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- 2025-12-25 17:28:52
- Policy
- Xultophy Flex Touch pen·Afstyla can be reimbursed
- by Lee, Hye-Kyung Dec 08, 2020 06:11am
- Novo Nordisk's Xultophy Flex Touch pen (Insulin Degludec and Liraglutide) and CSL Behring's Afstyla (Antihemophilic Factor) were set higher in the amount applied by pharmaceutical companies compared to the adequacy evaluation of Benefits. The HIRA (President Kim Sun-min) released the results of the deliberation on the adequacy of medical treatment benefits for the drugs applied for decision deliberated by the 12th Pharmaceutical Benefits Advisory Committee in 2020. Two items, Xultophy Flex Touch pen, a treatment for improving blood sugar control in adults with type 2 diabetes, and Afstyla, a treatment for preventing and preventing bleeding in adults and children with hemophilia A, were proposed in the Pharmaceutical Benefits Advisory Committee. As a result of the evaluation of the Pharmaceutical Benefits Advisory Committee, the reimbursement was appropriate, but the amount submitted by the pharmaceutical company was determined to be expensive. These drugs are reimbursed if they receive less than the evaluation amount suggested by the HIRA. Meanwhile, the HIRA is evaluating the adequacy of reimbursement of drugs after deliberation by the Pharmaceutical Benefits Advisory Committee in accordance with Article 11-2 of the National Health Insurance Standards for Medical Care Benefits. In the event of changes in the detailed coverage range and standard items of the deliberation drug, changes in the permission details of the item requested for decision, and withdrawal of permission (cancellation), the final evaluation result may be changed.
- Policy
- Benefit redemption of α-GPC will be promoted soon
- by Lee, Hye-Kyung Dec 07, 2020 06:06am
- As the clinical re-evaluation of Choline alfoscerate is imminent, the NHIS' benefit redemption contract is expected to be pursued sooner or later. The consortium of Daewoong and Chong Kun Dang On the 1st of the month, an online briefing session for clinical reevaluation was held, and it was announced that it would recruit pharmaceutical companies to participate in the joint clinical trial of Choline alfoscerate by the 9th. The consortiums divided into degenerative and vascular in the case of mild cognitive impairment, and each investing a clinical cost of ₩9.5 billion for 54 months. It has a plan to invest about ₩10 billion in 60 months by adopting a method. Korea United Pharm recruited pharmaceutical companies to participate in the joint clinical trial of mild cognitive impairment until the 4th. As pharmaceutical companies participating in the clinical re-evaluation of Daewoong Bio and Chong Kun Dang's consortium group and United Group are confirmed within this week, the MOHW is also expected to proceed with the redemption of benefits according to the results of clinical re-evaluation. The MOHW has been reviewing a generic negotiation plan that states,'If the clinical trial fails, the entire health insurance prescription amount from the date the MFDS to conduct the clinical trial will be returned to the NHIS'. According to the Rules on the Standards for medical Benefits by the NHIS, If the Minister of Health and Welfare acknowledges that it is necessary for the stable supply of drugs that have already been notified of medical care benefits and the upper limit, it applies to the chairman of the NHIS. Negotiations may be ordered with drug manufacturers, consignment manufacturers, and importers on matters referred to in Article 11-2 (7) 4. In this case, the procedures in Article 11 (7) to (9) shall be applied mutatis mutandis. In the case of Choline alfoscerate, it is highly likely that the MOHW will issue a collective negotiation order to the NHIS during this week as the clinical usefulness re-evaluation can be included in the'etc.' in the phrase'stable supply, etc.' If the MOHW issues a negotiation order within this week, the NHIS will be able to proceed with a generic medical care benefit contract that includes reimbursement of benefits for pharmaceutical companies that have submitted a clinical re-evaluation plan as early as next week. In preparation for the failure of a clinical trial, if the approval is canceled after reevaluation or the criteria for benefits are changed, the contract will contain details such as the full refund of the benefits or the recovery of the benefits of the deleted indication. If a pharmaceutical company participating in clinical reevaluation does not comply with the NHIS' contract, it will take the procedure to delete benefits. It is stated that the procedures in Article 11, Paragraph 7 to Paragraph 9 of the Medical Benefit Standards are applied mutatis mutandis to items subject to clinical re-evaluation such as Choline alfoscerate, and thus there is a possibility of the deletion of benefits if the Minister of Welfare does not comply with the negotiation order. The NHIS predicts that if it signs a contract related to reimbursement of benefits along with clinical reevaluation of Choline alfoscerate, it can protect health insurance finances of more than ₩300 billion per year.
- Policy
- SB16 has been approved for phase III clinical trial
- by Lee, Tak-Sun Dec 07, 2020 06:06am
- Samsung Bioepis headquartersSamsung Bioepis is the first in Korea to enter Phase III clinical trial of Prolia's biosimilar, an osteoporosis treatment. The MFDS approved the Phase III clinical trial protocol for a biosimilar candidate for Prolia, SB16, which Samsung Bioepis applied on the 1st. Prolia developed by Amgen was approved in Korea in September 2014. It is the first biological agent to appear as a treatment for osteoporosis and is jointly sold by Chong Kun Dang in Korea. Based on IQVIA, sales in the first half of this year alone reached ₩34.9 billion, an increase of 102.7% from the same period last year. Samsung Bioepis started Phase I clinical trial of Prolia's biosimilar in France in October. Multinational clinical trials were conducted for global sales. Domestic development is expected to be faster than overseas with the approval of the phase III clinical trial of the MFDS.
- Policy
- HIRA completes selective reimbursement listing
- by Lee, Hye-Kyung Dec 04, 2020 05:54am
- To reinforce the National Health Insurance (NHI) coverage, the South Korean health authority granted selective reimbursement on 16 out of 23 anticancer therapies without the healthcare reimbursement standard or left as a non-reimbursement with 100-percent copayment rate. According to the list of anticancer treatments with selective reimbursement as of Oct. 31 the Health Insurance Review and Assessment Service (HIRA) submitted to the National Assembly, the selective reimbursement has given to 23 therapies including Halaven injection (July 1, 2017) to Blincyto injection (Apr. 1, 2020). Since the government has announced the Moon Jae-in Care initiative on Aug. 9, 2017, the government has been expanding coverage standard on insured drug and turned non-reimbursed drugs as selectively reimbursed drugs to lessen the financial burden for the medically vulnerable community. At a meeting convened in June 2018, the Health Insurance Policy Deliberation Committee (HIPDC) of the Ministry of Health and Welfare (MOHW) announced 48 anticancer therapies would undergo standard expansion or selective reimbursement listing for three years to come From 2017 through 2018, the health authority reviewed providing selective reimbursement on anticancer treatments used in rare cancer and female-specific cancer, which gave the benefits to nine items in 11 therapies, including Halaven injection, Vidaza injection, Revlimid capsule, Afinitor injection, Imbruvica capsule, Avastin injection, Blincyto injection, Votrient tablet and Sutene capsule. Besides the rare and female-specific cancers, the selective reimbursement was given to eight out of 12 anticancer therapies, starting from Xtandi soft capsule on May 20, 2019 to Blincyto injection on last Apr. 1. The items covered with selective reimbursement from last year are managed according to HIRA’s revised notice on drug prescribed to patients with cancer. ◆ Perjeta: The copayment ratio has changed from 100/100 to 30/100 for the combination of Perjeta and Herceptin for the adjuvant treatment of patients with locally advanced, inflammatory or HER2-positive early breast cancer (over 2 cm). It was turned essential reimbursement (partial copayment rate 5 percent), because the therapy was decided for the patients to cover the entire cost as the effect was insignificant compared to the cost, regardless of the proven clinical efficacy. However, it was applied with selective reimbursement (30 percent), as the therapy has superior improvement in clinical efficacy but no other alternative with same level of treatment. ◆ Halaven injection: The selective reimbursement with 50/100 patient’s copayment was granted on the Halaven monotherapy that demonstrates clinically improved effect, compared to Xeloda (capecitabine) monotherapy used as a standard of care. The therapy has substitutable therapies like Xeloda, Gemcitabine and Vinorelbine monotherapies and paclitaxel-based combination therapies. ◆Xtandi: The reimbursement standard was to be adjusted as the treatment expanded indication to treat patients with non-metastatic castration-resistant prostate cancer (CRPC) with no or mild symptoms. A Phase III clinical study reported the Xtandi-administered group showed improved median progression-free survival compared to placebo group. But the selective reimbursement with copayment rate of 30 percent was set as the treatment is too expensive for the benefit targeting patients with no or mild symptoms. ◆Caelyx: The committee decided granting the essential reimbursement (patient copayment 5 percent) would not be adequate for the treatment as it shows similar value of overall survival, compared to the currently reimbursed capecitabine monotherapy in metastatic breast cancer patients. But the committee granted selective reimbursement with patient copayment of 50 percent, because liposomal doxorubicin monotherapy is the only treatment that lowers heart damage while maintaining the antitumor effect, but the high-cost treatment shows similar results with the capecitabine monotherapy. Regardless, the treatment is covered with the essential reimbursement, when treating patients with AIDS-relevant Kaposi's sarcoma (KS), as it costs about the same as the off-label use of paclitaxel monotherapy. ◆ Thalidomide capsule and Velcade injection: As the healthcare reimbursement standard on the hematopoietic stem-cell transplantation (HSCT) regarding the target age group expanded from ‘age 65 or lower’ to ‘age 70 or lower,’ the age limit in the remission-induction therapy reimbursement standard for multiple myeloma was removed. ◆ Gazyva: Although the evidence to prove the clinical efficacy in maintenance therapy for follicular lymphoma is insufficient, the treatment received selective reimbursement with patient copayment of 30 percent, considering the absence of other alternative option to use when relapsed or show no response after using an anticancer treatment including rituximab. ◆ Nexavar tablet: The reimbursement was expanded to Child-Pugh class B7, as a large-scale prospective observational study on patients with hepatocellular carcinoma confirmed improved survival period at Child-Pugh class B7. ◆ Blincyto: The committee has decided to give reimbursement (5/100) for remission-induction therapy (two cycles) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. The committee evaluated the reimbursement (partial copayment 5/100) would not be adequate for the remission-consolidation therapy administering extra three cycles, because the high-cost treatment was clinically effective when only HSCT is difficult immediately after the remission-induction therapy.
- Policy
- Life expectancy regulations for RSA drugs will be maintained
- by Lee, Jeong-Hwan Dec 03, 2020 06:01am
- The MOHW has announced that it will not change the two-year life expectancy rule applied to the 'risk sharing system (RSA)' applied to high-priced new drugs such as the latest anticancer drugs and rare disease treatment drugs. This regulation was established by referring to similar overseas systems such as the UK and Australia, and it is based on the fact that it is applied flexibly in the evaluation process of expert members. On the 30th, the MOHW made such a statement in a written inquiry by Choi Hye-young, a member of Democratic Party of Korea. Risk-sharing drugs are anti-cancer drugs or rare disease treatments that do not have a cure, and there are regulations that are applied in consideration of whether drugs are used for serious diseases that threaten survival, that is, diseases with a life expectancy of only two years. Choi Hye-young, a member of Democratic Party of Korea inquired, "There is a need to amend the two-year life expectancy rule." The Ministry of Health and Welfare said it would keep it as it is. The MOHW said, "The criteria for determining serious diseases that threaten survival,' in case of progressive serious diseases or life expectancy of less than 2 years', were set by referring to similar systems abroad (UK and Australia). The HIRA's expert committee considers the characteristics of the disease comprehensively and applies it flexibly when evaluated. The MOHW added, "For matters that need to be supplemented so that the guarantee of patient access to treatment can continue to be improved, the system will be supplemented by collecting opinions from pharmaceuticals, patients, and related organizations."
- Policy
- 16 new drugs listed including Kisqali, Verzenio & Ibrance
- by Kim, Jung-Ju Dec 03, 2020 06:00am
- A total of 16 major new drugs for which insurance benefit coverage was initiated this year were counted. A total of 4 drugs have lowered the burden on patients due to lower benefit standards. Regardless of the estimated size of insurance finance, the tendency to expand flexible coverage was established according to social importance and patient needs. From January this year until recently, new drugs that were newly listed on the drug benefit list and drugs with enhanced coverage among the new drugs already registered were expanded, resulting in a total of 20 drugs, and it is more than doubled when all items by content are summed. Penciclovir Cream, Rinvoq 15mg, and Kisqali 200mg were newly listed as of this month. Penciclovir Cream, a treatment for herpes simplex virus, is expected to be used by about 18,000 patients in Korea. The annual insurance budget is 34 million won, which is relatively small, but the satisfaction level of coverage is expected to be high. Rinvoq15mg, a treatment for rheumatoid arthritis, is expected to cost about ₩4.2 billion per year for 800 domestic patients. Kisqali 200mg, a new drug for advanced or metastatic breast cancer, is expected to cost about ₩12.2 billion as it is covered by approximately 400 patients in Korea. This year, the government and insurers used about ₩164.6 billion per year to grant access to expensive new drugs to approximately 262,907 patients.
- 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.
- 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
- 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."
