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- 2026-04-29 04:03:52
- Policy
- 2nd Approval-Evaluation-Negotiation pilot project imminent
- by Kim, Jin-Gu Sep 26, 2024 05:51am
- The initiation of the 2nd pilot project for the ‘approval-evaluation-negotiation linkage system,’ which was introduced to shorten the time from drug approval to reimbursement, is imminent. The Ministry of Health and Welfare has completed receiving drug submissions for the 2nd pilot project from pharmaceutical companies and is in the final review stage. The MOHW plans to implement the 2nd pilot project after reflecting on the improvements identified during the 1st pilot project. Eun-Joo Lee, an official from the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits, announced so regarding the pilot project linking the approval-evaluation-negotiation system at the ‘Roundtable on Improving Access to Rare Disease Drugs' that was held at the National Assembly on the 24th. The government implemented the 1st pilot project for the approval-evaluation-negotiation linkage system last year. The project consists of simultaneous approval by the MFDS, reimbursement evaluation by the Health Insurance Review and Assessment Service, and drug price negotiations by the National Health Insurance Service. The project shortens the 300-day review period required for new drug access in Korea – which consists of an MFDS approval period of 120 days, 150 days of reimbursement evaluation by HIRA, and 60 days of drug price negotiations by the NHIS - and strengthens Korea’s access to new drugs. Two drugs - Qarziba Inj (dinutuximab, Recordati) and Bylvay (odevixibat, Ipsen) – were selected for the 1st pilot project. At the time, the government proposed the following criteria for selection: ▲a drug for cancer or rare diseases with a life expectancy of less than one year; ▲has a small number of patients; ▲lacks alternative drugs; ▲has a survival period over two years and demonstrated a superior treatment effect. Several companies submitted applications to participate in the pilot program, among which the government ultimately selected 2 drugs that met the selection criteria. Although the 1st pilot project has not been completed yet, the Ministry of Health and Welfare has been promoting to launch of the second pilot project. “We have completed receiving applications for the 2nd pilot project. We now need to select the drugs that meet the conditions of the 2nd pilot project,” said Lee. He added, “The number of drugs for the 2nd pilot project has not been decided upon yet. There are no criteria that require us to select only 2 drugs as in the 1st project. We will select drugs that meet the conditions.” The Ministry of Health and Welfare has proposed 4 criteria for selecting drugs for the 2nd pilot project: ▲ drugs that can apply for approval and decision by the end of June next year; ▲ drugs with sufficient effect for the treatment of life-threatening diseases (life expectancy of less than 1 year) or rare diseases; ▲ drugs that have no existing treatment or have shown clinically significant improvements in efficacy over existing treatments; and ▲ drugs that have been designated or are eligible for Global Innovative products on Fast Track (GIFT). To be selected as a drug for the 2nd pilot project, the drug needs to satisfy all the conditions above, and the company needs to submit the following data: ▲estimated financial expenditure per capita and total estimated financial expenditure; ▲results of overseas reimbursement evaluations; ▲the number of listed overseas countries; ▲the name of listed countries; and ▲name of the company. The MOHW plans to analyze the pros and cons of the 1st pilot project and apply them to the 2nd pilot project. In the 1stpilot project, the approval and reimbursement evaluation processes for Qarziba have been completed. The agenda had passed the Drug Reimbursement Evaluation Committee review and is currently being reviewed upon the company's reapplication. Compared to the existing system, the time from its approval to reimbursement evaluation has been significantly reduced. However, in the case of Bylvay, there are some delays due to difficulties in the evaluation process. The marketing authorization was completed on the 23rd of last month, but the reimbursement evaluation process was hampered due to the use of a difficult evaluation tool. However, the government is focusing on shortening the timeframe by conducting pre-negotiations at the same time. The HIRA explained that it will focus on how the companies manage uncertainties during the reimbursement evaluation process in the 2nd pilot project “In the future, uncertainty management will be important in the reimbursement evaluation process,” said Kook Hee Kim, Director of the Pharmaceutical Benefits Management Division at HIRA. ”Since the drugs are expected to be effective but not yet certain, the pharmaceutical companies should discuss how to address the uncertainties and prove their drug’s effect in the post-marketing process after the fact and share the risk with the government.” “The approval-evaluation-negotiation process is not a guarantee that the drug will be reimbursed. It means that the evaluation period is shortened,” explained Kim. ”The companies should submit data on how they will prove the uncertainties in the post-marketing process. Otherwise, the drug’s reimbursement may be delayed.”
- Policy
- Higher dosage Eylea expected to strike back at biosimilars
- by Lee, Tak-Sun Sep 26, 2024 05:51am
- The competition in the market for the macular degeneration drug Eylea has recently intensified with Samsung Bioepis and Celltrion, which have recently launched biosimilars. The original developer is set to strike back against the competitors. Bayer will release Eylea Inj 8 mg (aflibercept), with an extended treatment interval, into the market next month at a relatively cheaper price. According to the industry on September 25th, Eylea Inj 8 mg will be listed for reimbursement next month at a price lower than the evaluation price, KRW 795,000. Eylea Inj 8 mg provides a long-lasting, effective dosage within the eye at a four times higher dosage than the previous 2 mg. It extends the treatment interval while reducing the number of injections. Eylea Inj 8 mg is injected once monthly for an initial 3 months. Then, based on visual and anatomical test outcomes, a treatment interval can be extened up to 16 weeks at the physician's judgement. After the initial extension of the treatment interval, it can be extended up to 20 weeks with the Treat-and-Extend(T&E) therapy. This approach allows flexibility in adjusting the treatment interval depending on the patient's condition while maintaining stable vision and anatomical test outcomes. The original and biosimilars currently sold in the market are at a 2 mg dosage. For neovascular age-related macular degeneration (nAMD) treatment, the drugs are injected once monthly for an initial 3 months, followed by a once every 2 months treatment regimen. Using the new 8 mg will extend the treatment interval more than twice, from once every 2 months to once every 4 months. The PULSAR study secured non-inferiority results of the new product by showing that patients treated with Eylea 8 mg at a 12-week interval had the best corrected visual acuity (BCVA) of 6.7 letters on average from the baseline at 48 weeks, those at a 16-week interval had BCVA of 6.2 letters, and those at an 8-week interval had the BCVA of 7.6 letters. However, the drug price is not more than double the original price. Due to the biosimilar release, the current ceiling price for Eylea Inj·Prefilled Syringe is KRW 496,118, a 30% reduction from the highest price. The newly listing Eylea Inj 8 mg costs KRW 795,000. Despite extending the treatment interval more than twice, the price has not doubled because Bayer has set the price lower than the evaluated price. However, the price is double that of biosimilars. Samsung Bioepis' Afilivu Inj 40 mg/ml costs KRW 350,000, and Celltrion's Eydenzelt Inj costs KRW 330,000. Although the price of biosimilars is low, newly diagnosed patients are likely to choose the high-dose original drugs, which require fewer injections due to the extended treatment interval. Hence, Eylea Inj 8 mg will likely be a direct competitor to biosimilars. Eylea is a blockbuster product, recording KRW 96.8 billion in sales last year, based on IQVIA. Due to its marketability, Samsung Bioepis and Celltrion, which have released their products in May and September, respectively, are trying to seize the market by partnering with pharmacists who are specialists in ophthalmology. Industry personnel said, "Patients who are benefiting from the existing Eylea 2 mg are less likely to switch products. However, new patients are likely to choose from biosimilars, with lower cost, and high-dosage original drug, with fewer injections," adding, "An intense competition among overseas original developer and Korean biosimilar developers is expected."
- Policy
- Potential expanded indication for obestiy drug 'Wegovy'
- by Lee, Hye-Kyung Sep 26, 2024 05:51am
- Product photo of Wegovy. A clinical trial for Novo Nordisk Pharma's obesity drug, 'Wegovy (semaglutide),' will be conducted in South Korea for expanded indication. On September 20th, the Ministry of Food and Drug Safety (MFDS) has approved the 'Phase 2 clinical trial to evaluate the efficacy, safety, and dosage testing of NNC0519-0130, subcutaneously administered once-weekly, in comparison to Ozempic (semagluide) 1.0 mg and placebo in overweight or obese patients who have or do not have type 2 diabetes.' The clinical trial will involve 456 individuals worldwide from December 2024 to September 2026. In South Korea, the study will enroll 32 patients and will be conducted at Pusan National University Hospital, Ilsan Hospital, Hallym University Medical Center, Seoul St. Mary's Hospital, Hanyang University Guri Hospital, and Korea University Guro Hospital. Wegovy received domestic marketing authorization in April with indications to ▲aid weight-loss overweight patients who have a Body Mass Index (hereafter referred to as BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and having one or more weight-related accompanying diseases (abnormal glycemia, type 2 diabetes, high blood pressure, dyslipidemia, obstructive sleep apnea, or cardiovascular diseases) ▲reduce risks of major cardiovascular events in overweight or obese patients with early BMI of 27 kg/m² or higher with cardiovascular diseases. Additionally, the company will conduct the Phase 2 clinical trial to add indication to treat chronic kidney disease. Based on Phase 3 SELECT study results, presented by Dr. Katherine Turtle, a professor at the University of Washington School of Medicine, at a recent European Renal Association meeting, Wegovy can reduce the risk of kidney failure and death in patients with chronic kidney disease because of type 2 diabetes. The clinical trial involved 3533 patients with type 2 diabetes and chronic kidney disease. Half of the participants received weekly semaglutide injections for 3 years, and the rest received weekly placebo. Patients treated with semaglutide had a lower possibility of worsening symptoms that require dialysis or kidney transplant by 24% and a lower possibility of death due to major cardiovascular disease, including heart attack, than those treated with placebo by 29%. Patients treated with semaglutide had a 20% lower possibility of death of all causes during the study period. However, investigators studying semaglutide have not found an exact mechanism by which this drug helps the kidney, and the study was limited in that around two-thirds of the participants were white males. Meanwhile, Wegovy's active ingredient, semaglutide, is a 'Glucagon-like protein (GLP)-1' agonist. GLP-1 receptors lower blood pressure and regulate appetites. The basis for Wegovy's approval in South Korea was the STEP study, in which patients treated with Wegovy (1306 patients) had a 14.9% weight loss across 68 weeks compared to the baseline, showing a significant difference from a 2.4% of the placebo group (655 patients). According to Novo Nordisk Pharma's business performance reporting for the first half of 2024, Wegovy generated US$3.07 billion, up 74% year-over-year.
- Policy
- First generic version of Qudexy XR Cap is approved in KOR
- by Lee, Hye-Kyung Sep 25, 2024 05:49am
- The first generic version of the topiramate-based extended-release epilepsy treatment ‘Qudexy XR Cap’ has been approved in Korea. The Ministry of Food and Drug Safety granted marketing authorization for Intrio Biopharma’s ‘Topimed XR Tab. 50mg’ on the 23rd. Unlike ‘Qudexy XR Cap’ which is an oblong hard capsule formulation, Topimed XR Tab was developed as a circular extended-release film-coated tablet. Intrio Biopharma has been developing Topimed XR Tab since 2022. The original epilepsy drug that contains topiramate was Janssen's ‘Topamax Tab,’ but in 2014, the U.S. generic company Upsher-Smith developed and received U.S. FDA approval for Qudexy XR Cap, which is an extended-release capsule formulation that is not available with Topamax. Qudexy XR Cap is also the topiramate approved in Korea. The drug was also supplied by SK Chemicals in August 2017 and is listed on the KFDA's Green List and protected until January 2034. However, the newly approved Topimed XR Tab is likely to be released as a film-coated tablet formulation, rather than the capsule formulation that is being protected with a patent. This is because no pharmaceutical company has attempted to avoid Qudexy XR Cap’s patent. Topimed XR Tab is indicated ▲ as initial monotherapy in patients 6 years of age and older with partial-onset or primary generalized tonic-clonic seizures and ▲ as adjunctive therapy in children 2 years of age and older and adults with partial seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome (LGS). While existing immediate-release topiramate formulations are taken twice daily, this medication is an extended-release formulation that is absorbed into the body more slowly and can be taken once daily. Topiramate-based formulations are the most prescribed ingredient in the KRW 80 billion antiepileptic drug market with a sales volume of KRW 30 billion, and the outpatient prescription value of Qudexy XR Cap was KRW 3.5 billion based on UBIST last year. The drug has been covered through insurance reimbursement in Korea since February 2018.
- Policy
- Takeda's drug pricing negotiations see different results
- by Lee, Tak-Sun Sep 25, 2024 05:48am
- The drug pricing negotiations for ‘Ceprotin (Protein C Concentrate (Human))’ a new drug for severe congenital protein C deficiency supplied by Takeda Pharmaceuticals Korea, fell through. On the other hand, the company reached an agreement and completed negotiations to expand the reimbursement for the ovarian cancer treatment Zejula Cap. According to industry sources on the 24th, the National Health Insurance Service announced so while updating the list of drugs that have completed drug price negotiations. Ceprotin passed the NHIS’s Drug Reimbursement Evaluation Committee in June and began negotiating with the NHIS in July, which is the final step to a drug’s reimbursement in Korea. The drug was first approved in Korea in 2022 for the treatment of severe congenital protein C deficiency. Congenital protein C deficiency is a rare genetic condition that causes a fatal defect in the regulation of blood clotting due to a lack of protein C. It affects 1 in 4 million newborns. As the only treatment available, patients have been longing for its reimbursement, but the opportunity has passed this time. Therefore, it remains to be seen whether Takeda will reattempt its reimbursement in the future. Meanwhile, reimbursement for Takeda's Zejula Cap, which passed DREC review along with Ceprotin, will be expanded in October with the finalization of negotiations. Zejula is currently reimbursed for patients with BRCA mutations as maintenance therapy in the first- to second-line treatment of platinum-sensitive advanced ovarian cancer who have responded to platinum-based chemotherapy. In October, the reimbursement standards will change from ‘patients with BRCA mutations’ to ‘patients who are Homologous Recombination Deficiency (HRD) positive.’
- Policy
- Pharmbio releases first generic Revolade with reimb in OCT
- by Lee, Tak-Sun Sep 24, 2024 05:46am
- The first generic version of the immune thrombocytopenia treatment ‘Revolade (eltrombopag olamine)’ will be released into the market in October. Pharmbio Korea’s Revolade generic has succeeded in receiving reimbursement listing 1 year after its approval in Korea. The company had been delaying its launch due to the burden of patent infringement, but its recent success in avoiding the patent prompted it to launch the product in full force. According to industry sources on the 23rd, Pharmbio Korea’s Elpag Tab. 25 mg and 50 mg will be listed for reimbursement from October 1st. The items were approved in March last year. As a rare disease drug used for thrombopenia, Elpag Tab is a generic version of Novartis’s Revolade. Although Revolade's product patent has expired, 3 composition patents are listed on MFDS’s green list, making it difficult for latecomer generics to enter the market. Pharmbio Korea and SK Plasma sought to evade Revolade ‘s substance patent by filing for a passive trial to confirm the scope of the patent. The Intellectual Property Trial and Appeal Board ruled in favor of the generic companies’ claims in the first half of this year, clearing the patent hurdle. However, the patent dispute is not completely resolved as Novartis immediately filed a following suit to cancel the decision. In this situation, Pharmbio has decided to preemptively launch its product through reimbursement listing. Revolade treats immune thrombocytopenia (ITP), a type of bleeding disorder, by stimulating platelet production. ITP is an autoimmune disease in which the immune system mistakes the body’s platelets as foreign and attacks them. According to IQVIA, Revolade’s domestic sales amounted to KRW 9 billion last year. Pharmbio is challenging the original drug with a lower price. It has applied for a drug price lower than the calculated price, setting the price at KRW 22,849 for Elpag Tab 25 mg and KRW 44,405 for Elpag Tab 50 mg. This is 30% lower than the price of the original Revolade 25mg, which is priced at KRW 32,641, and Revolade 50mg at KRW 63,435. In the case of orphan drugs, the price is set at the same level as previously listed drugs. Pharmbio seems to have adopted a strategy to increase its market share through a relatively low price.
- Policy
- AZ's bispecific ab 'Rilvegostomig' vs Keytruda trial
- by Lee, Hye-Kyung Sep 20, 2024 05:51am
- A Phase 3 trial comparing a combination therapy containing 'Rilvegostomig (Trial name: AZD2936),' AstraZeneca's bispecific antibody gathering attention as the next-generation medicine, to 'Keytruda (pembrolizumab),' a type of immunotherapy drug used to treat cancer, will be conducted in South Korea. The Ministry of Food and Drug Safety (MFDS) has approved a Phase 3, randomized, double-blind, multicenter, and global ARTEMIDE-Lung03 study, evaluating Rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous PD-L1-positive metastatic non-small cell lung cancer (NSCLC). Rilvegostomig is a PD-1/TIGIT targeting bispecific antibody that AstraZeneca acquired from Compugen, a company specializing in developing bispecific antibodies. The drug targets PD-1 and TIGIT, which are receptors that inhibit anti-cancer T-cell activities. The Phase 3 trial is being conducted worldwide, enrolling 858 patients. In South Korea, the MFDS approval grants the study to enroll 50 patients at Seoul National University, Severance Hospital, Seoul Asan Medical Center, Samsung Medical Center, Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, and Seoul Boramae Hospital. The current clinical trial is a follow-up study of 'ARTEMIDE-Lung01' and 'ARTEMIDE-Lung02' to evaluate the safety of Rilvegostomig. Keytruda will be used as a control drug to Rilvegostomig, and platinum-based chemotherapy (carboplatin, paclitaxel, and lead-paclitaxel) will be used in combination. Participants will use Rilvegostomig 750 mg or Keytruda 200 mg in combination with the participant's choice of a platinum doublet chemotherapy for the first 4th cycle, administering a single dose infusion every 3 weeks. When the patients do not show clinically significant infusion response within 21 days after the second blinded trial treatment, the investigator will choose to immediately administer pemetrexed upon the completion of the blinded trial treatment, followed by administration of cisplatin and carboplatin in all other cycles. AstraZeneca has been conducting the global Phase 3 trial of Rilvegostomig in South Korea for bile duct cancer and NSCLC. Meanwhile, the data from Rilvegostomig's Phase 1/2 ARTEMIDE-01 study (NCT04995523), presented at the 2024 IASLC International Lung Cancer Summit, have shown that the drug induces continual responses and favorable drug tolerance in patients with metastatic NSCLC. When the patients were given a dose of Rilvegostomig 750 mg every 3 weeks in those with PD-L1 tumor proportion score (TPS) of 1%-49% (n=31), it resulted in an overall response (ORR) of 29%, with 38.7% continuing treatment at the time of data cutoff.
- Policy
- Cushing’s syndrome drug Isturisa is approved in Korea
- by Lee, Hye-Kyung Sep 20, 2024 05:51am
- Various doses of ‘Isturisa’ (osilodrostat), a treatment for Cushing's syndrome, are expected to be approved in Korea soon. According to industry sources on the 19th, the Ministry of Food and Drug Safety concluded the safety and efficacy review of Recordati Korea's Isturisa Film Coated Tab 1mg earlier this month and recently completed the safety and efficacy review of the 5mg dose as well. Isturisa was previously approved by the US Food and Drug Administration (FDA) on March 6, 2020, the European Medicines Agency (EMA) on January 9, 2020, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on March 23, 2021. Among the three dosage forms available – 1, 5, and 10 mg – the MFDS has completed a safety and efficacy review for the 1 and 5 mg doses. Isturisa has been under review for approval in Korea since November last year after being designated as a Global Innovative products on Fast Track (GIFT) by the MFDS. As the safety and efficacy review is the final step in the approval process, the drug’s approval is expected soon. Isturisa inhibits CYP1181, an enzyme responsible for the final step of the cortisol pathway in the adrenal glands, and was designated as a GIFT product in April 2022, when Novartis' ‘Signifor Inj’ was withdrawn from the market and the only existing treatment option was eliminated. The drug is indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative and is taken orally twice a day. Cushing's syndrome occurs when the body is exposed to excessive amounts of a hormone called glucocorticoids. Glucocorticoids are produced by an endocrine organ called the adrenal glands, which are located on top of the kidneys and can occur when the adrenal glands produce more glucocorticoids than necessary, or when excessive amounts of glucocorticoids enter the body from the outside for various reasons. Cushing's syndrome is characterized by a rounded, moon-shaped face and excessive subcutaneous fat deposits on the back of the neck and shoulders, and is most common in adults between the ages of 30 and 50. It affects women three times more often than men. It can cause health issues such as hypertension, obesity, type 2 diabetes, blood clots in the legs and feet, fractures, a weakened immune system, and depression, and can be diagnosed through a blood test and a 24-hour urine test. Isturisa is also the first FDA-approved drug to work directly on cortisol overproduction by blocking an enzyme known as 11-beta-hydroxylase and preventing cortisol synthesis. The safety and effectiveness of Isturisa were demonstrated in a clinical study involving 137 adult patients, where approximately half of the patients reached cortisol levels within normal limits at Week 24. After Week 24, 71 patients who did not require further dose escalation and tolerated the drug participated in an 8-week double-blind, randomized withdrawal study in which withdrawals were treated with either Isturisa or placebo. Results showed that 86% of the patients in the Isturisa arm maintained cortisol levels within normal limits. On the other hand, only 30% of the placebo arm reached the same result.
- Policy
- MFDS approves Hemgenix for Hemophilia B in Korea
- by Lee, Hye-Kyung Sep 19, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS) announced on the 13th that it has approved the orphan drug ‘Hemgenix Inj (etranacogene dezaparvovec)’ imported by CSL Behring Korea. Hemgenix is used to treat moderate-to-severe hemophilia B (congenital blood clotting factor IX deficiency) in adults without a history of Factor IX inhibitors. The drug is expected to provide new treatment opportunities for hemophilia B patients by offering a long-term, single-shot treatment option, unlike existing treatments. The MFDS explained that the quality, safety and effectiveness, manufacturing and quality control standards of Hemgenixwere thoroughly reviewed and evaluated scientifically in accordance with the review criteria outlined in the “Act on The Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products (“Advanced Regenerative Bio Act”),” which enabled the product’s expedited review and prompt introduction into the field. Hemgenix will be subject to long-term follow-up under Article 30 of the Advanced Regenerative Bio Act, which requires pharmaceutical companies to follow up on the occurrence of adverse events for 15 years from the date of administration. The MFDS said, "Based on our expertise in regulatory science, we will continue to make our best efforts to ensure that novel therapies for severe and rare diseases are promptly supplied to patients in Korea.”
- Policy
- Moderna’s COVID-19 vaccine is approved in Korea
- by Lee, Hye-Kyung Sep 13, 2024 05:50am
- A new COVID-19 variant vaccine, which is the only mRNA-based COVID-19 vaccine that will be manufactured domestically (by Samsung Biologics) has been approved in Korea. The Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh) announced on the 11th that it has authorized the manufacturing and sale of ‘Spikevax JN.1’ that Moderna Korea applied for. Like Pfizer's COVID-19 vaccine, which was approved on August 30, Spikevax JN.1 is a vaccine that contains an mRNA designed to express the JN.1 variant antigen as the active ingredient. It is indicated for the prevention of COVID-19 in persons 12 years of age and older and is administered as a single intramuscular injection of 0.5mL. Those who have previously received a COVID-19 vaccine should administer Spikevax JN.1 at least 3 months after his or her most recent COVID-19 vaccination. Samsung Biologics will receive the active pharmaceutical ingredient supplied by Moderna and manufacture the finished drug through filling and labeling, and its domestic manufacture is expected to ensure a smooth supply of the vaccine. The Ministry of Food and Drug Safety said, ‘While strictly examining the safety, effectiveness, and quality of this vaccine, we worked to promptly approve the drug in 2 months so that there would be no disruption to the National Immunization Program for high-risk groups that are scheduled to begin next month.”
