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- 2026-04-17 19:19:01
- Policy
- Who holds the key to end financial toxicity?
- by Lee, Hye-Kyung Dec 22, 2019 09:52pm
- (From left) Professor Kim Hee-jun of Chung-Ang University Hospital, Professor Lee Dae-Ho of Seoul Asan Medical Center Department of Oncology, Professor Park Ji-hyun of Konkuk University Medical Center Department of Hemato-oncology, Professor Suh Dong-Churl of Chung Ang University College of Pharmacy, Baek Jin-young Korea Kidney Cancer Association, and Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW Doctor: “Although it’s non-reimbursed, the immunotherapy option is recommended for kidney cancer. But it’s expensive” Patient: “How much is it?” Doctor: “It’s about 10 million won per month”. Patient: “Can I get fully recovered”. Doctor: “It’s not guaranteed”. Patient: “It’s too expensive”. Doctor: “Discuss and decide with your family after checking the price, if you have a private insurance.” At a policy seminar convened on Dec. 19 about enhancing coverage for immunotherapy, President Baek Jin-young Korea Kidney Cancer Association enacted a common conversation between a doctor and kidney cancer patient. The seminar was organized by Lawmaker Kim Kwang-soo at a seminar room in the National Assembly Member’s Office Building. President Baek said, “During the three-minute counseling time, cancer patients have to listen to a doctor talk about financial toxicity first than the severity of their own health. It happens quite often.” Professor Kim Hee-jun of Chung-Ang University Hospital and Professor Park Ji-hyun of Konkuk University Medical Center Department of Hemato-oncology nodded their heads at President Baek’s story. Professor Kim stated, “It’s dishearteningly relatable. Once when a colleague visited and listened to a conversation between my patient and me, she commented it sounded like I was selling a private insurance. I have to ask patients about their private insurance status and limits. And even if I show a survival rate graph after the talk, I know they are not paying an attention anymore.” She added, “When Obdivo announced its launch in Korea in 2015, I was excited. But it’s disheartening that I cannot use it for all patients.” President Baek and Professor Kim proposed that the special case benefit applying five percent patient copayment rate from first-line therapy could be raised. President Baek claimed “Cancer patients should also stop being stubborn about the five percent copayment rate, but embrace the opportunity to choose different options with higher copayment rate. It is also crucial for pharmaceutical company, patient and government to share the initial risk of uncertainty in treatment efficacy, and to establish reasonable standard of reimbursement.” Professor Kim also added, “At first, I was grateful for the five-percent copayment rate. But the more new drugs were launched, the longer patients had to fight against cancer. Back in the day, cancer patients had about less than a year to survive. But the survival period has gotten longer. We need to carefully consider raising the copayment rate a little bit for all cancer patients to benefit from the system.” Professor Lee Dae-Ho of Seoul Asan Medical Center Department of Oncology pointed out, “The root of all problem is money.” The professor elaborated, “We need to consider if the people would be happy to enhance coverage on four major severe diseases, and if they would be happy to spend their tax money on cancer patients,” and “I also don’t mean to reduce the price of drugs for those pharmaceutical companies trying to bring new drugs to Korean patients.” “It’s skeptical if profit-seeking pharmaceutical companies are truly for the patients,” because it is “unconvincing for insurer paying for the health insurance expenditure [to expand coverage on anticancer treatment], when the companies demand for improved access on new drug, but don’t put an effort to lower their drug price,” the professor added. New drug reimbursement application, it’s up to pharmaceutical companies After a series of criticisms from the panels, Ministry of Health and Welfare (MOHW) defended their position with vulnerable financial situation. Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW urged, “Besides people’s overestimation of immunotherapy as a miracle elixir, it is still an unknown territory as an insurer who has to pay for the insurance expenditure. We need at least a tool to confirm its response rate to grant insurance reimbursement”. Accordingly, Health Insurance Review and Assessment Service (HIRA) is conducting a RWD research for post-marketing evaluation, and National Health Insurance Service (NHIS) is conducting a study on expenditure efficiency for financial feasibility. Deputy Director Choi noted, “We always feel sorry for patients and their family, and we are regretful that we cannot provide the right weapon for medical profession to fight against cancer with. However, it is also regretful that all the responsibility for the unfortunate state is blamed on the government”. The government basically pointed out the public thinking the government is keeping the last key back to end the pharmaceutical company’s tug-of-war against the government, insurer and NHIS with the new drug pricing negotiation. Deputy Director Choi elaborated, “The government is not the one with the last key. MOHW, NHIS and HIRA exist to keep health insurance expenditure justifiable. As the insurance finance is not from a bottomless pot, the ministry set the drug pricing regulation for pharmaceutical companies to apply for reimbursement with according to their drug’s financial impact and patient protection measures and to have negotiation with government for the reimbursement listing.” Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW “Negotiation does not proceed with a unilateral yielding, but it is rather a process of reaching an agreement and seeking a way within the system. The government asks for new drug’s response rate, financial toxicity, and clinical data to base reimbursement decision. But some companies don’t even speak a word. We are not to name names, but the pharmaceutical companies are the ones holding back the key”, the deputy director reprehended. The government official also mentioned of a foreign financial support system, Cancer Drugs Fund. Deputy Director Choi said, “Some have suggested a sort of ‘money pot’ is needed when setting up the National Health Insurance Comprehensive Plan. So we are trying to make an individual account to cover anticancer and rare disease treatments with money saved from reevaluating drugs with low efficacy or not delivering expected effect”. Regarding the five-percent special case reimbursement rate, the official said “We are considering on expanding selective reimbursement scope.” “We are contemplating a realistic solution like preliminary pricing reduction for a limited number of cancer patients. Although monotherapy exists, also having a combination therapy makes the situation complicated. We would do our best to improve patient’s new drug accessibility,” said the deputy director.
- Company
- Drug trade volume to hit all-time high over USD 10 bln
- by Kim, Jin-Gu Dec 22, 2019 09:51pm
- Korea’s accumulated trade volume is expected to surpass USD 10 billion for the first time. The biggest impact is from a significant surge of pharmaceutical export volume. This year’s overall pharmaceutical export volume is projected to go over 3.6 billion dollars. The number almost doubled, compared to four years ago in 2015. According to statistic data from Korea Customs Service, the accumulated pharmaceutical trade volume, as of November, reached 9.34 billion dollars (approximately 10.91 trillion won). If the trend continues, the pharmaceutical trade volume from this year alone is expected to surpass the 10 billion-dollar mark for the first time. Pharmaceutical import and export volume by year. 2019 includes projected December figure based on performance as of November. (Source: Korea Customs Service) In recent years, the trade volume grew constantly reaching 6.27 billion dollars, 7.44 billion dollars, 7.94 billion dollars, and 9.37 billion dollars in years from 2015 to 2018, respectively. The pharmaceutical export volume had the biggest surge. As of November, the pharmaceutical export volume reached 3.34 billion dollars (approximately 3.91 trillion won). Outperforming last year’s export volume at 3.27 billion dollars, this year’s volume is expected to easily make over 3.6 billion dollars by the end of the year, hitting the highest point in the history. The all-time high export volume was possible this year due to strong performance from Celltrion and Samsung Biologics’ biosimilars and Daewoong Pharmaceutical’s Nabota export. Moreover, the government building stronger ties with Southeast Asian countries have helped the increase in export to their markets. On the other hand, pharmaceutical import volume has reached 5.99 billion dollars as of November (approximately 7.32 trillion won). The trade surplus, balancing export and import volumes, is to get better by a bit. Last year’s pharmaceutical trade made a deficit of 2.83 billion dollars. This year’s deficit is expected to be around the similar level of 2.8 billion dollars. Pharmaceutical import and export volume from January to November, 2019. (Source: Korea Customs Service) Apparently, Korea’s overall trade volume has surpassed one trillion dollars this year. The trade volumes in last three years have exceeded one trillion-dollar mark since 2017. China, the U.S., Germany, Japan, the Netherlands, France, the U.K. Hong Kong and Italy as well as Korea are the only ten countries around the world to have overall trade volume over one trillion dollars.
- Company
- Astrazeneca-SK supplying Diabetics worth $100 million/year
- by Eo, Yun-Ho Dec 22, 2019 09:51pm
- President Dong-hyun Jang (left) & President Leif Johansson (right) AstraZeneca and SK announced that the drug was manufactured and produced under the partnership signed by the two companies in January 2018 and is being supplied to 3 million people with diabetes in 98 countries. The agreement contributed to SK's successful entry into the global biopharmaceutical manufacturing and production business and the growth of AstraZeneca, with a value of approximately $ 100 million annually. At the headquarters of SK Group, Leif Johansson, Chairman of AstraZeneca and Dong-hyun Jang, SK CEO exchanged commemorative plaques to celebrate the achievement of important milestones through the cooperation of the two companies. The event was attended by Swedish Foreign Minister Anna Hallberg, Minister of Trade, Industry and Energy, Jung-yeol Yoo, Director of Health and Welfare , In-taek Im, government officials, and officials from both companies. In accordance with the agreement between the two companies, SK Biotech, a wholly owned subsidiary of SK, manufactures and produces APIs (Active Pharmaceutical Ingredients) for diabetes treatments such as AstraZeneca's blockbusters, Forxiga (Dapagliflozin) and Onglyza (Saxagliptin). Raw materials manufactured and produced in Korea will be converted into pharmaceuticals at the SK Biotech Ireland plant in Swords, Ireland, which SK Group acquired in 2018. AstraZeneca is responsible for producing and supplying treatments to patients around the world using this materials. Leif Johansson, Chairman of AstraZeneca said, “SK Biotech is an important strategic partner of AstraZeneca and is a good example of Korea's high value and quality level in the manufacture of pharmaceutical products, Since 2018, the two companies have collaborated to deliver medicines that change the lives of patients and contribute to the patient and the society as well as to business growth”. Dong-Hyun Jang, president of SK, said, “We have been cooperating for common social values since 2018 through partnership with AstraZeneca to provide innovative medicines to patients. SK Pharmteco (SK CMO Integrated Subsidiary) will continue to solidify our partnerships by expanding the production of raw materials for a wider range of diseases”. On the other hand, AstraZeneca signed a memorandum of understanding (MOU) with the KOTRA, the KHIDI, the KoreaBIO and the KPBMA in the Korea-Sweden Business Summit held in Seoul on the 18th and announced that the company would strengthen cooperation to accelerate innovation in the Korean biohealth industry.
- Company
- SK Holdings reaffirms partnership with AstraZeneca
- by Lee, Seok-Jun Dec 20, 2019 06:36am
- On Dec. 19, SK Holdings CEO Jang Dong-hyun met with Chairman Leif Johansson of AstraZeneca at the SK Group Headquarters, Seoul. At the meeting, SK Biotek and AstraZeneca announced they have been supplying diabetes treatment to about hundred countries since their partnership deal signed in January 2018. The two companies stated their partnership is valued at approximately USD 100 million. After the acquisition of Bristol-Myers Squibb’s (BMS) manufacturing facility in Ireland, SK Biotek also gained a partnership with a global pharmaceutical giant, AstraZeneca. The Korean company took over the manufacturing facility and specialized human resources, as well as the supply contract with AstraZeneca. The industry evaluates the acquisition was a successful M&A that took in account of earning the extra global partnership. Reportedly, AstraZeneca last year generated 22 billion dollars (about 26 trillion). SK Holdings CEO Jang Dong-hyun (left) and AstraZeneca Chairman Leif Johansson met and briefed about performance so far at a partnership signing meeting on Dec. 19 More than half of BMS manufacturing contract in Ireland was signed by AstraZeneca SK Biotek and AstraZeneca’s relationship goes all the way back to June of 2017. SK Biotek, wholly-owned subsidiary of SK Holdings, made a decision on the acquisition of BMS manufacturing facility in Ireland (currently owned by SK Biotek Ireland). BMS’s facility in Ireland used to manufacture active pharmaceutical ingredients for anticancer, anti-diabetic and cardiovascular disease treatments. Among array of contracts, approximately 50 percent of them were signed by AstraZeneca. Accordingly, when BMS sold its manufacturing facility in Ireland, SK Biotek also took over the contracts by AstraZeneca along with the facilities and human resources. After making the final decision on the acquisition, SK Biotek immediately scheduled a meeting with the headquarters of AstraZeneca in July that year. Apparently, they talked about maintaining the contract for the future. SK Biotek not only took over BMS’ manufacturing facility, but also expanded global partnership roster. Now the company works with Pfizer and Novartis, as well as AstraZeneca. The Thursday’s meeting reaffirmed the ties between SK Biotek and AstraZeneca is still strong. A stock trading firm insider noted, “It was only natural for SK Biotek, with the complete acquisition of BMS’ manufacturing facility in Ireland, to start a business with the facility’s existing clients. The terms of SK Biotek-BMS deal stated details of transferring facility, human resources and some of synthetic ingredient manufacturing contracts”. “However, it was not so clear whether or not SK Biotek would be able to maintain the existing partnership. The new partnership signing could have been held for SK Biotek to secure global partnership with AstraZeneca, on top of the manufacturing contract in Ireland”. SK Group’s focus on pharmaceutical sector is led by a SK Holdings and SK Discovery expanding business in two different sub-sectors. SK Holdings own SK Biopharmaceuticals (drug discovery) and SK Pharmteco (CMO). SK Chemicals (pharmaceutical business), SK Plasma (blood products), and SK Bioscience (vaccine) are formed under SK Discovery. SK Holdings, following its acquisition of SK Biotek Ireland and AMPC Fine Chemicals, established SK Pharmteco as the U.S.-based holding company. SK Holdings and SK Discovery are thriving in their respective field of business while not sharing shares between them.
- Policy
- Only one case of non-tumor initial human administration test
- by Lee, Tak-Sun Dec 20, 2019 06:35am
- Among the clinical trials conducted by multinational pharmaceutical companies in Korea, the first human-administered trial was found to be very rare. According to the Korea Clinical Trial White Paper No. 2 published by the Korea National Enterprise for Clinical Trials (CEO Dong-Hyun Ji, KoNECT) on the 18th, there was only one initial human dosing study in non-tumor fields conducted by multinational pharmaceutical companies from 2016 to 2018. The initial human administration study mainly examines the pharmacological effects and side effects of the human body in healthy adults and determines the tolerated dose. It will also identify pharmacokinetic properties. Proceeding with the patient will explore the potential for effectiveness. Clinical progress and analysis is known to be difficult because it determines the direction of successful commercialization of the drug. Activation of Phase I clinical trials by multinational pharmaceuticals, such as the first human administration trial, is essential for raising the domestic clinical level. In addition, it means that commercialization of new drug development will be carried out from the beginning, which is related to the activation of new drug development in Korea. In the case of new drugs developed in Korea, Phase I clinical trials are often conducted overseas. Table 63. Characteristics of Phase 1 Clinical Trials in Non-tumor Fields (206-2018) In the first phase clinical trials of the tumor field, the first human trial of multinational pharmaceutical companies was rare. The white paper explained that at least six were approved. During the same period, Korean pharmaceutical companies undertook 28 trials of the first human trial in the non-tumoral field. This is only 7.9% of all phase I nonclinical trials. Even if it was not the first human trial, multinational pharmaceutical companies (including multinational CROs) accounted for only 4.5% of the phase I clinical trials. Tumor field was 23.3%. However, the share of multinational pharmaceutical companies increase as they move to Phase II clinical trials. In Phase II, multinational drug makers accounted for 32.3% of non-tumors and 33.6% of tumors.
- Policy
- Parliament pushes for drug revocation bill w/o sales record
- by Lee, Jeong-Hwan Dec 20, 2019 06:35am
- A bill was proposed by the National Assembly to prohibit the renewal of drug items without sales records. The legislative goal is to minimize damage to Valsartan-Ranitidine impurities (NDMA) by eliminating drugs that some pharmaceutical companies produce only the minimum quantity and do not sell in order to update the product, which is a prerequisite for permit maintenance. On the 18th, Sang-hee Kim, a memeber of the National Assembly's Health and Welfare Commission announced that she proposed a partial amendment to the pharmaceutical affairs law. Current legislation requires the renewal of a drug license and declaration in order to sell the drug after the expiration of the drug product approval and the validity date. Drugs that are not manufactured or imported during the expiration date cannot be renewed Recently, NDMA has been detected in drugs such as high blood pressure treatment, Valsartan and antacid drugs, Ranitidine. It was pointed out that a drug that manufactured and imported only a minimum quantity for the item update and was not actually sold or distributed. Representative Sang-hee Kim pointed out the problem that the drug can be renewed without submitting the data. When renewing a drug product, it is necessary to submit data such as side effects collected during the expiration date, quality control and improvement measures to confirm safety and effectiveness. Drugs that are not actually sold can be renewed without submitting data. In order to protect the public health, it is necessary to check the status of safety and quality control of all medicines when updating drug products. Representative Kim said, “It is the core of the bill to restrict the renewal of product licenses and notifications for drugs that are not manufactured or sold within the validity period, I will build a foundation to provide safe and effective medicines”.
- Company
- Companies done submitting metformin record, what now?
- by Chon, Seung-Hyun Dec 20, 2019 06:32am
- Ministry of Food and Drug Safety (MFDS) Pharmaceutical companies in Korea have completed submitting usage record of metformin medicine to the government body. The industry seems to be patiently waiting for the government’s follow-up action on finding impurity in metformin-containing drugs. According to pharmaceutical industry insiders on Dec. 18, pharmaceutical companies have completed submission of metformin medicine manufacturing status report as requested by Ministry of Food and Drug Safety (MFDS). They compiled data from respective manufacturing plant and sent in the material until Dec. 17. On Dec. 13, MFDS has asked the companies to hand in manufacturing record of drug items containing ‘metformin hydrochloride’ and detailed research result of using the active ingredient by Dec. 17. MFDS requested information on the total number of pharmaceutical products containing metformin, name and number of items with manufacturing record, and name and number of items without manufacturing record. The information should cover all items distributed considering use-by date of complete products. For example, when an items’ use-by date is three years, then the item’s entire manufacturing record after December 2016 should have been submitted. The ministry has also called for a full report on active ingredients used in the metformin products. It is collecting detailed information on DMF registration number and manufacturing plant of a complete product containing the ingredient under each serial number. MFDS preemptively taking a detailed look into the records of active ingredient usage, in case impurity is found. When a specific active pharmaceutical ingredient and complete product is discovered with an issue, the ministry plans to take a prompt and accurate action based on the collected information. Molecular structure of metformin Impurity risk in metformin first started from Singapore. On Dec. 4, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin containing drugs they investigated. The result confirmed contamination of N-Nitrosodimethylamine (NDMA) has surpassed daily acceptable level. The pharmaceutical industry is anxious that the Korean regulator is “considering on taking follow-up actions like sales ban when the active ingredient is found contaminated”. In fact, before the government body took an action on ranitidine and nizatidine cases, the ministry had reviewed detailed information on complete product and the active ingredients. The ministry held back on the action for ranitidine and nizatidine medicine, until the thorough review on complete products and the ingredients was completed. The ministry may decide to ban sales on metformin medicine, if it confirms the same active ingredient recalled in Singapore has been imported to Korea. In the case of valsartan, MFDS had immediately ordered a sales ban on drugs with the substance when Europe decided to recall the products. Metformin-containing complete products recalled in Singapore have not been imported to Korea, yet. But whether or not the recalled active ingredient has been imported yet has not been confirmed. Reportedly, the Singaporean health regulator decided to recall the products based not on testing result of active pharmaceutical ingredient, but on complete products. However, it is highly unlikely that the Korean regulator would take an action in just a few days as it has not collected samples of metformin ingredients and complete products for testing. Both for ranitidine and nizatidine medicine, the regulator announced the follow-up measure after collecting samples of ingredients and complete products from different manufacturing dates, along with a thorough review on usage record. Ironically, the ministry has not presented an official procedure of NDMA testing for metformin, yet. MFDS is currently working on NDMA testing for metformin, which is scheduled to be completed by the end of the year. When the official testing procedure is set, the ministry is to collect the active ingredient and complete products for testing.
- Policy
- Swiss companies to benefit from mutual recognition of GMP
- by Lee, Tak-Sun Dec 19, 2019 11:20pm
- A mutual recognition agreement of Good Manufacturing Practice (GMP) with Swiss pharmaceutical regulator Swissmedic would not only invigorate pharmaceutical trade between two countries, but also it is expected to be a meaningful step towards Korea earning recognition of international level of regulation. The mutual GMP recognition agreement would bring significant influence on Korea, as Switzerland is one of A7 countries, which the Korean regulators refer to when deciding new drug pricing, and is also a pharmaceutical powerhouse with headquarters of Novartis, Roche and other major global companies. Korea’s Ministry of Food and Drug Safety (MFDS) announced on Dec. 18, it would be officially signing a Mutual Recognition Agreement (MRA) of GMP with Swissmedic. When the agreement comes in effect, GMP evaluation when applying for new drug approval in either country would be exempted. GMP certificate from either country would be validated in the other country. As a result, local due diligence, written review and other review procedures would be eliminated and ultimately accelerate the drug approval process. Korean pharmaceutical and bio companies would be able to reduce commercialization preparation period in Switzerland with the mutually recognized GMP certificate. The same goes for Swiss pharmaceutical and bio companies. Their new drug would be exempted from MFDS’ GMP evaluation. Actually, Korea has more drugs importing from Switzerland than exporting to them. Pharmaceutical powerhouse Switzerland houses major global pharmaceutical companies like Novartis and Roche. To this date, MFDS reviewers paid a visit to the local manufacturing plant and conducted GMP due diligence when reviewing Swiss pharmaceutical products. The MRA would drop GMP due diligence and other written review, which would reduce Swiss drug’s approval period in Korea by three to four months. It would be remarkable benefit for Novartis, Roche and other Swiss pharmaceutical companies. Targeting the Korean market, the Swiss companies now have the upper hand against other U.S. or European pharmaceutical companies. Although Korea exports less volume of pharmaceutical products to Switzerland, the intangible value generated from the MRA would shine through for the Korean industry later in the future. Signing of the MRA could mean that such a major pharmaceutical powerhouse recognizes Korea’s regulatory capability. The GMP recognition agreement MFDS signed with Ecuador in 2014 only applies to Korean drugs applying for approval in Ecuador, and it does not apply on Ecuadorian drug in Korea. MRA can only be signed by two countries when their regulatory standards are mutually recognized as equivalent level. Accordingly the signing of the MRA proves Switzerland also thinks highly of Korean regulatory standards. This could be favorable for Korea when negotiating with other countries. MFDS is currently seeking for opportunities to negotiate MRA on GMP with countries that have joined Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/s). Increasing number of countries with high faith in Korean regulatory system would simplify local new drug approval process for Korean-made drugs and also positively influence the industry’s business. MFDS official explained, “As Switzerland is not part of EU, it had an independent regulation apart from EMA and Korean companies had to go through another set of review process. The country is a home of global companies like Roche and Novartis, and CMO companies like Lonza. Korea has been recognizing Switzerland as one of A7 external reference pricing countries with their outstanding review capability that other advanced countries also approve of”. “MRA with Switzerland on GMP would be an opportunity for Korea to raise awareness of Korea’s trustworthy regulatory capability to other countries”, the official added.
- Company
- Anti-ulcer market fluctuates from impurity risk aftermath
- by Chon, Seung-Hyun Dec 19, 2019 06:41am
- Apparently, the anti-ulcer treatment market is still shaken with the impurity contamination risk. The market volume of nizatidine drugs, with a recent discovery of impurity exceeding an acceptable level, subsided within a month. A several cases of impurity found in products brought down the H2 receptor antagonist prescription volume, but rather pushed up the proton-pump inhibitors (PPI) prescription volume. Among PPI class drugs, esomeprazole has been the strongest in the market. On Dec. 18, pharmaceutical industry research firm UBIST reported the outpatient prescription volume of H2 receptor antagonist last month marked 9.3 billion won with a 5.6-percent decrease from the month before. Immediately after the sales ban on ranitidine, the prescription volume of the medicine has plunged to 40 percent level and the descending trend line continued to last month. Monthly trend of outpatient prescription volume of H2 receptor antagonist-containing drugs (unit: KRW 1 million) Source: UBIST Monthly trend of outpatient prescription volume of H2 receptor antagonist-containing drugs, except ranitidine drugs (unit: KRW 1 million) Source: UBIST Ruling out ranitidine, the H2 receptor antagonist market showed inconsistent prescription volume. The H2 receptor antagonist prescription volume, except ranitidine, skyrocketed from 6.4 billion won in September to 9.8 billion won in October by 53.5 percent. As most of ranitidine prescriptions were switched to other H2 receptor antagonist substance, the general market volume also expanded. But the H2 receptor antagonist prescription volume went down only in a month. Specifically, the nizatidine drugs took a noticeable fall. Monthly trend of outpatient prescription volume of major H2 receptor antagonist substance (unit: KRW 1 million) Source: UBIST In last month, nizatidine drug prescription volume fell by 30.5 percent from the previous month and generated 2.3 billion won. When ranitidine drugs were banned, nizatidine drugs’ perception soared by 42.5 percent from September to October. But merely in a month, the volume went back down to the September volume. The fall was affected by the discovery of impurity in some of the items. On Nov. 22, Ministry of Food and Drug Safety (MFDS) found unacceptable level of cancer-causing N-nitrosodimethylamine (NDMA) in nizatidine-containing drugs, and banned sales on 13 items. Unlike ranitidine, only some of nizatidine drugs were banned. Doctors could choose other nizatidine-containing items other than the banned ones, but they started prescribing other options due to unsettling risk of the substance. Benefitting from the sales ban on ranitidine and nizatidine drugs, famotidine and lafutidine drug prescription volumes reached their highest peak. Famotidine prescription volume doubled in October from the previous month, and was increased by 10.6 percent from October to November as well. Whereas lafutidine prescription volume reached 2.6 billion won, increased by 13.3 percent from the previous month and reached its peak. Cimetidine’s prescription volume was at 1.1 billion won last month and took a slight fall. Insufficient supply of active ingredient depleted stock and was excluded the drugs from the impurity risk benefit. Drugs in PPI class maintained a positive trend line last month as well. Last month, PPI-class treatments had outpatient prescription volume of 42.2 billion won with an increase of 1.0 percent from the previous year and recorded the highest volume of the year. In September, the volume reached 37.3 billion won and had a 17.7-percent surge in a month. Monthly trend of outpatient prescription volume of PPI-containing drugs (unit: KRW 1 million) Source: UBIST Meanwhile, esomeprazole-containing drugs had the steepest growth. Last year, the drug’s outpatient prescription volume grew by 5.0 percent in a month and reached 17.7 billion won. After making an increase of 21.3 percent from September to October, the drug’s prescription volume was expanded even more. Esomeprazole prescription volume last month soared by 27.4 percent from September. As of November, esomeprazole dominated 40.0 percent of the PPI medicine market. It could be interpreted that the doctors have switched from ranitidine and nizatidine to esomeprazole as they prefer the medicine the most within the PPI class. Rabeprazole’s prescription volume in last month went up by 1.2 percent from the month before, but lansoprazole, pantoprazole, ilaprazole and omeprazole’s prescription volume in November were dropped by a little than in October. But in general, the said PPI-class medicines had more than a ten-percent surge from September, benefitting from the impurity contamination risk. Monthly trend of outpatient prescription volume of major PPI substances (unit: KRW 1 million) Source: UBIST
- Policy
- Mandatory evaluation of MFDS when using all off label drugs
- by Lee, Jeong-Hwan Dec 19, 2019 06:35am
- A bill is piloted to require government assessments when using 'off-labeled drugs' in patients that go beyond the indications that have been proven in clinical trials, which are phases of drug marketing. Representative Sang-hee Kim of the National Assembly on Health and Welfare on the 18th proposed the partial revision of the Pharmaceutical laws and regulations. Off-labeled use of current drugs differs from individual use procedures, such as those subject to reimbursed benefits and non-reimbursed, over-the-counter and anticancer drugs. Representative Sang-hee Kim said that the pharmaceutical industry is passive in research and development of medicines that meet the medical needs such as rare and severe diseases, children, and pregnant women, and encourages the use of off-label. It is pointed out that the use of off-labeled drugs with different efficacy, effect, indications, and dosage is not frequently recognized by the Ministry of Food and Drug Safety, which is a drug approval authority. Representative Kim criticized that MFDS conducts off-label use evaluation only for non-reimbursed generic drugs according to the Ministry of Health and Welfare, so systematic safety management of over-licensed drugs is not possible. Representative Kim said, “To prevent this, we need to establish a legal basis for the safety and effectiveness evaluation of MFDS for all use of off-label drugs, we will promote public safety by establishing a systematic evaluation environment for non-permission use”.
