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- 2025-12-23 07:53:04
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- Prescriptions of HCV market leader Mavyret halves in 1 yr
- by Kim, Jin-Gu Nov 09, 2023 05:43am
- Pic of Outpatient prescription performance of ‘Mavyret,’ the No. 1 product in the hepatitis C treatment market, has shrunk to less than half in just 1 year. In addition to the decrease in overall market size due to the decline in hepatitis C patients, Mavyret’s newly released competitors 'Epclusa' and ‘Vosevi’ have been rapidly expanding their influence in the market. According to the market research institution UBIST on the 8th, outpatient prescriptions of Mavyret in Q3 amounted to KRW 3.7 billion. This is a 52% decrease in 1 year compared to the KRW 7.8 billion it had posted in Q3 last year. Mavyret is a pan-genotypic hepatitis C treatment that was released by AbbVie. Since its release in Q3 2018, it quickly replaced Sovaldi and Harvoni which previously led the market. ‘Mavyret.’ can be used for patients with hepatitis C virus types 1 to 6, while Harvoni cannot be used for types 3 and Sovaldi cannot be used for types 5 and 6. The long treatment period of 12 weeks for Harvoni and Sovladi, compared to 8 weeks for Mavyret, also served as a weakness for Harvoni and Sovaldi. Mavyret’s share in the HCV treatment market share rose vertically from 3% in Q3 2018 to 56% in Q4. Subsequently, its market share exceeded 60% in Q1 2019 and then 70% in Q2 of the same year. Subsequently, its market share steadily increased and expanded to more than 80% in Q3 last year. Contrary to its expanded market share, prescription performance has been declining since 2019. Mavyret’s prescription performance, which recorded KRW 41.5 billion in 2019, decreased for 3 consecutive years to KRW 34.4 billion in 2020, KRW 32.8 billion in 2021, then to 31.2 billion won in 2022. Quarterly prescription performance of major hepatitis C treatments (Unit: KRW 100 million, Data UBIST) The analysis is that this is due to the steadily shrinking overall market size. The size of the HCV treatment market has steadily decreased from KRW 135.3 billion in 2017 to KRW 73.7 billion in 2018, then to KRW 65.1 billion in 2019, and KRW 47.4 billion in 2020, KRW 35.1 billion in 2021, then to KRW 34.2 billion in 2022. Compared to 2017, when the market had expanded to its maximum, the market had shrunk to a quarter in 5 years. The industry pointed to the characteristics held by the HCV treatments as a cause of the market contraction. Before the introduction of direct-acting antivirals (DAAs) like Mavyret, HCV had been a very critical disease. However, the treatment effect of HCV drugs had increased dramatically with the introduction of BMS’s Daklinza and Sunvepra. With Gilead Sciences' Sovaldi and Harvoni, MSD’s Zepatier, and Abbvie’s Mavyret that followed, the treatment effect had further increased. Ironically, as these new treatments offer an effect high enough to be close to a complete cure, the market size quickly contracted with the number of patients being prescribed the drug increasing within the finite number of patients in the market. As a result, the market size is shrinking. Pic of The entry of its competitors also affected the decline in Mavyret’s prescription performance. Gilead Sciences released Epclusa and Vosevi as next-generation hepatitis C treatments in November last year. The combined prescription performance of the two products is on the rise, reaching KRW 300 million in Q4 last year, then KRW 1.6 billion in Q1 of this year, KRW 2.7 billion in Q2, then to KRW 2.5 billion in Q3. During the same period, the market share of the two products had rapidly expanded from 4% to 19%, 34%, then 39%. If the current trend continues, it is predicted that it will surpass Mavyret and become a leader in the hepatitis C treatment market within the next year. However, like Mavyret, the fact that the overall market size is shrinking is expected to become a concern for Epclusa and Vosevi as well.
- Company
- Velexbru can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 09, 2023 05:43am
- Velexbru, a new drug for lymphoma, can be prescribed at general hospitals. According to related industries, Ono Pharmaceutical's BTK (Brutons Tyrosine Kinase) inhibitor Velexbru recently passed the Drug Committee of top general hospitals such as AMC and Sinchon Severance Hospital. In addition, major medical institutions, including Samsung Seoul Hospital, are also conducting landing procedures. Velexbru was approved domestically in 2021 by the Ministry of Food and Drug Safety as a monotherapy for patients with Primary Central Nervous System Lymphoma. This drug is the first BTK inhibitor approved in Korea for the treatment of patients with relapsed or refractory B-cell primary central nervous system lymphoma for which there is no standard treatment. The effectiveness of Velexbru was confirmed through ONO-4059-02, a non-blinded, uncontrolled phase 1/2 clinical study of Velexbru conducted in Japan in patients with relapsed or refractory primary central nervous system lymphoma. A total of 44 patients were enrolled in the study and were administered Velexbru 320 mg (80 mg per tablet, n = 20), 480 mg (n = 7), and 480 mg (n = 17) on an empty stomach orally once daily. Drug administration continued until the disease progressed or unacceptable toxicity occurred. The primary endpoint was ORR according to BICR. As a result of the study, the ORR for the approved dosage and dosage of 480 mg (fasting) was 52.9%. Major adverse reactions corresponding to grades 3 and 4 included neutropenia, leukopenia, and hypertriglyceridemia, which occurred in 11.8% of patients each. PCNSL is a very rare disease, so it is quite difficult to estimate the nationwide patient population. In general, it is reported that approximately 6,000 lymphoma patients occur annually in Korea, and about 2,000 primary brain tumors occur annually. Among these, PCNSL is known to account for approximately 2% of all brain tumor patients. Considering that PCNSL is reported to occur at 0.44 cases per 100,000 people in Western countries, it is estimated that approximately 200 to 250 new PCNSL patients will occur annually in Korea.
- Company
- Whether Ilaris for 10 will receive reimb gains attention
- by Eo, Yun-Ho Nov 08, 2023 05:37am
- Attention is focused on whether progress will be made on discussions for the insurance reimbursement of 'Ilaris', a treatment that is used by around ten patients in Korea. According to industry sources, reimbursement discussions for Novartis Korea’s Ilaris (canakinumab) are currently being negotiated between the government and pharmaceutical companies at the Drug Reimbursement Standards Subcommittee stage. Half a year had passed since the company reapplied for reimbursement in line with the addition of its pediatric indications in April at registration. The company had failed to list the drug for reimbursement two times. A bumpy road lies ahead for its reimbursement still. The current focus of Ilaris’s reimbursement discussion is whether or not the drug can be applied the pharmacoeconomic evaluation exemption system. Ilaris's listing will become more difficult if its reimbursement evaluation is not carried out through the PE exemption track, Ilaris was initially approved in 2015 as a hereditary recurrent fever syndrome treatment. Its disease type is specified according to the mutated gene. Among the various specific syndromes that accompany hereditary recurrent fever, Ilaris is approved in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF), and ▲ Systemic juvenile idiopathic arthritis (JIA). Among these, CAPS is further classified into ▲Familial Cold Autoinflammatory Syndrome FCAS)/ Familial Cold Urticaria (FCU), ▲Muckle-Wells Syndrome (MWS), ▲Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurologic Cutaneous and Articular. Due to the very small number of subject patients and complex indications, it was difficult to progress discussions for its reimbursement. The number of patients who are applied the various indications for Ilaris is extremely small. Some indications for Ilaris do not even have disease codes or are only recently registered. In fact, the number of domestic patients that can use Ilaris is estimated to be around 13. Due to Ilaris’s non-reimbursement, patients have been receiving a treatment they can with an alternative that is not really an alternative. Patients with CAPS have been using ‘Kineret’ which is being supplied through the Korea Orphan & Essential Drug Center. As this drug has not been officially approved by the Ministry of Food and Drug Safety and is being supplied through the center, when supply disruptions occur, no entity in Korea has the obligation to ensure its supply, rendering the communication channel unclear and limits to improving its supply. In the case of FMF, colchicine is recommended as a first-line treatment but is not available in Korea. Ilaris is approved for use in patients with FMF who are contraindicated, intolerant, or achieved inadequate response with the highest-dose colchicine. However, since colchicine has not been introduced domestically, it will be difficult for FMF patients to use Ilaris, even if it receives reimbursement if colchicine's approval and reimbursement issues are not resolved. To solve this problem, an academic society applied for non-reimbursed off-label use of colchicine and reimbursement extension for the drug. In addition, voices calling for Ilaris’s reimbursement listing had risen in the recent NA audit. The National Assembly’s Health and Welfare Committee audit of the National Health Insurance Service and the Health Insurance Review and Assessment Service, Rep Sun-woo Kang of the Democratic Party of Korea, said, "Patients are spending KRW 80 million to as much as KRW 100 million a year to purchase non-reimbursed drugs. We ask the government to promptly list the drug for reimbursement to improve the quality of life for children and ease the financial burden borne by the patients' families.” Therefore, it remains to be seen whether the company and health authorities can reach a consensus and achieve reimbursement listing for ‘Ilaris’, a drug for a very small number of patients.
- Company
- Budesonide’s price to be raised due to increased demand
- by Chon, Seung-Hyun Nov 07, 2023 05:34am
- Health authorities are working to increase the price of asthma medications containing ‘budesonide’, which have been experiencing supply shortages. Quarterly prescriptions of budesonide, which was less than KRW 1 billion, more than tripled after the COVID-19 pandemic, intensifying the supply and demand imbalance. According to industry sources on the 6th, the Korean health authorities have been reportedly working to increase the prices of two drugs that contain the asthma treatment ingredient budesonide. The authorities are known to be reviewing a price increase due to the recent surge in their demand. Budesonide is used to treat bronchial asthma and acute laryngotracheobronchitis in infants and children. Two products, AstraZeneca's Pulmicort and Kuhnil Pharmaceutical's Pulmican, are currently available in the Korean market. According to the pharmaceutical research institution UBIST, the prescription amount for Pulmicort and Pulmican in Q3 this year was KRW 1.6 billion. The amount decreased by 0.2% from Q3 last year but is 155.8% in 2 years from the KRW 600 million in Q3 2021. In 2020, the prescription market for budesonide was only KRW 3.8 billion. The average quarterly prescription amount was less than KRW 1 billion. In 2021, prescription performance was less than KRW 1 billion from Q1 to Q3. Quarterly outpatient prescriptions of Pulmicort(grey) and Pulmican(green) Budesonide prescriptions increased 39.0% YoY to KRW 1.4 billion in Q4 2021, then soared again to KRW 3 billion in Q4 last year, recording an over threefold increase from 2 years ago. This year, budesonide continued to increase in sales, recording KRW 2.5 billion and KRW 2.8 billion in Q1 and Q2, respectively. The cumulative prescription amount for budesonide in Q3 this year was KRW 6.9 billion, approximately 3 times higher than KRW 2.3 billion during the same period in 2021. The prescription market for budesonide has also increased significantly with the surge in the number of confirmed COVID-19 cases since the end of 2021. Recently, the demand for asthma drugs has increased due to the increase in not only confirmed cases of COVID-19 but also cold and flu patients, resulting in a supply-demand imbalance where supply cannot meet demand Prescriptions for Pulmican and Pulmicort both surged from the end of 2021. Pulmicort’s quarterly prescriptions from 2020 to Q3 2021 ranged around KRW 300 million to 500 million. It jumped 36.6% YoY to KRW 800 million in Q4 2021 and exceeded KRW 1 billion in the of last year. The cumulative prescription amount for Pulmicort in Q3 this year was KRW 3.4 billion, up 194.7% from the cumulative KRW 1.2 billion in Q3 2021. Pulmican’s quarterly prescriptions from Q1 2020 to Q3 last year fell below KRW 1 billion. However, sales surged to KRW 1.8 billion in Q4 last year, and recorded KRW 1.5 billion and KRW 1.4 billion in Q1 and Q2 this year, respectively. The cumulative prescription amount of Pulmican in Q3 this year was KRW 3.4 billion, a threefold increase from 2 years ago. If raised, budesonide will become the fourth drug to receive a price increase since last year, following acetaminophen, magnesium hydroxide, and pseudoephedrine. The Ministry of Health and Welfare raised the insurance price ceiling of 18 acetaminophen 650mg items by up to 76.5% in December last year. The insurance price limit for 650mg acetaminophen, which ranged between KRW 43 to 51 before then, was raised to KRW 90. The government made an unprecedented decision to raise the price of all acetaminophen together when pharmaceutical companies expressed reluctance to increase production due to the drug’s poor cost structure. However, it is a temporary increase that will be adjusted to KRW 70 from December this year. Pharmaceutical companies had promised to increase production of acetaminophen in line with the price hike. The Ministry of Health and Welfare has also raised the price of magnesium hydroxide-based laxatives since last June. The price of Magmil was raised by 27.8% from KRW 18 to KRW 23. Cho-A Pharmaceutical's Marogel was raised from KRW 15 to KRW 22, and Sinil Pharm’s M Tab Sinil was raised from KRW 16 to KRW 22. Last month, the prices of the 4 types of pseudoephedrine single-agent drugs were increased by up to 45%. The insurance price of Sinil Pharm’s Pseudoephedrine Tab Sinil increased by 45% from KRW 20 to KRW 29. The price of Sam Il Pharmaceutical's Sudafed rose 39% from KRW 23 to KRW 32. The insurance drug price of Sama Pharm’s Schdafen and Kolon Pharmaceutical's Cosue was raised by more than 30% from KRW 23 to KRW 30 and KRW 31, respectively.
- Company
- Chong Kun Dang signs KRW 1.7 tril deal with Novartis
- by Kim, Jin-Gu Nov 07, 2023 05:34am
- On the 6th, Chong Kun Dang Pharm announced on the 6th that it signed a licensing out agreement worth KRW 1.7 trillion for its new drug candidate 'CKD-510' with the global pharmaceutical company Novartis. Under the agreement, Novartis will have exclusive rights to the development and commercialization of CKD Pharm’s CKD-510 worldwide, excluding Korea. CKD Pharm will first receive an upfront payment of USD 80 million (approximately KRW 106.1 billion), followed by milestone payments of USD 1,225 billion (approximately KRW 1.624 trillion) for future development and approval milestones, in addition to sales royalties based on net sales CKD-510 is a new drug candidate in the low molecular substance histone deacetylase 6 (HDAC6) inhibitor class being developed by CKD Pharm. It has applied a highly selective non-hydroxamic acid (NHA) platform technology. It had confirmed its efficacy in a preclinical study in several HDAC6-related diseases including cardiovascular disease. Also, it demonstrated safety and tolerability in Phase 1 trials conducted in Europe and the United States. Young-Joo Kim, CEO of CKD Pharm, said, “We have previously licensed out the anemia drug biosimilar ‘Nesbell,’ and new antidiabetic drug ‘Duvie’ in Japan and the US, respectively. This is the largest agreement ever made by the company and is the result of our continuous investment with over 12% R&D to sales.” Mi-Yeop Lee, Head of CKD Pharm’s Product Development Division, said, “We expect Novartis will develop CKD-510 into a global new drug based on Novarits’s long new drug development know-how and commercialization capabilities. Using the agreement as momentum, CKD Pharm will spur clinical development of its new drug candidates to achieve a result as soon as possible.” CKD Pharm plans to use its own HDAC6 platform to continue developing treatments for various diseases in the future. In addition, the company is speeding up the development of a new bispecific antibody anti-cancer bio drug 'CKD-702' and a dyslipidemia treatment 'CKD-508', which are currently in Phase 1 trials. In addition, the company plans to expand the scope of new drug development to advanced biopharmaceuticals such as gene therapy and ADC anticancer drugs to develop first-in-class new drugs and drugs with unmet needs.
- Company
- First GIFT drug Lunsumio in reimb process after approval
- by Eo, Yun-Ho Nov 07, 2023 05:33am
- The new lymphoma drug ‘Lunsumio' started the insurance reimbursement process immediately after its approval in Korea. According to industry sources, the anti-CD20/CD3 T-cell engaging bispecific antibody Lunsumio (mosunetuzumab) is starting the listing process using the approval-reimbursement evaluation linkage system. Lunsumio is the first product that was designated for the Global Innovative Product on Fast Track (GIFT) program. It received approval by the Ministry of Food and Drug Safety on the 3rd. The GIFT system supports the rapid commercialization of drugs for which there are no other existing treatment options, such as those aimed at treating life-threatening serious diseases or rare diseases. Lunsumio was considered a 'drug without an existing treatment’ and was designated as the first product for the GIFT program in November 2022. In addition to the GIFT designation, Roche sought more efficient market access by applying for an approval-reimbursement linkage system. Accordingly, attention is being paid to whether Lunsumio, the first GIFT drug, can produce significant results. Lunsumio can be prescribed to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Follicular lymphoma is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymphoid tissue become malignant. Because the symptoms are mild and progress slowly, approximately 80% of cases are discovered in Stage 3 or 4 after disease progression and show worse progression with relapse. Although the median progression-free survival (mPFS) for first-line treatment patients is 10.6 years but is reduced to 2 years in third-line treatment patients. Lunsumio is a first-in-class anti-CD20/CD3 T-cell engaging bispecific antibody for relapsed or refractory follicular lymphoma and is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. The dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. It was released as a finished product and can be administered immediately without waiting for the treatment manufacturing process, and outpatient treatment is possible without the need for hospitalization. The administration period is fixed to 8 cycles, and if the patient does not achieve complete remission during this period, it can be administered up to 17 cycles. Seok Won Kim, Professor of Hematology-Oncology, said, “Follicular lymphoma is considered a benign lymphoma with a life expectancy of up to 20 years, but the disease becomes more aggressive and the prognosis worsens with repeated relapses. Therefore, there is an urgent need for an effective treatment option that can provide a cure for patients who have relapsed more than twice.
- Company
- Scemblix may be prescribed at Big 5 Hospitals in KOR
- by Eo, Yun-Ho Nov 06, 2023 05:27am
- The next-generation chronic myeloid leukemia drug ‘Scemblix’ can now be prescribed at general hospitals in Korea. According to the industry sources, Novartis Korea's Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) treatment ‘Scemblix (asciminib)' has passed the drug committees of the Big 5 tertiary hospitals in Korea- Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, Sinchon Severance Hospital – as well as major medical institutions nationwide. As the drug was listed for reimbursement in June, the prescription environment seems to have been created quite quickly. Scemblix is reimbursed as a treatment for patients aged 18 and older with Ph+ CML in the chronic phase who are resistant or intolerant to two or more prior tyrosine kinase inhibitors (TKIs). However, Scemblix is only allowed reimbursed for patients without the T315I or V299L mutations in Korea. Meanwhile, Scemblix was approved in June last year as a treatment for adult patients with Ph+ CML in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs). Chronic myeloid leukemia is a malignant blood disorder that occurs when myeloid cells produce white blood cells. Although it progresses slowly, if left untreated, it can gradually progress to acute leukemia, and result in spleen enlargement and frequent infections as well as bleeding. Currently, TKIs are used to treat patients with chronic myeloid leukemia, but treatment may be limited due to intolerance or resistance, and the longer the treatment period, the higher the failure rate. Research results show that up to 70% of patients treated in the second line did not achieve major molecular response (MMR) within 2 years. Contrary to existing TKIs that had the potential to develop resistance due to mutations in the ATP binding site, Scemblix specifically binds to the ABL1 myristoyl pocket to overcome mutations at the defective BCR::ABL1 gene, which is associated with the over-production of leukemic cells., and is also called the STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. Through the mechanism of action, it shows high specificity for BRC-ABL1 and is unlikely to cause resistance due to mutations in the BCR-ABL1 gene, which is associated with resistance and intolerance in patients with chronic myeloid leukemia that used to occur with existing treatments. Meanwhile, Scemblix demonstrated its efficacy through the Phase III ASCEMBL study, which confirmed its clinical utility and safety profile in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who received at least two or more TKI treatments. Study results showed that Scemblix improved the rate of major molecular response (MMR) compared to its comparator bosutinib by 2 times. Also, the rate of treatment discontinuation due to adverse reactions in the Scemblix group was 5.8%, about one-fourth of the control group's 21.1%, confirming its overall safety profile.
- Company
- Wegovy and Mounjaro begin to dominate the obesity market
- by Kim, Jin-Gu Nov 06, 2023 05:27am
- Wegovy and Mounjaro Novo Nordisk Wegovy and Eli Lilly Mounjaro have grown explosively in the global market. The two products together generated sales of close to 4 trillion won by the third quarter. In the future, if Mounjaro officially obtains an obesity treatment indication from the FDA, competition between the two products is expected to become more intense. The obesity market rises vertically to Wegovy 4.1 trillion won and Mounjaro 3.9 trillion won According to the pharmaceutical industry on the 4th, Novo Nordisk's obesity treatment Wegovy recorded cumulative sales of approximately 4.1248 trillion won in the third quarter of this year. Sales increased nearly six times compared to the same period last year. Wegovy is a Semaglutide GLP-1 receptor agonist drug. Novo Nordisk first developed Ozempic as a diabetes treatment with the same ingredient and then relaunched it as Wigobi after proving its effectiveness in treating obesity. Since its launch, Wegovy has received a lot of attention. In the U.S. market, demand was high enough to cause shortages within a few months of launch. Thanks to Wegovy's sensation, Novo Nordisk's sales also increased significantly. Novo Nordisk's total cumulative sales in the third quarter amounted to approximately 31.67 trillion won, an increase of 33% in one year. Eli Lilly Mounjaro, which is considered a potential competitor to Wegovy, also posted sales close to 4 trillion won. According to the third-quarter performance data released by Eli Lilly on the 2nd (US local time), Mounjaro's cumulative sales in the third quarter amounted to $2.957.5 billion (approximately 3.91 trillion won). Compared to the same period last year, sales rose vertically by more than 14 times. It is estimated that most of the sales come from off-label prescriptions aimed at treating obesity. Currently, Mounjaro has been approved by the U.S. FDA as a treatment for diabetes. However, as the effectiveness of this product in treating obesity became known, it received great attention and was widely prescribed off-label in the United States. It contributed significantly to Lilly's overall sales growth. Lilly's cumulative sales in the third quarter were $24.77 billion (about 32.77 trillion won), a 16% increase compared to $21.2936 billion in the third quarter of last year. It is analyzed that although the sales of Trulicity, Lilly's highest-selling product, decreased by 7% due to supply instability, this was offset by the significant increase in sales of Mounjaro. Mounjaro will compete with Wegovy in earnest once its official obesity treatment is approved. Attention is focused on the timing of Mounjaro's official approval as an obesity treatment. Lilly has proven its weight loss effect through a separate phase 3 obesity clinical trial and is currently going through the approval process for obesity indications. Lilly expects to receive additional approval for obesity indications from the U.S. FDA within this year. If Mounjaro is officially approved as an obesity treatment within the year as Lilly plans, full-scale competition with WeGobee is expected after next year. Although there are no studies directly comparing the two drugs, looking at each clinical trial alone, Maunzaro's weight loss effect is evaluated to be slightly superior. In Mounjaro's SURMOUNT-1 study, the weight loss effect was found to be 15.0-20.9% depending on the drug dose. This study was conducted on 2,539 adults with a body mass index (BMI) of 30 or higher or a BMI of 27 or higher who suffered from one or more weight-related complications other than diabetes. When they were administered 5mg, 10mg, and 15mg of Mounjaro for 72 weeks, the weight loss rates were 15.0%, 19.5%, and 20.9%, respectively. Wegovy's STEP study showed a weight loss effect of 14.9%. The study was conducted on 1,961 adults with a BMI of 30 or higher or a BMI of 27 or higher who suffered from one or more weight-related diseases other than diabetes. When these people were administered Wegovy 2.4mg for 68 weeks, the weight loss rate was 14.9%. Additionally, the proportion of people who lost more than 5% of their body weight was 86.4%.
- Company
- Polivy’s reimb soon to receive CDDC review
- by Eo, Yun-Ho Nov 06, 2023 05:26am
- Whether progress will be made for the reimbursement of the lymphoma treatment ‘Polivy,’ which has applied for reimbursement again after changing its indication to the first-line, is gaining attention. According to industry sources, schedule coordination is underway for the review of the agenda of reimbursing Roche Korea’s Diffuse Large B-Cell Lymphoma (DLBCL) treatment Polivy (polatuzumab vedotin) by the Cancer Disease Deliberation Committee (CDDC), after completing opinion collection from academic societies. Polivy is the first-in-class ADC targeting CD79b that binds to CD89b, a protein expressed in the majority of B-cells, to induce apoptosis. The drug had applied for reimbursement with its first indication, as a third-line treatment in combination with standard BR therapy (rituximab-cyclophosphamide), in 2021, but failed to pass review by the Cancer Disease Deliberation Committee. The company resubmitted an application for its reimbursement in the first half of this year after extending its indication to the first line in November last year. In addition, the patient group Korea Alliance of Patient Organizations added its support, urging that for the prompt review of Polivy’s reimbursement at the CDDC level. On the 2nd, KAPO submitted a written opinion to the HIRA, requesting rapid CDDC review and reimbursement adequacy revaluation for Polivy. Therefore, whether Polivy’s reimbursement agenda will be submitted for review at the CDDC meeting scheduled for the 22nd remains to be seen. Diffuse large B-cell lymphoma is an aggressive type of hematological cancer and the most common form of non-Hodgkin's lymphoma. In Korea, the number of new patients diagnosed with DLBCL is estimated to be near 5,000 each year. As the most common form of non-Hodgkin lymphoma, DLBCL is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. DLBCL is generally responsive to treatment as over half of the patients reach remission, however, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP, or experience relapse after first-line treatment. Its first-line indication was approved based on the Phase III POLARIX trial. In the POLARIX trial, all patients were followed for over 24 months, and at a median follow-up of 28.2 months, the risk of disease progression, relapse, or death was reduced by 27% with Polivy + R-CHP compared with R-CHOP alone.
- Company
- Expansion of coverage for SMA treatment Spinraza
- by Nov 03, 2023 05:32am
- Biogen Korea held a press conference on the 2nd at the Conrad Hotel in Yeouido, Seoul to commemorate the expansion of the reimbursement standard for Spinraza, the first SMA treatment developed Differentiation between single-dose Zolgensma and oral Evrysdi “Spinraza welcomes relaxation of salary standards” Hyeongjun Park, Professor of Neurology at Gangnam Severance Hospital, gave a presentation on changes in the SMA treatment environment. Biogen's Spinraza, a treatment for spinal muscular atrophy (SMA) with the advantage of direct intrathecal administration and multiple administration, succeeded in easing the age limit for reimbursement. It showed the potential to differentiate itself from competing drugs such as Novartis' Zolgensma, a one-shot treatment, and Roche's Evrysdi, a PO drug. Biogen Korea held a press conference on the 2nd at the Conrad Hotel in Yeouido, Seoul to commemorate the expansion of the reimbursement standard for Spinraza, the first SMA treatment developed. In order to receive Spinraza coverage in Korea, patients with 5q SMA must be 5q ▲ genetically diagnosed with a deletion or mutation in the SMN-1 gene ▲ not using a permanent ventilator ▲ develop SMA-related clinical symptoms and signs under the age of 3 All criteria had to be met. Due to this benefit expansion, the age limit for children under 3 years old has been deleted. As a result, SMA type 3 patients who developed symptoms after the age of 3 can now begin treatment with Spinraza for which reimbursement is applied. This expansion of the reimbursement standard is considered to be one step ahead of competing drugs in dominating the SMA treatment market. Zolgensma, a one-shot treatment, works by inserting a functional replacement copy of the SMN1 gene into a carrier called a ‘vector’ and then delivering it to motor neurons in the body through intravenous injection. The disadvantage is that it is difficult to administer multiple doses to patients who cannot be treated with a single administration. Evrysdi, an oral medication, has a similar mechanism to Spinraza but has the disadvantage of not being able to be administered directly intrathecally. Park Hyeong-jun, a professor of neurology at Gangnam Severance Hospital, said, “Zolgensma can only be administered once, so if the patient has experienced the virus once, an immune response will occur, making multiple administrations difficult.” He added, “Due to the risk of an immune response, it is only administered to patients under 2 years of age.” He continued, “In the case of Evrysdi and Spinraza, there is no direct comparative study, so it is difficult to say which drug is better. The difference is that Spinraza can be administered directly intrathecally. Because Evrysdi is an oral medication, there is no guarantee that the drug will only go to the spinal cord when administered. “There may be a shortage of doses,” he added. He said that it is meaningful to see improvement in symptoms in a wider range of patients by lifting Spinraza's age restriction. Professor Park said, “It was getting worse, but it’s important to feel like it’s improving. The probability of a patient who cannot walk walking and a person lying down and rolling to the side are different. There are many patients whose movements gradually improve. “This is why we need Spinraza, a multi-dose drug,” he said, adding, “It is true that people are cautious because Spinraza is a drug that costs more than 10 million won per bottle, but it is meaningful that the scope of what can be done for patients has expanded due to this expansion of coverage.” Ultra-rare disease SMA, the advantage of Spinraza is that can be administered directly. SMA is a rare, genetic, neuromuscular disorder whose symptoms are caused by a deficiency of the survival motor neuron (SMN) protein caused by a damaged or missing SMN1 gene. People with SMA may have difficulty sitting, standing, and walking. SMA is a leading cause of death in infants and young children, affecting approximately 1 in 10,000 live births, and causes a variety of disabilities in patients older than their teens. It is classified into types 1 to 4 depending on the time of symptom onset. Spinraza is an antisense oligonucleotide (ASO) with a mechanism of action that continuously increases the amount of SMN protein. In order to deliver the treatment to the cause of the disease, it can be administered directly to the central nervous system where motor neurons are located through intrathecal injection therapy. Spinraza can be differentiated in administration method because it can be administered multiple times. The treatment has confirmed its continued effectiveness and safety profile across all ages and types based on clinical research data and real-world use evidence (RWE) accumulated through treatment for up to 8 years or more.
