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- 2026-05-18 11:04:05
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- Non-reimbursed prescriptions for migraine drug Ajovy begin
- by Eo, Yun-Ho Nov 09, 2021 05:55am
- The new migraine drug ‘Ajovy’ is now being administered without reimbursement in Korea. According to industry sources, Teva-Handok Pharma’s Calcitonin gene-related peptide (CGRP) targeting migraine drug, Ajovy (fremanezumab), which was released in Korea on the 18th of last month, is now available for prescriptions at several medical institutions, including the Shinchon Severance Hospital. However, the drug has only passed a few drug committee (DC) reviews at general hospitals yet. Instead, the company had set a pre-order system for the drug for supply due to a flood of inquiries from patients whose symptoms recurred after taking Lilly's Emgality (galcanezumab)', another migraine drug that was released before Ajovy, also without reimbursement. Patients with severe migraines have shown expectations that Ajovy will bring different results based on the fact that the two migraine drugs have different dosages and methods of administration, although the two are from the same class. Emgality can currently be prescribed in medical institutions nationwide, in the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. Ajovy is administered two ways: 225 mg monthly, or 675 mg every 3 months (where 3 subcutaneous injections of 225mg are injected consecutively). The drug demonstrated its efficacy in the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 patients with episodic migraines (EM) and chronic migraines (CM). In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to a placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. 44.4% of subjects in the monthly dosing, 47.7% of subjects in the quarterly dosing group, and 27.9% in the placebo group showed a 50% or more reduction in migraine days. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and 4.3±03 days in the quarterly dosing Ajovy group, both were significant compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive therapies that had to be taken every day, patients may manage their migraines with once-a-month injection with CGRP targeted antibody drugs. The treatment cost remains an issue, however, we have high expectations for the drug because the more the patient receives the targeted therapy, the easier it is to treat."
- Company
- Will Ildong sell Nexium with annual sales of 50 billion won?
- by Kim, Jin-Gu Nov 09, 2021 05:54am
- Daewoong and AstraZeneca will terminate a joint sales contract for Nexium, a PPI-based gastroesophageal reflux disease treatment. The new joint sales partner of the large item, which generated about 50 billion won in sales last year, is said to be likely to be Ildong. According to the pharmaceutical industry on the 9th, Daewoong and AstraZeneca agreed to terminate the joint sales contract of Nexium last month. The contract is until December 31 this year. Nexium is a PPI-based gastroesophageal reflux disease treatment launched in Korea in 2000. Daewoong has been jointly selling with AstraZeneca since 2008. Sales have steadily increased over the next 14 years, making it the No. 1 item in the same ingredient market. According to the two companies, Nexium's sales reached 49.4 billion won last year. Instead of breaking up with Nexium, Daewoong plans to focus on sales and marketing of Fexuprazan, which is expected to be released next year. Daewoong is developing Fexuprazan, a P-CAB-based gastroesophageal reflux disease treatment. It is a drug of the same family as K-CAB of HK inno.N, which is rapidly growing in the market. Phase 3 clinical trials in 2019 have been completed. Currently, it has applied for item permission from the MFDS. It is also expected to be available as early as the end of this year. Daewoong Pharmaceutical has already been approved for generics with components such as Nexium in 2019. Starting next year, it is expected to sell Nexierd containing esomephrazole along with Fexuprazan. Ildong is said to be the most likely new co-selling partner of Nexium. Ildong is already jointly selling diabetes treatments such as Onglyza, Kombiglyze, and Qtern with AstraZeneca. On top of that, it is expected to further strengthen the combined front with AstraZeneca by jointly selling Nexus from next year. An official from Daewoong said, "The joint sales contract of Nexium will end at the end of this year," adding, "We decided not to extend the contract to focus on Fexuprazan, which is expected to be released next year." An official from the pharmaceutical industry said, "As far as I know, Ildong is likely to be the new partner of AstraZeneca, which will jointly sell Nexium," adding, "Unless there is a major change, the contract is expected to be signed soon."
- Policy
- Moderna vaccine produced by SB has been applied
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- The MFDS announced on the 8th that Moderna Korea has applied for permission to manufacture and sell the COVID-19 vaccine SPIKEVAX produced by Samsung Biologics in Korea. The vaccine induces an immune response by injecting antigen genes from COVID-19 in the form of mRNA to produce antigen proteins in the body. The MFDS announced that it will closely review the submitted quality, non-clinical, and clinical data and check the safety and effectiveness of the product to decide whether to approve it. An official from the MFDS emphasized, "We will continue to do our best to quickly supply safe and effective vaccines to the Korean people." Meanwhile, the COVID-19 vaccine developed in Moderna, USA, was approved for import items with SPIKEVAX on May 21.
- Policy
- LG Chem seeks approval for its ‘Zemiglo+SGLT-2i’ combo
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- DPP-4 inhibitor class diabetes drug developed by LG Chem LG Chem has applied for the marketing authorization of a combination drug that combines the DPP-4 diabetes treatment ‘Zemiglo (gemigliptin)’ with an SGLT-2 class inhibitor to the Ministry of Food and Drug Safety. With the new application, whether Zemiglo, one of the most successful locally developed novel drugs, will continue on its success with this new combination therapy is raising attention. According to the industry on the 7th, LG Chem recently applied for the marketing authorization of its dapagliflozin+gemigliptin combination therapy. The product name is known to be ‘Zemidapa,’ coined using the first letters of the two ingredients. LG Chem trademarked the name to the Korea Intellectual Property Office last month. In July last year, LG Chem received approval for a Phase 1 trial protocol that compares the pharmacokinetics, safety, and tolerance of gemigliptin 50mg and dapagliflozin 10mg administered separately and in combination. Also, in February 2020, the company was approved to conduct a Phase III trial that compares the efficacy and safety of metformin+gemigliptin+dapagliflozin with gemigliptin+metformin or dapagliflozin+metformin in Type 2 diabetes patients whose blood sugar level cannot be adequately controlled with metformin alone. The company applied for the approval of its combination drug to the MFDS based on the study results above. Dapagliflozin is the generic name of AstraZeneca’s SGLR-2 inhibitor, ‘Forxiga.’ The three DPP-4i+SGLT-2i combos currently available are all imported finished products. The products are Boehringer Ingelheim's ‘Esglito tab,’ AstraZeneca’s Qtern (saxagliptin monohydrate+ dapagliflozin propanediol hydrate),’ MSD’s ‘Steglujan (ertugliflozin l-pyroglutamic acid + sitagliptin phosphate hydrate). However, the products above have not been approved for insurance reimbursement, and therefore are not being sold fully in the market. However, reimbursement discussions on the drugs have made rapid progress recently, raising expectations that their prices will be listed soon. In fact, AstraZeneca had made joint marketing agreements for its Qtern with Ildong Pharmaceutical. Although no locally developed combo is available yet, DongKoo Bio applied for the approval of a citagliptin+ dapagliflozin combo in the first half of this year, raising the possibility that local products will also receive approval soon. Zemiglo is the 19th homegrown drug that was released in 2012. It recorded ₩35.9 billion in outpatient prescription sales last year. Zemiglo and ‘Zemimet,’ a combination of gemigliptin+metformin that recorded ₩79.9 billion last year, have been leading the domestic diabetes treatment market. The industry analysis is that a combination therapy that uses dapagliflozin will well show competitiveness in the market, as the market share of the gemigliptin ingredient is high in Korea's diabetes treatment market.
- Policy
- Will a recombinant flu vaccine be released in Korea, too?
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- The tetravalent flu vaccine supplied by Sanofi in Korea A gene recombinant influenza vaccine is expected to be released in Korea. Currently, flu vaccines made by using eggs or culturing cells are also on sale in Korea. The MFDS approved a phase 3 clinical trial plan for Sanofi's RIV4 vaccine on the 2nd. RIV4 is an abbreviation for Quardrivalent Recombinant Influenza Vaccine, which, in direct translation, is a quaternary recombinant influenza vaccine. This test is aimed at describing the immunogenicity and safety of quaternary recombinant influenza vaccines compared to quaternary inactivated influenza vaccines in 300 patients aged 18 or older in Korea. A tetravalent recombinant influenza vaccine has not yet been released in Korea. The recombinant influenza vaccine is a new concept vaccine that produces large quantities of antigen proteins cultured in plant-derived cells through gene recombination technology. The U.S. FDA approved Flublok developed by Protein Science in 2013, creating the first trivalent influenza vaccine. Sanofi acquired Protein Science for $650 million in 2017. In 2016, a quaternary recombinant protein vaccine developed by protein appeared, and in November last year, it was also approved by the European Commission. In the United States, the product name is Flublok, but in Europe it is called Supemtek. Sanofi is currently supplying a quaternary flu vaccine to Korea under the product name Vaxigriptetra. This product is a conventional inactivated vaccine using an oil well. So far, there are two types of tetravalent flu vaccines supplied in Korea: the oil well egg method and the cell culture method, and SK Bioscience's SKY Cellflu is a representative cell culture vaccine, and the rest are all fertile eggs vaccines. The quaternary recombinant influenza vaccine, which Sanofi conducts clinical trials in Korea, is known to have a higher preventive effect in the age group over 50s, including three times more antigens than those in oil fertilizer and cell culture vaccines. It is also an advantage that there are no vaccination restrictions on pregnant women or people with egg allergies. As Sanofi is also conducting clinical trials in Korea, industries predict that recombinant vaccines will be available as early as the 2022-2023 season. When a recombinant vaccine is released, the existing vaccine market structure is also expected to change.
- Company
- It is expected that the SGLT-2 combination will be activated
- by Eo, Yun-Ho Nov 08, 2021 05:52am
- Domestic approved SGLT-2 inhibitorsExpectations are also rising for revitalization of the combination drug market along with the expansion of combined benefits for the drug SGLT-inhibitors. According to related industries, pharmaceutical companies with SGLT-2 inhibitors and DPP-4 inhibitors, such as Beringer Ingelheim, AstraZeneca, and MSD, will go through the registration process of the complex when discussions on expanding the combined diabetes benefits are completed. However, it is expected that there will be differences in the actual registration speed due to the expiration of patents. ◆Esglito, co-developed by Beringer Ingelheim =Beringer Ingelheim and Lilly, is a combination of SGLT-2 inhibitor Jardiance and DPP-4 inhibitor Trajenta. Esglito was originally approved in Korea under the product name Glyxambi in 2017, but changed its product name at the beginning of this year. Currently, Jardiance has applied for an increase in benefit and is waiting for the HIRA's action. Beringer Ingelheim and Lilly's diabetes pipelines have been led by domestic promotion partners Yuhan Corporation. It remains to be seen whether Esglito will join Yuhan Corporation after the benefit issue has been resolved. ◆ AstraZeneca's Qtern= Unlike other complex, Qtern, combination of Forxiga (Dapagliflozin) and Onglyza (Saxagliptin) was launched in about four years. Ildong Pharmaceutical signed a domestic exclusive sales contract with AstraZeneca and began marketing and supply it in earnest from the 1st. Ildong Pharmaceutical is also expected to make decisions on Qtern if Forxiga's benefit is expanded. ◆MSD's Stegluzan=Stegluzan, combination of Steglatro and Januvia was released in October last year. MSD has also submitted an application for the expansion of Steglatro's combined benefits and is waiting for the HIRA's review. MSD plans to switch Stegluzan to release as soon as Stegluzan's benefit expansion is decided. A meeting of diabetes experts convened by the HIRA in September concluded in the direction of integrating and recognizing the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors. At the meeting, TZD-related drugs, which had cardiovascular side effects, were required to be judged by drug. Accordingly, prescription restrictions are expected to continue only for the combination of TZD. The HIRA is currently discussing the schedule for formal procedures, including the introduction of the Drug Reimbursement Evaluation Committee.
- Policy
- "Reference pricing will activate sales of generic drugs"
- by Lee, Jeong-Hwan Nov 08, 2021 05:51am
- A pharmacist-politician Seo Young-Seok of the Democratic Party of Korea criticized the generic drug policy failure of the government, saying that Korea should also aggressively implement the ‘reference pricing system’ used in the US and Europe to break collusive ties between doctors and drug companies and lead the generic policy system on the road to success. The basic notion is that the authorities should implement supply regulations to lower the price of generics while regulating the demand to encourage the increased use of cheaper generics and save NHI finances. Seo said that the pharmaceutical expenses can be drastically reduced by reducing the price of generics through reference pricing and profit control and drastically increasing the use amount through systems such as generic incentives for doctors and pharmacists’ generic substitution. On the 6th, Dailypharm analyzed the joint policy report ‘Suggestions on pharmaceutical policies’ that Seo published with a social co-op ‘GungangBut.’ In the report, Seo said that as of 2019, the finished product market accounts for 19.8 trillion won’s worth of the 22.3 trillion won domestic pharmaceutical industry (finished·API drugs). In particular, only 1.7% of the domestic pharmaceutical companies that manufacture finished products produced more than 500 billion won’s worth of products, and the most, 31.9%, produced less than 1 billion, followed by 20.1% that produced 10 billion to 50 billion won’s worth of products. Seo believes that generics can be the source for reducing NHI finances as it has a lower price with the same efficacy. In this sense, Seo stressed that supply-side regulations that set the price of generic drugs as low as possible, as well as demand-side regulations that encourage the use of inexpensive generic drugs, should be implemented together. For this, Seo said that a mechanism in which a lower price ensures market share is essential for market competition between generic developers to work and encourage pricing competition between the companies. More specifically, Seo asked the government to impose demand regulations so that products that voluntarily cut prices are used in the market instead of the current supply regulations that set generics’ prices in the order of entry. Under the current structure, the lowest-priced generic drugs are not used much because the doctors prescribe a drug from a specific pharmaceutical company regardless of the price level. “The reality is that it is more advantageous for the pharmaceutical companies to maintain their high drug price and give rebates to doctors rather than lower their drug prices. This is why there is no pricing competition between generics, and no health insurance savings are taking place.” As a solution, Seo proposed using the reference pricing system as a policy to reduce NHI expenditures by activating the use of generics. The reference pricing system refers to a system in which a certain reimbursement level is set for all drugs with the same efficacy and that level of the drug price is covered by NHI finances, while the patient bears the difference in high-priced drugs that exceed this. To implement the reference pricing system, Seo said we would first need to establish a decision-making system that goes from doctor's prescriptions - pharmacist's generic substitution and information provision - patient’s information acceptance and selection. She pointed to various reasons such as low trust in generic drugs, quality distrust about low-priced drugs, and infringement of doctors' prescriptions’ rights as to why the generic drug policies have failed and financial savings are not being achieved due. If the reference pricing system is implemented, patients will be prescribed drugs in need regardless of brand or ingredient name, and pharmacists will be required to provide generic substitutions, and patients will be given pricing information based on the reference price. Seo also said that the reference pricing system allows patients to express their opinion in choosing their prescription drugs, and pay an additional fee when choosing a drug that exceeds the reference price or receives an incentive of paying no out-of-pocket cost when choosing a drug below the reference price. “The reference pricing system will ultimately allow the government to reduce NHI finances by inducing pricing competition by breaking collusive ties between doctors and pharmaceutical companies and activating the use of drugs that are priced at the reference price level. It also has the advantage of preventing the mushrooming of generics, regaining the public’s trust, and providing an opportunity to make patient-focused decisions," said Seo. Seo added, “We can also expect the system to eradicate negative pharmaceutical sales activities and contribute to diversifying the domestic industry that is currently focused on generic production without competition. Also, the system will allow Korea to achieve substantiality by diversifying and enriching the industry with R&D-focused companies and generic companies.
- Policy
- Will RWD drive accessibility to ultra-high-priced drugs?
- by Kim, Jung-Ju Nov 08, 2021 05:51am
- Korea’s RSA system is moving to become more of a performance-based mechanism rather than a finance-based system. Performance-based RSA means that the system will be using real-world data (RWD) from clinical practice as real-world evidence (RWE). Ultra-high-priced drugs like Kymriah inj. (tisagenlecleucel) have had difficulties in reimbursement, and the government's RSA expansion attempt may be an important tool that can increase patient accessibility. Ji-Hye Byun (Ph.D. in Social Pharmacy), Head of Evidence-based research at the Health Insurance Review & Assessment Service, presented on ‘Plans for reimbursement management in Korea, including pharmaceuticals using RWD, etc’ at the Innovation Research Symposium, ‘Establishing measures for RWD collection to manage pharmaceutical reimbursement management,' that was hosted by HIRA today (4th). Innovative anticancer therapies like Kymriah are ultra-high-priced drugs with much demand for prompt listing from patients and requests for high prices from pharmaceutical companies. The insurance authorities are having difficulty allowing reimbursement for these innovative drugs that have an ultra-high price despite uncertainties in their effectiveness, safety, and cost-effectiveness. This issue is not just a concern for Korea alone, as the trend in new drug development now turned to focus on high-priced drugs that innovatively treat rare diseases. Advanced countries in insurance or new drug development have also been facing the same issue and pursuing the use of RWD to suit each country. According to ‘The UK’s integrated management and use of RWD (Current and future role of RWE in NICE)' that was presented by the copresenter, Jihyung Hong, Professor of College of Social Science at Gacheon University, the UK has been rapidly reinforcing the state-led data integrated system. Patient accessibility to anticancer drugs or rare disease drugs that have a high uncertainty has been reinforced through the "Managed Access Scheme (MAA)" during which additional data (including RWE) are collected. Under the Cancer Drug Fund (CDF), a separate fund for high-priced anticancer drugs, NHS England and pharmaceutical companies collect additional data to agree upon the details on reimbursement. The reimbursement level and degree of uncertainty collected in over 2 years of managed access are used as a basis to conduct further reassessment, based on which NICE will decide on whether to make a final recommendation. In France, reimbursement for rare disease drugs that have uncertain clinical grounds is not deliberated immediately, but applied a temporary use system ‘ATU,’ and allowed conditional use upon reassessment. The UK, France, Germany, Italy, and Spain are all using RWE to resolve the uncertainty in the decision-making process for Kymriah. Spain uses an RWD (patient registration) system that it established that considers the ‘post-marketing safety-economic evaluation analysis.’ In Korea, HIRA has also been operating an expert advisory council since 2019 and had studied RWD cases in partnership with the Korean Cancer Study Group in the process. Another co-presenter and KCSG president, Professor Dae Young Zang (Division of Hematology-Oncology, Hallym University), presented on the ‘Study on efficacy and safety of gastric cancer drugs using electronic medical records (EMR),’ on the RWD items of ramucirumab (Cyrmanza). As such, Korea is also seeking to manage the whole lifecycle of reimbursed drugs using RWE. RWE is a viable alternative that can overcome the limitations of the current system, including the fact that there is no cost-effectiveness benefit management mechanism for applying results that have changed since reimbursement, lacks data collection suited to the purpose of collecting clinical data for HTA (economic feasibility assessment), and the fact that reassessment will only take place after a certain period passes after the submission due to prospective data collection based on reimbursement notices. During the presentation, Byun proposed several measures for systematically managing reimbursed drugs using RWD. One key example was using an RSA system based on patient unit performance. Korea is currently using an RSA mechanism that is overwhelmingly focused on finances when reimbursing high-priced drugs. The main point of a performance-based RSA that uses RWD is in that the pharmaceutical company's responsibility increases with the high price of its drugs in order for the authorities to meet the continued challenge of reimbursing ultra-high-priced drugs with limited finances.
- Company
- K-Rare Disease Drug Hunterase that is more popular overseas
- by Chon, Seung-Hyun Nov 08, 2021 05:51am
- Hunterase, developed by GC Pharma, is speeding up its efforts to target global markets. It is successful as a treatment for rare diseases developed in Korea, generating more than three times more sales than domestic demand in overseas markets. According to GC Pharma on the 4th, Hunterase's sales rose 77.7% year-on-year to 23.1 billion won in the third quarter. It more than doubled from 11 billion won in the previous quarter. In the third quarter of this year, cumulative sales jumped 63.9% year-on-year to 47.2 billion won. Sales exceeded 46.2 billion won recorded over the past year. Hunterase, which was approved in Korea in 2012, is the world's second treatment for Hunter syndrome. Hunter syndrome, called Mucopolysaccharidosis type II, is a rare disease known to occur in the remaining 100,000 to 150,000 people. Hunter syndrome, a congenital metabolic abnormality disease, is a genetic disease that shows unpredictable symptoms such as skeletal abnormalities and decreased intelligence, but dies early around the age of 15 in severe cases. The number of patients in Korea is only about 70 to 80. Hunterase's recent steep growth is based on a high rise in overseas markets. Hunterase's export performance in the third quarter was 17.4 billion won, more than doubling from 7.8 billion won in the same period last year. It tripled in one quarter from 5.8 billion won in the previous quarter. Hunterase's domestic sales in the third quarter rose 9.6% year-on-year to 5.7 billion won, which means that it has realized a significant growth in overseas markets. Exports accounted for 75.3% of Hunterase's third-quarter sales. The company explained, "The use of Hunterase abroad has increased significantly and demand has soared in Russia." Hunterase is on sale in 14 foreign countries, including Russia, Egypt, Turkey, and Brazil. It is analyzed that Hunterase's competitive drugs are not many, and that it is recording stable sales growth due to the characteristics of rare disease treatments that are expensive and must be administered for a lifetime. Prior to the appearance of Hunterase, Eleapase was the only treatment. GC Pharma is also speeding up Hunterase's entry into the Asian market. In October last year, it obtained an item license for Hunterase from the NMPA. Earlier this year, it received permission for Hunterase ICV items from the MHLW. Hunterase ICV is a new formulation that inserts a device into the head and administers the drug directly to the ventricle. It has the advantage of overcoming the limitations of existing intravenous formulations that do not improve symptoms of intelligence degradation because drugs cannot penetrate the cerebrovascular barrier (BBB). China's licensed item is a Hunterase intravenous injection (IV) formulation, and the market preoccupation effect is expected in that there was no previously approved Mucopolysaccharidosis type II treatment in China. It is predicted that it will serve as a catalyst for overseas sales growth as it starts selling to China and Japan, which have large markets.
- Policy
- The introduction of a double price system is empty talk
- by Lee, Jeong-Hwan Nov 08, 2021 05:51am
- When the government responded that it was introducing a double price system instead of opposing the National Assembly's criticism that incentives such as exclusion and suspension of PVA should be given to new domestic drugs, the domestic pharmaceutical industry negatively evaluated it as an "empty talk-style administration." Critics say that PVA has virtually no complementarity and that there are no cases of new domestic drugs that benefit from the double price system. On the 2nd, the domestic pharmaceutical industry is disappointed with the MOHW's position on the issue of "Exclusion and Suspension of New Drugs for Development of Innovative Pharmaceutical Companies," which has become a hot topic during this year's parliamentary audit. Multiple domestic pharmaceutical companies that have domestic new drugs or are about to be released in the future in the development stage are in a position to minimize cases in which domestic new drugs receive reverse discrimination from global new drugs. PVA should reflect the specificity of domestic new drugs that complete the sequential lineup with years of R&D investment after electing the most marketable or fastest-to-market indications. When the health insurance authorities, led by the MOHW, answered that they were already implementing a double price system to support exports of new domestic drugs or innovative pharmaceutical drugs, the domestic pharmaceutical community criticized, saying, "It is a rigid attitude." In particular, the National Health Insurance Service said, "There are many cases in which PVA drug prices have been lowered consecutively for multinational companies other than domestic pharmaceutical companies." When he replied, "There is no reverse discrimination," Korean companies countered, "It is a generalization error of simple statistics." The intention is that it is meaningless to simply compare the number of consecutive PV negotiations with the reverse discrimination of domestic new drugs that actually contributed to reducing health insurance finances. In particular, he pointed out the government's position that domestic companies are supporting domestic new drugs through a double price system instead of PVA incentives. The PVA incentive is a policy for domestic new drugs to grow successfully in the domestic pharmaceutical market, and the government has pushed for a double price system that has no impact on the domestic market. HK inno.N's K-CAB is the only drug currently implementing the double price system, and MA officials in Korea say that most of the new domestic drugs and new domestic drugs to be developed and released are unlikely to benefit from the double price system. They also said that the double price system is not a huge preferential treatment or incentive system because it has to maintain the existing drug price and return the drug price through post-settlement, but there is also administrative work necessary for it. Critics say that the double price system is actually a "nothing burger" for a new domestic drug that has to make profits in the domestic market unless it is a new domestic drug developed for overseas exports. An official from Company A, who owns a new domestic drug, said, "The double price system requires administrative work for both the industrial complex and the pharmaceutical company. In particular, it is a system that does not require applying for a double price system for new domestic drugs, where the domestic market is important, he said. "This is a representative case in which Kanarb quit in the middle because there was no real benefit after implementing the double price system. In the end, there is no double price drug other than K-CAB," he pointed out. An official from Company A said, "PVA incentives are policies for the domestic market, but seeing that they are suddenly pushing for a double price system and supporting new domestic drugs, I felt that it was an inevitable repetition of empty talk." He criticized, "If it is difficult to exclude or suspend PVA, other alternative methods should have been devised, so the double price system is out of the blue."
