- LOGIN
- MemberShip
- 2026-05-17 06:39:27
- Company
- Montelukast sales 22%↓ in 2 years and adds impurity issue
- by Kim, Jin-Gu Jan 25, 2022 05:55am
- The market for the montelukast ingredient used to treat allergic rhinitis and asthma has contracted for two consecutive years. The reduction is analyzed to be due to the combined effect of the US FDA’s side effect warning request for the ingredient in 2020 and the prolonged COVID-19 crisis. Industry eyes are on how the impurity issue that recently emerged would additionally affect the market. ◆Conflicting results by product… Singulair ↓ 32% vs Monterizine ↑ 15% According to the industry research institution UBIST on the 25th, outpatient prescription sales of the allergic rhinitis and asthma treatment market for montelukast was ₩94.8 billion last year. The market had risen from ₩76.1 billion in 2016 to 121 billion in 2019 but had seen a decline for two consecutive years since. Compared to 2019 when the market expanded to its greatest, the market had shrunk 22% over the recent 2 years. Montelukast is one of the most common drugs used to treat allergic rhinitis and asthma. The original drug is Organon Korea’s Singulair. In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient. Most of the key products were unable to avoid the reduction in their prescription amount. Sales of the market lead Singulair shrunk 32% from ₩39.2 billion in 2019 to ₩26.5 billion last year. Other montelukast drugs also saw a double-digit reduction in sales. HK Inno.N’s ‘Lukio’ dropped 31% (₩12.8 billion→₩8.8 billion), Hanmi Pharmaceutical’s ‘Montezal’ dropped 35% (₩7.3 billion→₩4.7 billion), Hutec Korea Pharmaceutical’s ‘Singuldown’ dropped 26% (₩5.3 billion→₩3.9 billion), Daewon Pharmaceutical’s ‘Singuluka’ dropped 42%(₩3.1 billion→1.5 billion). On the other hand, prescription of some products has increased greatly. Sales of Hanmi Pharmaceutical’s ‘Monterizine’ increased 15% from ₩8 billion to ₩9.3 billion in the same period. Monterizine is a combination of montelukast and a third-generation antihistaminic agent ‘levocetirizine.’ It is the only combination drug sold in Korea. ◆ FDA’s ‘black box warning’ and ‘prolonged COVID-19 crisis’ cause combined effect Analysts believe that this was a combined effect from the prolonged COVID-19 and FDA’s side effect warning. The FDA required a ‘Black box warning’ on montelukast products in March 2020. The black box warning is the FDA's most stringent warning for drugs and medical devices in the market. In particular, the FDA strongly advised health care providers to avoid prescribing montelukast to patients with mild allergic rhinitis, as it is the FDA’s judgment that the risk outweighs the benefits for mild patients. According to the FDA, serious adverse reactions, including suicide, have been reported with the use of Singulair since 2008. Some of these side effects occurred while the patients were treated with montelukast and disappeared after discontinuing the drug. The prolonged COVID-19 incidence had also reduced the prescriptions. The pediatric clinics have been one of the areas most affected by the COVID-19 crisis. Since most patients with allergic rhinitis and asthma are children and adolescents, the prolonged COVID-19 crisis has aggravated the reduction in prescriptions of montelukast. ◆MFDS orders NDPA impurity tests…rises as a ‘new variable’ in market The industry has also been paying attention to the impurity issue that had arisen recently. The Ministry of Food and Drug Safety had recently ordered pharmaceutical companies to conduct an investigation into their montelukast ingredient and finished products for impurities and submit the reports by April 25th. This precautionary measure was issued after the ministry received safety information that N- nitrosodipropylamine (NDPA) was detected in the API montelukast. The NDPA is a new nitrosamine impurity that has been identified. Since 2018, two types of nitrosamine impurities, - ‘N-nitrosodimethylamine (NDMA)’ and ‘N-nitrosodiethylamine (NDEA)’ were detected in valsartan, ranitidine, and nizatidine. The MFDS predicts that NDPA occurred in the API manufacturing process of montelukast. Contrasting opinions have been produced on how the impurity concern may affect prescriptions in the field. Those who believe that impurity will not affect the market are focusing on the fact that such impurity issues have risen every year. After the valsartan incident in 2018, impurities were consecutively detected in ranitidine, nizatidine, metformin, losartan, varenicline, etc., building resistance among frontline clinics and hospitals regarding the issue. The government had also initially suspended the sale of all items, but recently ordered only specific lot numbers to be recalled. Others who have opposing views argue that it is too soon to predict that the impurity concern will not be significant, given that the montelukast are mainly prescribed to children and adolescents, unlike other items.
- Policy
- The MOHW has won the original drug price lawsuit
- by Lee, Jeong-Hwan Jan 25, 2022 05:55am
- The government won all dozens of lawsuits to cancel drug prices due to the expiration of original drug patents, but no civil lawsuits have been filed to get back drug benefits paid during the suspension period. The government says it is practically impossible to file a civil suit against individual pharmaceutical companies against dozens of drug price reduction lawsuits and get back the loss of health insurance finances. In response, the pharmaceutical community is confronting the need for the government to dispute in court over the feasibility of the redemption through a separate civil suit, rather than enacting the retroactive redemption of drug benefits already paid under the drug price reduction refund bill. On the 24th, the MOHW and the pharmaceutical industry disagree over some amendments to the National Health Insurance Act, which includes provisions for the return and refund of drug prices. Of a total of 64 lawsuits from 2011 to last year, a total of 20 lawsuits were filed to cancel drug prices due to the first generic registration after the expiration of the original patent. The MOHW was recognized by the court that the disposition of drug price reduction was valid without losing 20 original drug price reduction lawsuits. The MOHW did not file a civil lawsuit for redemption to receive the drug benefits paid within the suspension period after winning the case. The MOHW believes that recovering drug benefits through additional lawsuits is not a solution to preserve fundamental health finances, and that it is reasonable to stipulate the regression and refund provisions of drug prices as legislation. The MOHW said, "It is difficult to apply it in practice to file a civil lawsuit." The MOHW said, "It is inefficient and virtually impossible to file multiple civil lawsuits against each pharmaceutical company for each dozens of drug lawsuits." The MOHW said, "Excessive administrative power consumption, litigation costs are triggered, and the government has a burden of causing additional judicial disputes over cases that have already been filed," and added, "It is reasonable to clearly define health insurance losses by law to prevent waste of cost and administrative and cost." Some in the pharmaceutical industry say that the MOHW needs to file a separate civil suit for redemption rather than legalizing refunds according to the results of the administrative dispute over drug prices. The judiciary's decision to suspend the execution of drug cuts applied by pharmaceutical companies should be recognized separately from the original ruling, and whether or not drug benefits already paid can be redeemed retroactively due to winning the original bill should be judged again by the court. A pharmaceutical company's pharmaceutical manager said, "The decision to suspend execution is the authority of the judiciary, and the MOHW, the executive branch, should not affect that authority. If the drug price reduction refund bill is implemented, the court's decision to suspend execution itself could become meaningless." In particular, the judiciary has not determined whether the MOHW has the authority to recover drug benefits paid to pharmaceutical companies during the suspension period in line with the results of the lawsuit on the merits. The bill to redeem drug prices is feared to cause excessive damage to the pharmaceutical industry,"he added.
- Company
- United to complete P2T enrollment for its inhaled Covid drug
- by Lee, Seok-Jun Jan 25, 2022 05:55am
- Korea United Pharm will complete patient enrollment of its Phase II trial for the world’s first inhaled COVID-19 treatment ‘Corobin Activair (budesonide+ arformoterol).’ According to the company on the 24th, Korea United Pharm had been enrolling patients for its trial at specialized COVID-19 hospitals in Seoul to assess the safety and efficacy of Corobin Activair in patients with moderate-to-severe COVID-19 since last year. Korea United Pharm aims to receive conditional approval for its drug within the first half of this year after demonstrating its efficacy and safety in the Phase II trial. The company had completed manufacturing investigational Corobin Activair for the clinical trial last year. Its Sejong plant 2 is equipped with cGMP manufacturing facilities that can produce several million courses of Corobin Activair per year according to domestic and global demand immediately upon approval. A company official said, “With the COVID-19 virus continuing to prevail around the globe with variants such as the Omicron variant, Korea United Pharm will work with various institutions and focus all its capabilities on developing the world's first inhaled COVID-19 treatment.”
- Policy
- MFDS has completed verification of the efficacy of Retevmo
- by Lee, Tak-Sun Jan 25, 2022 05:55am
- The RET (Rearranged during transfection)) gene target anticancer drug developed by Lilly seems to be at the end of the domestic approval process. It is a drug called Retevmo (Selpercatinib), which began licensing last year, and safety and efficiency evaluation have recently been completed and is about to be approved. According to the pharmaceutical industry on the 21st, Retevmo's safety and efficiency evaluation by Lilly applied for permission, has recently ended. Analysts say that the end of safety and efficiency evaluation has further increased the possibility of product approval. In the case of new drugs, the MFDS will conduct GMP review to check safety, effectiveness, product quality, and compliance with manufacturing process standards through analysis of result data such as clinical trials to determine final product approval. The termination of safety and efficiency evaluation, which verifies drug efficacy, is interpreted as meaning that it is almost done. Retevmo is highly likely to obtain a domestic product license in that it has already received approval from the U.S. FDA based on multinational clinical trials such as data on safety and efficiency evaluation by the MFDS. At the time of FDA approval in May 2020, the drug was approved for use in adult patients with metastatic RET fusion-positive non-small cell cancer, medullary thyroid carcinoma over the age of 12, and Radioiodine-Refractory Thyroid Cancer. The RET gene is a phosphate enzyme that can cause cancer and is known to promote the proliferation of cancer cells when mutated or combined with other genes. About 2% of non-small cell carcinoma patients are found to have RET gene mutations. As RET gene mutations are also found in various carcinomas, Lilly is conducting an expanded study on Retevmo's indications. Retevmo was also designated as a rare drug in Korea by the MFDS in February last year. In addition to Retevmo, Roche's Gavreto (Pralsetinib) targeting the RET gene is also being introduced in Korea. In addition, among domestic pharmaceutical companies, HK inno.N introduced the RET target anticancer drug "VRN061782" from Voronoi in February last year and began commercialization development.
- Company
- Hanmi & Celltrion are producing generic COVID tx
- by Chon, Seung-Hyun Jan 25, 2022 05:55am
- Hanmi and Celltrion produce oral COVID-19 treatments developed by MSD and supply them to underdeveloped countries. According to the industry on the 20th, Hanmi and Celltrion have completed a license-in contract with the MPP for the production of generic drugs for Molnupiravir (Lagevrio) treatment for COVID-19. The license contract is based on the granting of a non-exclusive license by MSD, the original developer of "Molnupiravir," that allows the sale of mid- to low-income countries through MPP, an international institution, to expand access to COVID-19 treatments. A number of pharmaceutical companies around the world submitted letters of intent to select licensees, and only 27 companies were given licenses. Hanmi Pharmaceutical and Celltrion will receive know-how in manufacturing Largevrio from Merck, and patent fees will be exempted until the WHO declares the end of the pandemic. Among domestic companies, DongbangFTL, a raw material company, was also selected. Under this contract, Hanmi Fine Chemical, a raw material drug company of Hanmi Pharmaceutical Group, will start producing raw materials for Largevrio. The produced raw materials will be transferred to Hanmi Pharmaceutical's smart plant located in Paltan, Gyeonggi-do, and put into the production of finished drugs. In the case of Celltrion, the development and production of Molnupiravir generic finished products will be handled by its affiliate Celltrion Pharmaceutical and supplied overseas by Celltrion. Celltrion Pharmaceutical has launched a formulation study with the aim of completing product development by the end of this year. Celltrion and Hanmi Pharmaceutical plan to produce generic for Largevrio and supply and sell them to some of the 105 underdeveloped countries. MPP is a UN-supported non-profit medical organization that signed an agreement with MSD in October last year on the provision of patent licenses for Molnupiravir. The contract between Hanmi Pharmaceutical and MPP was made in a surprise move in line with the aim of adding strength to the world's efforts to end COVID-19 by greatly increasing accessibility to underdeveloped countries. Largevrio is RNA analog and is a drug that is inserted instead of normal ribonucleic acid necessary for the virus replication process to induce virus death. Largevrio received EUA in the UK in November last year and was approved in the United States in December last year to administer it to patients who were unable to use "other approved COVID-19 treatments." Currently, the screening is being conducted in Korea. The "COVID-19 Treatment/Vaccine Development Pan-Government Support Committee" under the MOHW began behind-the-scenes support for the selection of Korean pharmaceutical companies by conducting prior consultations with MPP for the domestic production of oral COVID-19 treatments since November last year. In this regard, the government said it plans to continue to support the domestic production and global expansion of oral COVID treatments through corporate meetings. An official from Hanmi Pharmaceutical said, "Hanmi's decision has begun to end the COVID-19 pandemic." He said, "We will do our best to start production as soon as possible in close consultation with MPP and MSD and quickly supply high-quality medicines to the world based on Korea and the United States' excellent drug manufacturing technology and production capabilities." An official from Celltrion Group said, "Through this license acquisition process, we were able to reaffirm that Celltrion Group's chemical drug production capacity and technology met global demand and standards, and at the same time were competitive."
- Company
- Sales of SGLT-2 diabetes drugs surpassed 150 billion won
- by Ji Yong Jun Jan 24, 2022 05:56am
- Sales of SGLT-2 inhibitor-based diabetes treatments exceeded 150 billion won for the first time last year. The SGLT-2 inhibitor market, including Forxiga and Jardiance, continues to grow at double digits every year. ◆ Sales of SGLT-2 inhibitors have increased five times in the past five years According to UBIST, a pharmaceutical market research firm on the 21st, the total amount of outpatient prescriptions for SGLT-2 inhibitors last year was 150.1 billion won, up 17.2% from the previous year. Sales of SGLT-2 inhibitors in Korea, which amounted to 28.6 billion won in 2016, have more than tripled in the past five years. The market size of SGLT-2 inhibitors has grown year by year. It rose from 50.1 billion won in 2017 to 70.3 billion won (40%) in 2018, followed by 96.9 billion won (37.8%) in 2019. The following year, it achieved 127.9 billion won (32%) in 2020. This growth is expected to continue for the time being. Both Forxiga and Jardiance, SGLT-2 inhibitors, are likely to increase their prescription performance in the future as their indications expand to patients with full heart failure in addition to diabetes treatment. SGLT-2 plays a role in reabsorbing glucose from urine into blood. SGLT-2 inhibitors are mechanisms that inhibit this reabsorption action to prevent glucose from entering the bloodstream and release it into urine. ◆SGLT-2 inhibitors such as Forxiga and Jardiance lead the growth The leading items in the domestic SGLT-2 inhibitor market are AstraZeneca's Forxiga and Jardiance. Last year, Sales of AstraZeneca's Forxiga and Xigduo recorded 79.5 billion won. The domestic market share alone is 52.9%. By product, Forxiga's outpatient prescription amount was 42.6 billion won, up 12% from the previous year. During the same period, Xigduo recorded 36.9 billion won, up 21.3%. It is analyzed that AstraZeneca got the preemptive effect when it first introduced Forxiga in Korea in 2014. The joint sale with domestic companies from the beginning of entering the market is also believed to have affected the increase in performance. AstraZeneca started co-selling with CJ Healthcare (currently HK inno.N) from the beginning of its launch. Since March 2018, it has been jointly selling with Daewoong Pharmaceutical. Jardiance and Jardiance Duo of Beringer Ingelheim and Lilly are closely chasing Forxiga. Last year, Jardiance achieved 40.9 billion won in outpatient prescription performance, up 10.8%. During the same period, Jardiance Duo also rose 46.7% to 24.5 billion won. The performance of these two items is 65.3 billion won, with 43.5% market share. Jardiance was released in 2016, two years later than Forxiga in the domestic SGLT-2 inhibitor market. Although it is generic, it is evaluated that it is acting as a positive factor in expanding prescription performance by proving the effect of reducing cardiovascular mortality through clinical trials. Astellas' Suglat and MSD's Steglatro's prescription performance was poor. Suglat's outpatient prescription amount stood at 3.5 billion won last year, similar to the previous year. Suglat has been in charge of distribution, marketing, and sales since April 2018. At that time, a synergy effect was expected when Handok, which had diabetes treatments such as Tenelia, introduced Suglat, but its performance was not good. MSD's Steglatro rather reduced prescription performance. Last year, Steglatro's outpatient prescriptions fell 21.8% from the previous year.
- Two points to note in Kymriah’s reimbursement process
- by Eo, Yun-Ho Jan 24, 2022 05:56am
- The era where a single shot can cure one’s cancer may be imminent, but with a catch: The single-shot would cost ₩500 million. Novartis’s novel CAR-T therapy ‘Kymriah (tisagenlecleucel)’ cleared all the steps necessary for reimbursement under the Health Insurance Review and Assessment Service by receiving approval on its adequacy of reimbursement at the ‘1st Drug Reimbursement Evaluation Committee meeting’ on the 13th this month. Although another hurdle -the drug price negotiation process with the National Health Insurance Service - still remains, Kymriah’s passing of the DREC review was in itself an encouraging event. The case is also notable in terms of its speed in review and reimbursement criteria. ◆10 months after MFDS review…Result of ‘longing’ and need Kymirah’s insurance reimbursement listing process was in itself a hot issue. In its every step from reimbursement application, HIRA’s Cancer Disease Deliberation Committee review, to DREC review, the issue caught the attention of the industry, patients, and the media. The drug started its reimbursement listing process under the approval-reimbursement evaluation linkage system in March last year after receiving MFDS approval. 6 months later, the agenda was put up for deliberation by the CDDC but deferred. As soon as the results were released through the media, the Korean Alliance of Patient Organizations among others issued a statement condemning the government and the pharmaceutical company. The patient association had before criticized the delay in CDDC review of Kymriah’s reimbursement. Kymriah finally passed the CDDC review in October of the same year. This was also the first day HIRA disclosed CDDC results. And then, Kymriah passed review at the first DREC meeting held in 2022. Statements from KAPO and other associations had poured out at the news of Kymirah’s agenda being deliberated at the DREC meeting. Another drug that received good news on the same day with Kymriah was MSD’s immunotherapy drug ‘Keytruda (pembrolizumab),’ which awaited 5 years (to extend its reimbursement to first-line in non-small-cell lung cancer). For patients in dire need, even the 10 months spent waiting for Kymirah would have been too long. However, considering the average time spent on listing innovative new drugs in Korea and even taking into account the disease and number of patients that benefit from the two drugs, Kymriah’s reimbursement progressed quickly. This progress is highly likely due to a combination of the patients’ ‘desperate longing’ and execution ability. The government would have felt some burden. In addition, Novartis Korea’s efforts in presenting a fiscal-sharing plan through the persuasion of its headquarters are also expected to have played a part. ◆Pediatric B-ALL indication is excluded from being applied the performance-based restriction Also, it is notable that the reimbursement standard set by DREC for B-Acute Lymphoblastic leukemia (B-ALL) is relatively lenient among Kymriah’s 2 indications. Kymriah’s indication is for the treatment of ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse. Kymriah, which is going through the reimbursement listing process through the pharmacoeconomic evaluation exemption system, is applied the expenditure cap type of Risk Sharing Agreement (RSA) scheme. As it is an ultra-high-priced new drug, the prevailing industry assumption was that additional restrictions would be set for its reimbursement in addition to the expenditure cap. This is in line with the government’s plan to converge performance-based type and the expenditure cap type of RSA as an alternative necessary for expanding coverage of high-priced new drugs. As expected, the performance-based type was additionally applied to the DLBLC. indication. The performance-based type limits reimbursement of drug expenditures according to treatment effectiveness after administration. However, no other options were set to restrict reimbursement of Kymriah other than the expenditure cap for the B-ALL indication. Although limited to B-ALL, this could be seen as the government’s allowance of a freer administration of Kymriah in the disease. In such various aspects, Kymriah’s every step of the reimbursement progress is receiving attention Whether the effective but expensive Kymriah can push through the remaining processes and get its name on the reimbursement list remains to be seen.
- Company
- BI-Boryung concludes copromotion deal for NOAC ‘Pradaxa’
- by Kim, Jin-Gu Jan 24, 2022 05:56am
- Boehringer Ingelheim and Boryung Pharmaceuticals have concluded its co-promotion deal for Boehringer Ingelheim’s non-vitamin K antagonist oral anticoagulant (NOAC) therapy ‘Pradaxa (dabigatran).’ Boehringer Ingelheim plans to directly sell Pradaxa starting this year. According to industry sources on the 21st, Boehringer Ingelheim and Boryung Pharmaceuticals concluded their co-promotion deal for Pradaxa at the end of last year. Rather than find a new partner company to sell its product, Boehringer Ingelheim decided to sell Pradaxa directly. An official from Boehringer Ingelheim said, “The two companies agreed to terminate the copromotion deal at the end of last year. The company will be directly selling the product starting this year.” Pradaxa is a dabigatran NOAC anticoagulant that received attention for having a better effect in preventing blood clots with fewer bleeding side effects compared to the anticoagulant warfarin. Pradaxa has started replacing warfarin in the early 2010s, increasing its influence in the prescription field. Boehringer Ingelheim received approval for the drug in Korea in 2011 and released the drug the next year. A the time of release, the company joined forces with Yuhan Corp for its sale, Boehringer Ingelheim taking charge of hospital-level institutions, and Yuhan of private clinics. Then for 4 years from 2018 to the previous year, Boehringer Ingelheim worked with Boryung Pharmaceuticals for the copromotion of Pradaxa. However, the drug’s sales performance was less impressive than its competitors in the Korean market. Compared to Daiichi Sankyo’s ‘Lixiana,’ Bayer’s ‘Xarelto,’ BMS’s ‘Eliquis’ that grossed ₩50-₩60 billion per year in outpatient prescriptions, Pradaxa made less than ₩15 billion. Also, the drug’s substance patent expired in July last year. Intro Biopharma, Aju Pharm, Jinyang Pharm, and Huons had invalidated Pradaxa’s salt and composition patent and was granted generic exclusivity.
- Company
- The growth rate of the DPP-4i market increased slightly
- by Ji Yong Jun Jan 24, 2022 05:55am
- The domestic DPP-4i diabetes treatment market, which is formed at 600 billion won a year, slowed down last year. It recorded the lowest growth rate in the last seven years. In the DPP-4 inhibitor market, where growth has slowed, the position of domestic companies has also expanded significantly. Rx sales for foreign company products fell. ◆DPP-4 inhibitor, growth rate of 1% in 7 years According to UBIST, a pharmaceutical market research firm, on the 19th, the total market for DPP-4 inhibitors last year was 611.3 billion won, up 1.3% from a year earlier. The growth rate of the DPP-4 inhibitor market is the lowest since 2014. In the past seven years, the market for DPP-4 inhibitors has grown rapidly. It increased 21.5% from 299.5 billion won in 2014 to 363.9 billion won in 2015. Since then, it has surpassed 600 billion won for the first time, recording 437.6 billion won in 2016, 468.6 billion won in 2017, 502.3 billion won (7.1%) in 2018, 569.1 billion won (13.2%) in 2019, and 602.9 billion won (5.9%) in 2020. Since MSD's Januvia was released in 2007, it has become a trend by replacing existing diabetes drugs. Since then, nine active ingredients have been released in the DPP-4 inhibitor market and are fiercely competing. ◆LG Chem, Dong-A ST, and Handok's expansion of influence in the DPP-4i market It was confirmed that domestic companies made strides in the DPP-4i market last year. The prescription amount of all three domestic pharmaceutical companies, LG Chem, Dong-A ST, and Handok, has increased. LG Chem's three types of Zemiglo prescriptions, Zemiglo, Zemimet, and Zemiro, totaled 130.3 billion won, up 8.8% from the previous year. The market share also expanded 2.1%p from 19.2% in 2020 to 21.3% last year. Despite the slowing growth of Zemiglo , the combination drug has expanded its influence. Zemiglo's prescription amount last year was 38.9 billion won, up 2.6% from the previous year. Sales of Zemimet reached 90.8 billion won over the same period, up 11.6% from the previous year. Dong-A ST's self-developed new drug Suganon series also saw its prescription amount rise. Last year, the total amount of prescriptions, including Suganon and Sugamet, surpassed 30 billion won for the first time with 32.6 billion won. The market share was 5.3%, an increase of 1.3%p from the previous year. Suganon's outpatient prescriptions last year amounted to 13 billion won, up 23.51% from a year earlier. During the same period, Sugamet also increased 39.72% to 19.6 billion won. Handok's Tenelia series recorded 46.2 billion won in prescriptions last year. Tenelia's prescription amount was 21.4 billion won, up 83% from the previous year. During the same period, Tenelia M (Tenerigliptin + Metformin) increased by 9% to 24.8 billion won. ◆ Multinational corporation DPP-4 inhibitor, slowing prescription performance The prescription performance of items from multinational companies has fallen. Last year, the total amount of prescriptions for the MSD Januvia products was 171 billion won, down 2.9% from a year earlier. Among the Januvia products, the decrease in prescriptions for Januvia was the largest at 5.8%. Sales of Janumet fell 3.8% from the previous year to 76.2 billion won, while Janumet XR's sales rose 1.8% to 50.4 billion won. Sales of the Trajenta prodcuts also slowed down. It decreased by 1.5% from 61.6 billion won to 60.7 billion won. Trajenta Duo's sales recorded 65.5 billion won, down 2.6%. Sales of Novartis' Galvus products decreased by 0.8% from 47 billion won to 46.6 billion won, and Sales of Takeda's Nesina fell 3.7% from 32.1 billion won to 30.9 billion won. In 2020, Takeda sold its rights to Celltrion in the Asia-Pacific region of 18 Rx drugs and OTC drugs. It was found that Nesina's transfer process has not yet been completed. Sales of AstraZeneca's Onglyza and Kombiglyze also fell 1.2% from 27.6 billion won in 2020 to 27.3 billion won last year.
- Policy
- Xeloda in breast cancer patients is also reimbursed
- by Lee, Hye-Kyung Jan 24, 2022 05:55am
- The stage and target of administration of Roche Korea's breast cancer treatment Xeloda (Capecitabine) and Korean Pfizer's acute lymphocyte leukemia treatment Besponsa (Inotuzumab Ozogamicin) will be changed. With the establishment of a new chemotherapy benefit standard that has deleted the classification of anticancer drugs in the first and second groups, six new items, eight changes, and eight deletion items will be made in the case of urological cancer-related anticancer drug benefit standards The HIRA announced on the 18th that it will disclose the "Amendment of Announcement (proposal) according to drugs prescribed and administered to cancer patients" and conduct an opinion inquiry until the 24th. According to the revision to the announcement, on June 1, Xeloda, which "single therapy first or higher, formal chemotherapy" was changed to "second or higher" in consideration of permission and current benefit status, requested the re-establishment of the benefit standard. Xeloda is a drug licensed as a local progressive or metastatic breast cancer treatment without an anthracycline treatment plan as a result of the HIRA review that failed both chemotherapy and 'Anthracycline' drugs, and there were no authorized countries related to the first use of the administration phase. However, the textbook mentions the advantages as an oral drug and minimization of hair loss, and the NCCN guideline recommends [I,A] (consensus 71%) when prioritizing avoiding hair loss in the 'preferred category 2A' and ESMO guidelines regardless of order. The HIRA was judged as a necessary drug for treatment at the clinical site, and the administration stage and subjects of administration were changed to patients with primary metastasis and recurrent breast cancer. Besponsa is a drug licensed under the treatment of recurrent or refractory precursor B-cell acute lymphocytic leukemia (ALL) adult patients with 'the patient with relapse or refractory precursor B-cell acute lymphocytic leukemia should have failed at least one tyrosine kinase inhibitor (TKI). The NCCN guidelines recommend category 2A for Philadelphia chromosome-positive recurrence or refractory B-cell acute lymphocyte leukemia, and the HIRA also judged it as a necessary drug for treatment and provided induction therapy (500) for "philadelphia chromosome-positive recurrence or refractory precursor B-cell acute lymphocyte." Considering that Besponsa's permission from the MFDS states that the recommended administration period is 2 cycles for patients performing hematopoietic stem cell transplantation (HSCT), CR or CRi after remission induction therapy, and an additional 1 cycle will be paid 30/100. The HIRA reorganized the standards for "details on the application standards and methods of medical care benefits for drugs prescribed and administered to cancer patients" related to urinary cancer. Since last year, the HIRA has been setting up a new anti-cancer treatment benefit standard that deleted the classification of anticancer drugs in the first and second divisions after preparing a standard (draft) in related fields and collecting opinions from related societies. When the anti-cancer drug benefit standard was enacted in 2006, drugs subject to retrial, rare drugs, or abuse were classified as second-tier anticancer drugs and used within the scope of each drug's benefit standard, and clinicians were required to properly judge and administer them. A total of 21 items were revised, including 6 new items (6 therapy), 8 changed items (26 therapy), and 8 deleted items (22 therapy). According to the specific changes by cancer type, 1 kidney cancer, 1 change (10 therapy), 2 delete (10 therapy), 5 urinary epithelial cancer (6 therapy), 3 change (10 therapy), 4 delete (3 therapy), 4 prostate cancer change (6 therapy), and 2 delete (9 therapy) were carried out
