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- 2026-04-16 14:43:38
- Policy
- Hanmi loses out on patent trial, drops Vildagle approval
- by Lee, Tak-Sun Jul 09, 2020 06:26am
- Hanmi Pharmaceutical dropped the sales approval on antidiabetic dipeptidyl peptidase-4 (DDP-4) inhibitor Vildagle 50 mg tablet (vildagliptin hydrochloride) that the company won by excluding the indication relevant to Galvus’ extended patent. Sources interpret the Korean company’s action was following up with the failed attempt to evade the original drug Galvus’ patent at a patent trial earlier this month against Novartis Korea. According to Korea’s Ministry of Food and Drug Safety (MFDS), Hanmi Pharmaceutical’s withdrawal of the sales approval on Vildagle 50 mg tablet was decided as of July 6. The product received the health authority’s item approval on Jan. 21 and even received reimbursed pricing in last April as well. The drug was initially targeting an early release to the market by applying for the approval without indication based on the original Galvus’ extended patent, which is to last until Mar. 4, 2022. However, the product was not yet released as the patent evasion was not fully approved during the legal proceedings. On July 1, Intellectual Property Trial and Appeal Board rejected Hanmi Pharmaceutical’s request to confirm the negative scope of the original’s patent. Without the complete patent evasion, the product would be able to enter the market only after Mar. 4, 2022 when the original patent term expires. The Korean company could have judged it would be better to reapply for the approval with all indications identical to Galvus. The company has already succeeded in shortening the extended original patent term through the Intellectual Property Trial and Appeal Board, and is ready to launch the product from Aug. 30, 2021. But Ahn-gook Pharmaceutical is also launching its vildagliptin drug from then. As Hanmi Pharmaceutical withdrew the approval, there is no need for Novartis to continue on with the litigation proceedings against MFDS to revoke Hanmi Pharmaceutical’s approval. Novartis has filed litigation against MFDS claiming the government body has neglected its duty to notify the patent owner, according to the Patent-Approval Linkage System, when Vildagle applied for an approval. Now that Hanmi Pharmaceutical has retracted its early release scheme, other pharmaceutical companies also targeting for an early release would inevitably have to revisit the strategy on approval application and challenging the original patent.
- Policy
- The Korean New Deal was confirmed by supplementary budget
- by Kim, Jung-Ju Jul 09, 2020 06:26am
- During the COVID-19 situation, supplementary budget of ₩1.088 trillion was established to strengthen the MOHW for the so-called 'Korean New Deal' project. At the plenary session of the National Assembly on the night of the 3rd, the MOHW focused on ▲strengthening K-disinfection capabilities and R&D investment, ▲ establishing a non-face-to-face basis (infrastructure) for infectious diseases, and ▲expanding the Korean jobs and social safety nets. The government announced that it had increased by ₩34.6 billion compared to the government proposal (₩1.054 trillion). The increase was ₩22.4 billion for the National Immunization Program for influenza targeted at ages 62-64, ▲ ₩12 billion for supporting medical personnel such as COVID-19, ▲ ₩200 million for the establishment of an integrated information system for epidemiological investigations of infectious diseases. ◆Strengthening K-disinfection capabilities and R&D investment =₩48.9 billion was set for the expansion of national immunizations (45.5 million people) for 14~18, 62~64 yearolds in preparation for the possibility of COVID-19 in the future and ₩200.9 billion was set for quarantine items such as level D protective clothing and masks. ₩10.2 billion established for the construction of negative pressure screening clinics in the 67 public health centers in order to expedite medical treatment at local areas, Following the first supplementary ₩400 billion in medical institutions with a sharp drop in sales due to COVID-19, additional ₩400 billion in financing was also established. COVID-19 treatment and vaccine support for clinical trials, advancement of quarantine equipment, and expansion of research and development (R&D) related to the expansion of the infrastructure of the National Institute of Virus and Infectious Diseases will be able to invest ₩140.4 billion. ◆The Korean New Deal project = 5G network, monitoring equipment, etc., including the establishment of non-face-to-face infrastructure for infectious diseases, increased ₩6 billion to minimize the risk of infection in hospitals and establish smart hospitals (3 locations) for efficient treatment. In order to prepare a safe medical treatment system for patients with respiratory diseases and prepare for the possibility of secondary epidemics, ₩50 billion was set up to establish a dedicated respiratory clinic (500 locations), and ₩1.1 billion was confirmed to expand health management projects (130→140 locations) through local clinics and public health centers using ICT devices. ◆Expansion of jobs and social safety netwrok =₩58.3 billion for temporary job support (6,312 people) to provide quarantine support for health centers and hospital-level medical institutions, and extended periods for relief of urgent welfare support requirements (July → end of the year) to expand support for low-income households threatened with livelihood According to the supplementary budget, the total spending by the MOHW in 2020 increased from ₩86.165 trillion to ₩87.146 trillion. Projects that are difficult to execute with COVID-19 will be used as additional financial resources by reducing ₩107.7 billion through restructuring expenses. The MOHW announced that it would thoroughly prepare for the rapid execution of the supplementary budget, and will actively strive to protect people's safety from COVID-19 and support public economy.
- Company
- Phase III clinical trial plan for Rimatil has been submitted
- by Nho, Byung Chul Jul 08, 2020 09:14am
- Chong Kun Dang added a clinical pipeline for COVID-19 treatment following Nafabeltan. On the 18th of last month, Chong Kun Dang began the development of a COVID-19 treatment (clinical phase II) for its anticoagulant and acute pancreatitis treatment drug Nafabeltan (Nafamostat) on the 18th of last month. It is estimated that the mechanism of Nafamostat inhibits protease TMPRSS2, which is known to play a major role in the cell invasion process of COVID-19, and shows several hundred times more antiviral efficacy in human lung cell experiments compared to Remdesivir. On the 30th, IND application for Rimatil (Bucillamine) which is marketed as a rheumatoid arthritis treatment was submitted to the FDA. The Phase III clinical trial for Bucillamine is not directly controlled by Chong Kun Dang, but is hosted by the Canadian pharmaceutical bio company Revive Therapeutics. Rimatil is a safe drug that has been sold in East Asian countries for over 30 years, and is a licensed-introduced drug from Santen company, Japan. If the clinical trial phase III of Bucillamine is successful, Chong Kun Dang, which has exclusive domestic sales rights, will obtain COVID-19 treatment indication. Bucillamine reported that N-Acetyl-L-cysteine significantly alleviates the symptoms of respiratory viral infections and produces significantly positive results in small-scale clinical trials in preclinical and COVID-19 mild patients. According to Revive Therapeutics, the FDA has recommended the clinical phase III of COVID-19 treatment, Bucillamine, and will begin a full-scale clinical trial in the third quarter of this year. The clinical trial is conducted in a double-blind manner in 800 patients with mild COVID-19. Clinical participants receive Bucillamine 100 mg and 200 mg three times a day. The median result is 28 days after the first dose, which is the time when the dose for 210 patients is completed.
- Company
- “Liver cancer option expands, but needs further evidence”
- by Eo, Yun-Ho Jul 08, 2020 05:38am
- Professor Kim Doyoung When a new drug development in a specific area is sluggish, there are two prominent reasons why; either the disease area has low marketability or the drug development itself for the disease is very difficult. In the latter case, a new drug gets an obvious spotlight when it is released to the market. Liver cancer (hepatocellular carcinoma) would be a good example. For over a decade, Nexavar (sorafenib) was technically the only option to be used on liver cancer patients. But now, the disease specialists have heightened anticipation on other options to come. Stivarga (regorafenib) entered the market as a second-line treatment, and Lenvima (lenvatinib) was added as another first-line treatment option at the same level as Nexavar. In the U.S., Tecentriq (atezolizumab) and Avastin (bevacizumab) were approved as a combination therapy recently, which newly added an immunotherapy as an option. The situation in Korea is also taking a step at a time. Early this year, the healthcare reimbursement standard on Nexavar has been adjusted to grant the benefit on patients in Child-Pugh scoring of class B7, a severe case of the disease. The change raised the usability of the pharmaceutical treatment in liver cancer. Daily Pharm interviewed Professor Kim Doyoung of Gastroenterology Department at Severance Hospital and spoke of the hepatocellular carcinoma treatment strategy with more options available now. -First of all, what does expanded coverage on Nexavar mean for a healthcare provider? The patients in Child-Pugh class B7 were considered somewhat of ‘grey area.’ The patient’s liver function level is comparatively close to normal state, but they have risk of developing ascites or jaundice. The patients stuck in the middle did not have a clear answer to choose as a treatment option. These patients need treatment without building liver toxicity. And Nexavar, as proved in various evidences, demonstrates less liver toxicity. Basically, the liver cancer patients hopeless without a proper treatment option can now be treated with Nexavar. -What are some points to consider—like dosage control or administration suspension—when prescribing Nexavar on patients in Child-Pugh class B7? There are no specific precautions to consider. In the GIDEON study that produced global real-world data (RWD) from over 3,000 intent-to-treat participants, Nexavar barely showed much difference between patient groups in Child-Pugh class B7 and Child-Pugh class A. Regardless of class A6 or class B7, normal dosage is recommended but reduced dosage is recommended for patients showing adverse reaction. The dosage does not have to be adjusted from the beginning. -Would the transarterial chemoembolization (TACE) have some changes as Nexavar is now reimbursed and the systemic anticancer therapy option has expanded? Would it be safe to assume this is the period when healthcare providers are trying to reach a consensus on the recommended frequency of TACE and treatment ceasing point? Due to the coverage expansion, some may think of using Nexavar when the patient’s Child-Pugh scoring gets worse after repeated TACE. But the patient’s survival rate would worsen if the Nexavar administration timing is delayed and liver function starts failing according to Child-Pugh scoring. In fact, the talk of when to use systemic anticancer therapy on patients with failed attempt of TACE or refractory condition has continued for over a decade. Although some of the consensus among the healthcare providers has been documented, but it would take a while for the medical practice environment to accept the change and apply it. After practicing TACE for many times, I can see whether or not the patients either should continue on with TACE. Many healthcare providers would agree with me. The decision to continue with TACE should be made promptly but carefully, and switch to another option, if need be. At some point, there was a talk on how beneficial it is to quickly switch to systemic anticancer therapy after TACE. But the argument lacks sufficient evidence in improving the survival rate. -Does that mean, in some cases, there is a concerning factor when following up promptly with a systemic anticancer therapy after TACE? In the past, when Nexavar was the only option of systemic therapy for treating liver cancer, the healthcare providers regarded switching to a systemic anticancer therapy after TACE as a ‘last resort.’ So the treatment switch was not fast enough and it was worrying. But now the healthcare providers seem to agree more that a systemic anticancer therapy is not a ‘last resort,’ as Nexavar is prescribed to patients with comparatively good functioning liver, and also because a follow-on drug Stivarga is commercialized. -As Nexavar is the only systemic anticancer therapy with coverage for patients in Child-Pugh class B7. These patients do not have a choice in later-line treatment with coverage Stivarga’s global REFINE study conducted in a real-world practice conditions in 1,000 patients, diagnosed with unresectable hepatocellular carcinoma, included many of patients in Child-Pugh class B and other more severe cases. Regardless, the study confirmed improved efficacy against Stivarga in global Phase III RESOURCE trial. Based on these findings, Stivarga’s coverage should be expanded to patients in Child-Pugh class B7 for them to resume treatment after Nexavar. -Recently, a combination of immunotherapies was passed by the U.S. health authority. What is your expectation on it? I expect that the prospective competitor of Nexavar to be the combination of immunotherapies. To be honest, I had a great expectation on Opdivo (nivolumab) for treating patients with hepatocellular carcinoma, because its clinical trial had two patients who demonstrated complete response (CR). But using it in the actual practice, the response rate was not as good as I expected. And apparently, Tecentriq combination has exhibited improved result than Nexavar, and it looks ‘good’ at face value. But we need to watch if the combination therapy can show better efficacy in uncontrolled real-world practice conditions. There is also the catch—the patients have to frequently visit the hospital to receive the injection. And of course, the biggest problem of expensive price is still unresolved.
- Policy
- 13 drugs were sold before patent termination
- by Lee, Tak-Sun Jul 08, 2020 05:37am
- Domestic pharmaceutical companies were caught largely on charges of sales before patent termination. These pharmaceutical companies reported to the MFDS that they would sell after the end of the patent at the time of the application, but the sale was made even before the end of the patent through reporting on supply. The industry believes that they have committed illegal acts due to a lack of understanding of patent-linkage system introduced in 2012. However, there are criticisms that pharmaceutical companies have responded too easily because the allegations of selling before the end of the patent are just the reason for canceling the license. The MFDS has recently disclosed the results of disposing of products suspected of being sold prior to the termination of the patent. A total of 13 items were revoked by the 5th. These items are generic (Varenicline) for Pfizer's anti-smoking treatment 'Champix', and generic (Bazedoxifene Acetate) for Pfizer's osteoporosis treatment 'Viviant'. It was discovered that the items for cancellation of license were sold before the patent expired. According to the Pharmaceutical Affairs Act, the drug is withdrawn before the period expires if a person who applied for approval or revised approval of a drug is filed to market the drug after the period of a registered patent expires. This was reflected in the Pharmaceutical Affairs Act at the time of the introduction of the licensed patent linkage system in 2012. In the case of generic drugs with original patent rights, the application for permission is accompanied by a confirmation of the relationship of the patent, which is to be sold before patent termination through patent challenge or after patent termination. This is notified to the patent holder so that the patent holder can prepare in advance. A patent owner may make a request for prohibition of sales for nine months with a lawsuit against an item deemed to be infringement of a patent to the MFDS. Although the item that was caught this time has been applied for permission to be sold after the patent is over, it is suspected of being sold even before the patent expires. It is known that the MFDS caught the items sold before the end of the patent through report on supply history and field investigation. Administrative measures are underway because more items are caught than the 13 items that have been released so far. According to the industry, hepatitis B treatment and erectile dysfunction treatment are also included. It is known that some companies have additionally approved salt-altering items in preparation for cancellation of the license or have obtained the same active ingredients through affiliates.
- InterView
- Post-corona KSC academic conference finds answer in hybrid
- by An, Kyung-Jin Jul 08, 2020 05:37am
- (From left) KSC Secretary General Kang Seokmin, Academic Director Gwon Hyeon Cheol and Head of Convention Service team at Gyeongju Hwabaek International Convention Center, Park Seo-Joon. The Korean medical academy scene also took a hit from the novel coronavirus (COVID-19). Still not contained COVID-19 pandemic had affected the spring academic conference and other events, which left the academic event coordinators in a tight spot. So what is it like to have an academic conference in the day and age of ‘Post-coronavirus?’ The executives of Korean Society of Cardiology (KSC) say they found the answer in ‘hybrid.’ They concluded both online and offline events have to be simultaneously conducted to continue exchange academic findings and network while joining the movement to stop the spread of COVID-19. KSC Secretary General Kang Seokmin (Cardiovascular Department at Severance Hospital) and Academic Director Gwon Hyeon Cheol (Cardiology Division at Samsung Medical Center) at ‘2020 Annual Spring Scientific Conference of KSC with Affiliated Cardiac Societies’ claimed, “Simultaneously convening offline and online events would become the standard style of academic conferences post-coronavirus.” The academic society intends to share the tips they have learned from organizing the spring conference with other societies and to overcome the tough time together. ◆From special guideline to simulation, a month in making Only a month ago, KSC had decided to convene the annual spring conference in the first week of July at Gyeongju Hwabaek International Convention Center. Considering a large number of frontline healthcare providers of COVID-19 response had to participate, the society had internal dispute over having a complete virtual event. But some argued back it would diminish the level of networking and academic exchange and result in long-term loss. The executives pondered on the subject and finally found the solution; a hybrid event with an offline event strictly following the disease control guideline combined with the real-time presentation streaming online. Professor Kang Seokmin elaborated, “The annual spring conference is a massive scale of an event, where seven academic societies, including KSC, Korean Heart Rhythm Society, Korean Pediatric Heart Society, Korean Society of Heart Failure, Korean Society of Interventional Cardiology, Korean Society of Cardiometabolic Syndrome, Korean Society of Echocardiography and Korean Society of Lipid and Atherosclerosis, come together. As the participation of world renowned scholars was canceled, the invited professors were disappointed in losing a chance to expand their network.” Event staffs usher in conference participants to a lecture hall after checking their body temperature The executive committees of KSC had to struggle for a month to make an exemplary event amid COVID-19 pandemic. Professor Kang personally drafted the COVID-19 Response Guideline and edited eight times. The final version of the guideline reviewed by Korean Society of Infectious Diseases (KSID) defined the infection of COVID-19 and specified the floor plan and entrance management of the conference venue, management of the venue surroundings, management of relevant staffs, enforcement of disease prevention rules in participating members and operating the conference, and management of the event planning agency staffs. A day before the conference, the professor convened the convention center service team to conduct a simulation on contacting the public health center in case of spotting a suspected case of COVID-19 and transferring the patient. Professor Kang said, “The number of pre-registered members exceeded 1,700, and 900 of them participated in the morning of the first day. Keeping the safe distances in the seating arrangement, many had to listen to the live-streamed lecture from the lounge area,” and “We are grateful for the event staffs and participants complying with the guideline and safely and successfully closing the event.” ◆Hybrid academic conference with advantages of online and offline events to become a norm While the executive directors were busy organizing a safe event, academic committees were also hectic as well. They collected presentation material and voice or video recording of the foreign speakers unable to participate, and set up an online streaming system for the academic society members to conveniently use. By analyzing the pros and cons of international and domestic conferences convened online recently, the committees were able put up the basic framework of the event. As the spring conference was postponed over two months, the committees also simultaneously worked on the fall conference to come in three months time. As a result, they developed a system to watch lectures streaming from seven conference halls by simply clicking on a Smartphone app. The voice and video recordings from the foreign speakers were played from respective conference halls in a set order. Professor Kang demonstrates the real-time streaming lecture video on a Smartphone appProfessor Gwon Hyeon Cheol explained, “According to respective hospital guideline, many of the members are not allowed to participate in the conference unless they are speaker, mediator, or a panel,” and “Insisting on convening a virtual event would bring a serious impact on academic activity and networking.” The professor says the hybrid style of academic conference that fully embraces the advantages of both online and offline events would get more prevalent in the future. Professor Gwon also stated ultimately the executives of those academic societies hosting an academic event and the government should contemplate together on further improving the hybrid academic conference on more intricate level. The professor plans to create a system that enables real-time two-way feedback for question and answer session with the foreign speakers for the next conference. Professor Gwon advised, “The government also seems to have a lot to think about on setting the sponsorship standard as the conferences are changing their forms. Hopefully, they would also talk of setting detailed standard for the hybrid style with both online and offline events,” and “They should seek the most idealistic platform together with the relevant stakeholders to reflect their opinions”.
- Company
- Pfizer seeks for coverage on EGFR TKI to launch this year
- by Eo, Yun-Ho Jul 07, 2020 06:13am
- Pfizer Pharmaceutical Korea is quickly taking steps to join the competition in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) market. According to the pharmaceutical industry sources, Pfizer is in process of listing EGFR TKI Vizimpro (dacomitinib) for healthcare reimbursement. Vizimpro took the pricing negotiation exemption track by accepting the weighted average pricing as an alternative option, taking into account that first generation Iressa (gefitinib), Tarceva (Erlotinib) and directly competing second generation Giotrif (afatinib) have already settled in the market. The drug would be able to launch with reimbursement in the second half of the year. The dacomitinib drug seeking for the reimbursement is a targeted therapy treating patients with non-small cell lung cancer (NSCLC), who have confirmed EGFR gene deletion in exon 19 or 21 L858R substitution mutations. The efficacy of Vizimpro was confirmed in Phase III trial ‘ARCHER 1050.’ The clinical trial compared dacomitinib’s efficacy head-to-head against AstraZeneca’s first generation EGFR TKI Iressa. Total 452 NSCLC patients have registered for the trial. The study reported Vizimpro lowered the risk of progression or death by 41 percent against Iressa, and the median progression-free survival (PFS) was 14.7 months in the Vizimpro group and 9.2 months in the Iressa group. However, Vizimpro demonstrated more adverse reactions. Frequently reported grade 3 events in Vizimpro group were dermatitis acneiform (14 percent) and diarrhea (8 percent), whereas over 8 percent of the Iressa group was reported with abnormal level of liver enzyme. As a result, 60 percent of the dacomitinib group had to adjust the dosage due to the adverse events. Meanwhile, Vizimpro has received marketing approval on three doses (15 mg, 30 mg and 45 mg) from Ministry of Food and Drug Safety (MFDS) in last February.
- Policy
- Ticagrelor Napadisylate by Chong Kun Dang was applied
- by Lee, Tak-Sun Jul 07, 2020 06:13am
- It has been shown that Chong Kun Dang developed a salted product of Ticagreler (Brilinta, AstraZeneca) and applied for permission to the MFDS. It is the first product to be approved as a Ticagrelor salt product. Anti-thrombotic agent, Ticagrelor, is a poorly soluble drug and is known to have poor solubility, so it has been noted whether salted drugs can overcome disadvantages. According to the industry on the 6th, Chong Kun Dang developed Ticagrelor napadicylate and applied to the MFDS on the 26th of last month. AstraZeneca Korea’s Brilinta (Ticagreler) was approved in July 2011. This product has indications that reduce the incidence of thrombotic cardiovascular events (death due to cardiovascular events, myocardial infarction, stroke) in combination with Aspirin in adult patients. Domestic pharmaceutical companies have made generics for Brilinta and have been sequentially approved since November 2017. However, due to the remaining material patents, it cannot be launched immediately, and will be sold from November next year. 25 items have obtained the right to monopolize the market from November 21, 2021 to August 20, 2022 by obtaining generic exclusivity by overcoming the remaining patents excluding material patents. Chong Kun Dang also obtained generic exclusivity. It is Ticarex 90mg which is unsalted form of Ticagreler. Accordingly, it is expected that Chong Kun Dang will release salt added products and salt free products simultaneously. In particular, it is expected that the salt additive product has improved solubility of Ticagrelor and will be able to secure competitiveness in the market. Brilinta is a blockbuster drug with a record of ₩10.3 billion in outpatient prescriptions (based on UBIST) last year.
- Policy
- Daewoong's Camostat was approved for clinical trial phase II
- by Lee, Tak-Sun Jul 07, 2020 06:12am
- Daewoong’s FoistarDaewoong has been approved for clinical trials in patients with mild and moderate COVID-19 as a drug with Camostat Mesilate used as a treatment for pancreatitis. The MFDS approved a plan for phase II clinical trial for 'DWJ1248', which Daewoong applied for on the 6th. DWJ1248 is known as Camostat Mesilate. Daewoong holds Foistar (Camostat Mesilate). This clinical trial is a double-blind, randomized, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of DWJ1248 in 90 patients with mild and moderate COVID-19. A team of researchers from Georg-August-Universität Göttingen is raising hopes as a candidate for COVID-19 treatment by announcing the results of an experimental study in which the Camostat prevents lung cell infection of COVID-19 in the global journal “Cell”. The research team at Aarhus University Hospital in Denmark started a phase II clinical trial to check the effectiveness of COVID-19 of Camostat Mesilate after receiving research funding from the Lundbeck Foundation. In Korea, Crystal Genomics was approved for the first time in a phase II clinical trial to evaluate the effectiveness and safety of Camostat for COVID-19.
- Policy
- Stepped drug pricing applied on maximum price as of Aug 1
- by Kim, Jung-Ju Jul 07, 2020 06:12am
- The Korean government unveiled the specified schedule and plan to apply stepped drug pricing system, also known as the upper limit price reevaluation on listed drug. Although the Regulatory Reform Committee ordered Ministry of Food and Drug Safety (MFDS) to drop the ‘1+3 joint bioequivalence test system’ from the revised ‘Regulation on Pharmaceutical Approval, Notification and Review,’ the health authority’s intention to limit joint bioequivalence test and to promote drug master file (DMF) registration are still apparent in the newly revised policy. Ministry of Health and Welfare (MOHW) officially disclosed the ‘Plan on Reevaluating Pharmaceutical Maximum Reimbursed Price,’ and spoke of the key dates such as a base date for reevaluated pricing and evidence submission period for the responsible pharmaceutical and bio companies. ◆Reevaluation subject and exemption conditions: Drugs listed for reimbursement before the government finalized the ‘Pharmaceutical Decision and Adjustment Criteria (MOHW notice No. 2020-51)’ as of Feb. 28 are subject to the reevaluation. But some are exempted from the reevaluation; drug requested for decision by the President of Korea Orphan and Essential Drug Center (KOEDC), or oxygen, nitro oxide, basic parenteral nutrition, artificial perfusates and radiopharmaceuticals are ruled out from the reevaluation. Other exempted drugs include low-cost drug, shortage prevention drug, orphan drug and other drugs specifically designated by the Minister of Health and Welfare, according to the Example 가 (Ga) to 라 (Ra) of the Item 2 of the Notice Appendix 4, that require stable supply and management essential for medical service. Moreover, a first drug in the class to be listed is also excluded from the list of subject drugs. If the first-in-class drug is not on the list of reimbursed drugs, the drug that MFDS notified as a reference drug for bioequivalence test among the same substance drugs would be considered as the first-in-class drug. ◆Adjusted drug pricing and criteria: The base price for the upper limit pricing adjustment (reduction) is the maximum price among the same substance drug. However, drugs with premium pricing benefit would base their reevaluation on the original pricing without the premium. As announced previously, the maximum price of a listed drug would be reduced by passing two, one or none of the criteria—submitting individual bioequivalence test data or clinical trial confirmation data, and submitting evidence of using active pharmaceutical ingredient registered with DMF. A drug meeting two of the criteria would receive the maximum price lowered to the adjusted base price, and meeting one criterion would lower the price down to 85 percent of the base price. And the maximum price of a drug clearing none of the criteria would be reduced to 72.25 percent of the adjusted base price. MOHW does not plan to lower the maximum price of a drug with the price already lower than the adjusted base price. And if the adjusted price is lower than the base price of a low-cost drug, the maximum price would be reduced down to the low-cost drug’s base price. But the pricing would be adjusted as the original policy, if an item is listed with minimum unit (1 mL, 1 g, 1mCi etc.) or its maximum price is labeled with minimum unit. The bioequivalence test reference drug, not a first-in-class drug, would be only considered to have met the first criterion of submitting the individual bioequivalence test evidence or submitting the evidence of clinical trial. ◆Evidence submission: For the pharmaceutical companies to get the most of the maximum pricing, the reevaluation criteria should be met. The government has set the deadline on Feb. 28, 2023 for the evidential materials to be submitted to Health Insurance Review and Assessment Service (HIRA). Other details would be fine-tuned further by discussing with Drug Reimbursement Evaluation Committee (DREC).
