- LOGIN
- MemberShip
- 2026-05-04 12:09:26
- Policy
- Kadcyla to recieve reimb in early breast cancer from July
- by Lee, Tak-Sun Jun 22, 2022 05:59am
- Roche Korea’s Kadcyla inj. (ado-trastuzumab emtansine) is expected to additionally receive insurance benefits for early breast cancer in Korea. Kadcyla, a breast cancer treatment that Roche released to succeed Herceptin, has been limitedly used in patients with locally advanced or metastatic breast cancer in Korea until now. The Health Insurance Review and Assessment Service announced that it will conduct an opinion inquiry on the revision of the ‘notice on pharmaceuticals prescribed and administered to cancer patients’ that contains the reimbursement standards for Kadcyla in early breast cancer until the 27th. Its expected implementation date is July 1st. The revision contains the addition of a reimbursement standard for Kadcyla to be administered as ‘a single agent for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.’ The drug is administered for a total of 14 cycles. The revision also recognizes the use of trastuzumab as monotherapy for the remaining period of cycles if continuous administration of Kadcyla is rendered impossible due to the occurrence of adverse events. Also, co-administration with endocrine therapy is allowed for eligible hormone receptor-positive patients. Kadcyla was approved for insurance benefit through the risk-sharing assessment (RSA) scheme in 2017 for the ‘treatment of patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer who have failed after receiving trastuzumab and a taxane.’ Its reimbursement price cap is set at ₩2,081,200/vial for Kadcyla 100mg injection, and at ₩3,118,000/vial of Kadcyla 160mg injection. Based on IQVIA results, its sales amounted to ₩52.7 billion last year. The reimbursement expansion is expected to further increase Kadcyla’s annual performance this year.
- Policy
- Alecensa's price cut 4.5%, Remodulin 4% due to excess sales
- by Kim, Jung-Ju Jun 22, 2022 05:59am
- Roche Korea’s non-small cell lung cancer treatment Alecensa 150mg Cap. (alectinib hydrochloride) became subject to negotiations under the Price-Volume Agreement (PVA) and will be supplied at a 4.5% discounted price starting next month. Price of Remodulin Inj. (treprostinil) that is used to treat patients with pulmonary arterial hypertension will also be discounted 4% for each strength. Also, premium pricing on Daewon Pharmaceutical’s Pelubi S Tab. (pelubiprofen tromethamine) will expire on August 1st, after which its price will fall 23.2%. According to industry sources on the 20th, the Ministry of Health and Welfare planned an ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the changes mentioned above for application on July 1st. ◆PVA negotiation results= The government and the National Health Insurance Service conduct PVA negotiations with pharmaceutical companies after classifying drugs with increased claims by each type, then discount each drug’s price according to the negotiation results. As a result, six items will receive price cuts after completing negotiations. Price of Roche Korea’s Alecensa 150mg Cap. (alectinib hydrochloride) has been cut by 4.5%, and the price of each strength of Antereogen’s Remodulin Injection was cut by 4%. Lilly Korea’s diabetes treatment supplement Trulicity 0.75mg/0.5ml (dulaglutide) disposable pen will be supplied at a 3% reduced price. ◆Preimimum pricing expiry and ex-officio adjustments = The premium pricing provided for Daewon Pharmaceutical’s Pelubi S Tab will expire as of August 1st, and its price will be reduced by 23.3%. The government applies premium pricing for first generics for 1 year since its date of listing. After the period expires, the drug’s price is automatically discounted to 53.55% of the original drug's price under the drug price reduction system. As a result, a total of two items received price cuts through ex-officio adjustments. The government makes ex-officio adjustments to the price ceiling of the first listed drug and the other product with the same administration route, ingredient, and formulation when the second product becomes listed. The drugs subject to price cuts under the system are two strengths of GE Healthcare AS’s Visipaque 270mg Injection (Iodixanol). The price of the 50mL strength is reduced by 2.6%, and the 100mL strength reduced by 0.1%. The price cuts will be applied as of July 1st. ◆Drugs designated for preservation of production cost prevention and price ceiling adjustments under the drug shortage prevention program = One drug received ‘mandatory designation’ and was designated for the preservation of production cost. The drug is Yuyu Pharm’s Allopurinol tablet, and its price ceiling will be set at ₩70 for supply. Two items have received ex-officio adjustments after being designated for the preservation of production cost. The drugs, Samil Pharmaceutical’s Zyloric (allopurinol)’s price ceiling was increased from ₩70 to ₩72, and Access Pharma’s Tuberculin PPD AJV from ₩23,760 to ₩26,554. Also, two other drugs received an increase in their price ceiling to preserve production costs. The price ceiling of Ildong Pharmaceutical’s Ativan 4mg/1mL Injection (lorazepam) will be increased from ₩612 to ₩804, and the 2mg/0.5mL strength will be increased from ₩574 to ₩782. The new drug price will be applied as of the 1st of next month.
- Policy
- The benefit discussion for Steglatro was excluded
- by Lee, Tak-Sun Jun 22, 2022 05:58am
- While the HIRA is discussing the standard for combination therapy benefits for SGLT-2-suppressing diabetes treatments, only Steglatro (MSD Korea) has been excluded from the combination of TZD affiliates, drawing attention. While the combination of DPP-4 inhibitors between families is recognized, the combination between TZD families is differentiated by component. Kim Ae-ryeon, head of the HIRA Pharmaceutical Management Office, said at a briefing with the Korea Special Press Association on the 14th that she is conducting a financial impact analysis after reviewing the benefit criteria for Metformin + SGLT-2 inhibitor + DPP-4 inhibitor and Metformin + SGLT-2 inhibitor. The HIRA plans to review the pharmaceutical company's financial impact analysis, academic societies, and expert opinions, and then review the Drug Reimbursment Evaluation Committee within the processing deadline to complete the standard change and drug price evaluation. As a result, standards are expected to be prepared at least within this year. However, MSD's Ertugliflozin was excluded from the discussion in the combination of Metformin+SGLT-2+TZD among the three-drug therapy. It is different from the fact that Metformin+SGLT-2+DPP-43 drugs recognized combination between series regardless of ingredients. An official from the HIRA explained, "It reflected the approval of the MFDS." The efficacy set by the MFDS for SGLT-2 drugs only broadly define monotherapy and combination therapy for adult type 2 diabetes patients, but did not present specific ingredients. This is a simplification of the MFDS' permission to prepare a combined benefit standard for diabetes treatments. However, unlike other SGLT-2 inhibitors, only Steglatro does not have the results of combined clinical trials with the TZD family in the information for experts in the permit. However, clinical trial information with DPP4 inhibition such as Sitagliptin is provided. In the end, drugs that have not been verified for combined effect through clinical trials are believed to have been excluded from the discussion on standards. Metformin+SGLT2+DPP43 drug therapy seems to be possible because all of the SGLT-2 drugs (Forxiga, Jardiance, Suglat, and Steglatro) on the market in Korea have proven their efficacy through DPP-4 combined clinical trials. Steglatro has the lowest domestic market share compared to other SGLT-2 drugs. Another weakness is that it is excluded from the three-drug treatment benefit standard between TZD in the situation of chasing competitors.
- Policy
- Report of severe skin SE such as rash of Phenytoin
- by Lee, Hye-Kyung Jun 21, 2022 05:55am
- Precautions for severe skin abnormalities will be newly established in the anticonvulsant Phenytoin. The Drug Safety Evaluation Division of the MFDS has prepared a change (proposal) in domestic drug permits based on the results of the EMA's review of drug safety information. The changes will be checked by the pharmaceutical industry and others until the 29th under the terms of "careful administration", "general caution", "Adverse reaction" and "interaction" of the precautions for use. As a result of the EMA safety information review, severe skin adverse reactions such as deprivation dermatitis, dermal mucosal eye syndrome (Stephens-Johnson syndrome), and toxic epidermal necrosis (Lyell's syndrome) may occur in phenytoin preparations. Severe skin reactions occur without warning, but patients should be warned about signs or symptoms of hypersensitivity (skin rash, blisters, fever, itching, or other symptoms), and a cautionary phrase is added that medical advice should be sought immediately if significant symptoms or symptoms occur. If a rash appears, the doctor should advise the patient to stop treatment, and if the rash is mild, the treatment can continue after the rash has completely disappeared. If the rash occurs again after re-dosing, additional Phenytoin should not be administered. In addition, holders of impaired CYP2C9*2 or CYP2C9*3 mutants (middle or slow metabolites of the CYP2C9 substrate) may have increased Phenytoin plasma concentration and the resulting toxicity risk. Domestic licensed Phenytoin PO formulations include Bukwang's Phenytoin Cap100mg, Whanin's Hydantoin Tab, Myungin's Penytoin 100mg, Samjin's Penytoin Sodium Injection100mg & 200mg, Hanlim's Peniton, Jeil's Phenytoin Sod 50mg/ml, and Union Korea's Union Phenytoin Sodium.
- Policy
- The HIRA launched a benefit review for Tabrecta
- by Lee, Tak-Sun Jun 21, 2022 05:54am
- There are not many patients with MET mutation, but the prognosis is bad, so a treatment is urgently needed. It was found that the HIRA began a benefit review for targeted treatments for MET mutants, which appear in 3-4% of all non-small cell lung cancer patients. The MET mutation target anticancer drug landed in Korea in November last year with the approval of Novartis' Tabrecta and Merck's Tepmeko. Currently, it can be used as a non-reimbursement. According to the industry on the 17th, the HIRA has begun a process to determine the appropriateness of Tabrecta's benefit. Tabrecta was granted domestic permission on November 23 last year. It is the first drug used in patients with local progressive or metastatic non-small cell lung cancer where MET Exxon 14 deficiency was confirmed, and it was the first time that MET mutated targeted anticancer drugs were approved in Korea. MET mutations appear only in about 3-4% of all metastatic non-small cell lung cancer patients, but the prognosis is poor, so related targeted treatments are in urgent need. Tabrecta is known to block MET phosphorylation by binding to the phosphorylase region of receptors in cells. In the GEOMETRY mono-1 trial of 97 MET mutant patients, Tabrecta showed an overall response rate of 68% in patients who had never been treated and 41% in patients who had previously been treated. Tabrecta can be prescribed in major hospitals since early this year. However, since the benefit registration process is not completed, the patient must bear the price of about 10 million won. For this reason, the medical field is demanding rapid payment procedures. In the case of anticancer drugs, the HIRA's Cancer Disease Review Committee establishes standards, and then the Drug Reimbursment Evaluation Committee examines the appropriateness of benefits. It will be negotiated with the NHIS about the price and be placed on the final step through deliberation by the Health Insurance Policy Committee of the MOHW. Even if it goes fast, it takes about six months to get reimbursed.
- Policy
- Drug price cut refund bill’s fate depends on LJC Chair
- by Lee, Jeong-Hwan Jun 20, 2022 06:04am
- Industry expectations are rising on the prospect that the constitution of the NA leadership in the second half of the year will directly affect the fate of the Bill to recover and retrieve drug price cuts. If the People Power Party, which had been criticizing the inadequacy of the bill, takes Chair of the Legislation and Judiciary committee, it may significantly increase the possibility that the bill’s non-passage. On the 19th, the pharma-bio industry and the legal community are paying close attention to the progress made between the ruling and opposition parties’ negotiations regarding the composition of the NA leadership in the second half of the year. The National Assembly’s second half of this year’s term had started in June, but with the ruling and opposition party having difficulty agreeing on the composition of the NA leadership, the position of the Legislation and Judiciary Committee Chair has remained vacant for 3 weeks now. The determination of both the ruling and opposition parties to take the position has prolonged the confrontation even despite under-the-table negotiations. If the ruling party, the People Power Party assumes the Chair of the Legislation and Judiciary committee, this is expected to increase the possibility of the bill’s non-passage at the committee level. Therefore, on which party will assume Chair of the Legislation and Judiciary committee is expected to affect the bill for the recovery and retrieval of drug price cuts that can significantly impact sales and marketing in the pharmaceutical industry. The bill, which contains the measure for the government and pharmaceutical company to retreive or recovers the pharmaceutical benefits (reimbursement) amount that had not been settled during the drug price cut disposition suspension period, is currently pending in the 2nd subcommittee of NA’s Legislation and Judiciary Committee. The bill was proposed by members Woni Kim and Insoon Nam of the Democratic Party of Korea as representatives and passed NA’s Health and Welfare Committee with consensus between the opposition and ruling parties. However, the agenda was then put on hold by members of the People Power Party during review in the Legislation and Judiciary Committee’s plenary session. At the time, People Power Party member Joo-Hyae Jeon had criticized the bill for being unconstitutional. Jeon pointed out that the bill excessively restricts the pharmaceutical companies' right to file lawsuits to prevent them from applying for an injunction to suspend the execution of the drug price cut itself. Jeon added, “I want to express my deepest regrets on the fact that a bill that completely undermines the administrative litigation system has been put up for deliberation for the Legislation and Judiciary Committee. The bill requires the company to refund the whole amount of the drug price cut disposition that was not made during the execution suspension period, but this penalizes compulsory executions and neutralizes the suspension itself. The bill was unable to pass the plenary session then and was set to remain pending in the 2nd subcommittee of NA’s Legislation and Judiciary Committee for further review. The NA’s Health and Welfare Committee which believes in the need for the bill has set out to persuade the members of NA’s Legislation and Judiciary Committee, focusing on the PPP members that have opposed the bill, but to no avail. This is why there are prospects that the bill will not pass NA or be enacted if the PPP takes over the Chair position of the Legislation and Judiciary Committee in the second half of the year. With no decisive change or event arising for the PPP to change their mind on the bill, if the ruling party takes over the Chair position that can make or break the enactment of bills, experts believe that the possibility of the bill not being deliberated or being voted down may rise significantly. Also, the legal community and the pharmaceutical industry’s rising voices on the unjustness of the bill and strong opposition are also expected to hinder the passage of the bill. Therefore, on which party, the ruling or opposition party, takes over the Chair position of the Legislation and Judiciary Committee is likely to make or break the bill. An official from the pharmaceutical industry said, “Many domestic and multinational pharmaceutical companies have been strongly appealing and opposing to the unfairness and fatality of the refund and redemption bill, he said. "The reality is the appointment of the chairman of the Legislation and Judiciary Committee will inevitably affect the introduction, deliberation, and passage of the bill. This is why we are keenly following discussions on the composition of the NA leadership.” A lawyer from a Korean law firm who requested to remain anonymous, said, “From the legal community’s point of view, the bill nullifies the execution suspension system and overthrows the judicial system. From the pharmaceutical company’s point of view, they may not file a suit to cancel the drug price cut disposition or give up making appeals due to fear of the government's retrieval and collection of the drug price cut disposition amount after the trial. This by itself is an infringement of the right of access to courts and is against the constitution.”
- Policy
- Hanmi obtains generic exclusivity for Dapalon Duo
- by Lee, Hye-Kyung Jun 20, 2022 06:03am
- Hanmi Pharmaceutical obtained generic exclusivity rights for its SGLT-2 antidiabetic combination drug ‘Dapalon Duo SR Tab (Dapagliflozin Bis L-proline/ Metformin Hydrochloride),’ a generic version of ‘Xiguo XR Tab (Dapagliflozin Propanediol Hydrate/ Metformin Hydrochloride). The Ministry of Food and Safety recently granted marketing authorizations for the four strengths of Dapalon Duo - Dapalon Duo 5/500mg, 10/500mg, 5/1000mg, and 10/1000mg. Its original drug is AstraZeneca’s Xiguo XR Tab, and Hanmi is the second company to receive first generic exclusivity for its four strengths after Chong Kun Dang. The generic exclusivity will be in effect from April 8th, 2023 to January 7th, 2024. Hanmi Pharmaceutical’s Dapalon Duo is a combination of dapagliflozin bis L-proline and metformin hydrochloride that uses a different solvate from the original Xigduo XR Tab on its active ingredient, dapagliflozin. Meanwhile, 53 Xigduo generic items from 24 companies have received marketing authorization, among these, 12 items from Chong Kin Dang, KyungDong Pharm, Ildong Pharmaceutical, Boryung Pharmaceutical, and Jeil Pharmaceutical have been granted generic exclusivity. The solvent patent for the original drug was set to expire on June 21st, 2027, but the invalidation claim filed by the latecomers in Korea has been accepted and has left the patent invalid. As the companies of latecomers have won the first and second trials to invalidate Xigduo’s the second substance patent which is set to expire on January 8th, 2024, the companies will be able to sell the latecomer items upon the expiry of the first substance patent that expires on April 7th, 2021. Xigduo’s outpatient prescriptions (UBIST) amounted to 36.9 billion last year.
- Policy
- BA-linked listed drugs are about to be re-evaluated
- by Lee, Tak-Sun Jun 20, 2022 06:03am
- Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance. The MOHW announced that it would directly conduct BA tests and re-evaluate the price of listed drugs in July 2023 after a three-year grace period. Accordingly, the HIRA will receive data from pharmaceutical companies to prove whether they meet the standard requirements from October to February next year. The question is whether the item will be able to submit related data by the deadline as it has expanded to the aseptic formulation for BA test since October this year. The HIRA plans to consult with the MFDS on necessary measures such as the selection of control drugs for data submission. According to the industry on the 16th, the HIRA will hold a briefing session from 1:30 p.m. on the 22nd at the White Veil located in Seocho-gu, Seoul. It is expected that the number of pharmaceutical companies related to the re-evaluation of the listed drug, which is a face-to-face explanation circuit that takes place for the first time in a long time, will exceed the capacity of the place. The HIRA plans to re-evaluate listed drugs with the aim of applying them in July 2023 as scheduled. Accordingly, pharmaceutical companies are requesting to submit data to prove whether they meet the standard requirements from October to February next year. The core of the data is whether to prove equivalence through BA and others. Most of the requirements for using registered raw materials drugs are expected to be met. To this end, pharmaceutical companies have conducted BA tests by converting consigned manufactured items that have not undergone BA tests into their own production items. The problem is that the drugs will also be subject to the BA test from October, when the data is submitted. The health authorities say these aseptic drugs are subject to re-evaluation of drug prices. After October, the equivalence must be demonstrated through the BA test for aseptic drugs such as injections or the chemical equivalence test that replaces them. The problem is that comparators for tests will not be announced until after October. The pharmaceutical industry believes that it may be difficult to submit data by February next year if the process of selecting a contrast agent is delayed. An official from a pharmaceutical company pointed out, "It is unlikely that companies with many items will be able to manage their schedules," adding, "Aseptic drugs subject to BA tests in October need to extend the deadline for submitting data or hurry to announce control drugs." The MFDS is aware of this. Accordingly, the government plans to apply for and announce the control group drug from time to time, and improve the recognition process. At a meeting with the Korea Special Press Association on the 14th, Kim Ae-ryeon, head of the HIRA drug management office, said, "There is a need for consultation with the MFDS regarding the designation of contrast agents." In March, the HIRA unveiled 3,372 product groups of control drugs and first-time registered products that are excluded from revaluation among 33,618 listed items. As a result, it is expected that items subject to re-evaluation, including aseptic drugs, will be clearly disclosed at the briefing session on the 22nd.
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 20, 2022 06:02am
- The MFDS (Director Oh Yoo-kyung) announced on the 15th that it will change the efficacy, and indication precautions of "JAK Inhibitor", which is used as a treatment for inflammatory diseases. Patients can be used the same as before, but high-risk patients such as those aged 65 or older, high-risk cardiovascular groups, and risk of malignancy will be available only if the effect is insufficient with the existing treatment. JAK Inhibitor is used to treat various inflammatory diseases such as rheumatoid arthritis by blocking the action of JAK, an enzyme that controls immunity and inflammation, and 65 items of Tofacitinib, Baricitinib, Upacitinib, Abrocitinib, and Filgotinib are licensed in Korea. This measure is a follow-up measure to the results of the safety review conducted after the MFDS distributed the drug dear healthcare professional letter in September last year, and plans to order the permission to be changed in July. The MFDS received advice from the Central Pharmaceutical Affairs Review Committee and the Professional Association after a post-marketing survey of Tofacitinib and Baricitinib drugs conducted in the U.S. and Europe, and reviewed the results of a recent domestic anomaly analysis. Detailed permission changes (drafts) can be found at nedrug.mfds.go.kr.
- Policy
- The KDCA is pushing for the introduction of Tecovirimat
- by Lee, Jeong-Hwan Jun 20, 2022 06:02am
- The KDCA announced on the 14th that it will hold a joint meeting of related ministries to introduce 500 people of the antiviral drug Tecovirimat in July to respond to monkeypox. Kwon Joon-wook, head of the National Institute of Health, made this announcement at a briefing on COVID-19. The KDCA plans to hold a meeting of the monkeypox task force jointly with related ministries later in the day. The meeting will discuss detailed plans to introduce 500 antiviral drugs to Korea in July compared to monkeypox. The antiviral drug to be introduced is Tecovirimat, the only product licensed as a monkeypox treatment overseas. Specifically, the product name Tpoxx (Tecovirimat), has been officially approved by the US FDA, Europe EMA, and Canada. Although it is a relatively high-priced drug, the need to secure Korea is also being raised due to mass stockpiling overseas. In the future, if a monkeypox patient occurs in Korea, the patient will be treated in isolation at the National Medical Center until the point of loss of infectious power. Contacts are classified in three stages, and the KDCA is considering quarantining high-risk contacts for 21 days.
