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- 2025-12-21 20:03:58
- Policy
- MSD Welireg is about to be approved in Korea
- by Lee, Hye-Kyung Apr 19, 2023 05:51am
- Domestic approval of Welireg, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, is imminent. According to the pharmaceutical industry on the 18th, the Ministry of Food and Drug Safety completed the safety and efficacy review of MSD Korea's Welireg. This drug was approved in Korea in August of last year and was designated as an orphan drug for Von Hippel-Lindau indications in January of last year prior to MSD Korea's application for approval. Welireg obtained approval from the US FDA in August 2021 as an adult VHL treatment that does not require urgent surgery but requires the treatment of RCC, CNS hemangioblastoma, or pNET. Welireg, approved in the United Kingdom and Canada, starting with the United States, has a mechanism that reduces the transcription and expression of HIF-2α target genes related to cell proliferation, angiogenesis, and tumor growth. VHL is a rare genetic disease that occurs in about 1 in 36,000 people. Patients with VHL are known to be at high risk of developing some cancerous diseases, including benign hemangioma and renal cell carcinoma. The recommended dose for Welireg 40 mg tablets is 120 mg daily until tumor progression or unacceptable toxicity. Indications for application for domestic approval are also for the treatment of VHL adult patients who do not require immediate surgery but need treatment for VHL-related renal cell carcinoma, central nervous system hemangioblastoma, and pancreatic neuroendocrine tumor.
- Policy
- As a result of the PMS of Entresto·Xnepri,
- by Lee, Hye-Kyung Apr 18, 2023 05:38am
- As a result of a post-marketing investigation of the chronic heart failure treatment ingredient 'Sacubitril Valsartan Sodium Hydroxide', the incidence rate of adverse events was 24.62% regardless of the causal relationship. The MFDS prepares an order (draft) to change permission items based on the results of post-marketing surveillance (PMS) conducted by pharmaceutical companies on 3,075 people for 6 years for re-examination in Korea and proceeds with opinion inquiry by the 28th. do. The items in question are Novartis Korea 'Entresto Film Coated Tab' 50mg, 100mg, and 200mg and Sandoz 'Xnepri Film Coated Tab' 50mg, 100mg, and 200mg, which received product approval on April 14, 2016. As a result of a post-marketing survey conducted on 3,075 people for 6 years for re-examination in Korea, the occurrence rate of adverse events was reported to be 24.62% (757/3075 people, 1133 cases) regardless of a causal relationship. Among them, 0.29% (9/3075 patients, 11 cases) of serious adverse drug reactions that could not rule out a causal relationship and 1.33% (41/3075 patients, 47 cases) of unexpected adverse drug reactions that could not rule out a causal relationship ) appeared. Serious adverse reactions included congestive cardiomyopathy, acute myocardial infarction, exacerbation of congestive heart failure, bradycardia, pleural effusion, appendicitis, asthenia, acute renal injury, hypertension, and hypotension. Palpitations, dyspnoea, chest pain, and chest discomfort were uncommon occurrences, and indigestion, vomiting, abdominal discomfort, constipation, oral disorders, and edema were rare. The MFDS requested that if there is an opinion on the proposed change order, it should be submitted with specific reasons and related data attached.
- Policy
- Kyowa Kirin accepted the evaluation results for Nephoxil
- by Lee, Tak-Sun Apr 17, 2023 05:58am
- It is known that Kyowa Kirin Korea's hyperphosphatemia treatment 'Nephoxil 500mg' accepted the HIRA evaluation results. Accordingly, this drug is expected to move to the negotiation stage with the NHIS. Nephoxil is used for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Expectations are high because it is a product of Kyowa Kirin Korea, which stands out in the chronic kidney disease patient treatment market with Nesp·Regpara. Currently, non-calcium drugs such as Renvela are preferred in the hyperphosphatemia treatment market for hemodialysis patients, and the introduction of Nephoxil is expected to change the market structure. According to the industry on the 16th, Korea Kyowa Kirin of Nephoxil Capsule, which received conditional pass results at the Pharmaceutical Review Board meeting on the 6th, accepted the evaluation results. The HIRA judged that it was appropriate to receive reimbursement for this drug, which is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis when it was accepted below the estimated amount. In other words, it is interpreted that the Korea Kyowa Kirin side accepted less than the estimated amount suggested by HIRA. The proposed valuation seems to have been based on the price of non-calcium-based drugs like Nephoxil. Calcium-based drugs and non-calcium-based drugs are used to treat hyperphosphatemia in dialysis patients. Although calcium-based drugs are relatively inexpensive, non-calcium-based drugs are increasing in use due to the risk of causing vascular calcification. Representative items of non-calcium-based drugs include Renvela, Invela (SK Chemicals), and Fosrenol (JW Pharmaceutical). As domestic drugs containing Sevelamer are released one after another, the price has become much cheaper. Accepting this evaluation result, Nephoxil will proceed with negotiations with NHIS in the future. When the negotiations are completed, they will go through a report to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare and be listed on the list of benefits. In the market, as Kyowa Kirin Korea stands out in the domestic chronic renal failure drug market, Nephoxil is also expected to settle down early. Kyowa Kirin Korea is recording a high market share with Nesp, a treatment for anemia in patients with chronic kidney disease, and Regpara, a treatment for secondary hyperparathyroidism in patients with chronic kidney disease. Furthermore, Kyowa Kirin took the top spot in the hyperphosphatemia treatment market with Renagel before Renvela was launched in Korea. The domestic supply of Renagel was discontinued in 2015. Renagel and Renvela are drugs developed by Genzyme, and it is rumored that Renagel withdrew from the market after Renvela was supplied through Sanofi in Korea. From the perspective of Kyowa Kirin Korea, Nephoxil is expected to serve as an opportunity to further strengthen its position in the chronic renal failure patient treatment market. Meanwhile, Nephoxil received domestic approval in May last year.
- Policy
- Obesity treatment Mounjaro, soon to launch in Korea
- by Lee, Hye-Kyung Apr 14, 2023 05:49am
- Eli Lilly's Mounjaro, called a 'game changer' for obesity treatment, is imminent in Korea. Maunjaro GLP-1 agonists act on GLP-1, a hormone that makes patients feel full by acting on the hypothalamus of the brain, activates incretin, an intestinal hormone, and promotes insulin production to lower blood sugar levels. In this process, it slows down the movement of food from the stomach to the small intestine, increases satiety, and has been proven to be effective, becoming a 'hot' obesity treatment in the United States. According to the pharmaceutical industry on the 14th, the Ministry of Food and Drug Safety completed a safety and efficacy review of Maunjaro. Completing this review means that sooner or later, the product approval process will begin. Mounjaro is a successor to Lilly's blockbuster diabetes treatment 'Trulicity,' and was approved by the US FDA in May of last year as a dietary and exercise supplement to improve blood sugar control in patients with type 2 diabetes. The dosage includes 5mg, 10mg, and 15mg, and it can be used as monotherapy or combination therapy with 'Metformin', 'SGLT2 inhibitor', 'Sulfonylurea', and 'Insulin Glargine'. Last year, Lilly conducted a phase 3 clinical trial to study the effect of reducing morbidity and mortality in obese adults, including in Korea. The phase 3 clinical trial was a randomized, double-blind, placebo-controlled trial involving 15,000 participants worldwide and 60 obese and overweight patients in Korea. Meanwhile, representative drugs such as GLP-1 agonists include Novo Nordisk's 'Saxenda' and 'Wegovy'.
- Policy
- SGLT2+DPP4 combinations are to be released next month
- by Lee, Tak-Sun Apr 14, 2023 05:49am
- Domestic DPP-4·SGLT-2 diabetes complex ZemidapaAs the three-drug regimen of diabetes treatment Metformin + SGLT2i + DPP4i is also covered from this month, the SGLT2i + DPP4i complex is expected to be released next month. A total of five items are expected to hit the market in May. However, according to the reimbursement standard, these drugs are reimbursed only when used in combination with Metformin. According to the industry on the 13th, MSD Stegluzan, Boehringer Ingelheim Esglito, AstraZeneca Qtern, LG Chem Zemidapa, and Dong-A ST Sugadapa are expected to release benefits in May. Since April, regardless of ingredients, the three-drug regimen of Metformin + SGLT2i + DPP4i has been applied, allowing these items to enter the market. However, these combinations are difficult to use as monotherapy. This is because the three-drug regimen, including metformin, in the clinical trial for approval proved the blood sugar-enhancing effect, and the SGLT2i + DPP4i two-drug regimen is not covered under the reimbursement standard. The competitiveness of the combination drug, which contains two ingredients in one pill and enhances the convenience of taking it, has not been revealed due to the additional intake of metformin. This is because benefits are applied even if a DPP-4 single drug is added to the commercially available Metformin + SGLT2 complex. Metformin + SGLT2 combinations have been pouring out in droves due to the expiry of Dapagliflozin's patent on the 8th. Perhaps conscious of this, some SGLT2i+DPP4i combinations, such as Qtern and Zemidapa, all of a sudden went on non-reimbursement sales this month. Discussions on the two-drug regimen of SGLT2i + DPP4i are highly likely to resurface starting in September when Januvia's patent expires. This is because many domestic pharmaceutical companies have received approval for the combination of Dapagliflozin + Sitagliptin and are aiming to release a benefit when the patent expires. This is because the two-drug regimen of Dapagliflozin + Sitagliptin can still be used according to the approval. However, the full co-payment is applied to one of the two drugs. It is expected that there will be many reimbursement inquiries about the two-drug therapy in the field, conscious of confusion, and it is expected that the insurance authorities will somehow sort it out. Meanwhile, the domestic SGLT-2i new drug Envlo, developed by Daewoong Pharmaceutical, recently concluded negotiations with the NHIS. By accepting 90% of the price of this drug compared to alternative drugs, only the expected billing amount is negotiated without negotiation of the upper limit, and the reimbursement list is expected to be accelerated.
- Policy
- Domestic approval of Pemazyre is imminent
- by Lee, Hye-Kyung Apr 13, 2023 05:45am
- Domestic approval of Pemazyre, a treatment for advanced or metastatic cholangiocarcinoma, is imminent. According to the pharmaceutical industry on the 13th, the Ministry of Food and Drug Safety recently completed a safety and efficacy review of Pemazyre. Completing the safety and efficacy means that sooner or later, the product approval process will begin. Pemazyre is approved in the United States, Europe, and Japan for treating adult patients diagnosed with locally advanced or metastatic cholangiocarcinoma with a fusion or rearrangement of the FGFR2 gene who have received at least one prior systemic therapy. In Korea, after being designated as an orphan drug in November 2021, it has been designated as a treatment for life-threatening or serious diseases since December. Previously, the US FDA designated Pemazyre as a breakthrough therapy for the treatment of previously treated patients with advanced, metastatic, or unresectable FGFR2 translocation cholangiocarcinoma, and designated it as an orphan drug, conducting an expedited review through a priority review program. Cholangiocarcinoma is a rare type of cancer and is classified according to its anatomical origin into intrahepatic cholangiocarcinoma (iCCA) arising from the bile duct existing inside the liver and extrahepatic cholangiocarcinoma arising from the bile duct outside the liver. Cholangiocarcinoma is often diagnosed at an advanced or advanced stage with a poor prognosis. FGFR2 fusions or rearrangements are found in 10-16% of patients with intrahepatic cholangiocarcinoma. FGFRs play important roles in the proliferation, survival, migration, and angiogenesis of tumor cells. FGFR fusion, rearrangement, translocation, and gene amplification activities are closely related to the development of various cancers. Pemazyre is an oral FGFR inhibitor and is the first and only treatment approved by the FDA for this indication. After the domestic approval of Pemazyre, Handok will exclusively take charge of domestic distribution and supply.
- Policy
- Decreased commitment to production/sales/new generics
- by Lee, Jeong-Hwan Apr 13, 2023 05:45am
- "Financial expenses for health insurance drugs are calculated by multiplying volume and price. The government has been engrossed in finding reasons for reducing drug prices and establishing policies for decades while neglecting efforts to reduce usage." "(To the government), it seems that the price adjustment of generic drugs is always recognized as the easiest and easiest way. For pharmaceutical companies that are constantly striving to create new drugs, generics are the driving force. Only pharmaceutical companies that do not directly produce drugs or do research and development Please consider the hard way to regulate tweezers." Domestic pharmaceutical companies are becoming more concerned as the Ministry of Health and Welfare is preparing a policy for preferential drug prices for innovative pharmaceutical companies and moving to reduce the price of generic drugs at the same time. It is a reality that generic drugs are already cut as soon as they are cut and it is difficult to go down further, and they are playing a role as a cash generator for pharmaceutical companies that are keen on R&D. Appeals from pharmaceutical companies come out. In particular, as the 2nd Vice Minister of Health and Welfare Park Min-soo is personally leading the policy for this move to adjust generic drug prices, there are even burdensome observations that the price-cutting policy equivalent to the past batch drug price cuts and cascading drug price systems will be triggered. According to pharmaceutical industry sources on the 9th, the Ministry of Health and Welfare is in the midst of preparing and announcing a policy for price adjustment of generic drugs as well as a policy for giving preferential prices to medicines and essential medicines made by innovative pharmaceutical companies in the near future. The Ministry of Health and Welfare has held five public-private consultative body meetings since last February to reflect the appropriate value of innovative new drugs, which were completed last month. The Ministry of Health and Welfare is expected to disclose a policy proposal based on the results of the council meeting at the end of April at the earliest and begin collecting opinions from the pharmaceutical industry. In addition, the public-private consultative body to prepare measures to adjust or lower generic drug prices is expected to quickly begin seeking specific policies from this month, starting with a kick-off meeting at the end of last month, right after the innovative new drug consultative body meeting. The domestic pharmaceutical industry sees this move by the Ministry of Health and Welfare as a full-fledged commitment to the 'trade-off' drug price policy. It is the opinion that the Ministry of Health and Welfare chose the policy goal of sacrificing generics for preferential prices for innovative new drugs. Ironically, the Ministry of Health and Welfare's drug price trade-off was initiated by the National Assembly's request to resolve the fact that sub-statutes for preferential drug prices for innovative new drugs within the 'Special Act on Promotion and Support of the Pharmaceutical Industry' had not been made for several years. The National Assembly pressed the Ministry of Health and Welfare by repeatedly emphasizing the legitimacy and necessity of converting the sub-statute on preferential drug prices for innovative new drugs from the current voluntary regulation to mandatory regulation, and the Ministry of Health and Welfare promised to create a sub-statute as soon as possible instead of amending the law. At the same time, the Ministry of Health and Welfare made clear its will to "lower generic drug prices." On top of that, starting on the 8th, 170 generics for single and combination drugs of Forxiga, which have prescriptions exceeding 90 billion won per year, were released to the market all at once. As a result, the Ministry of Health and Welfare entered the process of materializing the willingness to cut drug prices, which was revealed in an inquiry about generic drug prices by Rep. Choi Jae-hyeong of People’s Power in a parliamentary audit in October last year. In response to this move by the Ministry of Health and Welfare, the domestic pharmaceutical industry is evaluating that it has chosen an easy way to secure health insurance finances by reducing generic drug prices. Some are criticizing that the drug price was cut from the two pillars of health insurance finance, 'Volume' and 'Drug Price', to secure financial soundness and secure financial resources for innovative new drugs. In particular, rather than blindly lowering the price of generic drugs, pharmaceutical companies should look closely at each company's management to make generics that contribute to health insurance finances or exclude companies that do not neglect R&D investment to discover new drugs from the reduction targets. They are also requesting consideration of delicate administration. “In order to create a preferential drug price system for innovative new drugs as soon as possible, we did not stop at operating a public-private consultative body to collect opinions from pharmaceutical companies, but also pulled out a generic drug price cut card,” said a drug price manager at domestic pharmaceutical company A. It is not true, but it is very regrettable that the Ministry of Health and Welfare blindly chooses an easy way to touch the price of generic drugs.” An official from Company A said, "Even if the price of generic drugs is reduced, we have to think about reducing the amount of usage together with drug prices, such as reducing unnecessary prescriptions by analyzing the prescription patterns of domestic drugs, but the Ministry of Health and Welfare shows no signs of doing so. There are many cases where prescriptions are not necessary or for a longer period of time than necessary. It is easy to price a drug with a pharmaceutical company, and it is difficult to adjust the prescription amount with a doctor. A person in charge of drug prices at domestic pharmaceutical company B also said, “Regulate pharmaceutical companies that are only making temporary money through CSO sales without having a production plant or new drug R&D efforts, and pharmaceutical companies that make and sell generics themselves and use them as cash cows for new drug development can lower drug prices. “I hope the government will think about a delicate policy that does not cut prices,” he said. A person in charge of company B said, "I don't expect much from the enactment of sub-statutes for drug price preferential treatment. Prior to preferential treatment, we need to select pharmaceutical companies that are making generics and new drugs properly, and create an environment in which the pharmaceutical company's drugs can be properly sold in the market."
- Policy
- The results of the PVA improvement plan study were disclosed
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- The NHIS, which is promoting PVA improvement, disclosed the results of service research conducted last year and announced plans to seek improvement measures with the private sector in May. In this improvement plan, it is expected that items with a 10% billing amount and more than 5 billion won will be added to the Ka-type negotiation target, which is a new drug, and a plan to raise the standard for exclusion from negotiation to 3 billion won to 5 billion won a year will be pursued. According to industry sources on the 11th, the NHIS released last year's 'PVA Performance Evaluation and Improvement Study,' in which Bae Seung-jin, professor of pharmacy at Ewha Womans University, participated as the research director. This seems to be a measure to secure transparency of the improvement plan by disclosing the research results internally and externally prior to the working group in May. The results of the study mainly suggest ways to relax the existing standards in terms of financial savings. In the case of Type Ka, it is currently included in the negotiation only if the billing amount increases by more than 30%, but like Types Na and Da, a plan to include items with a billing amount of 10% & 5 billion won or more were included. If items with an increase of 10% & 5 billion won or more in the ka type are included in the negotiation target, the amount of savings will increase by about 4.4 billion won (22.4 billion → 26.8 billion won) as of 2022. In addition, as a short-term improvement plan, it was proposed to increase the efficiency of negotiations and system acceptance by raising the exclusion standard from the current claim amount of 2 billion won to 3 to 5 billion won. Some of the research results were also disclosed at the meeting of Sang-Il Lee, executive director on salary, with the Korea Special Press Association on the 7th. The NHIS plans to make a booklet of the research results and distribute them to pharmaceutical organizations such as KRPIA, and to hold a meeting at the end of April prior to the operation of the working group in May. The working group runs from May to August and aims to implement improvement measures next year by revising related regulations in the second half of the year.
- Policy
- 16% of PVA-applied products cut more than 2 times
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- The items with the highest cumulative reduction rate fell 25.2% in total with three cuts. It was found that about 16% of the total products had the upper limit price lowered twice or more with PVA. The remaining 84% of products were cut once. Compared to the pharmaceutical industry's complaints about repeated cuts, the number of products with repeated cuts did not appear high. According to the 'PVA Performance Evaluation and Improvement Study report recently published by the NHIS, 62 product groups (16%) out of 380 identical product groups in which the usage-drug price interlocking system was applied from 2012 to 2021 had an upper limit twice or more. the amount has been reduced. 318 products (84%) of the same product group were cut only once. There were 36 product lines cut twice (19 domestic, 17 multinationals), 15 product lines cut three times (4 domestic, 11 multinationals), and 9 products cut four times (3 domestic, 6 multinational). The maximum number of iteration cuts reaches 6 times. For one product group, the upper limit was lowered six times due to the usage-drug price linkage system. The price of this product in 2012 was reduced by a total of 13.9% due to the application of the system six times. There was also one 5-time cut product line. The research team explained, “Among the products that were repeated less than three times, there were 9 products from domestic pharmaceutical companies and 17 products from multinational pharmaceutical companies. In addition, the product with the highest cumulative reduction rate was cut three times, a total of 25.2%. This investigation stemmed from the complaints of pharmaceutical companies over repeated cuts. Statistically, however, the repeated cut was not so large. The research team said, “About 16% of the total product groups were subject to repeated application twice or more, and when applied three or more times, they were generally blockbusters. At 14%, it was relatively low compared to the increase in finances.”
- Policy
- The alternative drug pricing system will be improved
- by Nho, Byung Chul Apr 12, 2023 05:53am
- It is expected that the specific direction of the public-private consultative body for rational drug price calculation of domestically developed innovative new drugs will be set, and system improvements will be promoted from May at the earliest. According to the industry, the public-private consultative body for improving the drug pricing system, composed of officials from the Ministry of Health and Welfare, KPBMA, and KRPIA, has held five rounds of discussions since last December and is expected to give positive incentives to new drugs. The drug price system improvement classification plan that the health authorities and the industry have formed a consensus on ▲innovative value for new drugs, ▲recognition of appropriate value for natural medicines (formerly new natural medicines), ▲derived system improvement for raw material self-sufficiency, and ▲stabilization of pharmaceutical supply maintenance of the period of accrual of the amount, etc. This proposal is a point of convergence in the larger framework, and the specific calculation method needs to be narrowed down through a general meeting of the public-private consultative body around the middle of this month. The most noteworthy part is the method of assigning value to new drugs and IMDs, and it is expected to be able to receive up to 10% higher drug prices than existing ones. If the alternative drug was reduced to 53.55% due to patent expiration, an additional 86.8% (100% 53.55%) is requested. IMD is expected to be recognized for up to 110% of development target products, including drugs for which the Ministry of Food and Drug Safety has approved data submission, as well as new usage and dosage. It is also eye-catching to prepare measures to strengthen its status as the originator of oriental medicine and to promote herbal medicine and herbal preparations. In the case of herbal medicines with improved clinical usefulness, it is likely to apply an additional 110% of the highest price of alternative medicines. For drugs using domestically produced drug substances, the additional period will be extended from 1 year to 5 years, and an exception to the follow-up management system will be applied. It is expected that the system will be improved so that if the number of companies for administration routes and products of the same dosage form is two or less, the addition of already-listed products will be maintained until there are three or more.
