regulations on Old Drugs and prioritize safety evaluation over efficacy." It is unreasonable to impose restrictions on drugs that have been used for a long time since there is no safety problem, and the effectiveness is evaluated in the market, and drugs that are not effective will be eliminated in clinical practice. However, the MFDS agrees that the need and use in the market can naturally induce eviction, but there is a limit to maintaining permission as it is effective in the absence of clinical data as foreign formularies, the basis for licensed drugs, disappear. At the meeting that day, it was decided to renew the p-Aminomethyl Benzoic Acid item on the premise of validation.
- Policy
- Will losses from drug price cut dispositions be recovered?
- by Lee, Jeong-Hwan Apr 15, 2022 06:03am
- The Ministry of Health and Welfare and the pharmaceutical companies are intensely arguing over the application of an indemnification system where the pharmaceutical company’s damages are refunded by the government if they win the administrative suits for price cuts and reimbursement suspensions. As the system has already met the administrative notice period and completed the Regulation Reform Committee procedures, all that is left is for the MOHW to decide upon its implementation and period, but the pharmaceutical companies have been raising issues and requesting the government to amend the specifics in the bill. On the 14th, the MOHW had announced it had started an internal review process for the partial revision of the “Criteria for Decision or Adjustment on Drugs.” The administrative pre-announcement of the amendment that was presented on January 17th contained guarantees that refunds losses incurred by drug manufacturers, etc. as results of administrative trials and litigations. In essence, the government will recover the damages incurred if the pharmaceutical company wins after filing an administrative lawsuit against the MOHW’s disposition such as drug price cuts, reimbursement suspensions, or deletions. The pharmaceutical industry has been protesting that the system does not fully reflect reality. The companies are stressing that, unlike the price cut dispositions where the price can be immediately restored if the company wins the suit, damages from dispositions such as reimbursement suspensions or reductions cannot be recovered even afterward. For example, just a 1 month's suspension of reimbursement would result in the deletion of the prescription code at healthcare institutions, due to which the drug would lose its foothold in the market. Reducing the scope of reimbursement would also render considerable losses in prescriptions as the doctors would switch to other drugs, but the refunded amount is too insufficient to cover the losses. The companies believe that if they win the suits after reimbursement suspension or reduction dispositions, the government should compensate for its damages until the company fully recovers the damages caused by the disposition. In addition, the pharmaceutical companies insisted that an appropriate rate should be set through calculation by the Loss Estimation Committee rather than the MOHW unilaterally calculating the refund rate for drugs subject to reimbursement application suspensions or reductions. Whether the government would accept the industry’s argument will affect the final implementation of the system. If the MOHW accepts a broad range of opinions made by the industry, it may be necessary for the authorities to take additional administrative notice procedures. The MOHW is currently preparing the final administrative notice for review by the Ministry of Government Legislation after completing the Regulation Reform Committee procedures as well as opinion collection from the industry. An official from MOHW said, “We are internally discussing whether to accept the opinion collected during the administrative pre-announcement period. It has not been decided whether we will be reflecting the changes, and after we make a decision, we will receive a review from the Ministry of Government Legislation."
- Policy
- Omicron recombinant XL mutation found in Korea
- by Lee, Jeong-Hwan Apr 14, 2022 05:56am
- In Korea, the sub-variant XL in which the Omicron COVID-19 mutant virus has been modified (recombined) has been confirmed for the first time. The quarantine authorities predicted that the XL mutation is a subfamily of omicrons, and that caution is necessary, but there will be no excessive concern. The intention is that there is a possibility of natural extinction rather than a dominant mutation after omicron, and various inspection institutions, including the KDCA, can manage and respond during monitoring. On the 12th, the head of the KSLM epidemiological investigation and analysis team said, "In a confirmed case on the 23rd of last month, Omicron recombinant mutation XL was confirmed, and related epidemiological investigations are underway." According to the KSLM, the patient did not have any symptoms, and the COVID-19 vaccination was completed until the third round. XL is a mixture of genes from omicron (BA.1) and stealth omicron (BA.2). It is one of the 17 recombinant mutations identified so far, and no specific characteristics have been reported. According to the World Health Organization (WHO), 66 cases of XL have been confirmed in the UK alone since its first discovery in February. Health and Safety Executive said on the 25th of last month that most recombinant mutations disappear without special diffusion. The KSLM said, "XL recombinant mutations are classified as omicrons by the WHO, so it is not expected that there will be significant changes in characteristics. We will continue to strengthen mutation monitoring because there are no analysis data such as propagation power and severity."
- Policy
- P3T for Roche’s Giredestrant was approved in Korea
- by Lee, Hye-Kyung Apr 14, 2022 05:56am
- A Phase III trial for Roche’s next-generation breast cancer treatment ‘giredestrant’ will be conducted in Korea. The Ministry of Food and Drug Safety approved the company’s application to conduct a randomized, open-label Phase III trial to evaluate the efficacy and safety of ‘giredestrant+ Phesgo’ in comparison to Phesgo in treatment-naïve HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer patients after ‘Phesgo+taxane’ induction therapy. The domestic Phase III trial will be conducted in Seoul St.Mary’s Hospital, Kyungpook National University Chilgok Hospital, the National Cancer Center, Seoul Asan Medical Center, Severance Hospital, and the Samsung Medical Center. Giredestrant is an oral anti-hormonal therapy in the selective estrogen receptor degrader (SERD) class that inhibits the proliferation of cells that bring estrogen to the breast cancer cells. In a Phase II study that administered giredestrant and anastrozole for two weeks in 191 treatment-naïve postmenopausal women with estrogen receptor-positive and HER2-negative early breast cancer, giredestrant showed a much greater effect than anastrozole. Also, comparison of the Ki67 protein levels produced when breast cancer cells divide and proliferate as identified through biopsies pre-and post- treatment showed that the mean relative Ki67 reduction from baseline to week 2 was 80% with giredestrant compared to the 67% with anastrozole. Meanwhile, the only SERD class drug to be approved by the US FDA is AstraZeneca’s ‘Faslodex inj. (fulvestrant),’ but the drug is an injection-type rather than an oral type.
- Policy
- Why Galvusmet is priced same as salt-modified and generics
- by Lee, Tak-Sun Apr 13, 2022 06:03am
- Prices of DPP-4 inhibitor Galvus (vildagliptin) and Galvusmet (vildagliptin+metformin) latecomers show that the original Galvus’s price is still set high, but the price of the original Galvusmet (50/500mg) is set at the same level as its salt-modified and generic versions. Also, Galvus’s price had fallen 30% with premium pricing after the introduction of generics, but Galvusmet’s price fell only 25.3%. Why the difference? This is due to the different standards in pricing between single-agent and combination drugs. Galvusmet’s pricing did not follow the general formula. First, combination drugs are not applied the premium pricing formulas. For original single agent drugs, the drugs’ price falls 30% in the first year due to premium pricing, then to 53.55%, same as generics after 1 year. Reimbursement listing status of vildagliptin(50mg)/metformin(500mg) However, original combination drugs are not provided a premium and therefore are discounted and set at 53.55% like its generics at the time of entry. If so, why did Galvusmet’s price drop only 25.3%? It was because its price had been set at a lower level during its initial listing. This is why the drug’s price was set at ₩310, which is a sum of ₩240, the ceiling price of Galvus before premiums, and ₩70, the ceiling price of metformin 500mg. The price of KB Pharma’s salt-modified drug Vildamet tab 50/500mg was also set at ₩310 under the same calculations. Also, United Pharma Korea’s generic version of Galvusmet, ‘Healusmet tab’ was listed at ₩310 like the adjusted price of Galvusmet by satisfying both the direct bioequivalence testing and Regulation on Registration of Drug Substances (DMF) requirements. This is why the original, salt-modified drug and generics were set at the same price upon market entry. On the other hand, the price of generics from companies that were not able to satisfy the direct bioequivalence testing requirements – those from Samjin, Ahn-gook, Ahn-gook New Pharm, and Shinpoong- were set at ₩264. Meanwhile, Hanmi Pharmaceutical’s ‘Vildaglmet 50/500mg,’ which was allowed the same price as KB Pharma’s at ₩310, was voluntarily listed at a lower price of ₩300. Yoon-Hee Choi, Team Head of the Health Insurance Review and Assessment Service’s Drug Pricing Department, said, “No premium is provided for combination drugs, therefore, the price of original combination drugs may be set at the same level as its generics upon entry of generics. However, as Galvusmet’s price had been set at a lower price in its initial listing, the price was not discounted 53.55%, but under a different standard.”
- Policy
- Korea loses $9 billion a year in exports
- by Lee, Jeong-Hwan Apr 13, 2022 06:02am
- If low- and mid-income countries such as Africa and Central America fail to raise their collective immunity levels sufficiently, it will have a negative impact on the economy, such as a decrease in export profits of high-income countries. This is because countries around the world are linked to each other by trade and investment, and the country that is expected to lose the most is expected to hit the U.S. with $50 billion a year, while Germany is expected to hit $30 billion a year as the second country to lose. Korea is also expected to lose $9 billion a year, and it is analyzed that having an international cooperation system that can fairly inoculate the COVID-19 vaccine will eventually bring economic benefits to rich countries. On the 11th, Kim Joo-kyung, a legislative investigator at the National Assembly's legislative investigation office, made the announcement through the "significance and task of international cooperation to respond to the pandemic of infectious diseases." The main point of the analysis is that in order to minimize economic losses caused by the COVID-19 pandemic, vaccine inequality between countries should be minimized and international cooperation should be strengthened. According to the international statistics site Our World in Data, the rate of COVID-19 vaccine booster shots per 100 people as of the 4th was very low in African continental countries and some Central American countries. Chile (83.3%) and Singapore (70.7%) finished booster shots, and Korea had a high vaccination rate along with 64.6% of Korea, Iceland (67.9%) and Italy (64.9%). Gabon and Cameroon accounted for 0.1% and Ethiopia 0.3%, with most of the African continent countries and Central American countries such as Jamaica (1.1%). The Legislative Research Service pointed out that vaccine nationalism poses health risks such as increasing death and morbidity by continuing the public health crisis situation, while also seriously affecting the global economy. Countries around the world are interconnected by trade and investment, leading to a decrease in economic demand in low- and medium-income countries leading to negative effects such as a decrease in exports to the economies of high-income countries. Kim explained, "If low-income countries fail to raise their collective immunity levels sufficiently, the cumulative economic cost to 30 high-income countries is estimated to be $216 billion in 2022-2023 alone and $258 billion in 2023-2024. Kim added, "The country that is expected to be hit the hardest among the 30 countries will incur $41.3 billion in 2022-2023 and $493 in 2023-2024, and Germany will lose $26.1 billion in 2022-2023 and $31.1 billion in 2023-2024. Korea is expected to suffer economic losses of $8.2 billion from 2022 to 2023 and $9.7 billion from 2023 to 2024, he said. "Quick vaccination is important because potential economic costs arising from the lack of vaccines to poor countries increase over time." Kim stressed that vaccine inequality should be improved through international cooperation. In particular, as Korea has been selected as a "global bio-human resource training hub," it said that it should start seeking international cooperation measures. The global bio-human resources training hub, organized by the World Health Organization (WHO), is a project that provides education and training across the production of vaccines and biopharmaceuticals. Korea will be selected alone and conduct vaccine and biopharmaceutical manufacturing training for 370 global bio-workers from July. Kim said, "The way to solve the COVID-19 pandemic is to improve the current vaccine and vaccinate the most vulnerable people," adding, "To this end, the WHO is trying to supply vaccines fairly through COVAX Facility and transfer vaccine technology to low-income countries." Kim said, "Korea did not have the original technology for COVID-19 vaccines, so it was difficult to supply and demand vaccines in the early days of the pandemic. In response, we have the task of becoming a leading country in the bio-pharmaceutical industry. As Korea has been selected as a global bio-human resource training hub, we need to seek international solidarity and cooperation to contribute to health security around the world."
- Policy
- Galvusmet latecomers face a price war since launch
- by Lee, Tak-Sun Apr 12, 2022 06:05am
- How price will affect sales of the DPP-4i antidiabetic treatment Galvusmet’s latecomers is gaining attention. Hanmi Pharmaceutical, which had been the first to release a drug to the market, had opted to set its price lower than planned, and the price of the original Galvusmet had also fallen due to the introduction of generics. The price of the generics had also been set accordingly. According to industry sources on the 11th, starting with Hanmi’s Vildaglmet, sales of Galvusmet generics had started in earnest in February, along with sales of KB Pharma’s salt-modified drug in March, all of which as latecomers of Novartis’s Galvusmet (vildagliptin/metformin). The latecomers have been eyeing the Galvusmet market as this fixed-combination drug has been prescribed more than the single-agent Galvus. According to UBIST, Galvus sold ₩8.5 billion and Galvusmet ₩38 billion last year in Korea. Among the latecomers that were newly introduced, only a generic version of the Galvusmet’s main dose - vildagliptin 50mg/metformin 500mg – was released in the market. The introduction of Galvusmet 50/500mg generic had reduced the price of the original by 25.3%, leaving no difference in price between it and the latecomer drugs. In particular, KB Pharma’s salt-modified Vildamet tab 50/500mg, and Korea United Pharm’s Healusmet tab, which received a pricing premium as an innovative pharmaceutical, were listed at ₩310, which is the same price as its original drug. However, Hanmi Pharmaceutical opted to set the price of its salt-modified Vildaglmet tab 50/500mg ₩300, and how this will affect market competition is receiving attention. 빌다글립틴(50mg)/메트포르민(500mg) 동일제제 급여등재 현황 Galvusmet latecomers were able to enter the market earlier after successful patent challenges. Although the original's substance patent was set to expire on March 4th this year, Hanmi and Ahn-gook succeeded in invalidating part of the extended term of the patent and released their generics earlier than the patent expiry date. On this, Novartis has filed an active trial to confirm the scope of its patent against companies other than Hanmi – KB Pharma, Korea United Pharm, Ahn-gook Pharmaceutical, Ahn-gook New Pharm, and Samjin Pharm – on grounds of patent infringement. With patent and drug prices so intricately intertwined, who will be the last to smile in this ₩40 billion market is expected to continue to draw attention.
- Policy
- The adverse drug reaction rate of Trulicity is 19%
- by Lee, Hye-Kyung Apr 11, 2022 05:58am
- As a result of a six-year post-marketing survey of Type 2 diabetes treatment Trulicity in Lilly Korea, 15 cases of serious adverse drug reactions that cannot be excluded from causal relationships were reported. The permit will be changed as 62 unexpected adverse drug reactions, which cannot exclude causal relationships, also occurred. The MFDS recently announced that it will pre-announce and reflect the order to change the permission according to the results of the re-examination of Trulicity 1.5 mg/0.5ml and Trulicity 0.75 mg/0.5ml disposable pens from July 6. Trulicity was developed as a disposable syringe formulation as a long-acting GLP-1 analog and obtained domestic permission in 2015. As a result of a post-marketing survey of 3,022 people for 6 years for re-examination in Korea, the incidence of abnormal cases was reported to be 19.49% (589/3,022 people, total 819 cases), regardless of causality. Significant adverse drug reactions were found to be 0.46% (14/3022 patients, 15 cases), with occasional blood sugar increases and rare dizziness, poorly controlled diabetes, diabetic gastritis, gastroesophageal reflux disease, acute kidney damage, and diabetic kidney disease. In the case of unexpected adverse drug reactions such as weight loss, weight gain, sensory degradation, and gastroenteritis, 1.99% (60/3,022 cases, 62 cases) occurred. Trulicity is administered as an adjuvant to dietary and exercise therapy to improve blood sugar control in adult type 2 diabetes patients. Among patients who have difficulty controlling sufficient blood sugar with Metformin and Sulfonylurea combination therapy, insurance benefit is being applied to the combination therapy of patients who cannot perform body mass index ≥25kg/㎡ or insulin therapy. Last year, it recorded 47 billion won in outpatient prescriptions based on UBIST, up 23% from 38.2 billion won in the previous year.
- Policy
- NHIS to study measures on improving the PVA system
- by Lee, Tak-Sun Apr 11, 2022 05:58am
- With a study on improving the price-volume agreement (PVA) system in plan, the possibility that the improvement may increase drugs subject to PVA is being raised. According to industry sources on the 8th, the National Health Insurance Service is preparing to conduct a research to ‘evaluate the performance of and improve the Price-Volume Agreement system’ and will post a bid for its research services soon. Its plan, as disclosed by the NHIS, indicates that the study will be conducted for 6 months from the period of its initiation and be completed at the end of the month. Through the study, the authorities plan to establish a mid-to-long-term roadmap for the PVA system and ensure the appropriateness of the drug expenditures to save excess resources and strengthen Korea’s NHI coverage. Feasibility reviews on alternatives that go beyond the existing agreement system and reference formulas will also be developed in the study. For example, the current system applies the rate of increased claims in the formula, but the study will review the application of a reference formula that considers the absolute claims amount and the amount of increase. In addition, the study will be used to prepare a reasonable plan that considers the fiscal impact of the selection/exclusion criteria that were already revised this month, and review diversifying the method used to make PVA. Based on the research results, NHIS also plans to hold public hearings with relevant institutions to improve the PVA system to prepare a system improvement plan that can enhance both acceptability and negotiation power, and propose a mid-to-long-term development direction for the PVA system based on legal and institutional review. NHIS announced its plan to research measures to improve the PVA system earlier this year. At a policy roundtable meeting on the ‘Rational improvement of the PVA system’ that was held by the National Assembly in January, Hyun-Deok Kim, Director-General of the Pharmaceutical Management Department, said, “We are aware of the issue caused by reviewing only the rate of increase without consideration of the absolute increase in claims amount. We agree that there is a need to conduct a comprehensive review on the PVA system and prepare improvements, and will be posting a bid for research services within the year.” As the main purpose of the study is to save NHI pharmaceutical expenses, friction with pharmaceutical companies seems inevitable in the process of its implementation. An industry official expressed regrets, "Contrary to the pharmaceutical industry’s opinion of reducing or deferring the PVA system, the government’s only plan seems to be to reduce its expenses. By the contents of the study alone, it seems that subject drugs and discount rate would only increase further."
