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- 2026-05-10 01:23:41
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- Intra-articular injection Conjuran can be reimbursed
- by Moon, sung-ho Jun 28, 2021 05:49am
- As the age of aging population begins in earnest, the number of osteoarthritis patients is increasing, and the market for related treatments is also heating up. Competition among pharmaceutical companies is fierce as various products of "Intra-articular injection," which has recently been in the spotlight, are newly included in the benefit. According to the pharmaceutical industry on the 23rd, the HIRA has recently been confirmed to have changed the reimbursement standard related to "treatment materials for Intra-articular," which is called joint strength injections, since June. Collagen is added to the existing intra-pulmonary infusion treatment material. Specifically, patients with knee osteoarthritis were added not only sodium polynucleotide but also collagen, including a total of two components of joint strength injections. An official from the HIRA said, "The addition of collagen is the result of the application for the benefit registration while the related products are recognized as new medical technology." The HIRA clarified the method and number of injections with Polynucleotide administered up to five doses per six months and collagen administered up to five doses per six months (within 180 mg of total collagen dose). These categories set patient copayment rate of 80% for Selective Health Benefit targets. PharmaReaserch's Conjuran is a Polynucleotide-based joint strength injection, and CartiZol is a collagen-based joint strength injection. Among them, PharmaReaserch's Conjuran has been subject to Selective Health Benefit since the second half of last year, leading the osteoarthritis treatment market as the administration of patients has increased, led by orthopedic and rehabilitation clinics. Recently, it had an influence on general hospitals by conducting a co-promotion with SK chemicall. Conjuran began competition with Sewoncellontech's CartiZol, a collagen-based injection of joint strength. Due to the increase in arthritis patients due to the aging population, competitors such as CGBIO also predicted challenges in the joint steel injection market. Osteoarthritis treatments market is growing. According to the NHIS, the number of arthritis patients increased by about 10% in five years from 4.4 million in 2014 to 4.86 million in 2018. "As the population ages and the number of patients with knee osteoarthritis increases, joint strength injections are in the spotlight recently," an official from a pharmaceutical company said. "In particular, the treatment market will begin to compete with companies." "The current market for this treatment is worth ₩100 billion a year, and it will grow year by year," he predicted
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- Will the new social distancing benefit the prescription mkt?
- by Chon, Seung-Hyun Jun 25, 2021 05:51am
- New social distancing rules will be applied from next month. The restrictions set on private gatherings will be eased, and the operating hours of multi-use facilities will also be extended. The pharmaceutical industry has its eyes on whether the outpatient prescription market, which has contracted due to a decrease in outdoor activities, will take a turn for the better under the new regulations. According to the pharmaceutical research institution UBIST on the 21st, outpatient prescription in May this year was around 1.15 trillion won, down 1.1% YoY. This is a 10.4% fall compared to the market’s performance in May 2 years ago. This downward trend has been continuing since last month, as outpatient prescription in April was also reduced by 0.3% YoY to record 1.18 trillion won. The accumulated outpatient prescription in May this year was 5.91 trillion won, down 2.4% from the same period of the previous year. The aggregate prescription sales in May were 5.91 trillion won, down 2.4% YoY. The prescription market was hit the hardest in April to May last year due to the aftermath of the COVID-19 outbreak. Monthly outpatient prescription sales trend (Unit: 100 million won, Source: UBIST) Prescription in April and May last year were each lower by 8.7% and 9.4% YoY. At that time, with the COVID-19 spreading in full pace, patients with chronic diseases such as hypertension and diabetes chose to avoid visiting medical institutions by receiving prescriptions for the long-term, creating a void in the prescription market. However, performance in April and May this year are even worse off than the prescription void period of the previous year. The prescription market, in general, has been sluggish compared to the previous year. Prescription sales in January and February this year were also down by 7.0% and 5.6% YoY, respectively. Experts pointed to the prolonged COVID-19 as the cause of sluggish sales in January and February this year. The increased interest in personal hygiene after the spread of COVID-19, including hand-washing and mask-wearing, may have greatly reduced the incidence of infectious diseases, leading to a decrease in visits to medical institutions. Although the performance had improved temporarily in March, marking a 1.9% increase, sales has again turned downward from April. Analysis predict that the increased personal hygiene management in the prolonged COVID-19 will inevitably continue to impact the prescription market for infectious diseases, etc., even though the flu season had ended. Another reason that was raised was that the social distancing level that was elevated since the end of last year due to a surge in COVID-19 cases may have led to decreased visits to medical institution. However, with eased social distancing restrictions to be applied from next month, many are expecting the prescription market to pick up. According to the Ministry of Health and Welfare’s Central Disaster and Safety Countermeasures Headquarters (CDSCH), a new, 4-level social distancing plan will be applied from next month. The key indicator used will be the weekly daily average confirmed cases per 100,000 people. Level 1 applies when the rate is less than one in 100,000, Level 2 when the rate is between 1 and 1.9, Level 3 when the rate is between 2 and 3.9, and Level 4 for 4 or greater. In the capital area, Level 1 will be applied if the weekly daily average is less than 250, Level 2 for 250 or more, Level 3 for 500 or more, and Level 4 for 1,000 or more. Regarding private gatherings, no restriction will apply in Level 1, and up to 8 people may meet at Level 2. Local governments may choose not to apply the 8-person restriction at their own discretion. In other words, the restrictions on private gatherings for 5 or more people that was enforced since December 23rd of last year may be eased down from next year. Also, the closing hours may be extended for multi-use facilities. Industry officials expect the increase in outdoor activities will increase the number of visits to medical institutions, and benefit the prescription market. Many believe that the sluggish sales in the prescription market will not continue long as drug use continues to increase with the increase in the elderly population and people with chronic conditions. Contrary to the tourism and culture industry, which is facing an extreme crisis after the COVID-19 outbreak, the pharmaceutical industry is more influenced by the patients’ demand rather than the external environment. Therefore, experts believe, the continued social distancing restrictions set in Korea will not lead to a sudden recession of the pharmaceutical market. Also, hopes that that the prescription market will rebound due to increased COVID-19 vaccination area also present. Recently, vaccination has sped up, and the cumulative total number of those vaccinated exceeded 15 million. This means that over 15 million people visited medical institutions in about four months since March, when vaccinations first begun. With more patients visiting medical institutions for COVID-19 vaccinations, some expect this will also lead to an increase in other drug use. An industry official said, “There is a high possibility that the prescription market will recover as some people who have been hesitant to visit hospitals due to COVID-19 have been requesting additional prescriptions for their usual medications during their vaccination visits.”
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- Telemisartan is excluded from impurity survey
- by Kim, Jin-Gu Jun 25, 2021 05:51am
- The MFDS has expanded the scope of the impurity investigation to ARB drugs as a whole. However, Telmisartan·Azilsartan·Eprosartan were excluded from the list of additional investigations. The pharmaceutical industry understands that Telmisartan was excluded from the impurity survey because it does not have a tetrazole ring. The MFDS said on the 23rd, an official letter was sent to analyze and evaluate the possibility of impurities occurring in Olmesartan, Fimasartan, and Candesartan. The company that owns the drug in question shall analyze and submit the possibility of 'AZBT/Azido Methyl Bipheny Tetrazole' by the 22nd of next month. The scope of impurity investigation has been expanded from the existing Irbesartan·Losartan·Valsartan to the entire ARBs. A total of nine ARB-based drugs are licensed in South Korea. Losartan, Valsartan, Azilsartan, Eprosartan, Olmesartan, Fimasartan, Candesartan, Irbesartan and Telmisartan. Telmisartan, Eprosartan and Azilsartan were excluded from further investigations by the MFDS. 797 products containing Telmisartan such as Micardis, 5 Azilsartan products such as Edarbi, and 2 items of Eprosartan such as Teveten do not need to be further investigated. ◆AZBT and NDMA can occur during the synthesis of tetrazole rings Tetrazole ring molecular structure. Many ARBs contain this molecular structurThe pharmaceutical industry understands that the shape of each component's molecular structure influenced the MFDS' decision on the scope of the investigation. The MFDS ordered an investigation into impurities, limiting only ingredients with "tetrazole rings" in molecular structure. The MFDS estimated that Azido impurities are produced by reacting 'Br-OTBN (4'-Bromomethyl-2-cyano-biphenyl) and 'Sodium Azide (NaN3). Br-OTBN is the main intermediate in the synthesis of tetrazole rings. Add a reagent called Sodium Azide and the tetrazole ring is synthesized. In other words, the reagent (azide) used to synthesize tetrazole rings may have been produced as a "suspicious substance (AZBT)" in response to certain conditions. It is estimated that NDMA (N-Nitrosodimethylamine), which was detected during the Valsartan crisis in 2018, also occurred after a similar process. At that time, the MFDS (DMF), which was used as a solvent to make the tetrazole ring, was decomposed into dimethylamine during the high temperature process, and was produced by reacting to NaNO2. The same is true of NDEA (Nitrosodiethylamine). It is believed to have been produced by reacting to the impurities dimethylamine and nitrite contained in the triethanolamine (TEA) itself used as reagents. The MFDS judges that ARB drugs, including tetrazole rings, are likely to develop AZBT or NDMA and NDA at any time. ◆Of 9 ARB drugs, six contain tetrazole rings Looking at the molecular structure of ARB drugs, tetrazole rings are found only in Eprosartan, Olmesartan,Fimasartan,Candesartan,Irbesartan, Losartan. This is not the case with Telmisartan, Azilsartan, and Eprosartan. The tetrazole ring determines whether the Ministry of Food and Drug Safety will order an investigation into the possibility of impurities. An official from a pharmaceutical company said, "Even if it is the same ingredient, the possibility of detecting impurities is divided depending on which reagent or solvent is used." "In addition, the possibility of occurrence varies depending on whether or not there is a tetrazole ring in the molecular structure. "In Telmisartan's case, there is little chance of impurities occurring because there is no tetrazole ring."
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- Sillajen acquirer GFB seeks further partnership opportunity
- by Jun 24, 2021 05:55am
- "Using ShillaJen’s anticancer virus platform, we can add many new substances to be developed as novel drugs. Korea owns many excellent early-stage novel drug candidates, and we also may additionally introduce promising new substances in Korea." At the interview with DailyPharm, Ajit Gill, CEO of Greenfire Bio, Ajit Gill expressed his strong will to build additional partnerships with Korean bio-ventures in Korea. CEO Ajit Gill Greenfire Bio (GFB), a U.S. joint bio-venture firm of M2N that recently acquired Sillajen for 6 billion won, has been established by various industry experts including the company’s CEO Agit Gill who had previously headed Nektar Therapeutics, and CBO Sanjeev Munshi who had served over 20 years at MSD (U.S. Merck) as a BD reviewing and introducing new substances. During his service as head of Nektar Therapeutics from 1999 to 2006, Gill had contributed to raising the company’s market value to more than 20 trillion won. CBO Munshi had been in charge of searching biotech companies around the world to develop new drugs for intractable diseases such as Alzheimer's and NASH at MSD. Hanmi Pharmaceutical’s ‘efinopegdutide’ for nonalcoholic steatohepatitis (NASH) is also one of the numerous new drug substances he introduced at MSD, GFB, which has been developing the bio business with M2N Chairman Seo Hong-min, has been interested in developing new drugs using next-generation technology. In this context, Sillajen’s anticancer virus platform has caught the company’s interest. Anticancer virus, or oncolytic virus, induces immunogenic cell death (ICD) by loading viruses that have excellent penetration capabilities with anticancer substances. Globally, the interest in oncolytic virus is high, but no ‘game changer’ has emerged yet. Amgen’s Imlygic that was first introduced in the field did not produce a satisfactory return compared to the investment. However, GFB has a strong belief in the potential of the oncolytic virus market. Gill said, “With immuno-oncology drugs having a response rate around 30%, adding oncolytic virus to the immunotherapy can increase the rate to 50 to 60%. The vaccinia virus used in Sillajen’s next-generation platform has the benefit of being able to load various anticancer substances, due to its large size. Just looking at the monoclonal antibody market, we see many cases in which the bio-industry makes explosive growth with follow-up products that have been improved to complement the shortcomings of the earlier drugs, so there is no concern about the potential of the anticancer virus market." CBO Sanjeev Munshi He added, “For new technology, securing safety is important. Sillajen has the advantage in the market as the company had identified the safety of its platform through clinical trials for many years,” and expects that their accumulated new drug development know-how and financial firepower will create synergy when met with Sillajen’s leading technology. Regarding the increased market concern over the discontinuation of the Phase III trial on Pexa-Vec in 2019, Gill said, “Failing Phase III trials is common in the bioindustry. The point to focus on is whether we own a potential platform. However, we would need to establish a richer pipeline. Just one success is all we need to significantly raise the value of the company.” However, Gill took a cautious stance on the development of Pexa-Vec will continue, stating that the decision will be made after observing the data that will be released after a year. Instead, GFB is eagerly searching for new substances to apply to Sillajen’s platform. CBO Munshi has been focusing on discovering a substance with the highest possibility of success based on his experience at MSD as BD. Munshi said, “We have reviewed over 200 substances over the past 6 months. We want to find the most promising pipeline. Self-development is also a possibility, but it is more likely that we will acquire a substance through external partnerships.” In this sense, GFB is deeply interested in partnering with Korean bio ventures. Munshi said, “Korea owns abundant early-stage research data, but lacks development experience in the US., which is the world’s largest market. GFB can complement this area as the company has a high understanding of the global market and owns extensive global network experience. Please don’t hesitate to reach out anytime if you have an innovative new drug technology. Gill said, “Nektar Therapeutics was also once a 4-person company. It grew to a company with 800 employees when I left. In that time, I had signed countless contracts and raised the 1.5 billion fund in various ways. When combined, GFB’s BD expertise, M2N’s high capital, and SillaJen’s technology will be the right mix of all the essential elements necessary for the development of a blockbuster drug.”
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- Benlysta can be reimbursed in general hospitals
- by Eo, Yun-Ho Jun 24, 2021 05:55am
- Benlysta, which has been covered by insurance benefits for the first time in seven years, can be reimbursed in general hospitals. According to related industries, GSK's Benlysta (Belimumab) has passed the drug committee (DC) of 20 hospitals nationwide, including Aju University Hospital, Chungnam National University Hospital and Hanyang University Hospital. Benlysta, prescribed for treatment of active systemic erythema lupus adult patients who are autoantibody positive, was non reimbursed by the Pharmaceutical Benefits Advisory Committee twice in December 2015 and November 2018. This is because it was difficult to prove cost-effectiveness as old drug such as Prednisolone, Hydroxychloroquine and Azathioprine are alternative drugs. Benlysta is eligible for active systemic ▲Lupus 18 years of age or older, who has been treating autoantibody positive for more than 3 months with standard therapy, if both ▲SELENA-SLEDAI 10 and above ▲ Anti-dsDNA antibody positive ▲ low complement (C3 or C4) conditions. Patients can be treated with 10% of their copay through special cases of calculating rare diseases. The administration method according to the benefit standard is recognized for an additional 6 months if SELENA-SLEDAI is reduced by more than 4 weeks after initial administration ▲ If the evaluation results of the first 24 weeks are maintained, the use is recognized for an additional 6 months. Lupus invades a variety of organs throughout his life, especially in major organs such as the heart, lungs, kidneys, and nerves, which can lead to irreversible damage and death Due to the nature of the disease, most patients are women of childbearing age, and 19% of pregnant women suffer from fetal death, loss of fetal development, low birth weight, and premature birth.
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- PARP inhibitors for primary ovarian cancer can be reimbursed
- by Jun 23, 2021 05:54am
- PARP inhibitors "Jejula" and "Lynparza" are expected to be applied to primary maintenance therapy for ovarian cancer as early as the third quarter. This is limited to BRCA mutations, and most patients without mutations do not benefit. According to the pharmaceutical industry on the 21st, Takeda followed by Lynparza (Olaparib) of AstraZeneca.The pharmaceutical company Zejula (Niraparib) also passed the Pharmaceutical Benefits Advisory Committee of the HIRA and is in negotiations with the NHIS. It is predicted that both products will complete the process of registering their benefits in third quarter. 80 to 90% of all ovarian cancer patients with BRCA negative effects will be excluded from the benefits. Zejula applied for the benefit as an All-Comer regardless of the mutation, but the HIRA's Cancer Drugs Benefit Apparel Committee only recognized positive mutations. Takeda Pharmaceutical has chosen a strategy of preferentially registering salaries for training BRCA. For secondary and higher maintenance, both Lynparza and Zejula have BRCA negative adaptations, but they also did not pass. This is why ovarian cancer patients filed a petition to allow them to use new drugs for BRCA negative. The monthly cost of medicine for non reimbursement is about ₩4.5 million. Lynparza's quarterly sales have been on a gentle rise from ₩2 billion last year to ₩3.7 billion in the first quarter of this year. Zejula, on the other hand, closely followed Lynparza in the first quarter of this year at ₩3.2 billion, up from ₩1 billion last year.
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- Pfizer Korea suspends distribution of Champix
- by Kim, Jin-Gu Jun 23, 2021 05:54am
- Pic. of Champix Domestic supply of ‘Champix (varenicline),’ a smoking cessation product, has been suspended altogether. Pfizer Korea, which is in charge of supplying the product, explained that this was a preemptive measure made regarding the impurity issue. According to industry sources on the 23rd, Pfizer Korea had sent an official notice to domestic distributors that Champix 0.5mg and 1mg is nearly out of stock. In the notice, Pfizer Korea explained that this was due to a ‘disruption in the global distribution.’ Pfizer Korea’s position is that this is a preemptive measure that was made with regards to the concerns over impurities in the product. The Champix supplied in Korea is manufactured in Belgium, and is different from the products that were recalled by the health authorities in Canada earlier this month. Those were a part of the products manufactures in a Pfizer plant located in Quebec, Canada. The Ministry of Health and Welfare also said that the pharmaceutical products manufactured by the same company as those recalled in Canada are not being distributed in Korea. However, Pfizer Korea explained that this preemptive measure was made in consideration of the potential possibility that the impurities may have arisen in the manufacturing process of the finished product, and that the company will suspend supply of the product while testing for the impurities. The MFDS presumes that the impurity in question, ‘N-nitroso-varenicline’ may have developed by a reaction between varenicline and the nitrite that remained during the manufacturing process of the finished product. An official from Pfizer Korea said, “An investigation is being conducted at the global headquarters level on the detection of impurities," he said. "We plan to temporarily suspend domestic supply until the results of the impurities test is released." He continued, “We will submit related data to MFDS as soon as the results of the impurities investigation are released from our HQ. Pfizer Korea will faithfully follow MFDS instructions.” Korean generic companies plan to first focus on testing for the impurities as requested by MFDS. Because their production scale is not large, the companies believe that separate measures to stop supply will not be necessary. Currently, 34 companies in Korea are approved to manufacture CHampix generics. Among these, 12 companies have generated revenue in the first quarter of this year. Hanmi Pharmaceutical’s ‘Nokotine S,’ recorded 500 million won in quarterly sales, and the other companies have recorded less than 100 million won in the same period. An official from a domestic company that sells a Champix generic said, “We plan to first focus on conducting an independent test for impurities. And we will promptly take necessary measures according to its results.” Another official from a different company said, “We currently only hold a permit for the generic. We have discontinued production and supply of our generic since last year. It seems that some of the products that were previously released are still being distributed., but we do not plan to halt that supply or separately recall the products.” he explained.
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- Patients implore for 1st line reimbursement of Tagrisso
- by Jun 23, 2021 05:54am
- After a series of failures in receiving reimbursement extension for the EGFR targeted therapy ‘Tagrisso’ in the first-line setting of lung cancer, the patients have taken the reimbursement issue into their own hands and implored the government to review its reimbursement again. On the 22nd, the 1,713 lung cancer patients and their families delivered a letter of appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca Korea, expressing their “sincere hope for the first-line reimbursement of Tagrisso.” The letter said, “With Tagrisso’s first-line reimbursement thwarted numerous times during the past 3 years despite the desperate hope of patients and the medical community, patients and families that had to use Tagrisso as first-line treatment have been suffering from the immense financial burden imposed by the high-price of the drug. The Health Insurance Review and Assessment Service’s Cancer Drug Review Committee had turned down the application to extend reimbursement of Tagrisso to the first-line setting of non-small cell lung cancer (NSCLC). Since adding this first-line indication in Korea in December 2018, AstraZeneca Korea had been attempting the reimbursement expansion since 2019 but was unable to pass the threshold of the Cancer Drug Review Committee. The Cancer Drug Review Committee’s had an issue with the sub-analysis results of the global FLAURA trial in Asians, although the drug demonstrated an improvement in overall survival in the total population. On this, AstraZeneca further submitted results from the FLAURA China trial on the Chinese cohort patients, however, the reimbursement was once again turned down in April. Faced with this high barrier, patients and families came forward and organized an online signature-gathering campaign. In only one day, over 1,000 people signed the petition, and in one week, 1,713 people joined the campaign. The patients and families implored, “We don’t need the clinical trial results on Asians that was conducted on Chinese patients. Just the domestic cases are enough to recognize that Tagrisso has the best treatment effect in lung cancer and can even prevent brand metastasis and recurrence. We are deeply hurt that the current government, which promised to improve the medical environment for cancer patients, neglected the promise to ‘actively review reimbursement for first-line treatment with Tagrisso’ that was made at a national audit last year.” They continued, “We earnestly ask that you understand the sincerity of our claim, rather than simply dismissing our request for the first-line reimbursement Tagrisso in lung cancer as a ‘protest.’ We sincerely ask you to reconsider the reimbursement of Tagrisso as first-line treatment in lung cancer,” asking for the prompt reimbursement of Tagrisso. They also asked for the Korean Association for Lung Cancer’s support for this initiative. “Many professors in the field recommend Tagrisso as first-line treatment, however, the members of HIRA’s Cancer Drug Review Committee keep deferring reimbursement claiming that it lacks clinical usefulness.” To AstraZeneca Korea, they said, “We feel hopeless faced with the reality of having to pay over 6 million won every 4 weeks for the treatment,” and asked for the company’s additional and multidimensional effort for approval.
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- Pneumococcal vaccination rate drops due to COVID vaccination
- by Whang, byung-woo Jun 23, 2021 05:54am
- Compared to rate of inoculation in 2020, rate of inoculation decreased significantly in first quarter of 2021. As COVID vaccinations begin in earnest, the inoculation rate of pneumococcal vaccines, which rose sharply last year, is decreasing. In particular, it is difficult for health centers to be in charge of vaccination and the situation of clinics is the same. As a result, related pharmaceutical companies also have a significant impact on sales decline due to a decrease in inoculation rates. According to the KDCA and the pharmaceutical industry on the 17th, the vaccination rate of pneumonia groups, which has steadily increased in recent years, has been falling significantly since the first quarter of this year. In fact, looking at the NIP (National Immunization Program) computer registration status announced by The KDCA over the past three years, NIP pneumococcal vaccinations for senior citizens aged 65 or older have risen every year to ▲283,687 in 2018, ▲580,793 in 2019, ▲839,461 in 2020. As of the first quarter of last year, the number of vaccinations decreased by nearly half from 145,796 in 2019 to 74,285 in 2020, but the inoculation rate also increased significantly as pneumococcal vaccinations were available at outside health centers from the second quarter. In particular, concerns about pneumonia, a major complication of COVID-19 infection, spread ahead of the flu epidemic, with a total inoculation rate of 414,596 cases in the third quarter alone, higher than the overall inoculation rate in 2018. However, this year, the rate of vaccination in the first quarter is again lower than previous years due to COVID-19 vaccination. The number of pneumococcal vaccinations in the first quarter of this year was 112,860, down from 145,796 in the first quarter of 2019, before COVID-19 outbreak. This is not NIP, but it was also confirmed by sales of 13 pneumococcal vaccines. According to the drug research firm IQVIA, Pfizer's pneumococcal vaccine Prevenar 13's sales in the first quarter of this year were ₩9.4 billion, down 46.7% from ₩17.6 billion in the first quarter of last year. Compared to the third quarter and ₩24.2 billion, which recorded the highest sales last year, sales declined by nearly 60%, and overall pneumococcal vaccinations decreased regardless of NIP. "The vaccination rate for pneumococcal vaccines has decreased a lot compared to previous years," said physician at a clinic. "We believe that the inoculation rate has decreased because the number of patients visiting the hospital is small and patients are not considered a priority." "There are also cases where patients who are vaccinated against corona do not think they need to get a pneumococcal vaccine," he said. "I'm not sure if we can increase the vaccination rate under the current situation." Prevenar 13's sales were ₩81.3 billion over the year. As it recorded 64.8% growth compared to 2019, its current low sales performance in first quarter could lead to reverse growth in 2021. "For pharmaceutical companies that have consistently emphasized the need for pneumococcal vaccinations, the decrease in inoculation rate is of course very upsetting," a pharmaceutical industry official said. "In particular, sales fell nearly half as of the same quarter last year." In this regard, experts stressed the need to share COVID-19 vaccination and pneumococcal vaccination separately from the concerns of pharmaceutical companies. "The basic principle is that vaccination of COVID-19 vaccines should not destroy the existing vaccination system. "I agree with the need for pneumococcal vaccinations, but the rate may rise as last year," said an official from the Korean association of internal medicine. "Pneumonia is one of the major causes of death, so the government needs to vaccinate and make efforts."
- Company
- Zolgensma applies for reimbursement... ignites discussion
- by Eo, Yun-Ho Jun 22, 2021 05:50am
- Another ultra-high priced ‘one-shot’ treatment has begun it process to be listed for reimbursement. Novartis, the developer of another one-shot treatment ‘Kyrmriah,' has announced its plans to list and release ‘Zolgensma’ in Korea. According to industry sources, Novartis has recently submitted an application for the reimbursement of Zolgensma (onasemnogene abeparvovec-xioi) through the approval-benefit appraisal linkage system. The company had first aimed at an earlier discussion of Zolgensma's reimbursement, but as the safety and efficacy review was completed later than expected, the listing process for the drug had started after the official approval. Zolgensma, which is a treatment for Spinal Muscular Atrophy (SMA) like ‘Spinraza (nusinersen)’ which was approved in 2017, is a gene therapy that contains genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved Zolgensma as the second advanced biopharmaceutical after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ companies can receive differentiated safety management including long-term follow-up studies as well as support for R&D and product commercialization for their advanced biopharmaceuticals. Despite being a one-shot treatment, the price of the single shot costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to its high price, the listing process for Zolgensma in Korea is also expected to be unsmooth. However, the expectations regarding its efficacy are very high. Results of the Phase III SPR1NT and STR1VE-EU studies for Zolgensma that were presented recently recieved much attention. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copy (Cohort 1) that were treated presymptomatically survived without requiring ventilatory or nutritional assistance, and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. Zolgensma is indicated in Korea for the treatment of pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) who ▲ have been clinically diagnosed with SMA Type 1; or ▲ has up to 3 copies of the SMN2 gene.
