- LOGIN
- MemberShip
- 2026-05-19 01:24:36
- Policy
- Moderna vaccine shows 94% prevention in overseas trial
- by Kim, Jung-Ju Jul 23, 2021 05:57am
- Moderna’s COVID-19 vaccine was found to be 94.1% effective in preventing COVID-19. The results were analyzed and presented by the disease prevention and control authorities based on the results of the observation made on 420,000 people who receive their first vaccination in Canada. In Korea, 290,000 doses of the Moderna vaccine were introduced on the 22nd. The COVID-19 Vaccination Response Team (Head: Eun Kyeong Jeong) explained the vaccine’s prevention effect as workers in hospital-level medical institutions were administered the Moderna vaccine from June to July, and people in their 50s will be receiving the Moderna vaccine from the 26th. ◆Effect of vaccination = Results from a Phase III clinical trial on 30,420 people showed that the Moderna vaccine was 94.1% effective. In its effect against preventing variants that were conducted on 421,073 people in Canada who received their first dose of the Moderna vaccine, the vaccine had an 83% effect on the Alpha variant, 77% effect on the Beta/Gamma variant, and 72% effect on the Delta variant. In addition, the vaccine’s effectiveness in preventing hospitalization and deaths after the first dose, the vaccine had a 79% effect on the Alpha variant, 89% effect on the Beta/Gamma variant, and 96% effect on the Delta variant 로나19 모더나 백신 변이주에 대한 백신효능. The authorities also provided guidelines on how to respond to adverse reactions for a safe vaccination with the Moderna vaccine. People who are vaccinated should stay at the institution for 15 to 30 minutes after vaccine administration to be observed for adverse reactions and should be closely monitored for over 3 hours even after returning home. The vaccinated person should be observed with special attention for at least 3 days after vaccination, and people with a high fever or abnormal physical symptoms must immediately seek medical attention. In particular, the Vaccination Response Team added that people who are suspected of symptoms of myocarditis or pericarditis after vaccination, and people with facial fillers who show facial swelling should seek immediate medical attention, and requested the institutions to report the adverse reactions. ◆Vaccine introduction status and plan = On the 22nd, the KDCA announced that a total of 24.92 million doses of COVID-19 vaccines, including the 290,000 doses of the Moderna vaccine that were introduced to Korea. In addition, approximately 31 million doses will be additionally introduced until late August, and the detailed schedule for each vaccine will be provided to the extent allowed as soon as the discussions are finalized with the relevant pharmaceutical companies. Meanwhile, the COVID-19 Vaccination Response Team said 77.2% (5,847,769) of the subjects eligible for vaccination completed their reservations as of midnight on the 22nd. 83.2 % of the subjects aged 55 to 59, and 72.3% of the subjects aged 50 to 54 completed their vaccine reservations.
- Company
- Generics for Betmiga, ↑19% market share in just one year
- by Kim, Jin-Gu Jul 23, 2021 05:57am
- Betmiga, Mirabek & Selebeta Generics for Betmiga (Mirabegron) are gaining market influence. Two generics for market share expanded to 19% in just one year after its launch. The release of generics resulted in a 14% drop in the amount of outpatient prescriptions for the original over a year. According to UBIST, a pharmaceutical market research institute on the 21st, the size of outpatient prescription market for irritable bladder treatments with Mirabegron ingredients in the second quarter was ￦17.3 billion. Compared to ￦16.5 billion in the same period last year, it increased by 5 %. The second-quarter prescription for the original Betmiga is ￦14 billion, down 14% from a year earlier. Hanmi and Chong Kun Dang released Mirabegron and Sellebeta in June and July last year, respectively. The amount of the original product decreased from ￦16.4 billion in the second quarter of last year to ￦16.1 billion in the third quarter, ￦15.9 billion in the fourth quarter, ￦15.4 billion in the first quarter and ￦14 billion in the second quarter. The market share fell from 99% to 81%. Considering that Betmiga's prices are almost the same as before, it is interpreted that the generics directly affected the original performance decline. Astellas has postponed the decision to lower the price of generics due to administrative litigation. However, since March of this year, the upper limit of insurance has been reduced by 5.5% in accordance with the price-volume agreement negotiation system. The total amount of prescription for two generics in the second quarter is ￦3.2 billion. Its share in the overall market is 19%. It succeeded in taking up one fifth of the market within a year of its release. Hanmi is ahead in the competition between the two generics. As of second quarter, Mirabek recorded ￦2.4 billion and Selebeta recorded ￦800 million. In particular, Mirabek is expected to achieve ￦10 billion per year. The key is the additional release of generics. Generic exclusivity period for Mirabek and Selebeta ended in February this year. Currently, 26 companies, excluding Hanmi and Chong Kun Dang, are preparing to launch with generic approval. Betmiga is an irritant bladder drug released by Astellas in October 2015. Annual prescriptions include ￦28.8 billion in 2016, ￦41.9 billion in 2017, ￦54.8 billion in 2018, ￦64.7 billion in 2019, and ￦65.1 billion in 2020. There are about 40 domestic companies that have entered into patent challenges. Since 2015, the company has filed defensive confirmation trial for the scope of a right. Among them, Hanmi and Chong Kun Dang won the generic exclusivity. The generic exclusivity period was from May 4 last year to February 3 this year.
- Company
- Sales of Lyrica's generics sales beat Lyrica in nine years
- by Kim, Jin-Gu Jul 23, 2021 05:57am
- Lyrica (Pregabalin) For the first time, sales of Lyrica's generics, which is worth ₩120 billion a year, surpassed the original sales. It is the first time in nine years that a generic has been released in Korea. The reason why it took a relatively long time to expand generic prescription performance is because the original company, Viatris, has registered material patent & use patent. Use patent of Lyrica has been registered since the expiration of the material patent in 2012, and generic companies have sold generics in earnest since August 2017, when use patent was expired. ◆ Generics ₩16 billion vs Original ₩14.6 billion According to UBIST, a pharmaceutical market research institute on the 21st, the size of Pregabalin market is estimated to be ₩30.6 billion in the second quarter of this year. The size of the market itself is almost the same as that of the second quarter of last year (₩30.6 billion). However, the market share between the original and generics has changed significantly over the past year. The prescription amount of the original Lyrica decreased 12% from ₩16.6 billion in the second quarter of last year to ₩14.6 billion in the second quarter of this year. Sales of generics recorded ₩16 billion in the second quarter of this year. Compared to the second quarter of last year, it increased by 14%. The team beat the original for the first time based on its quarterly performance. It is the first time in nine years since the generic was released in Korea. As of second quarter, market share of generic is 52%. ◆ Generics were sold in earnest after the expiration of the usage patent in 2017 Domestic companies released generics in 2012 in line with the expiration of material patent of Lyrica. However, indication expired at that time was limited to epilepstic seizure. Drugs were not available for neurological pain. Until August 2017, when use patent expired, the sale amount of generic prescriptions was around ₩1 billion per quarter. Its market share also fell below 10%. However, sales of generics have increased in earnest since the expiration of the patent. The market share of generic products rose to 34% in 2018 after the expiration of the patent. It increased to 42 % in 2019 and 49% last year. The difference between prescription amount between original and generic in the first quarter was only ₩100 million. It finally surpassed the original in the second quarter. As of the second quarter, 117 companies have been approved for 330 items. HK inno.N's second-quarter prescription for Kabalin was ₩3.2 billion. Last year, it was the only generic product that had a prescription record of ₩10.7 billion. As of the second quarter, Daewoong Bio's Lyribear's sales were ₩1.5 billion won, Hanmi's Prebalin sales were ₩800 million, Medica Korea's Prelika and Hanlim's Gabaneuro were ₩700 million, Samjin's Neurocover-PG, Celltrion's Lyfrega and Lyreca were ₩600 million, respectively. All of the remaining products are less than ₩400 million.
- Company
- Optimal doses of Effient and Brilinta different for Koreans
- by Eo, Yun-Ho Jul 22, 2021 05:53am
- The theory that East Asians, including Koreans, require dose adjustments when receiving dual antiplatelet therapy (DAPT) prescriptions is gaining strength. In other words, the ‘East Asian Paradox’ theory that antithrombotics' clinical effect and safety are different for East Asians compared to Westerners is now being recognized worldwide. In Korea, with Young-Hoon Jung, director of the Cardiovascular Center at Gyeongsang National University Hospital, marking the start, domestic researchers have emphasized that East Asians show a different response to antithrombotics due to their lower risk of atherothrombotic events and a higher risk for serious bleeding events than Westerners and that an appropriate treatment guideline needs to be developed for Koreans. This opinion had also been reflected in the joint statement published by the Korean Society of Myocardial Infarction last year. As a result, various de-escalation strategies were studied on patients with acute myocardial infarction, all of which significantly reduced bleeding risk. The TICO study that demonstrated the effect of aspirin discontinuation therapy after 3 months, the TALOS-AMI study that showed the effect of switching from 'Brilinta (ticagrelor)' ‘to 'Plavix (clopidogrel)' after 1 month, and the HOST-REDUCE-POLYTECH-ACS that showed the effect of the de-escalation therapy of reducing the dose of 'Effient (prasugrel)' to half, are representative cases of studies supporting dose reduction. In addition, various pharmacokinetic and clinical observation studies that support reduced-dose therapies using Efficient and Brilinta were recently published in Korea and are expected to be used to revise the treatment guidelines in the future. First, Professor Young-hoon Jeong’s team published the results of a multicenter A-MATCH study that was conducted at 8 university hospitals on acute coronary syndrome (ACS) patients in the latest issue of the international journal, Thrombosis and Haemostasis. In the study, ACS patients before discharge were assigned to a standard-dose prasugrel 10mg, half-dose prasugrel 5mg, or platelet function test (PFT)-guided group for a 1-month treatment. Results showed that the ratio of patients that show an appropriate antiplatelet effect was 3.8 times and 3.5 times higher in the latter two groups compared to the Effient 10mg treated group. Bleeding frequency was also lower by 42% and 45% in the other two groups compared to the Effient 10mg treated group. Patients who experienced bleeding were around twice more likely to change drugs within the 1-year treatment period. Professor Jeong explained, “The standard-dose prasugrel had shown excessive strong platelet inhibition in Koreans. On the other hand, the half-dose prasugrel showed a clear reduction in bleeding risk and appropriate antiplatelet effect.” Also, in the HOPE-TAILOR study published in the international clinical medicine journal, J Clin Med, in June by Dong-A University Hospital’s Professor Mooh Hyun Kim and his Circulatory Internal Medicine team, the half-dose Effient and Brilinta demonstrated a more adequate optimal platelet reactivity (OPR) than the standard dose. However, the half-dose Brilinta treatment still showed excessive strong platelet inhibition and had significantly increased bleeding events in the 9-month treatment period compared to half-dose Effient, and standard-dose Plavix (31.6% vs. 12.2%, HR=2.93), also presenting the need for a large-scale clinical study on the optimal drug and dose for Koreans. Pusan National University Hospital’s Professor Jin Sup Park and his Circulatory Internal Medicine team also published their results of the BLEEDING-ACS study that was conducted on ACS patients in the latest issue of an international medical journal. The researchers randomly assigned ACS patients with low platelet reactivity (LPR) to standard-dose (90mg) or half-dose (45mg) of Brilinta to compare their frequency of bleeding events and dyspnea. Results showed that the frequency of bleeding events and dyspnea were similar between the two groups at 6 months, and was most frequent within 3 months of treatment, then decreased over time. However, the researchers also saw a 70% reduction of the Bleeding Academic Research Consortium (BARC) events (BARC type ≥2) in the low-dose Brilinta group. This reduction was more prominent in patients with a BMI of less than 25 kg/m2 or patients over 65 years of age. As in the case of Effient, the result suggests that reducing Brilinta’s dose in patients with a higher risk of bleeding, such as older or underweight patients, may have a more noticeable effect. Professor Park said, “No increase in ischemic events were observed in Korean patients with ACS when reducing the dose of ticagrelor by half. The dose reduction only significantly reduced risk of serious bleeding events.”` Meanwhile, studies on the appropriate dose of Brilinta for Koreans are currently underway, just like the HOST-REDUCE-POLYTECH-ACS studies that demonstrated the effect of half-dose Effient. The EASTYLE study, which is being conducted by Professor Mooh Hyun Kim and Professor Young-Hoon Jung's team, is studying the clinical efficacy of a de-escalation strategy, using 60mg Brilinta (45mg for older and underweight patients), and a hybrid therapy of discontinuing aspirin after 3 months in 2,000 Korean patients
- Policy
- Onivyde reimb. to be expanded to 2nd-line pancreatic cancer
- by Lee, Hye-Kyung Jul 22, 2021 05:53am
- From next month, Servier Korea’s 'Onivyde (irinotecan liposome injection)' will be available with insurance benefits for use in second-line or higher treatment of pancreatic cancer. However, patients eligible for the insurance benefit are limited to patients with an ECOG(European Cooperative Oncology Group) of 0 to 1. The Health Insurance Review and Assessment Service recently disclosed the 'Revision of notice according to medicines prescribed or administered to cancer patients' that contain the changes mentioned above and is reviewing opinions until the 26th. If no objections are made, the agenda will be deliberated and passed by the Ministry of Health and Welfare's Health Insurance Policy Deliberative Committee this week and applied reimbursement from the 1st of next month. Onivyde was first approved in August 2017 'in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.' HIRA's review of the drug for reimbursement showed that Onivyde was recommended as Category 1 in the NCCN guidelines and as 'II, B' in ESMO guidelines for the second-line treatment of metastatic pancreatic cancer in patients who were previously treated with gemcitabine-based therapy. Its efficacy in second-line treatment was verified through the open-label, randomized Phase III NAPOLI-1 study conducted on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) over the age of 18. In the study, Onivyde demonstrated its clinical efficacy over the '5-FU + Leucovorin' combination. In relation to the policy to 'cover non-benefits for items that exceed the scope of coverage,' which is being implemented as part of the coverage enhancement policy, the benefit for G-CSF injections will also be expanded. The 'Neulasta prefilled syringe inj.', 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj.' were only be applied insurance benefit for cancer patients over the age of 19 years that belong to certain cancer types and in combination with anticancer therapies specified in the benefit standards. For coverage enhancement, the authorities reviewed whether to expand the benefit standards to the scope currently being paid in full by the patient as an out-of-pocket cost. As a result, the benefit was expanded to hyper CVAD, R-hyper CVAD, and ifosfamide + etoposide + mitoxantrone therapy in non-Hodgkin lymphoma that was confirmed to 'have an over 20% risk of neutropenic fever', as well as to Hyper CVAD therapy in acute lymphoblastic leukemia with an over 20% risk of neutropenic fever, in consideration of the risk of neutropenic fever found in clinical studies. The 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj' were not approved for acute lymphoblastic leukemia, however, G-CSF injections that prevent neutropenia are applied the same expansion of benefit as there is no clear difference in their effect in each cancer type.
- Policy
- The administration monitoring cycle of Samsca is changed
- by Kim, Jung-Ju Jul 22, 2021 05:53am
- The administration monitoring cycle of Samsca (Tolvaptan) is changed in more detail. Psoriasis arthritis treatment Ixekizumab, which have been used as secondary drugs, and Secukinumab such as Cosentyx will be expanded to primary biological treatments. The MOHW announced on the 20th a partial revision of the "Details on the Standards and Methods of Medical Benefits," which is based on this information, and began to inquire opinions by the 27th. The new drug standards will be applied as of August 1. ◆Samsca, a treatment for upper chromosomal polycystic kidney disease, changes the monitoring cycle for administration by reflecting the permission. The MOHW and the HIRA decided to change the monitoring cycle of ADPKD patients and electrolyte levels in consideration of domestic and foreign permits, textbooks, clinical care guidelines, and related academic opinions. Specifically, monitoring, which was conducted once a month before and after the initial administration of this drug, is changed to monthly for the first 18 months before and after the initial administration, and every three months after that. ◆Cosentyx and Taltz Prefilled Syringe = Taltz Prefilled Syringe and Cosentyx, which can be used as secondary treatment drugs for psoriasis arthritis, are expanded to primary biological treatments and cautions regarding the risk of tuberculosis infection of biological agents are specified. These drugs will be expanded to the DMARDs non-compliance activities and primary biological sanctions by referring to domestic and foreign permits, textbooks, clinical care guidelines, clinical research documents, and related academic opinions. It was added to implement the late tuberculosis test in the same way as the TNF- in inhibitor, reflecting precautions for use and expert opinions regarding the risk of tuberculosis infection in biological agents. Based on the conditions under administration, the benefits can be applied if two or more types of DMARDs have been treated for more than six months (each three months), or if they meet the conditions as active and progressive arthritis patients who have discontinued treatment due to side effects of drugs. There shall be at least three compressed joints and at least three edema joints, and shall be the result of two consecutive measurements at intervals of one month. The treatment guidelines for late tuberculosis should be followed when using the TNF- in inhibitor. The MOHW plans to inquire about the revision by the 27th and implement it as of August 1st if there is nothing special.
- 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).
