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- 2026-04-18 02:23:25
- Policy
- MFDS nizatidine investigation expands to drug products
- by Lee, Tak-Sun Nov 07, 2019 08:54am
- Signs of Ministry of Food and Drug Safety (MFDS) expanding investigation on nizatidine medicine have been spotted. Sources have reported the ministry is now collecting complete drug product samples for further investigation after collecting active pharmaceutical ingredient (API). Pharmaceutical industry is concerned over the ministry’s deepening investigation as it could mean the regulator’s administrative action is imminent. According the industry on Nov. 5, MFDS collected nizatidine products stocked at pharmaceutical companies on Nov. 4. After collecting API samples last week, the ministry is pushing boundary of investigation to confirm possible carcinogen contamination of complete product. API samples, manufactured from five years ago to date, were taken, and now drug products manufactured since 2018 were also sent to MFDS. The industry says API impurity analysis would take about two to three days, and product analysis would take about three to four days. Accordingly, MFDS would take some time to decide on next move based on the test result. But the industry believes MFDS has probably already found NDMA in a sample of nizatidine API at an exceeding level. “Standard level of NDMA in nizatidine is 0.32ppm. Highly likely that MFDS decided to collect more samples because it found a sample surpassing the standard level. As the ministry even collected API manufactured five years ago, it could be contemplating on the possibility of contamination in storage,” an industry associate commented. Apparently, many of manufacturing plants have already suspended production of nizatidine, while companies stopped marketing for the drug as well. Some reported a company dropped its drug approval application. In such turmoil, the industry predicts MFDS to take an action on nizatidine medicine next week at latest.
- Company
- Kisqali gets a nod from MFDS joining Ibrance and Verzenio
- by Eo, Yun-Ho Nov 06, 2019 09:00am
- Following the footsteps of Ibrance and Verzenio, a third CDK4/6 inhibitor announced its launch in Korean market. On Oct. 30, Novartis officially released news that Kisqali (ribociclib) has been approved by Ministry of Food and Drug Safety (MFDS) as a treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer. Ongoing competition between Ibrance and Verzenio, currently in insurance reimbursement review process as a combination therapy with Faslodex (fulvestrant), is to intensified even more. Kisqali was approved by the regulator as it demonstrated a meaningful improvement of prolonging progression free survival (PFS) from its clinical trial. Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as first-line treatment for pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer and proved the drug’s effect on significantly extending patient’s overall survival (OS). Professor Im Seock-Ah of Hemato Oncology Department at Seoul National University Hospital explained, “MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. This finding reflects how Asian region has a great need for a new treatment on premenopausal women with breast cancer”. In the Phase 3 MONALEESA-3, Kisqali proved to extend OS and demonstrated improved treatment efficacy when used as initial endocrine-based therapy in combination with fulvestrant for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination than using the existing endocrine-based therapy alone. The recommended dose of Kisqali is taking 600mg (three 200mg tablets) orally, once daily for 21 consecutive days followed by seven days off treatment. The treatment could be taken with or without food but at set time of the day. Meanwhile, Ibrance and Verzenio are waiting for deliberation by Drug Reimbursement Evaluation Committee (DREC) after Cancer Disease Deliberation Committee of Health Insurance Review and Assessment Service (HIRA) has passed both. Reimbursement review process of the both treatments started from same point of origin, cyclin-dependent kinase (CDK) 4 and 6. But their regulator review approaches are different. In November of 2017, Ibrance has already been listed as a first-line therapy (combination with Letrozole) via refund type risk sharing agreement (RSA). And now it is in process of expanding the reimbursed indication. Verzenio, on the other hand, is applying for reimbursement listing for the first time. The treatment has simultaneously applied for reimbursement not only as a second-line therapy, but also as a first-line therapy in combination with aromatase inhibitor. But under its current circumstances, Verzenio’s only option is RSA. Unfortunately, a follow-on drug is not yet eligible for RSA, so Lilly would likely to push on with the second-line therapy indication without any other drug available. Kisqali would also likely to take the same track.
- Company
- Korean companies competing for GSK’s OTC Drugs
- by Jung, Hye-Jin Nov 06, 2019 09:00am
- A pharmaceutical industry insider reported on Nov. 1 that three Korean pharmaceutical companies are competing against each other to acquire sales rights of ten popular over-the-counter (OTC) drugs manufactured by GlaxoSmithKline (GSK). The multinational drug manufacturer said it would soon decide on a partner company. In 2017, GSK signed a supply contract with Dong-wha Pharm for co-promotion and sales rights on ten OTC drugs including Lamisil, Otrivin, Voltaren, Nicotinell, Theraflu, Sensodyne, Breathe Right, Zantac, Polident and Driclor. The two companies’ contract was supposed to last until 2020, but as GSK and Pfizer Consumer Healthcare merged and established a new joint venture, the old contract is said to be terminated. Dong-wha Pharm recently announced that its OTC supply contract with GSK would be terminated on coming Dec. 31. As a result, GSK has been contacting several Korean pharmaceutical companies for a new partnership. Reportedly, GSK is in talks with three companies, including a well-known pharmaceutical company with strong pharmacy sales power along with a famous OTC drug. The pharmaceutical companies are proposing differentiated service fee rates based on sales performance and return policy to win the hearts of GSK for the sales right deal. As the multinational company’s OTC drugs are making about 60 billion won annually, a Korean company winning the deal would secure a stable cash cow. Sources report GSK is closely reviewing respective companies’ sales network, specifically their pharmacy sales power. Sales for OTC drugs are highly dependent on pharmacy sales power due to its nature. Some had predicted Dong-wha Pharm would terminate the contract by the end of the year and renew the contract from next year. But apparently the company is not included among the three candidate companies. However, some experts evaluate the ten popular OTC drugs would generate notable amount of sales, but it could be an unappealing deal to a distributor because of their low marketing margin. At the moment, Dong-wha Pharm is recalling Zantac with ranitidine and other nine items. A GSK official explained “For a new partner company to initiate distribution from January next year, the contract has to be signed before the end of the year. Insiders say the talks are wrapping up. The decision would be made very soon”.
- InterView
- 50-year-old Pfizer Korea “For both patients and innovation"
- by Eo, Yun-Ho Nov 06, 2019 08:59am
- CEO Oh Dong-wook Half a century in Korean pharmaceutical industry, Pfizer Korea seems to have mastered ‘how to win’ in the Korean market. Pfizer took its first step into the Korean market as a joint corporation with Joongang Pharmaceutical in 1962 and founded Pfizer Korea in 1969. Except for a couple of times, Pfizer Korea’s sales have been the top among global pharmaceutical companies in Korea. Last year, the company had the highest sales so far of 734.4 billion won, a level no global company has ever reached. The key to its driving force is in ‘evolution’. The company has sought after ‘cash cow drugs’ by acquiring numerous companies like Warner-Lambert Company, Wyeth, Pharmacia, and Hospira, and also undergone various organizational reform like the recent split-up with Upjohn. Through series of changes, Pfizer and Pfizer Korea have achieved successful ‘survival’ and ‘development’ every single time. But, not all good drugs can make a success. If it were not for Pfizer’s solid foundation, its profitable drugs would not have made it. Celebrating the 50th anniversary of Pfizer Korea, CEO Oh Dong-wook (50) of Pfizer Korea spoke of the company’s history and the future. - Half a century in Korea, what have been the most important milestones for Pfizer Korea? I can say about three major achievements to note. First, Pfizer contribution on making patients live happier lives by providing outstanding new drugs. Second, Pfizer’s continuous effort to become a responsible corporate citizen of the community and to conduct long-running corporate social responsibility (CSR) activities. Many of CSR activities Pfizer Korea provide are over a decade old. Last but not least, the fact that Pfizer Korea has consistently contributed in creating a healthy pharmaceutical and bio environment along with various stakeholders to advance new drug development, health and society in Korea. Numerous clinical trials have been conducted in Korea so far, which we expect the gained experience and tips on developing innovative new drug with global company would come through eventually and immensely contribute to the future of new drug in Korea. -‘Drug’ has a unique quality as a commodity, which is why the sense of ethics is always under the limelight. But as a business, profit would have to be the main objective. What is Pfizer doing to balance out two polarizing values? Pfizer seeks for an ‘innovation that changes patient’s quality of life’. Not only Pfizer, but many of pharmaceutical companies used to maximize profit centering customer (healthcare provider) in the past. However, this day and age requires immensely high level and standard of ethics. And it makes a sense for stakeholders to have higher level of expectation on the industry than any other industry. In such strict environment, Pfizer would never seize to make every decision prioritizing and centering patients. -Reflecting patients’ voice is not that easy. A pharmaceutical company directly engaging with patients has its limitation, and a lot of times patients cannot have their way regardless. Despite availability of a great new drug, limited access (health insurance coverage) puts a gap between patient and the treatment. That is why patient advocacy groups usually voice out on drug approval review and National Health Insurance (NHI) listing policy-making processes. Medical industry has a quite unusual ecosystem, where a patient is an ultimate consumer, but an experienced and knowledgeable healthcare provider is making decisions on prescription. While a company supplies drug, consumer and National Health Insurance Service (NHIS) are paying for the drug. Even the ultimate consumer raises an issue, changes can only be made when experts’ judgment and reasonable decision making coincide. The decision making process has improved significantly compared to the past, but it still has a room to grow. As a leading company in pharmaceutical and bio sector, Pfizer plans to engage in various activities with various stakeholders in community, such as industry organization, healthcare providers’ group and patient advocacy group, to reflect patients’ voices on government policies. -As you mentioned, patients’ voices in Korean society is skewed on ‘NHI reimbursement’ and now their interest is growing on drug pricing for the same reason. The administration plans to reduce their expense on drug with expired patent and reuse the saved finance on introducing new drug to Korean market. After separating the organization into two and ‘Pfizer Upjohn’ solely dealing with expired patent, the said government’s plan could be a bad news. As a whole company, what do you think of the direction government policy is taking? Pfizer Korea has a say in making the best choice for patients, regarding what Pfizer Upjohn Korea and Pfizer Biopharmaceuticals Korea do in respective treatment sectors. My role is to represent general operation of the company when discussing with government body and other stakeholders, and respective branches are to make a reasonable decision for their own businesses. -Going back to Pfizer’s principle of ‘centering patient’, would it be safe to say Pfizer Upjohn would not oppose against Korean government when it reduces pricing of drug with expired patent? That is correct. As I said before, Pfizer’s aim is to supply as many new drugs as possible to patients and to bring changes to their lives. Regardless of patent expiration, we believe changing the lives of patients has enough meaningful merit. -But as the age of high-cost drug approaches, the gap between the government and pharmaceutical industry’s views on drug pricing is getting wider. I assume Pfizer Korea would experience discrepancies when negotiating with Korean government and persuading the headquarter office. Some are concerned about global pharmaceutical companies giving up on Korean market as more countries are referencing drug prices in Korea. Many have contributed for patients to benefit from Pfizer’s innovative new drug, but our companies’ staffs had poured in vast amount of work into it as well. We do our best to promptly introduce new drug to Korean market. And in the process, the company tries to find the middle ground between negotiating with Korean government and convincing headquarter as soon as feasible. One could simply think, lowering drug price would be the answer for putting patients first. Or in an extreme sense, providing drugs for free would be the answer if we were to truly think of patients. But, in the end, we are a company, and a company has to be sustainable. We are always faced with discrepancy between insured drug pricing and headquarter-approved drug pricing. Obviously, we are working hard to make Korean patients to receive benefit as soon as possible, and that is that is the direction we taking. While Chinese market is growing rapidly, many markets around the globe, including Taiwan, Thailand, Saudi Arabia and China have started to reference drug price in Korea. The U.S. also announced it would reference price in Korea as well. As for the headquarter office, making deficit after investing astronomical amount in R&D for new drug and receiving inadequately low pricing would be a devastating result. It would ultimately hinder any company from investing in future pipeline. This is why we need an appropriate pricing. -Let us now focus more on Pfizer. Upjohn was split from the recent reorganization. What is it like to manage the company in the new state? To enhance efficiency of Global Pfizer’s organizational structure, Pfizer Korea separated itself into two; Pfizer Biopharmaceuticals Korea focusing on new drug development and innovative drug, and Pfizer Upjohn Korea providing drug with expired patent and generic. We expect the two corporate bodies to mutually strengthen potential growth in respective fields. Based on a variety of drug pipelines and treatments each business sector owns, Pfizer aims to improve patient’s quality of life by providing treatment timely to many more patients. The approaches we would take are still in talks, but staffs’ role and responsibilities would be unchanged. -When a drug owned by Pfizer Biopharmaceuticals has its patent expired, then is it transferred to Pfizer Upjohn? No, it wouldn’t be. Drugs are categorized by disease group. -It feels like in the future, Pfizer Biopharmaceuticals and Pfizer Upjohn would be completely split up and would become completely different two entities. For now, management direction or timing has not been specifically discussed, yet. Until everything is set, both bodies would be managed under the name of Pfizer Korea. -How is the current status of the consumer healthcare (OTC) sector joint venture with GSK? As far as Global Pfizer goes, it officially announced closing of joint venture with GSK, as of Aug. 1. And accordingly, Pfizer’s consumer health sector was transferred to the new joint venture. However, each region would have different timing as to when the joint venture would take over the management. In case of Korea, the closing is delayed as the company has to complete the necessary approval process and end some ongoing operations. When the deal is finally closed, Pfizer’s staffs would undergo some organizational changes and those would be notified after everything is set in stone. -How would you define the last 50 years and the next 50 years of Pfizer Korea? Looking back at past 50 years, the company went through absence of well-established healthcare and corporate environment when it was first founded in 1969. Back then, Separation of Prescription and Dispensing (SPD), or proper medical and pharmaceutical regulations were not stipulated. But now, we feel quite proud of how Pfizer Korea contributed in building the current healthcare environment alongside many stakeholders by placing a brick at a time. In the end, we think Pfizer contributed in bringing meaningful changes to local communities and patients suffering from disease. But it also means Pfizer Korea still has a long way to go, although it made proud achievements under the corporate objective and goal. As a responsible corporate citizen and leading pharmaceutical company, Pfizer Korea would continue to keep its leadership among patients and in local community.
- Company
- Is MFDS going to suspend sales on nizatidine with no NDMA?
- by Chon, Seung-Hyun Nov 06, 2019 08:59am
- Pharmaceutical industry is walking on thin ice as the government initiated impurity investigation on stomach ulcer medicine. Now that the U.S. detected impurity in nizatidine, following a case in Japan, probability of finding impurity in nizatidine has gotten higher in Korea. The industry is on high alert against the government’s possible order to suspend sales of nizatidine drug without detecting any impurity, which was the case with ranitidine. According to an industry insider, Ministry of Food and Drug Safety (MFDS) ordered pharmaceutical companies to submit complete nizatidine product manufacturing record and to test active pharmaceutical ingredient (API) chemically similar to the ingredient. MFDS ordered companies to submit API usage record and other archived evidences to confirm manufacturing record until Nov. 4. The ministry seems to be investigating uses of all complete product with both Korean-made and imported nizatidine Nizatidine is an H2-receptor antagonist similar to ranitidine suspended of sales from last September. After deciding to suspend sales of all ranitidine drugs, MFDS also set a plan to investigate similar APIs, starting with nizatidine first. Ministry’s nizatidine usage record investigation resembles that of ranitidine’s. On last Sept. 20, MFDS directed pharmaceutical companies to investigate ranitidine API usage record, and six days after on Sept. 26, the ministry announced sales suspension on all ranitidine items. The industry presumes MFDS is about to announce nizatidine investigation result based on the precedent case. And now, the industry is nervously waiting for the ministry’s decision on nizatidine items. .Possibility of finding N-Nitrosodimethylamine (NDMA) has been raised at home and aboard, already .A private U.S.-based research institute, Valisure unveiled their testing report on nizatidine last September and stated they have detected NDMA .Previously, Valisure proposed regulators to recall ranitidine as it detected excessive level of NDMA in the API .Their latest report state researchers found one-seventieth of NDMA in ranitidine was detected in nizatidine .Japanese Ministry of Health, Labour and Welfare announced Japan-based Ohara Pharmaceutical tested their nizatidine product and detected NDMA exceeding the accepted level .The ministry reported the company decided to voluntarily recall their products due to the issue .On Nov .4, the U.S .Food and Drug Administration (FDA) released a statement about their investigation on NDMA found in ranitidine, and stated four nizatidine items from two companies had NDMA .However, the said nizatidine drugs had NDMA within the accepted level and were not included in the voluntary recall subject group .Some of pharmaceutical companies in Korea are promoting that their nizatidine drugs are NDMA free .However, some have raised concern about possibility of detecting NDMA in nizatidine ingredient used in Korea .At the moment, total nine API manufacturing plants have been registered to produce nizatidine .Korean Medical Association (KMA) has already advised doctors to refrain from prescribing nizatidine .In last month, KMA official said “The recent ranitidine incident has created a social turmoil, so the organization advised members to refrain from prescribing nizatidine containing drugs until MFSD announces final investigation result and its further action” .Pharmaceutical companies are keeping a close eye on MFDS’ further action for when finding minuscule amount of NDMA in nizatidine .The companies are afraid of the ministry ordering sales suspension on all nizatidine drugs for questionable cases of NDMA not detected from most of the complete product, and a single manufacturing unit containing minuscule amount of NDMA exceeding acceptable level .As for ranitidine drugs, all seven manufacturing plants had NDMA surpassing acceptable level in the API, but each item manufactured in a same plant had different levels of NDMA .For instance, some ranitidine drugs manufactured from one plant were found with unacceptable level of impurity and others were not .Result of NDMA investigation on collected ranitidine API (Source: MFDS)At the time, MFDS official stated “After collecting issue API and investigating them, each registered items from one manufacturing plant had different levels of NDMA and similar cases have also been found in other countries” .After making the statement, the ministry ordered sales suspension on all ranitidine drugs, judging that ranitidine itself is too unstable to be consumed .A pharmaceutical research institute, UBIST reported last year’s volume of nizatidine drug prescription for outpatient reached 25.9 billion won .Although it would be about one tenth of the ranitidine market, some pharmaceutical companies are faced with serious damage from sales suspension on popular nizatidine products .Pharmaceutical companies continue to urge the Korean regulators to suspend sales limited to items exceeding acceptable NDMA level like the case in the U.S .Some of the industry is also questioning credibility of the NDMA testing methodology as same API has been detected with different levels of NDMA .A pharmaceutical industry insider stressed, “MFDS has decided to suspend sales on valsartan and ranitidine drugs, regardless of each sample showing different level of the carcinogen .The regulators should use more precise investigative methodology and limit penalty to items with exceeding level of NDMA only” .
- Dreaming of making a brighter world together with patient
- by Kim, Jin-Gu Nov 04, 2019 03:12pm
- About 40 patients with retinal degeneration and medical professions were taking a group walk on Namsan hiking trail. No one could tell who was the patient or doctor. Each seemed to be enjoying pleasant fall breeze brushing over their face. President Yu Hyeong-gon of Korean Association of Retinal Degeneration (KARD) hosted an event, ‘Making a Brighter World’, for his organization. A president of KARD and an ophthalmology professor at Seoul National University Hospital, Yu said, “As you can see, distinguishing a patient or non-patient is meaningless. We both can be considered non-patient as for retinal degeneration, but we could be a patient with other health issue”. KARD, the organization he leads differentiates itself from other patient group or academic society. Member consists of mix between patients and doctors, but at the same time doctors are not the face of the organization. While studying inherited retinal degenerations (IRDs), KARD also advocates for patient support and social awareness. During the interview, President Yu Hyeong-gon constantly emphasized the value his organization strives on; ‘making a society embracing both patients and non-patients’. ▶How about a short introduction of your organization? “Korean Association of Retinal Degeneration, or KARD, is a research organization that also supports severe retinal degeneration treatment. First it started as a small-scale study group for medical professions. The members contemplated much about providing practical support to patients. So the original members all agreed to make it a public interest group. And without any other outside donation, each professor put down some money and made an incorporated association. “Usually an academic society is formed centering doctors. But KARD wanted to take a step further and make a group for actual patients to participate in. In fact in the U.S., there are plenty of groups where patients and healthcare providers come together. The organization got bigger as time passed, and now we have 50 university hospital medical professions and bioengineering researchers, along with 30 patients as members. And there are some outside sponsors, KARD has numerous ongoing projects varying from treatment research to retinal degeneration awareness training and public relations for general public, and even to policy making.” ▶What inspired the ‘Making a Brighter World’ event? “The name of the event, ‘Making a Brighter World’ has two meanings; one is to bring a ray of light to patients with visual impairment by providing effective treatment, and another is to make a warmer society by bringing disabled, sick and healthy people together. That is how the name came about. “This marks a sixth event. In last five events, patients and non-patients took a walk together and tried rowing and tap dancing together. All events had different activities, but what meant the most is spending the time together”. ▶Apparently there is no clearly proven treatment for IRDs. But recent news reported now there are new treatments available like retina implant and gene therapy. “Gene therapy was developed first than the other. It has been about a year and a half. We predict it would be introduced to Korea at earliest next year. Apparently, about 260 out of 300,000 genes cause IRDs. And one of them is identified as ‘RP65’. “Currently approved treatment targets defect in gene RP65. It treats to prevent death of photoreceptor cell and recovers its function to a certain level. Eye sight may get better a bit, but the treatment cannot completely revive dead cells. But, it is still quite meaningful. Because most of retinal mutation is found after 20s, even a bit of improvement in sight helps the patient’s later life. “Prosthetic retina implant has been experimented many times, before gene therapy was as developed as now. A chip is inserted to replace dead photoreceptors. It literally stimulates cells to see artificially. And because the chip would replace photoreceptor cells, the principle is to conduct the procedure after the cell is completely lost. However, the procedure is quite burdensome without healthcare coverage”. ▶Going back to the medical condition, are symptoms mainly found in adulthood as you mentioned? “Most of patients recognize the condition after their early 20s. Some rare cases have detected symptom when they were younger than one. It is a condition called ‘Leber Congenital Amaurosis (LCA).’ Symptoms and progression are similar to normal retinal degeneration, but it starts at a very young age. And if it is the RP65 causing the condition, then the said gene therapy can be tried”. ▶You mentioned 260 out of 300,000 genes are responsible for IRDs and one of them is RP65. Then, out of a hundred IRDs patient, how many could use the gene therapy? “It would be about one out of hundred. Or maybe even less. It may seem significantly low, but having one effective treatment out makes a difference. After a success of this treatment, many pharmaceutical companies have initiated a pipeline on IRDs. At the moment, 26 ongoing clinical trials are conducted around the world. And the trials not only focus on RP65, but also on a gene called ‘MYO7A’”. ▶Is there any research done by the organization independently? “To be honest, independently researching a treatment is not that easy. It requires advanced facilities and tools, and the cost is exponential. So whenever there is a chance, we conduct a joint research with overseas research institute. “Also we are actively participating in clinical trials. Specifically, the organization has its own medical image analysis center for clinical trials. In Korea, Chong Kun Dang Pharmaceutical is conducting a clinical trial on biosimilars. 27 university-affiliated hospitals are part of the study. And there are other Korean companies running clinical trial on three or four other medicine. And of course, multinational pharmaceutical companies are developing many more medicine”. ▶Heard there is an ongoing cohort study. Have you found any new findings specifically for Korean patients? “General prevalence rate is not far off from cases in other countries. Studies have found about one out of 2,000 has a severe IRDs, and one out of a thousand has not-so-severe IRDs. And I published a book summarizing key findings of the condition. “Many cases of IRDs have different causes. Most of the cases were caused by uveitis, an eye infection, and sometimes it is found as symptoms of malnutrition, syphilis, tuberculosis, and other infectious diseases”. ▶Any notable plan in the future? “A patient has to take 200 genetic testing to get diagnosed with IRDs. They cost about a little less than one million won per patient. The cost is quite steep. The organization is trying to sponsor the diagnostic tests for some patients. We wish we can cover all patients, but the organization is not that well off. But still our goal is to support as many patients as possible. We are currently raising fund for 200 patients’ testing. “KARD is now six years old. When we turned a research group to a full-blown organization, we did not know what to expect. But for sure, what we wanted out of it was for the sake of the public. The organization’s schedule is getting full with events like ‘Making a Brighter World’, symposium and group counseling. And we are now ready take the organization into another level. So we could finally conduct creative research we have wanted to do”. ▶And lastly, few words to patients? “It must be difficult without a clear treatment, yet. But more treatments are getting coming soon. Please do not let go of your hope. KARD is here to provide various information and support for treatment. “What matters the most is the ‘togetherness’. Segregating patients and non-patients does not mean much. Retina degeneration could make one a patient, but other diseases could make anyone a patient. We hope we can bridge patients and non-patients for more help to be shared. “I would also like to express my gratitude for all active patient members of KARD. Many patients first join the organization for their individual agenda. But as time passes, more of them try to help other patients based on their experience. I know it is not that easy. It is a right thing to do, but not everyone can do it. We are just trying to be together and help each other. We believe the day would come when we get good results for all endeavors”.
- Company
- Biosimilar Ultomiris to follow Soliris next year at earliest
- by Kim, Jin-Gu Nov 04, 2019 03:12pm
- Sources predict Ultomiris would enter the Korean market and a competition against a blockbuster antibody, Soliris, next year. According to pharmaceutical industry on Oct. 30, the drug manufacturer of Ultomiris, Alexion is preparing for a launch in Korea at the end of next year. The follow-on antibody drug already has been approved by FDA in the U.S. and by EMA in Europe last December and July, respectively. Like the case with Soliris, Handok is highly likely to manage Ultomiris’ approval and healthcare reimbursement application in Korea, but sales and marketing company has not been decided, yet. Currently, Handok is in charge of Soliris’ sales and marketing in Korea. Both Alexion and Handok are hesitant to give a clear plan, as they are still working on Ultomiris’ approval in Korea first. An official from Handok said, “Handok would be handling Ultomiris’ application for approval and healthcare reimbursement listing. At this point, it is still too early in the process for both companies to discuss about approval application schedule in Korea” and “sales and marketing contract would be dealt with after they are handled”. Alexion insider hinted, “Specific schedule has not been set, yet, but we are aiming to get approval from Korea at the end of next year”. Now the title has been taken away, but Soliris used be called the ‘most expensive drug in the world’. In 2010, it costed 500 million won for a year-long treatment of Soliris. Worldwide sales marked USD 3.14 billion (about 3.59 trillion won). The patient size may be small but because of its extremely expensive price, the sales volume is still massive. However, Soliris is soon to face biosimilar competitors as its patent expiration date is approaching. In the U.S., Amgen has reportedly filed a suit invalidating patent for Soliris as a preparation for an early release of its biosimilars product. If Amgen wins the case, the original patent expiration in 2027 would be moved up as early as 2021. In Korea, Samsung Bioepis and Abxis are currently developing biosimilars. Prospective competitors expect their products to excel in the market considering the original cost 500 million won a year. Alexion’s Ultomiris launch prep is also closely related to the original patent case. The blockbuster original and the biosimilars have overlapping indication of ▲paroxymal nocturnal hemoglobinuria (PNH) and ▲atypical hemolytic uremic syndrome (aHUS). Also the market could favor Ultomiris over Soliris as number of annual injection is about a quarter of Soliris’. The original is supposed to be shot once every other week, whereas Ultomiris is shot once every eight weeks. Summing up a year worth of injections, Soliris and Ultomiris are shot 26 times and six to seven time a year (52 weeks), respectively. Accordingly, the drug expense for Ultomiris would be significantly lower. A global pharmaceutical industry analytic firm, EvaluatePharma has once evaluated Ultomiris’ market value at 10.9 billion dollars (about 12.26 trillion won). The figure is over a triple of Soliris’ global sales volume of 3.14 billion dollars.
- Policy
- “MOHW neglected 10000 practices by 56 suspended doctors”
- by Kim, Jung-Ju Nov 04, 2019 03:11pm
- Sources report tens of doctors, Korean medicine doctors and dentists with suspended licenses have practiced over 11,000 medical services and claimed over 800 million won of insurance reimbursement. The Board of Audit and Inspection of Korea (BAI) notified the details the health authority and ordered to take a corrective action on its negligence on obligated monitoring of suspended healthcare providers. On Oct. 31, BAI officially disclosed a Ministry of Health and Welfare (MOHW) management audit report on containing the details. The audit was conducted on the ministry’s inappropriate internal and external practices. The audit report on the ministry’s management negligence over healthcare providers with license suspended from illegal practice found 56 doctors, dentists and Korean medicine doctors have practiced 11,102 cases of medical service. Moreover, the doctors received 808,358,420 won of National Health Insurance (NHI) reimbursement claimed from HIRA, during their suspended license period. Field inspection on two doctors and a Korean medicine doctor randomly selected by MOHW from the 56 suspended doctors, confirmed their medical practices. The Korean medicine doctor, for example, practiced total 1,469 cases of medical service from last Jan. 1 to Mar. 6, such as acupuncture on outpatient with spinal pain. The doctor claimed and received 38,510,110 won of NHI reimbursement. BAI estimates two other doctors have practiced medical service on outpatient and inpatient during their suspension period and received back 176,649,200 won and 3,816,360 won, respectively, for NHI reimbursement. And BAI pointed out MOHW was completely unaware of the situation and did not revoke their licenses. Regarding the issue, MOHW accepted BAI’s audit result and suggested it would establish a system to inspect medical service practiced by suspended healthcare providers by cooperating with related government agencies, and also impose appropriate penalty to 56 doctors, who have been paid with NHI reimbursement, after a thorough inspection on any medical service practiced during their suspension period. BAI ordered Minister of Health and Welfare to take appropriate action on the 56 healthcare providers, such as field inspection, and establish a system to monitor and inspect healthcare providers’ practice during their license suspension period.
- Policy
- First year of Rare Disease Support Scheme
- by Eo, Yun-Ho Nov 04, 2019 08:13am
- The biggest issue of the policy is ‘lack of interest’. ‘Rare disease’ is not a specific categorization, but rather it is designated based on frequency of diagnosis. Korea defines ‘rare disease’ as a disease diagnosed to less than 20,000 people. With small patient size and lack of drug, these diseases are in dire need of new drug. But the voices of small handful of patients are easily lost in the air. At the moment in Korea, 951 diseases are designated as subject for Rare Disease Medical Aid Program, in which 927 of them are eligible for special case benefit. The total of 927 consists of 827 rare diseases as defined by the National Health Insurance special case copayment benefit system, and about 100 more added, as of August 2017, by a rare disease survey reflecting opinions of patients and their families, patient advocacy group, and medical experts. Previously, the government did not have a government-managed rare disease list without sufficient legal basis to back it up. So the size of rare disease patients was estimated according to the special case benefit subject list. Rare and chronic diseases were confused and defined as one keeping rare disease related policy making and researches limited. But growing voices criticized government for neglecting rare disease, and finally the Rare Disease Management Act was enacted in 2016. Since then, the first Rare Disease Management Plan was established, and in September 2018, the Rare Disease Patient Support Scheme was first implemented as more demanded for state-level rare disease patient support like disease management, treatment and prevention. ◆Rare disease patients supported by government:The objective of the Rare Disease Patient Support Scheme was to lessen patient’s financial burden of medical expense. The health authority applied special case benefit on the new rare diseases and expanded eligible disease for low-income patient medical aid. Including the newly designated 100 rare disease, now about 1,800 patients receive special case benefit, annually. Special case benefit system for rare disease patient started from applying 20 percent of copayment rate on artificial kidney dialysis or continuous ambulatory peritoneal dialysis for chronic kidney failure patients, and the benefit continued to expand on hemophilia, Gaucher’s disease, leukemia and cancer patients. But some undiagnosed rare disease patients had been excluded from the special case benefit due to unidentifiable diagnosis and disease code with limited patient size. And from last January, the roster for special case benefit and rare disease medical aid program subject diseases were unified. The revised regulation also stipulated special case benefit for undiagnosed rare disease patients without a disease code. Medical aid subject disease roster expanded significantly from 652 to 927 cases, granting financial support to about 2,600 more patients. Compared to last year, the Rare Disease Medical Aid Program bumped up this year’s budget and allocated about 32 billion won. The Rare Disease Patient Support Scheme includes Rare Disease Diagnosis Support Program to prevent patients from missing adequate treatment timing with difficulty in diagnosis. The diagnosis support program covers patients with Genetic Testing Support subject disease and undiagnosed condition. Also from this year, Rare Disease Regional Care Center Network has been expanded to ten centers, consisting of one Central Support Center and other Regional Support Centers. To sum it up, the Rare Disease Support Scheme mainly focuses on ▲establishing rare disease list and registration system, ▲increasing medical aid to reduce financial burden, and ▲expanding rare disease diagnosis support and Regional Support Centers. ◆Only 5% of diseases have treatment and NHI coverage rate is still low: Despite the government’s effort, some rare disease patients are still struggling to get access to treatment. Only about five percent of rare diseases have treatment developed. Diagnosis and treatment developments are far slower than other general medical conditions, because of small limited number of patients and prospective profit estimated low. And even if better treatments are developed, many of them are unapproved or non-reimbursed, leaving patients hopeless. Without guaranteed National Health Insurance (NHI) coverage on treatment, patients and their families would suffer not only from physical pain, but also with financial strain. More than 80 percent of rare diseases are inherited and patient’s family member show similar conditions. This vicious cycle leads medical expense in one single household to surge exponentially. However, the current Rare Disease Management Act does not specifically stipulate expansion of NHI coverage on rare disease treatments. Related industry claims Korea lacks a legal basis to back policy and regulation to boost pharmaceutical accessibility for rare disease patients catering unique qualities of the disease. Korea may have established a meaningful legislation of Rare Disease Management Act, but in fact, the law does not help many of struggling patients to get better access to drug to this date. Even at the National Assembly Annual Audit session, lawmakers urged the government to enhance NHI coverage on rare disease. Lawmaker Yoon Jong-pil of Liberty Korea Party spoke at Ministry of Health and Welfare audit session and pointed out, “Considering exceptionally limited number of patients and difficulty in developing effective treatment, rare disease treatment should be reviewed with more flexible criteria or they would not be accessible to patients in need”. .Drug pricing department of a multinational pharmaceutical company claimed, “An independent set of reimbursement review criteria should be designed for rare disease treatment as it is impossible to evaluate with common economic sense .And this is why special clause or supplementary article as a part of Rare Disease Management Act should stipulate expansion of coverage on rare disease treatment” .
- Policy
- Industry burdened but accepting of mandatory DSUR
- by Byun Kyung A Oct 31, 2019 09:59am
- Pharmaceutical industry initially complained of administrative strain when the government issued a notice on enforcing mandatory drug safety update report (DSUR)’, as advised by the National Assembly. But the industry also agrees with Korean government’s intention to enforce the pre-marketing regulation, which now has become a global trend. The pharmaceutical industry sees why the government would rather tighten the pre-marketing regulation than to cause actual corporate loss and public confusion over post-marketing recall and reimbursement and approval revocation. According to the lawmakers and pharmaceutical industry on October 27, Ministry of Food and Drug Safety (MFDS) plans to enforce mandatory submission of DSUR to strengthen clinical trial safety control. Currently, the Pharmaceutical Affairs Act does not stipulate mandatory DSUR submission. Along with post-marketing periodic safety update report (PSUR), DSUR has been an issue as a whistleblower from MFDS reported how “the ministry neglects its most basic job and does not even review submitted drug safety materials”. Criticism on MFDS neglecting drug review expertise grew intensely as drug quality and safety issues, such as ranitidine impurity incident and Invossa-K approval revocation, surfaced all at once. Accordingly, the lawmakers tackled the ministry on DSUR and PSUR management at the recent National Assembly Annual Audit. MFDS accepted the criticism and vowed to reinforce related regulation. MFDS official stated, “The ministry reviewed a total of 2,823 PSUR materials in last five years, and drug safety information reported from around the world were evaluated and reflected during the reexamination period”, and “mandatory DSUR would be enforced from 2020 based on the five-year National Health Insurance Comprehensive Plan announced last August”. Starting with new drug, MFDS is to phase in mandatory DSUR submission from next year considering pharmaceutical industry’s human resource, cost and other preparation procedure. Pharmaceutical industry showed mixed feelings of burden and need of the tightened regulation. Many also saw DSUR as unavoidable task the industry should take in as it is a pre-marketing regulation in clinical trial phase. “It is difficult to happily accept the new regulation as a company. DSUR submission, despite the phase-in introduction, would inevitably burden the industry with development cost and time,” but “we do agree the regulation is needed. Already many pharmaceutically advanced countries have enforced mandatory DSUR and it is now a global trend Korea cannot avoid,” a pharmaceutical administrative personnel from Korean pharmaceutical company commented. The Korean company associate also added, “Time would not be much of an issue, as it would be applied to new drug first, and give plenty of preparation time. The regulation aims to reinforce drug safety measures before commercialization, and not to be an excessive over-regulation. MFDS officials would probably convene a regulatory seminar for companies”. A multinational pharmaceutical company insider predicted DSUR would be less of a problem, as it regulates pre-marketing phase and not post-marketing. The multinational company associate said, “The authority has been trying to swiftly solve recent drug safety and approval revocation issues with strict regulation, retrospectively. Meanwhile, DSUR is a pre-marketing regulation that minimizes post-marketing measures but raises the bar for drug safety management. The actual strain on the industry would be relatively insignificant”.
