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Policy
Detailed screening for α -GPC begins in earnest next year
by
Moon, sung-ho
Dec 07, 2021 05:57am
Tensions are rising as the government announces the review of the revised supplementary budget bill starting next year amid deepening concerns among pharmaceutical companies over the issue of Choline Alfoscerate. According to the pharmaceutical industry and the medical community on the 1st, it has been confirmed that the MOHW has decided to strengthen the screening of prescriptions for hospitals and clinics starting next year in accordance with the clinical re-evaluation policy for Choline Alfoscerates. Over the past two years, the MOHW has set the first target of strengthening screening according to the drug clinical re-evaluation policy as the Choline Alfoscerate formulation. In fact, the Choline Alfoscerate drug is recognized as a drug in Italy, while it is sometimes used as a health functional food in other countries, so controversy over its efficacy has continued. The MFDS ordered a "clinical re-evaluation" last year to re-evaluate the Choline Alfoscerate formulation on its own, and 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. At the same time, the MOHW reduced the benefit of Choline Alfoscerate. Since August last year, patients who have not been diagnosed with dementia have raised the drug price burden rate from 30% to 80% when using Choline Alfoscerate. Then, pharmaceutical companies actively took legal action and began to defend their sales. However, unlike the pharmaceutical industry, which is preparing such a defense strategy, some say that the actual medical field has little impact on the reduction of benefits. It was expected to have a big impact as the government decided to reduce benefits, but the actual feeling at the medical field is quite low. "In fact, the HIRA is currently not cutting according to the reduced benefit policy," said a professor at University Hospital A belonging to Korean Dementia Association, who requested anonymity. "There is no big problem with maintaining similar billing guidelines," he said. In the end, the MOHW and the MFDS have strengthened their guidelines following the reduction in benefits, but they are actually prescribing them without paying much attention to them in the actual clinical field. This is why The HIRA has announced cuts through specific screening starting next year. An official from the HIRA said, "Strengthening the screening is a situation in which we have to go through the Central Review and Coordination Committee, an organization within the institution. He said, "It is not easy to apply a specific examination yet, but we will proceed quickly and strengthen the examination of prescriptions by medical institutions from next year."
Policy
The original patent's negotiation period will be reduced
by
Kim, Jung-Ju
Dec 07, 2021 05:57am
The period of ex officio adjustment drug price negotiations for the original drug that expires patents collectively cut drug prices will be reduced to one-third. It is aimed at improving cases of health insurance financial leaks by abusing the prescribed negotiation period as much as possible when the legal drug price cut rate is set. The MOHW announced that it held a Health Insurance Policy Deliberation Committee this afternoon (25th) and reported on the "improvement of the drug negotiation system." The government is currently negotiating all reimbursed drugs. This is in accordance with the policy to expand the negotiated drugs from the application of new drug insurance to the entire drug from October 2020 to strengthen the quality control and stable supply management of insurance drugs after detecting Valsartan impurities in 2018. For example, in the past, negotiations between the government and companies were conducted to register new drugs, adjust drug prices, and expand the scope of use. However, since the reorganization, negotiations have been underway to adjust the original drug price (100 → 70%) and re-evaluate according to the first generic insurance application. Although the negotiation system has been expanded in this way, the problem of confusion in the operation of the system has been exposed due to insufficient detailed procedural regulations. In the case of supply and quality management contracts, unnecessary overlapping negotiations were held, such as drug price adjustments, and some pharmaceutical companies delayed the negotiation deadline of 60 days to delay the timing of drug prices falling. Some also pointed out that there are no renegotiation and procedural regulations when negotiations break down. It was pointed out that the drug negotiation procedure under the narrow law was unclear about the regulations on follow-up measures, such as exclusion of benefits, in the event of a final breakdown. The improvement plan largely sets ▲ the target to be omitted when negotiating drugs, ▲ to adjust part of the negotiation period of , ▲ to prepare renegotiation procedures in the event of a breakdown of negotiations, and ▲ to clarify that benefits are excluded in the event of a final breakdown of. Specifically, the negotiations will be omitted if there is a contract between the corporation and pharmaceutical companies. In the case of ex officio adjustment negotiations due to the application of a package reduction in drug prices, it will be shortened from the current maximum of 60 days to 20 days. This is a measure designed to reasonably shorten the negotiation period in the case of original ex officio adjustment. When negotiations broke down, renegotiation procedures were also in place. In order to prevent confusion in the clinical field, the government asked to renegotiate the drug characteristics and the progress of negotiations after deliberation by the Drug Benefit Evaluation Committee. In addition, in the case of drugs whose final negotiations have broken down, grounds have been established to exclude benefits. The government has decided to push for the standard rules for medical care benefits and the individuality of notification sometime next month. Considering administrative procedures such as legislative notices, the implementation of the amendment is expected to be possible in the first half of next year.
Company
Five companies give up challenging Dukarb’s patent
by
Kim, Jin-Gu
Dec 06, 2021 05:54am
Pic. of Boryung Pharmaceutical Five out of the 45 companies that set out to evade the patent of Boryung Pharmaceutical's antihypertensive combination drug ‘Dukarb Tab. (fimasartan+amlodipine)’ decided to give up challenging the patent. The industry has pointed to the fierce competition in the two-drug fixed-dose combination market as one of the causes for the companies’ decision to give up their patent challenge. According to industry sources on the 6th, PharmGen Science voluntarily withdrew the trial to confirm the passive scope of patent rights that it had recently filed for the Dukarb composition patent. If the companies succeed in avoiding the composition patent for Dukarb which is set to expire on August 2031, the companies may release their latecomer drugs for Dukarb after February 2023 after the substance patent for the Kanarb ingredient expires. According to the pharmaceutical market research institution UBIST, outpatient prescription for Dukarb recorrect 36.1 billion last year. Prescriptions amounted to 30.2 billion won by Q3 this year. Other than the single-drug pill Kanarb, Dukarb has made the most prescription performance among the Kanarb family. Due to the outstanding performance of the drug, many companies have filed challenges to the drug’s composition patent. Starting with Arlico Pharm, a total of 45 companies have filed a trial to confirm the passive scope of patent rights. However, Yuyu Pharmaceutical was the first to drop the suit on August 24th. Since then, Hanwha Pharma, Daehan New Pharm, Kims Pharma, PharmGen Science voluntarily dropped their challenges. As a result, a total of 5 companies have now given up challenging Dukarb’s composition patent. The industry’s focus is now on whether more companies will follow suit. Due to the ongoing fierce competition in the antihypertensive drug market for the ARB+CCB class two-drug combo, there is still the possibility that more companies will be giving up patent challenges. In this context, the companies may have determined that the release of a latecomer Dukab generic may not have great marketability. Also, with the strong presence held by Boryung Pharmaceutical, some predicted that the market will be hard to penetrate with the release of several same-ingredient generics at the same time. However, one variable that remains is the impurity issue in the sartan ingredients. In addition to the growing concern over azido impurities in the losartan ingredient in Korea, azido impurities have also been found in irbesartan and valsartan ingredients abroad. If the impurity issue grows to exceed expectations, some expect that this will increase demand for a different ARB-class drug, fimasartan. No impurity has been detected in fimasartan up to date.
Product
Losartan's re-prescription & re-dispensing are imminent
by
Jung, Heung-Jun
Dec 06, 2021 05:54am
While the government's follow-up measures based on the results of Losartan impurity detection are expected to be announced this week, attention is being paid to the work guidelines for re-prescription and re-prevention. Items with problems with all manufacturing numbers are expected to be re-prescribed and re-manufactured, and items with problems with some manufacturing numbers will be exchanged. Earlier, the MOHW and the MFDS held two meetings with the Korean Medical Association and the KMA, the KHA, and the KSHP. In addition, meetings with the KPBMA and the KPDA were held and plans were made for follow-up measures such as cost settlement. According to the government's discussions with organizations so far, exchanges are likely to take the same measures as the detection of Azido impurities in September. If exchanged at a pharmacy according to patient needs, it will be changed to a normal lot number, and 110% of the drug price will be added to the drug price to settle by the pharmaceutical company. Since the Korean Pharmaceutical Association already has a related system and the exchange rate was low earlier, it is expected that there will be few problems with the exchange again this time. In the case of re-prescription, it will be a method in which the pharmaceutical company that received the claim details is reimbursed to the nursing institution every month. When a hospital or clinic re-prescribes the remaining amount of the patient's possession, the pharmacy proceeds with the claim through the existing claim program. It plans to assign a specific code to claims for re-dispensing. The HIRA and the NHIS check and deliver them to pharmaceutical companies every month. Since then, pharmaceutical companies have to pay hospitals, pharmacies, etc. within a set period (about a week). Detailed guidelines for the payment of expenses to nursing institutions of pharmaceutical companies are expected to be guided by the government through a confirmed guide. If mixed preparation is performed with powdered medicine, it is expected that drugs other than those subject to recovery will be exchanged. The size of the impurity detection items finally announced by the migrant government is expected to determine the impact on pharmacies.
Policy
KB Pharm's generic for Vildagliptin nitrate will be approved
by
Lee, Tak-Sun
Dec 06, 2021 05:54am
The post-inflammatory drugs of the diabetes treatment Galvusmet (Vildaglipin-Metformin Hydrochloride), which the Supreme Court ruled invalidating part of its extended duration, are appearing one after another. These items will be able to be released early in January next year if some of their duration is confirmed to be invalid. On the 30th of last month, three dosage products of Vildagliptin-Metformin HCl, a compound of KB Pharm, were approved. It is the seventh company to launch generic for Galvusmet. However, this is the first salt-changing drug containing Vildagliptin nitrate. Pharmaceutical companies participated in the development one after another. At first, only An-gook and Hanmi Pharm, which claimed invalidation of their duration, were developed, but when the Patent Tribunal achieved results, KOREA UNITED PHARM and KB Pharm also participated in the development. The lawsuit for invalidation of the extension of the duration ended on October 28 when the Supreme Court recognized 55 of the 1,068 extended days as invalid. If some of the invalidity of the duration is finalized, material patent of Galvusment will expire on January 9 next year. In this case, other pharmaceutical companies that have not participated in the lawsuit can also launch products on the market as their substance patents are terminated. Currently, generics for Galvusmet have been approved by Hanmi Pharm, KOREA UNITED PHARM, Ahn-gook, Ahn-gook Newpharm, Shinpoong, Samjin, and KB Pharm. However, Hanmi Pharmaceutical and KB Pharm are the only pharmaceutical companies that have been approved for three doses. The rest of the pharmaceutical companies were granted only 50/500 mg. In the case of generic for Galvusmet, there are no restrictions on selling products because there are no products that have received general for inclusion. In the case of single-drug Vildagliptin, Ahn-gook Newpharm has acquired generic for exclusivity, and the same drug will be banned from selling until May 29, 2022. Last year, Galvusmet recorded 36.4 billion won in outpatient prescriptions, continuing its popularity in the diabetes treatment market. Competition is expected to intensify when the generic market opens next year.
Policy
Asciminib's domestic approval is at a quick step
by
Lee, Tak-Sun
Dec 06, 2021 05:53am
Novartis' Asciminib, which is attracting attention as a fourth-generation targeted anticancer drug in the chronic leukemia treatment market, is also speeding up domestic permits. The drug, which was approved by the U.S. FDA last month, has recently been approved for four clinical plans in Korea alone, boosting the analysis that it is accelerating its entry into the Korean market. According to the MFDS on the 26th, Asciminib has been approved for four clinical plans since August. Asciminib is a TKI (tyrosine kinase inhibitor) family fourth-generation targeted anticancer, and is attracting attention in that it attacks targets different from those of the first to third generations. This is because different targets reduce interference between anticancer drugs. Chronic myelogenous leukemia treatment continued to evolve in 2001 when the world's first targeted anticancer drug, Glivec, was launched. The second generation was developed into Sprycel, Tasigna, and the third generation Iclusig. The survival rate of patients is also on the rise with the release of third-generation targeted anticancer drugs, but the rate of treatment failure due to resistance is known to increase as the treatment stage goes up. As a result, expectations for fourth-generation treatments are also growing. Asiminib is set to be officially released on October 29 as the FDA decided to approve. In Korea, the MFDS designated it as a rare drug for the "chronic Philadelphia chromosome-positive chronic myeloid leukemia" disease in May and opened the way for it to be used before official approval. If it is designated as a rare drug, it will be reviewed more quickly, so the speed of domestic approval is expected to accelerate. It is interpreted that it has considered expanding indications and bridging tests after a series of clinical approval permits. In August, a phase 3b test plan was approved to evaluate long-term safety in patients who completed the Asciminib clinical trial and judged that the tester would benefit from continued administration. In addition, in September, phase 1/2 was approved to determine the dose and safety of oral Asciminib in pediatric patients with chronic Philadelphia chromosome-positive chronic myeloid leukemia previously administered one or more tyrosine kinase inhibitors. On the 4th of this month, a phase 3b plan of oral Asciminib was approved in patients with chronic myelogenous leukemia in the chronic phase who had previously been administered two or more tyrosine kinase inhibitors. And on the 22nd, a phase 3 test of oral Asciminib versus TKI was approved in patients with newly diagnosed chronic myeloid leukemia positive for Philadelphia chromosomes. Industry sources say Asciminib is expected to speed up its approval in Korea with FDA approval, adding that approval is also possible as early as next year. The U.S. FDA has fully approved accelerated approval and chronic CML patients with T315I mutations for cases where two or more of Asciminib has been treated with Philadelphia chromosome CML patients, and it is known that the same indication is being reviewed in Korea.
Product
Why Tagrisso and Opdivo failed reimbursement expansions
by
Moon, sung-ho
Dec 06, 2021 05:53am
The 3rd generation targeted therapy for lung cancer, ‘Tagrisso (osimertinib)’ once again failed to expand reimbursement to first-line treatment. The reason was that the drug was more appropriate as a second-line treatment in terms of cost-effectiveness. By failing to expand reimbursement at the last Cancer Drug Review Committee meeting held this year, the two drugs will not have to wait until the next year to reattempt reimbursements. #According to the industry on the 26th, the National Health insurance Service held the 8th Cancer Drug Review Committee meeting on the 24th to deliberate on the reimbursement standards for drugs used by major cancer patients. As the last meeting planned for the year, the blockbuster drugs that were delayed deliberation due to data submissions from pharmaceutical companies and collecting academic opinions, the agenda of expanding reimbursement of the drugs was finally put on the table for deliberation. One representative drug that was put on the agenda for discussion was ‘Tagrisso (Osimertinib).’ With Tagrisso, which failed to extend reimbursement 3 times after adding an indication as a first-line treatment in lung cancer in December 2018, its company, AstraZeneca had attempted to receive approval once more with a more progressive cost-sharing plan. However, the company once again ‘failed.’ AstraZeneca had presented results from Phase III clinical studies conducted in China among others to support the need for extended reimbursement, however, the evidence provided by the company was not sufficient enough to convince the CDRC members. At the same time, the reimbursement approved for Tagrisso’s competitor, Yuhan Pharm’s ‘Leclaza (lasertinib),’ from the second half of this year as second-line treatment had also influenced the CDRC results. A CDRC official who requested animosity said, “We concluded that the use of Tagrisso or Leclaza as second-line treatment in line with the current reimbursement standards was more cost-efficient than using Tagrisso first-line as proposed. The cost-sharing proposal submitted by AstraZeneca was also adjusted and improved than before, it was not satisfactory. “ He added, “The discussions had been put on hold in the first half of this year because the level proposed by the company was not satisfactory in terms of cost-effectiveness. The other data submitted, such as the Chinese trial, were just referenced.” The CDRC also postponed the reimbursement extension for the cancer immunotherapy ‘Opdivo(nivolumab).’ Its company had applied to extend its reimbursement standards for melanoma, non-small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head, and neck cancer (240mg 2 weeks/480mg 4 weeks), but was unable to pass CDRC review. The CDRC official said, “Opdivo’s dosage was increased based on Europeans. Opdivo’s 240mg dose may be applied to Europeans in consideration of the 1kg/3mg dose recommendations as they weigh over 80kg.” He continued, “However, the average weight of Koreans is different from that of Europeans. They do not exceed 80 kg. Therefore calculating the dose by kg/3 mg is more cost-effective, but the company is attempting to expand reimbursement at a higher price.”
Policy
Companies in a dilemma over who bears losartan recall cost
by
Lee, Tak-Sun
Dec 03, 2021 05:55am
Pharmaceutical companies are unsatisfied with the health authorities’ request for companies to fully bear the cost of exchanging ‘losartan’ products that were found to contain azido impurities. While many companies have submitted the ‘cost-bearing letter of commitment,’ the companies have been left with a bitter aftertaste, due to the ongoing litigations and uncertainties on how much the exchanges will cost. Some companies have not submitted the letter of commitment yet. The Ministry of Food and Drug Safety had gathered the manufacturers and sellers of losartan products on the 29th of last month to request a ‘letter of commitment on bearing the cost,’ a commitment by the companies to bear the cost of exchanging, re-prescribing, and re-dispensing drugs that arise from recalls, saying that the cost should be borne by the pharmaceutical companies. After receiving the request, over half of the companies have submitted their letter by the 30th, the deadline for submitting impurity test results. Companies that submitted their letter of commitment did so because they do not expect the cost burden to be large, and that they could not disregard the government's request. An official from a mid-grade pharma company said, “ We submitted the letter of commitment as requested because we expect the number of recalls to be small, the number of products exchanged or re-prescribed by consumers to be even smaller.” As only specific lot numbers in issue are subject to recalls this time without stopping reimbursement, the companies expect the number of consumer recalls to be smaller than that for valsartan or ranitidine. In fact, the number of antihypertensive drugs that were recalled by consumers in September due to AZBT impurities was only 4, giving some credibility to these companies’ expectations. However, as there were no re-prescriptions, re-dispensing, and no public promotion activities informing the people about the recalls then, other companies believe the larger amount of recalls would increase the cost incurred as well. Another industry official said, “It may not have been so if the recalls were conducted quietly, but if the recalls become politicized, the cost of exchanging the products may grow bigger. Most of the losartan products are prescribed for long-term use, for over a month, and may become a big burden for pharmaceutical companies.” Another issue is that the letter of commitment may affect the ongoing non-existence of a debt suit being conducted on valsartan products. The suit arose after the National Health Insurance Service filed claims to pharmaceutical companies to retrieve the cost incurred while exchanging valsartan products that were found to have impurities. Companies have asserted that the indemnity claims were excessive as the unexpected impurities were only found due to the development of science and were unavoidable as the drugs were manufactured due process. However, the first trial court ruled in favor of NHIS and judged that a total of 2.03 billion won should be paid in claims for indemnity by 69 companies in September. The companies appealed, and the lawsuit is now being tried in a second trial. In this context, if the companies submit the ‘letter of commitment on bearing the cost,’ this contradicts the claims the companies had made at court and acknowledges indemnity. This is highly like to negatively affect the outcome of the lawsuit. This is why some companies have not been able to decide on whether to submit the letter of commitment. Recently, the MFDS is known to have been urging pharmaceutical companies to promptly submit the letter of commitment. A pharmaceutical company official said, “As the underdog, it would be difficult for us to reject the MFDS’ request. However, it is an unjust procedure for the government to unilaterally decide on the bearer of the costs and notify and companies to submit a letter of commitment.” Meanwhile, the MFDS is expected to soon announce a list of high blood pressure losartan drugs that contain excess azido-based impurities and start recalls from pharmacies, distributors, and consumers.
Company
Moderna Korea appoints Ji-Young Sohn as new GM
by
Dec 03, 2021 05:55am
Ji-Young Sohn, General Manager of Moderna Korea Ji-Young Sohn, the former GM of CSL Behring Korea, was appointed as the General Manager of the Korean subsidiary of the COVID-19 vaccine developer Moderna. The new GM will be leading Moderna’s business in Korea and is seeking executives to organize teams that can perform various tasks for the company. The company is currently hiring new executives and employees. Sohn majored in Pharmacy at Ewha University and holds an MBA degree from Korea University Business School. Since then, she has accumulated over 20 years of experience in various global pharmaceutical companies. Before Moderna, the new GM had served as the General Manager of CSL Behring Korea and led the establishment of its Korean subsidiary and the launch of its new products. She started her pharmaceutical career at Pfizer Korea, then expanded her scope of business in the industry at Roche Korea and Roche Headquarters. At Pfizer Korea, Sohn had led various marketing and strategy teams and served as the Head/Director of the company’s first Specialty Care Business Unit. At Roche Korea, she had served as the Head of the Oncology Business Unit, driving strong growth of the oncology business and people development. After then, Sohn moved on to become an international portfolio business leader at Roche Headquarters Switzerland and successfully implemented a global strategy of a mature product portfolio worth 1 trillion won. Patrick Bergstedt, SVP of Commercial Vaccines at Moderna, said, “Sohn is a recognized innovative and strategic leader in Korea and global markets, and we look forward to working with her to reinforce Moderna’s place in Korea.” Sohn said, “Korea is a very important market for Moderna, and Moderna has already made various strategic partnerships and considerable investments in Korea. We will work to build major relations and introduce Moderna’s mRNA science technology to Korea, increase stakeholder trust, and strive to help promote the people's health with Moderna’s excellent vaccines and other future treatments to come."
Company
COVID-19 vaccinations freeze up the premium vaccine market
by
Chon, Seung-Hyun
Dec 02, 2021 05:54am
The premium vaccine market that consists of vaccines used to prevent diseases like shingles, pneumococcal vaccines, etc has contracted greatly. Analysts believe that the demand for other vaccines had decreased due to medical institutions prioritizing COVID-19 vaccinations. However, the cervical cancer vaccine market continued to show growth due to the increase in demand for Gardasil 9. On the 1st, according to the medical research institution IQVIA, the shingles vaccine market size in Q3 was ₩8.9 billion, down 56.1% from the same period of last year. The cumulative sales by Q3 in the market was ₩29 billion, also a 47.3% drop from last year. Currently, two products - MSD's ‘Zostavax’ and SK Bioscience's ‘Skyzoster’ – are competing in the domestic shingles vaccine market. Since Skyzoster broke the monopoly of Zostavax and entered the market at the end of 2017, the market had recorded rapid growth. The market size had increased to record ₩27.9 billion by Q4 in 2019. Quarterly sales of shingles vaccines (Unit: ₩1 million, Source:IQVIA) However, the market had fluctuated after the full outbreak of COVID-19. In Q1 last year, the shingles vaccine market decreased by 37.8% and recorded ₩12.2 billion. The market size had contracted with patients avoiding visits to medical institutions earlier on during the outbreak. Although the market showed recovery, increasing to ₩22.6 billion in Q2, ₩20.3 billion in Q2, then ₩17.3 in Q4, sales have once again made a downward turn entering this year. Sales in Q3 had fallen 68.1% compared to two years ago, in Q4 2019. Sales of Zostavax and Skyzoster have fallen together. Zostavax sold ₩5.7 billion in Q3, a 53% drop YoY. In the same period, Skyzoster sold ₩3.2 billion and dropped by 60.7%. compared to Q4 2019, when the two vaccines peaked in their sales, Zostavax and Skyzoster’s sales both fell by 66.2% and 70.9%, respectively. The sluggish performance of the shingles vaccine market is analyzed to be an effect of the increased COVID-19 vaccinations. That the medical institutions’ tendency to administer COVID-19 vaccines first had resulted in a relative neglection of other vaccine products, is most convincing. The pneumococcal vaccine ‘Prevenar 13’ that had temporarily enjoyed an upsurge in sales with COVID-19 is also seeing prolonged sluggish sales. Prevenar 13 sold ₩7.4 billion in Q3, which was a 69.6% decrease from the same period of last year. Its cumulative sales by Q3 were ₩24.9 billion, which was also an immense 58.5% drop from the previous year. Quarterly sales of Prevenar 13 (Unit: ₩1 million, Source:IQVIA) ‘Prevenar 13’ is a PCV13 that prevents infection from 13 Streptococcus pneumoniae serotypes (3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). It may be administered to all those aged 6 weeks or older. Prevenar 13 for adults is being distributed in Korea by Chong Kun Dang, and for infants by Korea Vaccine. Prevenar 13’s performance this year is in stark contrast to the sharp rise in sales it made last year with the COVID-19 outbreak. Its sales in Q1 last year was ₩17.6 billion, a 52.2% increase from the previous year, which rose to ₩24.2 billion by Q3 last year. Prevenar13 sold ₩81.2 billion last year and made a 64.8% YoY increase. Demand for Prevenar 13 among adults had surged temporarily earlier in the COVID-19 outbreak with the expectation that while Prevenar13 cannot prevent COVID-19, it can weaken the pneumonia symptoms from COVID-19. However, its sales had greatly dropped entering this year. Sales of the vaccine in Q1 was ₩9.4 billion, a 55.5% decrease from the previous quarter, and continued to drop in the following quarters. Prevenar13’s sales dropped 32.8% compared to the pre-COVID-19 period 2 years ago. In other words, the vaccine, which enjoyed reflective benefits in the early phases of the COVID-19 pandemic, has been on the contrary, been negatively affected by COVID-19 and the increase of its vaccinations this year. Among the various products in the premium vaccine market, the cervical cancer vaccines market solely showed growth. In Q3, the cervical cancer vaccine market increased 22.7% from the previous year and recorded ₩21.9 billion. Cumulative sales by Q3 was ₩66.9 billion, increasing 42.3% from the previous year. Three products – MSD’s ‘Gardasil,’ ‘Gardasil 9,’ and GSK’s ‘Cervarix’ – are competing in the domestic cervical cancer vaccine market. The rapid rise of the relatively expensive Gardasil 9 is analyzed to have driven the growth of the market’s size. Quarterly sales of cervical cancer vaccines (Unit: ₩1 million, Source:IQVIA) Gardasil sold ₩5.4 billion in Q3, which was only a 3.9% increase from the previous year. However, Gardasil 9’s sales rose 37.2% in the same period, recording ₩16.1 billion. Cumulative sales of Gardasil 9 by Q3 was ₩50.8 billion, a 72.6% increase from the previous year. Cervarix’s sales in Q3 were only in the ₩0.3 billion range. Gardasil 9 is a vaccine is an HPV vaccine product that contains 5 additional serotypes (31, 33, 45, 52, 58) to the 4 serotypes (6·11·16·18) contained in Gardasil. It is being distributed at a higher price Among cervical cancer vaccines, it is being distributed at a high price with the distinction that it contains the most HPV types. Based on Q3 numbers, Gardasil 9's accounts for 73.6% of the cervical cancer vaccine market. Unlike Gardasil and Cervarix, Gardasil 9 is not part of the National Immunization Program in Korea. However, its effect in preventing other HPV-related diseases such as anal cancer, genital warts, and precancerous lesions in addition to cervical cancer has spread by word of mouth, increasing the annual number of male vaccinations. The age for its vaccination had also been extended to cover up to 45 years of age, increasing the rate of adult revaccinations.
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