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- 2026-04-14 03:36:11
- Company
- Celltrion's Regkirona was approved for EUA in Indonesia
- by Kim, Jin-Gu Jul 22, 2021 05:52am
- Celltrion said on the 20th that the coronavirus 19 antibody treatment drug Regkirona (Regdanvimab) has obtained an emergency approval (EUA) from the BPOM. The Indonesian government has approved the emergency use of Regkirona for minor and secondary patients in the high-risk adult group with COVID-19. According to the COVID-19 real-time statistics site "Worldometer," Indonesia's confirmed case of COVID-19 reached 2.88 million people and the death reached 73,600 on the 19th. The spread of delta mutations has led to a surge in the number of people infected with COVID-19. Celltrion said it recently confirmed Regkirona's neutralizing ability in animal testing of the delta mutation virus. Regkirona is expected to help prevent the spread of COVID-19 in Indonesia. A Celltrion official said, "We have obtained approval for EUA from the BPOM by proving its efficacy based on Regkirona's global clinical and quality data." "With this, we expect that Regkirona's export negotiations will go well. We will do our best to supply products globally quickly."
- Company
- Why Keytruda’s smile wavers after passing CDRC deliberation
- by Eo, Yun-Ho Jul 21, 2021 05:52am
- The drug finally was able to pass deliberations by the Review Committee for Cancer Diseases, but still, the company's smile wavers due to the bitter aftertaste left by the committee’s ‘conditional’ approval. With MSD Korea’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ passing deliberations by the Review Committee for Cancer Diseases in July, industry expectations are rising on the possibility of the drug’s benefit coverage being expanded to first-line in non-small cell lung cancer (NSCLC) However, under the air of anticipation there lies concerns as the Review Committee for Cancer Diseases had put forward a condition for granting the nod to Keytruda. During deliberations, the Review Committee for Cancer Diseases once again mentioned Keytruda’s equity with Tecentriq to MSD Korea, requesting additional modifications to be made to the cost-sharing plan. This indicates that the drug pricing negotiations with the Pharmaceutical Benefit Appraisal Committee or the National Health Insurance Service will act as a variable in the discussion of Keytruda's benefit expansion to the lung cancer indication. The agenda to expand Keytruda’s reimbursement to first-line in lung cancer had been introduced to the Committee for Cancer Diseases meeting 9 times, which took almost 4 full years. As a winning bid, MSD Korea had submitted what MSD Korea’s newly appointed managing director Kevin Peters described as an “unprecedented financial sharing plan” at the last meeting, determined to receive approval this time. Despite such effort, a serious ‘condition’ was attached to the approval. Due to this, some believe that the Review Committee for Cancer Diseases has 'passed' Keytruda's reimbursement mainly due to the ‘burden’ of leaving the agenda pending. This goes to show how much influence the condition to ‘cover the initial 3 cycles’ worth of administration cost’ that Roche Korea had accepted in the reimbursement process of ‘Tecentriq (atezolizumab)’ has in the drug reimbursement process. MSD had repeatedly proposed compromises and revised plans to the government and expressed that their proposal meets the requested condition. However, there is no doubt that the company finds it difficult to accept the 3-cycle cost burden as is. With no time to relish the joy of passing deliberations by the Review Committee for Cancer Diseases, the company immediately convened a meeting to discuss countermeasures. Keytruda's benefit expansion to the lung cancer indication can once again fall through in the process of drug pricing negotiations with the Pharmaceutical Benefit Appraisal Committee or the National Health Insurance Service. How the reimbursement journey for Keytruda will progress after the Review Committee for Cancer Diseases handed over the baton to the next regulators, and whether the government and pharmaceutical company will be able to reach an agreement remains to be seen. An official from the Review Committee for Cancer Diseases said, “We cannot estimate the price cut that would be applied to both drugs based on the ‘visible’ listed price as it is not the actual price. However, the additional discount requested for Keytruda will be quite significant. Although the agenda passed deliberations by the Review Committee for Cancer Diseases, whether the drug will be reimbursed is still unclear.”
- Company
- Antibiotic sales are decreasing due to prolonged COVID-19
- by Chon, Seung-Hyun Jul 21, 2021 05:51am
- The outpatient prescription market has also changed significantly as COVID-19 epidemic has been prolonged. The pharmaceutical market, which is mainly used for infectious diseases such as antibiotics, anti-septic drugs, and influenza (flu) treatments, has shrunk significantly. The flu treatment market has shrunk 99.9% in two years. According to UBIST on the 20th, the amount of outpatient prescriptions for Cephalosporin PO in the first half of last year was ￦87.7 billion, down 20.6% year-on-year. Compared to the first half of 2019, the amount of prescriptions decreased by 33.7% over two years. Cephalosporin is an antibiotic widely used in pneumonia, sore throat, tonsillitis and bronchitis. According to the amount of Cephalosporin prescribed on a quarterly basis, it fell 32.1% from ￦72.5 billion in the fourth quarter of 2019 to ￦49.2 billion in the fourth quarter of last year. The prescription amount of Cephalosporin in the first quarter of this year was ￦42.8 billion, down 32.8 % from a year earlier, and the prescription performance in the second quarter decreased 3.9%. As COVID-19 outbreak began in earnest, the market size of Cephalosporin has also decreased significantly and sales have decreased significantly until the first half of this year. It is analyzed that the antibiotic market has shrunk due to the prolonged COVID-19. Since the spread of COVID-19, sales of antibiotics have also decreased significantly as the flu outbreak has decreased due to strengthening personal hygiene management such as washing hands and wearing masks. Sales of major antibiotics have decreased significantly since the spread of COVID-19. The amount of prescription for Penicillin PO in the first half of last year was ￦46.8 billion, down 26.8% from a year earlier. Penicillin PO also decreased in size from the first half of last year when COVID-19 outbreak began in earnest. The prescription amount of Penicillin PO in the first half of last year was ￦63.9 billion, down 30.8% from a year earlier, and down 39.2% from a year earlier in the second half of last year. The amount of prescriptions in the first half of this year is only half that compared to ￦92.4 billion in the first half of 2019. Other antibiotics such as Macrolides also had similar circumstances. Macrolides and other prescriptions for the first half of the year were ￦37.9 billion, down 24.1% from a year earlier. It fell 41.3% compared to 2 years ago. In June of this year, the total amount of antitussive drugs was ￦24.8 billion, down 47.5% from ￦47.3 billion in the first half of last year. Compared to two years ago, it fell 59.0%. Since the spread of COVID-19, the amount of outpatient prescriptions for expectorants has decreased by one-third. Sales of antitussive drug (single) decreased by 62.8% from two years ago to ￦10 billion in first half of the year, while sales of antitussive drug's(combination) decreased by more than half from ￦33.6 billion in first half of 2019 to ￦14.8 billion in two years. In the first half of the year, the amount of outpatient prescriptions for Expectorants was ￦48.1 billion, down 32.9% from the same period last year. It has halved from ￦85.2 billion in the first half of 2019. As the number of flu patients decreased, the flu treatment market has virtually disappeared. In the first half of the year, the amount of prescription for flu treatment was only ￦14 million. It decreased 99.8% from ￦8.3 billion in the first half of last year, and the market size was only 0.1% compared to ￦14.4 billion in the first half of 2019.
- Company
- Harvoni’s growth spurt despite Hep C market downturn
- by Nho, Byung Chul Jul 21, 2021 05:51am
- With the domestic hepatitis C treatment market externally contracting from ₩120 billion to ₩68 billion in three years, the rapid strides of growth made by Harvoni in the market is drawing attention. On the 20th, Dailypharm analyzed the hepatitis C treatment market based on IQVIA data. The overall sales in the Hep C market amounted to ₩121.2 billion·₩89.9 billion·₩85.2 billion·₩68.8 billion in the years 2017·2018·2019·2020. The leading product in the market was AbbVie’s Maviret, which recorded ₩47.9 billion in sales last year. Maviret still is the sole lead product that accounts for 70% of the market, however, its sales fell ₩10.4 billion compared to 2019. Externally, Zepatier·Sovaldi·Daklinza·Sunvepra also showed sales of ₩2.6 billion·₩0.7 billion·₩0.6 billion·₩17 million in 2020 and recorded a decline in sales compared to the previous year. While products in the market showing negative growth, Gilead’s Harvoni was the only one showing an upward trend. Harvoni’s performance in the last 3 years (2018·2019·2020) was ₩6.8 billion·₩15.7billion·₩18.4 billion. With regards to its growth rate, it has ranked second to Maviret, accounting for 4.35%·13.88%·19.88% of the market. In the same period, Maviret’s market share was 12.50%·69.80%·75.43% The recent negative growth seen in sales of hepatitis C treatments recently is presumed to be due to the decreased inpatient treatment rate of hepatitis C in the COVId-19 pandemic. In addition, the reasons for Harvoni's sole increase in market share in the domestic market is attributed to its changed indication that allows its use in patients with renal impairment in March last year, and its reinforced safety and cost-effectiveness from the RWD presented at the Liver Week in May this year. In March 2020, Harvoni’s indication was changed to allow its use in patients with any degree of renal impairment, including end-stage renal disease (ESRD) on dialysis without dosage adjustment in addition to the previously approved for patients with mild-to-moderate renal impairment, allowing its use and prescription to a wider patient population. Also, the first multicenter RWD(Real World Data) on Harvoni in Korea was presented at Liver Week 2021, reinforcing the strengths of Harvoni, the only PI-free DAA agent in Korea, and having a positive effect on the domestic market share. As most hepatitis C treatments have excellent treatment effects, we now need to consider drug safety, cost-effectiveness, and convenience of administration, including drug-drug interactions (DDI) in addition to getting cured. Harvoni is the only hepatitis C DAA agent that does not contain a protease inhibitor (PI). This allows less drug-drug interactions, and therefore may be used in patients with comorbidities that require multiple drug intake, and is safe to be used by people with all stages of liver disease. Protease inhibitors can cause serious liver damage when taken by hepatitis C patients with severe liver disease. The U.S. Food and Drug Administration (FDA) had stated that patients with moderate to severe liver disease (Child-Pugh B, C) should take caution in using drugs containing protease inhibitors. In addition to such precautions, as DAA agents containing protease inhibitors have a narrower scope of use than Harvoni, this also may have had an impact on Harvoni's market share expansion. Harovni’s strength is not limited to its antiviral effect and safety. It is also cost-effective. Over 98% of the hepatitis C patients in Korea belong to genotype 1 and 2 of the virus, with over half of the patient population (45-59%) having genotype 1 of the virus. In this context, the 8-week treatment regimen of Harvoni that allows a cost reduction of 30% compared to existing hepatitis C treatments gained attention as the treatment option that can reduce the treatment burden for patients with genotype 1 of hepatitis C virus. Harvoni’s 8-week treatment regimen can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL. Also, Harvoni can be taken orally once a day in a single tablet without regard to food. This simple administration method increased convenience in administration for patients. Other hepatitis C treatments have limitations in administration, requiring more than 1 table intake during or after meals, but a single tablet of Harvoni is taken orally once daily with or without food. The World Health Organization (WHO) had proposed eliminating hepatitis by 2030, by raising awareness of the viral infectious disease hepatitis C and expand active prevention, testing, and treatment of the disease. Hepatitis C is a type of infection in which the blood or body fluids of a patient infected with the hepatitis C virus is transmitted through the injured skin or mucous membrane of normal people. With no vaccine available for its prevention, and new infections usually being asymptomatic, 70-80% of the patients are diagnosed after developing chronic HCV infection. 30% of these patients develop cirrhosis or liver cancer, therefore prevention and prompt treatment and diagnosis are required. Hepatitis C can be cured with only 8 to 12 weeks of treatment without concern about developing resistance with the introduction of direct-acting antivirals (DAA).
- Policy
- GSK & SK Bio also stopped supplying TD vaccines
- by Lee, Tak-Sun Jul 21, 2021 05:51am
- Greencross TD Vaccine Prefilled Syringe InjSK Bioscience will also withdraw its products from the TD vaccine market that prevents diphtheria and tetanus in adults. GSK, which had been importing and supplying TD vaccines last year, also stopped supplying them in the Korean market. As a result, GC Pharma, which is manufacturing domestic drugs, is expected to strengthen its position in the TD vaccine market. According to the MFDS on the 16th, SK Bioscience said it will stop importing SK Td Vaccine, which it is supplying, after the 18th of next month. It said, "As the company that was supplying the undiluted solution stopped supplying the finished product, the company also stopped supplying the finished product." Sk Td Vacine is known to have imported the undiluted solution from GSK in Germany and made it into a finished product in Korea. Last year, GSK announced that Novartis will stop supplying TD vaccines in the process of integrating and maintaining production lines for business efficiency after acquiring the vaccine business unit. Therefore, it is observed that this effect may have been caused by the discontinuation of Sk Td Vacine. The adult TD vaccines now available in Korea are GC Pharma's "Greencross TD Vacine Prefilled Syringe Inj" and Accesspharm's "diTeBooster SSI". GC Pharma's position is expected to be strengthened as GSK and SK Bioscience have stopped supplying TD vaccines. GC Pharma succeeded in domesticizing the TD vaccine in 2016 and contributed to reducing its dependence on imports. The product developed by GC Pharma has been commercialized for the first time in six years since 2010 with consulting support from the MFDFS. At the time, the MFDS said that the localization of the TD vaccine is expected to replace the import of 450,000 people every year. In terms of sales by IQVIA last year, Greencross TD Vacine Prefilled Syringe Inj was about ￦1.4 billion in sales. SK Td Vacine's sales were only about ￦900 million. GSK's products were discontinued, reaching only about ￦300 million, and Accesspharm's products also reached ￦300 million. Accesspharm is said to be imported from SSI in Denmark as complete products. The only domestic product is Greencross TD Vacine Prefilled Syringe Inj. An official from the pharmaceutical industry said, "As a result of the localization of TDI vaccines for adults, we can respond to the suspension of supply of imported products." "It seems that there will be little impact on the market because there is domestic product even when SK Bioscience products are not imported."
- Company
- Domestic Rx sales are showing strength in H1
- by An, Kyung-Jin Jul 21, 2021 05:51am
- Lipitor Pfizer's treatment for dyslipidemia ranked first in outpatients in the first half of the year. Drugs developed with domestic technologies such as "Rosuzet" and "Zemimet" led by HK-Inoen's "K-CAB" have increased their market influence despite the chaos of COVID-19 outbreak. The originals of multinational pharmaceutical companies, which once had sales, have stagnated since the expiration of patents. According to UBIST, a pharmaceutical research agency on the 19th, Pfizer's Lipitor topped the list with a cumulative prescription amount of ￦86.5 billion in the first half of this year. Lipitor (Atorvastatin) is a treatment for dyslipidemia, which was introduced to the domestic market in 1999 by Pfizer Korea. Since the expiration of the patent, insurance drug prices have fallen by half and more than 130 generics have been released, but they are still showing strong sales in the prescription drug market. Except for 2017, it has topped the prescription list for the past 10 years. Viatris, which was launched in November last year with the merger of Upjohn and Mylan, which have been in charge of Pfizer's patent-expired drugs, is in charge of sales. However, looking at the quarterly performance, the upward trend has slowed somewhat since COVID-19 outbreak began in earnest. By 2019, the average amount of Lipitor prescription per quarter was close to ￦48 billion, but the average of last year was barely over ￦46 billion. This year's performance was ￦43 billion in the first quarter and ￦43.5 billion in the second quarter, which is not up to its peak performance. The cumulative amount of prescriptions for the first half of the year decreased by 8.1% from ￦94.1 billion a year earlier. The prolonged COVID-19 situation is believed to have been affected by the contraction of hospital visits and the overall foreign prescription market. During the same period, Hanmi's Rosuzet ranked second in prescriptions, with outpatient prescriptions rising 13.8% year-on-year to ￦53.4 billion. Rosuzet is a combination drug composed of Ezetimibe and Rosuvastatin. Since its release in late 2015, it has ranked first in the market among the same ingredients. Analysts say that Hanmi's strategy to enter the composite market before its competitors was effective as it secured Ezetimibe license from patent holder MSD. Sales of Rosuzet rose more than 10% year-on-year every month even at a time when face-to-face sales marketing activities were severely restricted due to COVID-19 last year. In the second half of last year, the monthly prescription amount exceeded ￦8 billion, surpassing Gliatamin as the second-largest outpatient prescription. This year, the company set its own record of ￦9.4 billion in monthly prescription amount, narrowing the gap with No. 1 Lipitor. Sales of Daewoong Bio's Gliatamin was ￦46.3 billion in outpatients in the first half of last year, down 3.5% from a year earlier. Gliatamin is generic of the brain functional enhancer Choline alfoscerate. The government has received two sanctions, including a reduction in benefit. However, Gliatamin's influence in the prescription drug market remains robust. The competition item, Chongkundang Gliatirin, increased 0.4% year-on-year to ￦40 billion in outpatient prescriptions over the same period. The amount of outpatients for K-CAB in the first half of the year increased 47.8% year-on-year to ￦45.4 billion. If the current trend continues, it is predicted that the amount of outpatients will easily exceed ￦100 billion by the end of the year. K-CAB (Tegoprazan) is a flagship product of HK Inno.N (formerly CJ Healthcare), which is about to be listed. It is a new type of anti- ulcer drug called "P-CAB," which competitively combines proton pumps and potassium ions located in the final stage of acid secretion in stomach wall cells, thus inhibiting gastric acid secretion. Sales of K-CAB rose to ￦5 billion in the first year of its release, compared to ￦1.7 billion in monthly prescriptions. It secured gastrointestinal reflux disease as its first indication, and added gastrointestinal ulcer treatment in July of the same year. In the first half of this year, when most of the drug performance was sluggish, it rose to fourth place in prescription, threatening third-place Gliatamin. The joint sales strategy with Chong Kun-dang, which has a differentiated mechanism from the existing PPI. The increase in prescriptions for products developed by domestic companies was noticeable. The amount of outpatients for LG Chem's diabetes combination drug Zemimet in the first half of this year was ￦41.1 billion, up 8.4% from the previous year. Zemimet is a second compound that combines Metformin with Zemiglo (Gemigliptin), a new diabetes drug developed by LG Chem. It has been co-selling with Daewoong Pharmaceutical since 2016. Due to changes in the diabetes treatment market, which prefers multi-drug prescriptions, it has surpassed the performance of Zemimet. In the top 10 outpatient Rxs, sales of prescriptions for the past six months have fallen. The amount of outpatient prescription for Sanofi's anti-thrombotic drug Plavix was ￦44.8 billion, down 2.3% from the previous year. Boehringer Ingelheim's hypertension combination drug Twynsta and Gilead Science's hepatitis B treatment Viread fell 8.1% and 6.7% in the first half, respectively. AstraZeneca's treatment for dyslipidemia, Crestor, decreased 9.2% from the previous year to ￦38.8 billion in the first half of the year, ranking among the top 10 outpatients Rx.
- Company
- Patent ruling changes NOAC market…Eliquis surpasses Xarelto
- by Kim, Jin-Gu Jul 20, 2021 05:47am
- The Supreme Court’s ruling shook up the new oral anticoagulant (NOAC) market in the second quarter of this year. With Daiichi Sankyo’s ' Lixiana (Edoxaban) still in the lead, 'Eliquis(apixaban),’ which had experienced a decline in sales after its generics were released, made a successful rebound. On the other hand, Eliquis’s generics that had once rapidly expanded its share in the market virtually disappeared. The Supreme Court’s ruling in April had directly affected the disappearance of generics. The other two NOAC products - ‘'Xarelto (rivaroxaban)’ and ‘Pradaxa (dabigatran)’ - however, saw a continued decline in its prescription performance. ◆Original drug maker’s sales 7%↑ vs. generic companies 40%↓ after Supreme Court ruling According to the market research institution UBIST on the 20th, the overall size of the NOAC prescription market in Q2 this year amounted to 46.7 billion won. This was a 2% YoY decrease from Q2 of the previous year. The 4 original NOAC products saw mixed results in prescription performance. Prescription for Daiichi Sankyo’s Lixiana and BMS’s Eliquis had increased, whereas the same for Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa fell. Lixiana still kept a solid lead in Q2 this year. It sold 17.2 billion won in prescription sales ins Q2 this year, an 8% YoY increase from Q2 of the previous year. Prescription sales of Eliquis also increased by 7%, from 12.1 billion won to 13 billion won in the same period. Eliquis’ sales had fallen continuously since its release until Q1 this year and then made an upward turn for the first time in Q2 this year. In this process, the NOAC market’s rank also changed. Until Q1 of this year, Xarelto was second place in the NOAC market, but Eliquis outsold Xarelto and took second place in Q2. The Supreme Court’s ruling in April is predicted to have been the direct cause of the change in sales. In April, the Supreme Court overturned the first and second trial judgments in the dispute over Eliquis’s substance patent and ruled in favor of BMS. The ruling had alternate effects on Eliquis’s original drug maker and its generics. Immediately after the ruling, Eliquis’s sales turned upward. On the other hand, sales of Eliquis’s generics were nearing '0'. Companies that used to sell Eliquis generics, including Chong Kun Dang, Yuyu Pharma, Samjin Pharm, Hanmi Pharmaceutical, Aju Pharm, and Yoo Young Pharm rushed to discontinue sales of their products in response to BMS’s forewarning of filing a claim for damages. The cumulative sales of the generics had increased continuously from 0.3 billion won in Q3 2019, 0.6 billion won in Q4 2019, 1.2 billion won in Q1 2020, 1.7 billion won in Q2 2020, 2.2 billion won in Q3 2020, 2.6 billion won in Q4 2020, and 3 billion won in Q1 2021. However, after the supreme court’s ruling, its sales fell sharply to 1 billion won in Q2 this year. The 1 billion won sold in the second quarter is believed to be prescriptions on previously released quantities to distributors. ◆Xarelto·Pradaxa↓…Will the decline continue due to the release of generics? The other two NOAC products – Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa – continued to see a decline in their prescription performance. Xarelto's sales fell by 9% from 12.5 billion won in Q2 last year to 11.4 billion won in Q2 this year. In the same period, Pradaxa’s sales fell 15%, from 1.7 billion won to 1 billion won. In addition, generics of Xarelto and Pradaxa are expected to be released in the second half of this year, reinforcing the prospect that their prescription performance will continue to decline. Exclusive marketing approval for Pradaxa’s generics was approved on the 18th. Under the approval, Intro Biopharma, Aju Pharm, Jin Yang Pharmaceutical, and Huons may now release Pradaxa’s generics until April next year. For Xarelto, Hanmi Pharmaceutical and SK Chemicals succeeded in overcoming the original’s patent. The companies may release the 2.5mg formulation of Xarelto’s generics from October 4th this year.
- Policy
- CSO expenditure report Act, effective immediately
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The government promulgated the revised Pharmacist Act today (20th), which includes restrictions on co-living and clinical 1+3 of generic and new drugs and mandatory preparation of CSO expenditure reports. In accordance with the revised Pharmaceutical Law, restrictions on 1+3 generic and improvement new drugs and regulations requiring CSOs to be included in the scope of pharmaceutical suppliers and to prepare expenditure reports will be enforced immediately after promulgation. Dailypharm summarized the details and timing of implementation of the revised Pharmacist Act. ◆Limitation of 1+3 on generic and improvement new drugs ◆ The regulation shall be implemented immediately after the announcement to specify data to be submitted when marketing of generic and improvement new drugs. New generics and improvements to obtain marketing permits after today will be subject to restrictions on clinical data. However, the 1+3 regulation was not applied to medicines (IND), which are already undergoing clinical trials. At this time, pharmaceutical companies approved for the clinical trial plan must submit and report to the Minister of Food and Drug Safety within one month from the enforcement date of the revised Pharmaceutical Law, along with evidence that they have decided to jointly develop medicine. In addition, the government decided not to apply 1+3 regulations to the clinical trial data before the enforcement of the revised Pharmaceutical Law. It does not apply regulation retrospectively.(Article 31 (10 through 15) The provisions that prohibit reauthorization and reporting of items less than five years after the date of cancellation of item permits or reports of changes by false or illegal means, and medicines less than three years after the cancellation. (Article 31(16)) ◆Compulsory preparation and submission of CSO expenditure reports ◆ The provisions to include pharmaceutical companies and CSOs entrusted with drug sales promotion tasks to prevent MDs and pharmacists from providing economic benefits such as of January 21 next year. The CSO's regulation requiring preparation and submission of medical and pharmacist expenditure reports and requiring related books and evidence data to be kept for five years will also take effect on January 21st next year. In addition, regulations that allow the Minister of Health and Welfare to conduct a survey on the expenditure reports of pharmaceutical suppliers and announce the results and entrust the work to related institutions or organizations will take effect six months after the promulgation (January 21 next year. The regulation on the disclosure of CSO expenditure reports to the public by an ordinance of the MOHW shall take effect two years after the promulgation, that is, July 21, 2023.(Article 47, Article 47-2, Article 69-4, and Article 95) ◆Designation of Drug Day as National Anniversary =A provision that designates November 18 every year as Drug Day and allows local governments to conduct events, education, and promotional projects or support related group activities shall be implemented immediately. November 18 is expected to be the first day of Drug Day as a national holiday event.(Article 2) ◆Punishment of Rx drug buyers = Regulations that prohibit and punish steroid injections, ephedrine injections, and specialist drugs to consumers who cannot sell drugs such as medicine and pharmacists will also be enforced six months after the date of promulgation. That is, it will take effect on January 21 next year. If the regulation is enforced, consumers who illegally purchase Rx drugs will be fined up to 1 million won, and those who report illegal buyers will be able to pay rewards set by Presidential Decree.(Article 47-4 and 90 and Article 98 (1) 7-3) ◆Expanding the size of the Central Pharmaceutical Review Committee=The provision to increase the number of the Central Pharmaceutical Review Committee, an advisory body of the MOHW and the MFDS, from one to two. ◆Legalization of phase 3 conditional permission system = The provision to upgrade phase 3 conditional quick marketing permission to the Pharmacist Act, which is operated by the notice, shall take effect six months after its promulgation (January 21 next year). It allows the head of the MFDS to quickly approve medicines for serious or rare diseases prescribed by the Act on the Management of Serious or Rare Diseases after a central medical review, and clarified procedures and submissions. Pharmaceutical companies with conditional authorized medicines must check the implementation of the conditions and report them to the head of the MFDS, and the head of the MFDS is allowed to order the implementation of the conditions. If pharmaceutical company that receives conditional permission for facilities and items by fraud or fraudulent means fails to report or fulfills an order to fulfill the conditions, the conditional permission can be revoked. The Pharmaceutical Affairs Act has also raised the provisions related to pharmaceuticals that can be reviewed preferentially for other licensed medicines.(Articles 35 and 35-2 through 6)
- Policy
- Kymriah reimbursement was not discussed at CDRC meeting
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The Korea Leukemia Patients Organization (KLPO) The Korea Leukemia Patients Organization (KLPO) expressed its regrets to the government and Novartis Korea for excluding the first CAR-T treatment Kymriah from the agenda for deliberation at the Review Committee for Cancer Diseases meeting that was held on the 14th. On the 19th, KLPO said, “A disconcerting situation occurred. Kymriah was not even able to enter the first gateway for NHI listing and be put on the agenda for deliberation for the Review Committee for Cancer Diseases meeting. We will fight with the government and Novartis for the reimbursement of Kymriah.” The patient group demanded an explanation from the company and authorities on why Kymriah was not put up as an agenda for deliberation. 4 months had passed since its approval in March but no discussion on its reimbursement has started despite its use of the “approval-benefit appraisal linkage system.” The CAR-T therapy Kymriah is a one-shot personalized gene therapy. 8 out of 10 end-stage acute lymphoblastic leukemia patients and 4 out of 10 end-stage acute lymphoblastic lymphoma patients were found to survive in the long-term with Kymriah. The patient group insisted that the reimbursement discussions need to start as soon as possible as around 200 patients with relapsed or refractory end-stage acute lymphoblastic leukemia or lymphoma die within 3-6 months, KLPO said, “With the issue of reimbursement delays arising due to cost-sharing in ultra-high-priced drugs, we expected the committee to request the company to come up with a reasonable cost-sharing plan. The Ministry of Health and Welfare and Health Insurance Review and Assessment Service needs to explain why Kymriah, a drug in issue for its ultra-high-price rather than its treatment efficacy, was not put on the agenda for deliberation.” “The 6th Review Committee for Cancer Diseases meeting will be held on September 1st. Even if Kymriah is deliberated then, the drug will be listed 2 months later than if it was discussed at the last meeting. The treatment process for life-threatening diseases and the administrative process regarding their financial issues should be considered separately.” “We understand that Kymriah’s NHI listing may become the model for listing ultra-high-priced drugs in Korea and that the government needs to take a careful approach in its reimbursement. However, making excuses that they need the time to review the matter with no preparation in advance for the well-expected ultra-high-priced drug listing issue is negligence on the government’s part.” And as around 30 countries including the U.S. have been using Kymriah, and its treatment is already insured in Japan, KLPO stressed that Kymriah reimbursement should be discussed promptly. Lastly, KLPO added, “In addition to the government, the company also needs to prepare a reasonable cost-sharing plan. We are prepared to fight to our death with the government and Novartis Korea for the prompt benefit listing of Kymriah.”
- Policy
- Pfizer vaccine available in Korea for ages 12 or older
- by Lee, Tak-Sun Jul 20, 2021 05:46am
- Pfizer's COVID-19 vaccine has become available in Korea for people over 12 years of age. The MFDS announced on the 16th that it has approved the change of Comirnaty, which can be used to prevent COVID-19 among people aged 12 and older. The dosage and indications of the vaccine can be diluted once with 0.3ml and inoculated additionally after three weeks, just like the existing 16 years old or older. Pfizer vaccines have also been approved in the United States (May 10, Europe (June 2), Canada (May 5) and Japan (May 31). The MFDS determined that the overall safety was similar to that of those aged 16 or older and was in good condition. In the age of 12–15 years of age, the cases of adverse effects following the inoculation of Comirnaty were similar to those aged 16 and older, with no significant adverse effects. Common adverse effects were injection pain, fatigue, headache, muscle pain, chills, joint pain, and fever, most of the symptoms were mild to moderate and disappeared within days of vaccination. The effectiveness of the 12- to 15-year-olds was sufficient after evaluating the effects of COVID-19 prevention and immune responses. As a result of evaluating the preventive effect of 1,983 people (1,005 vaccine groups and 978 placebo groups) who were not infected with COVID-19 until the 7th after the 2nd vaccination, 0 people in the vaccine group and 16 people in the placebo group showed 100% prevention effect. The virus neutralization test was evaluated on 360 people (12–15 years of age 190, 16–25 years of age 170) who were confirmed not to have been infected with COVID-19 until one month after the second inoculation, and the virus neutralization test met the criteria for ages 16–25 years of age. When comparing immune responses at one month after two inoculations, it met 1.5 times the noninferiority standard. Pfizer vaccines have become available in Korea for people aged 12 and older, but the KDCA has not yet included the age group in the list. Attention is focusing on whether it will be included in the vaccination list after discussions.
