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- 2026-05-03 21:03:14
- Company
- Trelegy 200 Ellipta may be prescribed at tertiary hospitals
- by Eo, Yun-Ho Jun 25, 2024 05:46am
- The double dose Trelegy Ellipta, which received approval in Korea for asthma, not COPD, may now be prescribed at general hospitals in Korea. According to industry sources, GSK Korea's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) has passed the drug committees (DCs) of the Big 5 tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. Trelegy 200 Ellipta, which was listed for reimbursement since March this year, may be prescribed to treat patients with "severe asthma that is not adequately controlled with a maintenance combination of a medium or high dose of an inhaled corticosteroids (ICS) and long-acting inhaled beta-2 agonists (LABA). As such, it remains to be seen whether GSK will be able to expand the indication beyond COPD to asthma in the near future. The efficacy of Trelegy 200 Ellipta was verified through the Phase III CAPTAIN study, which evaluated Trelegy 200 Ellipta versus a two-drug combination of fluticasone furoate/vilanterol (FF/VI) in 2,436 adult asthma patients aged 18 years and older whose symptoms were not controlled despite maintenance ICS/LABA therapy. The primary efficacy endpoint of the study measured the change in FEV1 (Forced Expiratory Volume in 1 second) in each arm after 24 weeks of treatment. Results demonstrated statistical significance, with the Trelegy 200 Ellipta arm showing a 110 mL improvement over FF/VI Also, the safety profile of Trelegy 200 Ellipta in treating asthma was comparable to what was previously seen with the active ingredient and the existing combination products. The most common adverse reactions were nasopharyngitis (13-15%), headache (5-9%), and upper respiratory tract infection (3-6%), and serious adverse reactions occurred similarly across all treatment arms. Professor Jaewon Jeong from Inje University Paik Hospital said, “Asthma is a chronic respiratory disease that requires lifelong management. This is why patients who experience asthma exacerbations need to receive appropriate treatment.” Jeong added, "Major asthma practice guidelines also recommend triple combination therapy that adds LAMA to ICS/LABA before starting oral corticosteroid therapy as the optimal treatment regimen for patients with severe asthma whose symptoms are not controlled by the two-drug ICS/LABA combination therapy."
- Company
- 'Camzyos' receives DREC’s reconsideration decision
- by Eo, Yun-Ho Jun 25, 2024 05:46am
- BMS Korea’s Camzyos (mavacamten). The final decision was not reached on the first attempt. The path to getting 'Camzyos,' the first novel drug for obstructive hypertrophic cardiomyopathy (oHCM), listed for reimbursement seems to be challenging. According to the industry sources, BMS Korea’s Camzyos (mavacamten), a novel drug used to treat obstructive hypertrophic cardiomyopathy (oHCM), was considered for review by the Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) but received a 'reconsideration' decision. After clearing the Economic Evaluation Committee of Health Insurance Review, it was rapidly considered for the DREC review. However, as the drug is the first-in-class treatment option for the disease, it is likely not to have received a decision at the first attempt. Yet, since the government is making efforts to improve the value estimation of new drugs, including providing preferential measures for innovative new drugs, it is to be watched how these measures will affect the assessment of Camzyos in the upcoming DREC review. Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Its underlying mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, and thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Because no treatments have been available to treat oHCM for a long time, Off-label medications were used to manage symptoms. Because of Camzyos, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trial (RCT) have confirmed the significant effect of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. American College of Cardiology (ACC) and the American Heart Association (AHA) are preparing to update their guidelines. Furthermore, based on this phase 3 trial evidence, the U.S. FDA granted Camzyos Breakthrough Therapy Designation (BTD) and approval. Considering these factors, Camzyos appears to have met the criteria of an innovative new drug, announced by the government last year: ▲There are no alternative products, therapeutically equivalent products, or therapies available ▲Extending the survival period significantly and showing clinically meaningful improvements ▲Has been approved for MFDS’ GIFT (priority review designation), U.S. FDA’s BTD, or Europe’s EMA expedited review (PRIME). Meanwhile, Camzyos demonstrated efficacy through Phase 3 EXPLORER-HCM trials. In this trial, Camzyos improved primary endpoints, the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), by more than twofold compared to the placebo. 20% of the Caymzyos treatment group met NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by fourfold after exercise. 10 out of 7 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effect for 30 weeks.
- Policy
- LG Chem and Samsung Bioepis's biosimilars are reimbursed
- by Lee, Tak-Sun Jun 25, 2024 05:46am
- LG Chem and Samsung Bioepis’ biosimilar products will be listed for reimbursement in July. LG Chem is launching a biosimilar of the autoimmune disease treatment Humira, and Samsung Bioepis is launching a biosimilar of Stelara. Both are aiming to list at the lowest price to compete with their respective original products. According to industry sources on the 23rd, LG Chem's Humira biosimilar Xelenka Autoinjector Inj 40mg/0.4L and Xelenka Prefilled Syringe Inj 40mg/0.4mL will be listed at KRW 220,390 from month. Samsung Bioepis' Stelara biosimilars Epyztek Prefilled Inj and Epyztek Intravenous Inj will also be listed the same month at KRW 1,292,890 and KRW 1,355,393, respectively. These are the first Stelara biosimilars to be reimbursed in Korea. Humira is a TNF-a inhibitor used for 13 autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, ulcerative colitis, and adult Crohn's disease. The drug confirmed an effect in various diseases through its mechanism of action that inhibits TNF-α (tumor necrosis factor-alpha), which affects immune diseases. As of last year, its sales amounted to KRW 86.6 billion based on IQVIA. The domestic market for Humira biosimilars opened in earnest with Samsung Bioepis launching Adaloce with reimbursement in May 2021 and Celltrion launching Yuflyma in March 2022. According to IQVIA sales, Adaloce sold KRW 13.1 billion and Yuflyma sold KRW 1.8 billion last year. Sales of the biosimilars are fiercely chasing the original. LG Chem’s Xelenka was approved in December last year. It took 7 months for the drug to be listed for reimbursement after approval. Like other biosimilars, it is a high-concentration formulation that offers improved patient convenience. As a latecomer to the market, the company also paid attention to the price of Xelenka. Currently, for the 40mg/0.4mL dose, the original Humira is priced at KRW 280,891, and the biosimilars Adaloce and Yuflyma at KRW 248,877. LG Chem’s Xelenka is priced lower than these and will be listed at KRW 223,900. It is about KRW 20,000 cheaper than other biosimilars and KRW 60,000 cheaper than the original. Samsung Bioepis, the first company to introduce a Stelara biosimilar, also significantly reduced its product’s price from the estimated price. While biosimilars are usually priced at 80 percent of the original, Samsung Bioepis’s product will be listed at 50 to 60% of the original price. Stelara Prefilled Syringe Inj is priced at KRW 2,182,000, while Epyztek Prefilled Inj is priced at about KRW 900,000 cheaper at KRW 1,298,290. Also, when comparing the IV injection versions, Stelara IV Inj is priced at KRW 2,261,500, compared with EpyztekIV, which is priced at KRW 1,345,593. Stelara generated sales of KRW 47.4 billion last year based on IQVIA. Stelara is indicated and reimbursed for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older, active psoriatic arthritis in adults, active Crohn's disease in adults, and moderate-to-severe ulcerative colitis in adults. Following Samsung Bioepis’s footsteps, Celltrion received approval for Steqeyma PFS on March 12. Samsung Bioepis is believed to have adopted a lowest-price strategy to occupy the market before Celltrion's product is listed. Biosimilars are products approved after demonstrating equivalence and effectiveness to the original product. As biosimilar companies sell their products at a significantly reduced price compared with the original product, the financial burden borne by patients is greatly reduced upon the introduction of biosimilars.
- Policy
- Combinatory drugs with linagliptin+dapagliflozin
- by Lee, Tak-Sun Jun 25, 2024 05:46am
- Following the patent expiration of DPP-4 inhibitor Trajenta (linagliptin), combinatory drugs containing linagliptin have been released. Next month, a combinatory drug containing linagliptin combined with SGLT-2 inhibitory dapagliflozin will enter the market. It is a combinatory drug with a new combination being introduced in South Korea. According to the industry sources on June 24th, Aju Pharm’s 'Dapalina Tab,' containing dapagliflozin propanediol hydrate combined with linagliptin, will be listed for reimbursement on July 1st. It is a combinatory drug with a new combination of SGLT-2 inhibitory dapagliflozin with DPP-4 inhibitor linagliptin. The Ministry of Food and Drug Safety (MFDS) categorized Dapalina Tab as an incrementally modified drug (IMD). Therefore, Dapalina Tab’s drug price was credited 59.5% instead of an adjusted amount of 53.55% for a year. Aju Pharm’s Dapalina Tab will be priced KRW 883 per tablet. However, companies receiving CMO products from Aju Pharm have not received IMD approvals. Therefore, the drug prices were calculated based on adjusted amounts. This has affected the prices of drugs such as Hutex Korea Pharmaceutical’s Traxiga Tab 10/5 mg, Boyung’s Trudapa L Tab 10/5 mg, Whan In Pharm’s Posarina Tab 10/5mg, Hanlim Pharm’s Daparo L Tab 10/5 mg, Ilhwa’s Posijenta Tab, GC Biopharma’s Linadapa G Tab, and HK inno. N’s Dapa N Jenta Tab 10/5mg. The prices of these drugs were calculated as KRW 795 per tablet. According to Aju Pharm, phase 3 trials of Dapalina Tab were conducted in 30 university hospitals in South Korea. The results showed a 0.88% reduction in HbA1c at 24 weeks compared to the placebo group (MET+linagliptin). There were no significant differences in drug-related adverse reactions observed. Combinatory drugs containing SGLT-2 inhibitor and DPP-4 inhibitor have been released after the reimbursement criteria for these drugs were established in April of last year. The Ministry of Health and Welfare (MOHW) approves reimbursement of prescriptions for combinations of these two classes of drugs with metformin. Drugs with SLGT-2 inhibitory and DPP-4 inhibitory mechanisms of action are commonly used to treat diabetes. Due to the complementary mechanisms of the two drugs, a combinatory drug is expected to have a superior effect on regulatory blood glucose levels. After the patent expiration of SGLT-2 inhibitor Forxiga (dapagliflozin propanediol hydrate) in April of last year and DPP-4 inhibitor Januvia (sitagliptin phosphate hydrate), pharmaceutical companies in South Korea have launched combinatory drugs containing Forxiga and Januvia. As the patent for DPP-4 inhibitor Trajenta (linagliptin) expires this month, combinatory drugs containing linagliptin will be introduced.
- Opinion
- [Reporter's View] No more exemptions, just deferrals
- by Eo, Yun-Ho Jun 24, 2024 05:47am
- The Korean government has set out to fix the pharmacoeconomic evaluation exemption system. Although the authorities coined it as an “improvement,” the direction seems to be near a “reduction.” A report on a study commissioned by the Health Insurance Review and Assessment Service was released at the end of last year. The study, titled 'Study on Preparing a Plan to Improve the System for Exemption from Submission of Pharmacoeconomic Evaluation Data,' analyzed the current status and issues of Korea’s pharmacoeconomic evaluation exemption system, which was introduced in 2015, and proposed measures for its improvement. The report claims that the core of the improvement plan is to change the exemption system into a deferral system. The report pointed out that the core of the positive-listing system is the cost-effectiveness evaluation, therefore, Korea should not exempt drugs from evaluations when other countries do conduct evaluations. Based on the research results, HIRA proposed a revision of the current PE exemption system. To this end, the HIRA and the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently held their first meeting. The industry's reaction to this is understandably grim. The PE Exemption System is literally the only way out for drugs that are difficult to evaluate but deemed necessary. It contains various financial control devices and has embraced an "expenditure cap" design since its inception. In fact, the industry has been constantly claiming that the current system has too high a threshold and has consistently emphasized the need for its expansion. Of course, the contents of the recent report will not be reflected 100%. However, the proposed measures in the report will hardly be satisfactory for the industry. Even now, it is not easy for companies to apply for the PE exemption system, and the number of eligible drugs will be significantly reduced if the reform is implemented. For example, contrary to how the current 200 patients or fewer (the usual threshold required to be eligible for the PE exemption) requirement refers to the number of patients that fall within the drug's scope of use, the proposed reforms refer to a stand-alone disease, meaning that a drug that would have been eligible if it met the 200 patients or fewer requirement based on its genotype or line of therapy indication must now have 200 or fewer patients affected by the disease itself. The fundamental purpose of deferring the PE exemption is more difficult to understand. The pharmaceutical industry has constantly requested the application of a flexible ICER threshold. And we have heard endlessly about how Korea’s ICER threshold is too strict for drugs to be reimbursed. It is doubtful whether drugs that would not have been listed if not for the PE exemption system will be able to remain reimbursed when evaluated after the deferred period. If some regulations are tightened, some need to be loosened as well. The government is already planning to save national health insurance finances by implementing bold drug price reduction mechanisms such as external reference pricing reevaluations and revision of the price-volume linkage system. It may be that the number of applicable drugs has increased since the implementation of the system, rendering improvements necessary. However, it is also true that this system has served as a 'breathing hole' in Korea's listing system, we need to devise other ways out before closing that hole.
- Policy
- Will GMP One-strike-out be loosened?...MFDS, 'negative'
- by Lee, Hye-Kyung Jun 24, 2024 05:47am
- While pharmaceutical companies advocate for loosening the 'Cancellation of the GMP compliance decision' act, the Ministry of Food and Drug Safety (MFDS) says it will start a discussion once it receives an official submission of opinions. This is in response to biopharmaceutical companies’ submission of a statement last month regarding the necessity of improving the 'Cancellation of the GMP compliance decision' act. The groups have continuously voiced concerns over the policy. According to industry sources on June 24th, the MFDS’ GMP One strike-out was applied to Korea Syntex Pharmaceutical earlier this year, following Hutecs Korea Pharmaceutical at the end of last year. After the court suspended execution due to administrative claims, opinions were gathered to rediscuss the policy. “We are open to meeting regarding the issue,” Kim Sang Bong, Director of the Pharmaceutical Safety Bureau, said. “To our knowledge, there is an official committee within the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), and we would like them to submit an official statement of opinions.” According to a statement from biopharmaceutical companies, if non-compliance with GMP has been unintentional, a different set of measures should be applied instead of one strike-out. "The National Assembly legislation has enacted a policy for the cancellation of the GMP compliance decision,” Kim said. “As this policy is not part of the MFDS’ administrative rules, MFDS is simply carrying out the legislative body’s policy.” As a result, even if companies request that the policy be loosened within the law, MFDS has nothing to offer because it is a regulatory agency. “We acknowledge that the pharmaceutical industry regards the one-strike-out policy as a significant issue, we are open to meeting when they request discussion through the Quality Committee,” Kim said. “When there is an agenda, we will visit the KPBMA for a discussion.” On December 11, 2022, the MFDS initiated a GMP one-strike-out act. According to this act, when a company is found to violate the Good Manufacturing Practices (GMP) for medicinal products, such as falsely receiving GMP approvals or falsely documenting GMP repeatedly, their GMP compliance approval may be revoked. Hutecs Korea Pharmaceutical was the first target of this act and received a disposition, and their plant was suspended and then re-opened after the suspension of execution. Korea Syntex Pharmaceutical was in the process of canceling the GMP compliance decision, but it has been put on hold. Dongkoo Bio&pharma is expected to be the third target for canceling the GMP compliance decision. An official from the MFDS said, “In general, the details of disposition are posted through the website, and we cannot provide answers to a matter under review.” “We have released the first case details of Hutecs Korea Pharmaceutical through a press release to inform the industry of GMP adherence. We reviewed the scope of the disposition and criteria,” an official added. The MFDS states that apart from Hutecs Korea Pharmaceutical, other companies that receive the cancellation will not be disclosed when there is a suspension of the act through trials. Once the cancellation is confirmed, it will be posted on the website.
- Company
- K-Bios make bid into pancreatic cancer treatment environment
- by Son, Hyung-Min Jun 24, 2024 05:47am
- The domestic pharmaceutical and bio-industry has made a bid into the development of new drugs for pancreatic cancer through the use of combination therapy. Despite the development of various treatments to date, the five-year survival rate of pancreatic cancer has remained the lowest among the top 10 cancers, at 12.6%. Pancreatic cancer is difficult to detect early due to its organ location and is known for its poor prognosis. Domestic pharma and biotech companies have chosen 'combination therapy' as a strategy to improve the treatment effect of its pancreatic cancer treatments while reducing the side effects of existing platinum-based chemotherapy. Currently, NeoImmuneTech, CG Invites, MedPacto, and Prestige Biopharma have started development of new drugs for pancreatic cancer. Companies pursue new drug development as combination therapy…many enter clinical trials According to industry sources on the 22nd, NeoImmuneTech recently disclosed the results of its Phase IIa clinical trial that evaluated its new drug candidate NT-I7 in combination with Keytruda. NT-I7 is a treatment that amplifies T-cells and is currently being tested in patients with poor response to immuno-oncology drugs. The study evaluated the efficacy and safety of NT-I7 plus Keytruda in 50 patients with previously treated metastatic colorectal cancer and 48 patients with pancreatic cancer. Results showed that 3 of the 48 pancreatic cancer patients achieved a partial response (PR). The median overall survival (OS) was 11.1 months. In addition, NeoImmuneTech plans to investigate the feasibility of combining NT-I7 with an anti-cancer vaccine. CG Invites has finalized the dose and begun dosing patients in its Phase II clinical trial of ivaltinostat, which it is developing for pancreatic cancer. The company received investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) to initiate its Phase Ib/II trial in 2022. Ivaltinostat is an HDAC histone deacetylase (HDAC) inhibitor class anticancer drug. This new drug candidate binds to HDAC inhibits tumor cell activity and regulates the expression of oncogenes, inducing cancer cell death. Ivaltinostat is known to inhibit HDACs 1, 2, 3, 6, and 10. The Phase II trial evaluated the efficacy of the ivaltinostat plus capecitabine combination in 52 patients with advanced or metastatic pancreatic cancer whose disease has not progressed after receiving folfirinox therapy. Medpacto is identifying potential new medicines for pancreatic cancer by combining its vactosertib with FOLFOX therapy, and with a protein arginine methyltransferase 5 (PRMT5) inhibitor, ‘T1-44.’ PRMT5 is an enzyme that promotes cancer growth and shows increased expression in a variety of cancers, including pancreatic cancer Vactosertib selectively inhibits the transforming growth factor-beta (TGF-β) signaling pathway, which impairs the therapeutic effect of immuno-oncology drugs. Medpacto plans to maximize its treatment effect by combining its use with a PRMT5 protein inhibitor, which inhibits the enzyme known to promote cancer growth. The recently published preclinical results showed that vactosertib plus T1-44 showed anticancer activity in a mouse model with pancreatic cancer. Specifically, the combination of vactosertib and T1-44 increased mouse model survival by 60% compared to T1-44 alone. The combination also showed changes in genes involved in apoptosis and the extracellular matrix processes. Prestige Biopharma has initiated a clinical trial for its antibody-drug candidate PBP1510 in the US. PBP1510 neutralizes the Pancreatic adenocarcinoma up-regulated factor (PAUF) protein, a target for the treatment of pancreatic cancer. Prestige Biopharma plans to confirm the safety and tolerability of PBP1510 in combination with gemcitabine in a Phase 1 clinical trial. In addition, GC Cell is investigating the combination of its anticancer immune cell therapy Immunecell-LC with gemcitabine as a potential new drug for pancreatic cancer. GC Cell is also looking to expand the indication for Immunecell-LC, which is currently approved for liver cancer. The company received approval to initiate a Phase III clinical trial in 2021 and began dosing patients.
- Policy
- Price of BI’s diabetes drug Trajenta is cut 30% from July
- by Lee, Tak-Sun Jun 24, 2024 05:46am
- Price of Boehringer Ingelheim’s flagship diabetes drugs ‘Trajenta’ and ‘Jardiance’ will both be cut in July. Trajenta will receive an ex officio price cut due to the entry of its generic while Jardiance will see a price cut after completing price-volume agreement (PVA) negotiations. According to industry sources on the 21st, the insurance ceiling price of Boehringer Ingelheim’s diabetes drug brands Trajenta and Jardiance will be adjusted as of July 1st. Trajenta is a DPP-4 (dipeptidyl peptidase-4) inhibitor class, and Jardiance is an SGLT-2 (sodium-glucose co-transporter 2) inhibitor for diabetes. Based on UBIST, Trajenta generated KRW 61.3 billion in outpatient prescriptions, and Trajenta Duo, which is a combination of Trajenta and metformin, generated KRW 62.1 billion. In the same period, Jardiance generated outpatient sales of KRW 58.1 billion. The two are leading products in the diabetes drug market. Trajenta’s drug price cut is being made ex officio with its generic versions being listed for reimbursement from the 9th. 15 single-agent Trajenta generics and 108 combination Trajenta Duo generics are currently listed. As a result, the price of the single-agent Trajenta Tab will be reduced 30% from KRW 750 to KRW 525. In addition, the price of the 3 combination Trajenta Duo Tab products will be reduced from KRW 387 to KRW 338 for the 2.5/500mg and 2.5/850mg dose (12.7%p price cut), and to KRW 344 for the 2.5/1000 mg (11.1%p price cut) dose. Jardiance’s price ceiling was adjusted under Type B of the Price-Volume Agreement. Type B negotiations are initiated when a product’s insurance claims amount increases by more than 60% from the previous year, or when the product’s claims amount increases by more than 10% and the amount exceeds KRW 5 billion. Accordingly, the price of Jardiance Tab 10mg will be reduced from KRW 650 to KRW 618 and Jardiance Tab 25mg will be reduced from KRW 839 to KRW 798. The price reduction rate is 4.9% each. Jardiance is the only foreign SGLT-2 inhibitor class brand being used in Korea. Other SGLT-2 inhibitor class single agent drugs from abroad such as Forxiga, Steglatro, and Suglat withdrew from the Korean market. Among domestic brands, Daewoong Pharmaceutical's ‘Envlo Tab’ is available as an SGLT-2 inhibitor class drug.
- Company
- Pfizer reapplies for reimb listing of Vyndamax in Korea
- by Eo, Yun-Ho Jun 21, 2024 05:47am
- ‘Vyndamax,’ a new drug for transthyretin amyloid cardiomyopathy (ATTR-CM), is again attempting reimbursement listing in Korea. According to industry sources, Pfizer Korea had recently submitted an application for the insurance reimbursement of Vyndamax, its new drug for transthyretin amyloid cardiomyopathy (ATTR-CM). Vyndamax failed to receive the essential drug designation in its first reimbursement attempt in early 2021. The company then conducted a pharmacoeconomic evaluation in the first half of the same year and made its second attempt through the risk-sharing agreement (RSA) track, but to no avail. In April 2022, the drug again failed to pass the MFDS’s reimbursement standard subcommittee threshold again, then passed the threshold in July of the same year, but was rejected by the Drug Reimbursement Evaluation Committee after 9 months. It is believed that the government and the pharmaceutical company were unable to reach an agreement on the risk-sharing plan. Vyndamax is virtually the only treatment option available for ATTR-CM. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. In this area with a dire need, Vyndamax demonstrated a reduction of cardiovascular events in ATTR-CM patients and improvement in their functional athletic ability in the six-minute walk through the Phase III ATTR-ACT study. Based on these results, healthcare professionals in Korea are also insisting on the necessity of prescribing Vyndamax. Due to its high cost, the decision lies in the will of the government and the company. As the little attention paid to reimbursement listing of rare disease treatments is emerging as an issue, whether Vyndamax will bring a different result this time remains to be seen. Jung-Woo Son, Professor of Cardiology at Wonju Severance Christian Hospital, said, “The domestic ATTR-CM treatment environment has made rapid progress with the approval of Vyndamax last year, the only drug that provides practical survival benefits to ATTR-CM patients. However, the continued non-reimbursement of the drugs brought on the unfortunate situation where patients cannot start treatment even after diagnosis.”
- Policy
- Low-dose 'nicergoline' is increasingly becoming available
- by Lee, Hye-Kyung Jun 21, 2024 05:47am
- Il Dong’s Sermion, the original drug containing nicergoline. Old drugs containing the active ingredient 'nicergoline' are on the rise for substituting 'choline alfoscerate,' which is under reassessment of clinical and reimbursement. The lower doses are also being approved. Previously, companies mostly received approvals for items containing 30 mg doses, which obtained indications for the first-line treatment of symptoms associated with dementia. However, Hanmi Pharm, Chong Kun Dang Pharm, and Whan In Pharm have also secured 10 mg doses, following in the footsteps of the original 'Sermion' by Il Dong. According to the Ministry of Food and Drug Safety (MFDS), Whan In Pharm received approval for its 'Niceon Tab 10 mg' on June 19th. Low-dose items containing 5 mg and 10 mg nicergoline have the efficacy and effectiveness in ▲ improving cerebral infarction cerebral circulation ▲ migraine in elderly associated with arteriosclerosis ▲ adjuvant therapy for high blood pressure. For adults, 5-10 mg of these drugs can be taken orally 2-3 times per day, before each meal. After Il Dong Pharm received approval for 'Sermion Tab 10 mg' in 1986, the second approval came 27 years later with Hanmi Pharm’s 'Nicegoline Tab 10 mg.' In January of last year, Hanmi Pharm obtained approval for two doses of nicergoline: 10 mg and 30 mg. After that, pharmaceutical companies considered nicergoline as a potential substitute for choline alfoscerate and began releasing products containing 30 mg doses. There are now 35 products approved as nicergoline 30 mg, and 26 products simultaneously became reimbursed last month. Nicergoline is an antagonist of alpha-1 adrenoreceptors, leading to the dilation of blood vessels and increased artery blood flow. It then improves neurotransmitter functions, inhibits platelet aggregation, and increases metabolic activities. According to the market research firm QYResearch Korea, the global market size for nicergoline will likely grow by 16.6% annually on average, reaching US$2.35 billion (approximately KRW 3.14 trillion) by 2029.
