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- 2026-03-12 01:02:47
- Policy
- Januvia generics up for insurance price cuts… 119 combinati
- by Lee, Tak-Sun Sep 19, 2023 05:41am
- MSD Caution is required for the use of the generic versions CPP-4 inhibitor class antidiabetic drug ‘Januvia (sitagliptin, MSD)’ that have poured out into the Korean market as many are subject to price cuts due to inequality of price when they are prescribed in multiplications. According to industry sources on the 18th, HIRA recently added 119 combinations of Januvia single-agent generics to the list of oral drugs that require the use of cost-effective dosages. These combinations were selected as items subject to price cuts because the price of multiple doses of the lower-strength drug exceeds that of the single higher-strength drug. For example, the upper limit for Chong Kun Dang's Sitagrip 25mg Tab is KRW 254, but if it is double prescribed, it exceeds the price ceiling set for Sitagrip 50mg Tab, which is KRW 382. Even if you prescribe 4 times the amount of Sitagrip 25mg Tab, its price exceeds the price ceiling of KRW 575 set for Sitagrip 100mg Tab. This was why the lower-strength drug became subject to price cuts. The original Januvia, which had already been included as an item subject to price cuts, was still included in the list even though the price of the drug was lowered due to the introduction of generics. The price of Januvia 25mg Tab (KRW 261) in double or quadruple doses, exceeds the price ceiling set for Januvia 50mg Tab (KRW 393) and Januvia 100mg Tab (KRW 592). Also, the double dose of Januvia 50mg Tab exceeds the price ceiling of Januvia 100mg Tab, and therefore became subject to price cuts. 157 single-agent and 82 fixed-dose combination versions of Januvia generics were listed for reimbursement in Korea this month. The low-strength multiple prescription price cut system was introduced by the HIRA in 2007 to prevent additional financial expenditures and improve patient convenience. If the price of multiple prescriptions of a low-strength drug exceeds that of the same but high-strength drug, that difference is deducted from the price of the low-strength drug. Accordingly, if the subject drugs are prescribed or dispensed multiple times without any special reason, the relevant medical expenses and dispensing fees will be cut. If multiple prescriptions and dispensing are unavoidable, the reason must be stated in the medical expenses statement. Meanwhile, ‘Verquvo Tab’ which was newly listed for reimbursement this month, was also found to be subject to the multiple prescription price cut system.
- Policy
- Olumiant re-examination period extended by 35 months
- by Lee, Hye-Kyung Sep 18, 2023 05:26am
- In March of this year, the post-sales investigation (PMS) plan of Lilly Korea Olumiant, which was approved for severe circular alopecia indications in adult patients over the age of 18 from the Ministry of Food and Drug Safety in March of this year, will also be changed. According to the minutes of the meeting of the Central Pharmaceutical Review Committee held on August 16th and 18th, which was recently released by the Ministry of Food and Drug Safety, it was concluded that it is reasonable to extend the investigation period and change the subject in consideration of the current status of the usability permission to change the indication of the target after the market. The original PMS period was six years, but this adds 35 months. The subjects also decided to include 800 atopic dermatitis and 753 protomy alopecia with no change in the total number of cases in the existing 3000 cases (350 atopic dermatitis). The rest of the cases are filled with patients with rheumatoid arthritis. Olumiant is an oral autoimmune disease treatment with JAK inhibitory method, and it has only indications for rheumatoid arthritis at the time of approval in 2017, but it has additional efficacy and effect for atopic dermatitis in May 2021 and circular alopecia in March of this year. Regarding the change in the number of PMS cases, Commissioner Han said, "The drug permit indications have been added sequentially, and the case composition and investigation period adjustment are reasonable for sufficient collection of safety information on the newly added indications." By April of this year, the actual cumulative number of PMS registered patients for rheumatoid arthritis and atopic dermatitis was 1214 cases of rheumatoid arthritis and 310 cases of atopic dermatitis, according to Commissioner Lee. Another commissioner needed to adjust the number of cases at an appropriate level, but this time Olumiant agreed to adjust the number of cases filed by the company because the PMS period is very short. Commissioner Lee emphasized, "After being applied to clinical practice, many rheumatoid patients improve, and it has a good effect on other rheumatic diseases such as psoriatic arthritis, so it is thought that there will be more applications in the future. Patients with rheumatoid disease can be seen as a higher risk group related to cardiovascular side effects than patients with atopic circular alopecia, so it should be properly distributed to the patient group suitable for checking the side effects of drugs during the purpose of PMS." Regarding the existing recruitment of 3,000 cases, it was also said that it would be difficult to secure patients with rheumatoid arthritis as atopic dermatitis and prototype alopecia were added to the indications. "Despite the addition of atopic dermatitis and circular alopecia to the efficacy items, this drug may not be able to secure enough patients with rheumatoid arthritis expected by the highest number of approved efficacy items, which may not fill the planned patients until December, which is the re-examination period," said one commissioner. Excessive competition with the same line of drugs and biological agents will be difficult to recruit patients. It seems reasonable to allow the re-examination period to reach the necessary 3000 cases of re-examination by extending the re-examination period and changing the number of subjects. Meanwhile, if the PMS period of Alumiant is adjusted to 6 years + 35 months, it will end on November 10, 2026.
- Policy
- Super-antibiotic Tygacil reauthorized for use in Korea
- by Lee, Tak-Sun Sep 18, 2023 05:26am
- The ‘super-antibiotic’ Tygacil (Tigecycline, Pfizer Korea) received reauthorization in Korea and is expected to be able to avoid the treatment disruptions that had remained a lingering concern in the industry. Due to the lack of other drugs containing the same ingredient, there had been concerns that Tygacil’s failed renewal would cause disruptions in patient treatment. The drug had previously failed to renew its marketing authorization due to administrative reasons. The Ministry of Food and Drug Safety approved Pfizer Korea's ‘Tygacil Inj’ on the 14th of this month. The approval comes less than two months after its marketing authorization was canceled due to the expiration of the validity period on July 30. At the time, Pfizer explained that the failure to renew Tygacil’s marketing authorization was due to “administrative issues" and that they were “in the process of obtaining reauthorization." The company added, “Reimbursement is allowed during the 6-month reimbursement grace period after the marketing authorization expires, during which prescriptions can made with the same reimbursement code as before. We are making efforts to receive reimbursement as quickly as possible.” After failing to receive marketing authorization, Tygacil’s reimbursement listing was also deleted from the list on the 1st of this month. However, a grace period of 6 months is granted, and reimbursement can be applied until March 1 next year. Pfizer dispelled concerns about disruptions in treatment, saying it had sufficient inventory. A Pfizer official said, "We have secured a sufficient amount of inventory to supply prescriptions with reimbursement as before during the 6-month benefit grace period. We will continue to make efforts to ensure smooth supply. After the reimbursement claim period ends, pharmacies can return the remaining inventory that has the previous reimbursement code to wholesalers from whom it was purchased.” With stock for the existing Tygacil still available until March of next year, and since new authorization has been made, it appears that there will be almost no interruptions in using the treatment. Tygacil is a ‘super-antibiotic’ that is effective against many resistant bacteria that cannot be treated with existing antibiotics and is the only preparation of its ingredient in Korea. The drug is indicated for people 18 years for the treatment of ▲complicated skin and skin structure infections, ▲Complicated Intra-abdominal Infections, and ▲Community-Acquired Bacterial Pneumonia. In particular, due to its advantage of being able to be used as a monotherapy for complicated infections, the drug is currently registered as a National Essential Medicine in Korea. Regarding its supply issue, experts have stressed the need to resolve its supply issue. Currently, one drug with the same ingredient as Tygacil is approved in Korea. Penmix received marketing authorization for its ‘Piperacillin Inj’ in 2016, but the drug was not listed for reimbursement due to patent issues. Tygacil’s patent is valid until March
- Policy
- Authorization rate for No.16 is still 0%
- by Lee, Hye-Kyung Sep 18, 2023 05:26am
- While the Ministry of Food and Drug Safety recently completed the designation of 'Global Innovative Product Rapid Review (GIFT)' No. 16, there are still no items that have been approved using this system. The Ministry of Food and Drug Safety established the Global Innovative Products on Fast Track in September last year. It also contains innovative, gifted medicines that can pioneer new areas of treatment. The most recently designated GIFT item is the 'BI 1015550' substance, a treatment for idiopathic pulmonary fibrosis. The product name has not been confirmed. The drug has been designated as a GIFT for improved effectiveness, and is currently being approved by the U.S. FDA in BTD process. In Korea, it was also designated as a gift item on September 12th. The items subject to GIFT are limited to ▲medicines for the purpose of treating serious diseases such as life-threatening cancers or rare diseases ▲medicines for the prevention or treatment of infectious diseases that may cause serious harm to public health, such as the spread of bioterrorism infections or infectious diseases ▲new drugs developed by innovative pharmaceutical companies designated by the Ministry of Welfare ▲combination of drugs and medical devices . There are no existing treatments or have been clinically meaningful improvements in effectiveness than existing treatments. If designated as a target for Hinban GITF, it will be received at least 25% reduction in the review period (e.g., 120 working days → 90 working days), application of rolling review from the prepared materials first, close communication between reviewers and developers such as item briefing sessions and supplementary briefing sessions, and regulatory-related professional consulting. The GIFT system is a branded rapid examination program that has been operated since the establishment of the rapid examination department, and was prepared to activate the rapid examination conducted for two years and to strengthen the rapid commercialization of innovative products. Since the rapid examination was established in August 2020 and the rapid examination was started, a total of 33 items were designated for rapid examination until July, of which 28 items, or 85%, were approved. The gift-designated items are aiming to shorten to 75% of the 120 working days, which is the general screening period, but there is still no news of the approval of Roche Korea’s product, which was designated in November last year. An official from the Ministry of Food and Drug Safety said, "There are no GITF approved items as it takes time for the company to prepare supplementary materials after the actual first screening, but it is expected that the GIFT designated items will be linked to the permission in the second half of this year."
- Policy
- Celltrion receives approval for Nesina Met SR
- by Lee, Hye-Kyung Sep 15, 2023 05:33am
- Celltrion, which acquired the Asia-Pacific distribution rights for Takeda Pharmaceutical products, used them to create an improved new drug. One of the acquired products, Nesina Met SR, a type 2 diabetes treatment, received approval from the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety announced on the 14th that it had approved Celltrion's type 2 diabetes treatment Alogliptin Met SR. This is the first time that Celltrion has received domestic approval for a chronic disease treatment. Alogliptin Met SR appears similar to Nesina Met, which Celltrion acquired from Takeda in 2020 and has domestic licensing rights but is a domestically developed product with a different formulation and dosage. First of all, the dosage form of Nesina Met is a rectangular film-coated tablet, but Alogliptin Met SR is approved as an oval-shaped SR film-coated tablet. SR has the advantage of reducing the number of medications taken because the efficacy lasts for a long time with a single dose. Nesina Met was released with Alogliptin and Metformin doses of 12.5/500 mg, 12.5/800 mg, and 12.5/1000 mg, respectively, but the two Alogliptin Met extended-release tablets have the same dosage and are released at 25/1000 mg instead of 12.5/1000 mg. In the case of Nesina Met or Alogliptin Met SR, the maximum recommended daily dose of each ingredient should not exceed Alogliptin 25mg and Metformin 2000mg. When taking Alogliptin Met SR, taking 2 tablets of the existing Nesina Met once a day becomes easier by taking 1 tablet at a time. Celltrion acquired the Asia Pacific rights to 18 Rx and OTC items, including Nesina Met, from Takeda for $278.3 million in December 2020. Currently, the domestic sales rights for Nesina Met are held by Celltrion Pharmaceuticals. Attention is focused on whether Celltrion will enter the domestic chronic disease treatment market as it has developed Alogliptin Met SR, conducted clinical trials, and obtained product approval.
- Policy
- Which P-CAB generic will come first, K-CAB or Vocinti?
- by Lee, Tak-Sun Sep 15, 2023 05:33am
- Companies have started developing generic versions of the P-CAB (potassium-competitive acid blocker) class gastroesophageal reflux disease (GERD) treatments K-CAB (tegoprazan, HK Inno.N) and Vocinti (vonoprazan, Takeda Pharmaceuticals Korea). The post-marketing surveillance (PMS) period for the original drugs, which are being targeted by the generic companies, is set to end in 2024 and 2025, respectively. The release of their generic versions will then depend on whether they can avoid the originals’ patents. According to industry sources on the 14th, approvals for bioequivalence tests using K-CAB and Vocinti as reference drugs have been continuing this year. In the case of bioequivalence tests filed for the approval of K-CAB generics, starting with SamChunDang Pharm in May, Kukje Pharm, Jinyang Pharm, and Hutecs Korea have been approved to conduct bioequivalence tests with K-CAB. Hanlim Pharm was first to receive approval to conduct a bioequivalence test for its Vocinti generic on September 12th. In terms of the expiry of the PMS term, K-CAB's generics will likely be approved first. K-CAB’s PMS term expires on July 4, 2024, and Vocinti on March 28, 2025. The PMS system also serves a data protection function, therefore generic can only be approved after the end of the PMS period. However, the market release date may be delayed much further as the patent term for the original drug is in effect until 2036. K-CAB and Vocinti In the case of K-CAB, its substance patent expires on August 25, 2031, and its crystalline patent on March 12, 2036. Over 70 generic companies have filed for trial to avoid the two patents. If the companies succeed in avoiding both patents, the release date of K-CAB generics may be pulled forward. Patent challengers are focusing on avoiding the extended term of K-CAB’s substance patent. If they succeed, they may launch their generic versions after December 6, 2026, the expiration date that had been set before HK Inno.N filed to extend their patent term. On the other hand, if the companies fail, the first generic may only be launched in 2036 after the crystalline patent expires, or in 2031 if the companies only succeed in avoiding the crystalline patent. In the case of Vocinti, one patent expires on December 20, 2027, and the other patent expires on November 17, 2028. No pharmaceutical companies have filed patent challenges yet. But in terms of patent duration, Vocinti ‘s generic can hit the market sooner. However, unlike K-CAB, Vocinti has not been released yet and is non-reimbursed in Korea. If Vocinti is not released in the Korean market before the end of the PMS period, its marketing authorization may be revoked. In this case, there is a possibility that the generic will have difficulty procuring the control drug needed for the bioequivalence test. Also, if Vocinti remains non-reimbursed, the latecomer will have to go through the process of reimbursement listing as a drug subject to pricing negotiations, so it may be reimbursed later than K-CAB generics which will receive a set reimbursement price. Therefore, the launch of the generic drugs will ultimately depend on whether or not the companies succeed in avoiding their patent. An industry official said, "K-CAB had posted sales of KRW 100 billion, so generic companies are very eager to release their generic versions of the drug as soon as possible as its commercial viability has been proven. However, if the companies do not succeed in avoiding the patents, their launch date may be delayed, therefore, releasing a Vocinti generic can also be a good alternative.”
- Policy
- Imfinzi recieves RSA reevals and seeks to extend reimb
- by Lee, Tak-Sun Sep 15, 2023 05:32am
- The Risk-Sharing Agreement (RSA) reevaluations for term renewal are underway for Imfinzi Inj (durvalumab, AZ), which applied for reimbursement extensions to its biliary tract cancer indication. The reevaluations are being conducted in preparation for the RSA contract renewal set for March next year. According to industry sources on the 14th, AstraZeneca Korea recently submitted the pharmacoeconomic evaluation data for Imfinzi to the Health Insurance Review and Assessment Service for RSA renewals. Korea's RSA system requires companies to submit PE evaluation data for reevaluation within 1 year of RSA term expiry. The company signed an RSA for Imfinzi, and the drug was listed for reimbursement in April 2020 for patients with locally advanced, unresectable NSCLC whose disease has not progressed following platinum-based concurrent chemoradiation therapy (CRT). The drug was reimbursed through two types of RSA: Refund-type and Expenditure cap-type RSA. The RSA term expires on March 31st. The company refunds a certain proportion of the claims amount back to NHIS, and if the claims amount exceeds the expected amount, a certain proportion of the exceeded amount is also returned to the NHIS. The expected claims amount at the time was KRW 22 billion. Imfinzi’s sales last year, based on IQVIA, amounted to KRW 52.4 billion. The company has recently been working to extend reimbursement to biliary tract cancer. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. Imfinzi’s effect as a combination therapy was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment-naïve patients with unresectable locally advanced or metastatic biliary tract cancer. Results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a 20% improvement in overall survival (OS) versus the placebo arm (placebo+gemcitabine+cisplatin). At 2 years, the survival rate in the Imfinzi arm was 24.9% compared with the 10.4% in the placebo arm. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to. the 5.7 months in the placebo arm. Whether AstraZeneca will be able to kill two birds with one stone and renew its RSA and extend reimbursement to the biliary tract cancer indications remain the focus of industry interest.
- Policy
- Reevaluation difficult for Ildong and Abbott’s Lypsta
- by Lee, Tak-Sun Sep 14, 2023 06:40am
- There are slightly ambiguous aspects to Abbott Korea's ‘Lypsta Plus Tab,’ whose drug price was lowered on the 5th after the insurance price ceiling reevaluations. This drug was jointly developed between Abbott Kore and Ildong Pharmaceutical, and the bioequivalence test data among the clinical trial data was submitted by Abbott. Perhaps for this reason, Abbott opposed the price cut and filed for a stay of execution, due to which the drug price will be maintained as is the 28th. According to industry sources on the 13th, The price of Lypsta Plus Tab’s 10/5mg formulation had been lowered from KRW 895 to KRW 761; the 10/10mg formulation from KRW 1,251 to KRW 1,063; and the 10/20mg formulation from KRW 1,263 to KRW 1,074. However, the execution of the price cut is set to be suspended until the 28th due to Abbott’s application for a stay of execution. The drug is a combination drug for hyperlipidemia that combines rosuvastatin and ezetimibe. Lypsta and 'Droptop Tab’ were jointly developed by Ildong and Abbott. During the reevaluations conducted this time, a price reduction could only be avoided if the company proves that it has conducted its own bioequivalence test or clinical trial, even for jointly developed products, In a Q&A session before the reevaluation, HIRA said, “Even for drugs that were developed through joint clinical trials, in-house bioequivalence test or an in-house clinical trial must be conducted, and data of such proof be submitted to meet the standard requirements. In the case of products approved through clinical trials, the clinical trial has to be conducted under the supervision of the marketing authorization holder (pharmaceutical company).’ However, HIRA added that the standard requirements do not apply if the product that was approved through joint clinical trials is the first product to be listed for reimbursement in Korea. However, Lypsta is not the first product reimbursed in its class. Rosuzet is the first product that was ever listed, and Lypsta was released two years after Rosuzet’s reimbursement. However, HIRA’s self-bioequivalence test verification requirements are a little ambiguous. This is because the two companies divided the clinical trials and shared the results with each other. For example, Ildong Pharmaceutical submitted drug interaction test and therapeutic confirmatory clinical trial data among quality assessment data, non-clinical trial data, and clinical trial data, and Abbott submitted the biopharmaceutics test data among clinical trial data. Excerpt from Lypsta In other words, Abbott conducted the Phase I bioequivalence test, and Ildong conducted the Phase III therapeutic confirmation trial. The two items were shared between the companies and the drug was approved in December 2017. This aspect is indicated in the approval report disclosed by the Ministry of Food and Drug Safety. It is understood that health authorities concluded that although there was a bioequivalence test submitted by Abbott, the core clinical trial was conducted by Ildong Pharmaceutical, its joint development partner, therefore the data did not meet the standard requirements. During reevaluations, Ildong Pharmaceutical's 'Droptop’ was excluded from receiving drug price cuts for meeting the standard requirements. With an administrative suit in place, whether Lypsta Plus Tab meets the standard requirements is expected to depend on the court's judgment in the future.
- Policy
- [Reporter's view] Focus on non-face-to-face contraceptives
- by Lee, Jeong-Hwan Sep 14, 2023 06:37am
- The Ministry of Health and Welfare will hold a public hearing to prepare a reform plan for the non-face-to-face medical treatment pilot project from 2 p.m. today (14th). After disclosing the status of the pilot project, the plan is to hold a panel discussion to hear opinions from the medical community, pharmaceutical industry, platform app industry, and patient and consumer groups. The Ministry of Health and Welfare has not officially commented on the direction of the pilot project reform. Some media outlets only 'leaked' a statement that they are considering a reform plan to expand the scope of non-face-to-face first visitation. For this reason, some criticize that “the Ministry of Health and Welfare is busy using the media to gauge public opinion in order to expand the implementation of the non-face-to-face medical treatment pilot project.” Some even point out that rather than starting administration based on specific policy implementation grounds, they are belatedly formulating policies that suit their tastes after being conscious of public opinion. Non-face-to-face medical treatment is a policy that Minister of Health and Welfare Cho Gyu-hong and Second Vice Minister Park Min-soo have repeatedly emphasized over the years as to the need for institutionalization, but I wonder why they are so unsure about it. First of all, the Ministry of Health and Welfare plans to prepare a reform plan after holding a public hearing on the non-face-to-face medical treatment pilot project, but there are already media reports that there is a strong direction to expand the permitted time zone for the non-face-to-face first treatment to nights, late at nights and public holidays, and to expand the permitted area to areas with a shortage of medical institutions. The purpose is to enable residents in vulnerable areas who are not guaranteed access to medical care in the current pilot project to benefit from non-face-to-face medical treatment. There is some criticism of the direction of the Ministry of Health and Welfare's reorganization that it is trying to allow unlimited non-face-to-face first visits by modifying the 'time zone' regulations, but if evidence is presented that the truly unreasonable reality of pilot projects can be improved, there is some sympathy with the direction of the Ministry of Health and Welfare's reorganization. It can be expressed. This means that the Ministry of Health and Welfare should specifically present cases where non-face-to-face treatment is not available due to a lack of medical institutions nearby, even though the area is not remote, such as islands or mountainous regions. The Ministry of Health and Welfare has not made a single comment on how to manage the side effects that are concentrated in non-covered high-risk prescription drugs such as morning-after contraceptives, isotretinoin-based acne treatments, and finasteride-based hair loss treatments, which have been pointed out several times as representative side effects of non-face-to-face therapy. The Ministry of Health and Welfare only reiterated its position that it would discuss expanding the scope of prescription-restricted drugs through a pilot project advisory group meeting but did not present any measures or blueprints on how to manage the concentration of prescriptions for high-risk medications. Even after the implementation of the pilot project, non-face-to-face treatment prescription patterns or statistics are not disclosed. Due to this situation, pharmacist professional organizations such as the Seoul Pharmaceutical Association and the Korean Pharmaceutical Association are individually calculating and publicizing their own statistics. The justification for implementing and institutionalizing the non-face-to-face medical treatment pilot project announced by the Ministry of Health and Welfare is ‘strengthening medical access for medically vulnerable groups and residents.’ It is questionable whether the concentration of non-covered prescriptions for morning-after contraceptives, acne medicines, and hair loss medicines is in line with the Ministry of Health and Welfare's goal of strengthening the medical rights of the medically vulnerable. Even in this situation, the Ministry of Health and Welfare is considering improvement measures to expand the scope of initial and repeat visits for non-face-to-face medical treatment, and it is highly likely that the Ministry of Health and Welfare will continue to mention the need to expand the scope at the public hearing to be held today. The fact that the Ministry of Health and Welfare has not made any comments regarding regulatory measures for non-covered prescription drugs influenced Democratic Party lawmaker Jeon Hye-sook to come to the conclusion that she suspected 'collusion between platform operators and the government.' The National Assembly and medical groups have been calling for several years since the COVID-19 pandemic to address the side effects of unnecessary medications being excessively prescribed through non-face-to-face treatment and platforms, but the Ministry of Health and Welfare has not made any specific comments. Vice Minister Park Min-soo strongly opposed Rep. Jeon Hye-sook's point that the Ministry of Health and Welfare is pushing for non-face-to-face medical treatment to save the platform. Rather than protesting, the first priority is to create an alternative that can solve the problem of wasting health insurance funds through excessive treatment and overprescription and increasing the risk of side effects from medicines for patients. Platforms have gained too much power and have grown into 'super apps', standing over medical institutions and pharmacies to gather opinions on how to address side effects that could damage the healthcare delivery system. The public hearing for the non-face-to-face medical treatment pilot project should be held in a format where the Ministry of Health and Welfare directly discloses the prescription statistics and patterns that occurred during the guidance period over the past three months, while also collecting opinions on solutions that will erode concerns about the concentration of prescriptions for high-risk non-reimbursed drugs and concerns about platform side effects. It should not just be a formality and a basis-building effort to expand the scope of non-face-to-face first and return visits. The slogan that face-to-face treatment is the principle and non-face-to-face treatment is an auxiliary means was put forward every time the Ministry of Health and Welfare insisted on the need to implement pilot projects and legislate. The Ministry of Health and Welfare is breaking the principles of face-to-face treatment by discussing a pilot project reform plan that blindly expands the scope of first and repeat visits without any valid basis.
- Policy
- Monterizine generics prepare for release in Oct
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Hanmi Pharm’s asthma and rhinitis combination drug Companies are preparing to release their generic versions of Hanmi Pharm’s Monterizine (Montelukast+Levocetirizin) in October at the earliest. The generic drugs that were approved in August obtained first generic exclusivity and were able to move up their reimbursement listing date. According to the industry sources on the 8th, the price calculation process for Monterizine generics has been completed and it is expected to be listed with reimbursement next month. HIRA is known to have been conducting pricing calculations for Monterizine generics that applied for reimbursement after being approved in August. The generics, which received generic exclusivity, are expected to be released in October. Unlike general drugs that take 3 months to reimbursement listing, it only takes 2 months for drugs that are granted generic exclusivity to reimbursement listing. 10 Monterizine generics that were granted generic exclusivity by HIRA are owned by Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical. The difference between the generics and the original Monterizine Capsule is that the to-be-released generics are tablet formulations. The pharmaceutical companies succeeded in avoiding Monterizine’s formulation patents with that difference. The MFDS therefore granted them exclusive rights so other companies may not sell the same drug until May 2024. Monterizine is Hanmi’s incrementally modified drug that it received approval in May 2017. It is the world’s first combination of montelukast, which blocks the action of leukotriene that causes tightening of airway muscles, breathing difficulties, and runny nose, and levocetirizin hydrochloride, an antihistamine used to treat allergic rhinitis. Hanmi demonstrated its combination’s superior efficacy compared to a single agent in a Phase III trial targeting domestic patients. Monterizine exceeded the blockbuster drug threshold of KRW 10 billion for the first time last year. Based on UBIST, the amount of its outpatient prescriptions was KRW 11.5 billion last year, up 24% points from the KRW 9.3 billion it had posted in the previous year. Supported by its marketability, the generic companies are expected to make efforts to market their drugs early into their release. An official from a related company said, "Because it is effective in relieving allergic rhinitis symptoms in patients with asthma and perennial allergic rhinitis, we expect to achieve high performance if we focus on marketing our product to HCPs in Korea." The current insurance ceiling price of Monterizine Cap is KRW 886/capsule. Hanmi also owns a chewable tablet formulation of the same drug at the same price.
