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- 2025-12-23 02:32:29
- Policy
- Is "Platform of Drug Delivery" starting?
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- The Ministry of Science and Technology recently decided on the demonstration exception of OTC teleconference bending machine at the 22nd ICT regulatory sandbox meetingWill the new government's implementation of the OTC teleconference bending machine demonstration special case serve as a signal for full-fledged activation of the "drug delivery platform"? Analysts say that as the government introduced the OTC teleconference bending machine, which is virtually not allowed by the Pharmaceutical Affairs Act, regulations on platform operators such as drug delivery apps are also likely to be eased significantly in the future. In particular, the Ministry of Science and ICT seems to be more proactive in looking at deregulation as the situation develops rather than the MOHW at the forefront of management and regulation of non-face-to-face treatment and drug delivery apps. On the 23rd, the health and medical community is paying keen attention to the direction of the new government's digital platform policy operation. Yoon Seok-yeol's government has decided to foster the digital online platform industry as a national task. In order to revitalize new industries, it is in a position to boldly break down existing regulatory barriers and collect opinions from industries quickly and actively. The OTC teleconference bending machine regulation special case seems to be the result of reflecting this new government policy. The problem is that the OTC teleconference bending machine is a regulatory exception that is relatively local and has little ripple effect. Digital platform technology is not used in that electronic devices are installed inside and outside existing pharmacies to allow the sale of general drugs in some efficacy groups with the pharmacist's OTC teleconference bending machine medication map. In the end, it is evaluated that deregulation of digital platforms in the health care sector will gradually flow in the direction of activating drug delivery platforms. The new government is implementing a one-sided policy of deregulation of digital platforms every day. The Ministry of Science and Technology is planning to lead the promotion of platforms by jointly announcing strategies for developing digital platforms within this year. Minister of Science and Technology Lee Jong-ho recently held a policy forum with digital platform companies such as Naver, Kakao, and Coupang and promised to "establish a private-led self-regulatory organization." The plan is to increase the effectiveness by providing legal grounds for establishing and supporting self-regulatory organizations so that the private sector, not the government, can set up platform regulations on its own. Of course, health and medical platform companies such as drug delivery apps did not attend the forum, but the wider the scope of the government's promotion of the platform industry, the more likely the drug delivery apps will also benefit from deregulation. The opposition Democratic Party of Korea is expressing some concern about the stance of the new government. Even if the digital platform industry is fostered, the Democratic Party of Korea believes that deregulation should be applied conservatively in health care fields such as non-face-to-face treatment and drug delivery apps. It's directly related to national health It takes into account the fact that it can bring considerable shock waves to the health care delivery system such as local clinics and the ecosystem of pharmacies. An official from the Democratic Party's policy committee said, "The OTC teleconference bending machine was applied by the government to the regulatory sandbox track after it was put on hold during the legislative debate in the National Assembly. Although it was allowed, I don't think the actual ripple effect will be significant, he said. "However, there will definitely be an effect of activating platform operators such as drug delivery services." The OTC teleconference bending machine is an agenda limited to pharmacists in a way, but the activation of health care platforms such as non-face-to-face treatment and drug delivery apps will have a great impact on the medical community and the pharmaceutical community, the official said. It will be necessary to respond to platform regulations in the health care sector," he added.
- Policy
- A suspected Monkeypox patient entered Korea
- by Lee, Jeong-Hwan Jun 24, 2022 05:46am
- With two suspected Monkeypox infections confirmed to have entered Korea, President Yoon ordered accelerated approval of vaccines and antiviral drugs from quarantine authorities. On the 22nd, President Yoon ordered, "Strengthen the management of entry and quarantine through airports and closely monitor the additional occurrence in Korea." Currently, the quarantine authorities are conducting tests on one foreigner suspected of being infected with Monkeypox and one Korean among domestic arrivals. A suspected foreign infection entered the country by air on the 20th. From the 19th, blistering skin lesions occurred along with systemic symptoms such as sore throat and lymph node disease, and visited a hospital in Busan on the morning of the 21st. The hospital reported a suspected foreigner as a suspected monkeypox case and is currently being treated in an isolation bed. The suspected Korean entered Incheon International Airport from Germany at around 4 p.m. on the 21st and reported himself suspiciously to the Korea Centers for Disease Control and Prevention and was classified as a doctor by the airport quarantine office and the central epidemiological investigator. Suspected patients are suspected of monkeypox in consideration of clinical symptoms or epidemiological associations, but there are no test results that meet the test criteria for diagnosis. The suspected patient was transferred to Incheon Medical Center for treatment after waiting for an airport quarantine facility. The quarantine authorities plan to hold a briefing as soon as the results of the Monkeypox diagnostic test and epidemiological investigation are released. In the news, President Yoon ordered the rapid distribution of vaccines and treatments and ordered the introduction of third-generation smallpox vaccines and Monkeypox treatments in Korea. President Yoon ordered, "If necessary, prepare fully so that the vaccines and treatments currently secured can be quickly distributed to the medical field and complete the introduction of additional third-generation vaccines and antiviral drugs for Monkeypox as soon as possible."
- Policy
- Abnormal cases of Inlyta in PMS for 9 yrs is 82.8%
- by Lee, Hye-Kyung Jun 24, 2022 05:45am
- As a result of a post-marketing survey of Korea Pfizer Pharmaceutical's kidney cancer treatment Inlyta, the incidence of abnormal cases was 82.88% regardless of the causal relationship. As a result of conducting PMS on 111 people over 9 years for re-examination, 92 people (338 cases in total) showed abnormal cases regardless of causality. Among them, 7.31% of the serious adverse drug reactions that cannot be excluded from the causal relationship and 14.41% of the unexpected adverse drug reactions. The MFDS announced that it plans to reflect it from September 21st after completing a preliminary notice of changes to permits according to the results of PMS. Serious drug adverse reactions in 7 out of 111 patients were pulmonary artery thrombosis, cerebral infarction, anemia, helplessness, and diarrhea. Unexpected adverse drug reactions appeared in 16 out of 111 people, and side effects such as rhinitis, gingivitis, pneumonia, edema, chest discomfort, acne, difficulty in urination, difficulty in swallowing, toothache, peripheral neuropathy, and gout appeared. Meanwhile, Inlyta was approved for domestic market on August 22, 2012. At the time of approval, it was given 6 years of re-examination for indications of progressive renal cell cancer that failed to treat one systemic therapy, but the PMS period increased to 9 years as it maintained non-reimbursement for 3 years due to delayed registration. According to the AXIS phase 3 comparing the treatment effects of Inlyta and Nexavar, the median duration of progression-free survival in the Inlyta administration group was 8.3 months, which reduced the disease progression risk by about 34% compared to 5.7 months in the Nexavar administration group.
- 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.
