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- Hemlibra's reimbursement criteria to be rediscussed
- by Nho, Byung Chul Jun 11, 2021 05:53am
- Interest is rising as the Health Insurance Review and Assessment Service (HIRA) plans to call an expert advisory meeting to discuss the more effective operation of immune tolerance induction (ITI·antibody removal) therapies. At the end of this month, HIRA’s Pharmaceutical Standard Department plans to conduct deliberations to come up with reasonable improvement plans by comparing the review results regarding the revision of the reimbursement criteria for Hemlibra that was requested by academic societies and patient groups with cases overseas. The deliberation that will be held is significant in that it responds to the need for the re-establishment of the reimbursement criteria in accordance with the global trends, taking into account the hemophilia patients under the age of 12 that were unattended by existing standards and the convenience of administration. Of course, the best-case scenario would be to reflect the specific criteria for unfeasibility of ITI therapy to the notification in advance, however, the biggest victim and the ones worst affected by the criteria are the pediatric hemophilia patients who were discontinued prescription of Hemlibra since last April, pressing the need for the urgent revision of the standards. On the revision, the Korean Society on Thrombosis and Hemostasis has suggested improving the current reimbursement standards from three aspects. The first is for pediatric patients ineligible for ITI therapy. Patients who are not in year 1-5 of developing antibodies have a very low possibility of success using ITI therapies, however, under the current standards, these pediatric patients are not allowed to use the novel new drug Hemlibra injection until the age of 12 or older, and therefore has to use bypassing therapies. Other advanced countries abroad do not require compulsory use of ITI therapies through reimbursement criteria, and the domestic environment that restricts the use of new drugs needs to change. Also, the authorities do not not require prior use of ITI therapies for the use of bypassing therapies. Also, requesting objective data on why pediatric patients under the age of 5 cannot receive ITI therapy is considered to be the most difficult by HCPs in practice. In this sense, HIRA has the responsibility and duty to objectively and closely review such conditions to reflect reality. Other countries (U.K, Australia, etc.) are reviewing reimbursement for Hemlibra even in patients who are eligible for bypassing therapies. Cost-effectiveness analysis of pediatric patients showed that Hemlibra, which is used as maintenance therapy, is more cost-effective than bypassing therapies that can be used at every bleeding event. These data support the rational validity of the academic society's request to remove the priority consideration criteria of ITI therapies. Even HIRA’s Pharmaceutical Benefit Evaluation Committee had determined that the annual pharmaceutical expense of Hemlibra was cheaper than bypassing therapies in pediatric patients in October 2020. If the current reimbursement criteria reflect even a fraction of the requests and perspective of the patients and prescription circumstances, the situation would dramatically improve for the pediatric patients who were left to use only bypass treatment or bear the severe pain from bleeding. “We hope that the reimbursement criteria are revised soon in consideration of the pediatric hemophilia patients and their families," said an official from the Korean Society on Thrombosis and Hemostasis, expressing his hope.
- Company
- What is the most likely treatment for Alzheimer's?
- by Kim, Jin-Gu Jun 10, 2021 05:55am
- With 2021 Bio Korea held on the 9th, an innovative strategy session is being held for early diagnosis and treatment of Alzheimer As Biogen's Aducanumab (Aduhel) was approved by the U.S. Food and Drug Administration (FDA) for the first time in 18 years as a treatment for Alzheimer's, competition for development of Aducanumab. Currently, Roche, Eli Lilly, Ezai, Johnson and Johnson are considered companies that have started to develop treatments for Alzheimer's. In Korea, GemVax & KAEL and Aribio, Ildong, MEDIPOST, and Hyundai are developing dementia drugs. Among them, Zembax and Aribio are said to be fast in development. At the "2021 Bio Korea" held at COEX in Seoul on the 9th, the current status of development of Alzheimer's drugs at home and abroad was discussed under the theme of "Innovative Strategies for Early Diagnosis and Treatment of Alzheimer's Disease." In particular, the session drew keen attention due to the influence of Aducanumab's FDA approval a day ago. ◆Aducanumab, positive impact on development of dementia treatment drugs by domestic companies GemVax has completed phase 2 of GV1001 in Korea. Earlier this year, it applied for Phase III clinical trials, but the MFDS rejected. The reason was that the number of test subjects was insufficient. GemVax plans to re-apply for Phase III clinical trials by recruiting additional subjects. GemVax is also preparing for Phase II clinical trials in the United States. "We are actively discussing the resumption of clinical trials as COVID-19 situation calms down in the U.S.," Song Hyung-gon, CEO of GemVax & KAEL, said in an announcement on the day. "We are also in contact with local companies in Europe for clinical progress." Aribio is on clinical trial in the United States. In March, the company announced interim results of Phase II clinical trials on AR1001. In a six-month clinical trial of 210 patients, both Aribio 10 mg and Aribio 30 mg groups showed improved cognitive function. In the case of Aribio 10mg group, it was observed that the cognitive function improved 25.6% compared to the placebo group at 26 weeks. Based on these results, Aribio plans to apply for Phase III clinical IND in the United States within this year. With 2021 Bio Korea held on the 9th, an innovative strategy session is being held for early diagnosis and treatment of Alzheimer Ildong received approval for phase 3 clinical trials of 'ID1201' in South Korea in 2019. ID1201 is a natural product derived from the Pérsian lílac fruit. The company believes that the ingredient will improve cognitive function by inhibiting the production of β-amyloid and brain inflammatory substances. However, it is said that it is difficult to recruit subjects due to COVID-19 situation. MEDIPOST completed Neurostem's Phase I and Phase 2a clinical trials. In phase 2a, statistical significance was not obtained the Alzheimer's disease evaluation scale. However, MEDIPOST plans to confirm the tendency of β-amyloid levels to fall and reaffirm the results after long-term tracking by continuing clinical trials like Biogen. ◆Phase 3 clinical trials such as Roche's Gantenerumab and Solanezumab by Lilly are underway Colin Masters, Professor of University of Melbourne, introduced the development of global Alzheimer's drugs. According to him, in addition to FDA-approved Aducanumab by Biogen, there are Gantenerumab by Roche, Solanezumab and Donanemab by Lilly, Crenezumab co-developed by Roche and Genentech, Bapineuzumab co-developed by Pfizer and Janssen, and BAN2401 jointly developed by Eisai and Biogen. Progress in development confirms that Solanezumab and Gantenerumab are relatively advanced. Phase III clinical trials are under way. Both treatments target β-amyloid, such as Aducanumab. The target is the same, but there is a slight difference in how it is involved in β-amyloid. Aducanumab removes β-amyloid directly. Solanezumab neutralizes toxicity in the intermediate stage of β-amyloid formation. Gantenerumab prevents amyloid from accumulating in the first place. The β-amyloid reduction effect shown to date is comparable to that of Aducanumab. A PET scan of the brain's β-amyloid buildup showed that Aducanumab succeeded in removing 70%. Gantenerumab, Lecanemab, and Donanemab are similar. Bapineuzumab is 12-25% lower, while Solanezumab and Crenezumab do not have separate PET imaging data. "There is no doubt that we need to treat Alzheimer's with combination drugs," Professor Masters said. "We need to use a variety of mechanisms at the same time to lower our amyloid levels." However, it is appropriate to start with low capacity in the early stages and gradually increase it to high capacity."
- Company
- Korean novel drug Leclaza may become cheaper than Tagrisso
- by Eo, Yun-Ho Jun 10, 2021 05:55am
- The daily drug cost of Korea's novel anticancer drug 'Leclaza' is expected to be set at a level that is around ₩10,000 cheaper than ‘Tagrisso.’ Dailypharm found that the price of Yuhan Corp.’s 3rd generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Leclaza (lazertinib) was set at ₩69,000 per each 80mg tablet after drug pricing negotiations with the National Health Insurance Service (NHIS) on the 7th. If a patient takes the daily recommended dose of 240mg every day, the total cost will be around ₩207,000 per day. The recommended daily dose of Tagrisso (osimertinib) is 80mg, and each 80mg tablet costs ₩217,782. Both prices are based on the list price. The relatively generous price that was set for Leclaza, despite it being a latecomer drug, was deemed possible due to the drug being a domestic novel drug, and in consideration of its potential indication expansions in the future. Accordingly, if Leclaza passes the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee this month, the drug will be available with reimbursement from July. This may start a full-scale competition in the second-line treatment of non-small cell lung cancer (NSCLC) between Leclaza and AstraZeneca’s Tagrisso. Leclaza's reimbursement is being processed at an unprecedented pace. After receiving marketing authorization in Korea on January 18th of this year, in one month the drug passed the Health Insurance Review & Assessment Service’s Cancer Disease Deliberation Committee, then passed HIRA's Pharmaceutical Benefits Assessment Committee (PBAC) review in April. Also, MOHW had ordered a negotiation period a week earlier for Leclaza compared to other drugs that passed the PBAC to further speed up the listing process. If the drug is listed in July, the whole listing process from approval to listing would have taken less than 6 months in total. Leclaza was first approved for the second-line treatment of lung cancer, specifically, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive EGFR T790M mutation who have been previously treated with an EGFR-TKI. The approval was based on the clinical trial results of its Phase II clinical trial (therapeutic exploratory trial) that was conducted in Korea, under the condition that the company conducts and submits Phase III trial (therapeutic confirmatory study) data after the market release. Currently, first-generation EGFR TKIs AstraZeneca's Iressa (gefitinib) and Roche's 'Tarceva (erlotinib)'; second-generation EGFR TKIs 'Geotrif (afatinib)' and 'Vizimpro (dacomitinib)'; and third-generation EGFR TKIs Leclaza and Tagrisso(osimertinib) are being prescribed in Korea.
- Company
- Former GSK GM Yoo-Seok Hong to head D&D Pharmatech
- by An, Kyung-Jin Jun 10, 2021 05:55am
- Yoo-Seok Hong, New CEO of D&D Pharmatech Yoo-Seok Hong, former General Manager of GSK Korea will be joining the leadership of the biotech company, D&D Pharmatech. On the 9th, D&D Pharmatech had announced that the company has appointed Yoo-Seok Hong as its new CEO. Hong is a seasoned expert with extensive experience in marketing and business management at multinational pharmaceutical companies. Hong was as Marketing Director for Eli Lilly's osteoporosis treatment and Senior Director of Strategy in the Emerging Market Business Unit of Eli Lilly and Company, after which he served as General Manager at various Korean subsidiaries of multinational pharmaceutical companies including Lilly Korea, Teva-Handok, and GSK Korea. In February 2018., Hong was appointed General Manager of Pharmaceutical in GSK Canada, then as the Vice President of the GSK headquarters in the U.S., and was in charge of commercializing the company’s innovative liver treatment from September 2020. As a leader, Hong is considered to have played a significant role in elevating the status of Korean managers in the international market. D&D Pharmatech was established in 2014 by Professor Seulki Lee of Johns Hopkins School of Medicine. It has headquarters in Korea (Pangyo) and the U.S. (Gaithersburg, MD), and has five U.S. subsidiaries focusing on specific therapeutic areas, where it conducts global clinical research and development. 10 global clinical projects using new drug candidates that were developed by the company’s research team in Korea and abroad for neurodegenerative diseases, fibrotic diseases, and metabolic diseases are being tested at sites in the U.S. and Europe. The company’s treatment in development for Parkinson’s disease (PD) and Alzheimer’s disease (AD) is currently in a large-scale Phase II trial. Recently, the company has expanded its business to biomarkers that can diagnose neurodegenerative patients and big data to analyze its cause. D&D Pharmatech plans to present the proposal to appoint Hong Yoo-Seok as an inside director at the general shareholders' meeting on the 18th, and appoint Hong as CEO at the Board of Directors meeting. Through the appointment, the company will be operated under an independent representative system with Dr. Seulki Lee, the founder, and CEO overseeing the entire R&D business, and CEO Yoo-Seok Hong in charge of the company's business development, management, and operation. The company anticipates that Hong will speed up the global technology export and commercialization of ongoing clinical projects. On his appointment, Hong said, “I have high expectations for D&D Pharmatech’s core pipeline and believe in its market potential and possibility of success. As CEO, I aspire to create a successful Korean global biotech model in which its three components - continuous discovery of new candidate substances, successful clinical development, and global commercialization – can operate in harmony.”
- Company
- Once again, the fear of impurities
- by Chon, Seung-Hyun Jun 10, 2021 05:55am
- Fear of impurities is spreading again in the domestic pharmaceutical industry. There is a high risk that the aftermath of large-scale withdrawal of impurities from Canada will also damage Korea. Pharmaceutical companies are nervous in that it is a new type of impurity that is different from the one that has built a verification system over the past three years. ◆Start investigating impurities of new types from Canada and panic because there is no test method According to the industry on the 7th, pharmaceutical companies are looking at the details of impurities of angiotensin II receptor blockers (ARB) such as Irbesartan, Losartan, and Valsartan. On the 4th, the Ministry of Food and Drug Safety ordered the three ingredients to submit the results of the "Azido" impurity evaluation and test test by the 14th, and began to seek countermeasures. Health Canada announced on the 31st of last month that Azido was detected in Irbesartan, Losartan and Valsartan from nine pharmaceutical companies, including Teva and Sandoz, and that voluntary recovery is underway. They are large enough to reach a total of 227 lot numbers. Irbesartan had 124 lot numbers, Losartan with 97 and Valsartan with 6 lot numbers. Health Canada announced on the 31st of last month that Azido was detected in three ingredients of nine pharmaceutical companies: Irbesartan, Losartan, and Valsartan, and voluntary recovery is underway. Pharmaceutical companies are very nervous in that impurities detected in Canada are new types that have not been previously found. An official from a pharmaceutical company said, "We asked the supplier for data on Azido, but we are not sure if there is any." Azido is a type of carcinogenic substance in the azide family. There is no known specific risk of cancer in the human body, although it may increase the risk of cancer. Nitrosamines such as "NDMA" and "NDEA" have been detected in Korea since 2018, but no recovery measures have been taken due to the detection of azide-based impurities. In raw materials such as Irbesartan, Losartan, and Valsartan, Azido is a harmful substance without standardization. The risk of Azido detection was not recognized in advance, and there are currently no Azido impurities test methods. The development is similar to that of the detection of NDMA in Valsartan three years ago. NDMA, a carcinogenic substance detected in the Valsartan issue, is a harmful substance that does not have a standard. Neither government nor pharmaceutical companies were able to recognize the dangers of detecting NDMA from raw materials for Valsartan. The MFDS drew up a test method to detect NDMA in the raw materials of Valsartan, and prepared a new standard. The fact that the cause of Azido is unknown also amplifies anxiety. The MFDS looked at the manufacturing environment in which NDMA can be produced after the impurity Valsartan wave erupted. NDMA detected in Valsartan-based drugs was created by chemical reactions during the manufacturing process. In the process of manufacturing Valsartan, a major intermediary, "Biphenyltrazol", was manufactured, and NDMA was created in the process of synthesizing Biphenyltrazol and rapidly cooling it using nitric acid after tetrazol formation. As with the initial discovery of NDMA, the risk of Azido is still unknown. "People who take daily medicines containing Azido below the acceptable level for 70 years are not expected to increase their risk of cancer," Health Canada said. Until recently, pharmaceutical companies have completed inspections of nitrosamine impurities such as NDMA and NDEA. In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of nitrosamine-based impurities in all raw materials and finished drugs, and the data submission was completed in a year and a half. The MFDS must submit data on impurities in all medicines to allow lot release without testing for nitrosamines impurities. However, if a large-scale suspension of sales due to the detection of excess impurities of a new type rather than nitrosamines, confusion over impurities is expected to spread throughout the industry. An official from the MFDS said, "Recovery of drugs including Azido is currently underway in Canada alone.""In Canada, we expect to be able to collect related data through raw material drug clients as we have tested the impurities. We are in the process of collecting information."
- Company
- Family testing for rare genetic diseases are needed
- by Eo, Yun-Ho Jun 09, 2021 06:08am
- As the number of rare genetic diseases that can be managed increases, the importance of early diagnosis through family tests is emerging. According to the KDCA's "2019 Statistical Yearbook of Rare Disease Patients," the number of new rare diseases in 2019 stood at 55,499 with about one per 1,000 population. The number of patients suffering from each rare disease is rare, but the total population is indescribably large. Many neighbors around us are already living with rare diseases. However, the development of the medical and pharmaceutical industries has enabled prediction and management of certain genetic diseases. For example, Fabry disease, one of the most common resource accumulation diseases, is a genetic disease passed down from parent generation to child generation. The cause of Fabry disease is that women with genetic variation have a 50% chance of passing it on to their children regardless of gender, and men are 100% inherited from their daughters and not from their sons. Therefore, patients with Fabry disease may not be their fault, but sometimes live under the social stigma and negative perception of "genetic disease" as the patients. Genetic possibility of Fabry disease However, since Fabry disease is a treatable, it is most important to inform family members as soon as one of the family members is diagnosed and start treatment before the disease progresses to severe conditions. This can prevent worsening symptoms and irreversible organ damage, and especially the younger generation can relieve vague anxiety about childbirth by making family plans in advance. In fact, patients with Fabry disease often postpone or avoid the second-generation plan for fear that their children will inherit the disease. Fabry disease is a legally designated "preconception genetic diagnosis" that allows patients with Fabry disease to conceive a healthy fetus. Preimplantation diagnosis is a method of transplanting embryos that do not have the gene of the disease into the womb through pre-pregnancy genetic testing to help pregnant a child without genetic disease. Fabry disease patients often hesitate or give up pregnancy itself," said Kwon Young-joo, a professor of kidney medicine at Korea University Guro Hospital. Professor Kwon said, "But with institutional help, we can give birth to healthy children without worrying about heredity." If Fabry disease has been diagnosed after pregnancy, it is recommended that a newborn screening test is performed to determine whether a child is born with Fabry disease or not for proper treatment and prognosis. This is because if a child is diagnosed with Fabry disease, he or she will visit the hospital periodically as he or she grows up to monitor the progress of the disease, and if necessary, the prognosis may be good if treatment begins early in childhood. There is also an unmet demand. Genetic diagnosis before implantation is non-reimbursed, and not yet been covered by health insurance. Consequently, there may be an economic burden on the cost. "Genetic diagnosis before implantation is not covered by health insurance yet," said Professor Kwon Young-joo. Diagnosis is also recommended for the healthy life of children. "As much effort is being made by health authorities and all walks of life to overcome the low birthrate problem, consideration and review are needed in these careful areas."
- Company
- Merz’s OTC drug Pantogar released as health functional food
- by Nho, Byung Chul Jun 09, 2021 06:08am
- The hair loss OTC drug Pantoga received attention after its unexpected release as a health functional food recently, after removing some of its ingredients. Pantogar was approved by the Korean Ministry of Food and Drug Safety in 2002, and the original developer, Merz in Germany, had globally launched Pantogar in 1976. The newly launched Pantovigar Vegan has not been officially released in Korea but is being sold in pharmacies in Germany. According to industry sources, the import of Pantogar was discontinued for the reason of change in manufactories last year, and the drug currently out of stock in all online pharmaceutical shops including Onlinepharm and theSHOP. However, if the import was discontinued simply due to the change of manufactories as Merz Korea explained, the health functional food Pantovigar that was launched recently would generally be manufactured in line with the existing OTC drug Pantogar. Also, in terms of demonstrating its efficacy, it is not easily understood why the company decided to sell it as a health functional food instead of an OTC, which is better for verifying the drug’s efficacy. The OTC Pantogar is composed of L-cystine 20 mg, medicinal yeast 100 mg., Keratin 20 mg, Thiamine nitrate 60mg, Para-aminobenzoic acid 20 mg, and Calcium D-Pantothenate 60 mg, etc. On the other hand, the new Pantovigar Vegan contains cystine, Pantothenate, Thiamine Nitrate, D-Biotin, Iron, Zinc, Rice Germ Protein, Yeast power, etc. One difference to note is that the Pantovigar vegan does not contain keratin, an animal protein. Under these circumstances, Merz's German headquarters had completely split the aesthetic business and over-the-counter drug business of Merz Korea in July last year. As a result, Merz Korea’s business domain now only covers medical aesthetics products such as its botulinum toxin, Xeomin, etc. The company’s representative OTC Pantogar is now being sold and marketed by HUH Pharma, its scar treatment Contractubex by C&C Healthcare, and its API of the liver during Hepamerz by Hanwha Pharma in Korea. According to IQVIA, Pantogar sold 1.3 billion and 0.6 billion won in 2019 and 2020. Regarding Pantogar, Merz Korea said, “The pharmaceutical business unit and aesthetics business unit of Merz Korea was separated into two parts in the middle of last year. The pharmaceutical business is now controlled directly by our headquarters in Germany, so we cannot provide exact information on whether or when Pantogar will be launched in Korea.”
- Company
- MNCs bid for ‘themed’ victory with innovation and legacy
- by Eo, Yun-Ho Jun 09, 2021 06:07am
- Whichever the cause, the decision of the Big Pharmas to ‘focus on their strengths’ is more than just a pretext for reorganizing their businesses. Setting a clear ‘theme’ can have a positive effect on the image of a company. Also, dividing its business does not mean a loss of drive. However, such divisions will bring one company to lose its cash cow, and the other to lose its new product line. In this sense, the divisions will intensify companies’ competition for survival and movement to specialize their domain. ◆Reorganizing by theme for a reason=The theme of a company's pipeline leads to consistency of its message. For example, Pfizer’s Upjohn was a spin-off of its off-patent drug business, but its merger with Mylan added biosimilars, generics, and over-the-counter drugs to its pipeline. Organon, which pursues leadership in women’s health, has established its pipeline in the field of cardiovascular, urinary, respiratory, dermatology, and biosimilars. In other words, the spin-offs can let one company can purse innovation, while the other succeeds legacy brands. The brand power held by legacy product lines is also a competitive edge that cannot be ignored. In this sense, the restructuring, which enabled Pfizer and MSD to focus on developing and launching innovative new anticancer and rare disease drugs while their spinoffs - Viatris and Organon - became specialty pharmaceutical companies that focus on chronic disease or women’s health, was a convincing move from the stockholder’s viewpoint. However, there is a loophole in the reasoning of these spin-offs and sales. Ironically that Pfizer’s biosimilar, as well as MSD’s blockbuster drugs such as the diabetic drug ‘Januvia,’ Takeda’s OTC drug ‘Actinum’ remains in the original company. ◆Specificity of the Korean market= Also, the Korean subsidiaries of the multinational pharmaceutical companies may face a different situation due to the inherent characteristic of the Korean market. In Korea, original drugs tend to sell strong regardless of their patent status. This may partially be due to the generic drug pricing policies in Korea, but many Korean subsidiaries of multinational pharmaceutical companies have been enjoying strong sales even after patent expiry. In fact, Viatris Korea accounts for more than half of Pfizer Korea's sales. Just last year, Viatris's lead statin product ‘Lipitor,’ recorded 185.5 billion won in prescription sales. Also, even without the ‘Januvia’ family, Organon Korea’s originals ‘Atozet,’ ‘Cozaar,’ ‘Singular’ had in total recorded around 150 billion won’s worth in sales last year. Launching combination drugs that succeed the originality of originators is therefore a strategy that companies can choose to take in the Korean market. Viatris had recently released ‘Lipitor Plus,’ an atorvastatin and ezetimibe combination drug. Viatris aims to target the Korean market with Lipitor’s brand power and the fact that they use the original API. Under the stepped pricing system that was newly applied, Lipitor Plus’s price was set lower than Atozet. The results remain to be seen, however, Korea is an adequate market for testing new strategies based on manufacturing pharmacy such as by improving the convenience of chronic disease drugs, etc. On the other hand, the Korean subsidiaries that have let go of their cash cows may need to brace for sluggish sales growth depending on their reimbursement situation, as due to the nature of Korea’s national health insurance system, new drugs are not easily prescribed without reimbursement in Korea. Pfizer is currently working to list its ‘Vyndamax,’ and two other follow-on drugs that have been listed are facing RSA re-evaluations soon. MSD recently failed to expand its 'Keytruda' reimbursement to first-line lung cancer, which was key to expanding the scope of prescription for the drug. These are risks that cannot be ignored from the Korean subsidiary’s perspective. An official from a multinational pharmaceutical company said, “The separation of roles seems to be happening between multinational pharmaceutical companies as well. In the future, the companies will be divided into those that reduce their sales division while focusing on reimbursing high-price drugs, and those that increase collaboration with domestic companies and implement various sales strategies.”
- Company
- Patent dispute over Pelubi SR is not over
- by Kim, Jin-Gu Jun 09, 2021 06:07am
- Pelubi SRThe patent dispute of Daewon's anti-inflammatory drug Pelubi SR continues. Youngjin, Huons, and Chong Kun Dang won patent dispute of Pelubi. Among them, Youngjin has received generic for exclusivity alone. According to the pharmaceutical industry on the 7th, at least three companies are considering patent challenges for Pelubi SR: Mothers Huons, and Chong Kun Dang. Although they have not filed a formal patent judgment yet, it is known that they have started developing their own generics. The industry expects the Pelubi SR patent dispute to be fiercer than the previous case of Pelubi. This is because Pelubi SR's Rx performance is higher than that of Pelubi. According to UBIST, a pharmaceutical market research firm, Rx performance of Pelubi SR last year was ₩30.1 billion. Among them, Pelubi SR's sales account for 60-70%. Pelubi & Pelubi SR are registered with composition Patent. The patent for Pelubi SR expires in October 2033. Huons and Mothers are officially in the development of generics for Pelubi SR . Biological equivalence tests were approved in May and July last year respectively. Recently, Chong Kun-dang is said to have started developing its own generic. The pharmaceutical industry understands that these companies' patent challenge for Pelubi SR is imminent. In addition to the three companies, attention is also being paid to whether companies that have challenged existing Pelubi patents such as Youngjin will try again. If one of them files a patent trial, the remaining companies' patent challenges are expected to follow within 14 days. Pelubi and Pelubi SR are said to be difficult to develop due to the nature of the preparation. "It is expected that it will be more difficult to prove biological equivalence than to win a patent dispute," a pharmaceutical industry said. "We understand that three companies voluntarily withdrew their patents in the previous patent dispute for Pelubi because they also failed to develop generics." In the case of Pelubi, which expire in November 2028, Youngjinl, Huons, and Chong Kundang won the first trial. Mothers, Hutecs, and Nexpharm, which challenged patents with them, voluntarily withdrew their judgment on patents. The generic for exclusivity of generic for Pelubi was acquired exclusively by Youngjin. Youngjin received a license for Peluvi's generic Pelps late last month. The MFDS granted Pelps generic for exclusivity on the same day. Huons was also granted Hubirofen, generic for Pelubi on the same day, but generic for exclusivty was not given. It is said that this is because the MFDS ordered supplementation of data. It is known that Chong Kun Dang did not apply for permission for generic for Peluvi.
- Company
- Hemlibra reimbursement disapproval raises anxiety
- by Nho, Byung Chul Jun 08, 2021 06:01am
- The head-on clash between the ‘standard to first consider immune tolerance induction (ITI·antibody removal) therapies’ and the ‘due prescription rights of doctors·convenience in administration·saving NHI finances’ have received industry attention. On the 3rd, the Health Insurance Review and Assessment Service (HIRA) held a Pediatric Department Special Review Committee to review medical benefit reimbursement of Hemlibra and disapproved its reimbursement. Therefore the clash between the industry·patient groups and the authorities in normalizing its reimbursement is deemed inevitable. The reimbursement standard for Hemlibra that was implemented in February this year allows reimbursement for pediatric hemophilia patients ▲who failed ITI therapy; ▲who meet the ITI eligibility requirements but have a doctor’s note proving they cannot receive ITI therapy; and ▲whose antibodies reappeared after a successful ITI therapy. On the other hand, for hemophilia patients with antibodies, the reimbursement guidelines recommend to HCPs to first consider using ITI therapy. HIRA’s regulations prioritize the use of ITI therapy in high-antibody patients in years 1-5, patients with frequent bleeding, and patients with intracranial bleeding. The issue arose regarding the reimbursement standard ‘Those who meet the ITI eligibility requirements but have a doctor’s note proving they cannot receive ITI therapy.' The committee requested objective data proving that it was difficult to secure venous blood vessels and that it was impossible to attempt ITI therapy when administering Hemlibra. However, the medical community and patient groups protest saying that “Most patients are under 5 years of age, therefore, providing data on the state of their blood vessels following intravenous injections and objective measurement of their pain is virtually impossible. The specificity of the circumstances and environment isn't being considered.” In other words, their argument is that requesting data based on scientific grounds when there is no objective data to present is in itself nonsense. Two large hospitals, A and B Hospital in Seoul and Daegu, had administered Hemlibra to 4 hemophilia patients under the age of 12 during the last two months according to doctors’ justifiable opinion. The pharmaceutical cost of Hemlibra amounted to 30 million won per patient for the 2 months, and if the hospitals decided to exercise their right of claim rather than suffer the loss, the cost will solely be imposed on the patients. On this, an official from the Korean Society on Thrombosis and Hemostasis said, “Insisting or forcing pediatric hemophilia patients under the age of 12 to receive intravenous ITI therapy is not a desirable means of treating the disease. Also, the HIRA's disapproval of reimbursement for Hemlibra this time is inconsistent with the reimbursement standard that explicitly states that Hemlibra may be administered with a justifiable doctor’s note." Patient groups also strongly expressed their objection, pointing out that “Current standards do not require ITI therapies before existing bypassing therapies. Making the decision to administer Hemlibra does not mean that the doctors did not consider ITI therapies. The committee’s decision to restrict only Hemlibra with such a condition is unacceptable.” Meanwhile, the deliberation results of the Pediatric Department Special Review Committee will be finalized after resolution by the Central Review & Assessment Coordination Committee, and the claims for re-examination and objections to adjust drug costs may be filed within 60 days. Attention is now on whether the voices of the pediatric patients and their parents will be reflected in addition to the efforts made through Cheong Wa Dae’s public petition and Anti-Corruption and the Civil Rights Commission’s adjustment efforts.
