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- 2026-04-16 14:43:38
- Company
- Choline alfoscerate companies anxious of returning claims
- by Chon, Seung-Hyun Jul 31, 2020 06:34am
- Companies with cognitive enhancer choline alfoscerate products are to face another hurdle. Specifically, the companies are concerned of the clause stipulating the return of the claimed reimbursement when failing the clinical reevaluation during the pricing renegotiation for a product surging in sales. As South Korea’s Ministry of Food and Drug Safety’s (MFDS) clinical reevaluation process has been set, some companies are faced with marketing approval revocation and prescription sales return in the worst case scenario. According to pharmaceutical industry sources on July 30, the price-volume agreement (PVA) negotiation that National Health Insurance Service (NHIS) and pharmaceutical companies are to engage has included a number of choline alfoscerate generics. PVA allows an adjustment of pricing of a drug with a significant surge in use volume through a negotiation between pharmaceutical company and NHIS. Regardless of original or generic, a drug falling under the category of ‘making over 60 percent increase in claim amount compared to the year before, or making over 10 percent increase but increased by over 5 billion won,’ would be designated as a subject for PVA negotiation. Apparently ten choline alfoscerate products have been included for the coming PVA negotiation. As the medication market tends to expand rapidly every year, many generics in the market saw a sharp increase in prescription volume. A pharmaceutical market research firm UBIST found the choline alfoscerate’s outpatient prescription volume in the first half of the year reached 224.1 billion won, growing 19.6 percent from last year. The market volume has tripled in five years from 70.5 billion won in the first half of 2015. Quarterly outpatient prescription volume made in choline alfoscerate (Unit: KRW 1 million) Source: UBIST Regardless, the choline alfoscerate companies notified to participate in the PVA negotiation seems to be pressured about the sales return regulation. In accordance to NHIS drug pricing agreement, a company conducting a clinical trial for item approval renewal and pharmaceutical reevaluation by MFDS is stipulated to notify the details to NHIS. In case the company fails the reevaluation and loses approval, the responsible company has to pay NHIS back all reimbursement claimed from the date the MFDS ordered clinical trial through the date the listing was removed. Ultimately, if a company decides to withdraw its product from the market due to reevaluation outcome after agreeing on the choline alfoscerate’s pricing cut according to PVA negotiation, the company has to return all sales generated in between to NHIS. Choline alfoscerate is actually subjected to undergo clinical reevaluation. MFDS has recently demanded companies with choline alfoscerate products to submit clinical trial data. The relevant protocol has to be submitted by Dec. 23. The companies unable to prove efficacy of their choline alfoscerate during the clinical trial, the products may lose the government approval. And those companies that settled on the PVA would have to refund all prescription sales made from negotiation through approval revocation. And the product partially changing the indication due to clinical reevaluation would also have to return the prescription sales generated from the removed indication. Choline alfoscerate has been indicated to treat patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome— impairment of sense of direction, motivation, judgment and concentration due to confusion and degenerated memory, judgment and motivation; changes in emotions and behaviors—emotionally insecure, hypersensitive to stimulation, and indifferent to surrounding; and senile pseudo-depression. If any one of the indication gets removed, the pharmaceutical companies would have to pay back a part of their sales to NHIS. And the pharmaceutical industry experts predict the clinical reevaluation would likely to remove at least one of the indications. In fact, another cognitive enhancer acetyl-L-carnitine has lost one of indications after undergoing the clinical reevaluation. The original acetyl-L-carnitine Nicetile by Dong-A ST was indicated to treat patients with primary degenerative disease and secondary degenerative disease induced by cerebrovascular disease. However, the medication failed to demonstrate the efficacy of treating primary degenerative disease in the clinical reevaluation ordered by MFDS in 2015, the indication was removed in July last year. Acetyl-L-carnitine product that had PVA negotiation has to pay back all prescription sales made from the point of negotiation through indication removal. While the health authority has decided to apply selective reimbursement on choline alfoscerate, the companies with the medication subjected to PVA negotiation are heavily burdened. On July 24, MOHW convened the Health Insurance Policy Deliberation Committee (HIPDC) meeting and deliberated reimbursement reevaluation result and applying selective reimbursement on choline alfoscerate. The patient copayment rate on choline alfoscerate would be raised from 30 percent to 80 percent. MOHW preannounced the amendment and plans to enforce it from August. A pharmaceutical company insider complained, “When the market is unstable due to coverage reduction and clinical reevaluation, the company feels even more strained about the risk of returning prescription sales only because of making a significant growth in recent sales and clinical reevaluation result.”
- Company
- LG Chem begins development of Zemiglo + SGLT-2 inhibitor
- by Kim, Jin-Gu Jul 31, 2020 06:33am
- LG Chem will develop a combination of DPP-4 inhibitor and SGLT-2 inhibitor. Currently, three items are permitted as a combination, but no drug has been developed by a domestic pharmaceutical company. According to the pharmaceutical industry on the 29th, the MFDS recently approved LG Chem's Phase I trial plan which comparing the pharmacokinetics, safety and tolerability when Gemigliptin 50mg and Dapagliflozin 10mg are administered respectively and together. ZemigloGemigliptin is a DPP-4 inhibitor developed by LG Chem itself. It is Zemiglo. Dapagliflozin is generic for AstraZeneca's SGLT-2 inhibitor Forxiga. Currently, there are three products approved in Korea for the combination of DPP-4 inhibitor and SGLT-2 inhibitor. No products have been developed by domestic companies yet. Beringer Ingelheim's Glyxambi (Empagliflozin-Linagliptin) and AstraZeneca's Qtern (Dapagliflozin-Saxagliptin) were each approved in March 2017. MSD's'Steagluzan (Citagliptin + Ertugliflozin)' was approved in September 2018. If LG Chem succeeds in developing complex drugs, it will be the fourth drug in the Zemiglo series. Currently, LG Chem possesses ▲DPP-4 inhibitor single ingredient Zemiglo ▲DM complex, Zemimet (Gemigliptin/Metformin) ▲DM and hyperlipidemia complex Zemiro (Gemigliptin/Rosuvastatin). The total prescription amount for the three products last year was ₩97.9 billion. This year, ₩56 billion worth was prescribed until the first half. The products are likely to exceed ₩100 billion annually. ◆The key is whether DPP-4·SGLT-2 combination therapy benefits are recognized. The Korean Diabetes Association submitted an opinion to the government in April that a combination of DPP-4 inhibitors and SGLT-2 inhibitors would require benefits. Prior to this, in 2018, the government tried to find a way to apply benefits. In February of this year, LG Chem and Dong-A ST launched in June, and in June, Handok launched clinical trials. In the case of LG Chem, it is to verify the combination therapy of Zemiglo and Dapagliflozin or Empagliflozin. Dong-A ST also entered a combination clinical trial of its DPP-4 inhibitor, Suganon (Evogliptin) and Dapagliflozin or Empagliflozin. Handok has also been approved for a clinical trial plan to verify the combination therapy of its DPP-4 inhibitor Tenelia (Teneligliptin) and SGLT-2 inhibitor. An official in the pharmaceutical industry said, "If the government recognizes the combination therapy of DPP-4 inhibitors and SGLT-2 inhibitors as reimbursed items, it will be possible to prescribe combination drugs as well as combination therapy."
- Policy
- MFDS to independently investigate data manipulation
- by Lee, Jeong-Hwan Jul 31, 2020 06:33am
- Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau at MFDS (left) and Democratic Party Lawmaker Kang Byungwon “This day in K-Bio is a hurdle we have to overcome to become the new drug developing country that tackles unmet medical needs. But we have already started working on creating fertile grounds to leverage the Korean-made pharmaceuticals in the global market by utilizing this hurdle as an opportunity to tighten administrative investigational power.” On July 29, South Korea’s Ministry of Food and Drug Safety (MFDS) official declared relevant regulations would be tightened for the ministry to independently investigate data manipulation among approved and distributed pharmaceuticals without the help of prosecutors. A discussion panel on strengthening business ethics in pharmaceutical industry was convened by Democratic Party Lawmaker Kang Byungwon, where Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau participated as a panel and presented the ministry’s plan to reinforce quality control in biopharmaceuticals. MFDS means to assertively extend administrative power to prevent previous scandals like revoking marketing licenses of Kolon Life Science’ Invossa and Medytox’ Meditoxin due to their accusation of manipulating data for their biopharmaceutical approval review. Director Kim addressed recent issues like Invossa and Meditoxin and said “ethics and morals in advanced biopharmaceuticals” are the crucial matters to contemplate on at the moment. And he said Korea’s pharmaceutical industry of today stepped on to a phase of developing drugs to treat disease that has never been cured before. The director urged, “The K-Bio is shooting for two key goals of growing the industry and curing diseases. In the process, we have forgotten ethics and morals as if they were like oxygen,” and “unfortunate events like data manipulation and license revocation occurred. We need to mark these events as a turning point.” Director Kim noted it was regrettable that MFDS’ investigation was unable to fully disclose the detailed causes of data manipulation incident, whereas the judicial authority did. Accordingly, the director promised to considerably strengthen the ministry’s current administrative investigational power. His vision is to improve the current macro approach of MFDS evaluation standards and system, to take micro approach to match the speed of advanced biopharmaceutical development, and to systematically enhance the competency of MFDS reviewers in charge. The director elaborated, “The existing segmentalized but short and simple evaluation standards have been expanded to cover 109 items. This would mark the beginning of enhancing administrative investigational power,” and “compared to synthetic pharmaceuticals, advanced biopharmaceutical needs frequent intervention of observer’s objective evaluation. As the future of the industry like cell therapy and gene therapy require close attention, the precedent data manipulation cases cannot be treated as a simple incident.” Director Kim said, “The ministry goal is not to target the judicial authority, but to build a system for the ministry, as an administrative authority, to directly investigate data manipulation,” and “it would require securing general investigational capability, instead of relying on a few reviewers’ specialty.” The director also pin pointed, “The pharmaceutical companies may feel that the ministry is taking a medical evidence-based approach. In the past, a company with archived record was able to dodge the penalty, but they would be penalized without photographed evidence from now on,” because “the ministry would consider it as data manipulation, if a company cannot retrospectively prove the evidence according to the disclosed approval standards agreed upon the industry.” This is the ministry’s effort to step away from the past of concentrating on enhancing the global credibility of the Korean-made drugs. But now the ministry aims to create a ground to develop new drug for the unmet medical needs. The ministry intends to take Invossa and Meditoxin incidents as an opportunity and ask the industry, government, academic societies and the people to play their roles in evolving the Korean pharmaceutical industry. The director concluded, “Expanding the evaluation standards up to 109 items is only a beginning. It would be fine-combed to eradicate any loophole of data manipulation.” He also stressed, “This is relevant to all bio and pharmaceutical industries, not just for specific company or incident.” Lawmaker Kang Byungwon, the organizer of the discussion panel, compared the Invossa and Meditoxin incidents to the Volkswagen’s scandal of cheating the pollution emission test and said he would fully support for the legislation of preventing unethical business practice. Based on his experience of passing the bill to prevent Volkswagen incident and imposing reasonable fine on the responsible company, Lawmaker Kang aims to create an environment for the pharmaceutical industry to never repeat the data manipulation incidents again. The lawmaker urged, “The Korean industries have been blindly advancing forward without looking back. The process did not matter as long as the outcome was satisfying. But such behavior cannot lead Korea to become a developed country, and achieving K-Bio is impossible.” He noted, “The consumers who purchased the imported automobiles did not realize how they were damaging their own body. But the company knew exactly. When the Korean pharmaceutical industry realizes the gravity of their responsibility, it would finally become a global pharmaceutical industry.”
- Company
- GC Pharma, applied for Phase II clinical trial of GC5131A
- by Kim, Jin-Gu Jul 31, 2020 06:31am
- GC Pharma announced on the 29th that it had applied to the MFDS for a clinical trial phase II plan for COVID-19 blood plasma tx, 'GC5131A'. Samsung Medical Center, Asan Medical Center, Chung-Ang University Hospital, Korea University Ansan Hospital, and Chungnam National University Hospital are targeting 60 people. 'GC5131A' is a Hyperimmune globulin made by extracting various effective immune antibodies from the plasma (liquid component of blood) of COVID-19 recovery patient. It has been reported that Hyperimmune globulin has been used in the human body for a long time, so it has been developed rapidly. If the MFDS approves the clinical trial plan, it will enter the Phase II clinical trial in Korea among the candidates for new drugs, excluding products that have initiated the clinical trial through drug re-creation. The GC Pharma explained that production of clinical trial preparations has been completed and that patients will be administered as approved by the MFDS. “We will do our best to put GC5131A into the medical field in a short period of time,” said Kim Jin, head of Medical division, GC PHarma. On the other hand, it is explained that the blood plasma treatment is different from convalescent plasma therapy, which is used to transfuse the plasma of patients in the recovery phase to severely ill patients. Blood plasma therapy is a kind of medical practice, and blood plasma treatment is a medicine made by fractionating only the immunoprotein containing antibodies from the plasma and concentrating it at a high concentration.
- Policy
- “Primary care-based remote medicine as a supplement"
- by Lee, Jeong-Hwan Jul 30, 2020 06:20am
- Professor Hong Yun-chul at Seoul National University Hospital (left) and Secretary General Jeong Ji-yeon at Consumers Union of Korea To respond against novel infectious disease like COVID-19 and super-aged society, experts claim the South Korean society should prepare for an introduction to digital healthcare and remote medicine. In particular, the experts pointed out the remote medicine (non-contact medical care) would not replace the traditional medical care, but it should take root in the society as supplementary care for senior patients and other medically invulnerable community. The experts added the remote medicine should be limited to local clinics practicing primary care to balance out efficiency and equality. At a seminar convened at National Assembly Library on July 29, Professor Hong Yun-chul at Seoul National University Hospital and Secretary General Jeong Ji-yeon at Consumers Union of Korea (CUK) said the above while discussing about plans to strengthen local community primary care competency and digital healthcare. Professor Hong and Secretary General Jeong giving a presentation argued a foundation to utilize digital healthcare and remote medicine in the society should be built. Professor Hong stated COVID-19 and super-aged society have further extended the needs to bring digital healthcare into the social system. While the people and the society are demanding new responsive strategy amid pandemic, the post-coronavirus medical strategy is becoming increasingly more relevant to the society. Professor Hong named it the ‘Post-coronavirus Public-private Collaborative Medical System.’ The system aims to realize Smart medicine based on an integrated platform consisting of state university hospital, regional hospital, public healthcare center and local primary care provider. The professor elaborated the public-private collaborative medical system can be activated by comprehensively utilizing digital healthcare technology in society and medical system and focusing remote medicine on primary care. Professor Hong said, “Since the outbreak of COVID-19, we have actually been in the times of crucial societal changes. The current society is experiencing a historic increase in senior citizens,” and “the society would struggle to support the senior patients in two decades time. Basically, a system should be constructed for the digital healthcare to help senior citizens to maintain their good health.” The professor stated, “In the end, medical care in close enough proximity should be provided. The role of a personal doctor in the center of primary care would be the key.” The professor added, “Remote medicine is a hot potato. The entire competitive system would be faltered when remote medical practice in primary, secondary and tertiary healthcare institute is allowed; primary care providers cannot sustain the competition.” Professor Hong further explained, “Ultimately, the remote medicine should be supported by the government to be applied around local community primary care and utilize personal doctors for it,” and “face-to-face medical care is a principle that should not be shaken. Remote medicine is merely a supplementary tool.” Secretary General Jeong urged the remote medicine should be introduced as a medical system that enhances convenience for the consumers. Her point was healthcare consumer and providers should not blindly oppose against infection- preventive and beneficial remote medicine, but discuss where to put a safety tools in the system. Secretary General Jeong was also against providing non-contact medical service from the beginning of the medical care. She explained using remote medicine as a supplementary tool after a personal doctor sees a patient would be closer to the answer. Secretary Jeong insisted sufficient discussion should be conducted regarding opposing opinion or criticism against remote medicine like commercialization of medical service, and the government should draw up a reasonable means to adopt the system. The secretary general stated, “The remote medical service should be practiced for the consumers. Already experiencing COVID-19, the non-contact industry is rapidly permeating through the society,” and “remote medicine is not optional, but necessary for the society. But it should be a system to support the traditional medical service based on primary care.” Secretary General Jeong added, “Remote medicine should serve a role of completing the patient-centered medical service. The success of primary care-based remote medicine would be only possible, when medical service consumers’ trust is prioritized,” and “also, the introduction of the remote medicine should be discussed from the perspective of improving access to medical service in the age of digitization and aged society.”
- Policy
- Biosimilars are growing at 52% among pharmaceutical exports
- by Lee, Hye-Kyung Jul 30, 2020 06:18am
- Pharmaceutical exports in the first half of this year were $3.8 billion, up 52.5% from the previous year's $2.5 billion. Biosimilars account for 52% of export items ($1.98 billion). he KHIDI (Director, Deok-cheol Kwon) held a press conference at 11:00 am on the 29th and announced major performance trends such as health industry exports, jobs, and management performance in the first half of 2020. The announcement was made by the director of the Health Industry Innovation Planning Team, Dong-Woo Han. In particular, in the first half of this year, despite the deteriorating external conditions caused by the worldwide spread of COVID-19, the domestic health industry emerged as a growth export industry as it was rated as a 'K-defense' model country. Since the occurrence of COVID-19, exports of diagnostic devices and sanitary products have surged, and domestic biopharmaceutical exports have continued to expand, ranking sixth in the export rankings, rising four levels compared to the same period last year. ◆Export trends in the first half of this year=exports of the health industry in the first half totaled $9.6 billion, followed by pharmaceutical products of $3.8 billion, cosmetics of $3.4 billion, and medical devices of $2.3 billion. In the case of pharmaceuticals, exports of domestically produced disinfectants (Korea Customs Service's import and export classification HSK 3808940000) increased explosively ($3.35 million → $230 million) compared to the same period last year, and exports increased 52.5% year-on-year. Exports to the United States, where COVID-19 is continuously spreading, surged since March, accounting for 52.1% of total disinfectant exports, followed by 25.6% in Japan and 5.4%. in China. The countries that export biosimilars are Germany ($640 million), the United States ($350 million), Turkey ($320 million), and Belgium ($160 million). Exports of medical device diagnostic products have increased significantly since March, and have exported $730 million in the first half of the year to 173 countries such as the United States, Brazil, India, and Italy. This is 31.4% of total exports. However, despite increasing exports of diagnostic products, ultrasound imaging equipment (US$50.1 million → US$15 million) and implants (US$54.5 million → US$48.8 million), faced disruption in face-to-face operations in China, suspension of dental operations, and reduction in inpatients after COVID-19 For example, sluggish earnings also contributed to the decline in exports. The total number of workers in the health industry in the first half of this year was 931,000, an increase of 29,000 compared to the same period last year. By sector, drugs were 74,000, medical devices 52,000, cosmetics 37,000, and medical services 768,000. In the field of pharmaceuticals, the number of workers increased 4.2% compared to the same period last year due to the development and investment of influenza vaccines caused by COVID-19. Among the detailed industries, the number of drug manufacturing workers increased by 2,043 compared to the same period last year, the largest increase, and the manufacturing of pharmaceutical compounds and antibiotics increased by 533. ◆Management performance in the first quarter of this year=280 companies listed in the health industry, and the total sales amounted to ₩1.07 trillion, an increase of ₩1.1 trillion compared to the same period last year. In terms of sales growth by sector, pharmaceuticals are 20.5%, medical devices 28.2%, and cosmetics 5.6%. The R&D expenditure amounted to ₩800 billion, accounting for 41.5% of pharmaceuticals and 7.4% of medical devices. 156 companies were listed in the first quarter, with sales of ₩6 trillion. Despite the COVID-19, the domestic prescription drug market rose slightly, and the sales of pharmaceutical companies increased due to increased sales of biosimilar products to the European and US markets. n particular, Celltrion Healthcare's biosimilar products are accelerating to the U.S. (Inflectra, Truxima, Herzuma), and biosimilar products are continuing to be popular in Europe (Ramshima SC) and Chong Kun Dang's existing flagship items and the growth of newly introduced items (Kcab Prolia) has been strong. Sales growth by pharmaceutical companies increased by 159.6% for Celltrion Healthcare, 80.5% for Celltrion, 25.2% for Chong Kun, 65.3% for Samsung Biologics, and 41.1% for Dong-A ST. The KHIDI predicted that the domestic pharmaceutical industry will continue to maintain its competitive edge over global pharmaceutical companies by preoccupying the market by launching new products and expanding prescriptions for biosimilar products in Europe and the US. ◆Accelerated advancement into biosimilars =The creation of high value-added products through the expansion of global market share, such as the launch of new drugs in the global market and the expansion of overseas technology transfer, led to the export of medicines. Among domestic pharmaceutical companies, Celltrion and Samsung Bioepis are preoccupying the market by obtaining first biosimilars in Europe and the United States. In the European market, Ramsima accounted for 60%, Trukshima 39%, and Hersuma 19%. As of January of this year, the status of domestic and overseas biosimilar licenses obtained at domestic and international markets is as follows: Celltrion’s Remsima, Truxima, and Herzuma, Samsung Bioepis’ Benepali, Eticovo, Flixabi, Renflexis, Imraldi, Hadlima, Ontruzant, and Samfenet. “The global economy and supply chain uncertainty have increased due to the prolonged COVID-19, but the domestic health industry has maintained growth compared to other industries, such as exports, jobs, and management performance, until the first half,” said Dong-Woo Han. He emphasized, "In the future, the domestic health industry needs to support policy to preemptively prepare for the post COVID-19 era by accelerating the Korean version of the new deal, such as strengthening the D.N.A ecosystem and non-face-to-digital transformation."
- Company
- Big 5 green lit another CDK4/6 inhibitor Verzenio
- by Eo, Yun-Ho Jul 30, 2020 06:18am
- General hospitals in South Korea are entering prescription code for anticancer treatment Verzenio. According to pharmaceutical industry sources on July 28, drug committees at the Big Fives including Seoul National University Hospital, Severance Hospital and Samsung Medical Center, and other major general hospitals like National Cancer Center, Ajou University Hospital, and Chonnam National University Hwasun Hospital have passed Lilly’s Verzenio (abemaciclib) for prescription. From last month, the treatment was listed for healthcare reimbursement as a combination therapy with an aromatase inhibitor for treating perimenopausal women with HR+/HER2- advanced or metastatic breast cancer for first-line endocrine therapy, or as a combination therapy with fulvestrant for treating women with HR+/HER2- advanced or metastatic breast cancer. All doses of 50 mg, 100 mg, and 150 mg of the medication are priced at 49,587 per tablet. The medication has settled a risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). As the major general hospitals green lit Verzenio, the cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor prescription war would get escalated. A CDK4/6 inhibitor Verzenio can be prescribed to perimenopausal women with HR+/HER2- advanced or metastatic breast cancer either for first-line endocrine therapy combined with an aromatase inhibitor, or for combination therapy with Faslodex after receiving endocrine therapy. The first-in-class CDK4/6 inhibitor Ibrance by Pfizer requires seven days of off treatment after 21 consecutive days of once-daily 125 mg administration, whereas Verzenio can be administered every day. Ibrance has also expanded the coverage as a fulvestrant combination therapy along with Verzenio. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 study. Besides patients with early stage breast cancer, the CDK4/6 inhibitor also showed consistent effect in patients with stage 4 metastatic breast cancer that affected their lungs and bones. Verzenio has recently attracted the industry’s interest, when it completed MONARCH2 study that showed improved PFS as well as overall survival (OS). The achievement was unprecedented for a CDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
- Policy
- NECA, the safety and effectiveness of Epidyolex & Sativex
- by Lee, Hye-Kyung Jul 30, 2020 06:17am
- The NECA announced on the 28th that it has drawn the first social consensus on the safety and effectiveness of Epidyolex and Sativex, a hemp-derived drug approved in Korea. Recently, With Byung-Joo Park, Professor of the Department of Preventive Medicine, Seoul National University, Young-Chul Kang, Professor of Department of Pediatrics, Severance Hospital, Ji-Eun Kim, Professor of Department of Neurology, Ewha Womans University Seoul Hospital , Won-Gu Lee, Professor of Kosin University Gospel Hospital, Jae-Moon Kim, Professor of Chungnam National University Hospital, Won-Chul Shin, Professor of Kyung Hee University Hospital, Chang-Woo Han, Professor of Gangnam Eulji Medical center, Dong-Kyung Hur, representative of the Korea Bureau for Epilepsy’s patients family, and Dong-Chan Cho, SBS Medical Journalist , a round-table conference was held with the theme of providing the right information on the hemp ingredient medicine. This round-table conference allowed limited use of hemp for medical purposes after the revision of the Act on the Management of Narcotics, but as information lacking evidence spread indiscriminately, it aims to present the correct information about the safety and effectiveness of hemp drug products and the potential for expansion of indications. The scope of the agreement is limited to Epidiolex (CBD) and Sativex (CBD and THC complex), which are approved for handling by the MFDS and used in domestic clinical trials. As a result of the round-table meeting, Epidiolex was evaluated to have side effects such as drowsiness, dizziness, and headache, but the potential dependence of the drug was not high. Sativex may also cause side effects such as headache and dizziness, but it is acceptable and the drug dependence is not high. However, it is necessary to fully discuss the benefits and risks of taking medicine with medical staff and patients, and that dependence should be followed up. In the case of effectiveness, Epidiolex has the effect of reducing seizures in some patients with epilepsy syndrome (Dravet's syndrome, Lennox-Gasto syndrome), and Sativex has the effect of improving stiffness and pain in patients with multiple sclerosis. In this agreement, the possibility of expansion of indications for hemp component drugs was examined, and the necessity of further research necessary for this was suggested. Based on the research findings that the hemp drug is effective against adult epilepsy, Alzheimer's disease, Parkinson's disease, neuropathic pain, Huntington's disease, Tourette's syndrome, sleep apnea, and brain tumors, participants of the roundtable agreed to the possibility of future indication expansion. They emphasized that the establishment of an effective management system for the accumulation of reliable clinical evidence observed over a long period of time and prevention of misuse should be preceded. “This round-table conference has great significance for improving the social prejudice or misconception about hemp-based medicines and suggesting the first milestones that can be prescribed to patients in need,” NECA Director Kwang-Hyup Han said, "We will make an active effort with various stakeholders to produce and spread the correct information based on."
- Policy
- Nesp, cheaper than biosimilar due to voluntary price cut
- by Lee, Tak-Sun Jul 29, 2020 09:45pm
- Original Nesp (top) and Biosimilar Nesbel (bottom)The second-generation EPO 'Nesp' (Darbepoetin alfa/Kyowa Kirin, Korea) has become cheaper than biosimilar through voluntary cuts in insurance premiums. According to the MOHW, as of August 1st, Nesp cut its insurance upper limit by 12.5% for each dose. Accordingly, in the case of Nesp PFS 20, it was lowered from \19,898 to \17,411. Last year, Chong Kun Dang, which released Korea's first biosimilar 'Nesbel', also voluntarily cut the price on the same month. However, the price was reversed because the difference in price cuts was less than that of Nesp. Nesbel PFS 20 was priced at about \17,908 from \19,898, about 500 won higher than Nesp. Insurance cap trend for Nesp and NesbelNesbel was registered at 80% of the original in April of last year. The 80% drug price compared to the original is the highest price that a biosimilar can receive. In Korea, biosimilars can receive an insurance premium of up to 70% of the original before expiration of patents, but up to 80% for innovative pharmaceutical companies. Chong Kun Dang was included in the innovative pharmaceutical company and received the highest price of 80%. In the case of the original drug, when the biosimilar is registered, the upper limit is lowered by 20% to 80% of the previous price. Accordingly, from May 8 of last year, Nesp and Nesbel were insured at the same price. However, the price difference occurred when both drugs were voluntarily cut, and the original company's cut was even larger, leading to a reverse phenomenon. Nesp is a second-generation anemia treatment drug based on Darbepoetin alfa. It is a drug that is frequently used for the treatment of anemia in a patient suffering from chronic renal insufficiency . Chong Kun Dang entered the market for the first generic in Korea after developing Nesp biosimilar in 2012. It was also approved in Japan last September. However, it is only a short time since it was released, and sales are largely different from the original. According to data from IQVIA, Nesbel recorded sales of \400 million in Korea in the first quarter, and Nesp posted a performance of \5.7 billion in the same period. However, Nesp suffered negatively 14.9% decrease in sales compared to the same period last year. The voluntary drug price cut is also determined to win the biosimilar competition. It is noteworthy how the market will react when the original becomes cheaper than the biosimilar.
- Company
- 2,000 reimbursed items were registered for 3 months
- by Chon, Seung-Hyun Jul 29, 2020 06:34am
- Pharmaceuticals have launched generic products enormously ahead of the new drug price system. In the last three months, about 2000 generics have been licensed and listed. It is to receive upper limit price before applying cascading drug price system that the later it is registered, the lower the price. The government's restrictions on generics have led to the release of many generics. According to the MOHW's announcement on the 28th, “The Amendment of the Pharmaceutical reimbursed list and the upper limit price table”, from August 1st, a total of 836 products will be newly added to the health insurance reimbursement list. Most of the new drugs listed are generics. Products listed in August are Pregabalin (14), Gabapentin (13), Aceclofenac (6), and Celecoxib (7). More than 100 eye drops have been newly registered, and it is identified as newly registered products by dose among previously approved products. For eye drops, the upper limit price should be separately listed in the reimbursed list by dose. In particular, small and medium-sized pharmaceutical companies were actively launching generic products. Kims Pharma registered 48 generics in August. Union Korea Pharm (40), SCD Pharm (36), Reyon (36), Mothers Pharm (31), Kukje pharm (27), Korea United Pharm (22), DHP Korea (20) ), Lite pharm (20), Pharvis Korea (20) have newly registered eye drops, and many small-sized companies have registered generics. Number of new monthly registered drugs (unit: # of Drug, data: The MOHW) The number of new drugs listed in August is the highest this year. From January to May of this year, about 300 medicines were newly added to the reimbursed list every month. Following the list of 558 in June and 653 in July, the number of products on the list is increasing rapidly. In the last three months, more than 2000 generics have been newly registered. The intention is to receive upper limit price before the new price system is implemented. The new generic drug price system, which has been in effect since last month, includes cascading drug price system that lowers the upper limit as the registration period is delayed. If more than 20 generics are listed in a particular generic market, the upper limit for new listed items will be up to 85% of the existing lowest price. According to the MOHW, the previous drug price system is applied to the products that were registered in May. Most products listed in August are products that have been registered in May. This means that generic drugs that have been registered for benefits since June will receive a lower price than existing products due to the cascading drug price system. Since there are more than 20 generics in the majority of patent expiration drug markets, generics listed from September are forced to receive lower drug prices than before. Since the cascading drug price system does not apply only to generic products listed in August, the application in May is the last chance to receive the previous high price. In fact, until May, generic approval has been increased significantly. There were an overwhelming number of products that were approved by other companies as a consignment method without direct production. According to the MFDS, a total of 1399 generics were approved in the first half of this year through a full-process consignment method. This is the number of generics licensed through another company's bioequivalence study data. In January and February, 161 and 206 consigned generics were approved, respectively, and exceeded 300 in April and May. In 2013, the number of consigned generic licenses began to increase, but since the government's generic license and drug price regulation policies began to be established last year, the consigned generics are approved. In 2012, 50 licensed generics were licensed, but in 2013, the number was 500, a 10-fold increase in a year. In 2015 and 2016, there were more than 1,000 generics licensed for consignment. In 2017 and 2018, 681 and 751 commissioned generics were approved, respectively. Last year, 3,173 consignment generics were approved. It was more than twice as many as 1,306 cases in 2016. From last year to the first half of this year, there were 4,572 consigned generics. According to the HIRA, the total number of registered drugs in August this year is 26,328. It is the largest for 8 consecutive months. It increased by 3,066 from 27,754 in December last year, and more than 3,000, up from 20,689 in November 2018, a year and nine months ago. Despite the government's movement to regulate generics, many generics were released. However, starting in September, the number of new generics are expected to drop significantly. It is analyzed that pharmaceutical companies are equipped with as many generics as possible prior to the implementation of the cascading drug system. In fact, there were 12 licensed generics in June with the cascading drug price system, less than a tenth of the previous month.
