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- 2025-12-20 21:53:36
- Policy
- Multiple low-dose Kerendia Rx subject to reimb cuts
- by Lee, Tak-Sun Feb 20, 2024 06:00am
- Kerendia Tab, a new drug for chronic kidney disease with diabetes mellitus that was reimbursed in February this year, was added to the list of low-content multiple-dose prescription reimbursement cuts. As the price for the high and low-dose formulations were set the same for the drug, there is virtually no incentive to prescribe multiple doses. According to industry sources 18th, the Health Insurance Review and Assessment Service on Monday added Kerendia (finerenone, Bayer) to its list of cost-effective formularies. The price of Kerendia 10 mg and Kerendia 20 mg are the same at 1,670 won per tablet. It is indicated as a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. The initial dose is based on the patient’s eGFR. Patients who are eGFR ≥ 60 mL/min/1.73m2 start with an initial dose of 20 mg once daily, and those 25 ≤ eGFR < 60 mL/min/1.73m2 start with an initial dose of 10mg once daily. As the dose is set according to each patient’s condition, and both the 10mg and 20mg doses were released at the same time, there is little incentive to prescribe two 10mg doses. This is why the company strategically set the price for the low and high doses the same for the drug. Its domestic price of 1,670 won is significantly lower than the A7 adjusted average price. Among the A7 countries, Kerendia is listed in 6 countries except France - the United States, Japan, Germany, Italy, Switzerland, and the United Kingdom, with an adjusted average price of 6,810 won for 10 mg and 6,910 won for 20 mg. The drug is recommended as a treatment for chronic kidney disease patients with type 2 diabetes in clinical practice guidelines in Korea and abroad, and its cost-effectiveness was recognized through pharmacoeconomic evaluation and succeeded in being listed for reimbursement just 1 year and a half after it was approved in June 2022. The National Health Insurance Service expects the drug to be used by around 16,324 people a year and has reportedly agreed with the company on KRW 9.95 billion ($9.9 billion) as the expected claims amount. It is the first blockbuster drug for a chronic disease released in a long time. Chong Kun Dang signed a copromotion agreement with Bayer on the 6th of this month. With Chong Kun Dang, which has a large sales and distribution network in Korea, joining in on its sales, Kerendia is expected to quickly land in the domestic market. Meanwhile, in addition to Kerendia, Januglip Tab. 50mg, 100mg, Esoum Tab 20mg, and 40mg were also included in the list of oral drugs that require cost-effective use.
- Policy
- Hanmi launches Zytiga generic combo after first generic
- by Lee, Tak-Sun Feb 16, 2024 06:00am
- Hanmi Pharmaceutical, which attracted wide attention by launching the first generic version of the prostate cancer treatment Zytiga last year, set out to target the market again by quickly developing a combination drug. On the 14th, the Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's Abiteron Duo Tab 500/2.5mg. The product is a combination drug that combines abiraterone and prednisolone. The original drug is Janssen’s ‘Zytiga Tab 500mg (abiraterone acetate).’ Hanmi Pharmaceutical received approval for the first generic version of Zytiga, ‘Abiteron Tab 500mg,’ last year, and released the drug at a more economical price than the original in October of the same year. Currently, Zytiga costs KRW 11,746 per tablet, while Abiteron costs KRW 8,537. From November last year, the co-payment rate for abiraterone drugs was reduced from 30% to 5%. This is expected to reduce the financial burden on the patients and increase their usage. In this context, Hanmi Pharmaceutical introduced a new combination drug that even the original company did not have. The newly approved ‘Abiteron Duo Tab’ is used in combination with androgen deprivation therapy (ADT) for the treatment of patients newly diagnosed with high-risk metastatic hormone-sensitive prostate cancer (mHSPC). It is administered once daily, and the dosage is two tablets. Hanmi’s Zytiga generic was released last yearThe fact is that Zytiga and Abiteron are both used in combination with prednisolone, a steroidal hormone that is synthesized in the adrenal cortex. Therefore, patients taking Zytiga or Abiteron must take two 500 mg tablets per day, plus an additional 5 mg of prednisolone. This is a total of three tablets, but those who take Abiteron Duo need to only take two tablets, which shows improved convenience. Hanmi Pharmaceutical will focus on increasing its market share with both its single-agent generic Abiteron and combination generic Abiteron Duo. Zytiga is a blockbuster drug that posted KRW 18.3 billion in outpatient prescriptions last year (source: UBIST), and if Hanmi, a latecomer to the market, can secure its competitiveness by improving product quality, its generic version is also expected to post high sales.
- Policy
- MFDS will inspect growth hormones and cold chains this year
- by Lee, Hye-Kyung Feb 16, 2024 05:59am
- The Ministry of Food and Drug Safety has included 'medical institutions and pharmacies handling growth hormone drugs' and 'cold chain compliance of high-risk items such as vaccines' in this year's planned inspections. The ' Biopharmaceuticals and Herbal Medicine Bureau’s Basic Plan for Manufacturing and Distribution Management in 2024,' which was released by the MFDS on the 15th, contains this year's planned joint surveillance for biopharmaceutical manufacturers and importers, drug advertisers, and wholesalers. The planned joint surveillance program is designed to preemptively respond to hazardous factors that threaten public safety, including growth hormone drugs, which became an issue during last year's National Assembly inspections. At the NA audit, Rep. Young-Joo Kim of the Democratic Party of Korea pointed out that “Growth hormone drugs are being misused on children and adolescents who are a little shorter than their peers to grow taller, which is not the purpose of the approved indication.” And requested a follow-up report on its abuse and misuse. In Korea, growth hormone drugs are indicated for: ▲ growth failure in children due to pituitary growth hormone secretion disorder ▲ idiopathic short stature (ISS) in children ▲ growth failure in children whose bone ends are not closed and confirmed as Turner syndrome by chromosomal analysis ▲ growth disorder in short children born small for gestational age (SGA), however, most of them are used off-label on-site as 'height growth injections'. According to data from the MFDS, the National Health Insurance Service, and the Health Insurance Review and Assessment Service, of the 10.66 million growth hormone injections supplied to 5,761 medical institutions nationwide from September 2021 to September 2023, only 3%, 307,000 were prescribed to patients with reimbursement, and the other 97% were prescribed without reimbursement for height growth. As a result, the MFDS plans to include false and exaggerated advertisements of growth hormone drugs as a target for joint surveillance this year and check whether hospitals, clinics, pharmacies, etc. are directly promoting 'injections to increase height' in their advertisements. The MFDS conducts year-round monitoring of social issue items, including mass advertising of specialized drugs and illegal distribution. This year, the MFDS plans to expand the scope of online advertisements to include social media in the joint monitoring of growth hormone drugs, as well as false and exaggerated advertisements. In addition, the cold chain management status of wholesalers handling high-risk products such as vaccines and refrigerated and frozen storage products will be intensively checked. For this year's regular monitoring of biopharmaceuticals, the authorities included the decision to continuously monitor the data integrity of biopharmaceuticals. The MFDS assesses the risk of domestic manufacturing plants twice a year using independent risk assessment indicators tailored to the characteristics of biopharmaceuticals. This year, 22 sites are scheduled for regular inspections. The company is notified 7 days in advance of the surveillance in accordance with the Framework Act on Administrative Investigation, without coordinating the schedule in advance.
- Policy
- ‘Trelegy 200 Ellipta’ concludes negotiations with the NHIS
- by Lee, Tak-Sun Feb 15, 2024 05:59am
- ‘Trelegy 200 Ellipta Inhaler,’ a COPD triple combination therapy, has completed the negotiations with the NHIS in Korea. ‘Trelegy 200 Ellipta Inhaler,’ a triple combination therapy for COPD, has completed the negotiations with the National Health Insurance Service (NHIS). The drug is expected to be listed for health insurance reimbursement soon. According to industry experts on the 13th, ‘Trelegy 200 Ellipta Inhaler,’ a COPD triple combination therapy, has completed the negotiations with the NHIS and is expected to be listed for reimbursement after the final reporting to the Health Insurance Policy Review Committee. This drug has a unique feature of doubling the dosage of GSKs first triple combination therapy Trelegy Ellipta (ICS/LABA/LAMA). ‘Trelegy 200 Ellipta’ is used as a maintenance therapy for adults with asthma when the combination of long-acting beta2-adrenergic agonist and inhaled corticosteroid therapy is not providing adequate control. It contains three ingredients: fluticasone furoate, umeclidinium, and vilanterol. A combination of three ingredients provides enhanced therapeutic effects compared to existing drugs. The inclusion of LAMA in a drug combination is anticipated to help patients with asthma that is not adequately controlled with double therapy of ICS/LABA. When Trelegy 200 Ellipta is listed for reimbursement, the market for COPD triple combination therapy will become even more competitive. In January, Kolon Pharmaceutical released Trimbow (beclomethasone dipropionate plus formoterol fumarate hydrate plus glycopyrronium bromide), a single inhaler triple combination therapy. Clinical trials have shown that Trimbow has significant treatment effects by reducing exacerbations of moderate to severe symptoms, improving respiratory function, and enhancing the quality of life. Furthermore, Trimbow has been shown to improve respiratory function and reduce exacerbations of moderate to severe symptoms in patients with asthma. These results demonstrate that Trimbow is effective in managing symptoms and has a good safety profile in patients with COPD or asthma. Trimbow is advantageous for patients with small airway problems because its extra-fine particles can penetrate small airways. Trelegy 200 Ellipta passed the Drug Reimbursement Committee of the Health Insurance Review and Assessment Service (HIRA) last November. Afterwards, it was under negotiations with the NHIS.
- Policy
- The guidelines for PVA will be revised soon
- by Lee, Tak-Sun Feb 15, 2024 05:58am
- The National Health Insurance Service (NHIS) is likely to seek opinions from the pharmaceutical industry soon to revise the operational guidelines on the price-volume agreement (PVA) program. The revised guidelines draw attention as they include an agenda for easing on products that have reduced their prices more than three times in five years, as announced last year. According to industry experts, on the 14th, the NHIS plans to revise the PVA negotiation’s operational guidelines, including an agenda announced last December regarding easing the PVA for innovative new drugs. The pharmaceutical industry expects the NHIS to conclude revising the guidelines before the type ‘Da’ monitoring starts in April. Therefore, the NHIS will likely consult with pharmaceutical organizations, including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), for their opinions. What is most interesting is the agenda focusing on easing regulations for products that have reduced their prices more than three times. On December 22nd, the Biohealth Innovation Committee, chaired by the Prime Minister, released a report stating that pharmaceuticals produced by companies that have received an innovative designation or meet the standards will be eligible for an adjusted rate of price reduction on the third round. For instance, drugs that have already undergone two rounds of price reduction through PVA negotiations will receive a reduced rate of price reduction this year. Products undergoing the fourth and fifth rounds of price reductions will be subject to a lower rate of reduction. Upon completion of the revision guidelines this year, many products are expected to receive benefits. The industry anticipates that the rate of price reduction will fall between 30-50%. If the set reduced price is 1,000 won, then 300 won to 500 won may be deducted. However, the final revision measures will be determined following discussions among departments including the Ministry of Health and Welfare (MOHW). According to research conducted in 2022 on the evaluation of achievements and improvement measures of the PVA program, 26 products with the same ingredient have repeatedly undergone price reductions more than three times in 10 years. Among these products, nine from Korean pharmaceutical companies and 17 from multinational pharmaceutical companies have experienced price reductions more than three times. As a result, adjustments are expected to lead to lower reduction rates for many products. The revised guidelines are expected to include differential application of reductions based on claim amounts. Higher reduction rates will likely be applied to higher claim amounts, with 30 billion won as a reference amount. Also, exclusion criteria will likely be updated to include measures that raise the claim amounts to 3 billion won, up from the current claim amount of less than 2 billion won. Furthermore, the guidelines may contain measures for products with temporary increases in volume due to infectious diseases and drug shortages, allowing for a reduction rate or refund. However, the plan to increase the maximum reduction rate from the current 10% to 15% will be reflected through future revisions.
- Policy
- Price cut hold for Forxiga, Xigduo, Atmeg Combi are extended
- by Lee, Jeong-Hwan Feb 14, 2024 05:40am
- The administrative stay of execution of the price reduction disposition for AstraZeneca's diabetes drugs Forxiga (dapagliflozin), Xigduo (dapagliflozin+metformin), and Korea United Pharm’s Atmeg Combigel (atorvastatin 10 mg + omega 3) has been extended, and the insurance ceiling price for the drugs will remain unchanged until June 30. On the 7th, the Ministry of Health and Welfare announced the extension of the stay of execution of these drugs in ‘the drug reimbursement list and reimbursement ceiling price table.’ This is the result of the Seoul Administrative Court's decision to grant AstraZeneca and United Pharmaceuticals Korea's request to suspend enforcement of drug price cuts as filed by AstraZeneca and Korea United Pharmaceuticals. AstraZeneca filed for the stay of execution, claiming that the price reduction was unfair due to the difference in indications between the original Forxiga and generic drugs. Korea United Pharm also filed for a stay of execution after its 2-year drug price premium was terminated due to the listing of other 'atorvastatin 5 mg + omega-3 combination drugs' that contain different dosages of the ingredients. The company had received the pricing premium because there had been fewer than 3 generic companies that produced the same ingredient. As a result, the price of Forxiga will remain at KRW 734, and the price of Xigduo XR Tab 10/500 mg and 10/1000 mg will remain at KRW 736. The MOHW’s reduced price is KRW 514 for Forxiga, KRW 473 for Xigduo 10/500 mg, and KRW 512 for Xigduo 10/1000 mg. The insurance ceiling price of Atmeg Combigel will remain at KRW 1,219. The MOHW’s reduced price was KRW 960.
- Policy
- Chinese MM drug Xpovio reattempts reimb listing in KOR
- by Lee, Tak-Sun Feb 14, 2024 05:40am
- A new drug for multiple myeloma that was developed by the Chinese pharmaceutical company Antengene is attempting reimbursement listing again in Korea. The drug’s name is Xpovio Tab 20mg (Selinexor). The drug received a non-reimbursement decision at the Drug Reimbursement Evaluation Committee meeting that was held in November last year. According to industry sources on the 8th, Antengene applied for the reimbursement listing of its Xpovio 20mg Tab. to HIRA. The drug was approved in August 2021 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. The company has since applied and filed for reimbursement coverage, but its first reimbursement attempt was thwarted by a non-reimbursement decision at the DREC level in November last year. Established in 2017, Antengene is an anticancer drug specializing company that has received investment from the global pharmaceutical giant BMS Pharmaceuticals. Its headquarters is based in Shanghai, China. In Korea, the company obtained import authorization for the drug in 2021 and appointed Min-Young Kim, former head of Ipsen Korea, as its General Manager. Antengene successfully applied for Xpovio ‘s reimbursement from Canada in August 2022, raising expectations for its reimbursement listing in Korea. Canada is one of the 8 countries that Korea references for new drug reimbursement. The company's success in obtaining reimbursement in the US after Canada raised expectations that it would be able to set an appropriate drug price in Korea, but it failed to cross HIRA’s threshold. However, multiple myeloma patients are calling for its expedited reimbursement, explaining how Xpovio is the only drug available in the fifth line for their treatment. Therefore, the public’s eyes are on whether the authorities will fulfill the dire wishes of the patients and reimburse the drug this time. Meanwhile, the first new drug made by a Chinese pharmaceutical company to be reimbursed in Korea is Beigene Korea's blood cancer drug ‘Brukinsa’. The drug has been reimbursed for Waldenström macroglobulinemia (WM) since May last year.
- Policy
- Will Enhertu·Ilaris·morning sickness drugs be reimbursed
- by Lee, Tak-Sun Feb 14, 2024 05:40am
- Whether Enhertu Inj 100mg, Ilaris Injection Sol, and the morning sickness drugs that had passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review on the 1st, will be listed for reimbursement in April is gaining attention. As all three drugs are highly sought-after by patients and the public, the government is trying to get them on the reimbursement list ahead of the 22nd National Assembly election scheduled on April 10. According to industry sources on April 13, the companies for Enhertu Inj 100 mg (trastuzumab deruxtecan), Ilaris Injection Sol (canakinumab), and morning sickness drugs (doxylamine succinate + pyridoxine hydrochloride) I are expected to enter drug pricing negotiations with the National Health Insurance Service soon. Enhertu Inj is used to treat HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. It is considered to be one of the most potent breast cancer drugs ever developed. Ilaris is used for rare diseases such as criophorin-associated periodic fever syndrome, which affects only 13 patients in Korea. Also, morning sickness drugs have been sold off-label at a price of KRW 100,000 per month ever since its launch in 2016. Due to its high price, voices had been rising even among the general public, requesting its reimbursement listing. At the DREC meeting that was held on the 1st, the committee members acknowledged the reimbursement adequacy of Enhertu and Ilaris, and granted conditional approval for the 7 morning sickness drugs including Diclectin Enteric Coated Tab, on their reimbursement adequacy if the companies accept a price below the assessed amount. Accordingly, the NHIS and the companies immediately started the drug pricing negotiation process for Enhertu and Ilaris, and the companies of the morning sickness drugs can also start negotiations if they accept the assessed price within 30 days. The government had expressed determination to expedite the reimbursement listing of these drugs. Also, the National Health Insurance Service had reportedly held preliminary discussions with AstraZeneca to expedite the pricing process. Furthermore, as Enhertu had been reviewed by DREC twice to reach the appropriate drug price level, its pricing negotiations with the NHIS are expected to be conducted relatively smoothly. The company had faced difficulties passing the economic evaluation process for Enhertu, and although the drug’s ICER ICER (incremental cost-effectiveness ratio) value was reportedly slightly higher than the threshold, the government decided to flexibly apply the threshold and accept its reimbursement adequacy. Ilaris is also expected to be reimbursed quickly as the National Assembly and patient organizations are calling for its prompt reimbursement. The NHIS has 60 days to negotiate the drug price, but it aims to reach an agreement sooner and submit it to the Health Insurance Policy Deliberation Committee by late March. Although a price acceptance process remains for the morning sickness drugs, the government's willingness to move forward with the process is raising the possibility of their speedy reimbursement as well. Through the imbuement listing, the health authorities are hoping to create a favorable public opinion for the ruling party before the general election. In response, the Ministry of Health and Welfare is expected to hold a meeting with the 8 morning sickness treatment companies around next week to clarify the government’s stance on their speedy reimbursement. An industry official said, "The fact that the MOHW is in talks with companies even before the NHIS negotiations have started is a positive sign for reimbursement. We believe the government will also hold an open ear to the company’s voices for prompt reimbursement listing.”
- Policy
- HIRA to revise guidelines on new drugs utility assessment
- by Lee, Tak-Sun Feb 13, 2024 05:52am
- The Health Insurance Review and Assessment Service (HIRA) will revise the guidelines on indirect comparison for assessing the clinical utility of new drugs. For this purpose, HIRA is currently recruiting researchers for contract research work. On the 1st, the HIRA initiated public bidding for ‘Research services to revise guidelines on indirect comparison for assessing the clinical utility of new drugs.’ “When used as a resource for evaluating clinical utility of new drugs, direct comparison with substitute drugs through randomization are prioritized to assess their efficacy improvements. However, in cases where the submitted product was the sole treatment group in a clinical study or where no direct comparison data with a substitute drug is available, an evaluation basis through a valid indirect comparison becomes necessary,” the HIRA explained. “Based on the findings of the ‘Research on developing the guidelines on indirect comparison for assessing the clinical utility of new drugs (2010),’ the guidelines on the required documentation for new drugs will be formulated. The guidelines will help applicants submit objective effect comparison data for new drugs, and they will also serve as a resource for assessing the suitability and cost-effectiveness of new drugs. However, revisions to domestic guidelines may be necessary to accommodate improved methods, particularly when overseas countries have revised their guidelines,” the HIRA added. Furthermore, once the system updates based on last year’s 'Research on the improvement of the cost-effectiveness evaluation waiver system for drugs (current status and evaluation)’ are implemented, the guideline will serve various uses. According to findings from last year’s research on improving the cost-effectiveness evaluation waiver system for drugs, the existing waiver system will change into a ‘deferred’ system. Drugs that are granted deferred status will have their clinical utility assessed during the post-reimbursement management evaluation. The post-reimbursement evaluation is expected to be important for the drugs that are granted cost-effectiveness deferment. “There are increasing cases of drugs that cannot produce direct comparison clinical data, such as in cases of anti-cancer drugs and orphan drug treatments featuring a single treatment group in clinical research. Consequently, the indirect comparison method is expected to become a valuable source following the revision to the cost-effectiveness evaluation waiver system for drugs,” the HIRA explained. The HIRA plans to sign a contract with external services in February and begin research in March. The deadline for submitting the final report is set for December.
- Policy
- Ulcerative colitis drug Omvoh is approved in Korea
- by Lee, Hye-Kyung Feb 13, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh) announced that it has approved Lilly Korea's new drug Omvoh Inj (mirikizumab-mrkz, recombinant) for the treatment of ulcerative colitis on the 7th. Omvoh Inj. 20 mg/ml is a monoclonal antibody drug that binds to the p19 subunit of interleukin (IL)-23, providing a new therapeutic opportunity for patients with ulcerative colitis by inhibiting interleukin receptor downstream signaling that causes inflammatory responses. Omvoh Inj. is indicated for the treatment of adult patients (aged 18 years or older) with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic treatment. It binds to interleukin (IL)-23, which plays a central role in the pathogenesis of several immune-mediated and chronic inflammatory diseases, including ulcerative colitis, to help maintain resistance to bacterial and viral infections in the gut while supporting clinical improvement of inflammation. The MFDS added, "We will continue to make our best efforts to ensure that treatments with sufficiently verified safety and efficacy are promptly supplied based on regulatory science.”
