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- 2026-04-14 03:36:12
- Company
- Mother's and Kyung Dong won the patent dispute
- by Kim, Jin-Gu Jul 26, 2021 05:50am
- Tenelia M SR Mother's and Kyungdong Pharmaceutical won the patent dispute over DPP-4 Inhibitor Series Diabetes Complex Tenelia M SR (Metformin HCl + Teneligliptin Hydrobromide Hydrate). This is expected to compete with Genuonescience, which won ahead of the two companies with the early release of generic for Tenelia M SR. According to the pharmaceutical industry on the 22nd, the Intellectual Property Trial and Appeal Board decided on the 21st at the Defensive Confirmation Trial for the Scope of a Right, which Mother's and Kyung Dong filed against Korea. The patent applied to Tenelia M SR is a formulation patent that expires in 2034. In January this year, Genuonescience filed a trial alone. Then in April, Mother's and Kyung Dong claimed. However, Mother's and Kyung Dong did not meet the "first request for trial" requirement to acquire generic for exclusivity. This is because the trial was not filed within 14 days of the filing date of the patent trial by Genuonescience. Genuonescience, which filed a trial three months earlier, won. On May 24, it was billed by the Intellectual Property Trial and Appeal Board. Two months later, Mother's and Kyung Dong succeeded in the challenge. Three companies are expected to compete with the early release of generics for Tenelia M SR in the future. However, Genuonescience is said to be one step ahead in this competition. This is because two out of three requirements have already been acquired for generic for exclusivity. The key is the initial application for permission. Earlier last month, Genuonescience and Mother's applied for permits at the same time. It is not clear which of the two submitted the application first. If Genuonescience had applied first, it would be possible to obtain generic for exclusivity from the MFDS. The company can monopolize the generics market without competing with other companies for nine months after Tenelia M's material patent expires on October 25 next year. If Mother's first submitted an application, no company can obtain generic for exclusivity. Thus, Genuonescience, Mother's, and Kyung Dong can release the generic regardless of generic for exclusivity. Tenelia is a DPP-400 inhibitor series of diabetes treatments introduced in Korea by Handok from Mitsubishi Tanabe Pharma. Korea developed its own compound Tenelia M SR by adding Metformin to a single-agent Tenelia. According to UBIST, a pharmaceutical market research firm, Tenelia posted a prescription record of ₩19.7 billion and Tenelia M, ₩22.8 billion last year. It was prescribed ₩10 billion and ₩11.7 billion respectively until the first half of this year.
- Policy
- Controversy over the manufacturing location of QTP104
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- The location of COVID vaccine, which was approved for phase 1 of clinical trial by South Korea's bio-venture Quratis on the 19th, is controversial. Quratis vaccine is the first of its kind in South Korea, similar to Pfizer and Moderna. However, the MFDS says the vaccine is an overseas development product and discriminates against other domestic development products. On the 20th, the MFDS approved Phase 1 clinical trial plan for QTP104. The clinical trial will be conducted for 36 people at Gangnam Severance Hospital, which is aimed at increasing capacity, multiplying institutions, disclosing and phase 1 of clinical trials to evaluate the safety of vaccines to prevent COVID-19 among healthy adults. QTP104 is a self-replicating mRNA-based vaccine, which is known to produce more antigen proteins by inserting replication genes involved in self-explosion, unlike conventional mRNA vaccines. QTP104 is the first RNA vaccine in Korea. The COVID-19 vaccine, which is currently undergoing clinical trials in Korea, is a DNA vaccine from Genexine and Geneone, a virus vector vaccine from Cellid, and a recombinant vaccine from SK Bioscience and EuBiologics. The RNA vaccine was first developed by Curatis. The MFDS also marked Quratis' vaccine as a domestic development shortly after clinical approval. However, since QTP104's original developer is a foreign company, it has changed to foreign development. There was no press release that was distributing approval of vaccine for domestic development. According to the clinical trial approval information, the original developer of QTP104 is HDT Bio Corp in the U.S. But, HDT Bio also failed to commercialize the vaccine. Quratis explains that QTP104 is a development vaccine in Korea. A company official said, "Vaccines are manufactured at the Osong plant, and it is a vaccine developed in Korea. We also asked the MFDS to change it to domestic development." However, the MFDS said, "No data related to domestic manufacturing have been submitted, and nothing has been officially applied for domestic development." There is also a new drug developed in Korea by bringing substances from overseas. K-CAB (Tegoprazan), which was approved as Korea's new drug No. 30, is also said to have been introduced from Japan. However, it is called a new drug developed in Korea because CJ Healthcare conducted a clinical trial for commercialization. QTP104 can be said to be a new domestic development drug if Quratis gets permission first in Korea and has never been commercialized overseas. The standards for overseas development are also unclear. Until now, overseas development products are known to refer to multinational clinical trials by global pharmaceutical companies that are conducted not only in Korea but also in other foreign countries. However, it is questionable whether the QTP104 will be considered multinational clinical even if partner companies are receiving clinical approval from the U.S. and India and product development is underway. This is because individual companies are conducting clinical trials in each country. Quratis is a company that participates in the "Vaccine Business Council" led by the MOHW, and is also supported by the government. Therefore, even if Quratis vaccine is commercialized later, controversy over whether it is a domestic or overseas vaccine is expected to continue.
- Company
- Glaucoma tx Taflotan demonstrates long-term effectiveness
- by Jul 26, 2021 05:49am
- Santen (CEO Lee Han-woong) announced on the 21st that an open-angle glaucoma high-pressure treatment called Taflotan has confirmed the effects of long-term intraocular pressure lowering and glaucoma inhibition in comparison with PGA. The results of the PGA analysis were published in the Journal of Clinical Medicine. The LOTUS study is the first multi-organ retrospective cohort study that compares and analyzes the long-term effects and safety profiles of PGA, the primary treatment for glaucoma, in Korean patients. From January 2010 to June 2016, we evaluated the progression of visual impairment and the effect of reduced intraocular pressure on primary glaucoma or normal intraocular glaucoma patients, including Taflotan, Latanoprost, and Travoprost. Based on electronic medical records (EMR), the patient group was classified into primary glaucoma or normal eye pressure glaucoma group (216 patients) and normal eye pressure glaucoma group (177 patients). The study found that the MD Slope in the Taflotan treatment group remained stable for a long time in the early open-angle glaucoma or early normal eye pressure glaucoma, similar to that in the case of administration of Latanoprost and Travoprost. Measurements of eye pressure changes after administration of Taflotan showed a decrease of -1.89±2.77mmHg in the primary open angle glaucoma or normal intraocular pressure glaucoma group and -2.20±2.64mmHg in the normal intraocular pressure glaucoma group. The reduced eye pressure remained stable for a long time. The effects between the three PGA's were identified at similar levels in both patient groups, with no significant adverse reactions. Glaucoma is a disease in which the optic nerve becomes weaker due to increased intraocular pressure, and it is fatal because it can lead to blindness. Glaucoma is divided into open-angle glaucoma and angle-closure glaucoma, one of the most common types of open-angle glaucoma in domestic glaucoma, depending on whether the discharge passage for waterproofing the eye pressure is open. Normal eye pressure glaucoma is within the normal range of 21mmHg or less, but active drug treatment is needed because the optic nerve is vulnerable and easily damaged. PGA is the drug family with the highest intraocular pressure drop effect among glaucoma single drugs developed so far, and is most often used as a primary treatment for glaucoma due to its high patient conformity and little systemic side effects. "LOTUS research is meaningful in that it compares the long-term effects and safety profiles of PGA, which are most commonly used in glaucoma treatment, for the first time in Korea," said Kim Joon-mo, an ophthalmologist at Sungkyunkwan University's medical school. "In particular, we expect that it will help patients preserve their vision and vision from an early stage, as the glaucoma progression of Taflotan-only treatment has been confirmed to be equivalent to that of the existing PGA," he said. Meanwhile, Taflotan is a glaucoma treatment released by Santen in 2010 and is available for patients with open-angle glaucoma and ocular hypertension, including normal eye pressure glaucoma.
- Policy
- Tamsulosin and Donepezil insurance cuts were most objected
- by Lee, Hye-Kyung Jul 23, 2021 05:57am
- It was found that most amount of objections were filed for examination fees and outpatient prescription drugs after the Health and Insurance Review Service's adjustments such as cutbacks on items that do not meet the review criteria for insurance benefits. HIRA had recently held a ‘2021 Briefing session on filing objections’ for medical care institutions. In the session, HIRA introduced cases of 1st adjustments after review that received the most amount of objections. By each treatment category, objections filed for examination fees accounted for 23%, followed by outpatient prescription drugs 20%, emergency aid and operation fees 17%, and injection fees 12%. Among outpatient prescription drugs, adjustment on the oral tablets ‘Tamsulosin’ and ‘Donepezil,’ and the denosumab injection received the most objections. Results of objections filed for adjustment made showed that Tamsulosin was being applied insurance benefit for its indication, ‘dysuria from benign prostatic hypertrophy,’ and for the off-label use in neurogenic bladder. However, in many cases, adjustments were made for unconfirmed benign prostatic hypertrophy or bladder disease diagnosis. When the medical institution files an objection regarding the adjustment, the institution needs to attach a medical record that shows proof of diagnosis related to benign prostatic hypertrophy. Cases of adjustments made to the denosumab injection showed that cuts were made due to unconfirmed osteoporosis disease, unconfirmed BMD test results, and an excessive number of follow-up tests results, among others. Applicable medical institutions need to confirm the eligible subjects and period of administration as specified in the notification, and when filing an objection, medical records that can confirm osteoporosis, period and frequency of administration, etc. or radiation reading sheets, bone density test results that can confirm osteoporotic fractures need to be attached to the objection. Most adjustments were made for Donepezil oral tablets due to unconfirmed Alzheimer-type dementia diagnosis, unconfirmed test results including CDR, MMSE, and errors in description format. To avoid insurance cuts, medical institutions need to check the subject eligible for administration, evaluation method and enter the dementia test results under the specific classification code ZT007 as specified in the instructions on how to write up the claim for benefits. In filling out the Donepezil claim form, the test results should be listed in the order of MMSE, CDR, and GDS, then the test dates should be listed. When filing an objection, the diagnosis and test results that can confirm Alzheimer’s must be attached. Meanwhile, HIRA has been operating inspection services including the pre-inspection service that allows for inspection, modification, and remedies before submitting the claim and a claims error service that allows for corrections and supplements to be made within 2 days after filing the claim. Medical institutions may check for errors identified before claiming benefits through the pre-inspection service to prevent adjustment of medical expenses, minimize supplementary claims, and prevent filing objections.
- Policy
- Moderna vaccine shows 94% prevention in overseas trial
- by Kim, Jung-Ju Jul 23, 2021 05:57am
- Moderna’s COVID-19 vaccine was found to be 94.1% effective in preventing COVID-19. The results were analyzed and presented by the disease prevention and control authorities based on the results of the observation made on 420,000 people who receive their first vaccination in Canada. In Korea, 290,000 doses of the Moderna vaccine were introduced on the 22nd. The COVID-19 Vaccination Response Team (Head: Eun Kyeong Jeong) explained the vaccine’s prevention effect as workers in hospital-level medical institutions were administered the Moderna vaccine from June to July, and people in their 50s will be receiving the Moderna vaccine from the 26th. ◆Effect of vaccination = Results from a Phase III clinical trial on 30,420 people showed that the Moderna vaccine was 94.1% effective. In its effect against preventing variants that were conducted on 421,073 people in Canada who received their first dose of the Moderna vaccine, the vaccine had an 83% effect on the Alpha variant, 77% effect on the Beta/Gamma variant, and 72% effect on the Delta variant. In addition, the vaccine’s effectiveness in preventing hospitalization and deaths after the first dose, the vaccine had a 79% effect on the Alpha variant, 89% effect on the Beta/Gamma variant, and 96% effect on the Delta variant 로나19 모더나 백신 변이주에 대한 백신효능. The authorities also provided guidelines on how to respond to adverse reactions for a safe vaccination with the Moderna vaccine. People who are vaccinated should stay at the institution for 15 to 30 minutes after vaccine administration to be observed for adverse reactions and should be closely monitored for over 3 hours even after returning home. The vaccinated person should be observed with special attention for at least 3 days after vaccination, and people with a high fever or abnormal physical symptoms must immediately seek medical attention. In particular, the Vaccination Response Team added that people who are suspected of symptoms of myocarditis or pericarditis after vaccination, and people with facial fillers who show facial swelling should seek immediate medical attention, and requested the institutions to report the adverse reactions. ◆Vaccine introduction status and plan = On the 22nd, the KDCA announced that a total of 24.92 million doses of COVID-19 vaccines, including the 290,000 doses of the Moderna vaccine that were introduced to Korea. In addition, approximately 31 million doses will be additionally introduced until late August, and the detailed schedule for each vaccine will be provided to the extent allowed as soon as the discussions are finalized with the relevant pharmaceutical companies. Meanwhile, the COVID-19 Vaccination Response Team said 77.2% (5,847,769) of the subjects eligible for vaccination completed their reservations as of midnight on the 22nd. 83.2 % of the subjects aged 55 to 59, and 72.3% of the subjects aged 50 to 54 completed their vaccine reservations.
- Company
- Generics for Betmiga, ↑19% market share in just one year
- by Kim, Jin-Gu Jul 23, 2021 05:57am
- Betmiga, Mirabek & Selebeta Generics for Betmiga (Mirabegron) are gaining market influence. Two generics for market share expanded to 19% in just one year after its launch. The release of generics resulted in a 14% drop in the amount of outpatient prescriptions for the original over a year. According to UBIST, a pharmaceutical market research institute on the 21st, the size of outpatient prescription market for irritable bladder treatments with Mirabegron ingredients in the second quarter was ￦17.3 billion. Compared to ￦16.5 billion in the same period last year, it increased by 5 %. The second-quarter prescription for the original Betmiga is ￦14 billion, down 14% from a year earlier. Hanmi and Chong Kun Dang released Mirabegron and Sellebeta in June and July last year, respectively. The amount of the original product decreased from ￦16.4 billion in the second quarter of last year to ￦16.1 billion in the third quarter, ￦15.9 billion in the fourth quarter, ￦15.4 billion in the first quarter and ￦14 billion in the second quarter. The market share fell from 99% to 81%. Considering that Betmiga's prices are almost the same as before, it is interpreted that the generics directly affected the original performance decline. Astellas has postponed the decision to lower the price of generics due to administrative litigation. However, since March of this year, the upper limit of insurance has been reduced by 5.5% in accordance with the price-volume agreement negotiation system. The total amount of prescription for two generics in the second quarter is ￦3.2 billion. Its share in the overall market is 19%. It succeeded in taking up one fifth of the market within a year of its release. Hanmi is ahead in the competition between the two generics. As of second quarter, Mirabek recorded ￦2.4 billion and Selebeta recorded ￦800 million. In particular, Mirabek is expected to achieve ￦10 billion per year. The key is the additional release of generics. Generic exclusivity period for Mirabek and Selebeta ended in February this year. Currently, 26 companies, excluding Hanmi and Chong Kun Dang, are preparing to launch with generic approval. Betmiga is an irritant bladder drug released by Astellas in October 2015. Annual prescriptions include ￦28.8 billion in 2016, ￦41.9 billion in 2017, ￦54.8 billion in 2018, ￦64.7 billion in 2019, and ￦65.1 billion in 2020. There are about 40 domestic companies that have entered into patent challenges. Since 2015, the company has filed defensive confirmation trial for the scope of a right. Among them, Hanmi and Chong Kun Dang won the generic exclusivity. The generic exclusivity period was from May 4 last year to February 3 this year.
- Company
- Sales of Lyrica's generics sales beat Lyrica in nine years
- by Kim, Jin-Gu Jul 23, 2021 05:57am
- Lyrica (Pregabalin) For the first time, sales of Lyrica's generics, which is worth ₩120 billion a year, surpassed the original sales. It is the first time in nine years that a generic has been released in Korea. The reason why it took a relatively long time to expand generic prescription performance is because the original company, Viatris, has registered material patent & use patent. Use patent of Lyrica has been registered since the expiration of the material patent in 2012, and generic companies have sold generics in earnest since August 2017, when use patent was expired. ◆ Generics ₩16 billion vs Original ₩14.6 billion According to UBIST, a pharmaceutical market research institute on the 21st, the size of Pregabalin market is estimated to be ₩30.6 billion in the second quarter of this year. The size of the market itself is almost the same as that of the second quarter of last year (₩30.6 billion). However, the market share between the original and generics has changed significantly over the past year. The prescription amount of the original Lyrica decreased 12% from ₩16.6 billion in the second quarter of last year to ₩14.6 billion in the second quarter of this year. Sales of generics recorded ₩16 billion in the second quarter of this year. Compared to the second quarter of last year, it increased by 14%. The team beat the original for the first time based on its quarterly performance. It is the first time in nine years since the generic was released in Korea. As of second quarter, market share of generic is 52%. ◆ Generics were sold in earnest after the expiration of the usage patent in 2017 Domestic companies released generics in 2012 in line with the expiration of material patent of Lyrica. However, indication expired at that time was limited to epilepstic seizure. Drugs were not available for neurological pain. Until August 2017, when use patent expired, the sale amount of generic prescriptions was around ₩1 billion per quarter. Its market share also fell below 10%. However, sales of generics have increased in earnest since the expiration of the patent. The market share of generic products rose to 34% in 2018 after the expiration of the patent. It increased to 42 % in 2019 and 49% last year. The difference between prescription amount between original and generic in the first quarter was only ₩100 million. It finally surpassed the original in the second quarter. As of the second quarter, 117 companies have been approved for 330 items. HK inno.N's second-quarter prescription for Kabalin was ₩3.2 billion. Last year, it was the only generic product that had a prescription record of ₩10.7 billion. As of the second quarter, Daewoong Bio's Lyribear's sales were ₩1.5 billion won, Hanmi's Prebalin sales were ₩800 million, Medica Korea's Prelika and Hanlim's Gabaneuro were ₩700 million, Samjin's Neurocover-PG, Celltrion's Lyfrega and Lyreca were ₩600 million, respectively. All of the remaining products are less than ₩400 million.
- Company
- Optimal doses of Effient and Brilinta different for Koreans
- by Eo, Yun-Ho Jul 22, 2021 05:53am
- The theory that East Asians, including Koreans, require dose adjustments when receiving dual antiplatelet therapy (DAPT) prescriptions is gaining strength. In other words, the ‘East Asian Paradox’ theory that antithrombotics' clinical effect and safety are different for East Asians compared to Westerners is now being recognized worldwide. In Korea, with Young-Hoon Jung, director of the Cardiovascular Center at Gyeongsang National University Hospital, marking the start, domestic researchers have emphasized that East Asians show a different response to antithrombotics due to their lower risk of atherothrombotic events and a higher risk for serious bleeding events than Westerners and that an appropriate treatment guideline needs to be developed for Koreans. This opinion had also been reflected in the joint statement published by the Korean Society of Myocardial Infarction last year. As a result, various de-escalation strategies were studied on patients with acute myocardial infarction, all of which significantly reduced bleeding risk. The TICO study that demonstrated the effect of aspirin discontinuation therapy after 3 months, the TALOS-AMI study that showed the effect of switching from 'Brilinta (ticagrelor)' ‘to 'Plavix (clopidogrel)' after 1 month, and the HOST-REDUCE-POLYTECH-ACS that showed the effect of the de-escalation therapy of reducing the dose of 'Effient (prasugrel)' to half, are representative cases of studies supporting dose reduction. In addition, various pharmacokinetic and clinical observation studies that support reduced-dose therapies using Efficient and Brilinta were recently published in Korea and are expected to be used to revise the treatment guidelines in the future. First, Professor Young-hoon Jeong’s team published the results of a multicenter A-MATCH study that was conducted at 8 university hospitals on acute coronary syndrome (ACS) patients in the latest issue of the international journal, Thrombosis and Haemostasis. In the study, ACS patients before discharge were assigned to a standard-dose prasugrel 10mg, half-dose prasugrel 5mg, or platelet function test (PFT)-guided group for a 1-month treatment. Results showed that the ratio of patients that show an appropriate antiplatelet effect was 3.8 times and 3.5 times higher in the latter two groups compared to the Effient 10mg treated group. Bleeding frequency was also lower by 42% and 45% in the other two groups compared to the Effient 10mg treated group. Patients who experienced bleeding were around twice more likely to change drugs within the 1-year treatment period. Professor Jeong explained, “The standard-dose prasugrel had shown excessive strong platelet inhibition in Koreans. On the other hand, the half-dose prasugrel showed a clear reduction in bleeding risk and appropriate antiplatelet effect.” Also, in the HOPE-TAILOR study published in the international clinical medicine journal, J Clin Med, in June by Dong-A University Hospital’s Professor Mooh Hyun Kim and his Circulatory Internal Medicine team, the half-dose Effient and Brilinta demonstrated a more adequate optimal platelet reactivity (OPR) than the standard dose. However, the half-dose Brilinta treatment still showed excessive strong platelet inhibition and had significantly increased bleeding events in the 9-month treatment period compared to half-dose Effient, and standard-dose Plavix (31.6% vs. 12.2%, HR=2.93), also presenting the need for a large-scale clinical study on the optimal drug and dose for Koreans. Pusan National University Hospital’s Professor Jin Sup Park and his Circulatory Internal Medicine team also published their results of the BLEEDING-ACS study that was conducted on ACS patients in the latest issue of an international medical journal. The researchers randomly assigned ACS patients with low platelet reactivity (LPR) to standard-dose (90mg) or half-dose (45mg) of Brilinta to compare their frequency of bleeding events and dyspnea. Results showed that the frequency of bleeding events and dyspnea were similar between the two groups at 6 months, and was most frequent within 3 months of treatment, then decreased over time. However, the researchers also saw a 70% reduction of the Bleeding Academic Research Consortium (BARC) events (BARC type ≥2) in the low-dose Brilinta group. This reduction was more prominent in patients with a BMI of less than 25 kg/m2 or patients over 65 years of age. As in the case of Effient, the result suggests that reducing Brilinta’s dose in patients with a higher risk of bleeding, such as older or underweight patients, may have a more noticeable effect. Professor Park said, “No increase in ischemic events were observed in Korean patients with ACS when reducing the dose of ticagrelor by half. The dose reduction only significantly reduced risk of serious bleeding events.”` Meanwhile, studies on the appropriate dose of Brilinta for Koreans are currently underway, just like the HOST-REDUCE-POLYTECH-ACS studies that demonstrated the effect of half-dose Effient. The EASTYLE study, which is being conducted by Professor Mooh Hyun Kim and Professor Young-Hoon Jung's team, is studying the clinical efficacy of a de-escalation strategy, using 60mg Brilinta (45mg for older and underweight patients), and a hybrid therapy of discontinuing aspirin after 3 months in 2,000 Korean patients
- Policy
- Onivyde reimb. to be expanded to 2nd-line pancreatic cancer
- by Lee, Hye-Kyung Jul 22, 2021 05:53am
- From next month, Servier Korea’s 'Onivyde (irinotecan liposome injection)' will be available with insurance benefits for use in second-line or higher treatment of pancreatic cancer. However, patients eligible for the insurance benefit are limited to patients with an ECOG(European Cooperative Oncology Group) of 0 to 1. The Health Insurance Review and Assessment Service recently disclosed the 'Revision of notice according to medicines prescribed or administered to cancer patients' that contain the changes mentioned above and is reviewing opinions until the 26th. If no objections are made, the agenda will be deliberated and passed by the Ministry of Health and Welfare's Health Insurance Policy Deliberative Committee this week and applied reimbursement from the 1st of next month. Onivyde was first approved in August 2017 'in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.' HIRA's review of the drug for reimbursement showed that Onivyde was recommended as Category 1 in the NCCN guidelines and as 'II, B' in ESMO guidelines for the second-line treatment of metastatic pancreatic cancer in patients who were previously treated with gemcitabine-based therapy. Its efficacy in second-line treatment was verified through the open-label, randomized Phase III NAPOLI-1 study conducted on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) over the age of 18. In the study, Onivyde demonstrated its clinical efficacy over the '5-FU + Leucovorin' combination. In relation to the policy to 'cover non-benefits for items that exceed the scope of coverage,' which is being implemented as part of the coverage enhancement policy, the benefit for G-CSF injections will also be expanded. The 'Neulasta prefilled syringe inj.', 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj.' were only be applied insurance benefit for cancer patients over the age of 19 years that belong to certain cancer types and in combination with anticancer therapies specified in the benefit standards. For coverage enhancement, the authorities reviewed whether to expand the benefit standards to the scope currently being paid in full by the patient as an out-of-pocket cost. As a result, the benefit was expanded to hyper CVAD, R-hyper CVAD, and ifosfamide + etoposide + mitoxantrone therapy in non-Hodgkin lymphoma that was confirmed to 'have an over 20% risk of neutropenic fever', as well as to Hyper CVAD therapy in acute lymphoblastic leukemia with an over 20% risk of neutropenic fever, in consideration of the risk of neutropenic fever found in clinical studies. The 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj' were not approved for acute lymphoblastic leukemia, however, G-CSF injections that prevent neutropenia are applied the same expansion of benefit as there is no clear difference in their effect in each cancer type.
- Policy
- The administration monitoring cycle of Samsca is changed
- by Kim, Jung-Ju Jul 22, 2021 05:53am
- The administration monitoring cycle of Samsca (Tolvaptan) is changed in more detail. Psoriasis arthritis treatment Ixekizumab, which have been used as secondary drugs, and Secukinumab such as Cosentyx will be expanded to primary biological treatments. The MOHW announced on the 20th a partial revision of the "Details on the Standards and Methods of Medical Benefits," which is based on this information, and began to inquire opinions by the 27th. The new drug standards will be applied as of August 1. ◆Samsca, a treatment for upper chromosomal polycystic kidney disease, changes the monitoring cycle for administration by reflecting the permission. The MOHW and the HIRA decided to change the monitoring cycle of ADPKD patients and electrolyte levels in consideration of domestic and foreign permits, textbooks, clinical care guidelines, and related academic opinions. Specifically, monitoring, which was conducted once a month before and after the initial administration of this drug, is changed to monthly for the first 18 months before and after the initial administration, and every three months after that. ◆Cosentyx and Taltz Prefilled Syringe = Taltz Prefilled Syringe and Cosentyx, which can be used as secondary treatment drugs for psoriasis arthritis, are expanded to primary biological treatments and cautions regarding the risk of tuberculosis infection of biological agents are specified. These drugs will be expanded to the DMARDs non-compliance activities and primary biological sanctions by referring to domestic and foreign permits, textbooks, clinical care guidelines, clinical research documents, and related academic opinions. It was added to implement the late tuberculosis test in the same way as the TNF- in inhibitor, reflecting precautions for use and expert opinions regarding the risk of tuberculosis infection in biological agents. Based on the conditions under administration, the benefits can be applied if two or more types of DMARDs have been treated for more than six months (each three months), or if they meet the conditions as active and progressive arthritis patients who have discontinued treatment due to side effects of drugs. There shall be at least three compressed joints and at least three edema joints, and shall be the result of two consecutive measurements at intervals of one month. The treatment guidelines for late tuberculosis should be followed when using the TNF- in inhibitor. The MOHW plans to inquire about the revision by the 27th and implement it as of August 1st if there is nothing special.
