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- 2026-04-09 03:05:55
- Policy
- Pulmican & Pulmicort price increase discussed on the 9th
- by Lee, Tak-Sun Nov 06, 2023 05:26am
- The agenda to increase the prices of asthma drugs Pulmican and Pulmicort, suffering from supply and demand problems, will be discussed at the 12th Pharmaceutical Reimbursement Evaluation Committee held on the 9th. On this day, the appropriateness of the drug price increase will be reviewed. If it passes the Pharmaceutical Review Committee, it is expected that the drug price increase will be realized as early as December through adjustment negotiations with NHIS. Attention is being paid to whether supply will increase due to drug price increases and whether the supply-demand problem will be resolved. According to the industry on the 5th, Kunil Pharmaceutical and AstraZeneca Korea, suppliers of Pulmican and Pulmicort, applied to HIRA for adjustment of the upper limit of the drug, and the final review of the suitability of the application for adjustment will be held by the committee on the 9th. Both drugs are used as a suspension and nebulizer for treating bronchial asthma and acute laryngotracheobronchitis in infants and children. This is a representative drug whose supply and demand have been disrupted since last year as the number of respiratory patients has increased rapidly due to the impact of COVID-19. Recently, the need to increase the prices of two drugs was raised in a public-private consultative body in response to the unstable supply and demand of medicines, and the adjustment process began. The procedure for adjusting the upper limit amount is set when ▲ there is no alternative drug, ▲ a drug that is essential for medical treatment, ▲ a drug that is necessary for medical treatment but has a lower administration cost than a drug that can be replaced, ▲ or there is only one company in the drug with the same administration route and ingredients. The committee plans to review whether the two drugs meet the conditions. If it passes the committee, it will undergo adjustment negotiations with NHIS regarding the specific ceiling amount increase rate. Currently, the upper prices for Pulmican and Pulmicort are 946 won and 1,000 won per bottle, respectively. In the NHIS negotiations, an increase in supply is expected to be presented as a condition for increasing drug prices. Considering that the previous negotiations for adjustment of acetaminophen and pseudoephedrine preparations were concluded in a short period of time, this price increase for budesonide preparations is also expected to be applied as early as December after completing the negotiations this month if passed by the Pharmaceutical Review Committee. In the case of acetaminophen, for which a drug price increase was decided in December last year, the drug price increase is considered the most effective policy as a solution to the out-of-stock problem in that the supply and demand problem has gradually escaped after the upper limit amount was adjusted.
- Policy
- Prevenar competitor Vaxneuvance is approved in KOR
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- MSD Korea’s 15-valent pneumococcal vaccine ‘Vaxneuvance Prefilled Syringe (Pneumococcal/diphtheria CRM197 Protein conjugate vaccine) has been granted marketing authorization in Korea. Vaxneuvance, which is expected to rise as a strong competitor to ‘Prevenar 13,’ is a 15-valent pneumococcal conjugate vaccine, that induces active immunization for the prevention of invasive pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F. Vaxneuvance holds significance in demonstrating its effect in preventing serotypes 22F and 33F, the common serotypes that cause invasive pneumococcal disease (IPD) in adults. Serotypes 22F and 33F are not contained in Prevenar 13. The vaccine must be administered by intramuscular injection in children aged 6 weeks or older. Infants under 6 months of age who have previously received one or more doses of Prevenar 13 can complete their vaccination schedule with this drug. In the clinical trial, Vaxneuvance was non-inferior to Prevenar 13 (PCV13) for the 13 shared serotypes as assessed by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs). Also, its immune responses were superior to Prevenar 13 shared serotype 3 and for the two serotypes unique to Vaxneuvance, 22F and 33F. In particular, in the Phase III PNEU-AGE (V114-019) trial, Vaxneuvance demonstrated greater OPA GMT ratios for serotypes 22F and 33F. However, randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to Prevenar 13 have not been conducted. Meanwhile, Vaxneuvance was approved by the U.S. Food and Drug Administration (FDA) in October 2021 to prevent pneumococcal disease in adults 18 years of age or older. According to MSD, Vaxneuvance's sales last year amounted to $138 million. Meanwhile, Pfizer is also working to extend its indications by launching Prevenar 20, its successor to Prevenar 13, in the United States.
- Policy
- Tramadol classified as narcotics abroad but not in KOR
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- The Ministry of Food and Drug Safety stated that there is insufficient evidence to designate tramadol, a so-called narcotic painkiller, as a controlled narcotic in Korea. On the 1st, the MFDS submitted a written response to the written inquiry issued by Rep. Sun-Woo Kang of the Democratic Party of Korea regarding the need to designate tramadol as a narcotic. Since the Korean Pharmacists for Democratic Society proposed the designation of tramadol as a psychotropic drug in 2014, there has been ongoing controversy over the need for its designation as a narcotic. Accordingly, the Ministry of Food and Drug Safety recently conducted a 'Study on the misuse and abuse of opioids’ and concluded that there is insufficient evidence to designate tramadol as a narcotic based on the results. However, considering how some countries including the United States and the United Kingdom designate the drug as a narcotic, the MFDS said they will continue to monitor its misuse and abuse and whether it should designated as a controlled substance at the United Nations level and will consider designating it as a narcotic if necessary. However, as the survey in the research study was conducted only on doctors, Rep. Kang pointed out, "Talks on their side effects were raised by patients and pharmacists' groups. How credible would a survey only on doctors be from that aspect?” The MFDS responded, "Products containing tramadol are prescription drugs that can only be used with doctor's prescriptions, so the survey was conducted on doctors who regularly treat actual patients and prescribe tramadol. We will monitor adverse events including drug dependence and regulatory trends overseas and review the need to conduct a research service to survey various groups including pharmacists and patients if necessary.” Tramadol is a painkiller used for moderate-to-severe acute and chronic pain, but due to its structure, which is similar to narcotics, it can cause dependence, withdrawal symptoms, and respiratory depression. This is why it is classified and managed as 'Schedule IV' drug in the US. Recently, according to the monitoring group of the Seoul Pharmaceutical Association, one patient received prescriptions for a total of more than 200 tablets of the narcotic painkiller Tritol (Tramadol) and cough and phlegm medicine Cough Tab from 4 to 5 clinics over a period of 5 days under the names of several family members, raising the issue of misuse and abuse. Rep. Kang requested an explanation at the very least on the drug’s precautions, saying, “It is inconsistent to strengthen the labeling requirements by deleting the phrase ‘tramadol is less dependent’ from its precautions for use while stating that there is no need to designate it as a narcotic.” In the precautions for tramadol use, there is a phrase that goes 'mental and physical dependence may occur due to intolerance from long-term administration. For patients with drug abuse or dependence, it should be administered for a short period of time under strict supervision.’ To this, MFDS stated, “Tramadol can cause mental and physical dependence, so we believe that safety management for the drug should be conducted even though there is insufficient evidence to designate it as a narcotic. We strengthened its safety management by deleting the phrase on its dependence due to worry that it may raise misconceptions that it causes no problem due to low dependence.”
- Company
- Expansion of coverage for SMA treatment Spinraza
- by Nov 03, 2023 05:32am
- Biogen Korea held a press conference on the 2nd at the Conrad Hotel in Yeouido, Seoul to commemorate the expansion of the reimbursement standard for Spinraza, the first SMA treatment developed Differentiation between single-dose Zolgensma and oral Evrysdi “Spinraza welcomes relaxation of salary standards” Hyeongjun Park, Professor of Neurology at Gangnam Severance Hospital, gave a presentation on changes in the SMA treatment environment. Biogen's Spinraza, a treatment for spinal muscular atrophy (SMA) with the advantage of direct intrathecal administration and multiple administration, succeeded in easing the age limit for reimbursement. It showed the potential to differentiate itself from competing drugs such as Novartis' Zolgensma, a one-shot treatment, and Roche's Evrysdi, a PO drug. Biogen Korea held a press conference on the 2nd at the Conrad Hotel in Yeouido, Seoul to commemorate the expansion of the reimbursement standard for Spinraza, the first SMA treatment developed. In order to receive Spinraza coverage in Korea, patients with 5q SMA must be 5q ▲ genetically diagnosed with a deletion or mutation in the SMN-1 gene ▲ not using a permanent ventilator ▲ develop SMA-related clinical symptoms and signs under the age of 3 All criteria had to be met. Due to this benefit expansion, the age limit for children under 3 years old has been deleted. As a result, SMA type 3 patients who developed symptoms after the age of 3 can now begin treatment with Spinraza for which reimbursement is applied. This expansion of the reimbursement standard is considered to be one step ahead of competing drugs in dominating the SMA treatment market. Zolgensma, a one-shot treatment, works by inserting a functional replacement copy of the SMN1 gene into a carrier called a ‘vector’ and then delivering it to motor neurons in the body through intravenous injection. The disadvantage is that it is difficult to administer multiple doses to patients who cannot be treated with a single administration. Evrysdi, an oral medication, has a similar mechanism to Spinraza but has the disadvantage of not being able to be administered directly intrathecally. Park Hyeong-jun, a professor of neurology at Gangnam Severance Hospital, said, “Zolgensma can only be administered once, so if the patient has experienced the virus once, an immune response will occur, making multiple administrations difficult.” He added, “Due to the risk of an immune response, it is only administered to patients under 2 years of age.” He continued, “In the case of Evrysdi and Spinraza, there is no direct comparative study, so it is difficult to say which drug is better. The difference is that Spinraza can be administered directly intrathecally. Because Evrysdi is an oral medication, there is no guarantee that the drug will only go to the spinal cord when administered. “There may be a shortage of doses,” he added. He said that it is meaningful to see improvement in symptoms in a wider range of patients by lifting Spinraza's age restriction. Professor Park said, “It was getting worse, but it’s important to feel like it’s improving. The probability of a patient who cannot walk walking and a person lying down and rolling to the side are different. There are many patients whose movements gradually improve. “This is why we need Spinraza, a multi-dose drug,” he said, adding, “It is true that people are cautious because Spinraza is a drug that costs more than 10 million won per bottle, but it is meaningful that the scope of what can be done for patients has expanded due to this expansion of coverage.” Ultra-rare disease SMA, the advantage of Spinraza is that can be administered directly. SMA is a rare, genetic, neuromuscular disorder whose symptoms are caused by a deficiency of the survival motor neuron (SMN) protein caused by a damaged or missing SMN1 gene. People with SMA may have difficulty sitting, standing, and walking. SMA is a leading cause of death in infants and young children, affecting approximately 1 in 10,000 live births, and causes a variety of disabilities in patients older than their teens. It is classified into types 1 to 4 depending on the time of symptom onset. Spinraza is an antisense oligonucleotide (ASO) with a mechanism of action that continuously increases the amount of SMN protein. In order to deliver the treatment to the cause of the disease, it can be administered directly to the central nervous system where motor neurons are located through intrathecal injection therapy. Spinraza can be differentiated in administration method because it can be administered multiple times. The treatment has confirmed its continued effectiveness and safety profile across all ages and types based on clinical research data and real-world use evidence (RWE) accumulated through treatment for up to 8 years or more.
- Opinion
- [Reporter’s view] WLA Registration
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- WHO announced on October 26 that the Ministry of Food and Drug Safety was listed on the WHO Listed Authorities. The news became known in Korea on the afternoon of the 30th, when WHO posted a list of WLA-registered countries on its website and then suddenly deleted it. It was confirmed that the error was due to detailed coordination, and it was on the afternoon of the 31st that the Ministry of Food and Drug Safety officially heard the news of WLA registration. WHO also officially distributed a press release and announced that Korea was listed in the WLA. The good news about the Ministry of Food and Drug Safety's WLA is that although Korea is a full member of the ICH, it has not been listed on the WHO's SRA (Stringent Regulatory Authority), which means that the domestic pharmaceutical and bio industries have not been able to receive incentives in bidding for the procurement of medicines and vaccines from UN-affiliated organizations. In particular, in 2021, when COVID-19 was prevalent, Hong Kong limited the scope of countries recognizing vaccination certificates to countries listed in the SRA, raising controversy over the reliability of the regulatory level of domestic pharmaceuticals. This is a happening that occurred as the WHO has not been operating the SRA registration application process since 2015. WHO has been promoting WLA, in which WHO directly evaluates regulatory agencies, since 2016 to replace SRA, which is based on ICH membership requirements. Korea had no choice but to wait for an evaluation system to replace SRA since 2016, and submitted its first letter of intent for registration in 2021, when WHO began accepting letters of intention to register WLA. The news of the Ministry of Food and Drug Safety's WLA registration is a great achievement after two years. However, the specific incentives that the domestic pharmaceutical and bio-industry will experience once WLA registration is achieved are unknown. The Ministry of Food and Drug Safety also provides advantageous conditions by applying exceptions to WHO quality certification (Pre-qualification (PQ)) when SRA countries bid for the procurement of medicines and vaccines from UN-affiliated organizations, and WHO provides equivalent standards to countries listed in the WLA. The only announcement was that they expected to implement support measures. The pharmaceutical bio-industry is expecting WHO's PQ exception to be applied through this WLA listing. Although WHO is not a regulatory agency, it conducts PQ when procuring medicines and vaccines from UN-affiliated organizations, which includes data review, testing, and on-site inspection. In the end, it seems that domestic sites will only be able to realize the Ministry of Food and Drug Safety's WLA registration if they are able to receive exceptions to WHO's PQ. We hope that the Ministry of Food and Drug Safety will be able to announce in detail WHO's incentives for WLA registration as soon as possible.
- Company
- Cosentyx is approved for hidradenitis suppurativa
- by Eo, Yun-Ho Nov 03, 2023 05:32am
- 'Cosentyx' has entered the field for hidradenitis suppurativa where no other treatment option than ‘Humira’ had been available until now. Moreover, the company plans to immediately enter the market for the indication in Korea as well. According to industry sources, Novartis Korea recently submitted an application to the Ministry of Food and Drug Safety to extend the indications for its interleukin (IL)-17A inhibitor Cosentyx (secukinumab) to hidradenitis suppurativa (HS). Considering how the indication was approved by the US FDA on the 1st, the company is rapidly preparing to introduce the treatment to Korea. Cosentyx is the first interleukin inhibitor to receive approval for the hidradenitis suppurativa indication and is an achievement made in 10 years after Humira (adalimumab). Hidradenitis suppurativa is characterized by pain and skin lesions such as subcutaneous nodules, abscesses with sinus tract formation, and scars. Repeated inflammation and pus can cause odor, interfering with daily life and adversely affecting the patient’s quality of life. Hot and humid weather makes these symptoms worse, and when the initial inflammation and subcutaneous nodules worsen, sinus tracts can form to the inside of the skin and cause scarring. Its prevalence, which is around 0.00033-4.1% worldwide, has been increasing gradually. According to data from the Health Insurance Review and Assessment Service, about 10,000 patients were reported with hidradenitis suppurativa in Korea as of last year, but the actual number is estimated to be greater. Studies in North America and Europe showed that it occurs more commonly in women, but in Korea, it occurs more commonly in men. Cosentyx's approval was based on the results of the SUNSHINE and SUNRISE trials, which were the largest Phase III clinical trials conducted in the field of hidradenitis suppurativa. Study results showed that the proportion of patients who achieved clinical response (HiSCR50) for hidradenitis suppurativa was higher in the Cosentyx 300mg arm than in the placebo arm when administered every 2 or 4 weeks. Cosentyx for hidradenitis suppurativa is administered at a dose of 300 mg every 4 weeks, and the dose can be increased every 2 weeks if the patient shows inadequate response. In the SUNSHINE study, the percentage of patients achieving HiSCR was 44.5% in the Cosentyx arm, compared to a mere 29.4% in the placebo arm. The HiSCR achievement rates in the SUNRISE study were 38.3% and 26.1%, respectively. In addition, the Cosentyx 300mg 4-week treatment arm also showed a significantly higher HiSCR achievement rate than the placebo arm. In the SUNSHINE study, the HiSCR achievement rate in the Cosentyx 300mg 4-week treatment arm was 41.3%, but 29.4% in the placebo arm. In the SUNRISE study, the rates were 42.5% and 26.1%, respectively. In addition, as a result of exploratory analysis up to 52 weeks of treatment, the HiSCR rate of the Cosentyx arm was sustained through week 52 of the study.
- Company
- Novartis Jakabi expands graft-versus-host disease coverage
- by Nov 02, 2023 05:35am
- Novartis Korea announced that Jakabi, a Janus Kinase (JAK) inhibitor, will be covered by insurance for the treatment of acute or chronic graft-versus-host disease from November 1. About 1 year and 6 months after Jakabi was approved for graft-versus-host disease indication in May of last year, insurance benefits were applied to patients aged 12 or older who did not respond sufficiently to previous corticosteroid treatment. Graft-versus-host disease is a disease that occurs after allogeneic hematopoietic stem cell transplantation when the donor's T cells recognize the patient's normal cells as foreign substances. A variety of symptoms appear across multiple organs and greatly reduce the patient's quality of life. Steroids are used as the first treatment, but there is a risk of various side effects. In addition, about half of patients do not respond to treatment and show dependence on steroids, which reduces the effectiveness of treatment. Jakabi is a targeted treatment that selectively inhibits JAK hyperactivity signals and acts on both JAK1 and JAK2, the main causes of inflammation and tissue damage in graft-versus-host disease. Jakabi acts as a mechanism to lower the excessive production of inflammatory cytokines that cause tissue damage in graft-versus-host disease and to suppress the expansion of T cells. Jakabi has proven its effectiveness in patients with acute graft-versus-host disease refractory to corticosteroids through REACH2,3 clinical studies. Kim Hee-je, a professor at Seoul St. Mary's Hospital (Department of Hematology), said, "Patients with hematological diseases who have suffered from severe acute or chronic graft-versus-host disease that occurs after allogeneic hematopoietic stem cell transplantation have not been able to establish a standard treatment after the failure of primary steroid treatment, so there is no effective treatment available. “There was no such thing,” he said. The professor added, "Jakabi's listing on the payroll means that for the first time, a treatment that will solve the unmet need for treatment that has not been addressed in Korea has been prepared for the first time, and at the same time, patients can receive effective treatment without financial burden." Lee Ji-Yoon, managing director of Novartis Korea's Blood and Oncology Division, said, "We are pleased that this reimbursement listing has laid the foundation for domestic graft-versus-host disease patients to receive treatment comfortably without financial burden." Managing Director Lee said, “We will continue to strive to provide better treatment opportunities for domestic graft-versus-host disease patients and create an environment where they can focus solely on treatment.”
- Company
- Reblozyl can be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Nov 02, 2023 05:35am
- Reblozyl, a treatment for myelodysplastic syndrome, can now be prescribed in general hospitals in Korea. According to industry sources, BMS Korea’s Reblozyl (luspatercept-aamt) passed the drug committees (DCs) of several medical institutions in Korea including Samsung Medical Center and Sinchon Severance Hospital. Reblozyl is indicated to treat anemia in patients who showed inadequate response to or are intolerant to treatment with an erythropoiesis-stimulation agent (ESA) who have ▲ very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS), or ▲ very low- to intermediate-risk myelodysplasia/myeloproliferative tumor with ring sideroblastic cells and thrombocytosis, or ▲myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, or ▲ anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. The starting dose is 1.0 mg/kg subcutaneously once every 3 weeks for myelodysplastic syndrome and beta-thalassemia. Reblozyl has a mechanism of action that induces red blood cell maturation by inhibiting hyperactivation of the Smad 2/3 pathway caused by TGF-β superfamily ligands. Reblozyl demonstrated efficacy in the Phase III MEDALIST trial. Study results showed that the proportion of patients in the placebo arm who achieved continuous blood transfusion (transfusion independence) for at least 8 consecutive weeks during the 24-week observation period was only 13% while 38% in the Reblozyl arm reached 38%. During the same period, the rates of achieving transfusion independence were 8% and 28% respectively for 12 weeks or longer, and 4% and 19% respectively, for 16 weeks or longer in the placebo and Reblozyl arm, When extending the period to 48 weeks, only 7% of patients in the placebo arm achieved transfusion independence for longer than 16 weeks, whereas in the Reblozyl arm, the rate was 28%. Meanwhile, myelodysplastic syndrome is a malignant disease that occurs in hematopoietic cells in the bone marrow. It is a geriatric disease whose incidence increases rapidly in people over 60 years of age. It is characterized by ineffective and dysplastic hematopoiesis in the bone marrow and a decrease in normal white blood cells, red blood cells, and platelets in the peripheral blood. The most common symptoms include fatigue, general weakness, and decreased exercise capacity due to anemia. In severe anemia, symptoms such as palpitations, shortness of breath, and chest pain may also appear and develop into acute myeloid leukemia. Due to different clinical manifestations and course of the disease in each subcategory, some people live stably for decades with only mild anemia, but others develop complications due to a decrease in red blood cells or develop acute leukemia and die within a few months.
- Policy
- SR version of gabapentin enters Korean market
- by Lee, Tak-Sun Nov 02, 2023 05:35am
- The first sustained-release formulation of gabapentin, which is used for nerve pain, has been introduced to Korea. The drug is Alvogen Korea’s Gralise SR Tab. The drug will be reimbursed from November and is expected to improve the convenience of intake for patients. According to industry sources on the 1st, Gralise SR Tab 600mg will be listed at KRW 648/tablet. It has improved the dosage guidelines from the 3 times a day with existing immediate-release tablets to once a day. The drug may be taken once daily with dinner. The Gralise SR was recognized as a drug that offers a new dosing method and strength, and the drug price was calculated at 110% of the insurance price ceiling set for the development target products. Therefore, its listed price became 10% higher than the highest price of KRW 589 given to the existing gabapentin immediate-release tablet 600 mg. However, its scope of indication is narrower than those for existing immediate-release tablets. Gralise SR 600 mg is only indicated for pain associated with postherpetic neuralgia. The immediate-release versions were also allowed used for epilepsy and neuropathic pain. The original gabapentin is Neurontin from Viatris Korea. The drug was introduced to Korea in 2000, and 174 products are currently approved on the market, indicating the highly competitive market. Based on UBIST last year, the original Neurontin's outpatient prescriptions amounted to KRW 21.4 billion. In a clinical trial on 359 patients with postherpetic neuralgia, Gralise SR showed a higher Cmax (highest blood concentration after drug administration) and a lower steady-state AUC (blood drug concentration) than its immediate-release version. The time to reach maximum plasma concentration (Tmax) was 8 hours, about 4 to 6 hours longer than immediate-release gabapentin. Graliz SR is an imported product developed by the US pharmaceutical company Almatica Pharma. It was approved by the FDA in 2011. Attention is rising on whether this drug, which offers an improved convenience, will rise to become a rival to Neurontin.
- Policy
- There were more than 20 doses of Dapagliflozin 5mg
- by Lee, Tak-Sun Nov 02, 2023 05:35am
- Forxiga 5mg, it was withdrawn from the domestic market Even though there are 21 SGLT-2 series Dapagliflozin propanediol hydrate 5mg products listed for reimbursement, the stepped drug price was not applied to the newly listed items in November. Why? This is because all 21 products were viewed as first-time registered products. According to the industry on the 1st, Nexpharm Korea's 'Floga 5mg' met the standard requirements when it was listed for reimbursement in November, and was added to the 59.5% given to first generics to the existing highest price of the same drug, setting a price of 291 won per tablet. Even though there are already 21 generics on the benefit list, they were calculated using the highest price formula. The stepped drug price system implemented in 2020 is such that when generics enter the market with more than 20 already listed identical products, the price is capped at 85% of the lowest price for the same drug or 38.69%. However, this time, the stepped drug price was not applied. This is because, in the case of a first-registered product, multiple products are considered one. Dapagliflozin 5mg was listed for the first time in Korea on April 8. AstraZeneca's original drug, Forxiga 5mg, was listed on the reimbursement list in 2014 but was deleted in 2018, so there was no identical drug on the reimbursement list at the time of listing the generics. Therefore, all 21 products listed for reimbursement on April 8 were recognized as first-listed. However, for the same drug that will be registered in the future, a stepped drug price will be applied. From now on, drug prices will be calculated based on the total number of registered items, including the first listed products. Therefore, the next item listed for benefit is calculated at 85% of the lower of the lowest price for the same product or 38.69%, regardless of whether the standard requirements are met. Nexpharm Korea's Floga 5mg was listed for reimbursement 7 months later than competing drugs, but was fortunate enough to receive a high price. An industry official said, "The generic calculation standards themselves were complicated, so in the case of Dapagliflozin 5mg, it was not possible to know whether the stepped drug price would be applied in the field." He explained, “It was only later that I understood why Nexpharm products received the highest price plus extra.”
