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- 2025-12-25 02:56:38
- Policy
- Zejula max reimbursed price 76,400 won from Dec. 1
- by Kim, Jung-Ju Nov 14, 2019 09:08am
- From December, Takeda Pharmaceutical Korea’s ovarian cancer treatment, Zejula 100mg capsule (niraparib) would be on the insured drug list at a price of 76,400 won. Although it is more cost-effective than the alternative option Lynparza, Zejula received the same price cap because Lynparza was listed via pharmaceoeonomics (PE)-exempted risk sharing agreement (RSA). Zopista would also be listed from next month at a price of 108 won per 1mg tablet. Health Insurance Policy Deliberation Committee (HIPDC) convened a meeting on Oct. 30, and decided to revise the list of reimbursed drug and upper limit reimbursement rates. Ministry of Health and Welfare (MOHW) explained the reimbursement listing schedule reflects the actual supply schedule of each listed drug, for instance, Zopista from Nov. 1, Zejula from Dec. 1 and Velphoro chewable tablets (sucroferric oxyhydroxide) from Jan. 1, 2020. ◆ Zejula 100mg capsule: Zejula 100mg capsule was approved as an oral maintenance therapy for platinum-sensitive adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Reaching an agreement with National Health Insurance Service (NHIS) on drug pricing negotiation, Zejula’s reimbursed price was set at 76,400 won per capsule. The drug was passed with expenditure cap as its alternative drug Lynparza was passed with a case of PE-exempted expenditure cap type RSA. Takeda released Zejula in Korean market after Ministry of Food and Drug Safety (MFDS) approved it on Mar. 22. On Mar. 25, the company submitted an insurance reimbursement listing application. The application was deliberated by Severe and Cancer Disease Deliberation Committee and Drug Reimbursement Evaluation Committee on June 12 and July 25, respectively, and the drug’s price was negotiated from Aug. 13 to Oct. 10. MOHW official explained patient’s burden on the drug is expected to be lowered significantly as the drug’s daily cost for patient reimbursement the cost is now at 7,640 won, whereas without reimbursement was at 152,800 won before. ◆ Velphoro chewable tablet: Velphoro is a new drug used to control serum phosphorus levels in patients with chronic kidney disease on dialysis, and HIPDC passed the drug at a reimbursed price of 1,697 won per tablet. The tablet was approved by MFDS on Mar. 20 last year, and it applied for reimbursement on Oct. 24 the same year. DREC deliberated and passed the drug on Apr. 25 this year, and NHIS conducted a pricing negotiation from May 22 to July 19. ◆Zopista tablet: An insomnia treatment, Zopista was approved by MFDS on last May 3, and it applied for reimbursement on May 31. The treatment was passed by DREC on Aug. 29 and reached an agreement with NHIS on pricing negotiation from Sept. 24 to Oct. 21. The tablet’s reimbursed cap price was set to 108 won, 162 won and 203 won for 1mg, 2mg and 3mg tablets, respectively. Director Kwak Myeong-Seop of Pharmaceutical Benefits Division stated “The updated reimbursed drug list has expanded insurance coverage on recurrent ovarian cancer treatment, and accordingly enhanced treatment access but lessened patient’s financial burden. The updated list would be officially in effect from Dec. 1, providing National Health Insurance reimbursement on newly added Zejula, Velphoro and Zopista”.
- Policy
- 62 DI including Belviq® and CONTRAVE®,added to DUR
- by Lee, Tak-Sun Nov 14, 2019 09:07am
- The MFDA(Ministry of Food and Drug Safety) has announced additional contraindicated DI(Drug Interaction) medicines that will be updated in the DUR (Drug Utilization Review). Especially, one of the antiobesity medicines, Contrave®(Bupropion-Naltrexone) is contraindicated with Belviq® (Locaserine HCl), and , Cough®, one of expectorants was added Category X which means highly unsafe in pregnant woman. MFDA announced on Nov 11 the partial amendment proposal of 'Regulations on Designation of Contamination of etc.'. This amendment will be implemented immediately after the opinion submission period and will be reflected in the DUR. The revised contents includes 62 DI medicines including Bupropion & Naltrexone-Locaserin, which are considered necessary for contraindication DI. The Bupropion / Naltrexone preparations are generic for Contrave® recently approved. It was added to DUR not to take with Belviq®. Also Belviq® is anti-obesity medicine. 42 contraindicated drugs for pregnany women including Dihydrocodein tartrate was added to DUR, too. Cough® and Codaewon-Forte® are the main medicines including Dihydrocodein tartrate. Remarks have been changed and added to Fentanyl and other ingredient, which are designated as category X. Fosfomycin, on the other hand, was lifted from category X. 10 contraindicated drugs for certain age criteria like Atomoxetine added age-specific contraindications and dosage forms. In addition, the age criteria for 4 ingredients including Bicalutamide were changed. The ingredient name and dosage forms for 4 components including Mesalazine were changed. MFDA officer said, “This amendment will be implemented after the opinion submission period and will be reflected in the DUR immediately” and added “ The amendment was based on the information in the drug insert".
- Policy
- Ultomiris®, follow-up Soliris® to set with clinical trial
- by Lee, Tak-Sun Nov 14, 2019 03:21am
- Follow-up medicine after Soliris® which is a very expensive Orphan drug and ₩40 billion sales in domestic market reached out the end of clinical trials. That’s what the medicine named Ultomiris®, and Phase III clinical trials was approved for PNH and Myasthenia gravis patients. There is high probability of becoming available in the domestic market the end of next year. The MFDS(Ministry of Food and Drug Safety) approved Ravulizumab’s (generic for Ultomiris®) multi-state models in clinical trials. The Clinic trial is proceeded in SNUH, Severance Hospital, SMC. And, The test client is INC Research. Domestic subjects are 8 patients, and it will progress clinical test on until next September. Prior to this, multi-state models in clinical trials for myasthenia gravis patients without administering C5 complement inhibitor evaluating saftey and efficacy in was approved. Domestic subjects are 7 patients, and the Clinic trial is proceeded in 6 medical institutions including SMC. Handok retains the reimbursement and dometic approval for Ultomiris®. Also, the company imports and sell Soliris®, PNH treatment. Alexion, original developer is targeting domestic approval of Ultomiris® by the end of next year. Alexion received FDA approval forUltomiris® last December, and EMA approval this July, too. Ultomiris® improved medication compliance compared to Soliris®. Ultomiris® is injected every 8 weeks, while Soliris® is injected every 2weeks. Soliris®is very expensive, and the RSA(Risk Sharing Agreement) was ended in last October. The pharmaceutical price is ₩5,130,000 per 300mg /30ml bottle. It costs ₩5 billion annually per patient, and IQVIA’s Standard sales was ₩41.5 billion last year. It seems that they put a high price on Ultomiris®. Reimbursement negotiation is expected to be the key to market release.
- Policy
- DREC passes Imfinzi, Liporaxel ‘conditional'
- by Kim, Jung-Ju Nov 11, 2019 10:41pm
- AstraZeneca AstraZeneca’s immunotherapy Imfinzi (durvalumab) passed the first threshold to receive its insurance reimbursement in Korea. The treatment is soon to initiate its negotiation with National Health Insurance Service (NHIS) under the order of drug pricing negotiation by Ministry of Health and Welfare (MOHW). On the other hand, Daehwa Pharmaceutical’s stomach cancer treatment Liporaxel (paclitaxel) received a conditional right to initiate a drug pricing negotiation with NHIS, when the drugmaker accepts proposed evaluated price (weighted average) by Health Insurance Review and Assessment Service (HIRA). In the morning of Nov. 8, HIRA published results of Drug Reimbursement Evaluation Committee (DREC) meeting convened on Nov. 7, deliberating insurance reimbursement feasibility review applications. First, Imfinzi is approved for the treatment of locally-advanced non-small cell lung cancer following chemotherapy and radiation therapy. Unlike other immunotherapy, Imfizi specifically targets Stage III lung cancer. DREC reviewed reimbursement feasibility of the treatment and passed it, 11 months after the application was submitted. Liporaxel is a new anticancer treatment, improving inconvenience of Taxol as an oral regimen. But the Korean regulator once denied reimbursement on the treatment last year. In the latest deliberation, Liporaxel was granted with conditional non-reimbursement status. The treatment’s efficacy was well noted but it came down to the issue of relatively high cost than other alternative drugs. When the pharmaceutical company proposes a price lower than HIRA’s feasibility-evaluated price, the drug is to receive reimbursement.
- Policy
- World's most expensive drug Zolgensma to challenge Spiranza
- by Lee, Hye-Kyung Nov 11, 2019 06:11am
- Launching of the most expensive drug in the world, Zolgensma (onasemnogene abeparvovec-xioi), with a price tag of 2.5 billion won per dosage, has gotten Korean health authority and pharmaceutical industry anxious. Although the drug had an allegation of data manipulation from animal testing two months after the U.S. Food and Drug Administration’s (FDA) approval, the industry experts see Zolgensma would enter Korean market soon as the allegation is unlikely to cancel its approval. In last May, the U.S. FDA approved Zolgensma, indicated for the treatment of pediatric patients less than two years of age with spinal muscular atrophy (SMA) with bi-allelic mutation in the survival motor neuron-1 (SMN1) gene. Also, its applications for Fast Track, Breakthrough Therapy, Priority Review and orphan drug were granted. But the treatment has not been introduced to Korean market, yet. The drug is a gene therapy designed to target the genetic root cause of the Type 1 SMA through one single session of therapy. Meaning, one injection of the therapy replaces the function of the missing or nonworking SMN 1 gene with a new, working copy of a human SMN gene and prolongs patient’s overall survival. Institute for Clinical and Economic Review (ICER), a U.S. based organization reviewing drug’s cost-effectiveness, set Zolgensma’s price at USD 90,000 (about 95 million won), but the drugmaker claimed it should be four million to five million dollars (about 5 billion won), because it is an one-time treatment. Currently, Zolgensma is sold in the U.S. for 2.1 million dollars (about 2.5 billion won), and the pharmaceutical company provides an option of five-year installment with an yearly payment of 425,000 dollars, with partial refunds if it does not perform as expected. Followings are major motor milestones of the final result of clinical study on 12 SMA Type 1 patients with the onset of clinical symptoms before six months of age (average age of 3.9 years, as of March 8, 2019); all patients at the 24-month study closeout, survived and are free of permanent ventilation; 11 patients were able to hold their head erect for three seconds and longer, and sit without support for five seconds and longer; ten patients were able to sit without support for ten seconds and longer; nine patients were able to sit without support for 30 seconds and longer; two patients were able to stand alone, walk with assistance and walk alone. The key results resemble that of Spinraza, listed on Drug Reimbursement List in Korea as of April 8, this year. In 2016, the US FDA granted approval on Spinraza, an antisense oligonucleotide (ASO), for treating SMA caused by mutations in chromosome 5q. At the point of approval, ICER evaluated price of first year Spinraza therapy to be 750,000 dollars (about 800 million won), and 350,000 dollars (about 400 million won) from second year and on. As of now, Spinraza is covered by National Health Insurance (NHI) in Korea with risk sharing agreement (RSA), and its price cap for a single vial (5ml) is at 92,359,131 won, and patient copayment is about 9.23 million won, a ten percent of the full price. Reimbursement is granted for patients with SMA caused by mutations in chromosome 5q satisfying all conditions of preliminary review. The conditions include, patients diagnosed with absence or mutation of SMN1 gene, having onset clinical symptoms of SMA from age of three or less, and not using permanent ventilation (more than 16 hours a day continuously for more than 21 days). Spinraza is an intrathecal injection, administering four loading doses of 12mg (5ml) into cerebrospinal fluid. The first three loading doses should be administered at 14-day intervals. The fourth loading dose should be administrated 30 days after the third dose. A maintenance dose should be administered once every four month thereafter. In July, Spinraza published an interim report of 60-month long-term Phase 2 NURTURE clinical trial. NURTURE is an ongoing Phase 2 study of 25 infants with the genetic mutation of SMN, who received their first dose of the drug in a pre-symptomatic stage and before six weeks old. 45.4 months into the trial, all 25 patients have survived without permanent ventilation and are able to sit without support. Apparently, 88 percent (22 patients) can walk without support, suggesting the drug could be effective for infants not showing SMA symptoms, yet. SMA is a rare recessive neuromuscular disorder caused by bi-allelic mutation in the SMN1 gene’s chromosome 5q. The disorder causes a deficiency of motor neuron protein called SMN, and about 95 percent of people with SMA have onset symptoms when SMN1 gene mutates. SMN1 gene mutation reduces production of SMN protein as downstream processing from DNA to RNA cannot develop enough SMN gene, and also it induces apoptosis of anterior horn cell causing degenerative change in motor neurons, which leads to a relatively fast progression and symmetrical muscle weakness resulting in early death. Reported estimated incidence rate of the condition is one in 6,000 to one in 10,000 live births and carrier frequency is about 1/40-1/50. Infants with symptoms are unable to independently move as they lose motor function due to muscle degeneration. Infants with SMA have the highest severity and frequency, which their symptoms are prevalent from birth or around six months after the birth. These patients with severe case rapidly lose motor neuron, in control of activities like breathing, swallowing, speaking and walking, and without a treatment their muscles weaken fast and die from respiratory failure, as even their respiratory root loses its function by the age of two. Currently Spinraza and Zolgensma are only two SMA treatments available. Spinraza is a SMN2-directed ASO, approved to treat 5q SMA with its results of ENDEAR study. Whereas Zolgensma is a gene therapy that replaces missing or mutated SMN 1 gene, and was approved to treat children less than two years of age having bi-allelic mutation in SMN1 with results demonstrated in STR1VE study. Zolgensma had a comparatively small-size clinical trial than Spinraza, which demonstrated its efficacy in Type 1 patient before the age of six months and Type 2 and 3 patients at the age of two to 12 with onset symptoms from six months after birth. On the other hand, Zolgensma can only be used for SMA patients before the age of two. As for their pricing, Spinraza is priced at around 100 million won per injection and needs continuous administration, but a single-administration therapy Zolgensma is priced at around 2.13 million dollars (about 2.52 billion won) per injection. Zolgensma currently holds the title of the most expensive drug in the world for the price of single dosage. However, Spinraza and Zolgensma still need more research and follow-up monitoring on the drugs’ efficacy and safety through long-term clinical trials. There are also needs for more reasonable pricing for better treatment access.
- Policy
- On a mission to eradicate KOEDC’s deep-rooted ill practice
- by Lee, Jeong-Hwan Nov 10, 2019 10:00pm
- Sources confirmed Korea Orphan and Essential Drug Center (KOEDC) submitted the National Assembly (NA) a plan to resolve its issue of redirecting profit made from drug expense gap, as it was pointed out at the latest NA Annual Audit. The center is committed to eradicate its deep-rooted practice of making profit from drug price difference and reusing it as the center’s budget. However, some point out the center would eventually need significantly increased budget approved by the center’s affiliated government body, Ministry of Food and Drug Safety (MFDS) and Ministry of Economy and Finance (MOEF). On Nov. 6, NA Health and Welfare Committee lawmaker, In Jae-Keun’s office explained “KOEDC submitted a proposal to cease their ill practice of redirecting unfairly made profit”. By the end of the year, KOEDC plans to compile ‘Evidences for Drug Pricing Readjustment Application’, needed to remove profit from drug price differences. Until February next year, KOEDC is to initiate a negotiation with Health Insurance Review and Assessment Service (HIRA) on modifying drug pricing, and in March, it would execute a lump-sum reevaluation on drug price gap. The center claims it would be done with redirecting drug pricing gap profit to budget use after HIRA completes drug reimbursement listing procedure by December next year. Newly appointed KOEDC Chairperson Yun Young Mi is reportedly determined to eradicate unethical practice within the center and normalize its internal management. As a matter of fact, KOEDC has been under a criticism for last five year on re-utilizing 6.5 billion won, made from differences in orphan drug’s actual transaction price and National Health Insurance Service (NHIS) billing price, as the center’s budget. The center official explained the practice actually has been a solution to MFDS’ insufficient budget support rate of average 37 percent. Although the center has consistently confessed of abnormal use of drug price differences and urged MFDS to boost its budget support, KOEDC did not get any answer. So in the end, it is up to MFDS to allocate budget support for the center to ultimately resolve the budget redirecting practices, according to the plan submitted to the NA. Apparently, the center used drug price differences of about one billion won every year as their organizational operation expense. But after HIRA’s adjustment on the drug pricing, the center would lose budget of one billion won. However, it is not going to be an easy ride. KOEDC has already asked for next year’s budget of 14.03 billion won, but the government only passed about 17 percent of the requested amount, 2.39 billion won. The NA is already reviewing the government’s next year budget plan, but the Health and Welfare Committee’s ‘Budget and Accounting Evaluation Subcommittee’ and ‘Budget Deliberation Special Committee’ have not yet made a decision on whether or not to increase KOEDC’s budget. Even after the committees decide to increase the overall budget, the key to the problem is then passed to MFDS and MOEF’s decision to provide the center’s requested budget. KOEDC official said, “A number of lawmakers at the NA Health and Welfare Committee audit session demanded the government to work on the center’s drug price gap profit redirecting issue, insufficient budget and low government support funding rate. For the center to operate properly, the addressed issues have to be resolved completely, and it ultimately comes down to the matter of budget allocation. The center would do its best waiting for the NA make a decision.” “For now, Health and Welfare Committee is to request Budget Deliberation Special Committee to consider increasing budget for KOEDC basic operation expense, personnel expense, and regional center operation expense. As the center’s issue of redirecting profit from drug price difference has been addressed, the lawmakers have asked MFDS to submit a solution to KOEDC’s problems,” an official from Lawmaker In Jae-Keun’s office commented.
- Policy
- Eliquis faces 42 generics after patent invalidated
- by Lee, Tak-Sun Nov 10, 2019 10:00pm
- The list of generics launched in the New Oral Anticoagulant (NOAC) Eliquis (apixaban) market is getting longer by the day. Especially after generic manufacturing companies won the case invalidating Eliquis’ patent in last March, number of regulator-approved generics has skyrocketed. Ministry of Food and Drug Safety (MFDS) confirmed that the total number of MFDS-approved apixaban medicine products as of Nov. 6, including the original Eliquis by BMS, is 84 supplied by 42 companies. 19 companies supplying 38 items have been approved by the ministry after the patent was invalidated at a court decision. Daewoong Bio and GC Pharma are a few of latest additions. At the moment, 38 items by 19 companies are listed with reimbursement and competing in the same market. After winning the patent invalidation case, Chong Kun Dang, Alvogen Korea, Huons and Yuhan immediately applied for reimbursement listing and entered the market from last June. Other freeloading pharmaceutical companies did not participate in the patent litigation, but decided to launch their generics expecting the patent to be invalidated. More generics are projected to be released in the future based on the number of approved products. Currently, an appeal against the patent invalidation decision has been filed but is pending at the Supreme Court. But as generic companies won both first and second trials, the Supreme Court would likely to rule in favor of the generics. On Oct. 18, the Supreme Court dismissed a trial on a medicine patent invalidation case, finalizing the previous judiciary decision to invalidate the patent. In other words, the generics sales would not have any legal barrier against sales, when the Supreme Court decides to invalidate the medicine patent. As for apixaban market, even the preferential sales approval period on the patent challenger, banning sales of other equivalent generic, has passed already. Three items, including Yuhan Apixaban, were granted with preferential sales period from May 12, 2018, to Apr. 2, 2019, but their actual sales were suspended as BMS’ sales ban application was accepted. Sales ban injunction was lifted only after the Patent Court invalidated apixaban patent. Now the key is on how well generic companies would expand the trending NOAC market. Among all NOAC medicine, only Eliquis has generic competitors. As NOACs are mostly used in general hospitals, Korean generic companies are focusing on the clinic market instead. But it seems like it would take some time for NOAC generic market to fully flourish. Since its sales started from June, Chong Kun Dang’s Liquisia made disappointing sales of 178.35 million won (Source by UBIST) until September. Meanwhile, the original Eliquis reaffirmed its market leadership by making accumulated prescription sales of 31.3 billion won by September, hiking up 32.1 percent from the year before.
- Policy
- “Less on chronic drug, but more on innovative drug”
- by Lee, Jeong-Hwan Nov 10, 2019 09:59pm
- Principal Boo Ji-hong Claims have been made that the government drug expenditure model should be fundamentally reformed, instead of adopting new drug-centered drug pricing policy, to simultaneously better Korean patient's access to new and breakthrough treatments, and to secure financial health of National Health Insurance (NHI). The criticism is that the government should face the reality of excessive use of digestive medicine, antacid, and antibiotics and other chronic drug, and rather limit the frequent use of those mild condition and chronic disease drug to redirect the saved expense on enhancing access to new drug and healthcare coverage. On Nov. 7, a principal of IQVIA Korea, Boo Ji-hong spoke at a policy seminar regarding the social value of new drug and NHI financial management. Principal Boo gave a presentation on sustainability of NHI and advancement of pharmaceutical expenditure model. The principal explained Korean government’s pharmaceutical coverage enhancement plan for unmet needs of severe and rare disease treatment is established based on moderately controlled drug expenditure. Boo also reproached, although the government’s NHI coverage enhancement initiative has improved access to innovative drug and rare disease treatments than before, coverage on specialty drug, such as anticancer and AIDS-like infectious condition treatment, is still fairly low. Specifically, Principal Boo sees that need for innovative drug access is clearly unmet, when comparing Korea and developed countries’ pharmaceutical expenditure models and the ratio of new drug expenditure. He also explained comparatively low medical expenditure in Korea has affected the country’s perception that local drug expenditure is higher than that of other developed countries. As a result, Principal Boo argued, the government can catch two birds, new drug access enhancement and NHI financial health, when it drastically reforms and advances pharmaceutical expenditure structure. He advised the government’s unconditional reduction of drug pricing would basically threaten patient’s access to treatment. Instead, it should lessen excessive use of chronic and mild condition treatments, and reuse it as resource to cover severe disease treatment and orphan drugs. Moreover, the principal stated NHI expenditure would be raised only by 0.6 percent at highest with financial impact of healthcare coverage expansion on new drug, including coverage on non-reimbursed drug, and approving and listing not-yet launched drug in Korea and investigational drug. “Volume of digestive medicine, antacid and antibiotics frequently used in Korea doubles the volume in other advanced countries, which is why the government should consider limiting the volume. Also, efficiency of insurance income allocation could be improved by studying overseas cases of innovative payment system, drug usage volume control, and public-private collaborated management of chronic disease patient”, said Principal Boo. He also stressed, “To enhance NHI coverage on patient-centered breakthrough innovative drug, expenditure structure should get further upgraded and incentive should be granted for the recognized value of an innovation. The effect of price-centered new drug expenditure management policy would be mediocre. But so the government should consider moderately controlling drug usage volume and amending expenditure structure”.
- Policy
- Law firms shakes hands with 8 government officials this year
- by Lee, Hye-Kyung Nov 07, 2019 08:55am
- Large-scale law firms in Korea are adding more and more former government officials affiliated with National Health Insurance (NHI) to their roster. A former Executive Director of Planning at Health Insurance Review and Assessment Service (HIRA), Hwang Eui-dong, 61, was recently welcomed by law firm ‘LK Partners’ as an advisor. Lately, LK Partners formed a pharmaceutical affairs team to handle diverse law suit related to pharmaceutical rebate case and medical, pharmaceutical and medical device industries. Attorney Kim Hyeong Seok, formerly a director of Food and Drug Inspection Division at Supreme Prosecutors’ Office, was added to the pharmaceutical affairs team at LK Partners, where Hwang was also agreed to join as an advisor. The team also shook hands with Attorney Jung Dawoon, a former director of Administrative Law Division at HIRA. Advisor Hwang majored in law at Sungkyungkwan University, and joined National Medical Insurance Corporation, now National Health Insurance Service (NHIS), in 1986. He served as chief of ICT Division, director of Daegu District Office, director of Automobile Insurance Review Center, director of Medical Information Analysis Division and retired after serving as executive director of planning. After his retirement at HRIA, Advisor Hwang was appointed as a chief of Policy Development Division at Korea Institute for Healthcare Accreditation (KOIHA), but decided to join LK Partners recently. Law firms’ demand and interest on medical, medical device and pharmaceutical and bio industries have been constantly expressed. And it finally exploded as major law firms ‘Kim & Chang’ and ‘Lee & Ko’ started revving up the NHI-associated government official recruitment market from last year. Just in this year alone, eight former government officials have been scouted by law firms, including former chief at HIRA Kang Kyung-soo; former vice-minister of Health and Welfare Choi Won-young; former Regional Office Director at National Health Insurance Service Cho Yoo-hyun; former executive director at HIRA Hwang Eui-dong; former director at HIRA Jung Dawoon; and former director at Ministry of Health and Welfare Ryu Yang-Ji. Large-scale law firms are appointing government officials for titles like advisor, senior consultant and consultants, which previously were taken by industry and drug pricing experts. Other law firms are also quick to follow and open healthcare or medical and pharmaceutical specific teams. At first, Kim & Chang welcomed Lee Byung-il, a former chief of Pharmaceutical Management Department at HIRA, as an advisor in May, 2018, and continued on to scout Ko Su Kyoung, formerly associated with HIRA, NHIS and multinational pharmaceutical company, as an expert consultant. Kim & Chang’s rivaling law firm, Lee & Ko organized Healthcare team consisting of former Minister of Health and Welfare Rim Chemin, former vice-minister of Health and Welfare Sohn Gunn Yik, and former director general at Ministry of Food and Drug Safety Han Young Sup. Their last addition was Kang Kyung Su, a former chief at HIRA, in last February. The firm is also strengthening their healthcare expertise with senior consultant Byun Youngshik, a former senior director at AstraZeneca Korea, and Advisor Kim Sungju, a former executive director at Novartis Korea. Law firms like ‘HMP Law’, ‘Yulchon’ and LK Partners have been busy this year lining up pharmaceutical expert teams with health sector experts. In last March, HMP Law organized Healthcare team for the first time since the firm was founded. The team invited former vice-minister of Health and Welfare Choi Won-young as an advisor and former chief of Legal Affairs Support Team at HIRA Byen Chang-suk as a chief of the team. Moreover, Park Young Hwa, formerly a medical case judge at Incheon Regional District Court, joined HMP Law as a Managing Partner, whereas Cho Woo-hyun, a former director of NHIS Seoul and Incheon District Office, and Lee Chung-gu, a former director of Administration Department at Hallym University Hospital, joined the firm as advisors. Yulchon has had a full-fledged Healthcare and Pharmaceuticals team with Choi Hee Joo, a former chief at MOHW, Kim Sung Jin, a former director at MFDS, and Choi Cheol Su, and a former chief at HIRA. But its roster recently made an addition, a former director at MOHW now a senior advisor Ryu Yang Ji, to boost the firm’s strength. These law firms assertively seeking out for healthcare related government officials could mean that the need for legal consulting and lawsuit is growing fast in related industries, specifically regarding pharmaceutical and medical device insurance reimbursement listing and application, various administrative penalty, medical dispute and government policy.
- 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.
