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- 2026-04-16 00:16:36
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- Hanmi's Xoterna wins first trial in patent dispute
- by Kim, Jin-Gu Dec 02, 2020 06:06am
- Xoterna Hanmi won the patent dispute between Hanmi and Novartis over Xoterna (Indacaterol/Glycopyrronium), a treatment for COPD (chronic obstructive pulmonary disease). The Intellectual Property Trial and Appeal Board recently issued a trial decision for partial approval and dismissal in a trial for invalidation of a patent for the Xoterna partial approval composition that Hanmi recently requested against Novartis. The trial of partial dismissal was based on Novartis' deletion of some of the claims during an invalidation trial. It is the judgment of partial approval that the deleted claim is inappropriate because there is no subject of judgment. In reality, Hanmi won. Respiratory disease inhalation treatments were rare in patent challenges by domestic companies. This is because localization was difficult in that it had to develop not only drugs but also devices for inhalation. The share of imported items is absolutely large. In the case of Xoterna, in 2015, after Novartis launched the product in Korea, Hanmi, Ahn-Gook, and Chong Kun Dang challenged the composition patents in turn, requesting an invalidation trial, but all three companies dropped the judgment shortly after. However, Hanmi once again challenged itself in June of last year. Having succeeded in overcoming the composition patent in about 1 year and 6 months, Hanmi has advanced the release of the first generic by 2 years. The expiration date of composition patent of Xoterna is May 2025, and Hanmi can release the generic for Xoterna from January 2023, when the substance patent expires. If Hanmi releases generic for Xoterna early, it is expected to strengthen its line-up of inhaled treatments. Hanmi was the first domestic company to license Fluterol, generic for Seretide, in 2014, and Tiotropium, generic for Spiriva, in 2015. At the same time, Hanmi device was also independently developed. Both products are used for both asthma and COPD. Xoterna was launched in July of the following year after Novartis obtained domestic approval in 2014. It is jointly sold by Novartis and Yuhan. The prescription amount last year was ₩7.7 billion. In particular, as the Korean Academy of Tuberculosis and Respiratory Diseases revised the COPD guidelines at the end of 2017, Xoterna's performance is also steadily increasing. At that time, the society designated LABA (beta-2 agonist) and LAMA (persistent anticholinergic) combination as the first-line treatment. Xoterna is a representative two-component combination.
- Company
- The sales of Dupixent tripled in a year
- by Kim, Jin-Gu Dec 02, 2020 06:06am
- DupixentSales of Dupixent (Dupilumab), a treatment for severe atopic dermatitis, are increasing. Sales have increased since it was applied to health insurance benefits in January of this year. It posted a cumulative sales of ₩15.6 billion in the third quarter, and is expected to exceed ₩20 billion by the end of the year. According to IQVIA, a drug market research firm on the 30th, Sanofi Aventis' third-quarter sales of Dupixent, a treatment for severe atopic dermatitis, were ₩7.1 billion, an increase of 3.4 times from ₩2.1 billion a year earlier. It is analyzed that what was listed on the health insurance pay list in January of this year was decisive. In fact, if you look at Dupixent's quarterly sales, ▲₩1.5 billion in the first quarter of last year ▲₩1.7 billion in the second quarter ▲₩2.1 billion in the third quarter ▲₩2.7 billion in the fourth quarter, from ₩1 billion to 2 billion in the first quarter of this year with benefits applied. In the second and third quarters, sales jumped even further. It recorded sales of ₩5.2 billion and ₩7.1 billion, respectively. The cumulative sales amount until the third quarter of this year is ₩15.6 billion. Quarterly sales of Dupixent (unit: ₩100 million, data from IQVIA) In March 2018, Dupixent was licensed, and in August of the same year, it was released for non-payment. However, there were many difficulties until it was listed. In February 2019, it was not submitted to the HIRA's Pharmaceutical Evaluation Committee for nearly a year. It was judged by the government that the price of drugs exceeding ₩2 million per month was too expensive. Patients with severe atopic dermatitis appealed for the application of benefits through a national petition at Cheongwadae. Eventually, the government expanded the scope of the risk-sharing contract system (RSA). Subsequently, code for a severe atopic dermatitis disease was newly established. Finally, from January this year, Dupixent's benefit was applied. It was the first drug to be listed after RSA expansion. Dupixent's sales growth is expected to continue for some time. Currently, Dupixent is the only drug released in Korea as a treatment for severe atopic dermatitis. Until now, mainly non-steroidal topical treatments have been used, but there is a disadvantage that the probability of cure is lowered even after long-term treatment only helps relieve symptoms. Accordingly, the expectations of the medical staff and patients for Dupixent are high. In addition, Sanofi plans to expand its scope more actively by releasing new doses and expanding indications. Sanofi released a new dose of 200mg on October 26 this year. The previously approved dose was 300mg. It is in phase III clinical trial to expand indications with nodular prurigo. It is a skin disease similar to hives. It is also a disease that causes secondary infection after scratching due to severe itching. Like atopic dermatitis, currently available drugs only relieve symptoms in the short term, and there is no fundamental treatment. Dupixent is a mechanism that selectively inhibits the signaling of two major cytokines, interleukin-4 and interleukin-13, considered to be atopic dermatitis triggers. It was jointly developed by Sanofi and Regeneron, and is also the first drug designated by the US FDA as a 'breakthrough therapy' for skin diseases other than skin cancer in 2014.
- Policy
- 3 reimbursed Spinraza use applications from Oct. all cleared
- by Lee, Hye-Kyung Dec 02, 2020 06:05am
- The South Korean health authority has approved of all three cases submitted preliminary approval applications from last month seeking to use spinal muscular atropy (SMA) treatment Spinraza with coverage. Four months after a reimbursement approval, the drug user has to submit an administration monitoring reports for approval on maintenance dose. And the health authority also granted approval on all 24 cases of the monitoring reports. On Nov. 30, the Health Insurance Review and Assessment Service (HIRA, President Kim Sun-min) disclosed the results of October cases reviewed by the Treatment Review and Assessment Committee. One of the most expensive new drugs in the world, Sprinraza costs 92.35 million won per 5 ml vial and it requires a healthcare institute to apply for pre-administration approval for reimbursed use. In last month, a 17-year-old male patient, a 25-year-old female patient and a 10-year-old male patient submitted the application. Especially the 10-year-old had received the approval before for the fifth administration, after administering initial dosage (four doses), but reapplied for the approval as he refused to visit the healthcare institute with the concern of COVID-19. HIRA official said, “As the patient has halted the administration for about eight months (skipped two doses), it would be effective to administer in four-month interval, according to the pharmaceutical company’s clinical trial report, to maintain the optimal exposure of cerebrospinal fluid, because Spinraza’s efficacy increases when the fluid exposure is higher. Considering the current situation of COVID-19 and the main healthcare provider’s opinion, additional dose administering 14 days after resuming the administration is approved.” Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab). And four new applications from last month and one case of reevaluation were denied. Last month, the HIRA Treatment Review and Evaluation Committee disclosed four review cases on the uses of Spinraza, ventricular assist device (VAD), allogeneic hematopoietic stem cell transplant and Soliris. Other details of the Treatment Review and Evaluation Committee’s deliberation can be found on HIRA website (www.hira.or.kr) or the healthcare institute business portal website (biz.hira.or.kr).
- Policy
- 3 month-lasting birth control injection withdraws from Korea
- by Lee, Tak-Sun Dec 01, 2020 06:19am
- Pfizer’s contraceptive injection Sayana (medroxyprogesterone acetate) initially received the public’s limelight for the convenience of injecting once every three months, but it has decided to withdraw from the South Korean market. The injection even extended the post-marketing surveillance (PMS) period and showed its commitment to stay in the South Korean market, but the company has made a decision to pull out from the market before its PMS ends in next January. The underperforming sales seems to have affected the decision. On Nov. 23, Pfizer Pharmaceutical Korea has dropped the marketing license on Sayana injection. Approved by the health authority in January 2013, the contraceptive injection was evaluated to have significantly improved the convenience, compared to other female contraceptive drugs, by lessening the administration frequency as it is subcutaneously injected once every three months (12 weeks to 14 weeks). Besides the contraceptive function, the injection is indicated to control the pain induced by endometriosis. Regardless of improved convenience, the market’s reaction to the injection was cold. As a prescription drug, raising the public awareness in the new contraceptive injection was strictly limited. Also the short recommended duration of administration up to maximum two years, and adverse reactions like elytrorrhagia could have affected the sluggish sales growth as well. According to IQVIA, the injection sales marked 250 million won and 210 million won in 2018 and 2019, respectively. Approved as a new drug, the injection was to run PMS until Jan. 28, 2019, but Pfizer requested the number of cases to be reduced from 600 to 300 in 2018. The health authority denied the request, and the PMS period was extended for two years, expiring in January next year. Ultimately, the injection could not finish the PMS. Pfizer has sent out a notice to distributors last October explaining the supply suspension would be prolonged due to the unstable manufacturing. As Sayana withdraws from the South Korean market, now the contraceptive drugs available in the country would be only oral options.
- Company
- Talzenna didn’t pass the Cancer Assessment Committee
- by Eo, Yun-Ho Dec 01, 2020 06:15am
- The government is conservative about breast cancer-related insurance benefits for PARP inhibitors. According to related industries, Pfizer's Talzenna (Talazoparib) was submitted to the HIRA's Cancer Assessment Committee held on the 25th, but failed. As the range of indications for breast cancer of PARP (poly ADP ribose polymerase) inhibitors such as Talzenna is wide, insurance authorities are concerned. Prior to the Cancer Assessment Committee was skeptical about the indications for breast cancer even at the time of AstraZeneca's Lynparza (Olaparib). As a result, discussions about the benefit of PARP inhibitors for breast cancer have to look forward to next year. There are some differences in the indications for breast cancer between the two drugs. Lynparza includes ▲adult patients with breast cancer susceptibility gene (gBRCA) mutation and human epithelial growth factor receptor 2 (HER2) negative metastatic breast cancer who have previously experienced chemotherapy treatment, and in the case of Talzenna, locally advanced patients are added. Indications for these drugs include the area of triple-negative breast cancer (TNBC), which lacks treatment options, and is attracting attention from academia. Another PARP inhibitor, Takeda's Zejula, has not yet secured an indication for breast cancer. However, in the case of Zejula, ▲ there is a single maintenance therapy for platinum-sensitive recurrent highly serous ovarian cancer that fully or partially responds to platinum-based chemotherapy that is negative for gBRCA, that is, All-comer. The discussion is also skeptical. Talzenna's efficacy was evaluated by comparing the Talzenna alone group and the group selected by the research team in the 431 HER2-negative local advanced or metastatic breast cancer patients with gBRCA mutations who had previously experienced up to 3 chemotherapy treatments. It was verified through an open label, randomized, multinational, large-scale phase III clinical study, EMBRACA. The median progression-free survival (mPFS), the primary endpoint of EMBRACA, was 8.6 months in the Talzenna group alone, and significantly improved compared to 5.6 months in the chemotherapy group. The risk was found to be 46% lower.
- Company
- Lynparza, a big change in the tx of BRCA-mutated cancer
- by Dec 01, 2020 06:15am
- "Most ovarian cancers are found in the 3rd to 4th stage because there is no subjective symptoms. After the first treatment, 70% recur within 3 years, and the 5-year survival rate is only 38%. Maintained by the release of Lynparza. The prognosis of patients is greatly improved through therapy. In particular, the first published 5-year follow-up result among PARP inhibitors suggests the possibility of long-term survival of ovarian cancer." Professor Byungki KimByung-ki Kim, Professor of obstetrics and gynecology, University College of Medicine, told a press conference on the 27th that the appearance of the first PARP inhibitor Lynparza (Olaparib) had on the treatment of ovarian cancer. On this day, AstraZeneca Korea held an online press conference on the topic of Lynparza's clinical value and significance in the field of ovarian cancer treatment, in celebration of the 5th anniversary of Lynparza's launch in Korea. Lynparza, launched in Korea in August 2015, is a targeted anticancer drug targeting BRCA. Not only can it be used for secondary or higher therapy, but recently it is expanding its scope to maintenance therapy. The SOLO-1 study is a phase III demonstrating the efficacy of Lynparza as a primary maintenance therapy for advanced ovarian cancer with BRCA mutations. At the third year of study, Lynparza reduced the risk of disease progression and death by 70% compared to placebo. Subsequent SOLO-2 studies demonstrated the effectiveness of Lynparza as a second-line maintenance therapy. A real-world study in Korea was conducted on Lynparza maintenance therapy. This study shows actual clinical results in the field of BRCA mutant highly serous recurrent ovarian cancer. As a result of the analysis, the median progression-free survival (mPFS) of patients taking Lynparza was 14.6 months, and the progression-free survival rate (PFS) was 42.4% at 24 months of treatment. This data is similar to the results of the Lynparza STUDY-19 study, which did not include Koreans, and Professor Kim interpreted it to mean that the effect of Lynparza appeared at least the same or better than the clinical trial of Korean patients. In particular, Professor Kim viewed Lynparza as the best option for patients with BRCA mutations. Currently, Zejula, the competitive drug, can be used as a first-line maintenance therapy for ovarian cancer patients regardless of the BRCA mutations. Zejula is widely used, while Lynparza provides specialized treatment options for patients with BRCA mutation and HRd positive. Of course, Zejula also obtained data on BRCA mutations and HRd positive patients through subgroup analysis. However, the Lynparza data dominate when it comes to drug selection. Professor Kim said, "All-comer (Zejula) drugs also have subgroup analysis data, but there is definitely a difference in mortality risk (HR)." "When it comes to patients with BRCA mutant ovarian cancer, Lynparza is a breakthrough without a choice. The benefits they receive are completely different," he said. What are Lynparza's future prospects? Professor Kim expected that in the future, Lynparza could be used as a drug used at all stages, such as platinum-based chemotherapy at all stages. He said, "According to the current data, Lynparza is a one-time use only for the 1st or 2nd phase. Whether it can be used in both 1st and 3rd phases, it is necessary to secure evidence through additional research." He said, "If the recurrence occurs after a certain period of time after taking Lynparza in the future, it is expected that Lynparza can be used again."
- Policy
- NSCLC treatment Vizimpro 30 mg KRW 25,684 per tablet
- by Kim, Jung-Ju Dec 01, 2020 06:15am
- From December, Pfizer Pharmaceutical Korea’s non-small cell lung cancer (NSCLC) treatment Vizimpro (dacomitinib) 30 mg tablet would be priced at 25,684 won with the healthcare reimbursement. The insured pricing for Amgen Korea’s osteoporosis treatment Evenity (romososumab) injection prefilled syringe was set at 123,700 won. South Korea’s Ministry of Health and Welfare (MOHW) announced the National Health Insurance Policy Deliberation Committee (HIPDC) convened a 17th general meeting on last Nov. 27 and made the said decisions for the revised List of Reimbursed Drugs and Upper Limit Pricing. ◆Vizimpro tablet: In the South Korean market, Vizimpro is indicated as a first-line treatment for patients with locally advanced or metastatic NSCLCL with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R substitution on exon 21. About 1,100 patients in South Korea can use the product. The pharmaceutical company earned the Ministry of Food and Drug Safety’s (MFDS) approval on Feb. 14 this year and applied for the healthcare reimbursement to the Health Insurance Review and Assessment Service (HIRA) on following Mar. 27. HIRA convened a meeting for the Drug Reimbursement Evaluation Committee (DREC) on Oct. 12 and evaluated the product’s coverage listing would be feasible if it is priced lower than the weighted average pricing of its alternative drug. DREC assessed the clinical efficacy of Vizimpro is non-inferior to other alternative options like Iressa, Tarceva and Giotrif, as textbooks and clinical guideline recommended the drug as a first-line treatment for the patients with EGFR mutation-positive advanced NSCLC. Among the A7 countries, the health authorities in the U.S., the U.K, Germany, Switzerland and Japan have listed the drug, and the adjusted average pricings of the 15 mg, 30 mg and 45 mg tablets are 164,217 won, 194,948 won and 179,010 won, respectively. The company reached an agreement after negotiating the projected claim cost with the National Health Insurance Service (NHIS) from Oct. 20 through Nov. 17. The two parties have negotiated that the projected claim cost would reach 6 billion won, considering the alternative treatment options, clinical efficacy and market ratio based on the administration cost. NHIS predicts no additional financial cost as there are alternative options. The product’s insured pricings are set at 16,052 won, 25,684 won and 32,105 won for 15 mg, 30 mg and 45 mg tablets, respectively. ◆ Evenity injection prefilled syringe: An osteoporosis treatment for post-menopausal women with high risk of bone fracture, Evenity injection received the MFDS approval as of May 31 last year. The company submitted an application for the NHI coverage to HIRA on Mar. 27 this year, and HIRA evaluated the drug would be feasible for the listing if it were to be priced lower than the weighted average pricing of alternative options at a DREC meeting convened on last Sept. 9. DREC assessed the drug is clinical effective, compared to an alternative option Forsteo injection, as textbooks and clinical guideline mentions the drug as an option for the indication. Also, academic societies claimed the drug increases patients’ bone density in hip and femoral neck and demonstrates outstanding effect, compared to other treatment options. While the U.S., the U.K. Germany and Japan have listed the drug, the adjusted average pricing is set at 527,302 won. The company then negotiated the projected claim cost with NHIS from Sept. 19 through Nov. 17. The two parties have agreed on 3.6 billion won, considering the administration cost difference with alternative drugs and clinical efficacy. NHIS predicts no additional financial cost as there are alternative options. The insured drug pricing, effective from December, is set at 123,700 won. Meanwhile, Janssen Korea’s pulmonary multi-drug resistant tuberculosis treatment Sirturo 100 mg tablet, currently covered with NHI when administered according to the label since May 2017, is to expand the indication and also change the insured pricing. The upper limit pricing is set at 145,676 won per tablet. MOHW official said, “The newest revision in the list should come in effect from Dec. 1 for expanded NHI benefit.”s
- Company
- Whanin ends sales of Sandoz antidepressants
- by Dec 01, 2020 06:15am
- Sandoz's supply of four antidepressants, which Whanin supplied, will end this year. According to the drug distribution industry on the 27th, Whanin announced that the supply of four Sandoz antidepressants will be suspended as the contract with Sandoz ends on the 30th. The items are ▲Sandoz Escitalopram 5·10·15mg ▲Paroxetine 20mg ▲Sultran 50·100mg ▲Mirtax 15·30mg/Mirtax ODT 15·30mg. The actual contract termination is on December 24th. Whanin has been selling Sandoz antidepressants since 2011. In February 2011, it signed an exclusive domestic sales contract for Sultran and Paroxetine, and in 2012, Sandoz Escitalopram was added. In 2015, it continued co-promotion for 4 antidepressants, including Mirtax. As of last year, Whanin's psychiatric treatment sales amounted to ₩130 billion, accounting for 81.7% of total sales (₩159.1 billion). Whanin is focusing on strengthening its own lineup of products for CNS, such as treatments for epilepsy and Parkinson's disease. In addition, in preparation for the recent increase in production, it has decided to acquire a pharmaceutical plant in Hyangnam of Janssen Korea for ₩46 billion. Whanin is also planning to end supply of Novartis Korea's Atorvin Tablet 10·20mg on the 24th of next month.
- Company
- TNBC treatment adds newly approved immunotherapy option
- by Eo, Yun-Ho Nov 30, 2020 06:21am
- Anticipation is heightening for the use of an immunotherapy Tecentriq (atezolizumab) in the triple-negative breast cancer (TNBC) treatment scene. Pharmaceutical industry sources reported Roche Korea’s PD-L1 inhibiting immunotherapy Tecentriq has recently successfully expanded the indication as a first-line treatment for TNBC, combined with nanoparticle albumin-bound (nab) paclitaxel, in the U.S. and now in South Korea. Moreover, the U.S. health authority also additionally indicated the drug to treat the disease in combination with Merk’s PD-1 inhibiting chemotherapy Keytruda (pembrolizumab) as a first-line treatment. The medical scene is closely following the news with an anticipation of opening more practical options of immunotherapy in TNBC treatment area currently lacking a variety of options. Since Roche Korea submitted the National Health Insurance (NHI) reimbursement application last month, the South Korean health authority is currently in process of reviewing the coverage on Tecentriq. However, it is still unknown how long the listing procedure would take. Tecentriq’s first reimbursed indication, treating patients with non-small cell lung cancer (NSCLC) as a second-line treatment, was approved by the South Korean government after the company accepted the condition to cover the initial administration cost. However, Roche has not commented if it would take the same condition for the expanded coverage. In the Phase III IMpassion130 trial, the combination of Tecentriq and nab-paclitaxel demonstrated median progression-free survival (mPFS) of 7.5 months in first-line treatment of patients with PD-L1 positive metastatic TNBC, and lowered the risk of progression or death by 40 percent compared with nab-paclitaxel alone. Keytruda has even longer way to go. Although there is no apparent barrier yet, the drug’s reimbursement expansion for the first-line lung cancer treatment has been sluggish so far. In the KEYNOTE-355 study, evaluating PFS in patients with locally recurrent unresectable or metastatic TNBC, the Keytruda combination therapy resulted in statically meaningful improvement in reducing the risk of disease progression or death by 35 percent through a first-line treatment in patients, who had not been previously treated with chemotherapy and the expression of tumor PD-L1 was over CPS 10. The mPFS in the Keytruda combination therapy group marked 9.7 months, when the chemotherapy-only group reached 5.6 months. To this date, the needs for the treatment in patients specifically with TNBC—reacting negatively on all receptors (estrogen, progesterone and HER2)—have been unmet. For a long time, chemotherapy was the only option for patients with TNBC. Roche’s targeted therapy Avastin (bevacizumab) still remains as a non-reimbursed option, although it was the first one to win the indication in South Korea. But the selection of TNBC treatment options has been widened recently with a poly ADP ribose polymerase (PARP) inhibiting targeted therapy Lynparza (olaparib) and other immunotherapy added to the market.
- Policy
- Reimbursement procedure for RSA drugs has been disclosed
- by Lee, Hye-Kyung Nov 30, 2020 06:21am
- The amount of risk-sharing refunds paid to patients by The NHIS for the last five years under the Risk Sharing Agreement (RSA) contract reached ₩5.46 billion. More than half of them, or ₩3 billion, were paid out from January to September of this year. Nam-seon Choi, head of the NHIS drug price negotiation department, recently revealed the procedure for paying the patient's co-payment difference at a risk-sharing drug price negotiation system and online information session for follow-up management for more than 100 pharmaceutical companies. RSA is a system in which pharmaceutical companies partially bear the risks of the efficacy and effects of new drugs or the financial impact of insurance, and pharmaceutical companies must set collateral to the NHIS according to the refund rate. "After monitoring the RSA drug claim data, the refund amount will be determined and notified according to the contract details with each pharmaceutical company," he said. "If the pharmacecutical company does not pay to the NHIS within one month, the security right will be exercised after the last notification." When notifying the refund amount = The NHIS monitors the billing data every one year due to the setting of the estimated billing cap for Expenditure Cap among RSA targets. The monitoring cycle is one year, but the final notification will be after '1 year + 6 months' as the exact amount of reimbursement can be known only after The HIRA's review of the request for treatment at a medical institution is completed and The NHIS' payment of medical care benefits is completed. For example, if a drug is listed in January 2020, after monitoring the treatment from January to December of that year, a notification of the refund amount will be made to the pharmaceutical company around June 2021. “Other claims are monitored every six months and additional claims are notified.” He said, "In Expenditure Cap, the cap setting is based on the treatment start date, so the monitoring can be notified only when the billing data and the actual payment is accumulated based on the treatment start date." For types other than Expenditure Cap, the amount of refund is notified after 2 months after monitoring of the payments paid every 3 months. If it is paid from January to March, the notice will be made in May. He explained, "The NHIS calculates the refund amount for the billed amount, excluding the total amount of copayment, the share of other agencies, and the HIRA's review and adjustments among the requested data for medical institutions." The difference in part of the patient's copayment =How will the actual amount of reimbursement for patients who use RSA drugs will be determined? In the case of anticancer drugs subject to RSA, the listed price is ₩1 million, and the refund rate is 30%. Patients receive a copayment of 5% at the time of treatment and pay ₩50,000 as a drug fee. Choi said, "The NHIS receives a refund of ₩300,000 from a pharmaceutical company, and patients pay ₩35,000, 5% of the actual price of ₩700,000." He also said, "If the refund amount is notified to the pharmaceutical company and the calculation of the refund amount for the previous year's co-payment limit system is completed, based on the completed claim, ₩15,000 will be refunded." However, in order to prevent overlapping support, if the copayment cap refund is larger, the RSA drug refund will not be received. Patients taking positive listed drugs are paid the difference every quarterly four times a year. In this way, the NHIS paid the patient's co-payment difference, which increased ₩220 million from 1,020 cases in 2016 and to 1.08 billion, 4,194 cases in 2019. In particular, by September this year, 5,984 cases, amounting to ₩3.4 billion, were paid. Choi said, "There was an increase in RSA drugs, and as the number of patients with Refund type increased, nearly 6,000 cases were already refunded this year." He added, "It is expected to increase by one thousand by the end of the year." Reimbursement of the difference for patients by themselves in full =In a form in which the pharmaceutical company directly refunds the patient, the pharmaceutical company must notify the NHIS of the payment details monthly. The NHIS compares the reimbursement details of the pharmaceutical company with the full amount of the claims and sends a notice to the person concerned. If the medical staff determines and administers it as the subject of full self-payment, it can also be checked with a statement of medical expenses, receipts, and prescriptions as a refund target. Choi said, "We need to cooperate with pharmaceutical companies so that patients who pay the entire amount will know that the difference will be refunded." "It is easy for patients to receive reimbursement if they need to be in advance. It is necessary to provide guidance and guides in medical institutions."
