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- 2026-03-17 23:19:10
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- Novartis starts reimbursement discussions for Zolgensma
- by Eo, Yun-Ho Aug 20, 2021 05:56am
- After ‘Kymriah,’ Novartis has now begun the reimbursement listing process for ‘Zolgensma.' According to industry sources, the application for the reimbursement of Novartis Korea’s Zolgensma (onasemnogene abeparvovec-xioi) that was submitted through the approval-benefit appraisal linkage system will be put on the agenda for deliberation by the Central Review Adjustment Committee in coming September. As a result, Novartis, which already has Kymriah (tisagenlecleucel) set for review by the Cancer Disease Review Committee (CDRC) on September 1st, will be working with the government to list two of its blockbuster drugs for reimbursement benefit in September. And the industry's eyes are focus on whether and how the two drugs will be listed for insurance benefits. Zolgensma is a treatment for Spinal Muscular Atrophy (SMA), like ‘Spinraza (nusinersen)’ that was approved in 2017, and is a gene therapy that contains a genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved Zolgensma as the second advanced biopharmaceutical after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of a single-shot of Zolgensma costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to this high price, the reimbursement approval process for Zolgensma in Korea is also not going to be easy. However, expectations on the drug's efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was recently presented had received much attention to that effect. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copy (Cohort 1) that were treated pre-symptomatically survived without requiring ventilatory or nutritional assistance, and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. Zolgensma is indicated in Korea for the treatment of pediatric patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) who ▲ have been clinically diagnosed with SMA Type 1 or ▲ has up to 3 copies of the SMN2 gene.
- Company
- The Supreme Court again rejected α-GPC suspension
- by Chon, Seung-Hyun Aug 19, 2021 06:02am
- The Supreme Court again rejected α-GPC suspension to negotiate the withdrawal of Choline alfoscerate. Pharmaceutical companies finally lost the withdrawal negotiations. According to an industry on the 17th, the Supreme Court's special department 2 decided to reject discontinuance of trials in negotiations on the recovery of the Choline alfoscerate system filed by 27 companies including Chong Kun Dang on the 12th. Discontinuance of trials is a system that does not accept appeals if it is judged that there is no specific reason. At the end of last year, the MOHW ordered the NHIS to sign a medical care contract for the system. It means that if the clinical trial fails, the MFDS should proceed with a recovery negotiation to return the entire amount of the health insurance prescription to the NHIS from the date of submission of the clinical plan to the date of deletion. It means that if the clinical re-evaluation of the Choline alfosculate system, which is being pursued by the MFDS, fails, pharmaceutical companies will have to return the prescription results to the NHIS from the date of submission of the clinical plan to the date of cancellation of the permit. Pharmaceutical companies filed an administrative litigation and suspension of execution against the MOHW's order to negotiate the recovery. The lawsuit was divided into 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang. The suspension of execution, which was raised by the Chong Kun Dang and others, was rejected in May after the ruling was rejected in January. Chong Kun Dang and others filed for a re-appeal, but it was rejected again. Following the first and second trials, the Supreme Court ruled in July that Daewoong Bio and others rejected discontinuance of trials. The suspension of execution, which was requested by pharmaceutical companies, was finally rejected. Pharmaceutical companies have also claimed suspension of execution for re-ordering the recapture negotiations. When the MOHW ordered renegotiation in June, 26 companies, including Chong Kun Dang, and 26 companies, including Daewoong Bio, were divided into an action for nullity and suspension of execution. On the 6th of last month, Daewoong Bio's request for suspension of execution was dismissed, and on the 8th of last month, the decision was made to dismiss the suspension of execution, which was raised by Chong Kun Dang and others. Chong Kun Dang and others have filed another appeal for suspension of execution.
- Company
- Will AML drug Xospata be reimbursed through PE exemption?
- by Eo, Yun-Ho Aug 18, 2021 05:52am
- Whether the new leukemia drug Xospata that is attempting reimbursement through the PE exemption track will be able to be listed for insurance benefit in Korea is receiving attention. According to industry sources, Astellas Korea’s acute myeloid leukemia (AML) treatment Xospata (gilteritinib), which applied for reimbursement through the PE exemption track, passed the Health Insurance Review and Assessment Service’s RSA subcommittee last June. However, after passing the subcommittee, the drug’s reimbursement was no put on as an agenda of the Pharmaceutical Benefit Assessment Committee in July or August, therefore making no progress in its discussions. Accordingly, speculation is rising that ‘applying 80% of the A7-adjusted lowest price for PE exempted drugs', which has recently emerged as a hot topic in the industry, may be the cause of the delay. Xospata is the first FLT3-targeted anticancer therapy to be approved by the Ministry of Food and Drug Safety in Korea to treat FLT3 mutation-positive (FLT3mut+) relapsed or refractory AML. The drug targets both FLT3-ITD and FLT3-TKD of the FLT3 mutations and may be self-administered orally once daily as monotherapy at home without frequent hospital visits. Also, the drug demonstrated better efficacy and safety compared to chemotherapy. Xospata has received the highest - ‘Category 1’ - recommendation in the NCCN Clinical Practice Guidelines for treating patients with relapsed or refractory (R/R) AML with an FLT3 mutation. Interest in Xospata is high as a treatment option that had never existed before. In fact, the Korea Alliance of Patients Organization had delivered their opinion requesting prompt reimbursement of new drugs including Xospata at a roundtable with the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits in May. Healthcare professionals have also shown high expectations for the drug. Hee-Je Kim, Professor of Hematology at the Catholic University of Korea’s Seoul St. Mary’s Hospital said, “The approval of Xospata in Korea has resolved the specific concern of patients having to endure the condition without a proper treatment option. Of course, the cost remains a problem, however, if the drug is listed for the insurance benefit, I believe it will quickly settle as the standard of care in for its indication." Kim added, “FLT3mut+ R/R AML patients need to promptly receive adequate treatment as they have a poor prognosis and are at risk of rapid disease progression. This is why Xospata is being continuously being prescribed even without reimbursement.”
- Company
- Hanmi & Organon maintain ₩70 billion worth contract
- by Kim, Jin-Gu Aug 18, 2021 05:52am
- Hanmi has maintained a copromotion contract with Organon, which is separated from MSD. According to the Financial Supervisory Service on the 18th, Hanmi signed a domestic copromotion contract with Organon in the second quarter. The contract is due at the end of this year. The items include hair loss treatment Propecia, prostate hypertrophy treatment Proscar, and osteoporosis treatment Fosamax. The total amount of prescriptions last year amounted to ₩67.7 billion. Propsia's prescription amount is ₩41.3 billion, Prosca's prescription amount is ₩14.3 billion, and Fosamax's prescription amount is ₩12.2 billion. Hanmi had already signed a contract with MSD to promote its products. However, the contract was changed as Oganon spun off the MSD earlier this year. In the end, Hanmi and Organon signed a new contract with the same contents. Hanmi has signed contracts with MSD and Organon for more than 10 years. The renewal of the contract is also due to the contract made in 2014. At that time, the two companies drew attention by signing a two-way contract to mutually promote products from each company, rather than a one-way contract for domestic companies to promote items from multinational companies. Hanmi has decided to jointly sell MSD's Propecia, Proscar, Fosamax, Andriol, Livial, Cosopt-S, Emend, Invanz, and Ezetrol. MSD has decided to co-promote Hanmi (such as PalPal and Tamsulosin). Earlier in 2009, MSD signed an overseas export contract with Amosartan, a hypertension combination drug of Hanmi. It was the first time a multinational pharmaceutical company sold a drug developed by a domestic company. It is currently sold in more than 50 countries under the name Cozaar XQ. Last year, MSD signed a license agreement with Hanmi to develop, manufacture, and commercialize dual agonist for non-alcoholic fatty hepatitis (NASH) treatments, which was canceled due to the return of Janssen's rights. In March this year, Hanmi's hyperlipidemia combination drug Rosuzet was released in Mexico under the name of NAXZALLA, and Organon is in charge of local marketing. Hanmi signed an export contract with MSD in 2017 to 23 countries, but the contract was recently changed following the establishment of Organon.
- Company
- Will GSK-SK Bioscience distribute flu vaccines?
- by Aug 18, 2021 05:51am
- It is not clear whether the distribution contract for Fluarix Tetra, a seasonal flu vaccine under way between SK Bioscience and GSK, will be distributed ahead of the inoculation season. According to the pharmaceutical industry on the 13th, SK Bioscience is likely not to market GSK's Fluarix Tetra this year. Sanogi's flu vaccine, Vaxigrip, is expected to be distributed only in part. Initially, SK Bioscience decided not to produce its flu vaccine SKY Cellflu this year to focus on producing COVID vaccine. Instead, it discussed a joint sales contract with its competitor GSK for Fluarix Tetra. Last year, GC Pharma distributed Fluarix Tetra. It also signed a Vaxigrip supply contract with Sanofi. If the contract is signed, SK Bioscience has planned to supply Fluarix Tetra since early October. SK Bioscience's sales marketing and consumer counseling office guided the supply schedule of Fluarix to hospitals and clinics and received inquiries to confirm the contract between the two companies. Suddenly, the two companies' contract discussions are on the verge of breaking up. Although no specific reason has been revealed, GSK is expected to find alternative partners. The flu season began in September, and GSK does not have much time. Clinics are also confused. "I was informed that SK Bioscience will supply Fluarix this year, but I am currently at a loss where to contact," said clinic A in Seoul. An employee of pharmaceutical company B, which distributes the flu vaccine, also said, "There are a lot of inquiries at the headquarters about supplying Fluarix Tetra instead of SK Bioscience." "It is true that the Fluarix Tetra supply contract is under discussion, but it has not been finalized," SK Bioscience said. "Sanofi's supply of Vaxigrip will be supplied in the fourth week of September as scheduled." GSK also said, "The final contract with SK Bioscience has not been finalized," adding, "We are continuously discussing various things to find Fluarix Tetra's partners."
- Company
- Medication imports in July are the largest ever
- by Kim, Jin-Gu Aug 17, 2021 05:53am
- Pharmaceutical exports of ₩700 billion have remained strong since last year. In July, domestic drug imports reached ₩1 trillion, the highest record ever. It is analyzed that it is a phenomenon caused by the full-fledged import of vaccines from Pfizer and Moderna. ◆Monthly import amount is close to ₩1 trillion, up 25% year-on-year According to the Korea Customs Service on the 16th, Korea's drug imports amounted to $819.58 million in July, the highest ever. Compared to $657.91 million in July last year, it rose by 25%. It is analyzed that the increase in COVID vaccines has affected. In fact, imports of vaccines (export and import codes 3002.20) in Korea averaged only $28.77 million (approximately ₩34 billion) last year, but this year, it started to increase rapidly. When Pfizer vaccine began to be imported in earnest, it increased to $49.82 million (about ₩58 billion) in March and ₩120 billion in June, when moderna vaccine began to be imported in earnest. In July, the figure nearly doubled to $211.62 million. Monthly drug imports, excluding vaccine imports, are maintaining around $600 million, similar to last year's. ◆₩710 billion in exports in July Drug exports amounted to $611.09 million, up 20% from July. Domestic pharmaceutical exports have been steadily rising since last year. The monthly average amount of drug exports last year was $574.46 million, which is more than $646.71 million until July this year. Like last year, biosimilar is leading drug exports. Celltrion recorded ₩789.5 billion in exports through Celltrion Healthcare in the first half of this year. Compared to ₩777.2 billion in the first half of last year, it increased by 2%. The sales of Remsima and Remsima SC totaled ₩337.3 billion, Truxima's sales of ₩273.3 billion, and Herzuma's sales of ₩102.2 billion. Although Samsung Biologics' sales performance in the first half of the year is not specific yet, considering that its provisional sales in the first half of the year increased 31% year-on-year, CMO exports centered on biosimilars are also expected to have increased significantly. In addition, domestic diagnostic kits were exported to $77.34 million in July, up 14% from a year earlier. Exports of diagnostic kits have been maintained at $70 million to $80 million this year. Exports of domestic botulinum toxin in July amounted to $16.67 million, which was not much different from the same period last year ($16.96 million).
- Company
- Insulin·GLP-1 combo Xultophy lands in ‘Big 5’ hospitals
- by Eo, Yun-Ho Aug 17, 2021 05:52am
- The insulin and GLP-1 receptor agonist combination drug ‘Xultophy’ can now be prescribed in general hospitals. According to industry sources, Xultophy FlexTouch inj., a fixed-ration combination of Novo Nordisk Korea’s insulin Tresiba (insulin degludec)’ and the GLP receptor antagonist ‘Victoza (liraglutide injection),' has passed the drug review of drug committees (DCs) of 50 medical institutions in Korea, including the Big-5 general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. The drug is reaching practice quickly after being listed for insurance benefits in May. Xultophy was approved in August 2019 in Korea for the treatment of patients with insufficiently controlled type 2 diabetes even after taking a combination of GLP-1 receptor agonist and oral hypoglycemic agents or basal insulin and oral hypoglycemic agents. The drug demonstrated superiority or noninferiority in reducing HbA1c levels, reduced incidence of hypoglycemic episodes, and better weight control in various DUAL clinical trials (DUAL I ~ IX) over control groups using the unique complementary mechanism of action brought from the insulin degludec and liraglutide combination. In particular, In the 26-week DUALⅤstudy that was conducted on 557 Type 2 diabetes patients with type 2 diabetes inadequately controlled by insulin glargine U100 and metformin, Xultophy showed superior HbA1c lowering effect over basal insulin, significant weight loss control effect, and a significant decrease in the incidence of hypoglycemia events with a lower dose of daily insulin. In the DUAL V study, the Xultophy-administered group showed a superior HbA1c level reduction effect of -1.81% over the insulin glargine U100-administered group’s -1.13%. Also, in weight change, the Xultophy arm's weight loss was -1.4kg compared to the +1.8kg of the insulin glargine U100 arm, amounting to a total of -3.2kg weight loss in total. Also, Xultophy reduced hypoglycemic episodes by 57% compared to the insulin glargine U100 arm. Xultophy is a pen-type injector that contains a combination of basal insulin and GLP-1 analogue that can be administered once daily at any time of the day, with or without meals. The maximum daily dose of Xultophy is 50 dose steps, and for those transferring from insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps, after which dose adjustment is required based on the individual’s fasting blood glucose level.
- Company
- Reimb. to be expanded for PARP inhibitor Lynparza and Zejula
- by Eo, Yun-Ho Aug 13, 2021 05:58am
- The PARP inhibitors ‘Lynparza’ and ‘Zejula’ both crossed the last hurdle in extending their insurance benefits. According to industry sources, AstraZeneca Korea and Takeda Pharmaceuticals Korea have both completed drug pricing negotiations with the National Health Insurance Service (NHIS) to expand their PARP (poly ADP ribose polymerase) inhibitor Lynparza (olaparib) and Zejula (niraparib)’s indications to first-line maintenance treatment in ovarian cancer. Negotiation for the two drugs concluded at the same time because Lynparza’s negotiation period had been extended once. Upon passing the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee meeting this month, the insurance benefit of the two drugs is expected to be extended without difficulty. The approvals are also expected to quickly translate into actual prescriptions. In April, AstraZeneca has already completed the landing procedures for the Lynparza tablet formulation that will be used for the new extended indication in the ‘Big 5’ general hospitals - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital. Zejula’s formulation does not differ by indication, therefore, its prescription code has already been inserted in most medical institutions. However, the expanded reimbursement coverage will not benefit the BRCA-negative patients that account for 80-90% of the total ovarian cancer population. The Lynparza tablet had been approved as a maintenance treatment in the BRCA-positive patient population from the start. Zejula had applied for an ‘All-Comer’ indication regardless of the BRCA mutation status, however, HIRA’s Cancer Disease Deliberation Committee only approved the BRCA-positive indication. Faced with the high barrier to reimbursement, Takeda Pharmaceuticals decided to take the safe road and be first listed for the BRCA-positive indication. Lynparza and Zejula both own the BRCA-negative indication as a second-line or later maintenance therapy, however, reimbursement for these indications was not passed yet. Professor Jae-won Kim of the Obstetrics and Gynecology Department at SNUH said, “Using a drug as maintenance therapy in the first-line and second-line or higher-line is very different, and using the drug earlier will increase the rate of survival. Personally, I believe that coverage for the PARP inhibitors as maintenance treatment should be extended to benefit as many patients as possible in the first-line.” Zejula was first listed for insurance benefit at ₩76,400 under the Risk-sharing agreement (RSA) scheme, and was determined cost-effective over its substitute, Astrazeneca’s ‘Lynparza (olaparib).’ However, as Lynparza was listed through the PE exemption track, both were applied the RSA Expenditure cap type of reimbursement.
- Company
- Alvogen is targeting patents for Roche's Avastin
- by Kim, Jin-Gu Aug 13, 2021 05:58am
- Avastin Alvogen Korea has started patenting Roche's blockbuster anti-cancer drug Avastin (Bevacizumab). Two types of Avastin biosimilar are already licensed in Korea. According to the pharmaceutical industry on the 12th, Alvogen Korea recently filed an invalid trial on Roche's two patents of Avastin. Roche is registering a total of four patents with Avastin, including one material patent and three use patents. Material patent registered in Korea has already expired in April 2018. Two out of three patents are related to ovarian cancer treatment, and the other one is related to combined therapy. There are two patents related to single therapy that Alvogen is targeting. If Alvogen overcomes this patent, it will be able to release its product in Korea. Two Avastin biosimilars have been licensed so far. Samsung Bioepis' Onbevezy and Pfizer's Jairabeve. Boryung was in charge of domestic sales of Onbevezy. Both companies are expected to officially release them in the second half of this year. More companies are competing in the global market. Mvasi, co-developed by Amgen and Allergan, is competing with Avastin. In addition, Boehringer Ingelheim, Biocon, Astrazeneca, Kyowa Kirin Korea, Celltrion, Prestige BioPharma, and others are developing biosimilars. Avastin is used for metastatic colon or rectal cancer, non-squamous, non-small cell lung cancer, metastatic breast cancer, glioblastoma (GBM), metastatic renal cell carcinoma. As of 2019, it recorded about ₩8.8 trillion in sales in the global market. It recorded ₩118 billion in sales in the domestic market last year.
- Company
- SGLT-2 inhibitor Forxiga lands in Korea with CKD indication
- by Eo, Yun-Ho Aug 12, 2021 06:05am
- An SLGT-2 inhibitor is soon expected to be available for use in chronic kidney disease (CKD) patients in Korea. According to industry sources, the indication of AstraZeneca’s diabetes treatment ‘Forxiga(dapagliflozin)’ will be expanded to ‘the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes' within a few days. After receiving approval from the US FDA in April, the company had immediately begun the approval process in other major countries including Korea. In September, the company received EMA approval for the additional indication in September. With the indication, Forxiga can be used to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or hospitalization for HF (hHF). The approval of Forxiga’s CKD indication is based on positive results from the DAPA-CKD Phase III trial. The FDA had granted Priority Review for Forxiga earlier this year. In the DAPA-CKD trial, Forxiga reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39% compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion (UAE) levels. The absolute risk reduction of Forxiga was 5.3% in the 2.4 year median study period. CKD is a progressive condition that affects around 700 million patients around the world. With only a limited amount of treatment options available for CKD patients at present, a new treatment option had been necessary in the field as CKD increases the incidence of cardiovascular events such as heart failure and the risk of premature deaths. Forxiga is currently used as a treatment for Type 2 diabetes and chronic kidney disease. Its competitor, Boehringer Ingelheim’s ‘Jardiance (empagliflozin)’ also received the fast-track designation in the first half of last year and the company is conducting the EMPA-KIDNEY trial to expand the drug's indication like Forxiga. Unlike Forxiga’s DAPA-CKD trial, Jardiance's EMPA-KIDNEY trial includes severe CKD patients.
