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- 2025-12-22 03:13:52
- Policy
- Medical expenses exceed ₩1 trillion
- by Lee, Tak-Sun Oct 04, 2023 05:35am
- The number of lung cancer patients has steadily increased, and health insurance medical expenses exceeded 1 trillion won last year. The NHIS (Chairman Jeong Ki-seok) announced this by using health insurance treatment data to promote the status of health insurance treatment for lung cancer patients from 2018 to 2022. The number of patients treated increased by 25,236 (27.7%↑) from 91,192 in 2018 to 116,428 in 2022, and the average annual increase rate was 6.3%. The number of men will be 70,564 in 2022, an increase of 22.5% (↑12,969) compared to 57,595 in 2018, and the number of women will be 45,864 in 2022, an increase of 36.5% (↑12,267) compared to 33,597 in 2018. Looking at the composition of medical staff by age group, of the total medical staff (116,428 people), those in their 70s accounted for the most at 34% (39,541 people), those in their 60s accounted for 32.2% (37,516 people), and those in their 80s or older accounted for 17.8% (37,516 people). 20,704 people) followed. For men, those in their 70s accounted for the highest proportion at 37.3%, followed by those in their 60s at 31.1% and those in their 80s or older at 18.8%. For women, 33.9% were in their 60s, 28.8% were in their 70s, and 16.2% were in their 80s or older. Health insurance medical expenses for lung cancer patients increased by 39.9% (364.8 billion won) compared to 2018, from 915 billion won in 2018 to 1.2799 trillion won in 2022, with an average annual increase rate of 8.8%. Looking at medical expenses per person over five years, it increased by 9.6% from 10.03 million won in 2018 to 10.99 million won in 2022. Lung cancer refers to a malignant tumor that occurs in the lung and can be divided into 'primary lung cancer' in the tissues that make up the lung and 'metastatic lung cancer' in other organs and spreads to the lung. It is said that smoking is the leading cause of lung cancer known to date, with results showing that approximately 80% of deaths due to lung cancer are due to smoking. Lee Sang-cheol, a professor in the Department of Respiratory Allergy at National Health Insurance Ilsan Hospital, said, "More than 70% of the causes of cancer are due to environmental factors and lifestyle habits such as smoking, high-fat diet, drinking, and exposure to carcinogens. As we age, these risk factors decrease. “The amount of exposure increases,” he said. He explained, “The gradual increase in the elderly population due to aging is also the cause of the increasing cancer incidence rate in elderly patients.”
- Policy
- New pharmaceutical data protection system begins
- by Lee, Jeong-Hwan Oct 04, 2023 05:35am
- Legislation is being promoted to abolish the drug reexamination system, establish a separate legal basis for the drug data protection system, encourage research and development in the pharmaceutical industry, and strengthen the monopoly on the IMDs market. It also includes provisions to reduce the burden on pharmaceutical companies due to the reexamination system and overlapping operations by integrating the drug post-marketing safety management system into the risk management system. On the 3rd, Jeon Hye-sook, a member of the Democratic Party of Korea, announced that she had proposed a partial amendment to the Pharmaceutical Affairs Act to this effect. The Ministry of Food and Drug Safety has been insisting on the necessity of this legislation since 2020, and it is expected to be passed in the 21st National Assembly. The key to Representative Jeon Hye-sook's bill is to abolish the drug reexamination system and establish a separate legal basis for the drug data protection system. We encouraged domestic pharmaceutical companies to actively conduct clinical trials by expanding the scope of application of the law so that drugs approved by submitting new clinical trial data in addition to drugs under the existing reexamination system can also be subject to the data protection system. Looking at the data protection system contained in Representative Jeon Hye-sook's bill, 'orphan drugs' are 10 years from the date of product approval, 'new drugs' are 6 years, and 'the type of active ingredient is changed to improve the safety, efficacy, and usability of drugs that have already received product approval.' The protection period for clinical trial data was set at 6 years for 'medicines that require submission of new clinical trial data, such as 'for drugs that require submission of new clinical trial data to obtain product approval', and up to 4 years for 'other drugs that require submission of new clinical trial data to obtain product approval.' This is expected to lead to the effect of granting a 4-year data protection period to pharmaceutical companies that developed a new phase 3 clinical trial, allowing them to have market exclusivity for a certain period of time. This means that the current re-examination system has improved the irrationality of failing to grant a re-examination period to some IMDs. Rep. Jeon Hye-sook explained, “The drug re-examination system is intended to ensure post-marketing safety, and it has been pointed out that it does not fit the purpose of the data protection system.” She explained, "We will improve the pharmaceutical industry's research and development capabilities by submitting new clinical trial data in addition to drugs under the existing reexamination system so that approved drugs can also be subject to data protection."
- Policy
- Legislation to prevent reverse-payment agreements
- by Lee, Jeong-Hwan Oct 04, 2023 05:35am
- Legislation is being promoted to eradicate the so-called 'generic reverse-payment agreements’ that prevent the launch of generic drugs by delaying or suspending the price cuts made on new drugs. If passed, the legislation will stipulate the reduction in the reimbursement price or suspension of reimbursement of drugs that took part in unfair collusion, such as reverse-payment agreements. Rep. Young-Seok Seo of the Democratic Party of Korea announced on the 27th that he proposed a bill for the partial amendment to the National Health Insurance Act that contained the contents above. The current law sets the price of the original drug that is currently listed for reimbursement in Korea at 70% of its current price, and the price of the generic at 59.5% of the original drug’s price when the first generic version of the original drug is released. When the third generic drug is released, the price of the original and the generic drugs are set at 53.55% of the previous existing drug price. Rep. Seo believes that although the launch of generic drugs is what leads to the price reduction of the original drug, the issue is that some companies are employing expedient measures to avoid lowering the price of their drugs with collusion. The Fair Trade Commission had uncovered acts of collusion between companies, where pharmaceutical companies producing and releasing generic versions agreed not to produce or release their respective generic versions in return for receiving exclusive domestic distribution rights from the original company. In this regard, Rep. Seo proposed a bill to prevent pharmaceutical companies from making unfair profits through collusion by reducing the reimbursed insurance ceiling price or suspending reimbursement of drugs that took part in unfair collusion. Rep. Seo explained, “If generic drugs are not released due to collusion between pharmaceutical companies, it is the patients that suffer the burden of drug cost and the health authorities that bear the increased financial leakage burden. The bill can establish a fair drug sales order and prevent waste of Korea’s health insurance finances.”
- Policy
- Myung-in & Hwan-in are launching Fycompa’s generics
- by Lee, Tak-Sun Sep 27, 2023 05:44am
- 에자이 . It is to launch early , and through this, the drug price was added 6% more than before. According to the industry on the 25th, Myungin and Hwanin will be reimbursed, respectively, on the 14th, when Fycompa material patent expires. It is launched on the market with a total of 6 dosages, and it is the first of the same ingredient in Korea. They succeeded in evading Fycompa patent (expected to expire on October 14, 2026) for an early release. Through this, they also received permission of priority for exclusivity and obtained exclusive rights in the late-after drug market from the 14th to July next year. During this period, the same formulations as the two products cannot be put on the market. The original has never adjusted the upper limit to 53.55% because there are no generics. The government grants an additional to these first generics. The typical generic is adjusted to 53.55% of the original highest price, while the first generic is priced at 59.5%. Fycompa was released in Korea in February 2016. It can be used as a single therapy for patients with partial epiluretic seizures in adolescents 12 years and older. According to last year's IQVIA, sales were 5 billion won, up 8.9% from the previous year.
- Policy
- MFDS grants EUA of Moderna’s adapted COVID-19 vaccine
- by Lee, Hye-Kyung Sep 27, 2023 05:44am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) approved the emergency use of Moderna’s monovalent vaccine ‘Spikevax Inj (andusomeran)’ that targets the COVID-19 Omicron subvariant (XBB 1.5) on September 26. The emergency use approval was granted per request by the Korea Disease Control and Prevention Agency to carry out its vaccination plan to prevent COVID-19 in the 2023-2024 winter season. The vaccine has already been approved in the United States and Europe. Previously, on September 12, the MFDS had also granted emergency use approval of Pfizer’s ‘Comirnaty Inj 01.mg/ml (monovalent vaccine that targets the COVID-19 Omicron subvariant (XBB1.5). The MFDS expects that the approved vaccines will help prepare for the winter pandemic and expressed that it will continue to make the best efforts to ensure that the public can receive the vaccine with peace of mind by reinforcing its safety management, including thorough quality control and collection of adverse events.
- Policy
- Resolving Conflicts in Non-face-to-face Medical treatment
- by Lee, Jeong-Hwan Sep 27, 2023 05:44am
- The Ministry of Health and Welfare cited the legalization of non-face-to-face treatment through the revision of the Medical Act as a solution to resolve the conflict between the medical community and the medical community surrounding non-face-to-face-face treatment. In addition, the MOHW expressed his will to improve the non-face-to-face treatment pilot project as soon as possible, reflecting the on-site opinion that the scope of the first diagnosis is narrow, the criteria for re-examination is vague, and there is a gap between the medical field. On the 26th, the Ministry of Health and Welfare responded to the written question of Rep. Choi Young-hee, a member of the National Assembly Health and Welfare Committee. Rep. Choi Young-hee pointed out that it is necessary to institutionalize non-face-to-face treatment through the revision of the Medical Act based on the temporary non-face-to-face treatment results, but it is in a shutdown situation due to the non-infection of legalization. In response, the Ministry of Health and Welfare explained that the temporary non-face-to-face treatment conducted from the 2nd of 2020 to May of this year is only 0.3% of the total number of outpatient visits, and the pilot project carried out in June and July this year accounts for 0.2%, and explained that non-face-to-face-to-face treatment is being used as an auxiliary means of face-to-face treatment. The Ministry of Health and Welfare responded that revision of the law is essential to provide stable and predictable non-face-to-face treatment to the public, and it is urgent to deliberate on the revision of the medical law. In particular, the Ministry of Health and Welfare is that in order to resolve conflicts with the medical community and the pharmaceutical community, the National Assembly needs to reach a social agreement by revising the medical law. Furthermore, the Ministry of Health and Welfare has revealed a plan to objectively analyze and improve the current non-face-to-face treatment pilot project. The plan is to revise and improve the scope of the pilot project as soon as possible, reflecting the opinion that the scope of the initial diagnosis is too narrow and the criteria for re-examination is ambiguous, so there is a gap with the medical field. The Ministry of Health and Welfare said, "We will continue to prepare legislative and policy improvement measures for non-face-to-face treatment by reflecting the opinions of the field, evaluation and analysis results of pilot projects, discussions of advisory group, and satisfaction survey results. Legalization is essential to prevent illegal acts related to non-face-face-to-face treatment in advance and provide non-to-face treatment stably."
- Policy
- Why did the original Ninlaro voluntarily cut its price 34%
- by Lee, Tak-Sun Sep 27, 2023 05:44am
- The insurance ceiling price of Takeda Pharmaceuticals Korea’s multiple myeloma treatment ‘Ninlaro Cap’ will be discounted by 34% from October. 10% of the price cut is made due to the price-volume agreement system, but the company had voluntarily lowered the price significantly over the set 10%. It is rare for an original drug with no generic to reduce its insurance price ceiling by over 30%. Why did Takeda decide to make such an unexpected price cut? According to the industry on the 26th, from October 1, the insurance price ceiling of Ninlaro will be lowered by KRW 494,000 from the previous KRW 1,450,000 to KRW 956,000. This is a drastic reduction amounting to 34%. First, the maximum reduction rate for this drug was reduced by 10% through the price-volume agreement negotiations. It was reduced from KRW 1,450,000 to KRW 1,305,000. In addition, the company further lowered the insurance price ceiling to KRW 956,000 voluntarily. Regarding the price cut, Takeda Pharmaceuticals Korea, said, “In addition to the reduction due to the price-volume agreement negotiations, the change in the insurance price ceiling of Ninlaro Cap. is the result of the change in the company's internal policy. The company is pleased to be able to provide Ninlaro Cap. to patients with multiple myeloma in Korea at a reduced price." “All decisions within our organization are made in accordance with our code of conduct - Patient, Trust, Reputation, Business (PTRB) — which bring our values of Takeda-ism to life.” The nuance is that the price cut will provide economic benefits to patients. However, some analysts say that the reduction in the price ceiling will only change the list price, and there will be no actual change in the real price of the drug. Rather, the analysts expected that the company would benefit from tax reduction by lowering the list price. Ninlaro is reimbursed through an RSA (risk-sharing agreement) with the National Health Insurance Service. It is reimbursed through a refund-type RSA, which means that a certain percentage of the drug expenditure that exceeds the pre-agreed amount is refunded to the NHIS by the company. Refunds are made based on the actual price, not the list price (insurance price ceiling). Accordingly, the analysis is that if the actual price does not change, it will not affect product performance, health insurance expenditures, or the economic burden of patients. An industry official said, "The actual price may have gone down through the NHIS’s PVA system. But the voluntary cut seems to have only changed the upper limit of the list price." He added, "If the actual price remains the same, nothing much will change in the field.” He added, “However, by lowering the list price, you can benefit from tax savings during customs clearance. I understand that many companies that receive reimbursement through RSA are considering lowering their drug’s list price for tax benefits.”
- Policy
- Madopar triggers bioequivalence test verification requests
- by Lee, Hye-Kyung Sep 26, 2023 05:50am
- The demand has been rising for the government to verify the validity of bioequivalence tests conducted by generic versions of Madopar Tab (levodopa-benserazide), Roche Korea’s Parkinson's disease drug that had withdrawn from the domestic market. Opinions are being collected on the post ‘Regarding the validity of bioequivalence tests that serve as the standard for approving generic drugs’ that appeared as an open petition on the Petition24 website earlier this month. The opinion collection deadline is October 6. The petitioner, who described himself as a Parkinson's disease patient for 20 years, said, "Original drug manufacturers are withdrawing from Korea because of fake generic drugs. No matter how cheap the drugs are, we are in a situation where we have to put aside good drugs and take quack generic drugs.” The price of Madopar Tab was reduced with the introduction of generics in 2021, and Roche Korea voluntarily withdrew its marketing authorization on January 6 this year. The Ministry of Health and Welfare had been making efforts to supply the original in Korea, such as by extending the reimbursement term for Madopar that Roche voluntarily withdrew, from July 31 to December 31. However, Roche Korea submitted a written position on how it would be difficult to resupply the drug in Korea because the company has to obtain documents necessary for new domestic approval from its Italian manufacturing plant that produces Madopa Tab, and the manufacturing facility has been demanding a considerable price due as cost of restoring manufacturing facilities to produce the quantities for export. This is why patients have been demanding the Ministry of Food and Drug Safety to verify the validity of the bioequivalence tests that are conducted for the approval of generics. The petitioner said, "The withdrawal of original drugs and the introduction of generic drugs is a very natural phenomenon in some ways. I happily accepted this phenomenon and switched prescriptions to the relatively inexpensive generic drugs." "However, I physically feel the difference in effect when taking the medicine for a long time. Bioequivalence tests are designed on a logical and scientific basis, and many people have a great deal of trust in this bioequivalence test, I know that it is an internationally recognized test. But due to my personal experience, I can’t help but start to have doubts about its validity.” Therefore, the petitioner requested the government to create a bioequivalence test feasibility study team composed of experts to examine whether standards for generic drugs could be added to bioequivalence tests or whether new standards were needed and create an international standard for generic drugs that can be recognized around the world. However, the MFDS drew the line that the safety and effectiveness of generics that passed the bioequivalence test were equivalent to the original. An MFDS official emphasized, "In the case of generic drugs, bioequivalence tests that compare the drug with the original are required upon approval. When a generic drug demonstrates its bioequivalence to the original, its safety and efficacy are judged to be equivalent to the original drug. This is an internationally accommodated standard."
- Policy
- Pfizer’s Bosulif in pricing negotiations for reimb in KOR
- by Lee, Tak-Sun Sep 26, 2023 05:49am
- The reimbursement listing process for Pfizer’s Philadelphia chromosome-positive chronic myeloid leukemia (CML) treatment Bosulif (bosutinib) is gaining momentum. The drug has entered the drug pricing negotiation stage only 8 months after it received approval in January in Korea. As a late 2nd-gen Ph+ CML drug entrant to Korea, the drug is expected to contribute to increasing Pfizer's recognition in the domestic Ph+ CML treatment market. According to industry sources on the 25th, Pfizer accepted the results of the Drug Reimbursement Evaluation Committee (DREC) meeting that was held on the 7th. At the meeting, The efficacy and effect of Bosulif 100, 400, and 500mg were deemed adequate for reimbursement if the company accepts a price below the assessed price for Ph+ CML. DREC is understood to have presented a price lower than the weighted average of its alternative as other second-generation drugs, such as BMS Korea’s ‘Sprycel,’ Novartis’s ‘s ‘‘Tasigna,’ and Il-Yang Pharamceutical’s ‘Supect (ladotinib)’. In Korea, up to 4th generation Ph+ CML treatments have been released with the reimbursement listing of Novartis ‘Scemblix’ in July. As Pfizer accepted the conditions presented by DREC, Bosulif is expected to move on to the drug price negotiation stage. This is in 6 months since it the drug was first approved last January. At the HIRA's Cancer Disease Deliberation Committee that was held a month before DREC, the drug succeeded in setting reimbursement standards only for Ph+ CML as a second-line treatment. CDDC has decided to recognize the adequacy of the drug’s reimbursement only for Ph+ CML in the chronic phase (CP), accelerated phase (AP), and blast phase (BP) that shows resistance or intolerance to previous therapy. On the other hand, no reimbursement standard had been set for the treatment of newly diagnosed chronic phase Ph+ CML. Accordingly, Pfizer is expected to first list the drug as a second-line treatment as soon as possible, then move forward and expand its reimbursement as a first-line treatment. Given that the drug price negotiation deadline with the National Health Insurance Service is 60 days, there is a high possibility that the drug will be reimbursed within the year. If this happens, the drug will gain attention as a new drug that took less than one year from approval to reimbursement.
- Policy
- Hanmi is the first to release Zytiga generic at half price
- by Lee, Tak-Sun Sep 25, 2023 05:35am
- Hanmi Pharm has become the first to launch the first generic of Janssen's prostate cancer treatment ‘Zytiga (abiraterone acetate).’ In particular, the drug is expected to greatly reduce the financial burden borne by patients as it is sold at a much lower price than the original Zytiga. According to industry sources on the 22nd, Hanmi Pharm’s 'Abiteron Tab 500mg' will be listed for reimbursement on the 1st of next month. The drug is a generic that contains the same ingredients as Zytiga and is the first generic to be listed for reimbursement. Its insurance price ceiling is KRW 8,537 per tablet, which is almost half of that of Zytiga, which is KRW 16,780. It is even lower than 53.55% of the original price, which is the standard used to calculate the price of generics. The company said that it set a low price to reduce the financial burden on patients and improve accessibility. There are no patents registered on MFDS’s green list for Zytig. Nevertheless, the reason no other generic version has been approved so far is due to the difficulty in conducting bioequivalence tests. However, Hanmi succeeded in completing the bioequivalence test and won the first generic title. Abiteron has the same indications as Zytiga. The drug is indicated for ▲the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer, ▲treatment of f metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen, and ▲ treatment of newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). Among these, Janssen, which owns the original Zytiga, is taking steps to convert the selective reimbursement (30% copayment rate) status of the third indication to essential reimbursement (5% copayment rate). If the company succeeds in expanding reimbursement of its drug, Abiteron is also expected to benefit and receive expanded coverage. Based on IQVIA sales, Zytiga recorded sales of KRW 21.8 billion in Korea last year.
