- LOGIN
- MemberShip
- 2026-05-18 11:51:56
- Company
- 19% of valsartan Rxs disappear 3 years after impurity issue
- by An, Kyung-Jin Jul 27, 2021 05:35am
- Three years have passed since the valsartan impurity issue swept across the pharmaceutical industry, however, the valsartan market is still showing no signs of recovery. Prescriptions of products containing valsartan as monotherapy and combination therapy both decreased by nearly 20%. Analysts believe that distrust in valsartan after the impurity issue has led to switching prescriptions to similar drugs. According to the pharmaceutical research institution UBIST on the 26th, outpatient prescriptions for valsartan monotherapy products recorded ₩29.9 billion in the first half of this year, a 5.4% decrease from the same period of the previous year. This is the second consecutive year of decline since the 4.1% decrease to ₩31.6 billion last year. Compared to the ₩34.1 billion in 1H of 2018, prescription of valsartan monotherapy products decreased by 12.4% in three years. With losartan, valsartan used to occupy the largest share of the angiotensin II receptor blocker (ARBs) market for the treatment of hypertension. The valsartan market had contracted much since an N-Nitrosodimethylamine (NDMA) impurity was detected in the valsartan active ingredient from China's Zhejiang Huahai Pharamceutical, which led to unprecedented mass recalls and sales suspensions around the world. This incident had delivered a hard blow to the growing domestic prescription market for valsartan products. On July 8th, 2018, the Ministry of Food and Drug Safety had suspended the sale of 209 pharmaceutical products containing valsartan that were being distributed in Korea for using an active ingredient that was found with NDMA. Afterward, the authorities made remedies for products that did not use the active ingredient in question and additionally uncovered products that use NDMA containing active ingredients, resulting in a total of 175 products being suspended from sales. The valsartan combination prescription market, which had a larger market than the monotherapy market, was also unable to escape the aftermath of the impurity crisis. In the first half of this year, the prescription volume for valsartan in combination with a calcium channel blocker (CCB) class amlodipine amounted to ₩98.1 billion. This was a 19.0% decline from the ₩121.1 billion in the first half of 2018, just before the impurity was detected. The market had somewhat recovered – by 6.6% - compared to the first half of 2019 when the valsartan issue just hit the industry. The combination of valsartan and the diuretic hydrochlorothiazide sold ₩19.3 billion in prescriptions in the first half of this year. From the ₩25.5 billion that was recorded in 2018 to ₩21.5 billion in 2019, and to ₩21.1 billion in 2020, the record has continued to fall. Compared to 3 years ago, prescriptions of the valsartan and hydrochlorothiazide combination fell 24.5%. Combined, the monotherapy and combination therapy market for products containing valsartan recorded ₩147.3 billion in the first half of this year. This was an 18.5% decrease from the ₩180.8 billion recorded in 2018. Until the first half of 2018 before the impurity issue broke, the monthly prescription of valsartan monotherapy and combination therapy products exceeded ₩30 billion per month. The monotherapy market by itself had recorded ₩6 billion in prescriptions every month. However, the prescription of valsartan monotherapy and combination therapies that reached ₩30.5 billion in July of 2018, fell immediately after the impurity issue, falling sharply to ₩25.8 billion in August, and ₩22 billion in September. And for three years since then, the monthly prescription has never exceeded ₩30 billion. As of June this year, the prescription for valsartan monotherapy and combination therapy combined recorded ₩24.3 billion. In other words, one-fifth of the prescriptions for valsartan disappeared after the impurity issue. Analysts believe that the distrust built in valsartan after the impurity issue has led to an avoidance of prescriptions containing valsartan. It is highly likely that some of the existing valsartan prescriptions have been switched to similar drugs. In fact, the ARB-based anti-hypertensive drug market itself did not contract after the valsartan impurity issue. The prescription for ARB-class monotherapies in the first half of this year amounted to ₩188.2 billion. As the pharmaceutical market had contracted in general due to the prolonged COVID-19 pandemic, the ARB market had also seen a decrease of 5.1% compared to the same period of the previous year but had increased by 2.9% compared to the ₩182.8 billion in 2018. The dual combination therapy market for the ARB+CCB class of antihypertensive ingredients had grown even more steeply. The accumulated prescription amount for the ARB+CCB combination in the first half of this year was ₩399.5 billion. This was an 0.2% increase from the same period last year and an overwhelming 19.1% increase from the ₩335.5 billion in the first half of 2018.
- Company
- Sales in the SGLT-2 diabetes drug market rose by 10%
- by Kim, Jin-Gu Jul 27, 2021 05:35am
- Xigduo·Jardiance Duo Prescription performance of compound drugs has increased significantly in the market for diabetic drugs in the SGLT-2 inhibitors. Outpatient Rx increased by 23% in the second quarter of the year. The single formulation only increased by 4% during the same period, showing slowing down. According to UBIST, a pharmaceutical market research agency on the 23rd, the total amount of outpatient prescriptions for diabetes treatments related to SGLT-2 inhibitors in the second quarter is estimated at ₩32.2 billion. Compared to ₩29.2 billion in the second quarter of last year, it increased by 10%. Market growth was led by combination formulations. The combined prescriptions for Xigduo (Metformin HCl+ Dapagliflozin Propanediol Hydrate) and Jardiance Duo (Empagliflozin +Metformin HCl) increased from ₩10.6 billion in the second quarter of last year to ₩13 billion in the first quarter of this year. Sales of Jardiance Duo rose 42% from ₩3.7 billion to ₩5.2 billion. Xigduo rose 13% from ₩6.9 billion to ₩7.8 billion. Boehringer Ingelheim launched the product a year later than AstraZeneca. The total amount of prescriptions for AstraZeneca's Forxiga and Boehringer Ingelheim's Jardiance, Astellas' Suglat and MSD’s Steglatro rose from ₩18.7 billion to ₩19.3 billion in the second quarter. By item, Forxiga increased 4% from ₩8.8 billion in the second quarter of last year to ₩9.2 billion in the second quarter of this year. Jardiance increased 5% from ₩8.5 billion to ₩8.9 billion over the same period. Suglat posted a prescription record of ₩800 million in the second quarter of this year, following the second quarter of last year. Steglatro fell 27% from ₩600 million to ₩400 million during the same period.
- Company
- Ultomiris can be prescribed in general hospitals
- by Eo, Yun-Ho Jul 26, 2021 05:51am
- According to related industries, Ultomiris (Ravulizumab), a treatment drug for paroxysmal nocturnal hemoglobinuria (PNH) supplied by Alexion to the domestic market, recently passed the D.C. of Seoul National University Hospital. It will be quickly prescribed after obtaining approval from the MFDS in May last year and being listed on the insurance benefit list on April 7. Solaris (30ml), at ₩5,132,364, so if three vials are administered bi-weekly per patient, ₩400 million is needed per year alone. Ultomiris was listed at ₩5,598,942 per bottle, and Ultomiris can be administered once every eight weeks from two weeks after initial dose administration, which is expected to lower the annual dose per patient compared to Soliris. However, like Solaris, a pre-approval system is introduced, and health authorities inspect monitoring before and after administration. PHN disease is one of the rare life-threatening blood diseases characterized by the destruction of red blood cells by the body, which is part of the immune system. In particular, it is a serious disease in which four out of 10 people die within five years if they are not treated after diagnosis. It is known that there are about 200 patients in Korea. Soliris (Eculizumab), which was released in Korea in 2012, is the only treatment of PHN, and patients treated with soliris improved their 5-year survival rate by 95.5%. Ultomiris demonstrated its validity through two studies conducted on PNH patients ( study 301, study 302). In the studies, Ultomiris demonstrated non-equality of treatment results compared to conventional Eculizumab in primary evaluation metrics such as transfusion avoidance, LDH normalization, LDH rate of change, FACIT-Fatigue score change. In addition, 93% of patients preferred Ultomiris in a preference evaluation study conducted on patients with seizures night haemoglobinosis who had received treatment with both Solaris and Ultomiris as an extended treatment study in the study 302.
- Policy
- Onivyde listed at ₩672,320 as RSA refund type
- by Kim, Jung-Ju Jul 26, 2021 05:50am
- Servier Korea’s 'Onivyde injection(irinotecan liposome),’ which is used in second-line or higher treatment of pancreatic cancer, will be available with insurance benefits at ₩672,320 per vial starting next month. The Ministry of Health and Welfare announced today(23rd) that the Health Insurance Policy Deliberative Committee deliberated and passed the ‘amendment to the drug benefit list and the maximum ceiling price table’ containing the amendment mentioned above. The drug was approved by the Ministry of Food and Drug Safety as a ‘second-line treatment for metastatic pancreatic cancer,’ on August 29th, 2017. In the same year, the company applied for its reimbursement to HIRA, on October 31st. Although HIRA had held a Review Committee for Cancer Disease meeting to review its reimbursement on January 24th, 2018, the company withdrew its application in June, putting a stop to all discussions. On July 24th, 2020, the company reapplied for the insurance benefit listing. On April 8th of this year, HIRA held a Review Committee for Cancer Disease meeting and ruled that the drug is appropriate for reimbursement. At the time, the committee recognized that the clinical practice guidelines then had recommended Onivyde in combination with fluorouracil and leucovorin for patients whose disease had progressed after first-line cancer therapy and that Onivyde had an improved clinical benefit compared to the control group in clinical studies. Academic societies had also suggested compared to existing second-line treatments for pancreatic cancer that lacked evidence on their clinical usefulness, Onivyde had demonstrated its benefit through clinical studies and is being recommended as a preferred option in clinical practice guidelines for pancreatic cancer. Afterward, the government ordered pricing negotiations to NHIS, and the NHIS made negotiations with the company from April 23rd to June 21st. Among the A7 countries, the drug is currently listed in four countries - Japan, Germany, the United Kingdom, and the United States, and the A7 adjusted average price of Onivyde is ₩1,562,643. Based on the price, the company and the NHIS had drug negotiations with the company to reimburse Onivyde as a refund type under the RSA scheme. The refund type is a type of RSA agreement where the company refunds a certain proportion of the claimed drug cost. In consideration of the fiscal impact and the foreign drug price, the NHIS and the company agreed to set Onivyde’s price at ₩672,320 per vial starting next month. Through the reimbursement, approximately ₩12.1 billion of NHI finances is expected to be spent on Onivyde. Additional finances spent due to the nonavailability of an alternative drug are estimated to be approximately ₩9.6 billion.
- Policy
- New PBAC members to make big reimbursmeent decisions in 2H
- by Lee, Hye-Kyung Jul 26, 2021 05:50am
- From September, new members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service will be conducting evaluations on the adequacy of pharmaceutical reimbursements. PBAC members that will start committee activity from the second half of this year, will carry out major deliberations and tasks from whether the ultra-high-priced new drug ' Kymriah' is eligible for reimbursement to the coverage expansion of 'Keytruda' that has recently passed the Review Committee for Cancer Disease deliberations. HIRA received recommendations from relevant organizations to pool around 100 experts from relevant fields for the committee until the 23rd of last month. The 8th PBAC members are appointed among a double pool of candidates who are recommended from relevant organizations, who undergo qualification review. The number of recommendations requested by HIRA requested to relevant organizations was 192, including 112 from the Korean Academy of Medical Sciences (4 or more per society, 28 societies); 18 from The Pharmaceutical Society of Korea (6 or more per society, 3 societies); 10 from medical and pharmaceutical associations (6 or more per society, 3 societies); and 24 from civic and consumer groups (2 or more per group, 12 groups). Among the recommendations, HIRA will select 96 members in consideration of each member's professionalism, diversity, and connectivity to agendas. ▲Those performing pharmacoeconomic evaluation-related services for pharmaceutical companies; ▲executives, private practitioners, or private pharmacists in the recommended medical and pharmaceutical organizations; ▲those who are judged unfit to perform fair work during pre-diagnosis of work ethics ▲those subject to administrative disposition or punishment under the Medical Service Act, Pharmaceutical Affairs Act, National Health Insurance Act or Medical Care Assistance Act within the last 5 years; ▲ those who have served as a member of the PBAC for two or more consecutive terms, were excluded from recommendations. In the case of ‘two or more consecutive term’ standard' that was prepared to limit long-term appointment and duplicate appointments, reappointment is possible for members who have served as an advisory member or who are in specialized fields in consideration of their unique circumstances In case of data submitted for PE evaluations. the characteristics of each drug and disease are difficult to regularize or standardize due to various assumptions, methodologies, and models involved. To address this, appointment standards have been slightly relaxed to ensure continuous participation of certain committee members, which is necessary for maintaining consistency in PBAC review. The 8th PBAC will consist of 102 members. In addition to the 96 recommended members, HIRA plans to add one member from the Ministry of Health and Welfare, one from the Ministry of Food and Drug Safety, the Department head of the HIRA Pharmaceutical Benefit Department, and 3 panels from the Healthcare Review and Assessment Committee to compose the 8th PBAC. The PBAC meetings will be held by 3 fixed members from MoHW, MDFS, and HIRA, and 17 other members (19 for agendas related to oriental medicine) from the 120 members.
- Opinion
- [Reporter's view] The MFDS shouldn't selectively explain
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- In a recent series of incidents, the MFDS did not properly explain, causing confusion. It wasn't a big issue, but it's not something to skip. The issue of whether the RNA-based QTP104, which was approved for phase 1 clinical trial on the 20th, was initially marked as "domestic development" on a site where approval status can be checked, but it was changed to "foreign development." A reporter raised a question through an article, and this time it was changed to "domestic development." As a result, there was confusion among reporters. The vaccine could not be clearly processed because it was not distinguished whether it was the first RNA-based or overseas vaccine. As of 4 p.m. on the 22nd, it is marked as "domestic development," so it seems to be a domestic development vaccine, but there is no clear answer from the MFDS. It is the government's long-cherished project to localize the RNA vaccine that Pfizer and Moderna monopolized. As there is also a great interest in the public, it was important to understand the reality of phase 1 clinical approval of QTP104. However, the MFDS has changed its mark from "domestic development" to "foreign development" again, making it difficult to identify the reality. I also asked the MFDS. Even now, the MFDS should quickly answer whether QTP104 is a vaccine developed in Korea. It seems necessary to explain the use and capacity change of the 31st new drug "Leclaza" developed by Yuhan. The MFDS said it was legally changed at the request of the company, but the usage and capacity were changed a day before the benefit confirmation this month. .Moreover, it is necessary to clarify why the dosage and indications have been changed because the diagnosis method is different compared to Leclaza's competitive drug Tagrisso .The MFDS should not just announce on its website the cancellation of the item license of Daewoong's Albis D, but explain it more actively .Previously, the Fair Trade Commission and the Korea Intellectual Property Office detected data manipulation during the patent registration process of this product .The cancellation of item permits is the strongest disposition that the MFDS can make .It should be explained whether the disposition is an extension of the disposition of the Fair Trade Commission and the Korean Intellectual Property Office, or is part of the GMP investigation .Watching this series of events, I suspect that the MFDS is deciding what to explain .It also seems that there is no problem with procedural justification or neglects explanation if it does not become an issue .Even though the method of storing the Pfizer vaccine was changed last time, journalists of daily and economic newspapers raised questions because they did not notify it .Since the MFDS has not explained each and every change in permission, the reporter thought it would not be a big issue .However, As the MFDS' lack of objectiveness continues, it may not have been recognized as a public communication problem.
- 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.
