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- 2026-03-11 15:17:12
- 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.
- 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.
- Policy
- DLBCL treatment Epkinly is approved in Korea
- by Lee, Hye-Kyung Jun 21, 2024 05:47am
- The Ministry of Food and Drug Safety(Minister: Yu-Kyoung Oh) announced that it had approved the orphan drug 'Epkinly (epcoritamab)' that is being imported by Abbvie Korea on the 20th. Epkinly is a bispecific monoclonal antibody that binds to both the CD3 on the surface of T-cells and CD20 on the surface of B-cells and is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of systemic therapy. As one of the most common blood cancers, DLBCL is a type of non-Hodgkin's lymphoma it spreads out over a large area (diffuse) and is characterized by its rapid progression. Epcoritamab binds to CD3 to activate T cells and binds to CD20 to bring B cells to the side of activated T cells and induce T-cell–mediated killing of CD20+ malignant B cells. The MFDS said, “We expect Epkinly’s approval to prove new treatment opportunities to patients with relapsed or refractory DLBCL who have received two or more prior therapies. We will continue to build on our regulatory science expertise to ensure that new therapies are promptly supplied to expand treatment opportunities for patients with rare and intractable diseases.”
- Policy
- When will 'Paxlovid' become reimbursable?
- by Lee, Tak-Sun Jun 20, 2024 05:48am
- Pfizer The review of 'Paxlovid (nirmatrelvir‧ritonavir, Pfizer),' a COVID-19 drug, for reimbursement has been prolonged. It has been over eight months since the submission of the reimbursement application last October, yet it has not been considered for the Drug Reimbursement Evaluation Committee (DREC) review. Because the Paxlovid free-of-charge program ended in May and is now available with co-payment, there are postulations that this has caused delays in the reimbursement listing. The Paxlovid item was not considered for review during the 6th meeting for 2024 of the DREC of the Health Insurance Review and Assessment Service (HIRA), held on June 13th. The drug reimbursement application for Paxlovid was submitted in early October of last year. After that, HIRA initiated the reimbursement review, including seeking academic opinions. The government and Pfizer expected a reimbursement decision to be made within the first half of the year. However, since the item was not considered for the DREC review in June, it is unlikely to become reimbursable in July. Pfizer Korea, the distributor of Paxlovid, submitted a response letter to HIRA five times. However, HIRA appears to have requested additional supplementary documents. The industry postulates that the two parties have different opinions about setting the drug pricing. The free-of-charge program has ended, and Paxlovid is now available through co-payment. Patients are required to pay KRW 50,000, which is approximately 5% of the drug price, for the drug. However, it is still provided free of charge for medical reimbursement benefit recipients and those eligible for co-payment reduction due to having the second-lowest income. Since the free-of-charge program ended, the government has been under less financial burden. Analysis suggests that this may have reduced the need for the government to quickly make Paxlovid reimbursable. Furthermore, with the co-payment for the drug, there may be a decrease in its usage. Additionally, if Pfizer continues to advocate high drug pricing, the reimbursement listing process may take much longer. However, the demand for COVID-19 treatment remains high due to its ongoing occurrence and the spread of COVID-19 variants. Experts say that Paxlovid should become reimbursable shortly to lessen patient burden and improve treatment access. Meanwhile, researchers at Stanford University disclosed that a 15-day course of Paxlovid did not provide relief for 'long COVID' symptoms. In a study conducted for 15 weeks enrolling 155 patients with long COVID who have not recovered from COVID-19 for over 16 months on average, Paxlovid treated for 15 days did not significantly improve symptoms, including fatigue, difficulty breathing, feeling sick, stomach aches, and heart symptoms, compared to placebo. However, researchers additionally demonstrated that taking Paxlovid, which is a 5-day course of treatment, for 15 days is safe.
- Policy
- 'Approvals-Reimbursement Reviews-Price Negotiations' pilot
- by Lee, Hye-Kyung Jun 20, 2024 05:48am
- The government is preparing to commence “The 2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations” The pilot system is intended to concurrently process applications to the Ministry of Food and Drug Safety (MFDS), reimbursement assessment, and drug price negotiations. Following the first pilot program last year, the government initiated a demand survey to commence the second pilot program in the second half of the year. According to the industry sources on June 19th, the Ministry of Health and Welfare (MOHW)’s Pharmaceutical Benefits is conducting a demand survey for drugs to participate in the second approval-assessment-negotiations pilot program. This program aims to improve patient access to treatments for severe diseases and strengthen reimbursement management. “The 2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations” in preparation. The 'approval-assessment package system' is now in effect to strengthen patient access to reimbursable treatments. This system has been designed to handle the marketing approval from the MFDS and reimbursement appropriateness assessment of HIRA at the same time. By expediting the drug price negotiations stage, the goal is to shorten the time it takes for the entire process, ensuring prompt drug reimbursement. The drug can be applied to HIRA’s insurance listing after receiving marketing approval by passing the safety and efficacy review from the MFDS. The course of the process is that once a reimbursement appropriateness decision is made and selected as a drug price negotiation or reimbursable drug, the drug can be reimbursable. The approval-assessment-negotiation packages will handle all three tracks simultaneously. Drugs that are eligible for approval-assessment-negotiation packages must meet the following conditions. For a drug to be considered for the second pilot program, ▲The drug must be eligible for approval and decision application by the end of June next year. ▲It should be a drug intended for treating life-threatening diseases (with a life expectancy of less than 1 year) or rare diseases with sufficient efficacy. ▲The drug must demonstrate clinically significant improvements in efficacy compared to existing treatments or be for conditions without current treatments. ▲It must meet the prerequisites for designation under the MFDS's Expedited Review and Approval (GIFT) program or be eligible for application. Required documents must include the planned date of application for approval, product name, ingredients, classification, indication, approval alignment (domestic/foreign), drug pricing application system, life expectancy, 5-year survival rate, clinical stage, presence of placebo, reimbursement status in South Korea for placebo, evaluation criteria, substitute drug, current treatment, degree of improvement, and number of subjects. Additionally, the document must include the estimated per capita and overall estimated financial requirements, excluded country reimbursement evaluation results, number of countries where pricing is listed, names of countries where pricing is listed, and company name. This document will be used as a reference for selecting drugs for the pilot program. The registration deadline is August 12th, and the documents can be submitted to the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). Meanwhile, two items of treatments for pediatric rare diseases have been designated for the first pilot system and are under assessment for approval, reimbursement assessment, and drug pricing negotiations simultaneously.
- Policy
- "People do not recognize generic equivalence"…
- by Lee, Hye-Kyung Jun 18, 2024 05:48am
- "80% of the medicines approved in Korea are generics, which account for 53% of medical expenses. However, consumer perception of generics’ equivalence to original medicines remains at 50%. The Ministry of Food and Drug Safety (MFDS) should be concerned and ashamed of this outcome." Lee Eui-Kyung, a professor at the School of Pharmacy at Sungkyunkwan University who served previously as the Minister to the Ministry of Food and Drug Safety (MFDS), pointed out that stifling generic competition limits patient access to medicines. Lee Eui-Kyung, a professor at the School of Pharmacy at Sungkyunkwan University.Lee delivered a speech at the plenary session on the topic of 'Regulatory Science Innovation and Patient Access to Medicines' at the Korean Society of Food, Drug & Cosmetic Regulatory Sciences (KFDC)’s spring academic conference on June 14th. Lee said factors contributing to patient access to medicines could include ▲delays in pharmaceutical entry ▲stifling generic competition ▲a short supply of pharmaceuticals. Lee is particularly disappointed that several experts are voicing the differences in product qualities and people’s perceptions of generic and original medicines. "I wish people would recognize the equivalence of generics that have demonstrated equivalence through bioequivalence tests, and doctors prescribing also recognize them," Lee said. "Half of the people in Korea feel difference of generics in cultural and societal aspects is stifling patient access to medicines," she added. According to a survey presented at the conference (document prepared by researcher Park Hye-Kyung), around 50.9% answered ‘YES’ to the question, 'Do you think the effectiveness of generics is equivalent to original medicines?' "Arguments about the quality difference between originals and generics hinder improvements to the system, such as drug substitution preparation and drug pricing," Lee said. "The U.S. FDA is putting efforts into resolving arguments related to inequivalence by marketing generic equivalence. I tried to solve this problem during my tenure as the MFDS director but could not due to the COVID-19 pandemic,” Lee expressed concerns. Furthermore, Lee suggested that the MFDS should provide regulatory support for medicines with patent expired that do not yet have generics developed. According to the MFDS documents in October 2022, 476 of 1004 products with expired patents do not have generics available. For instance, Celltrion Pharm’s 'Godex Cap,' with annual production sales of approximately KRW 73 billion, is reimbursable, but the 53.55% price reduction has not been applied due to the absence of generics. "For Godex, having made of seven ingredient composition, complex generic development is difficult," Lee said. "The FDA established a 'research center for complex generics' to facilitate complex generics market entry and communications and information sharing among the government, academics, and pharmaceutical companies." Therefore, it is argued that if the Korean government also prepares solutions for developing complex generics, the prices of drugs with expired patents could be reduced, leading to savings in insurance finances. Lee delivered a speech at the plenary session on the topic of Lee expressed disappointment towards the conditional approval system and expedited review system introduced and implemented by the MFDS to address patient accessibility issues caused by delays in drug approval. "Expedited reviews and conditional approvals shorten the review period for new drugs, which is positive for early treatment access for severely ill patients. However, proceeding with conditional approval while clinical trials are not fully completed has increased uncertainty regarding the evidence," Lee said. From 2012 to 2021, the MFDS gave conditional approvals for 35 products. Among these, 15 products did not submit clinical data, siz had their approvals revoked, and eight had their Phase 3 clinical trial report submissions delayed. Only seven products, approximately 20%, submitted regular reports as required. "Out of all products with conditional approval, ten are new drugs developed in South Korea. Among these, eight items had not submitted clinical documents," said Lee. "Two products, 'tertomotide generic' and 'Olita,' have had their approvals withdrawn," she stated. "The MFDS is responsible for making the initial decision on new drugs in Korea, but the basis for the approval should not be influenced by conditional approvals," Lee said. "Efforts should be made to secure the workforce for reviewing regulatory standards and meeting requirements from the start of R&D,” LEE emphasized.
- Policy
- Ceprotin Inj passes reimbursement committee’s review
- by Lee, Tak-Sun Jun 18, 2024 05:48am
- The congenital protein C deficiency treatment ‘Ceprotin Inj’ was recognized as adequate for reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC). As a result, its final reimbursement will be determined through pricing negotiations with the National Health Insurance Service. The committee decided so at its 6th 2024 meeting that was held on the 13th. Takeda Pharmaceutical’s Ceprotin Inj (human protein C) is the first human protein C concentrate drug to treat congenital protein C deficiency. The drug, which was approved in Korea in 2022, treats venous thrombosis and fulminant purpura in patients with congenital protein C deficiency. Congenital protein C deficiency is a rare genetic disorder in which a lack of protein C causes a fatal defect in blood clotting control. It affects about 1 in 4 million newborns. The committee determined the drug’s reimbursement was adequate. As a result, the reimbursement listing process will now move past the DREC stage and enter the negotiation stage with the National Health Insurance Service. On the other hand, the new drug for symptomatic obstructive hypertrophic cardiomyopathy, Camzyos Cap received a redeliberation decision. As a result, the drug’s reimbursement is expected to be discussed again at the DREC meeting. Camzyos is the first treatment for symptomatic obstructive hypertrophic cardiomyopathy, and its mechanism of action dissociates myosin from actin and relaxes the over-contracted heart muscle, thereby improving the enlarged left ventricular structure and improving left ventricular outflow tract obstruction. Meanwhile, the adequacy of Zejula Cap’s reimbursement extension as a monotherapy maintenance treatment for patients with advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was also determined to be adequate at the meeting.
- Policy
- Fasenra·Xpovio reimb from July…Jardiance price cut
- by Lee, Tak-Sun Jun 18, 2024 05:47am
- Pic of Fasenra and Xpovio The severe asthma treatment Fasenra Prefilled Syringe 30 mg (benralizumab, AZ) and multiple myeloma treatment Xpovio Tab 20 mg (selinexor, Antengene) may be reimbursed as early as July. The companies that own the two products have completed drug pricing negotiations with the National Health Insurance Service, and are waiting for them to be reported to the Ministry of Health and Welfare’s Health Insurance Policy Review Committee. According to industry sources on the 17th, the companies reached an agreement in the latest round of drug price negotiations for Fasenra and Xpovio. Fasenra is a treatment for severe eosinophilic asthma and will be reimbursed through the Risk-sharing agreement track (Refund type, Expenditure Cap type). Although it is not an anticancer or orphan drug, it fell into the expanded scope and was applied RSA as a drug that threatens the patients’ quality of life. It is also rare for a latecomer to be reimbursed through the RSA track, as Nucala (mepolizumab, GSK) was the first drug in its class to receive reimbursement through RSA last October. Also, another drug, Cinqair (reslizumab, Teva-Handok), which also has the same mechanism of action, was reimbursed through the general track, making Fasenra’s RSA reimbursement the more rare. As a result, all 3 monoclonal antibody treatments for severe asthma will soon be reimbursed in Korea. Xpovio is a treatment for multiple myeloma developed by the Chinese pharmaceutical company Antengene. The drug is up for reimbursement 3 years after its approval in 2021. The drug was approved for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. Of these, only the multiple myeloma indication was approved as adequate for reimbursement. Xpovio is also applied the refund type and expenditure cap type RSA. Meanwhile, the insurance price ceiling of the SGLT-2 inhibitor class diabetes treatment ‘Jardiance 10mg, 25mg (empagliflozin, Boehringer Ingelheim) will be cut through the PVA system. Jardiance’s price had also been cut last year due to its increased usage. With SGLT2 inhibitors such as Forxiga and Suglat recently withdrawing from the market, Jardiance is expected to reap reflective interest.
- Policy
- Multiple myeloma drug Elrexfio receives conditional approval
- by Lee, Hye-Kyung Jun 17, 2024 05:46am
- The orphan drug ‘Elrexfio (elranatamab)' that is being imported by Pfizer Korea, has been approved subject to the submission of therapeutic confirmatory clinical trial data. Elrexfio is an orphan drug indicated as monotherapy to treat adult patients with relapsed or refractory multiple myeloma who have received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody Being a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy, it owns the advantage of being able to be administered immediately compared to CAR-T cell therapy. After receiving accelerated approval from the U.S. FDA in August last year as a fifth-line therapy for multiple myeloma, the European EMA granted conditional approval in December of the same year. In Korea, the drug was approved on the 30th of last month, and according to the minutes of the Central Pharmaceutical Affairs Council meeting disclosed by the Ministry of Food and Drug Safety on the 12th, the approval was conditional, and the council requested the company to submit Phase III results after the approval. Results from the Phase II trial showed that 84% of 63 patients who received Elrexfio as a fourth-line treatment, including with the standard B-cell mature antigen therapy, maintained a response for up to 9 months. Of those who achieved a response, 72% maintained it for 15 months. By targeting B-cell maturation antigen (BCMA), which is found on multiple myeloma cancer cells, and CD3, which is found on immune T cells, Elrexfio Inj binds bispecifically to both cells, triggering an immune response that destroys multiple myeloma cancer cells. A CPAC member said, "Based on the safety, efficacy, and regulatory aspects of the submission, and considering its overseas approval status, it is reasonable to grant approval under the condition that the company submits the final results of a therapeutic confirmatory clinical trial.” Another member added, “Elrexfio monotherapy is already approved in the US and EU based on existing studies. The toxicity data reported in the literature is sufficient to support a conditional marketing authorization." Meanwhile, Elrexfio’s competitor is Janssen's ‘Tecvayli(talquetamab).’ In Korea, a Phase III trial comparing Talquetamab Plus Pomalidomide (Tal-P), Talquetamab Plus Teclistamab (Tal-Tec), and Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone(PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide’ was approved in November last year.
- Policy
- External reference pricing reevaluations are nearly ready
- by Lee, Tak-Sun Jun 17, 2024 05:46am
- The external reference pricing reevaluation system is expected to be soon launched by the Korean government. At the 9th meeting held on the 10th of this month, there were disagreements over the specific details, but no change had been made in the big picture. The health authorities are reportedly planning to finalize the discussions within this month. According to industry sources on the 14th, the health authorities are expected to hold another meeting with the pharmaceutical industry within the month and conclude the opinion-gathering process. At this pace, the reevaluations may begin as early as the second half of the year. An industry insider said, "I can't share specific details due to confidentiality, but the government seems to be firm in its intention to end the discussion within this month. A meeting will be held soon to coordinate the details, after which HIRA will start reviewing its initiation. The external reference pricing reevaluation involves adjusting the domestic insurance ceiling price of patent-expired same-ingredient drugs in comparison with the highest price in the A8 countries - Japan, France, Germany, Italy, Switzerland, the United Kingdom, and Canada. The government plans to conduct the re-evaluations by comparing the weighted average price excluding the highest and lowest prices among the A8 countries to the domestic ceiling price. The pharmaceutical industry is concerned that this method will result in large losses due to the large drug price cut rates. With the revaluations coming near, the industry has reportedly been proposing slightly more favorable options to the government. For example, in the case of combination drugs, the company requested that the total price of each single-agent drug be guaranteed even after the reevaluations. The government will divide drugs into 3 groups and reassess them every 3 years. The industry is predicting that high-costing drugs (those with a high claims amount) such as hypertension and digestive system drugs will be the first to be reevaluated.
