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- 2026-05-03 02:58:52
- 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.
- Policy
- Leukemia Scemblix·Onureg passed the Evaluation Committee
- by Lee, Tak-Sun Apr 11, 2023 06:11am
- Leukemia treatments Scemblix and Onureg are recognized for their suitability for reimbursement and will move on to drug price negotiations with the NHIS. The HIRA held the 4th Pharmaceutical Reimbursement Evaluation Committee and reviewed the appropriateness of reimbursement for the six drugs for which the decision was applied. As a result of the deliberation, two out of six items passed, one item conditionally passed, two items failed, and one item decided to be re-discussed. The items that passed the committee first were Scemblix and Onureg. Scemblix 20, 40 mg is indicated for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) previously treated with 2 or more TKIs. At the beginning of the year, the Cancer Disease Review Committee succeeded in setting the reimbursement standard. Onureg 200, 300 mg is used for maintenance therapy after induction therapy in adult patients with AML. The item that passed conditionally was Nephoxil 500mg (ferric citrate monohydrate) from Kyowa Kirin Korea. This drug is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Tabrecta 150 and 200mg and Vyndamax 61mg are items that have not passed the committee due to non-reimbursement decisions. Tabrecta is a drug used for locally advanced or metastatic non-small cell lung cancer in which MET exon 14 skippings have been confirmed, and Vyndamax is a rare disease treatment used for ATTR-CM. Meanwhile, Lilly's RET-targeted anti-cancer drug Retevmo 40, 80mg will be discussed again. This drug has efficacy and effectiveness in RET fusion-positive non-small cell lung cancer, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer.
- Policy
- 3 combination DM drug is cheaper than the 2 combi
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- 2-drug combination therapy should also be provided with reimbursement standards From this month, as it is applied to the three-drug combination therapy of SGLT2 inhibitors, prescriptions for the existing two-drug therapy (SGLT2i + DPP4i) are expected to decrease significantly. The HIRA said on the 5th through a Q&A related to the reimbursement standards for diabetes medications that will change from this month, “The two-drug combination therapy of a combination of a DPP-4 inhibitor and an SGLT-2 inhibitor is only one type of combination within the scope of approval, as is the case at present. You can apply it with a burden,” he explained. DPP4i+SGLT2i that are currently within the scope of approval are Januvia and Forxiga. The amount the patient will pay is 987 won, which is the sum of 734 won (Forxiga, fully paid by the patient) and 253 won (Januvia, 30% of 846 won). If Metformin is included in the prescription, the drug cost will decrease. This is because from this month, regardless of the ingredients, benefits will be applied to the combined use of met+DPP4i+SGLT2i. This is because if Forxiga 10mg + Januvia 100mg plus Metformin 500mg (highest price 119 won), which is taken daily, the patient's co-payment is only 509 won because 30% is applied. From the patient's point of view, the cost of three drugs has become cheaper than the cost of two drugs. Accordingly, it is analyzed that there is a high possibility that the medical field will prescribe a 3-drug containing metformin instead of an expensive 2-drug. Some experts are concerned that prescriptions for metformin will increase even for patients who do not need to take metformin, and social costs may only increase if prescribed Metformin is not accepted. There is also an opinion of regret that the DPP4i + SGLT2i two-drug regimen is not provided in this reimbursement standard. However, as the reimbursement review for the two-drug combinations is underway, some say that the reimbursement criteria for the two-drug regimen will be established sooner or later.
- Policy
- Reimb review for Pompe disease drug Nexviazyme underway
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- Reimbursement review is underway in Korea for Nexviazyme Inj (avalglucosidase alfa-ngpt), Sanofi’s Pompe disease drug that had been approved by the Ministry of Food and Drug Safety on the 29th. Nexviazyme is the first biobetter among rare disease drugs to be approved in Korea. According to industry sources on the 7th, the Health Insurance Review and Assessment Service started the reimbursement review for Nexviazyme and requested the Ministry of Food and Drug Safety to confirm the drug’s Target Product Profile. Nexviazyme is regarded an upgraded version of the company's Myozyme. The MFDS has been approving products with improved safety, efficacy, and use over existing approved biodrugs or those that were recognized for their progressive technology, as biobetters. Nexviazyme is the first drug among rare disease drugs to obtain marketing authorization as a biobetter drug. Pompe’s disease is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA). When left untreated, it may lead to muscle damage, respiratory failure, movement disorders, and even premature death. The company has implemented innovative technology to increase the amount of mannose-6-phosphate (M6P), which plays a major role in the drug's cellular enzyme uptake, in Nexviazyme by 15 times compared with Myozyme. The company added, the increase in M6P also improves immunogenicity and provides safety benefits. Myozyme is currently reimbursed at KRW 653,000 per vial. In 2021, USD 7.7 million's worth of Myozyme was imported to Korea.
- Policy
- Only a few cold drugs will be subject to PVA negotiations
- by Lee, Tak-Sun Apr 10, 2023 05:52am
- The number of drugs subject to negotiations under the Price-Volume Agreement (PVA) system among cold medicines and antibiotics whose usage increased explosively with the rise in the number of confirmed COVID-19 patients, is expected to be small. When the National Health Insurance Service applied the correction plan it had devised after collecting industry opinion, results showed that little more than 10 items were subject to negotiations. Such results will be applied around the end of April when the government monitors PVA ‘Type C’ drugs. According to industry sources on the 8th, the NHIS corrected the use amount of about 2,600 cold medicines and antibiotics whose use had increased due to COVID-19 and simulated the number of items that will be subject to negotiations. Results showed that the subject drugs were reduced to around 10. The correction was made by comparing each drug’s use amount with the previous year after excluding their usage from a specific month when the number of COVID-19 cases increased explosively. When applying the correction, most of the drugs were not subject to receive negotiations. In other words, their amount of use was similar to the previous year, if not for the COVID-19 crisis. Drugs fall under Type C when claims of products in the same therapeutic class increase by over 60% from the claims amount filed in the previous year, or have increased by over 10% but the increased amount exceeds KRW 5 billion. Items that did not undergo NHIS negotiations on their expected claims amount fall under ‘Type C.' Most of the cold medicines and antibiotics that the correction plan will be applied to fall under PVA ‘Type C.' Therefore, the NHIS plans to apply the final correction plan when monitoring drugs for Type C PVA negotiations. As monitoring is expected to begin at the end of April, the industry expects the correction plan to soon be finalized.
- Policy
- Generics for Forxiga will be released simultaneously on the
- by Lee, Tak-Sun Apr 06, 2023 05:53am
- Chong Kun Dang, Hanmi, Donga ST, Jeil, Boryeong, Daewon, etc. new products launched As generics of the SGLT-2 diabetes treatment drug Forxiga (Dapagliflozin, AstraZeneca) were released simultaneously on the 8th, the related market is expected to intensify. Last year, outpatient prescription sales of Xigduo, a single drug combining Forxiga and Metformin, were 91.4 billion won (Forxiga's sales were 48.5 billion won, Xigduo's sales were 42.9 billion won), and a large market is forming. From the 8th, a total of 149 items (89 single drugs, 60 complex drugs) of Dapagliflozin will be covered by insurance, and fierce competition will unfold for the 90 billion won market. According to the industry on the 5th, the Ministry of Health and Welfare announced that 149 dapagliflozin diabetes treatment drugs would be added to the benefits list from the 8th. Including the two items of Dong-A ST Dapapro, which were on the existing list, a total of 151 Dapagliflozin active ingredient drugs are covered by health insurance. As the market size is large, generics include many large companies. Chong Kun Dang, Hanmi Pharm, Jeil Pharm, Boryung, and Daewon Pharm, which introduced salt-altering drugs, including Dong-A ST, which entered the market first through prodrugs last December, will enter the market. As Forxiga is the first original drug in the SGLT-2 series whose patent has expired, and Daewoong Pharmaceutical, which owns Envlo, is the only domestic company that owns SGLT-2, it is analyzed that large companies have also participated en masse in the generics market. The drugs entering the market this time include 5mg and 10mg of single active ingredients of Dapagliflozin, Metformin 1000mg + Dapagliflozin 10mg, Metformin 500mg + Dapagliflozin 10mg, Metformin 500mg + Dapagliflozin 5mg, and Metformin 1000mg + Dapagliflozin 5mg. Dapagliflozin 5mg is a drug for which the original drug is also registered for reimbursement. Therefore, it is expected that the effect of increasing the market size will be large with the introduction of generics. The upper limit is 262 to 342 won for Dapagliflozin 5mg and 334 to 514 won for 10mg. The highest price of Dapagliflozin 5mg is Dong-A ST Dapapro 5mg. The highest price of 10mg includes Dong-A ST Dapapro 10mg, Hanmi Pharmaceutical Dapalon 10mg, Boryung Trudapa 10mg, Kyungdong Pharmaceutical Dapazin 10mg, Sinil Foxigly 10mg, Han Wha Posilozin 10mg, KUKJE PHARM Focidi 10mg, Daewon Dapaone 10mg, etc. The most expensive drugs are prodrugs or salt-altering drugs, priced at 70% of the original upper limit. On April 8 next year, the additional price will end, and the drug prices will all be the same at 53.55% of the highest price. In the case of a single agent, 5mg is 262 won, and 10mg is 393 won. An official from the pharmaceutical industry explained, "As Forxiga accounts for a large portion of the diabetes treatment market, and since the combination of SGLT-2 drugs has been expanded since April, expectations for generics are also high."
- Policy
- Government's drug pricing policy
- by Lee, Jeong-Hwan Apr 05, 2023 05:48am
- The Ministry of Health and Welfare revealed its will to create a specific preferential drug price policy for innovative new drugs and essential drugs, and at the same time, it revealed a policy to use generic drugs by reducing drug prices, attracting attention. Recently, in the process of reviewing the amendment to the Special Act on the Promotion of the Pharmaceutical Industry, which was proposed by Rep. Jeong-sook Seo of the National Assembly’s Health and Welfare Committee, the 1st Bill Subcommittee of the National Assembly, 2nd Vice Minister of Welfare Park Min-soo revealed the direction of the operation of the drug price policy. The key to the bill proposed by Rep. Seo Jeong-sook is to convert the arbitrary regulations on preferential drug prices for drugs made by innovative pharmaceutical companies into mandatory regulations. The Ministry of Health and Welfare expressed difficulties with the provision and virtually opposes it while promising to make a specific provision that can give preferential treatment to innovative pharmaceutical companies through consultation with the pharmaceutical industry and discussions at the National Assembly. Rep. Seo Jung-sook and Democratic Party lawmaker Nam In-soon expressed doubts about the position of the Ministry of Health and Welfare but decided to believe it. Rep. Seo said, "If you look at the administrative flow of the Ministry of Health and Welfare if you say 'can do', will it be possible to support innovative pharmaceutical companies to the extent of sending a message?" Rep. Nam, who introduced a bill with an arbitrary clause giving preferential treatment to innovative pharmaceutical companies four years ago, pointed out the administration of the Ministry of Health and Welfare, which had not enacted sub-statutes, and even checked whether the WTO complaint problem was resolved. Rep. Nam said, “Is there any problem with the WTO complaint that I was concerned about? Vice Minister Park Min-soo said that he actively sympathized with the legislation that converts the preferential drug price provisions for drugs made by innovative pharmaceutical companies from voluntary regulations to mandatory regulations, but appealed that even if the amendments to mandatory regulations are ineffective. Vice Minister Park’s position was that the Ministry of Health and Welfare would come up with a specific drug price preferential policy through communication with the pharmaceutical industry even if the law was not changed due to the enforcement of preferential drug prices. In addition, he said that the drug price preferential policy for innovative pharmaceuticals was announced several times and the pharmaceutical industry was already aware of it and that the drug price preferential policy reflecting this was being communicated with the pharmaceutical industry. Vice Minister Park said, "There are few legislative precedents that revise the law to make it mandatory by saying that drug prices should be given preferential treatment. As the Ministry of Health and Welfare has already expressed its willingness to policy, if you keep an eye on it, we will come up with a policy plan by materializing the presidential decree and improving the health insurance drug pricing system." “It is a burden to do it as a duty,” he added. Vice-Minister Park said, "Even if the law is revised as 'must', even if the current drug price preferential system is not changed even one person, the revised law will not be violated." "For effectiveness, the government's will and policy direction must be firmly established. I raised the price of the drug I was using to 89 won. The preferential price for innovative drugs is steadily preparing and I have a firm will.” Vice Minister Park said, "In terms of WTO issues, most of the (preferential) targets are likely to become global companies if they are innovative pharmaceutical companies. The government's idea is to foster the domestic industry, but there was a dilemma in going global." are doing," he said. Regarding generic drug prices, it was clear that the system would be revamped in the direction of cutting. He is determined to operate the system so that pharmaceutical companies will no longer be seen engrossed in generic marketing competition rather than innovation, such as new drug discovery and research and development. Vice Minister Park said, "There has been a preference for generics so far, and now generics are being cut down mechanically and step by step in the order they come in." We just put in our effort," he said. "It is the Ministry of Health and Welfare's idea that this behavior should disappear from the industry and we will take action,” he added.
