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- 2026-03-18 22:46:43
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- Sky Zoster has the highest market share ever
- by An, Kyung-Jin Aug 28, 2020 06:17am
- SKY Zoster & Zostavax The shingles vaccine market successfully rebounded out of the affected area of COVID-19. Sky Zoster by SK Bioscience set a new record in market share by increasing market influence while sales of competitive products slowed. According to the drug market research agency IQVIA on the 28th, the size of the shingles prevention vaccine market in the first half of this year was estimated at ₩14.8 billion. This is a 11.4% decrease from ₩39.3 billion a year earlier. The domestic shingles vaccine market consists of the combined sales of MSD's Zostavax and Sky zoster by SK Bioscience. In the first quarter of last year, sales of two types of vaccine against shingles in Korea were ₩12.2 billion, a half year-on-year. This is the aftermath of the sharp drop in visits to medical institutions by patients due to the spread of COVID-19. However, in the second quarter, as the spread of COVID-19 in Korea decreased, sales recovered to ₩22.6 billion, and accumulated sales decline in the first half was reduced. It is an analysis that the sales exponentially caused by COVID-19 epidemic was large due to a preventive vaccine rather than a treatment used in an emergency situation. Zostavax and Sky Zoster quarterly sales trend (Unit: ₩100 million, Source: IQVIA) Zostavax and Sky Zoster rebounded in sales in the second quarter. However, as the quarterly sales of 'Sky Zoster' increased significantly compared to the competition, it recorded the highest market share since its release. In the first half of the year, the sales of Sky Zoster were ₩14.7 billion. In the second quarter, the cumulative sales in the first half declined only 2.1% from the previous year, with sales of ₩9.8 billion, up 32.7% year-on-year. As of the second quarter of this year, the market share was 43.2%, the highest level since its launch. The sales of Zostavax in the first half of this year fell 17.2% to ₩20.1 billion from ₩24.3 billion last year. Sales in the second quarter were ₩12.8 billion, an increase of 4.4% compared to the same period last year, failing to keep up with the growth of Sky Zoster. Market share of two shingles vaccines on the market in the first half of 2020 (Unit: %, Source: IQUVIA)
- Company
- Obesity drug market expands despite COVID-19 as Qsymia soars
- by An, Kyung-Jin Aug 28, 2020 06:17am
- Product image of Saxenda (left) and Qsymia The obesity treatment market in South Korea has marked a significant growth in the first half of the year. The treatment market expanded, although the consumers became reluctant to open their wallets amid COVID-19 pandemic. A newcomer Qsymia is now leading the market alongside with Saxenda, or so-called ‘Gangnam Diet Shot.’ On Aug. 26, a pharmaceutical market research firm IQVIA found Korea’s obesity treatment market in the second quarter jumped 13.2 percent from last year at 33.2 billion won to 37.6 billion won. The cumulative sales in the first half of the year grew 7.6 percent from last year at 65.4 billion won and generated 70.4 billion won. If the market continues to see the positive growth, it would be able to break through the 100 billion won mark for two consecutive years. Quarterly sales of obesity treatment market in South Korea (Unit: KRW 100 million) Source: IQVIA Novo Nordisk’s Saxenda and Alvogen Korea’s Qsymia were two stars of the market leveraging the growth. In the first half of the year alone, Saxenda made 18.3 billion won. Compared to last year at 19.8 billion won, the quarterly sales dropped by 7.4 percent, but the injection is still the top obesity treatment in the Korean market. Its market share in the first half of the year was at 26.0 percent. Saxenda was the world’s first obesity treatment to be approved as a glucagon-like peptide-1 (GLP-1) receptor agonist. Saxenda shares the same substance liraglutide with Victoza, prescribed to type 2 diabetes patients, but its administration route and dose are different. As the users became aware of the medication to be comparatively safer with its mechanism of working like appetite-regulating and weight loss-inducing GLP-1, Saxenda has been enjoying unprecedented popularity for last two years. Started off with 2018 third quarter sales at 1.7 billion won, Saxenda’s sales surged to 5.6 billion won in the fourth quarter and took the lead in the market. Ever since the sales in first quarter of 2019 broke through 10 billion won point, Saxenda has maintained the sales around 10 billion won and defended the market leader title. In the third quarter last year, the treatment sales peaked and it dominated market share of 33.7 percent. But Saxenda’s easy race was shaken up, when Qsymia has announced its release in last January. Quarterly sales of major obesity treatments in South Korea (Unit: KRW 100 million) Source: IQVIA Immediately after the launch, Qsymia generated 4.3 billion won in the first quarter and came in second in the Korean obesity treatment market. After making another 5.8 billion won in the second quarter, Qsymia accumulated 10.2 billion won in the first half of the year and consolidated its strong market presence next to Saxenda. As of the first half of 2020, Qsymia’s market share has reached 14.4 percent. The figure doubles the market share of Daewoong Pharmaceutical’s Dietamin (6.7 percet) that used to be the second in the market until the fourth quarter last year. Alvogen Korea licensed in phentermine and topiramate combined Qsymia from the U.S.-based pharmaceutical company Vivus in 2017 for the sales in the South Korean market. Alvogen Korea also signed a co-marketing deal with Chong Kun Dang late last year and came into the market with powerful sales and marketing activities. Well experienced in the obesity treatment market with Furing and Furimin, Alvogen Korea created a mutual synergy effect with Chong Kun Dang’s vast sales power and quickly took over the market. Except for Qsymia, other treatment generally experienced stagnating growth. Three products out of the top five—Daewoong Pharmaceutical’s Dietamin, Huon’s Hutermin and Alvogen Korea’s Furing—saw their sales fall compared to last year same time. Hutermin made 3.1 billion won and raised the sales only by 0.8 percent from last year, whereas Dietamin (4.7 billion won) and Furing’s (2.7 billion won) sales volume fell by 0.2 percent and 0.4 percent, respectively, against last year. The market was expecting an intense competition eyeing on the market share left by a blockbuster drug Belviq as it exited the market with risk of developing cancer. But the market experts say the pandemic and release of Qsymia have grounded them from soaring in the market.
- Company
- The KRPIA appoints Kim Minyoung to succeed Kim Seongho
- by Eo, Yun-Ho Aug 28, 2020 06:17am
- Kim Seong-ho (62), the former executive director of the KRPIA, has been decided to succeed. According to related industries, KRPIA has recently confirmed Kim Min-young, who was in charge of the JAPAC regional headquarters (region) in Amgen Asia, as the general manager of insurance policy and external cooperation. The position is executive director. He is known as a person with experience in marketing and sales, as well as foreign cooperation such as MA (Market Access). Meanwhile, former executive director Kim Seong-ho left the association, which he had been with for about eight years since 2012, ending last April. Kim, who has been in charge of policy affairs at the association, was at the forefront of communication with the government for the reform of the drug price system. It also played an important role in the process of improving the system, such as expanding the targets of the Risk Sharing Agreement (RSA) and applying the RSA, a generic drug awaiting announcement. Since the resignation of former vice chairman Lee Sang-seok (67), the KRPIA and its member companies, which had no officials from the government, were concerned about the gap of him, an expert in drug price and policy management. As such, interest in the successor was also high.
- Company
- Janssen's investment in Lazertinib has scientific basis
- by An, Kyung-Jin Aug 27, 2020 06:25am
- Professor Byeong-cheol ChoJanssen, a global pharmaceutical company, is supporting the development of a new anticancer drug, 'Lazertinib,' introduced by Yuhan. Since the introduction of the technology in November 2018, a total of three global clinical trials have begun in a year and a half. In April, It showed its willingness to continue development by paying a large-scale technology fee for the development of a combination therapy of Amivantamab and Lazertinib, which is being developed on its own. It is also strong to enter global phase III clinical trials related to the combination therapy of Lazertinib within this year. Although there may be a difficult process to pass through the final gateway of the US Food and Drug Administration (FDA), it is a great pleasure that a new drug candidate developed with domestic technology is fully supported by Big Pharma. The competing drug, Tagrisso (Osimertinib), which acts as a similar mechanism to 'Lazertinib', has been approved by major countries around the world early and is being actively prescribed, which raises further questions. What secrets are hidden in Janssen's aggressive investment confidence? Professor Byeong-cheol Cho (Oncology, Yonsei Cancer Center), an authority in the field of lung cancer, said, "(Janssen) has enough scientific evidence to be greedy. the answer is hidden in the ongoing clinical results of Amivantamab and Lazertinib." Professor Cho has been working on the development process of Lazertinib and Amivantamab for a long time. From the preclinical stage, Janssen and Yuhan are actively participating in ongoing clinical research. The results of the CHRYSALIS study evaluating the combination therapy of Lazertinib and Amivantamab will be presented at the annual conference of ESMO 2020, which will be held online in the middle of next month. The global oncology community is drawing attention as the first clinical data that can confirm the synergistic effects of the two drugs in patients with advanced non-small cell lung cancer showing EGFR (epithelial cell growth factor receptor) mutation findings. In particular, there is a lot of interest in the results of administration to patients who developed resistance after administration of Tagrisso. He said, "There are many EGFR-targeted anticancer drugs such as Iressa and Tarceva, but there are still no alternatives for patients who have failed Tagrisso treatment. It is a pity as a clinician because they know that they have no choice but to use strong chemotherapy, and it would be nice to look forward to the safety data of the Amivantamab combination therapy." Janssen received approval for a global phase I clinical trial plan related to 'Lazertinib' monotherapy in June last year, after 7 months of technology export. Three months later, it started to develop in earnest by entering into clinical trials related to the combination therapy of Amivantamab and Lazertinib. Johnson & Johnson (J&J) also showed affection at the group level, pointing out Amivantamab and Lazertinib as promising pipelines for the pharmaceutical division. Recently, a global phase III clinical trial plan related to the combination therapy of Lazertinib and Amivantamab was newly registered on Clinical Trials, a clinical trial registration site operated by the National Institute of Health (NIH). Patient recruitment starts in October of this year and ends in January 2024. It is evaluated that it has reaffirmed the goal of completing the NDA application for new drug approval by the US Food and Drug Administration (FDA) by 2023.
- Company
- Champix has the lowest sales in 5 years
- by Kim, Jin-Gu Aug 27, 2020 06:24am
- ChampixSales of Pfizer's stop-smoking aid, 'Champix (Varenicline)' declined. In the second quarter of this year, sales fell 26% compared to the previous quarter. Quarterly sales are the lowest since the third quarter of 2015. Despite the aggressive patent defense strategy, the number of applicants for the government's smoking cessation project steadily declined, and in the first half of this year, the COVID-19 outbreak led to a decline in sales. Moreover, since the generics were released in earnest after July, when the material patent expired, sales are expected to decrease significantly from 3Q. According to IQVIA on the 26th, 2Q sales of Champix amounted to ₩5.1 billion. It decreased by 8% compared to the second quarter of last year (₩5.5 billion), and It decreased by 26% compared to the first quarter of this year (₩6.9 billion). There is a big difference from what was once (Q1 2017) quarterly sales of ₩21.4 billion. Champix's sales surged as the government expanded its smoking cessation business. However, starting in the first quarter of 2017, the number of participants in the smoking cessation project steadily declined. In November 2018, with the release of generics, the drug price was reduced by 38.9% (₩1,100 ←₩1,800). In order to prevent a decline in sales, Pfizer has devoted all efforts to patent defense. In January 2019, the Supreme Court's ruling on Solifenacin was decisive. The Supreme Court ruled that it was illegal to evade a patent for salt-modified drugs. Most of the pharmaceutical companies that released generics for Champix withdrew from the market. This is because the legal dispute with Pfizer was a burden as the loss in the future became influential. In the end, in December of the same year, the Patent Court ruled the same on the salt-modifying drug for Champix. Even some of the generics that had not been withdrawn from the market were banned from selling. Pfizer's patent defense seemed to have some effect. In fact, sales rose slightly until the first quarter of this year after ruling on Solifenacin. Quarterly sales from ₩5.5 billion in the second quarter of 2019 recovered to ₩5.7 billion in the third quarter, ₩6.5 billion in the fourth quarter, and ₩6.9 billion in the first quarter of 2020. However, in the second quarter, sales decreased again to ₩5.1 billion. It is the lowest since the third quarter of 2015 (₩4.9 billion). This was before the government launched a smoking cessation support project. It is expected that sales will decline more sharply from 3Q. This is the effect of the massive release of generics as patent of Champix expired on July 20th. According to the MFDS, it is confirmed that as of August 25, 34 companies launched 66 generic items. An official from the pharmaceutical industry said, "The number of participants in the smoking cessation business drastically declined due to the COVID-19 incident in the first half, and the effect appeared in the second quarter. It will be greatly reduced."
- Company
- Dong-A ST, exports ₩3 billion in the first half
- by Kim, Jin-Gu Aug 27, 2020 06:24am
- Dong-A ST's Nesp biosimilar is targeting the Japanese market. After launching the product in the Japanese market at the end of last year, it made exports for the first time in the first half of this year. Chong Kun Dang is also targeting the Japanese market in earnest after launching Nesp biosimilar in the Japanese market around the same time as Dong-A ST. Two domestic biosimilar products increase the possibility of a soft landing in the Japanese market. According to the pharmaceutical industry on the 25th, Dong-A ST is selling a Nesp biosimilar named 'Darbepoetin-α (DA-3880)' in Japan. Dong-A ST obtained an item license for this product in Japan in last September, and started officially launching it from the end of November. Sales in Japan are handled by the local partner, Sanwa Kagaku Kenkyusho (SKK). It exported about ₩3 billion in the first half of this year. An official from Dong-A ST explained, "The amount that Dong-A ST exported to Japan was ₩700 million in the first quarter and ₩2.4 billion in the second quarter." Considering the fact that Dong-A ST's exports to Japan were hardly ever until the end of last year, it is calculated that virtually all of them are Nesp biosimilars. Chong Kun Dang, which entered Japan at the same time as Dong-A ST with the same Nesp biosimilar, also performed well. In the case of Chong Kun Dang, the product was released in December of the same year after obtaining an item permission for Nesp biosimilar 'Nesbell (CKD-11101)' from the Japanese government in September last year. Like Dong-A ST, sales are conducted through local partners. The Japanese subsidiary of the global pharmaceutical company Mylan is in charge of local sales. Chong Kun Dang's exports to Japan in the first half of this year were ₩21.4 billion, an increase of about ₩5.3 billion (32.7%) from ₩16.1 billion in the first half of last year. This is the total amount exported to Japan, including Nesbell. Considering that Chong Kun Dang's semiannual exports to Japan have been around ₩17 billion over the past five years, it is interpreted that such an increase in exports can be viewed as a result of Nesp biosimilars. A Chong Kun Dang official said, "It is difficult to disclose the sales performance of individual items in Japan, but the increase in exports to Japan is due to the even growth of not only Nesbell but also various products." Regarding this, an official from the pharmaceutical industry said, "Since both products are still in the early stages of release, it seems to be positive to enter the Japanese market, and the performance in Japan is expected to improve further." Nesp, the original of the two products, is a second-generation anemia treatment developed jointly by Amgen in the United States and Kyowa Kirin in Japan. It is mainly used for the treatment of anemia in chronic renal transition patients and anemia by chemotherapy. Nesp's global sales are estimated at $3 billion, of which Japan's sales are estimated at ₩560 billion, which is about 15%.
- Company
- Keytruda sales hit KRW 72.3 bln topping H1 2020
- by Chon, Seung-Hyun Aug 27, 2020 06:24am
- Apparently an immunotherapy Keytruda has made the highest sales revenue in the first half of the year. Keytruda has beaten the long-term industry leader, Lipitor. Two innovative new drugs from multinational pharmaceutical companies, Tagrisso and Spinraza have shown outstanding performances, and the sharp surge in pneumococcal pneumonia vaccine Prevenar 13 was notable as well. According to the pharmaceutical market research firm IQVIA on Aug. 24, MSD marked the highest sales in the first half of 2020 with Keytruda making 72.3 billion won. Compared to 57.2 billion won made last year, the figure leapt by 26.4 percent and placed itself on the top of the leader board. Top 10 pharmaceuticals in the first half of 2020 (Source: IQVIA) In the first quarter, Keytruda took the top spot by making 40 million won more than the dyslipidemia treatment Lipitor with 34.7 billion won. The gap between Lipitor was widened by 2.9 billion won in the second quarter as Keytruda defended the top title. Released in the Korean market in 2015, Keytruda is an immune checkpoint inhibitor that blocks PD-L1 receptor from biding with PD-1 pathway on the surface of T-cell and activates immune cells to treat the tumor cells. Immediately after the market release, Keytruda’s sales have remained around 3 billion won, but the figure grew rapidly since the second half of 2017. The demand on the drug has surged as the healthcare insurance coverage was granted from Aug. 2017 as a second-line therapy treating non-small cell lung cancer (NSCLC). Keytruda’s sales in the first quarter of 2018 surpassed 10 billion won, and it has been staying around the 30 billion won line from the second quarter last year. Keytruda quarterly sales (Unit: KRW 100 million) Source: IQVIA Pfizer’s Lipitor came in second with 69.3 billion won generated but it dropped by 4.8 percent from last year same time. Lipitor has been topping the chart since April 2015, but it stepped down to the second place from the last first quarter after four years. Meanwhile, anticancer treatment Tagrisso and rare disease treatment Spinraza continued their strong performance to this quarter. Making 51.1 billion won in the first half of this year, AstraZeneca’s Tagrisso came in fourth by growing the sales by 33.5 percent from last year. Tagrisso is a second-line treatment prescribed to NSCLC patients who developed tolerance in EGFR tyrosine kinase inhibitors (TKIs) like Iressa, Tarceva and Giotrif. The medicine is considered a third-generation treatment that overcame EGFR-TKI tolerance. After receiving healthcare reimbursement from December 2017, Tagrisso has been growing consistently. The sales in third quarter 2017 marked 2.7 billion won, but it grew by eight times in two years time. Product images of Tagrisso (left) and Spinraza Biogen’s rare disease treatment Spinraza landed itself on the ninth place by generating 38.9 billion won in the first quarter. After making 20.2 billion won in the first quarter, the treatment made 18.7 billion won in the second quarter. Spinraza has been consistently making more or less 20 billion won since it entered the market making 10.2 billion won in the second quarter last year. The rare disease treatment Spinraza is indicated to treat a genetic neuromuscular disorder called spinal muscular atrophy (SMA) that causes muscle twitching from damaged motor neurons in spinal cord and brain stem. The patient’s cognitive function stays normal, while their daily life is disrupted with weakening muscle and contracting tongue muscle. Approved by South Korean health authority in December 2017, Spinraza was listed for healthcare reimbursement after settling on a pricing of 92.35 million won per vial (5 ml) in pricing negotiation with National Health Insurance Service (NHIS). Although the eligible patient size is small, the patients have to undergo a complicated pre-review prior to the administration. Regardless of the long procedure to use, the treatment’s quarterly sales have reached 20 billion won quickly with its exceptionally high price. Product image of Prevenar 13 Meanwhile, a pneumococcal pneumonia vaccine Prevenar 13 had an abrupt exponential growth due to the novel coronavirus infection (COVID-19). Prevenar 13’s sales in the first half of 2020 skyrocketed by 70.2 percent from last year and made 36 billion won. Prevenar 13 is a pneumococcal conjugate vaccine (PCV13) that prevents infection from 13 types of pneumococcal pneumonia (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). The vaccine can be given to all age group older than 6-week-old. Chong Kun Dang is in charge of distributing the vaccine for adult in South Korea, whereas for infant and children vaccine distribution is handled by Korea Vaccine. The use of the vaccine in adults has surged sharply as many were convinced by some experts claiming the vaccine can weakened the pneumonia symptoms induced from COVID-19, although it cannot prevent the pneumonia itself.
- Company
- Statin+Ezetimibe reduces the burden of high doses Statin
- by Aug 27, 2020 06:23am
- Kim Dae-jung, a 50-year-old professor of endocrinology at Ajou University HospitalThe 'Statin + Ezetimibe' combination drug is shaking the market for hyperlipidemia treatment. In 2015, the 'IMPROVE-IT' study, which proved the low-density lipoprotein cholesterol (LDL-C) lowering effect of the combination therapy of Ezetimibe(non-statin) and Statins, targets a niche market that is concerned about side effects of high-dose Statins. Statin+Ezetimibe combination domestic market, led by 'Rosuvastatin + Ezetimibe', is growing day by day. This market, which was ₩23.8 billion in the first quarter of 2016, has expanded to ₩111.4 billion in the second quarter of 2020. The combination of Statin + Ezetimibe is also becoming a trend in the frontline medical field. Kim Dae-jung, a 50-year-old professor of endocrinology at Ajou University Hospital, said in a meeting with Dailypharm that "the trend is to use a combination of 'Statin + Ezetimibe' for preventive purposes not only for high risk of cardiovascular disease, but also for patients who need to lower LDL-C." "The combination of Statins and Ezetimibe reduces concerns about diabetes and provides metabolic benefits, which is a factor in considering this combination from the beginning." Prof. Kim also participated in a retrospective domestic cohort study of Koreans who concluded that taking a high dose of Statin for a long time increases the risk of diabetes. This study, published in the journal Cardiovascular Diabetology, an SCI-level international academic journal, was conducted in 13,698 adults aged 40 to 74 years old who were diagnosed with dyslipidemia without a history of diabetes or atherosclerotic cardiovascular disease(5,273 people in the Statin group & 5,273 people in the non-statin group), and the cumulative incidence of type II diabetes according to the annual accumulated daily dose of Statin was evaluated by follow-up method. As a result of the analysis, type II diabetes occurred in a total of 3,034 patients during the average observation period of 7.1 years, of which more than half of 1,871 patients (61.7%) occurred in the Statin group. As the duration of Statin administration was longer than 5 years, the risk of diabetes was significantly increased compared to that of the non-administered group, and the risk of diabetes incidence increased from 1.31 times to a maximum of 2.83 times compared to the non-administered group in proportion to the total cumulative dose of Statin consumed annually. ▶What is the implication of a recent study on the link between high statin doses and diabetes incidence? Long-term high doses of Statins increase the risk of diabetes. Conversely, Statins should be used as low as possible. However, in order to be effective enough to prevent cardiovascular disease, certain amount of Statin should be used. As the target LDL-C level is reached, the alternative to use less Statin is Ezetimibe combination, which is non-statin formulation In fact, there are many cases of prescribing a combination of Ezetimibe rather than a single statin drug to patients who need to use high doses of statins. Prescribing data proves this, and it seems that Ezetimibe combination is also preferred for the purpose of preventing cardiovascular disease. Even when I need to use a high dose of Statins, I often use ezetimibe complex from the beginning. ▶Are you concerned about the side effects of high doses of statins? According to the actual clinical data, the risk of developing muscle side effects such as rhabdomyolysis, which is commonly known, is rare, so it is not enough to worry. The same goes for concerns about side effects related to the liver. However, having these side effects (even if the side effects are rare) puts great stress on the doctor. The idea that I want to avoid it as much as possible makes me choose the alternative Ezetimibe combination. Concerns are higher about the occurrence of diabetes, which is cited as another side effect. In particular, high-risk groups for cardiovascular disease, who are prescribed high doses of Statin, are often highly likely to develop diabetes. Patients at high risk of diabetes may consider Ezetimibe combination from the start, as mentioned earlier. ▶Are there any other benefits of Statin+Ezetimibe? While Statins inhibit cholesterol synthesis in the liver, Ezetimibe's mechanism inhibits cholesterol absorption in the small intestine. When cholesterol is absorbed, it forms Chylomicron like triglycerides and moves into the blood, blocking the process. In other words, using Ezetimibe can reduce the absorption of not only cholesterol but also triglycerides. ▶In the area of hyperlipidemia, which used to be Statin only, combination drugs of other classes, such as diabetes and hypertension, seem to be increasingly taking up a larger proportion. This is because of the advantages of combination therapy. As with diabetes, rather than raising a certain drug to the highest dose, using one drug at an appropriate dose while using a little bit of another drug seems to be able to produce the desired effect while minimizing side effects. It is clear that the combination system is far more beneficial than using each single drug. As it is a chronic disease that must be taken for a lifetime, the number should be reduced and the dosage method should be simplified. This can increase patient compliance. ▶Research is ongoing to establish the basis for the combination therapy of 'Statin + Ezetimibe'. Recently, a study is underway in Korea to directly compare high doses of Statin and combination therapy in more than 3,000 domestic patients. You can't predict the outcome, but what if you predict the direction? Since the cardiovascular prophylactic effect is formulated according to the target LDL-C level, if the combination therapy with high-dose Statin and Ezetimibe similarly reduces the LDL-C level or reaches the target level, it will be considered similar in terms of efficacy. Furthermore, what is expected of Ezetimibe combination therapy is to reduce diabetes incidence or to show better safety data. It seems that we will have to wait for the results of the study to see if the predictions will come out as real data.
- Company
- Initiating talks on listing EBC adjuvant therapy Kadcyla
- by Eo, Yun-Ho Aug 26, 2020 06:24am
- The talks on granting healthcare reimbursement on Kadcyla as an adjuvant therapy following an early breast cancer surgery would begin. Today, South Korea’s Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee would deliberate providing the healthcare reimbursement on an antibody-drug conjugate (ADC) Kadcyla (trastuzumab emtansine), pharmaceutical industry sources reported.. The reimbursement expansion application is specifically targeting the indication as an ‘adjuvant treatment for HER2-positive early breast cancer in patients who have received a taxane plus Herceptin-based neoadjuvant treatment but have residual invasive disease.’ The expansion was requested not by the developer Roche, but by Korean Breast Cancer Society (KBCS). The medical society is demanding Kadcyla’s coverage to be expanded. Initially listed through a refund type risk sharing agreement (RSA) in August 2017, Kadcyla is indicated in HER2-positive, unresectable locally advanced or metastatic breast cancer in patients previously treated with Herceptin and taxane. Immediately after receiving the indication on early breast cancer in August last year, Roche failed in an attempt to expand the NHI coverage. However, some sees that the Cancer Deliberation Committee would unlikely to pass the expanded reimbursement on Kadcyla. Unlike other cancers, many of breast cancer treatments have been listed for reimbursement. In fact, two CDK 4/6 inhibitors—Pfizer’s Ibrance (palbociclib) and Lilly Korea’s Verzenio (abemaciclib)—have expanded their reimbursement standards. However, Kadcyla highlights the clinically proven treatment effect in early breast cancer patients having a high risk of recurrence. In the KATHERINE study, Kadcyla was used on treating a patient found with residual tumor and high risk of recurrence after completing chemotherapy. The investigational drug lowered the risk of recurrence of breast cancer or death 50 percent lower than that of the standard of care Herceptin. So far the medical need for the recurrence risk was unmet, but the treatment showed it would be possible to lower the risk. The Cancer Deliberation Committee would also focus on the fact that the breast cancer treatments listed so far have been too specified in ‘metastatic breast cancer.’ The treatment in breast cancer aims for different purposes depending on stages. The treatment strategy for metastatic cancer would be prolonging the overall survival, whereas early breast cancer would be a full recovery. Currently, the targeted therapy Herceptin (trastzumab) is the only covered adjuvant therapy following an early breast cancer surgery. Professor Sohn Joohyuk of Oncology Department at Severance Hospital said, “The healthcare reimbursement status on breast cancer treatment has significantly improved than the past. But the treatment environment would improve even further if the relevant experts’ opinions are reflected in the grey area. We need more flexible healthcare reimbursement system for a better access to treatments.”
- Company
- “Access to Onivyde should improve for more options"
- by Aug 26, 2020 06:23am
- “Besides the findings from global clinical study on treating metastatic pancreatic cancer patients, Onivyde even offers subset analysis on Asian patients and real-world evidence (RWE) in South Korea. It is regretful the treatment has not been listed for National Health Insurance (NHI) reimbursement.” Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center On Aug. 20, Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center commented so, when explaining the clinical profile of Onivyde (liposomal irinotecan hydrochloride). Currently indicated as a combination therapy with 5-fluorouracil (5-FU) and Leucovorin (LV) in treating a patient with metastatic pancreatic cancer who has failed to respond in Gemcitabine-based therapy, Onivyde has accumulated meaningful clinical evidence to prove itself as an effective later-line treatment for patients who struggled with the first-line treatment. The Phase III NAPOLI-1 study conducted in 14 countries around the world provided the outcome. The study found, when Onivyde plus 5-FU/LV therapy was given to patients with metastatic pancreatic cancer who has previously received Gemcitabine-based chemotherapy, the median overall survival (mOS) was 6.1 months, which is about 1.5 times longer than 4.2 months in 5-FU/LV therapy only group. The patient group with Onivyde combination therapy demonstrated median progression-free survival (mPFS) of 3.1 months, compared to 1.5 months in the 5-FU/LV therapy only group Professor Yoo noted Onivyde would be even more effective in Asian race. After separately analyzing Asian patients from NAPOLI-1, the clinical researchers found the Onivyde combination therapy demonstrated 8.9 months of mOS and 4 months of mPFS, which was superior to the other patient groups in the study. However, the subset Asian patients using the Onivyde combination therapy marked 8.8% in objective response rate (ORR) indicating the general reduction of tumor size. The figure was lower than the other patients groups at 16.2%. Professor Yoo elaborated, “Although the Asian group had lower ORR, the most important indicators of the efficacy are OS and PFS,” and “The outstanding outcomes from these endpoints could mean Onivyde is more effective to Asian patients.” Product image of Onivyde From the safety’s perspective, Asian patient group, compared to other patient groups, had half the frequency of adverse reactions in digestive system like vomiting or diarrhea, but the their drop in white blood cell count doubled that of the other groups. Professor Yoo commented, “The decrease in white blood cell count does not significantly affect a patient’s quality of life as long as they do not have fever. Generally the toxicity was similar, but the common adverse reactions in the Asian patients seemed to not too bothersome for the patient’s quality of life.” In fact, a retrospective real-world evidence study conducted on 86 patients administered with Onivyde in South Korea had similar outcomes as the NAPOLI-1 subgroup analysis data. Nevertheless, Onivyde is still not covered by the NHI. Professor Yoo noted the patients are in agony as the NHI coverage is barely applied on the expanded second-line treatments and technically more effective options. Professor Yoo stated, “When consulting with many of the pancreatic cancer patients, we talk about second and third-line treatments a lot. Without the NHI coverage, we have to discuss about their private medical insurance,” and “It is regretful that Onivyde, despite its abundant evidences from Phase III global clinical study, Asian patient subgroup analysis, and RWE in South Korea, is still not covered by the health insurance benefit.”
