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- 2026-05-02 03:39:15
- Policy
- ‘Introduce a Korean Cancer Moonshot Plan for patients'
- by Lee, Jeong-Hwan Sep 21, 2023 05:24am
- It has been pointed out that Korea also needs a policy that can improve the quality of life of cancer patients by providing reasonable compensation for cancer treatment technologies such as robot-assisted surgery and advanced radiation therapy to improve the quality of life of cancer patients in Korea, like in the case of the U.S. Cancer Moonshot Initiative or the EU’s Beating Cancer Plan. On the 20th, the AI law, regulation, and policy platform CODIT’s (Jeong Ji-eun Chung) Global Policy Empirical Research Institute pointed out in an issue paper called 'Implications of the development of advanced cancer treatment technology - Focusing on improving the quality of life of cancer patients.’.' According to the issue paper, countries around the world have been making national efforts with the explicit goal of improving the quality of life of cancer patients and their families, with plans such as U.S. President Biden's 'Cancer Moonshot Initiative' and the EU's ‘Beating Cancer Plan.’ On the other hand, the paper criticized that in Korea, improving the quality of life of cancer patients is being pushed back from the priority list of health authorities due to frequent transfers of officials from the relevant ministries and seasonal changes in national health issues. The issue paper introduced examples of advanced treatment technologies that have a significant impact on improving the quality of life of cancer patients and emphasized the need for the government to contemplate on an institutional level on improving the quality of life of cancer patients. The paper pointed to robot-assisted surgery reducing bleeding and complications by enabling sophisticated surgery based on hand tremor correction, wide joint range of motion, and delicate joint movements, as well as advanced radiation that maximizes effectiveness through customized radiation therapy using artificial intelligence (AI) as examples. Such advanced treatment technology can greatly contribute to improving the quality of life of patients during the treatment process by increasing the likelihood of their successful return to society after surgery. However, in the current healthcare system, it is not easy for people to receive the benefits of advanced treatment technologies due to cost issues, and the paper stressed that the government needs to actively make considerations on that aspect. In addition, the issue paper emphasized that the government needs to improve social and emotional awareness to prevent having been or being a cancer patient or from acting as an invisible stigma in this society, which is ranked among the Top 10 in regards to its economic achievement in the world, while at the same time actively improving healthcare policies to build a healthcare system that allows patients to enjoy a better quality of life physically.
- Policy
- Generics for Janumet competition begins in earnest in Oct.
- by Lee, Tak-Sun Sep 21, 2023 05:23am
- MSD DPP-4 inhibitory diabetes treatment The diabetes treatment market is expected to remain active in October. This is because salt-modifying complex drugs that were not registered in September are hitting the market all at once. According to the industry on the 20th, generics of MSD's DPP-4 inhibitory diabetes combination drug 'Janumet and Janumet XR' will be listed in large numbers next month. These are salt-modifying drugs, and due to the calculation criteria, they were not released when the patent expired on September 2nd. This is because salt-modified complex drugs can only be calculated if a single salt-modified drug with the same ingredient is registered first. Sitagliptin hydrochloride hydrate complex drugs are scheduled to be registered in October. On the 2nd of this month, 134 single products were registered. There are 304 combination drugs on the approved list that combine Sitagliptin HCl and Metformin. If there are no production issues, most of these are expected to be registered in October. A combination drug combining Sitagliptin phosphate and Metformin is expected to be released in October. Accordingly, the follow-up drugs of Janumet and Janumet XR are expected to enter into full-scale competition starting in October. Looking at last year's outpatient prescriptions based on UBIST, Januvia's single drug was 40.5 billion won, Janumet and Janumet XR combination drugs were 68.9 billion won and 48.2 billion won, respectively, totaling 117.1 billion won, forming a much larger market than single drugs. The key appears to be the speed with which Hanmi Pharmaceutical and Chong Kun Dang can dominate the market. Both companies were the only ones to list Janumet and Janumet XR generics on September 2nd. This was possible because only both companies obtained generic for exclusivity as a generic with the same ingredient. The entry speed of other generics is expected to be determined by how well the two companies with large sales forces dominate the market within a month. An official in the pharmaceutical industry said, "In the Janumet and Janumet XR generics market, only Hanmi and Chong Kun Dang had the opportunity to dominate the market due to the salary standards, and other generic companies entered the market a month late." He explained, “The key for other generic companies is how much of the overall market share the two companies that released a month early have taken.”
- Policy
- High-priced drugs need adjustment from the approval stage
- by Lee, Tak-Sun Sep 20, 2023 05:36am
- He also explained that he would conduct a pilot project to curb multi-drug prescriptions to reduce usage. Chairman Jeong made this announcement at a press conference for a health magazine held at a restaurant in Gwanghwamun, Seoul on the 15th. He said, “It is true that as income increases, prescriptions switch to more expensive drugs even if they have similar efficacy.” He said, “Moreover, doctors prefer original drugs with extensive research rather than generic drugs that have only received BA evaluation.” He said, "The authorities are continuing to set prices for generic drugs and are using a savings policy of refunding half of the money after verifying the efficacy of expensive drugs for a year, but I personally believe that the trend of rising drug prices is inevitable." Accordingly, as a policy to suppress drug prices, he emphasized that adjustments must be made from the start of approval. Chairman Jeong explained, “In the past, there were many high blood pressure medicines priced at 5 won, but now the old, cheap medicines that are no longer used are naturally being eliminated, and their place is being filled by expensive medicines.” He emphasized, “Therefore, there must be coordination from the start of approval with the Ministry of Food and Drug Safety and HIRA.” This was also said to be the reason for participating in the HIRA Pharmaceutical Reimbursement Evaluation Committee. Chairman Jeong said, "If NHIS participates in the drug evaluation committee, the listing period can be shortened through prompt negotiations linked to evaluation, and insurance finances can be reduced by preemptively reviewing the financial impact." He added, "Patient groups also believe that NHIS is for this reason. “I understand that they expressed the opinion that there is a need to participate in the committee,” he explained. “Although NHIS did not participate in this 9th committee, we will continue to discuss this issue with HIRA and the Ministry of Health and Welfare for the benefit of the public,” he said. “We will strengthen the public’s access to medicines through smooth communication and mutual cooperation, including data sharing with related organizations.” “We will strive to manage drug costs more efficiently,” he emphasized. Chairman Jeong emphasized that he will make various efforts to ensure the sustainability of health insurance and that he will pay particular attention to encouraging appropriate treatment. He said, "The Ministry of Health and Welfare, NHIS, and HIRA will cooperate to reduce medical expenses by establishing 'standard treatment guidelines' to prevent citizens from receiving unnecessary excessive tests or treatment," and added, "In order to prevent leakage of health insurance funds, a special judicial police officer system will be introduced in NHIS." “We will strengthen the detection of illegally opened institutions.” In addition, in order to prevent foreign dependents from entering the country for medical purposes, the plan is to strengthen subscription criteria, such as stipulating a 'required period of stay (6 months)' for health insurance applications. Chairman Jeong emphasized, "We will fundamentally work to normalize the fee structure and establish a proper medical delivery system to address the shortage of doctors and improve the labor intensity of medical staff." Chairman Jeong was inaugurated as the 10th Chairman of NHIS last July. He graduated from Seoul National University and served as Chairman of the Academic Research Committee of Hallym University Medical Center, Director of Hallym University Sacred Heart Hospital, and Director of Hallym University Medical Center. He also served as Director of the Korea Centers for Disease Control and Prevention. In this administration, he served as the head of the COVID-19 Special Response Team and contributed to the transition to routine management of COVID-19.
- Policy
- The NHIS begins negotiations to increase the size of PSE
- by Lee, Tak-Sun Sep 20, 2023 05:36am
- The NHIS has started negotiations to adjust the drug price increase for the ingredient formulation of the nose cold medicine Pseudoephedrine (PSE), which is struggling with supply and demand. The deadline for this negotiation is 60 days, but it is said to be targeting an agreement this month. If this month's negotiations are signed, it is highly likely that the drug prices raised from next month will be applied. According to the NHIS and the industry on the 18th, the NHIS has been negotiating a drug price adjustment with manufacturers of 60 mg of Pseudoephedrine HCl since last week. This ingredient was recognized for the validity of the adjustment of the drug price increase by the Pharmaceutical Benefits Evaluation Committee of the HIRA held on the 6th. Soon after that, the Ministry of Health and Welfare reportedly issued a negotiating order. The deadline for negotiations is 60 days. However, the government aims to speed up adjustment negotiations like acetaminophen, which was a drug price increase last year. The Acetaminophen adjustment negotiations were completed in about 20 days. If this month's negotiations is completed as targeted and a resolution from the Ministry of Health Insurance Policy Review Committee at the end of the month is received, the adjusted drug price will be applied from the 1st of next month. Currently, manufacturers are said to want to double the current drug price. Currently, the upper limit is 20 won for one item, and the remaining 3 items are all 23 won. Kolon , Sam-A , Samil, and Shinil are selling it. The key to negotiating speed is a cost analysis. It is analyzed that if the two opinions differ in the cost analysis, the negotiation is likely to be longer. Pharmaceutical companies are reportedly doing a cost analysis using the cost of production opportunities early in the negotiations. However, the NHIS is of the opinion that cost analysis should be done through more practical data. Pseudoephedrine HCl formulation has been a supply problem since last year due to COVID-19. Therefore, in May, the Pharmaceutical Society also provided an equal supply of one bottle per pharmacy to solve the supply and demand instability. The industry argues that a drug price increase is essential for additional production power.
- Policy
- Reimbursement imminent for some anticancer drugs in KOR
- by Lee, Tak-Sun Sep 20, 2023 05:35am
- Jeperli Inj (dostarlimab, GSK) and Braftovi Cap 75mg (encorafenib, Ono), which passed the Drug Reimbursement Evaluation Committee meeting last month, are currently in drug price negotiations with the National Health Insurance Service. According to industry sources on the 19th, the National Health Insurance Service recently updated the list of drugs receiving new drug pricing negotiations. According to the update, the drugs currently subject to negotiation are the asthma antibody treatment Cinqair Inj (Teva), Braftovi Cap 75mg, and Jeperli Inj. On the other hand, ‘Evrysdi Dry Syrup (risdiplam, Roche)', a spinal muscular atrophy (SMA) treatment that had been under negotiation for some time, was removed from the list after its company and the NHIS reached an agreement. Drug pricing negotiations with the NHIS are usually conducted for 60 days. Braftovi and Jemperli were deemed adequate for reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Review Committee held on the 3rd of last month and entered the price negotiation stage with the NHIS thereafter. Braftovi is an anticancer drug used for metastatic colorectal cancer with a confirmed BRAF V600E mutation and is used in combination with Erbitux (cetuximab). In the Phase III BEACON CRC, the Braftovi+cetuximab combination demonstrated a statistically significant overall survival (OS) improvement to the irinotecan+ cetuximab combination (HR 0.60, p=0.0003). Median OS was 8.4 months for Braftovi and 5.4 months for the control group. Jemperli is used to treat mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer. It is the third PD-1 inhibitor to be approved in Korea, following Opdivo (nivolumab, Ono·BMS), and Keytruda (pembrolizumab, MSD). However, among these immuno-oncology drugs, Jemperli is the first to be approved for endometrial cancer and is expected to greatly benefit patients in Korea. Jemperli’s approval was based on the cohort A1 analysis results of the Phase I multicohort GARNET trial. As a result of analyzing a total of 108 patients for a median follow-up period of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile, and the ORR of the Jemperli group was 43.5%
- Policy
- MFDS starts review on phenylephrine after FDA advisory decis
- by Lee, Hye-Kyung Sep 19, 2023 05:42am
- Syrup formulation of phenylephrine that is being used as a cold medicine With the Nonprescription Drug Advisory Committee (NDAC) concluding that the nasal decongestant ‘phenylephrine’ is not effective, Korea’s Ministry of Food and Drug Safety is also preparing to conduct its review. An MFDS official said, “We will decide on future measures after a comprehensive review, including discussion with experts, based on data on domestic use experience of medicines that contain the relevant ingredient. We do not know what sanctions the FDA will announce in the future, whether it will be banned or used, but we plan to conduct our review at the Ministry of Food and Drug Safety level.” The controversy over the effectiveness of phenylephrine arose after the results of the FDA’s advisory committee NDAC’s meeting which was held on the 11th and 12th, was disclosed. Phenylephrine is an ingredient that has been known to be effective for nasal congestion. It stimulates sympathetic nerve receptors in the nasal mucosa to constrict dilated blood vessels in the nasal mucosa. In the United States, experts have continuously pointed out problems regarding the effectiveness of phenylephrine, and have been evaluating data on its efficacy since 2007. After discussing the data evaluation and clinical trial results at the recent NDAC meeting, all committee members unanimously agreed that phenylephrine is no more effective than a placebo (fake medicine). The result applies to oral formulations, not to the other formulations such as nasal sprays or eye drops, and although there are no safety issues, the committee concluded that the drug lacks evidence in terms of effectiveness. According to NDAC meeting data, 242 million phenylephrine drugs were sold in the United States last year. Its sales amounted to $1.76 billion (about KRW 2.34 trillion). In Korea, 118 over-the-counter drugs contain phenylephrine as the main ingredient, including Kolon Pharmaceutical's 'Komi Syrup,’ Daewoo Pharmaceutical's ‘Coben Syrup,’ GSK’s ‘Theraflu Nighttime Dry Syrup,’ and Dong Wha Pharm’s ‘Pancol A.’
- 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."
