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- 2026-03-12 01:02:46
- 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.
- Policy
- Mifegyne, inadequate national essential drug system
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- Rep. Nam In-soon applies as a reference to the Pharmaceutical Society for a Healthy Society Anticipation of questions such as transparency of essential medicines. Problems with the national essential drug designation system and the issue of the miscarriage inducer Mifegyne not being designated as a national essential drug are expected to be discussed at this year's Ministry of Food and Drug Safety inspection. On the 22nd, after examining the final list of applications for witnesses and references for the National Assembly's Health and Welfare Committee of the National Assembly, Nam In-soon, a member of the Democratic Party of Korea, applied for Lee Dong-Geun, secretary general of the Pharmaceutical Association for a Healthy Society, as a reference. Rep. Nam's reason for applying as a reference is to inquire about problems with the national essential drug system. The Pharmaceutical Association for a Healthy Society has been pointing out problems with the Ministry of Food and Drug Safety's national essential drug designation system for several years now. The biggest problem that the Pharmaceutical Association for a Healthy Society is looking at is that the purpose and standards for reorganizing the national list of essential drugs are unclear, and that “miscarriage-inducing drugs,” which civil society has been continuously demanding, are not designated as essential drugs. Due to the decision in 2019 to make the abortion law unconstitutional, many women are receiving abortion procedures at medical institutions starting in 2021, but abortion through medication is still not performed in Korea, and the reason for this is the non-designation of Mifegyne as an essential drug. The Ministry of Food and Drug Safety has not designated Mifegyne as a national essential drug. Although the Ministry of Food and Drug Safety's failure to designate Mifegyne as an essential drug cannot necessarily be viewed as faulty administration, it has been pointed out that the national essential drug designation system must be disclosed more transparently in order to examine whether it is proper administration. This is also the reason why the Pharmaceutical Association for a Healthy Society is demanding that the Ministry of Food and Drug Safety reveal the standards for designating nationally essential drugs. In addition, the Pharmaceutical Association for a Healthy Society pointed out that it was a problem that nine items for the treatment of acquired immunodeficiency syndrome (HIV) were included in the list of drugs that can be de-designated as essential drugs. Acquired immunodeficiency requires a variety of medicines due to the nature of the disease, and it is unreasonable for the Ministry of Food and Drug Safety to consider lifting the designation even though there is a precedent in the past where multinational pharmaceutical companies unilaterally stopped supply for economic reasons. An official from the Pharmaceutical Society for a Healthy Society explained, “We plan to respond to questions from the National Inspector General regarding the non-designation of miscarriage inducers such as Mifegyne as essential drugs and urge that the standards for designation as national essential drugs be disclosed more transparently than they are now.” He explained, “Even if a lactic acid inducing drug is not approved for domestic marketing, it is possible to designate it as an essential drug, but the Ministry of Food and Drug Safety is holding on by refusing to respond.”
- Policy
- Vabysmo·Evrysdi will be reimbursed in October
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- New reimbursement standards for Vabysmo, SMA treatment Evrysdi, and hemophilia A treatment Jivi (Damoctocog Alfa Pegol) will be established from the 1st of next month. The scope of reimbursement for Spinraza, a cure for spinal muscular atrophy, will be expanded, and the reimbursement standard for the emergency introduction drug Ivexproglycem Suspension will be established within the range recognized by the Minister of Food and Drug Safety. The Ministry of Health and Welfare recently announced some revisions to the details of the standards and methods for applying such nursing care benefits. We plan to implement it from the 1st of next month after collecting opinions on the 25th. ◆Vabysmo=Vabysmo, an ophthalmic medication, is newly approved for neovascular (wet) age-related macular degeneration and diabetic macular edema. If the medication is replaced with Vabysmo with an administration opinion attached, and the treatment effect does not appear after 3 administrations, subsequent administration will not be reimbursed. In addition, for diabetic macular edema, reimbursement is recognized up to 14 times in total, including the number of administrations of Aflibercept and Ranibizumab. ◆Evrysdi=Evrysdi is newly reimbursed when administered to patients with 5q spinal muscular atrophy with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene. ▲If the SMN2 gene copy number is 3 or less even before the onset of symptoms and the start of treatment is less than 6 months old, or ▲Patients who have developed SMA-related clinical symptoms and signs and are Type 1 to Type 3 and are not using a permanent ventilator are eligible for the benefit. Reimbursement is not recognized for replacement or co-administration between Evrysdi and spinal muscular atrophy treatment. However, if improvement is confirmed during Spinraza administration and does not meet the discontinuation criteria, but the committee determines that there are clinical reasons for replacement with Evrysdi, one replacement administration is permitted. In addition, in-hospital prescriptions are the principle, but for long-term prescriptions, the dosage per prescription is limited to 2 bottles for discharge and outpatient use. ◆Jivi = Hemophilia A treatment Jivi is approved for reimbursement when administered to adult and adolescent (age 12 or older) hemophilia A patients with a previous treatment history (exposure for more than 150 days). The single administration dose (one serving) is 20-25 IU/kg. However, in case of moderate or higher bleeding, up to 30 IU/kg is allowed depending on the doctor's medical judgment. ◆Spinraza = Spinraza's benefits range is expanded based on the same standards as Evrysdi. Patients with 5q Spinal Muscular Atrophy (SMA) with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene are eligible for administration. Eligibility for coverage is ▲ SMN2 gene copy number of 3 or less even before symptom onset and less than 6 months of age at the start of treatment, or ▲ Type 1 to Type 3 with SMA-related clinical symptoms and signs and not using a permanent respirator. In addition, both Spinraza and Evrysdi will be added to the list of expensive drugs. The management period is 1 year, and those eligible for management are those who are over 18 years old at the time of first administration and have an HFMSE score of less than 5 points. ◆Other= Ivexproglycem Suspension is within the scope recognized by the Minister of Food and Drug Safety, that is, inoperable pancreatic islet cell adenoma, pancreatic islet cell carcinoma, or extrapancreatic malignant tumor in adults, leucine sensitivity, pancreatic islet cell hyperplasia, extrapancreatic malignant tumor, and islet cell in infants and children. Reimbursement is recognized for the treatment of hyperinsulinemia related to adenoma or pancreatic islet adenomatosis. It can be used not only as a temporary measure before surgery but also when hypoglycemia persists after surgery. Preda and Progynova, which are estradiol preparations, are approved for use not only within the scope of approval, such as prevention of menopausal disorders and postmenopausal osteoporosis, but also for hypoestrogenism (for women over 11 years of age) due to decreased gonadal function and ovarian dysfunction, and assisted reproductive technology.
