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- 2025-12-25 21:25:21
- Policy
- The number of generics in Korea is more than 10 times higher
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- It is pointed out that the number of generic drugs with the same active ingredient licensed in Korea is “more than 10 times higher” in foreign countries such as the United States and France. This is the result of comparing the top five items with the largest number of domestic marketing generics with overseas cases. In particular, it was added that generic drugs, which are more expensive than original drugs, are being prepared in Korea, and that the activation of generic substitution was necessary. On the 13th, nonpartisan representative Lee Yong-ho analyzed the top five products with the highest number of generic drugs in Korea and revealed as such. The top five items as of September this year were Rosuvastatin, Clopidogrel, Mosapride, Cefaclor, and Fluconazole. In Korea, the number of domestic generics for a drug reached 136 to 143. There were no generic or only 2 to 18 generics in the United States and France. Among these items, the lowest price for Fluconazole is from ₩395, the highest price is ₩1,784, and the original’s price is ₩1,726. The price difference between generics is ₩1,389, and the price of the generic is higher than that of the original. In addition, Rosuvastatin, Clopidogrel, and Mosapride, excluding Cefaclor, were also more expensive than the original drug price. He said, "The number of domestic generics is abnormally higher than that of other countries, and even though it is the exact same drug with proven bioequivalence, there is a large price difference between generics." He pointed out that there are too many, causing inconvenience in the people's prescription, dispensing, and drug selection due to information asymmetry. He said, "There are dozens of drugs that are cheaper than the drugs that the people are taking. Few people will know the facts whether or not the drugs they are taking are original, whether they are generics that are more expensive than the original, and whether they are the most expensive generics of the exact same generics with the same ingredients.” In addition, he said, "If bioequivalence testing and securing public confidence in the quality of generic drugs are preceded, drugs entrusted by the same manufacturing facility are exactly the same. As for the rights that the people need to know, generic substitution should be activated as much as for bioequivalence-approved items."
- Policy
- “Riavax problem even noticeable for incompetent officer"
- by Lee, Jeong-Hwan Oct 14, 2020 06:24am
- Former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (left) and Professor Park In-geun of Gachon University Gil Medical Center Witnesses at National Assembly annual audit reproached Riavax, the immunotherapeutic peptide for pancreatic cancer treatment revoked from marketing approval, has apparently submitted review materials that every researcher at Ministry of Food and Drug Safety (MFDS) would notice how they were poorly prepared. Regardless of the failure in global Phase 3 clinical trial and clinical data with highly suspicious reliability, they claimed MFDS did not reject the item approval application but decided to approve the product and even ignored the request for post-review approval revocation. At the National Assembly Health and Welfare Committee’ audit session on MFDS conducted on Oct. 13, former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (M.D.) and Professor Park In-geun of Gachon University Gil Medical Center answered Democratic Party Lawmaker Nam In-soon as witnesses. Lawmaker Nam summoned former Committee Member Kang, who reviewed Riavax approval materials, to point out the faults in Riavax approval review procedure MFDS sloppily handled. Former Committee Member Kang answered, “The submitted evidences were reviewed in August last year, and I sent an email to high-level executives in MFDS in charge of drug approval review to request revocation of the item approval as we found serious issues in the reviewed materials,” because “the eotaxin testing used in the approval review was not approved as itself, and its credibility is so low that it cannot properly prove anything.” She stressed, “The issues found during the review were noticeable even for an incompetent researcher at MFDS. The company submitted an approval application with retrospective analysis based on eotaxin and not a proper clinical trial,” and “it was approved for marketing without credible review standards.” Another witness Professor Park also addressed issues in the Riavax approval review. Professor Park urged, “I suspected there could have been some sort of special treatment for the company, when I read the news the ministry approved of Riavax by retrospectively analyzing eotaxin as a biomarker,” because “eotaxin is irrelevant to Riavax, and using the retrospective analysis on 80 patients out of over 1,000 clinical trial participants as an evidence for the approval was clearly problematic.” “An item approval should be based on evidence to confirm the item whether it would benefit patients in treatment or cause harm to them,” and “Riavax’ effect was weak, and approving these kinds of drugs could eventually take away patients’ treatment opportunity,” Professor Park added. Lawmaker Nam also raised suspicion that the Riavax received special treatment during the approval review as a former director of Review Coordination Division at MFDS was involved. Lawmaker Nam stated, “It is difficult to comprehend how it was possible to accept the result of retrospective analysis as Phase 2 clinical trial to grant an approval with evidence in development,” and “also, it was exceptional for the ministry to approve a treatment supplementary Leukine injection by individually purchasing it when it was not even approved in South Korea. The public criticized how the former director of Review Coordination Division was appointed as a vice-president of GemVax & KAEL and meddled with the review.” The lawmaker demanded, “It is problematic that a MFDS officer takes an executive position at a pharmaceutical company and leads the approval review procedure,” and that “the ministry should hand in results of its self-audit assessing the adequacy of the Riavax approval before the general audit.” A MFDS representative answered the ministry would follow Lawmaker Nam’s order. Minister Lee Eui-kyung said, “Although there was misunderstanding, the transfer of the former director of Review Coordination Division to GemVax & KAEL did not seem to have violated the employment review related regulation,”
- Policy
- What is the result of 759 illegal rebate-related drugs?
- by Lee, Jeong-Hwan Oct 14, 2020 06:23am
- In the last five years, 759 drugs were counted as having received administrative disposition for illegal rebates. Dong-A ST ranked first in the number of rebate disposals with 267 items, while CJ Healthcare ranked second with 114 items and Hanall Biopharma ranked third with 74 items. Among them, only 96 items were suspended from application of medical care benefits. On the 12th, Kwon Chilseung, a member of Democratic Party of Korea analyzed and released the data submitted by the MOHW. According to the data, 759 items of 32 pharmaceutical companies have received illegal rebates over the past five years. Of a total of 759 items, 532 were reduced in drug prices. 96 items were suspended from medical care benefits. The remaining drug disposal details are 94 penalties, 34 drug price cuts and warnings, and 3 warnings. The pharmaceutical company that received the most administrative disposition for drug rebates is Dong-A ST, which includes 267 items. Next, CJ Healthcare followed with 114 items, Hanall Biopharma with 74 items, and Inist Biopharma with 49 items. Kwon Chilseung, a member of Democratic Party of Korea, said, “For the rights that patients and citizens need to know, related information such as rebate providers, related drugs, and recipients should be continuously disclosed.” Also he added that administrative sanctions against providers should be strengthened in order to eradicate rebates.
- Policy
- Orphan drugs introduced in Korea are 'increasing'
- by Lee, Tak-Sun Oct 14, 2020 06:22am
- As the orphan drug market has recently emerged as Blue Ocean, the introduction of Orphan Drugs by global pharmaceutical companies is increasing in Korea. In particular, as the MFDS has given a PMS of up to 11 years to Orphan Drugs through amendment of regulations, the market monopoly is expected to be prolonged. According to the MFDS on the 12th, two of the recently approved Orphan Drugs have been granted PMS for more than 10 years. PMS, which means re-examination of new drugs, is subject to investigation conditions after being marketed during the period, but it also has a data protection function, blocking entry of generic drugs, and thus gaining market monopoly. Since 2017, the MFDS has been granting PMS for 10 years, up to 11 years, in recognition of its contribution to the development of Orphan Drugs with fewer patients and no alternative drugs, and 11 years are granted for pediatric clinical trials. Until last year, only two drugs were given PMS for 10 years. The two drugs are 'NexoBrid', which removes the eschar without harming viable tissue by BL&H in 2018 and 'Raxone', a treatment for visual impairment caused by Leber Hereditary Optic Neuropathy by DKSH Korea in 2019. In August, Pfizer's PMS of 'Vyndamax (Amyloid Cardiomyopathy (ATTR-CM) treatment)' was given 10 years, and in September Kyowa Kirin's PMS of ‘Crysvita' was given 11 years. Crysvita is a treatment for hereditary hypophosphatemia (XLH), and PMS has been recognized for 10 to plus 1 year, up to 11 years because of the results of pediatric clinical trials. Accordingly, Crysvita is exclusive in the market, with data protected until September 16, 2031. An official from the MFDS said, "PMS is granted for 10 years, up to 11 years for orphan drugs that do not have alternative drugs. " In addition, he explained, "In order to support the development of orphan drugs with a small number of patients, we are operating the existing PMS grant period (6 years for new drugs and 4 years for improved drugs)."
- Policy
- Copayment unchanged for using reimbursed Dupixent
- by Lee, Hye-Kyung Oct 14, 2020 06:22am
- When processing atopic dermatitis patients visiting tertiary hospitals, the healthcare institutes should now be aware that the 100-percent outpatient copayment rate does not apply to the severe case patients. On Oct. 7, the Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) provided information on the outpatient copayment rate billed to an atopic dermatitis patient at a tertiary hospital. The South Korean government is to enforce the revised regulation on healthcare reimbursement standard and methods from Oct. 8 that applies 100 percent of the healthcare reimbursement cost on patients visiting a tertiary hospital to treat cold and other mild cases. Previously, a mild case patient had to pay 60 percent of copayment rate for an outpatient treatment at a tertiary hospital, but it would be raised to 100 percent as the copayment rate ceiling system excludes the case from now on. Reflecting the change, the healthcare institute has to clearly distinguish between mild case and severe case of patients with atopic dermatitis. A mild case atopic dermatitis patient is to pay the entire copayment when visiting a general hospital, but a patient eligible to get prescribed with Dupixent (dupilumab) 300 mg prefilled injection would be applied with the previous 60-percent copayment rate. However, the issue is that hospitals may struggle to distinguish between the cases as they do not have an independent disease code for severe case atopic dermatitis, yet. The severe case disease code would be applied from Jan. 1 next year. MOHW official advised, “Even for severe case atopic dermatitis patients, their copayment rate may go up due to the revised regulation. The prescription of Dupixent from Oct. 8 through Dec. 31 to an atopic dermatitis patient would be calculated with premium rate by disease code and Healthcare Quality Evaluation Grant,” and “the hospitals should input general outpatient copayment rate instead of the unique code, ‘F025.'”
- Policy
- 'Adding CSO' to the target of rebate penalty
- by Lee, Jeong-Hwan Oct 13, 2020 06:05am
- A revision of the law is being promoted so that not only pharmaceutical companies that gave rebates to doctors and pharmacists, but also the Contract Sales Organization (CSO) that they delivered on their behalf, can be directly punished for violating the Pharmaceutical Affairs Law. It is to clarify the grounds for administrative disposition in case of illegal detection by including the pharmaceutical CSO in ‘Article 47 (Order in Distribution of Drugs, etc.) of the Pharmaceutical Affairs Act)’. On the 12th, Jung Choun-sook, a member of Democratic Party of Korea said in a phone call with Dailypharm that he plans to initiate a representative proposal next week as soon as possible on the revision of the Pharmaceutical Affairs Law. On the 8th, at the parliamentary inspection of the administration of the Ministry of Health and Welfare, she spoke to Minister Park Neung-hoo about the illegal rebates through CSOs of some pharmaceutical companies. Despite the fact that CSO is being abused as a place to provide new rebates, contrary to its basic purpose, it is criticized that the legal basis for punishment is insufficient due to the blind spot of Pharmaceutical Affairs Law. CSO was originally created to act as an agent for legal sales such as promotion of drug sales for pharmaceutical companies and to help pharmaceutical companies focus on new drug development. However, some pharmaceutical companies are exploiting CSOs by offering variant rebates because CSO is not considered a 'drug supplier' subject to a ban on rebates under the Pharmaceutical Affairs Act. According to the data submitted by the MOHW to her, it was unable to properly determine the current status of the number of CSO companies currently operating. In a survey of some pharmaceutical companies last year, only statistics were obtained that 27.8% of the 464 responding pharmaceutical companies were consigning sales. The MOHW said that there was only one illegal rebate through CSO, but this is also not an accurate statistics. Specifically, a pharmaceutical Company was prosecuted in 2018 on charges of providing rebates worth about ₩1.6 billion to a number of medical professionals with CSO and pharmaceutical wholesalers from 2013 to 2017. As a result, both executives and employees of pharmaceutical companies and CSO's CEO were notified of disposition for violating the Pharmaceutical Affairs Act. She is preparing an amendment to the Pharmaceutical Affairs Act that extends the provisions prohibiting the exchange of rebates so that CSO can't do anything related to rebates. This is a method of adding 'a person who has received drug business consignment from a pharmaceutical company or other business processing consignment' to the scope of drug suppliers in the Pharmaceutical Affairs Act. She said, "We will create a legal basis to directly punish those who act as pharmaceutical companies such as CSO through illegal rebates." In addition, she explained, "The scope of administrative disposition includes CSOs and wholesalers, thereby enhancing the eradication of illegality and the completion of the Pharmaceutical Affairs Act."
- Policy
- HIRA finally revises PE guideline after 9 years
- by Lee, Hye-Kyung Oct 13, 2020 06:05am
- Finally, the pharmacoeconomic evaluation (PE) guideline is to be revised after nine years. South Korea’s Health Insurance Review and Assessment Service (HIRA) is accepting public opinion until Dec. 6 for the unveiled draft of revised PE guideline that reflects most of the suggestions made in the 2019 research on PE guideline revision (Principle investigator: Professor Lee Tae-Jin of Seoul National University Graduate School of Public Health and Professor Bae Eun Young of Gyeongsang National University School of Pharmacy). HIRA has decided to partially amend the regulation on pharmaceutical reimbursement evaluation criteria and procedure to formulate detailed evaluation standards on projecting pharmaceutical efficacy and cost, to remove a clause on financial impact analysis and to bring down the discount rate from 5% to 4.5%. The new PE guideline is to remove the ‘financial impact analysis’ section. The financial impact analysis projects the total financial changes in National Health Insurance (NHI) caused by introducing the applicant drug, in which the analysis significantly affects the decision in drug pricing or listing decision. And HIRA means to include the part in the pharmaceutical decision application, but to completely omit it in the revised guideline. ◆Cost: In the consigned research report, the investigators pointed out there has been many cases where the guideline’s perspective did not match the cost scope the actual analysis included, because transportation cost, time cost, and nursing cost were omitted when analyzing from the limited social perspective. Therefore, the new guideline would rule out transportation cost, time cost, and nursing cost from the basic analysis as they are not caused within the healthcare system, although the patients and their families have to pay the cost. However, the applicant may separately elaborate on the items with increased or lowered cost, besides from the basic analysis, if the cost or benefit is substantial, such as for diseases with burdensome nursing cost or noticeable productivity loss. ◆Discount rate: HIRA also plans to lower the basic analysis discount rate from 5 percent to 4.5 percent. In South Korea, the Korea Development Institute’s (KDI) research in 2017 consigned by the Ministry of Economy and Finance (MOEF) estimated the social time preference to be 3.7 percent to 4.5 percent, and it lowered the social discount rate to 4.5 percent, generally considering the market interest rate and declining economic growth in last 10 years. HIRA evaluated reducing the discount rate is necessary for PE when the social discount rate is falling constantly due to the changes in social economic circumstances. When the PE guideline was first compiled, the social discount rate was as high as 7.5 percent. The discount rate of 5 percent has been applied so far considering it is a healthcare policy and the level of other countries’ discount rate. But for the revised guideline, HIRA adjusted it down to 4.5 percent to match the discount rate applied in preliminary feasibility evaluation. ◆Analysis techniques: The existing guideline recommended to conduct a ‘cost-minimization analysis,’ when the effects of applicant drug and reference drug can be proven to be equivalent, and to conduct ‘cost-effectiveness analysis’ or ‘cost-utility analysis,’ when the effects of applicant drug and reference drug differ. But the new revision clarified to conduct ‘cost-utility analysis as a basic analysis technique. A drug with evidence of unable to produce cost-utility analysis can conduct cost-effectiveness analysis instead, but in such case the indicator reflecting the outcomes of the drug should be used as endpoint. The endpoint for the cost-effectiveness analysis should use Quality-Adjusted Life Years (QALY). ◆Evaluation methodology: The revised guideline then presented a number of factors, other than market share rate, to be considered when selecting reference drug. The existing principle of selecting a reference drug with highest substitutability when listing a new drug would be maintained, but the guideline would now also accept alternative plans supported by decent quality evidence when the circumstances are limited. For instance, a new alternative reference subject along with the comparability-based reference subject can be considered when qualifying all following conditions; a reference drug is standard of care; it has no direct comparable grounds between a new drug and a reference drug with highest market share and the uncertainty is too big when indirectly comparing and the comparability becomes an issue; and it is used as a conventional therapy in South Korea regardless of the reference drug used in the clinical trial did not have the highest market share. When calculating the pharmaceutical expense, the unit price of the applicant drug has to be used. If other drug with same substance, content and formulation is not yet listed, then the price of the applicant drug would be used. And weighted average pricing would be applied to unit price of the reference drug, when multiple drugs with same substance, content and formulation are listed already.
- Policy
- Many companies apply for a patent challenge for Otezla
- by Lee, Tak-Sun Oct 13, 2020 06:05am
- Korean pharmaceutical companies' patent challenges are continuing on new psoriasis treatments that are not released in Korea due to the failure to apply insurance benefits. Otezla (Apremilast), which was approved in 2017 as a treatment for psoriasis and psoriatic arthritis in Korea, has recently received a patent challenge from domestic companies such as Daewoong. In particular, Otezla is not released in Korea, but is recognized for its marketability overseas. According to the industry on the 9th, Dongkoo Bio & Pharma filed a trial for a passive confirmation of the scope of rights for the patents of Otezla's use (expired on March 20, 2023) on the 8th and formulation (December 26, 2032) registered on the MFDS patent list. It started a procedure to evade a patent for generic drugs. Since Daewoong requested the first patent trial on the 29th of last month, four companies, including Dong-A ST, Chong Kun Dang, and Dongkoo Bio & Pharma, began to challenge the patent. Otezla is a drug that Celgene was approved in Korea in November 2017. As Amgen acquired the drug for $13.4 billion in August last year, it also acquired domestic copyright. Otezla is a prescription medicine approved for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate and for the treatment of adult patients with active psoriatic arthritis. In Korea, after approval, they tried to raise benefits, but the agreement failed due to differences of opinion between the company and the insurance authorities. Insurance authorities judged that Otezla was not cost-effective due to its high price compared to other drugs in psoriasis, and suggested less than the amount converted to the average price of alternative drugs, but importers and sellers did not accept this. It was not officially released in Korea after the reimbursement failure. However, in the global market, it is active as a blockbuster with annual sales of about ₩2 trillion. According to ESTEEM 1 and 2 studies in plate-shaped psoriasis patients (about 1250 patients), Otezla, a new family that specifically acts on intracellular cyclic AMP (cAMP) concentration, 33.1% of patients 16 weeks after taking the drug PASI 75 (75% decrease in PASI score) was reached, showing a significant improvement compared to the placebo group (5.3%). Moreover, it is evaluated as a drug that improves the life and quality of patients by improving symptoms of itchy nails, scalp, and itching, which are difficult to treat. Psoriasis treatments that were compared before insurance benefits as Enbrel records annual sales of over ₩10 billion (based on IQVIA), it is expected to guarantee high performance if reimbursement is carried out in Korea. Moreover, it is an oral medication unlike Enbrel. However, even if generic drugs have surpassed their patents, it is difficult to launch a product within a short period of time as new drugs still have reexamination. This is because Otezla's PMS remains on November 19, 2023, with about three more years left. It is expected that more domestic pharmaceutical companies will participate in the drug market.
- Policy
- Drugs exempt from economic evaluation are applied to RSA
- by Kim, Jung-Ju Oct 13, 2020 06:05am
- From today (8th), generic drugs under risk-sharing agreements (RSA), drugs exempt from economic evaluation, and drugs released with early permission under the condition of Phase III are also covered by RSA between insurers and pharmaceutical companies. A new legal basis for adjusting the limit upper price will be established in the case of drugs whose license requirements are changed. The MOHW revised and issued the 'Pharmaceutical Determination and Adjustment Criteria' on the 8th in accordance with Article 14 of the 'Rules on Standards for National Health Insurance Medical Care Benefits'. The biggest point among the revisions is to expand the scope of RSA application. Usually, RSA is applied in Korea as follows. ▲In case of being used for serious diseases that threaten survival as an anticancer drug or rare disease treatment that does not have an alternative or equivalent therapeutic range or treatment ▲The Pharmaceutical Benefits Advisory Committee's impact on disease severity, social impact, and other health care when it is evaluated that consensus on additional conditions is necessary in consideration of the impact, etc. ▲In the case of a drug that has the same therapeutic scope as the drug applied according to the preceding two criteria and is a cost-effective drug. According to the revised adjustment criteria, drugs judged to be cost-effective as a result of the adequacy evaluation of the benefits of the Pharmaceutical Benefits Advisory Committee, and drugs that were judged to be exempted from economic evaluation, and drugs with a conditional approval for phase III are included in the RSA. A new standard for price adjustment of drugs with changed licenses has been established. This includes drugs that the MOHW deems necessary to adjust the upper limit price. The decision was requested at the time of announcement, and the upper limit price is recalculated according to the reporting standards. However, the Pharmaceutical Benefits Advisory Committee can adjust it if deemed necessary.
- Policy
- Pharmaceutical reimbursement standards should be updated
- by Lee, Hye-Kyung Oct 12, 2020 06:13am
- It has been argued that the government should be active from screening for osteoporosis to creating a continuous treatment environment and establishing an integrated treatment system for preventing fractures in stages. On the 7th, Bong-min Jeon, a member of People Power Party (Health and Welfare Committe, Suyeong-gu, Busan), published a national audit policy booklet with The Korean Society for Bone and Mineral Research and the 'the Osteoporosis Policy Task for Establishing a Virtuous Cycle of Health in Ultra-aged Societies', pointed out the low recognition rate for osteoporosis and urged social interest and national investment. According to the policy databook as a problem in the management of osteoporosis in Korea, there is a lack of an integrated management system that does not prevent the cascade of osteoporosis worsening, such as ▲low disease awareness and low treatment rate, and ▲limited drug reimbursement standards that make continuous treatment difficult. Currently, only patients with a T-score of -2.5 or less when measuring bone density can receive insurance benefits for one year as the subject of treatment. He said, “If the T-score exceeds -2.5, even though there is still a risk of fracture, it is excluded from the benefit.” He added, “It is necessary to create a continuous treatment environment by spreading awareness of demand, establishing a reimbursement standard that fits clinical evidence, and establishing a system for preventing fractures in stages within the health insurance system.” Meanwhile, according to the policy materials, the prevalence of osteoporosis is gradually increasing with the aging of the population, and the number of osteoporosis patients exceeded 1 million in 2020. Since the health problems of the elderly population are directly connected to the problem of participation in economic activities and the ability to live independently, he pointed out that diseases such as osteoporotic fractures that deprive the elderly population of mobility can be a primer to increase the burden of support for the entire society. He said, "If the osteoporosis is intensifying and the fracture is stored, it is serious if the probability of death is 17%, but if 66 out of 100 patients with osteoporosis stop treatment within one year, continuous management is not performed." He stressed that the work to improve the reimbursement standards, which are pointed as the main cause of the disruption, will be corrected by discussing with the government and academia.
