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- 2025-12-22 04:52:52
- Policy
- Insurance price ceiling reeval negotiations to end on Aug 18
- by Lee, Tak-Sun Aug 09, 2023 05:49am
- The pricing negotiations for items subject to revaluations of their insurance price ceiling in Korea are taking place from the 4th to the 18th of this month. The negotiations are expected to be completed within the deadline as the National Health Insurance Service has been discussing the measures with pharmaceutical companies in advance. Therefore, the adjusted drug price will be announced on the 1st of next month after the results of the negotiations are reported to the Health Insurance Policy Deliberation Committee at the end of this month. According to the NHIS on the 8th, the Ministry of Health and Welfare issued a negotiation order on a total of 12,800 items by 206 companies that received insurance price ceiling reevaluations. Although 16,000 items were known to have received reevaluations, items that had already completed negotiations and were adjusted accordingly were excluded from the negotiations. The Generic Drug Division of the Pharmaceutical Benefits Department of NHIS plans to divide the companies subject to negotiation into 3 types and complete the negotiations by the 18th. HIRA had received data from pharmaceutical companies until last February and conducted a re-evaluation on the price ceiling of subject drugs. The first results were released in May after the results were reviewed by the Drug Reimbursement Evaluation Committee. After the results of the first evaluation were released, companies filed objections on 1,300 items, and the review results of the objections were finally deliberated by DREC on the 3rd. Afterward, HIRA transferred the results of the re-evaluation to NHIS. The NHIS had held discussions in advance with pharmaceutical companies before the main negotiations since last April and agreed on most of the terms of the negotiations. An NHIS corporation explained, "The pharmaceutical companies cooperated well with the NHIS during the preliminary discussion period and there seems to be no problem in completing the negotiations as scheduled." The reevaluation of the insurance price ceiling has been in progress to maintain or lower the upper limit set for insured drugs depending on whether or not the listed drugs meet the criteria for bioequivalence tests and DMF listing. Drugs that satisfy both requirements – DMF and self-bioequivalence tests – can maintain their price as is, and the price of those that only meet one of the requirements is adjusted to 85%, and those that meet none are adjusted to 72.25% of the previous price. Meanwhile, the 5,000 drugs subject to the second round of reevaluations by NHIS also submitted their data last month, and their review is expected to begin soon.
- Policy
- When will domestic COVID-19 Txs be officially approved?
- by Lee, Hye-Kyung Aug 08, 2023 05:30am
- Voices calling for the approval of domestic COVID-19 treatments are rising. Petitions and heated discussions are being made on the free bulletin board of the Ministry of Food and Drug Safety’s website for the marketing authorization and accelerated review of homegrown COVID-19 treatments. The items that are receiving attention on the yay or nay of approvals are Ildong Pharmaceutical’s ‘Xocova (ensitrelvir)’ and Hyundai Bioscience’s ‘Xafty.’ Xocova was developed by Japan’s Shionogi Pharmaceutical. Ildong Pharmaceutical conducted a domestic clinical trial for the drug. The drug was unable to receive EUA in Korea last year, and the company applied for official marketing authorization for the drug in January this year. However, 8 months have passed and the drug has not even been designated as a subject for expedited review until now. On this, an MFDS official said, "It is difficult to disclose specifics on why a certain drug’s EUA review is being delayed. In some cases, the pharmaceutical company is unable to make follow-up measures after the MFDS gives feedback like insufficient supplementary data after primary review. The reason may differ by individual drug.” In the case of Xafty, a new drug candidate for COVID-19, Hyundai Bioscience submitted the results of its Phase II trial on Xafty to the Korea Disease Control and Prevention Agency in April to request emergency use approval. According to Hyundai Bioscience, in a Phase II trial conducted on 300 patients, Xafty reduced the time to improvement of COVID-19 symptoms by 4 days compared with the placebo. In particular, the company stressed that niclosamide, the main active ingredient of Xafty, has a verified profile as it has been used as an insect repellent for 60 years around the world. Xocova applied for marketing authorization in January and and Xafty for EUA in April. With their results still unknown, voices urging for results have been rising through public petitions and MFDS’s online bulletin board. One person said, “It has been 6 months since Xocova applied for approval, and 3 months since the start of the EUA review for Xafty has started. Why hasn’t the government decided upon their approval or non-approval still? We’re talking about the same authorities that approved Paxlovid in only 7 days.” Another person wrote, "3 months have passed since the drug’s Phase II trial was completed, and the drug has not been granted the EUA still. This is contrary to the purpose of granting EUAs.” Another added, "It is ironic that we seek to become a pharmaceutical powerhouse with pharmaceutical sovereignty in this state. What is the reason for the delay in approval?”
- Policy
- The price of 6 items of Choline alfoscerate is cut
- by Lee, Tak-Sun Aug 08, 2023 05:30am
- Despite the government's decision to limit reimbursement, the brain function-improving drug Choline Alfoscerate continues to come out with price cuts due to increased usage. It was found that 6 Choline Alfoscerate items were included in the PVA type Da negotiations this year as well. According to the industry on the 7th, negotiations were conducted as Gliatamin drugs such as Gliatamin were included in the Type Da target this year. Choline Alfoscerate ingredient items that have been negotiated are Ahn-gook Kanoa Soft Cap., Korea Prime Pharmaceuticals Gria Soft, Daewoong Bio Gliatamine Soft Cap, and Gliatamine. They negotiated for the number of claims in 2022 to exceed the PVA Type Da standard. Criteria for each type is when the claim amount for the calculated drug increased by 60% or more from the previous year's claim amount or increased by 10% or more and the increase amount was 5 billion won or more. In the case of Ahn-gook Kanoa, the number of outpatient prescriptions based on UBIST was 6.8 billion won in 2022, up 68% from the previous year, Korea Prime Pharm. Gria’s sales were 29 billion won, up 17% from the previous year, and Daewoong Bio Gliatamin’s sales increased by 5% to 115.6 billion won. Kanoa and Gliatamine had their drug prices reduced last year as PVA. The use of Choline alfoscerate continues to increase despite the decision to reduce benefits in 2020. In September 2020, the government decided to allow reimbursement for Choline Alfoscerate drugs only for dementia patients and apply selective reimbursement by applying 80% patient copayment for the remaining indications. Specifically, 'secondary symptoms and degenerative or degenerative brain organic mental syndrome due to cerebrovascular defects: memory loss and confusion, disorientation due to decreased motivation and spontaneity, decreased motivation and spontaneity, and decreased concentration' in patients diagnosed with dementia It was agreed that reimbursement would be recognized for administration and 80% patient copayment would be applied to prescriptions other than the accreditation standards. The implementation has been suspended as related pharmaceutical companies filed lawsuits for suspension of execution and cancellation of benefit reduction. Since then, even the indications have been reduced in the process of clinical re-evaluation planning, but the amount of prescriptions in the field has not decreased. Even last year, the Choline Alfoscerate preparation Chongkundang Gliatirin Soft Cap. 10 items, including original drugs, were included in the PVA target, and the drug price was reduced.
- Policy
- Cough Syrup and Synatura Syrup complete PVA negotiations
- by Lee, Tak-Sun Aug 08, 2023 05:30am
- Respiratory drugs such as Cough Syrup and Synatrua Syrup were found to have been added as subjects for drug pricing negotiations under the Price-Volume Agreement (PVA) this year. The use of the items had increased significantly last year due to the sharp increase in confirmed COVID-19 cases last year. According to industry sources on the 7th, the National Health Insurance Service added 134 items and updated the list of drugs that completed drug pricing negotiations as ‘Type C PVA drugs’ recently. Previously, the number of items subject to PVA Type C negotiations this time was known to be 138, and a similar number of items had been added to the list as those that completed negotiations as of July 31st. Among the added items, antitussive expectorants, antibiotics, and antivirals stand out as the use of the drugs was presumed to have increased due to the increase in confirmed COVID-19 cases last year. Specifically, the drugs include Yuhan Corp’s ‘Cough Syrup,’ Daewon Pharmaceutical’s ‘Codaewon Forte Syrup,’ Ahngook Pharm’s ‘Synatrua Syrup,’ Hanmi Pharm’s ‘Cossac-L Tab,’ Hanwha Pharma’s ‘Muteran Cap. 200mg,’ Korea United Pharm’s ‘Kalomin Tab And Kalomin S Tab.’ According to UBIST, outpatient prescriptions of the Cough Syrup had increased 111% YoY to record ‘KRW 26.7 billion’ last year. Prescriptions of Codaewon Forte Syrup had also increased 88% YoY to reach KRW 21.6 billion, and Synatrua Syrup by 96% to record KRW 35 billion. Prescriptions of Cossac-L Tab increased by 121% to reach KRW 5.6 billion. Prescriptions of major items increased by around 100%, and the dominant analysis in the industry is that this is because prescriptions for respiratory drugs, such as antitussive expectorants and antibiotics increased significantly with the rise of confirmed COVID-19 patients last year. Drugs are subject to drug pricing negotiations as Type C of the PVA if its claims amount of a drug increases by over 60%, or by 10% but the increased amount exceeds KRW 5 billion. Therefore, drugs whose claims have increased by around 100% due to the influence of COVID-19 were highly likely to be included in the PVA negotiations and subject to price cuts. Regarding the issue, the pharmacuetical industry insisted that drugs whose use increased due to COVID-19 should be excluded from PVA negotiations, and the health authorities partially accepted this claim and decided to adjust the use amount of drugs related to COVID-19. For example, the government prepared a correction formula that excludes the 10 months last year when the number of COVID-19 patients surged and converts the claims amount of the 2 remaining months into 12 months to compare with the claims amount of the previous year. As a result, the use amount of 36 items of the same product group was corrected and completed negotiations with the NHIS. In addition to respiratory drugs, blockbuster drugs used to treat chronic conditions such as Boryung’s ‘Dukarb Tab,’ Hanmi Pharm’s ‘Rosuzet Tab,’ Chong Kun Dang’s ‘Telminuvo Tab,’ and AstraZeneca’s ‘Xigduo XR Tab’ were also found to have completed negotiations this time.
- Policy
- Paxlovid and Dong-A’s Diosmin Powder were approved in July
- by Lee, Hye-Kyung Aug 07, 2023 05:23am
- The number of prescription drug approvals decreased significantly in July. The approvals, which had continuously increased from 70 in May to 93 in June, had fallen to record 29 in July. However, the drugs approved were nevertheless as significant as Pfizer Korea’s COVID-19 treatment ‘Paxlovid (nirmatrelvir, ritonavir)’, which had first been introduced to Korea through the EUA (emergency use authorization) during the COVID-19 outbreak, received formal approval as a new drug in Korea, and the Takeda-developed Celltrion-owned ‘Alo Gliptinpio Tab’ was approved for export. Drugs Approved in 2023 In July, a total of 76 drugs were approved by the Ministry of Food and Drug Safety. Compared to the previous month, the ETC approvals were reduced by 64, and OTC approvals increased to 47 and exceeded the number of ETC approvals. ◆OTC drugs== A total of 47 over-the-counter drugs were approved (registered) in July. Among those, 3 were data submission drugs(incrementally modified drugs, IMDs), which are modified versions of existing drugs that underwent safety and efficacy reviews due to changes in ingredient, salt base, or dosage form. OTCs approved in July KyungDong Pharma’s Gnal-N Ace Soft Cap (IMD, approved on July 12) Gnal-N is the first product that made KyungDong Pharm, a pharmaceutical company that had previously been focused on clinical areas, familiar to the public. The Gnal-N series was first released in 2009 with the ibuprofen combo ‘Gnal-N Tab,’ followed by ‘Gnal-N Q Tab', ‘Gnal-N Nose Soft Cap, ‘Gnal-N Cold Soft Cap,’ ‘Gnal-N Cough Soft Cap,’ ‘Gnal-N Nose Plus Soft Cap.’ The company received additional approval for ‘Gnal-N Ace Soft Cap’ which contains a combination of acetaminophen and riboflavin on July 12, and increased its Gnal-N product line-up to 13. Gnal-N Ace Soft Cap is indicated for headache, toothache, pain after tooth extraction, sore throat, ear pain, joint pain, neuralgia, back pain, muscle pain, shoulder pain (stiff shoulder), bruise pain, fracture pain, sprain pain, menstrual pain. analgesia of traumatic pain, chills, and fever. Dong-A Pharmaceutical’s Dong-A Pharm Diosmin Suspension Powder (IMD, approved on July 18) Dong-A Pharmaceutical will soon be releasing its approved ‘Dong-A Pharm Diosmin Suspension Powder’ that offers improved convenience in intake to pharmacies in Korea. Each packet of the drug contains diosmin 600mg that can be dissolved into water for intake. It is indicated to improve symptoms related to venous insufficiency (leg heaviness, pain), as supplementary treatment for disorders caused by capillary fragility, and treatment of symptoms related to hemorrhoids. It will be released to pharmacies as a box with 10 packets. Meanwhile, latecomers such as Dong-A Pharmaceutical, Hanmi Pharm, Chodang Pharm, and Samjin Pharm have increased their presence in the diosmin market by releasing high-dose oral hemorrhoids treatments one after another. Dong-A Pharmaceutical's annual sales of Diomax Tab doubled from KRW 500 million in 2020 to KRW 1 billion in 2021, based on IQVIA data. Last year, Diomax posted sales of KRW 1.1 billion, occupying 48% of the market the high-dose (600mg) oral hemorrhoids treatment market. ETCs approved in July ◆ETC=Two new prescription drugs were approved in July. 14 data submission drugs and 13 generics and others were also approved the same month. Celltrion’s ‘Celltrion Alo Gliptinpio Tab 25·15mg, 25·30mg (for export, Approved on July 6 and 7) Celltrion received approval for Celltrion Alo Gliptinpio Tab 25·15mg, and 25·30mg for export on July 6 and 7, respectively. The drug is a new combination made by the company using its rights for ‘Nesina' and 'Actos', which it acquired from the Japanese pharmaceutical company Takeda Pharmaceuticals. Takeda Pharmaceuticals had been directly selling Nesina in Korea until 2020, but in December 2020, it sold all rights, including sales rights and patents, of 12 ETC drug brands and 6 OTC drugs in 9 Asia-Pacific countries to Celltrion Pharm to adjust the size of its debt. I did. Alogliptin and pioglitazone can help patients control blood sugar levels, and patients with Type 2 diabetes can take them to control blood sugar along with diet and exercise. Since last year, Celltrion Pharm has been strengthening its product lineup receiving approval for drugs to export overseas. Sanofi-Aventis Korea’s Enjaymo Inj (new drug, Approved on July 12) Sanofi’s ‘Enjaymo Inj,’ which is indicated to treat adults with cold agglutinin disease (CAD), was also recently approved in Korea. The drug is used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD), which is a form of autoimmune hemolytic anemia (AIHA), CAD is a rare type of autoimmune hemolytic anemia caused when antibodies called cold agglutinins bind to the surface of red blood cells. When cold agglutinins bind to the surface of red blood cells, the body's immune system mistakenly attacks and destroys healthy red blood cells. Pfizer Korea’s Paxlovid Tab (new drug, Approved on July 14) Pfizer Korea’s ‘Paxlovid,’ which was first introduced in Korea through the emergency use authorization (EAU) track during the spread of COVID-19, received official approval in Korea. Paxlovid was granted EAU by the MFDS on December 27, 2021, the same year the number of confirmed and seriously ill patients with COVID-19 surged and the Omicron variant spread, raising the need for an oral treatment for COVID-19. It has been formally approved as a prescription drug 1 year and 7 months after its introduction to Korea. Patients who take Paxlovid take two tablets at the same time. Nirmatrelvir blocks protease (3CL protease) to prevent the production of proteins necessary for viral replication, thereby inhibiting the proliferation of the virus, and ritonavir inhibits the enzyme (CYP3A4) that breaks down nirmatrelvir, extending its duration of effect. After a careful review of the results of the Phase III clinical trial (therapeutic confirmatory trial) conducted on adult patients, the drug was officially approved in Korea in accordance with the 'Pharmaceutical Affairs Act,’ The EAU for Paxlovid, which has allowed patients to use the drug free of charge, will remain in place as is.
- Policy
- Sotyktu, the world's first TYK2I, received domestic approval
- by Lee, Hye-Kyung Aug 04, 2023 05:38am
- The Ministry of Food and Drug Safety (Minister Oh Yoo-Kyung) approved BMS Korea's new plaque psoriasis drug 'Sotyktu 6mg' on the 3rd. Psoriasis is a chronic skin disease caused by immune abnormalities, and plaque psoriasis is the most common form. Sotyktu treats psoriasis by selectively inhibiting 'tyrosine kinase-2 (TYK2)' receptors related to inflammation and immune response by oral administration. The drug was approved by the US FDA in 2022 for use in adult patients with moderate to severe psoriasis who require systemic therapy or phototherapy. Sotyktu is the world's first and only TYK2 inhibitor approved for use and is the first oral drug available for moderate to severe psoriasis in 10 years. It is based on the comparative phase 3 POETYK PSO-1 and POETYK PSO-2 studies. This drug confirmed improved efficacy at 16 and 24 weeks after administration compared to the placebo and Otezla, and the clinical efficacy was found to last up to 52 weeks. This drug is expected to provide a new treatment opportunity for adult patients with moderate to severe plaque psoriasis who require phototherapy or systemic treatment. The Ministry of Food and Drug Safety said it would continue to do its best to expand treatment opportunities for patients by promptly supplying treatments whose safety and efficacy have been sufficiently confirmed based on regulatory science expertise.
- Policy
- Cancer immunotherapy Jemperli passes DREC review
- by Kim, Jung-Ju Aug 04, 2023 05:38am
- Jemperli GSK Korea’s immno-oncology latecomer drug ‘Jemperli (dostarlimab)’ has passed its first step to reimbursement in Korea. On the other hand, Koselugo (selumetinib), AstraZeneca’s new drug for pediatric patients with neurofibromatosis type 1 (NF1), received a redicussion decision, warning of a bumpy journey ahead. The Health Insurance Review and Assessment Service held its 8th 2023 Drug Reimbursement Evaluation Committee meeting and deliberated on the adequacy of reimbursement of 6 new drugs and made the decisions above. New drugs that were deliberated and deemed eligible for reimbursement include Jemperli and Ono Pharma Korea’s BRAF inhibitor for colorectal cancer, ‘Bratovi Capsule 75mg (encorafenib)’, and Roche Korea’s treatment for adult patients with neuromyelitis optica spectrum disorder (NMOSD), ‘Enspryng Prefilled Syringe (satralizumab)'. Among the drugs, Jemperli is the first drug in its class to be approved to treat adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) that has progressed on or following a prior platinum-containing regimen. BMS Korea’s ‘Zeposia Capsule 0.92mg‘ and ‘Zeposia Capsule Starter Pack 0.23mg/0.46mg (ozanimod hydrochloride) received a ‘conditional approval,’ allowing the drugs to proceed on to drug pricing negotiations with the National Health Insurance Service if the company accepts a price below the evaluated amount. These new drugs are indicated to treat moderate-to-severe ulcerative colitis (UC). AstraZeneca Korea’s Koselugo Capsule 10,25mg (selumetinib hydrogen sulfate) received a rediscussion decision. The drug is indicated to treat NF1 accompanied by plexiform neurofibroma, Koselugo had received a non-reimbursement decision by DREC in March last year, but attention had been rising on the possibility of it passing DREC review this time as the company immediately submitted supplementary data thereafter in May and a risk-sharing proposal this time. Although DREC did not decide to non-reimburse the drug this time, the industry predicts that it would take some time for Koselugo to receive reimbursement as DREC has temporarily postponed making a reimbursement decision on the drug. On the other hand, BMS Korea’s Reblozyl Inj 25,75mg (luspatercept) received a non-reimbursement decision. Reblozyl was designated an orphan drug in 2021 in Korea and is used to treat ▲ myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) and ▲anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.
- Policy
- Animal drugs can be manufactured at human drug factories
- by Kang, Shin-Kook Aug 03, 2023 05:35am
- The manufacture of veterinary drugs are now allowed at manufacturing facilities that manufacture human drugs. The Ministry of Agriculture, Food and Rural Affairs recently announced the legislation of an amendment to the ‘Decree on the Facility Standards for Veterinary Pharmacies and Manufacturers, Importers, and Retailers of Veterinary Drugs’ and will be collecting industry opinion until September 4th. According to the amendment, in order to minimize the impact on the existing industry, the products that can be manufactured at human drug manufacturing facilities are limited to those for companion animals. In addition, among the active pharmaceutical ingredients that have been approved for human use in Korea, those that have not been approved for animal use before August 31, 2023, can be manufactured until the expiry date. However, 22 ingredients that have been approved for both human and veterinary use are allowed for use in manufacturing drugs for companion animals. The amendment will take effect immediately after promulgation. The Ministry of Agriculture and Food and Rural Affairs said, "We seek to ease the burden of redundant investment that is required for the establishment of a separate manufacturing facility for veterinary drugs by enabling human drug manufacturers to produce drugs for companion animals using existing facilities." The goal of the amendment is to develop and produce high-value-added veterinary drugs and grow the domestic veterinary drug industry qualitatively and quantitatively through coexistence with existing veterinary drug manufacturers.”
- Policy
- Countdown to the Prime Minister’s Biohealth Committee
- by Lee, Jeong-Hwan Aug 03, 2023 05:35am
- Expected to be completed before the regular session of the National Assembly this year. The work of establishing a pan-governmental control tower dedicated to fostering Korea’s biopharmaceutical and healthcare industries has entered the countdown. The Ministry of Health and Welfare, along with the Office of the Prime Minister, plans to revise the order for the establishment of the Biohealth Innovation Committee in the near future. Although the specific schedule has not been disclosed to the outside world, the National Assembly and the pharmaceutical industry expect that the order will be completed by the time the regular National Assembly opens this year in September and October. On the 2nd, an official from the Ministry of Health and Welfare explained, "We plan to complete the establishment of the Biohealth Innovation Committee as soon as possible through the revision of the directive rather than legislation." The domestic pharmaceutical industry, led by the Korea Pharmaceutical Bio Association, has repeatedly requested the government to establish a Pharmaceutical Bio Innovation Committee directly under the President's Office. During the presidential election, President Yoon Seok-yeol pledged to become a member of the Pharmaceutical and Bio-Innovation Committee directly under the president, and after the inauguration of the new government, he put forward a plan to establish a new organization under the Prime Minister. Jeong-suk Seo also proposed a bill that the Pharmaceutical Bio Innovation Committee, chaired by the Prime Minister, serves as an industrial control tower. However, the establishment of the Biopharmaceutical Innovation Committee is promoted not by legislation, but by the revision of the Prime Minister's Office order, and the scope was also determined to target the 'bio health' industry, not just the 'pharmaceutical bio' industry. Accordingly, the name of the organization to be established by the revision of the directive is also expected to be the Biohealth Innovation Committee. This is in line with the attitude the Ministry of Health and Welfare showed in the process of reviewing the National Assembly's Health and Welfare Committee's proposal for Seo Jeong-sook. At the time, the Ministry of Health and Welfare expressed the view that an organization was needed to nurture a wider range of areas, such as medical devices and digital healthcare, in addition to the biopharmaceutical industry, regarding the provision of 'upgrading under the Prime Minister's Office of the Pharmaceutical and Bio-Industry Innovation Committee' contained in the bill of Congressman Seo Jung-sook. The external and internal structure of the BioHealth Innovation Committee, which will be newly organized by the Yoon Seok-yeol administration, can be predicted in detail only when the revised order is released. An official from the National Assembly's Welfare Committee said, "The Ministry of Health and Welfare has expressed its position to create a biopharmaceutical innovation committee by revising the Prime Minister's Office directive without legislation, and the outline will be revealed sooner or later." It may not be necessary, but it remains to be seen whether the effectiveness will be equal."
- Policy
- MOHW ‘Cannnot defer price cuts made under PVA'
- by Lee, Jeong-Hwan Aug 02, 2023 05:25am
- The government has once again put its foot down and opposed to the request made by the pharmaceutical industry and the National Assembly to postpone drug price cuts applied under the Price-Volume Agreement (PVA) system until the exchange rate and prices stabilize. The government also added that it is working on an improvement plan for the drug pricing system that includes a preferential drug pricing policy for homegrown new drugs or preferential drug prices for drugs using domestic APIs. On the 1st, the Ministry of Health and Welfare announced so through the ‘Report on the 2022 National Audit Results Correction and Processing Requirements'. The MOHW again expressed the opinion that a careful review is required to postpone the application of the PVA system. The reason was that for drugs whose use rises temporarily due to treatment of an infectious disease such as COVID-19 or where normal supply was not procured in the previous year due to problems with production facilities or API supply, etc., the authorities are already adjusting the negotiation reference price in comprehensive consideration of each drug’s supply and demand situation and their direct affect on NHI finances. The government added, if a volume-related issue arises due to an exceptional situation, the authorities are already reasonably adjusting the price according to the situation, therefore application of the PVA system does not need to be postponed. Regarding the criticism that the PVA system hinders cooperation between domestic pharmaceutical companies and global pharmaceutical companies for the development of innovative new drugs, the MOHW said it would come up with an improvement plan. The MOHW said, “Since these exceptional circumstances are being reflected in the negotiations, a careful review is required on temporarily suspending the system until the exchange rate or price level stabilizes. We will prepare a policy improvement plan based on the policy research service organized by NHIS and operate a public-private consultative body to come up with measures to improve policies.” Regarding preferential drug pricing for drugs developed by innovative pharmaceutical companies or pharmaceutical companies that produce and develop raw materials in Korea, the MOHW briefly replied, “We are preparing a policy.” The MOHW explained that it is reviewing measures to increase investment in innovative pharmaceutical companies and provide preferential treatment for drugs manufactured with Korean APIs while avoiding WTO disputes as the 3rd Comprehensive Plan to Foster and Support Pharmaceutical Bio-Industry. In particular, the MOHW added that it is preparing a drug pricing system improvement plan to provide preferential treatment for homegrown incrementally modified drugs and new drugs made with native natural products, and has begun to establish a bio-health innovation committee for the Pharma-Bio Innovation Committee that will be directly under the Prime Minister. The MOHW said, “We are preparing a plan for the improvement of the drug pricing system that compensates for innovative values such as preferential drug prices for domestically developed new drugs that have proven clinical superiority. Also, we have been pushing for a revision of order among others for the establishment of a new health innovation committee."
