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- 2026-05-18 17:10:28
- Policy
- Rate of reimbursement expansions is falling?
- by Lee, Hye-Kyung Oct 05, 2021 05:56am
- To the criticism that the rate of reimbursement extensions for anticancer drugs have been falling, the Health Insurance Review and Assessment Service had pointed to the increased number of high-priced drugs that are being covered with the RSA system. HIRA had explained that the increased number of drugs covered through the RSA system since 2017, such as immuno-oncology drugs and targeted drugs, have increased the need to consider the cost-effectiveness and fiscal impact of drugs that require reimbursement extensions. Ahead of the NA audit scheduled for the 15th, HIRA submitted a ‘Report on the results of the requested corrections and processes from the 2020 NA audit’ that contains the matters stated above. Last year, the NA requested the authorities to realign the reimbursement priorities due to the declining rate of NHI reimbursement extensions for anticancer drugs. On this, HIRA has convened a consultative body that consists of clinical experts, government, HIRA, NHIS, etc., to discuss measures to increase the reimbursement coverage of immuno-oncology agents. HIRA said, “We will continue our best efforts to collect opinions from various stakeholders in order to enhance coverage of anticancer drugs." Regarding the request to establish a specific standard for determining reimbursement priorities for high-priced drugs and a systematic follow-up management plan, the report explained that the body “plans to review the measures for listing high-price drugs by collecting opinions from various stakeholders and consultation with the government” The institution has been utilizing the approval-assessment linkage system, PE exemption system, and the rapid assessment of treatment for rare diseases in need of an urgent and prompt introduction to reimburse high-priced rare disease treatments, and also explained that it has been continuing efforts to enhance coverage (accessibility) for patients with rare diseases by expanding the RSA scheme.
- Policy
- Kymriah's fast track is needed
- by Kim, Jung-Ju Oct 05, 2021 05:56am
- Patient groups objected to the decision of the Cancer Drugs Benefit Appeal Committee on hold against Kymriah (Tisagenleclecel), which drew attention to insurance benefits as a cell therapy and a "one-shot treatment." This is because it is a new drug that is directly related to life for leukemia patients, and even though they have to be paid in a hurry through the fast track system, the progress is slow and causes pain. Korea Leukemia patients organization said it will submit a petition to the National Human Rights Commission of Korea on October 1. Kymriah is the world's first CAR-T treatment licensed as efficacy and effect indication for treatment of recurrent or refractory B cell acute lymphocytic leukemia patients and recurrent or refractory giant B cell lymphoma adult patients. Novartis Korea was approved by the MFDS on March 5 and applied with the HIRA on the 3rd, two days ago. However, at the 6th Cancer Drugs Benefit Appeal Committee held on September 1, the progress was blocked. At that time, members of the Cancer Drugs Benefit Appeal Committee decided to quickly re-discuss the amendments mentioned. It costs about 500 million won per dose, which is an ultra-high-priced drug. The patient group expressed regret over the slow progress, saying, "If the patients do not receive Kymriah treatment, most patients with end-stage acute lymphocytic leukemia and lymphoma can die within 3 to 6 months." In fact, the drug was previously expected to be discussed at the Cancer Drugs Benefit Application Committee in July, but the patient group's demand grew even greater because it was not even proposed and was suspended in the September discussion. What the patient organization requires is to include Kymriah in the fast track system. Insurance authorities are paying for drugs that are directly related to life by stepping on a track that can make fast tracks. Korea Leukemia patients organization plans to submit a petition to the Minister of Health and Welfare in the name of not introducing a "quick registration system for new drug health insurance directly related to life" to Korea. In addition, considering that the drug is an ultra-high-priced drug, the patient association will hold a press conference at the same time urging the preparation of active financial sharing measures for fast track.
- Company
- All 15 pharmaceutical unions gathered together
- by An, Kyung-Jin Oct 05, 2021 05:56am
- The chairmen of the union of 15 pharmaceutical companies constituting the consultative body (data: NPU) A labor union composed of workers from 15 domestic pharmaceutical and bio companies has begun in earnest to integrate. According to the industry on the 29th, representatives of labor unions from 15 pharmaceutical and bio companies currently active in Korea gathered to form the National Pharmaceutical & Bio Labor Union (NPU) and began official activities. NPU is a consultative body to launch labor unions by pharmaceutical and bio industries under the Federation of Korea Trade Union and The Federation of Korean Chemical Workers' Union. Currently, Novo Nordisk, Bayer Korea, Sanofi Aventis Korea, Alvogen Korea, Amgen Korea, Ipsen Korea, Novartis Korea, Merck Korea, Beringer Ingelheim Korea, Viatris Korea, AstraZeneca Korea, Janssen Korea, and Hyundai will participate. The total number of union members is about 2,500. The reason for the launch of NPU is because of the problem of recognizing the difficulties faced by pharmaceutical industry workers as common problems in Korea's pharmaceutical industry and finding solutions together. Although public interest in the pharmaceutical and bio industries is increasing in COVID-19 pandemic, industry workers point out that they are in danger of slowing industrial growth, job insecurity and income reduction due to changes in the business environment. However, it is known that the launch of the industrial union has been delayed in consideration of the COVID-19 pandemic situation. As strengthened "social distancing" measures continued and smooth communication between large-scale gatherings and members was restricted, the government decided to temporarily operate a consultative body, which is an intermediate level. According to Article 16 of the Trade Union and Labor Relations Adjustment Act and the conventions of trade unions by each company, more than two-thirds of the registered union members must agree with the resolution. As an alliance, NPU plans to strengthen solidarity and improve the working environment of workers in the pharmaceutical industry. It is predicted that the official industrial union will be launched as early as June next year, shifting the organization form sequentially from the organization where the union member vote was completed. The ambition is to work hard to raise the working level of 2,500 union members to the next level, led by Ahn Deok-hwan, chairman of the NPU. NPU Chairman Ahn Deok-hwan said, "Although it is launched as an intermediate consultative body, we will respect and solidarity with each other like the official industrial union," adding, "We will upgrade the wages and welfare of workers in the pharmaceutical industry through strategic and efficient bargaining support. We will also respond to problems such as employment insecurity caused by low growth and digital marketing by directly communicating with the National Assembly, the government, and civic groups."
- Company
- Liver cancer pioneer ‘Nexavar,' the star in its guidelines
- by Eo, Yun-Ho Oct 01, 2021 06:09am
- There are two reasons why new drug development is slow for a certain disease: its marketability is low or the development of the drug is difficult. When developed, new drugs developed in the latter situation attract more widespread attention. Liver cancer (hepatocellular carcinoma) is a typical example of this. And the only targeted anticancer therapy that was available in this difficult-to-develop field of liver cancer for over 10 years was ‘Nexavar (sorafenib).’ Of course, new drugs are now available, such as ‘Stivargar (regorafenib)’ as second-line treatment, and ‘Lenvima (Lenvatinib),’ which is used as first-line treatment like Nexavar. Also, an immunotherapy option was added in the field with the approval of the ‘Tecentriq (atezolizumab)+Avastin (bevacizumab)’ combination therapy. Still, Nexavar’s legacy remains strong ◆The liver treatment that was introduced for the first time in 30 years Nexavar, which was the first in the world to receive FDA approval for hepatocellular carcinoma, opened the door to targeted anticancer therapy in the field. At the time, Nexavar was a significant achievement that was made after a series of attempts and failures by pharmaceutical companies for around 30 years. In Korea, after receiving the first-ever approval for hepatocellular carcinoma from the Ministry of Food and Drug Safety in March 2008, the drug has accumulated the most amount of treatment experience as the only first-line targeted therapy for over a decade since then. And the drug kept on evolving. Data from the GIDEON study that was conducted on 3,371 liver cancer patients in 39 countries around the globe, the drug showed a consistent safety profile in Child-Pugh class B7 patients with liver damage (11%, n=359) and 에서 Child-Pugh class A patients (61%, n=1968). Based on this, Nexavar is currently the only drug recommended as a first-line systemic anticancer therapy in patients with Child-Pugh class B7 in the 2020 NCCN guidelines (Version 5). ◆The significance of reimbursement approval in Child-Pugh class B7 and the rising position of Nexavar By succeeding to expand its insurance benefit, Nexavar once again strengthened its position in the field. With Nexavar’s insurance benefit approved to Child-Pugh class B7 patients, or severe disease patients, the drug’s utility in liver disease has even more increased. Before then, Child-Pugh class B7 was a sort of ‘grey area’ in the field of liver cancer. With the approval, Nexavar can now be used with reimbursement in patients with advanced hepatocellular carcinoma (HCC, including pediatric patients) who cannot receive local treatment such as surgery or transarterial chemoembolization (TACE) that are: ▲Child-Pugh class A or B7; ▲at Stage Ⅲ or higher; or ▲ whose ECOG performance status (PS) is 0-2. Also, the biggest advantage of the first-line treatment Nexavar is that it has a second-line treatment Stivarga available for use in sequence with reimbursement. A clinical trial showed that the use of Nexavar in sequence with the second-line treatment Stivarga prolonged overall survival (OS). However, limitations still exist as Nexavar is the only systemic anticancer treatment reimbursed for Child-Pugh class B7 patients, and no sequential treatment is available for use with reimbursement after Nexavar. Also, there are unfavorable views on the limited reimbursement status of its competitor drug Lenvima. ◆Patent expiry, drug price cuts, and the entrance of competitor drugs However, in terms of sales, Nexavar is now on its descent. It's not about the prescription amount, but about the patent expiry and the resulting drug price cut. According to IQVIA, Bayer’s hepatocellular carcinoma treatment sold 5.6 billion won in the first half of the year. This is a 45% decrease from the 10.3 billion won that was sold in 1H last year. In the same period, sales of Eisai’s Lenvima increased 27% from 5.7 billion won to 7.2 billion won. With the steep fall in sales of Nexavar and a significant increase in sales of Lenvima, the position of the two drugs has changed. This is a first in 13 years since the drug started being used as a liver treatment and 3 years after the release of Lenvima. Nexavar took a hard blow in February this year with its insurance ceiling being reduced by 30%. The government cut Nexavar’s drug price 30% ex officio from 18,560 won to 12,992 won. This was because Hanmi Pharm’s released Nexavar’s generic after overcoming Nexavar’s patent.
- Company
- Only Taejoon’s succeeds in avoiding Simbrinza’s patent
- by Kim, Jin-Gu Oct 01, 2021 06:09am
- Taejoon Pharmaceutical succeeds in avoiding the patent for Novartis’s glaucoma treatment ‘Simbrinza eyedrops (brimonidine+ brinzolamide).’ Being the only company to successfully avoid Novartis’s patent, Taejoon Pharmaceutical will now be able to develop a generic version of Simbrinza Eye Drops in a relatively relaxed manner. According to industry sources on the 30th, Taejoon Pharmaceutical recently won the Passive Trial to Confirm the Scope of Patent Rights it filed against the composition patent of Novartis’ Simbrinza Eye Drops. Taejoon Pharmaceutical had filed the suit in July last year, and this is the only patent registered in Korea for Simbrinza Eye Drops. The patent will expire by June 2030, and its PMS has expired in June this year. With the victory, Taejoon Pharmaceutical prepared a foothold for the early release of its Simbrinza generic. If Taejoon Pharmaceutical succeeds in developing its generic and receives marketing approval, the company may immediately release its product. Currently Taejoon Pharmaceutical is the only company to succeed in avoiding its patent. Originally, Chong Kun Dang had challenged the patent with Taejoon Pharmaceutical, however, CKD had dropped its suit, and Taejoon continued on its challenge by itself. With no generic competitor, the company will be able to continue developing its generic in a relatively easier manner. Taejoon Pharmaceutical is currently selling other glaucoma treatments in the market. Its Xalost Eye Drops (latanoprost)’ is a generic of Pfizer’s ‘Xalatan Eye Drop,’ and its ‘Combisopt Eye Drops (timolol+dorzolamide’ is a generic of Santen Pham Korea’s ‘Cosopt Eye Drops.’ Taejoon Pharmaceutical plans to bring synergy into the glaucoma treatment market by adding a Simbrinza generic to its portfolio. According to the pharmaceutical market research institution IQVIA, its Xalost sold 6.5 billion won and Combisopt sold 0.2 bill won last year. Simbrinza Eye Drops have steadily sold around 2 billion won annually. The product has recorded 1.1 billion won in sales in the first half of this year.
- Product
- Smoking cessation tx, sold out due to impurities
- by Kim JiEun Oct 01, 2021 06:08am
- According to local pharmacies on the 1st, most Bupropions used for smoking cessation treatment are sold out or lack of inventory, making it difficult to order at online malls. This out of stock is related to the recent controversy over the detection of impurities in the Varenicline. As NNV, a carcinogen, was detected in Champix (Varenicline), the company decided to voluntarily recover it. The MFDS explained that N-nitroso-varenicline (NNV) is very low in the domestic Varenicline, but concerns about the ingredients remained in the market. Pharmacists say that most hospitals and clinics, which have consulted and prescribed patients under the government's anti-smoking treatment support project, often prescribe alternatively with Bupropion. A local pharmacist said, "I was contacted by the hospital to recommend a replacement drug," adding, "It was extremely rare for the hospital to ask the pharmacy to prescribe the drug first, but I was also embarrassed." Pharmacies that need to prepare related drugs are experiencing considerable confusion. In particular, the situation is more serious in pharmacies where nearby hospitals and clinics participate in the government's anti-smoking treatment support project and have a large number of related prescription preparations. These pharmacy pharmacists complain that it is not easy to secure inventory of medicines that are usually prescribed. Currently, Bupropion, where hospitals and clinics have replaced the existing Champix (Varenicline), is a total of 6 products, including Nicopion Sr (Hanmi), Healthpion ER(Myungin), Addpion SR 150mg(Whanin), Papion(Korea Pharma), Well SR(Unimed), and Wellviewderma ER(Hutecs). These items can be prescribed for the government's anti-smoking treatment support project, and most of them are currently out of stock at online drug malls or only a few are in stock. Another pharmacist in Seoul said, "In the past, Champix monopolized the prescription of smoking cessation treatment," adding, "We contacted a nearby hospital and asked them to prescribe even a small amount of products in stock."
- Policy
- Botulinum toxin by fraudulent means can be revoked
- by Lee, Jeong-Hwan Oct 01, 2021 06:08am
- Regulations on handling and management, such as reporting high-risk pathogens such as botulinum toxin and anthrax, will be strengthened, and permission for bioterrorism infectious disease pathogens licensed by fraudulent methods will be revoked. On the 28th, Baek Jong-heon (Busan Geumjeong-gu), a member of the National Assembly's Health and Welfare Committee, said that the "Partial Amendment to the Infectious Disease Prevention Act" has passed the plenary session of the National Assembly. The current law regulates those who want to install and operate high-risk pathogen handling facilities to obtain or report permission from the head of the KDCA by safety management level. If permission is obtained or reported by deception or fraudulent means, permission is revoked or the facility is ordered to be closed. In order for a person who has obtained permission to bring a high-risk pathogen into Korea to take over and move the high-risk pathogen, the movement plan must be reported in advance to the head of the KDCA. Rep. Baek Jong-heon pointed out that it is necessary to consider using facilities handling high-risk pathogens so that civilians or private businesses can diagnose and conduct academic research on infectious diseases. In particular, he pointed out the problem that there is no basis for processing high-risk pathogens when canceling permission for high-risk pathogens or ordering closure, and that there is no basis for canceling permission if they are not acquired for a long time after approval. In response, Rep. Baek proposed a bill that allows individuals and private businesses to use high-risk pathogen handling facilities for the purpose of diagnosing infectious diseases and academic research. In addition, it allows domestic entrants of high-risk pathogens to cancel if they have not taken over or reported, and also provides a basis for handling high-risk pathogens in case of cancellation or closure of handling facilities. He said, "With the passage of today's plenary session, safety management for high-risk pathogens will be further strengthened to protect the health of the people. In the future, we plan to come up with laws that can strongly punish high-risk pathogens such as botulinum toxin."
- Policy
- Domestic new drugs shouldn't be discriminated against
- by Lee, Jeong-Hwan Oct 01, 2021 06:08am
- Problems with the PVA system are expected to be discussed during this year's parliamentary audit of the National Assembly's Health and Welfare Committee. The domestic pharmaceutical community criticized that it is too harsh for the government to unilaterally decide on a drug price cut without acknowledging the innovation of new domestic drugs in the process of operating PVA. Accordingly, the National Assembly's welfare committee members agreed on this. On the 28th, the National Assembly's Health and Welfare Committee members plan to inquire about the current PVA system operation status, problems claimed by the pharmaceutical industry, and directions for improvement to government agencies such as the MOHW. Domestic pharmaceutical companies argue that a system should be introduced to exclude new domestic drugs developed by investing steady R&D costs from PVA targets or limit the number of drug cuts after negotiations. They say that PVA negotiations that do not consider structural and environmental differences between new drugs and domestic new drugs by overseas global big pharma are dampening domestic pharmaceutical companies' willingness to develop new drugs or invest in R&D. The National Assembly's welfare committee members also agree with the criticism of the pharmaceutical industry and try to raise the need to overhaul and advance the post-evaluation system for drug prices such as the PVA system. Due to the insufficient PVA system, domestic new drugs will be reversely discriminated against by global new drugs in the prescription market and inquire about the government's position. It is expected that inquiries will be made in a way that vaguely checks the problems of the system itself rather than preferential treatment of new domestic drugs over new global drugs. An official from belonging to the Welfare Committee said, "The PVA system is a post-drug price policy that realizes fiscal efficiency by improving the soundness of health insurance finances. However, some pharmaceutical companies with new domestic development drugs are complaining that the PVA system is unreasonable. "We plan to examine the operation status of the system itself and analyze whether there is a need for maintenance or improvement," he said. He added, "In this process, the government and the pharmaceutical industry will be able to improve their understanding of the PVA system," adding, "If the PVA system is insufficient as the pharmaceutical industry claims, we expect it to be improved through a parliamentary audit."
- Company
- Pfizer’s 2nd JAK inhibitor ‘Cibinqo’ to soon enter Korea
- by Eo, Yun-Ho Sep 30, 2021 05:57am
- Pfizer is planning to introduce a new JAK inhibitor after ‘Xeljanz’ to Korea. However, the new drug will target the ‘atopic dermatitis’ treatment market. According to industry sources, Pfizer Korea has recently submitted an application requesting marketing authorization for its Cibinqo (abrocitinib). The approval is expected to be made in the first half of next year. The drug, which is taken once daily, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over that are candidates for systemic therapy. The drug has not received marketing authorization in the U.S yet. Cibinqo is a selective Janus kinase (JAK)1 inhibitor that modulates multiple cytokines involved in AD including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSL). Xeljanz inhibits JAK3 rather than JAK1 or JAK2. With only Lilly’s ‘Olumiant (baricitinib)’ currently approved for the atopic dermatitis indication, more JAK inhibitors are expected to soon enter the market. Lilly is working to extend Olumiant’s insurance benefit to its atopic dermatitis indication Meanwhile, Cibinqo’s efficacy in atopic dermatitis was identified through the Phase III JADE Mono-1 trial. Study results showed that at Week 12, 62.7% of patients who received 200mg of Cibinqo showed improvement in their EASI (Eczema Area and Severity Index 75 response rate) score of 75% or higher, a significant improvement compared to the 11.8% in the placebo group. Also, the proportions of patients who achieved EASI-90 were 38.6% and 5.3% for Cibinqo 200mg and placebo, respectively Also, the proportion of patients achieving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin was 43.8% and 7.9% for Cibinqo 200mg and placebo, respectively, indicating that around half of the Cibinqo-treated group showed response within 12 weeks of treatment. Recently, the FDA had issued a Dear Healthcare Professional Letter regarding the safety of JAK inhibitors such as Pfizer’s ‘Xeljanz (tofacitinib),’ Lilly's ‘Olumiant (baricitinib),’ Abbvie’s ‘Rinvoq (Upadacitinib),’ etc. Whether the drugs may resolve the issue and settle as a viable treatment option for atopic dermatitis remains to be seen.
- Company
- It does not affect sales of Rivaroxaban 2.5mg
- by Kim, Jin-Gu Sep 30, 2021 05:57am
- Xarelto 2.5mg Hanmi dismissed the possibility of legal disputes over the patent registration of the original company ahead of the launch of Xarelto's generic. The company said that the scope of validity of patents registered late does not affect Hanmi's new drug to be released. In addition, Hanmi emphasizes that it did not take issue when it sent certification of contents to Bayer, the original company. According to the pharmaceutical industry on the 29th, Hanmi is planning to release Riroxban, Xarelto's generic, on the 4th of next month. 133 items from up to 66 companies, including Hanmi, will be released simultaneously after the expiration of Xarelto's patents. Expected items to be released are Rivaroxaban 10mg and Rivaroxaban 15mg. On top of that, Hanmi's Riroxban 2.5mg is the only one to release. This is because Hanmi succeeded in overcoming the composition patent registered exclusively in Rivaroxaban 2.5mg, and first of all, it received generic for exclusivity. In the case of Rivaroxaban 2.5 mg, there may be legal disputes with the original company. This is because Bayer registered a patent for use of Xarelto 2.5mg in September 2019, more than two years after obtaining generic for exclusivity. The patent expires in June next year. Regarding Bayer's registration, the pharmaceutical industry said it was aimed at hindering the early launch of generic. In addition, the pharmaceutical industry predicted that if Hanmi pushes ahead with the sale of Riroxban 2.5mg, it will lead to a legal dispute between the two companies in the future. Hanmi said, "There will be no impact on the launch of the Riroxban 2.5mg product." This is because the scope of validity of the registered patent is different from that of Hanmi's Riroxban 2.5mg. According to the Korean Intellectual Property Office, the patent registered by Bayer is about "Oxazolidinone for combination therapy." Specifically, it explains, "It relates to a composite agent of Oxazolidinone and other active ingredients, the preparation method and use of the composite agent as a drug, and in particular, its use as a drug for the prevention and treatment of thromboembolic disorders." In other words, if it is a "combination drug" with Xarelto 2.5mg added with other ingredients, Aspirin is likely to be added as another active ingredient if it is recognized as a patent for use. Bayer is said to have tried to register a combination therapy with other ingredients as a patent as a single drug. Bayer did not release domestic combination drug and only patents are listed. Hanmi said that Riroxban 2.5mg is not a combination type, so it is not a problem. An official from Hanmi said, "Actually, the use of Rivaroxaban 2.5mg is limited to combination drugs, so it does not affect the single drug Riroxban 2.5mg. There will be no problem with the launch of Riroxban 2.5mg."
