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- 2025-12-23 11:35:37
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- The DPP4i+SGLT2i diabetes combination drug market
- by Kim, Jin-Gu Oct 23, 2023 05:14am
- Qtern>Zemidapa> Esgliteo, Sugadapa product photo (clockwise from top left) The market for diabetes two-drug combination drugs that combine DPP-4 inhibitors and SGLT-2 inhibitors appears to be growing slowly despite the expansion of combination benefits at the beginning of the year. Since last May, two-ingredient combination drugs have appeared on the market one after another, but the cumulative prescriptions for related products in the five months until last September amounted to only 3.6 billion won. The pharmaceutical industry is paying attention to the possibility that the market will expand, focusing on generic drugs, as the combination drug of dapagliflozin + sitagliptin has been released since the Januvia patent expired in September. The cumulative prescription amount for 5 months: Qtern 1.1 billion won > Zemidapa 1 billion won > Esgliteo 800 million won. According to UBIST, a pharmaceutical market research firm, on the 23rd, the cumulative prescription amount for the two-drug combination of DPP-4 inhibitor and SGLT-2 inhibitor is 3.6 billion won. This market was formed last May with the launch of LG Chemical's Zemidapa, AstraZeneca's Qtern, Boehringer Ingelheim's Esgliteo, MSD's Stegluzan, and Chong Kun Dang's Exiglu-S. In June, Donga ST Sugadapa joined. These are all companies that possess original drugs in the DPP-4 inhibitor series. They began releasing related products last April when the health authorities expanded the combination coverage of diabetes treatments to the 'DPP-4 inhibitor + SGLT-2 inhibitor + Metformin' triple therapy. At that time, the patent for Forxiga, an SGLT-2 inhibitor type diabetes treatment, expired. They developed and released a combination drug by combining their original DPP-4 inhibitor drug with Dapagliflozin or their own SLGT-2 inhibitor drug. In the case of Chong Kun Dang, as it was about to acquire the domestic distribution rights to Januvia from MSD, it was able to release a combination drug of sitagliptin and Dapagliflozin before Januvia's patent expired. Despite the expansion of concurrent benefits, the related market appears to be growing slowly. By month, it is 300 million won in May, 400 million won in June, 600 million won in July, 900 million won in August, and 1.3 billion won in September. Based on the cumulative prescription amount, AstraZeneca Qtern is the highest at 1.1 billion won, followed by LG Chem's Zemidapa (1 billion won), Boehringer Ingelheim's Esgliteo ( 800 million won), Chong Kun Dang's 'Exiglu-S' ( 300 million won), and Dong-A ST's Sugadapa (200 million won ), etc. After Januvia’s patent expires in September, generics enter the market… Will there be a turnaround after the fourth quarter? In the pharmaceutical industry, as DPP-4 inhibitors and SGLT-2 inhibitors have shown high prescription performance in the existing diabetes treatment market, predictions have been raised that combination drugs combining the two ingredients will also rapidly expand the market size. Looking only at prescription performance through the third quarter, it is evaluated that the performance is somewhat below expectations. In fact, the prescription performance of dapagliflozin expanded very rapidly during this period. In the case of dapagliflozin single drug, prescription sales amounted to 20.5 billion won in the third quarter of this year. Compared to the third quarter of last year, it increased by 47% in one year. The price of the Dapagliflozin + Metformin combination increased by 31% from 11.7 billion won to 15.3 billion won during the same period. The key is the prescription performance after the fourth quarter when many combination drugs of dapagliflozin and sitagliptin will be released. This is because, with the expiration of Januvia's patent last month, combination drugs combining the two ingredients are entering the market one after another. According to the Ministry of Food and Drug Safety, to date, 89 pharmaceutical companies have received approval for two-ingredient combination drugs. Among these, 14 pharmaceutical companies released products last September, excluding Chong Kun Dang, which holds the distribution rights to Januvia. Many of the remaining 80 pharmaceutical companies are expected to release products after the fourth quarter.
- Company
- LG Chem-BR Pharm signs MOU for HP Vitaran in CHN
- by Lee, Seok-Jun Oct 20, 2023 05:31am
- On the 19th, LG Chem announced it had signed a Memorandum of understanding (MOU) with BR Pharm, a regenerative medicine technology research and manufacturing company, for the development and approval of its PN (polynucleotide) skin booster 'HP Vitaran' in China. BR Pharm's 'Vitaran', which LG Chem introduced to the Korean market in September this year, is a PN skin booster medical device created from purified DNA extracted from the reproductive cells of salmon fish. PN suppresses cytokines that cause skin inflammation and promotes skin tissue regeneration by proliferating fibroblasts. In a clinical trial for 'Vitaran Eye' that involved 250 Koreans, the treatment significantly improved the wrinkles around the corners of the eyes. Hye-ja Kim, Vice President of LG Chem (head of the aesthetics division), said, "We are focusing on expanding market influence through direct sales in China. For this, we have established an aesthetics sales corporation in China in 2021. We seek to create differentiated customer value in China’s aesthetics market through this reinforced partnership with BR Pharm.” Seok-Sun Kim, CEO of BR Pharm, said, “We will accelerate our entry into the Chinese market based on the synergy between the company’s manufacturing competitiveness and LG Chem’s Chinese aesthetic business capabilities.”
- Company
- Gilead’s TNBC drug Trodelvy is released in KOR
- by Son, Hyung-Min Oct 20, 2023 05:31am
- Gilead Sciences Korea announced on the 18th that it has launched its metastatic triple-negative breast cancer drug ‘Trodelvy (sacituzumab govitecan)’ in Korea. Until now, Trodelvy has been supplied through the Korea Orphan & Essential Drug Center, but from the 18th, Gilead will supply it domestically, and patients will be able to use it with prescriptions at hospitals. Trodelvy, a Trop-2 targeting antibody-drug conjugate (ADC), consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and a TOP1 inhibitor payload ‘SN-38’ that destroys cancer cells. By targeting only Trop-2, which is highly expressed in various types of cancers, including more than 85% of breast cancers, the cytotoxic drug is delivered with minimal impact on normal cells. Trodelvy was approved by the Ministry of Food and Drug Safety in May for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Excluding cytotoxic anticancer drugs, Trodelvy is the only treatment approved by the MFDS for the entire patient population, regardless of genetic mutation or biomarker, as a second-line or higher treatment for patients with mTNBC. The National Comprehensive Cancer Network (NCCN) breast cancer treatment guidelines recommend Trodelvy as Category 1 for the second-line or higher lines of treatment of adult patients with metastatic triple-negative breast cancer. Jae-yeon Choi, General Manager of Gilead Sciences Korea, said, “We are pleased to provide Trodelvy, which has been shown to significantly improve survival in patients with metastatic triple-negative breast cancer, as a new treatment option for those who have been long waiting for an innovative treatment option. We will continue to protect the daily lives of our cancer patients in Korea, including those with triple-negative breast cancer, and strive to not only supply innovative treatments but to also increase disease awareness and improve the treatment environment.” Triple-negative breast cancer is a subtype of breast cancer that is clinically negative for the expression of estrogen and progesterone receptors (ER/PR) and HER2. It is known to be the most aggressive among breast cancers. It also has a poor prognosis due to its high risk of metastasis and recurrence compared to other subtypes and high risk of metastasis to the brain (30%) or lungs (40%). Its five-year survival rate is only 12%, compared to the 30% in other breast cancer types.
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- War between the U.S. and Russia spreads Middle East risk
- by Kim, Jin-Gu Oct 19, 2023 05:29am
- Amid bloody conflicts continuing around the world, it was found that there was no direct impact on pharmaceutical export performance. The analysis is that this is because the proportion of pharmaceutical exports to countries in conflict is very small in the first place. However, it is predicted that if the conflict spreads to nearby areas due to the worsening local situation, it will have a significant impact on pharmaceutical exports. The share of pharmaceutical exports to Russia and Ukraine is around 0.8%. According to the Korea Customs Service on the 18th, pharmaceutical exports to Russia and Ukraine as of the third quarter of this year amounted to $33.22 million (about 44.9 billion won). It decreased by 16.1% compared to the same period last year. Last year, $39.61 million was exported through the third quarter. Although the decrease is relatively large, it is analyzed that it did not have a significant impact on Korea's overall pharmaceutical export performance. This is because the two countries account for a very small proportion of the total pharmaceutical export performance in the first place. Total cumulative pharmaceutical exports in the third quarter amounted to $4,255.12 million. Among these, Russia and Ukraine account for only 0.8%. Russia is 0.6% and Ukraine is 0.2%. The share of pharmaceutical exports to these two countries has consistently remained below 1%. The decline in vaccine exports to Australia and Taiwan took a direct hit rather than the Russo-U.S. war. By the third quarter, Korea's total pharmaceutical export amount was $4,255.12 million, a 13.8% decrease from $4,936.4 million in the same period last year. Analysis also suggests that it is difficult to interpret this as a direct effect of the war between Russia and Ukraine. The decline in overall pharmaceutical exports this year is largely due to the sharp decline in the supply of coronavirus vaccines to Australia and Taiwan. In fact, by the third quarter, exports to Australia had decreased by 92.7% from $428.99 million last year to 31.1 billion won this year. In the case of Taiwan, it decreased by 83.3% from $301.04 million to $5.03 million during the same period. In the case of Australia, it accounted for 8.7% of total exports until the third quarter of last year, but this year it shrunk to 0.7%. Last year, it had the fourth largest export volume after the United States, Germany, and the Turkic Republic, but this year it fell to 16th place. The proportion of exports to Taiwan also decreased from 6.1% to 1.2%. In 2021 and 2022, the Moderna vaccine produced on consignment by Samsung BioLogics has been exported to Australia as a vaccine. 10% of exports to the Middle East... Watch to see if the Israeli conflict will spread to nearby areas In this extension, the prevailing view is that the recent Israeli conflict will not have a direct impact on Korea's pharmaceutical exports. This is because pharmaceutical exports to Israel amounted to $3.84 million as of the third quarter of this year or only 0.2% of the total. There is also the prospect that if the conflict spreads to neighboring Middle Eastern countries, it will have a significant impact. As of the third quarter, pharmaceuticals exported from Korea to the Middle East totaled $408.98 million, accounting for about 9.6% of the total. Among these, Turkiye accounts for the majority (71.4%) with $291.92 million, and Saudi Arabia, Jordan, the United Arab Emirates, Egypt, and Iraq also account for a significant portion, at around $20 million.
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- Korean new drug cash cows bring in KRW 100 bil in 3 quarters
- by Chon, Seung-Hyun Oct 19, 2023 05:29am
- Domestically developed drugs are continuing to show strong performance in high ranks in Korea’s outpatient prescriptions market. Prescriptions of Hanmi Pharm’s combination new drug Rosuzet and HK Inno.N's K-CAB have exceeded KRW 100 billion in just 3 quarters. Daewoong Bio's brain function enhancer Gliatamin also performed well. According to the market research institution UBIST on the 19th, Viatris’s hyperlipidemia treatment, Lipitor, recorded the highest cumulative outpatient prescription amount of KRW 146.8 billion in Q3 this year. Although it decreased by 2.6% compared to the same period last year, it maintained its leading position. Lipitor, which was introduced to the domestic market in 1999, has been in the market for over 20 years. Despite the fierce competition with the entry of around 100 generics after patent expiry, the original Lipitor has been boasting its strong influence over the prescription drug market. Although it continued to exert a strong influence in the prescription drug market despite the entry of its generics after patent expiry, the growth seems to have slowed down recently. Lipitor had posted the most outpatient prescription sales for 5 consecutive years from 2018 to last year. Rosuzet and K-Cap, which were each developed by the domestic companies Hanmi Pharmaceutical and HK InnoN, continued on their high march at the forefront of the market, raising more than KRW 100 billion in just 3 quarters. Rosuzet ranked second overall, recording KRW 130.9 billion in cumulative prescriptions as of last September, a 19.5% increase from the previous year. Rosuzet, which was launched at the end of 2015, is a combination drug for hyperlipidemia consisting of 2 ingredients, rosuvastatin and ezetimibe. Rosuzet is experiencing rapid growth thanks to its market preoccupation strategy and the growing popularity of statin and ezetimibe combination drugs. The preference for the statin/ezetimibe combination drug has been increasing because the combination is excellent for lowering low-density low-protein cholesterol (LDL-C) and cost costs less than taking the two drugs separately. K-CAB's cumulative prescription performance in Q3 was KRW 114.1 billion, up 18.7% from the previous year. K-CAB’s prescription amount in Q3 was KRW 40 billion, up 20.6% YoY. The drug has been recording unceasing growth, rising 88.1% over the past 3 years from KRW 21.3 billion in Q3 2020. K-CAB is continuing to grow rapidly due to its advantages of showing an effect faster than existing proton pump inhibitor (PPI) products and the fact that it can be taken regardless of meal intake. K-CAB’s prescription volume exceeded KRW 100 billion in only the third year since its launch in 2021 and exceeded 100 billion won for 2 consecutive years until last year. This year, it already saved its spot in the ‘KRW 100 billion prescription club’. In addition to being approved for the treatment of erosive and non-erosive gastroesophageal reflux disease, and gastric ulcer, K-CAB acquired 5 additional indications, including as an antibiotic combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcer and/or chronic atrophic gastritis, and as maintenance therapy after treatment of GERD. Initially, the drug was granted reimbursement for the GERD and gastric ulcer indication and was additionally granted reimbursement for the other indications. Therefore, its growth rate is expected to continue only increase further. Among domestically developed new drugs, Daewoong Bio’s brain function enhancer Gliatamin’s prescriptions rose 23.5% YoY to record KRW 115 billion to rank third place. Gliatamin’s influence in the prescription market increased despite the difficulties faced due to narrowed reimbursement standards, controversy over its efficacy, and the order to start negotiations on refunded reimbursement claims amount. Chong Kun Dang Gliatirin, which contains choline alfoscerate, also continued its high march, recording a 12.2% YoY rise in prescription amount. Organon Korea's hyperlipidemia combination drug Atozet also made the top ranks with cumulative prescriptions in Q3 of KRW 74.9 billion, up 11.9% YoY. Atozet is a combination drug that combines atorvastatin and ezetimibe. Starting in 2021, more than 100 domestic companies entered the atorvastatin and ezetimibe markets with their generics, Atozet continued to show a solid rise in sales. The drug is being sold by Chong Kun Dang in Korea.
- Company
- Global 1 trillion won project
- by Kim, Jin-Gu Oct 19, 2023 05:29am
- Domestically developed new drugs in the P-CAB (Potassium-competitive gastric acid secretion inhibitor) series are accelerating their overseas expansion. HK inno.N K-CAB and Daewoong Pharmaceutical Fexuclue both set a global sales goal of 1 trillion won within five years. To this end, K-CAB has obtained product approval in 7 countries. In addition, the company announced expansion into a total of 35 countries, including technology and finished product export contracts. Fexuclue also obtained product approvals in four countries and signed technology and finished product export contracts with a total of 15 countries. According to the pharmaceutical industry on the 19th, Daewoong Pharmaceutical recently received product approval for Fexuclue from Mexican health authorities. As a result, the number of countries for which Fexuclue has obtained product approval has expanded to four countries. Daewoong Pharmaceutical received product approval in the Philippines in November of last year, followed by Ecuador and Chile in February and March of this year. The analysis is that the company is accelerating its overseas expansion in the second year of its domestic launch. Daewoong Pharmaceutical launched Fexuclue in Korea in July last year. Since then, the company has quickly begun targeting overseas markets by submitting product approval applications to a total of 12 countries. Among these, formal approval has been obtained in four countries, and approval is being reviewed in eight countries, including China, Vietnam, Indonesia, Thailand, Saudi Arabia, Brazil, Colombia, and Peru. If adding the countries with which technology and finished product export contracts have been signed, Fexuclue is expected to enter a total of 15 countries. The total contract size is estimated to be more than 700 billion won. Daewoong Pharmaceutical signed a technology export and finished product export contract worth $44.42 million with Mexico's 'Moksha8' in January 2020. In August, a contract worth $72.58 million was signed with Brazil's EMS. In March 2021, a contract worth $339.55 million was signed with China's 'Shanghai Haini Pharmaceutical'. In June of the same year, a development and commercialization license agreement worth $430 million was signed with Neurogastrx in the United States and Canada. However, this contract was terminated in June of this year. Daewoong Pharmaceutical announced that it has begun negotiations with multiple multinational pharmaceutical companies to enter big markets not only in North America but also in Europe and Japan. In addition, a contract was signed with 'Pharma Consulting Group (BIOPAS)' to transfer local licensing and sales rights in four Central and South American countries, and with 'Aghrass Healthcare Limited' to supply Fexuclue to six Middle Eastern countries, including Saudi Arabia, for the next 10 years. contracts were signed respectively. Daewoong Pharmaceutical plans to expand the number of countries applying for Fexuclue approval to 30 countries by 2025. The goal was to enter a total of 100 countries by 2027, including technology and finished product export contracts. Daewoong Pharmaceutical's plan is to achieve global sales of 1 trillion won through this. K-CAB launches products in 7 countries, exports contracts with 35 countries K-CAB, which entered the global market ahead of Fexuclue, also set its global sales target at 1 trillion won. Prior to this, the goal was to enter a total of 100 countries by 2028. The product has already been released in seven countries with product approval. Since April 2022, HK Innoen has released products one after another in China, the Philippines, Indonesia, Singapore, Mongolia, Mexico, and Peru. What is attracting attention is the Chinese market. China is known as the world's largest anti-ulcer drug market. According to IQVIA, a pharmaceutical market research firm, the size of China's anti-ulcer drug market last year amounted to approximately 3.3 trillion won. HK Innoen released a non-sales service under the name ‘泰欣赞’ in April last year. In March of this year, this product was applied for insurance benefits. Product approval has been applied for in Vietnam, Malaysia, and Chile. HK inno.N plans to apply for product approval in three to four additional countries in Central and South America within this year. HK inno.N has signed technology and finished product export contracts with a total of 35 countries, including this one. In October 2015, a technology transfer contract worth a total of $95 million was signed with Chinese pharmaceutical company Luoxin. Then, in February 2019, a contract was signed with Carnot, a Latin American pharmaceutical company, to export finished products to 17 Central and South American countries, including Mexico and Argentina. The total contract size is $84 million. Since September of the same year, contracts have been signed to export finished products to six Southeast Asian countries. In December 2021, a technology transfer agreement in North America was signed with the US pharmaceutical company Braintree. The contract size is $540 million, and phase 3 clinical trials are being conducted locally starting in September 2022. Last year, technology and finished product export contracts continued. In April last year, a contract was signed with Indian pharmaceutical company Dr.Reddy's to supply finished products to India, South Africa, Russia, Kazakhstan, Uzbekistan, Ukraine, and Belarus. In December of the same year, a technology transfer agreement was signed with Eurofarma to enter the Brazilian market. The total contract size is undisclosed.
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- Drug exports reduced by 14%... COVID-19 effect vanished
- by Kim, Jin-Gu Oct 18, 2023 05:48am
- Cumulative pharmaceutical exports in Q3 this year have fallen 13.8% YoY to a record KRW 5.8 trillion. With the global transition to a COVID-19 endemic, exports of COVID-19 vaccines fell sharply, leading to a decline in exports. According to the Korea Customs Service on the 17th, the cumulative pharmaceutical exports in Q3 this year amounted to USD 4.255 billion (about KRW 5.8 trillion). Compared to the USD 4.936 billion exported during the same period last year, the amount decreased by 13.8%. When expanding the period, the amount has been on a decline for 2 consecutive years. In Q3 2021, cumulative total exports recorded USD 5.760 billion. Korea has been enjoying a sales spike during the COVID-19 crisis that arose in 2020. In particular, in 2021 and 2022, the export performance of COVID-19 vaccines sharply increased. The Moderna vaccine produced on consignment by Samsung Biologics achieved high performance as it was exported to countries including Australia and Taiwan. Exports of homegrown domestic vaccines were around USD 173 million by 2020, but the amount tripled in one year to USD 519 million in 2021. In 2022, the amount further increased to USD 941 million. However, after the global COVID-19 pandemic turned into an endemic earlier this year, exports of COVID-19 vaccines also plummeted. In fact, domestic vaccine exports in 1H this year amounted to USD 167 million, down to 1/5 of the USD 778 million it had posted in 2022. Analysis suggests that domestic pharmaceutical export sales are returning to the level in the previous years. When comparing the numbers to Q3 2019, before the COVID-19 outbreak, the amount increased by 60.7% from USD 2.648 billion in 4 years. Additionally, exports of pharmaceuticals other than vaccines have been increasing compared to the same period last year. The same goes for imports as well. During the prolonged COVID-19 crisis, imports with the import of Pfizer and Moderna vaccines, but the amount has also stabilized somewhat this year. Korea's Q3 cumulative pharmaceutical imports increased 1.5 times in 3 years, from USD 4.840 billion in 2019 to USD 5.537 billion in 2020, USD 6.879 billion in 2021, then USD 7.482 billion in 2022. However, in Q3 of this year, it recorded a cumulative USD 7.155 billion, which is a decrease from the same period of the previous year. This year is the first time that cumulative pharmaceutical imports have decreased YoY in Q3.
- Company
- Controversy arises over illegal rebates made by Company A
- by Nho, Byung Chul Oct 17, 2023 05:28am
- The multinational pharmaceutical company A's illegal rebate activities have gone too far and are disrupting competition in relevant markets. According to an anonymous tip on the 15th, Company A has been providing economic benefits to prescribers at large general hospitals to promote drug sales. The same company was investigated by the Fair Trade Commission and the police around 10 years ago, and the Ministry of Food and Drug Safety imposed a fine for related products at the time. Company A owns several global blockbuster products, and although relatively inexpensive latecomer generics have been released for many of their blockbusters, the company’s performance improved by 20% over the past 3 years. Company A's major illegal business activities include providing golf entertainment to prescribing doctors and the use of corporate cards. Regarding this, the informant said, "Implicit rebate sales are rampant under verbal instructions by the CEO. Purchasing groceries at high-end restaurants and illegal card cash-backs are also being allowed." Also, the sales representatives have been providing golf entertainment for doctors. Typically, four players play a round of golf is played together, and its cost ranges from hundreds of thousands of won to well over a million won. According to CP regulations, the entertainment fee per doctor for holding a product briefing session is KRW 100,000, and the same person may not receive entertainment from the same company over 4 times a month. Promotions and souvenirs provided after a product briefing or symposium can be provided for up to KRW 50,000, and meals up to KRW 100,000. Promotional materials that sales and marketing personnel can provide when visiting doctors and pharmacists need to be priced at less than KRW 10,000, retail price.
- Company
- 'Verquvo is effective in high-risk heart failure patients'
- by Son, Hyung-Min Oct 17, 2023 05:28am
- Bayer Korea held a press conference celebrating the reimbursement listing of Verquvo in Korea at the Seoul Conrad Hotel in Yeouido. on the 16th Bayer’s new heart failure drug Verquvo (vericiguat) has been granted reimbursement listing in Korea, showing effect in high-risk patients. Based on the positive clinical results, experts have been claiming that Verquvo should be considered as a second-line treatment option. On the 16th, Bayer Korea held a press conference celebrating the reimbursement listing of Verquvo in Korea at the Seoul Conrad Hotel in Yeouido. Verquvo is an oral soluble Guanylate Cyclase (sGC) stimulator that plays an important role in the signaling pathway. The drug was approved in November 2021 and listed with reimbursement in September this year. Patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) whose left ventricular ejection fraction (LVEF) is less than 45%, and who satisfy specific conditions despite over 4 weeks of standard therapy may use Verquvo in combination with other standard therapies for heart failure. The drug's efficacy was demonstrated through the Phase III VICTORIA trial, which became the basis for its reimbursement listing. The trial enrolled 5,050 adult patients with symptomatic chronic heart failure, 1,132 of whom were Asian patients. Results showed that at a median 10.8 months of follow-up, the risk of death from cardiovascular disease or first hospitalization due to heart failure was around 10% lower than that of the placebo group, and the trial met its primary efficacy endpoint with an annual absolute risk reduction of 4.2%. Also, no significant difference was observed in terms of adverse reactions or serious adverse reactions between Verquvo and placebo. Both drugs also showed similar systolic blood pressure levels. Professor Eung-Ju Kim of the Department of Cardiology of Korea University's Guro Hospital said, “Unlike most clinical trials that exclude patients with reduced renal function, 41% of the patients enrolled in the VICTORIA were seriously ill patients. Even in high-risk patients such as those with an estimated glomerular filtration rate (eGFR) of 15 or higher, Verquvo showed significant clinical benefits. In terms of safety, there was no significant difference from the placebo group.” Kim emphasized, “Another point to note is that the drug secured significant results despite the high proportion of patients that were at high risk.” the prevalence of heart failure on a continuous rise in Korea… Verquvo’s role beomce important Professor Seok-Min Kang of the Department of Cardiology at Severance Hospital With population aging the prevalence of heart failure has also been steadily on the rise. The prevalence of heart failure in the total population increased from 0.77% in 2022 to 2.58% in 2020. Hospitalization rates and overall mortality due to heart failure have also continued to increase. Currently, treatment options such as RAAS inhibitors (angiotensin receptor blockers, beta-blockers, etc.) and SGLT-2 inhibitors that were originally used as a diabetes treatment are available for heart failure, but the risk of recurrence still remains. Major global guidelines, including those issued by the American Heart Association (AHA) and the European Society of Cardiology (ESC), recommend Verquvo’s use in heart failure patients whose symptoms have worsened despite standard therapy. Domestic guidelines recommend its use at a higher level than the ESC, so Verquvo is expected to play a significant role in secondary treatment of heart failure. Professor Seok-Min Kang of the Department of Cardiology at Severance Hospital said, “Patients with chronic heart failure whose symptoms are worsening have a higher risk of hospitalization and death despite standard treatment. “We need treatment options that can lower the death and hospitalization rates from heart failure and also reduce the burden of medical expense. Considering the comorbidities the patients can have such as high blood pressure and chronic kidney disease, Verquvo, which has shown effectiveness in clinical trials, can be a viable second-line treatment option. It is an attractive drug for patients who have been hospitalized multiple times.”
- Company
- Xtandi closes coinsurance gap with Erleada
- by Eo, Yun-Ho Oct 17, 2023 05:27am
- 'Xtandi' has virtually overcome its difference in drug price with ‘Erleada.’ Dailpharm’s coverage found out that Astellas Pharma Korea recently reached a final agreement with the National Health Insurance Service to negotiate the drug price for its prostate cancer treatment drug Xtandi (enzalutamide) to convert its indication for metastatic hormone-sensitive prostate cancer (mHSPC) to full reimbursement. The conversion will likely be made in November. Through the negotiations, the company was finally able to close the out-of-pocket coinsurance difference between its Xtandi and Janssen Korea’s ‘Erleada (apalutamide).’ Controversy was raised over Xtandi’s coinsurance rate after Erleada’s reimbursement approval. Xtandi’s reimbursement was extended in August last year through the selective reimbursement system. Selective reimbursement allows companies to waive the economic feasibility evaluations and quickly extend the scope of reimbursement for a different indication of a listed drug, but with a differentiated coinsurance rate, when the expansion of coverage for a previously listed drug is deemed urgent. Xtandi was first listed for metastatic castration-resistant prostate cancer (mCRPC) in 2014, and when the mHSPC indication became eligible for selective reimbursement, Astellas chose to receive reimbursement through the option. But the situation differed for Erleada. As a newly listed drug, selective reimbursement was not an option for Erleada, so it had no choice but to conduct a pharmacoeconomic evaluation and undergo the mandatory reimbursement procedures. Of course, the time required for reimbursement between the two drugs also differed significantly. However, the issue lay in the coinsurance disparity that arose from the patient's perspective. The out-of-pocket rate for Xtandi is 30% with selective reimbursement, but only 5% for Erleada, which received essential reimbursement and special calculations, resulting in a disparity in drug prices between these two drugs that are the same class. But this problem is soon to be resolved. Xtandi's conversion to essential reimbursement can be seen as the result of quick action made by Astellas and the government to address the issue. Considering how Erleada was listed in April, Xtandi's rate of conversion to essential reimbursement has been made quite rapidly. Meanwhile, Xtandi’s reimbursement agenda passed the Cancer Disease Review Committee in June, the Drug Reimbursement Evaluation Committee reviewed its cost-effectiveness in July, and drug pricing negotiations began in August after the company accepted the conditions set by DREC.
