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- 2025-12-19 04:43:40
- Policy
- HIRA sets plan for performance assessment of 'Qarziba'
- by Lee, Tak-Sun Dec 12, 2024 05:49am
- Product photo of QarzibaThe Health Insurance Review and Assessment Service (HIRA) has established a performance assessment plant for Qarziba and notified healthcare providers to submit documents. Qarziba is a high-cost treatment for severe diseases. As of December 1, the drug was listed for reimbursement under the condition of patient performance-based Risk Sharing Agreements (RSA) for treatment effects monitoring and follow-up of reimbursement appropriateness. According to sources on December 11, the number of drugs under the patient performance-based RSA increased to six, with the addition of Qarziba. Patient performance-based RSA is a new payment system in which pharmaceutical companies' refund rate varies depending on a patient's performance after receiving a medicine. As a result, healthcare providers that have administered those medicines must submit patient monitoring documents to HIRA to follow up on patient performance. The performance assessment, introduced to Kymriah in 2022, has expanded to six drugs, including Zolgensma, Spinraza, Evrysdi, Luxturna, and Qarziba. These drugs are subjected to 'Monitoring reimbursement for high-cost medicines.' Qarziba was designated the first drug for a "Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations." The drug's ceiling price is KRW 11.48 million, and patients can receive the medicine for KRW 10.50 million yearly with a 5% co-patient rate and the ceiling price for co-patients applied. The HIRA explained that healthcare providers must submit a document for a patient who qualifies for the reimbursement standard of Qarziba and has received a drug. The assessment period for the high-risk group is 3 years, and recurrent/refractory is 2 years. As a result, healthcare providers must submit monitoring reports every 6 months, 12 months, and every year. Required documents include ▲consent form for long-term follow-up investigation for Qarziba administration ▲patient information for Qarziba administration ▲monitoring reports for Qarziba administration. These monitoring reports must be submitted four times: within 7 months, 13 months, 26 months, and 38 months following the first treatment initiation. If a patient passes away, the monitoring report must be submitted immediately. For patients who die at a facility other than the one administering Qarziba, that facility should label the case as "lost to follow-up" and include detailed notes in the special remarks section. For patients who fail to attend follow-up visits, facilities should also mark the case as "lost to follow-up" and note relevant details. Additionally, cases where assessments cannot be conducted due to the patient's condition should be noted as "unable to evaluate" with relevant details. The HIRA will evaluate patient survival and condition at each evaluation point. "Until the monitoring system is developed, healthcare providers should submit monitoring reports via email. Once the system is ready, reports should be submitted through the "high-cost drug management system" available on the healthcare provider portal," a HIRA personnel remarked.
- Policy
- New drug approval fee to rise next year
- by Lee, Hye-Kyung Dec 12, 2024 05:49am
- The Ministry of Food and Drug Safety has begun finalizing plans to raise the new drug approval fee KRW 410 million from January 1 next year. The MFDS recently collected opinions on the “Operating Procedures for Approval and Examination of New Drug Products (Guideline for public officials)” from October 18 to November 15, and released the final revised guidelines that reflect consultative body discussions and industry opinion. The guideline, which is set to be enacted on the 11th, contains specific measures to implement the “Innovative Measures for New Drug Approval” that was announced by the MFDS on Sept. 9, including the operation of a dedicated review team for each product and prioritizing GMP-GCP on-site inspections. The new drug approval fee will be revised for new drugs (including advanced biopharmaceuticals) and orphan drugs that have been approved as orphan drugs and then converted to new drugs (change of approval). To expedite the approval of new drugs, MFDS has ▲shortened the approval period (295 days), ▲established a dedicated review team for each product, ▲prioritized manufacturing and quality control (GMP) and clinical trial (GCP) surveys, and ▲newly established a procedure for pre-registering supplemental submission data. The timing of each step, including the target approval date for new drugs under this procedure, is based on calendar days (including holidays and Saturdays) unless otherwise specified. Meeting the target approval date requires the cooperation of the pharmaceutical manufacturer to be met, with the caveat that the target date for receipt of the first supplement is D-60 and that there should be no delay in the on-site inspection schedule due to the applicant's circumstances. In addition, in the case of an application for conversion to a new drug after approval as an orphan drug (change of approval), a fee must be paid and a review conducted for the review of the areas requiring additional data review. However, no fee is required if the data submission has been completed and reviewed at the time of orphan drug approval. In addition, if the applicant reapplies for the same item within a period of 2 years from the date of rejection (withdrawal), only the supplemented data (other than the data that was reviewed before the rejection (withdrawal)) can be reviewed and processed. According to the procedure for the approval and examination of new drug applications, applicants can request a preliminary consultation before application. This can only be done a single time for each new drug that is scheduled to be filed within 3 months. The fee must be paid on the date of the application submission, and the fee cannot be canceled after submission. In the case of a complaint, the applicant may submit a possible on-site inspection period (at least three periods) for its local manufacturing site to be inspected. The preliminary review will be conducted within 7 days of application receipt, and the dedicated team for each item organized within 10 days of receipt. The initiation meeting for the marketing authorization review will be held within 14 days of receipt, either in person (in Osong), via video, or a combination of in-person and video. The outcome of the meeting will be notified to the applicant within 10 days from the date of the initiation meeting. The outcome of the initiation meeting will additionally include an estimated timeline for the agreed-upon milestones (GMP inspection schedule, expected date of first supplemental data notification, recommended date for completion of supplemental data submission for expedited processing (D-60), and target approval date). GMP inspections are conducted within 90 days of the application receipt and GCP inspections are conducted within 60 days of the first supplement. Various improvements have also been made to the supplement requests. Previously, the authorities only made the 1st and 2nd supplement notifications, but the revised proposal introduces a 1st supplement request briefing session and a 2nd supplement request briefing session to ensure that the complainant fully understands the supplement request. After the supplementation, the review process will be completed with a meeting of experts such as the Central Pharmaceutical Affairs Council, a final meeting (5 days before the target approval date), and final complaint processing by the approval department.
- Policy
- Cancellation policy for innovative pharmas certification
- by Kang, Shin-Kook Dec 09, 2024 05:47am
- Choi Sang-Mok, deputy prime minister and Minister of Economy and Finance It has been reported that the cancellation standards of 'Innovative Pharmaceutical Companies Certification' will be relaxed for pharmaceutical companies fined for rebates. Some argue that certification requirements for illegal rebates are strict. Further criticism is anticipated as these measures deviate from the government’s longstanding anti-rebate policies. On December 4, the government finalized the "Innovate Economic Regulatory Plan for Enhancing Corporate Dynamism and Promoting New Industries" at the Emergency Ministerial Meeting on Economic Affairs. This plan was prepared by the Ministry of Economy and Finance and the Office for Government Policy Coordination of South Korea, actively·promptly reflecting suggestions from economic organizations and companies. ◆Improvement of certification cancellation standards for 'Innovative Pharmaceutical Companies' = The government has determined that the strict certification requirements related to illegal rebates in the 'Innovative Pharmaceutical Companies Certification' system could discourage pharmaceutical companies from developing new drugs. In detail, the government plans to revise the standards stipulating that certification can be canceled if ▲A company receives two or more penalties for violating the Pharmaceutical Affairs Act due to illegal rebates within three years or ▲The total amount of rebates exceeds KRW 5 million. After consulting with experts from the industry and academics, the government plans to devise a draft for the revision to the cancellation standards for the 'Innovative Pharmaceutical Companies Certification' (according to the Ministry of Health and Welfare notice) next year. Meanwhile, 'Innovative Pharmaceutical Companies Certification' offers several benefits, including: ▲Incentives when participating in government R&D projects related to new drug development ▲Corporate tax deductions for research personnel development costs ▲Eased location regulations for constructing research facilities ▲Special loan arrangements for policy funds. ◆'Advanced regenerative clinical research' results to be used for drug approvals = Different standards from clinical trials under the Pharmaceutical Affairs Act have been applied to Advanced regenerative clinical research, making it difficult to use as a basis for approval in developing advanced biopharmaceuticals. Guidelines will be established this month to allow advanced regenerative clinical research results to be used as approval review data for advanced biopharmaceuticals. Guidelines will be established this month to allow advanced regenerative clinical research results to be used as approval review data for advanced biopharmaceuticals. A draft guideline, tentatively titled "Guidelines relating to the Advanced Regenerative Medicine Clinical Research and Marketing Authorization," will be developed to utilize research results that meet specific standards as part of the review data for marketing authorization. ◆To introduce simultaneous analysis methods for vitamin B products in functional foods = Currently, the "Standards and Specifications for Functional Foods" do not include a test method for simultaneously analyzing the Vitamin B group (B1, B2, B6, niacin, and folic acid), which has delayed the product development. In response, the government plans to develop·implement a test method capable of analyzing properties across various formulations for functional foods through a research project starting in January next year. ◆To develop a pilot service of a health management system for young children·adolescents = A health management service utilizing AI and digital technology will be implemented to minimize long wait times for treatment and reduce public inconvenience. In particular, with declining birth rates exacerbating the reduction of pediatric medical demand and resources, the government aims to develop a health management system for young children to address reduced access to pediatric care. The system will be designed to include AI-based support for diagnosis and treatment guidance, assistance with medical record documentation, health consultations for managing pediatric diseases and providing information to caregivers on pediatric rare diseases. The government will allocate a total of KRW 32 billion over four years for this project. Additionally, the government suggested other innovative measures, ▲Establishment·operation of a regulatory support center for digital medical products ▲Regulatory improvements for consumer direct-to-consumer (DTC) genetic testing for minors ▲Enactment of legislation to promote alternatives to animal testing ▲Support for precision oncology technology development using next-generation sequencing (NGS) panel data ▲Simplification of required documentation for filing innovative medical technology applications.
- Policy
- Janssen seeks reimb for Balversa in Korea
- by Lee, Tak-Sun Dec 09, 2024 05:46am
- ’Balversa (erdafitinib, Janssen),’ which has been approved as a targeted therapy for bladder cancer, has reportedly applied for reimbursement 2 years after being approved in Korea. It is believed that the company is seeking Balversa’s entry into Korea’s health insurance market based on its proven effectiveness in patients who have used immuno-oncology drugs. According to industry sources on the 6th, Janssen’s Balversa recently applied for a reimbursement decision to Korea’s Health Insurance Review and Assessment Service. Balversa was approved by the Ministry of Food and Drug Safety in January 2022. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. The drug gained attention as the first targeted therapy to target a specific gene mutation in bladder cancer. It works by inhibiting a mutation in the fibroblast growth factor receptor (FGFR), which is one of the biological signals involved in cancer cell growth, and 20 to 30% of patients are known to be carrying mutations. However, even after its approval, Balversa was not released in the domestic market for two years. Then, in October, the company held a business meeting and declared that it would officially launched the drug in the domestic market. The delay is explained by the fact that immuno-oncology drugs have settled as a major treatment option for bladder cancer. In response, Balversa has focused on demonstrating efficacy in patients whose disease progressed after immuno-oncology treatment. The THOR study included patients with metastatic urothelial carcinoma with FGFR3/2 mutations whose disease progressed after first-line treatment with an anti-PD-(L)1 immuno-oncology agent. The results showed a median overall survival (OS) of 12.1 months in the Balversa arm compared to 7.8 months in the chemotherapy arm over a median follow-up of 15.9 months, resulting in a 36% reduction in the risk of death. Based on the study, the U.S. FDA formally approved Balversa in January. With the efficacy data, the company seeks to start sales in Korea. It will be interesting to see if Balversa will enter the Korean health insurance market and become a new option in the bladder cancer treatment landscape.
- Policy
- Reimb extension discussions for Kyprolis break down
- by Lee, Tak-Sun Dec 06, 2024 05:57am
- The proposal to extend reimbursement coverage for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has failed to make it past the negotiating stage with the National Health Insurance Service. The negotiations, which began last October, have broken down. The National Health Insurance Service announced the news of Kyprolis' negotiation failure on the 4th while updating the list of drugs that have completed drug price negotiations on its website. Kyprolis was set reimbursement standards by the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee in April as a ‘combination therapy used with daratumumab and dexamethasone (DKd regimen) for the treatment of multiple myeloma patients who have received one or more prior therapies’. However, the coinsurance rate for daratumumab is set at 100%, for the patient to pay in full as out of pocket price. Since then, the agenda has passed the Drug Reimbursment Evaluation Committee review and was in negotiations with the NHIS since October. In February 2018, Kyprolis was successfully listed on the reimbursement list as part of the RSA (risk-sharing agreement, refund type) scheme. The reimbursed therapies at the time were KRd therapy (Kyprolis+lenalidomide+dexamethasone) and Kd therapy (Kyprolis+dexamethasone). With the reimbursement, the out-of-pocket cost for the patients was reduced from KRW 10 million to KRW 500 to 600 thousand. The DKd regimen had shown evidence that it was effective in patients exposed to lenalidomide, which is why it is expected to be beneficial to patients if reimbursed. However, the breakdown in negotiations means it will take longer for the drug to be reimbursed. The drug will have to undergo another review by HIRA DREC before it can be re-negotiated with the NHIS. As a blockbuster drug that recorded sales of KRW 32.2 billion last year (IQVIA), it will be interesting to see how Amgen will respond to its negotiation breakdown.
- Policy
- Expanded clinical use of orphan drug 'Joenja' in children
- by Lee, Hye-Kyung Dec 06, 2024 05:56am
- Product photo of Joenja. The administration·dosage in children for a clinical trial of 'Joenja (leniolisb),' an APDS treatment designated as an orphan drug in South Korea, is expected to be expanded. The meeting record of the Central Pharmaceutical Affairs Advisory Committee (CPAC), released by the Ministry of Food and Drug Safety (MFDS) on December 4, indicates that there has been a consultation regarding the application for approval of a medication on clinical trial intended for therapeutic use, which is currently undergoing clinical trials in a foreign country. It was reported that the medication is Joenja, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). In June, Joenja was designated as an orphan drug. APDS is caused by mutations in one of the genes encoding PIK3CD or PIK3R1 that is needed for the development and function of immune cells. The disease occurs in 1 in 1-2 million people. Patients exhibit autoimmunity and inflammatory symptoms. Symptoms include ears infections, paranasal infections, and upper·lower respiratory infections. Lymph nodes or the spleen may enlarge, and patients have increased risk of developing cancer, such as lymphoma. The approval of Joenja was based on the results of multinational, triple-blinded, placebo-controlled, randomized clinical 2/3 trials. The clinical trial involved 31 APDS patients over 12 years old. At the recent CPAC meeting, discussions were held on the age range eligible for approval based on pediatric administration·dosage and predicted through pharmacokinetic (PBPK) modeling data and case studies from a compassionate use program (10 patients). The CPAC concluded that approval could be granted for patients aged four years and older, with further discussions required for those under four. Regarding the PBPK modeling data, one committee member stated, "Metabolism is proportional to body weight and liver volume, with differences of about 20% observed even among adults, making application in children reasonable." "However, since kidney function, liver function, and body composition become similar to adults only after two, predicting results for patients under two years old is challenging." Most committee members state that the submitted modeling document presents no significant issue. One committee member commented, "FDA reports indicate that medication use in ages 4-11 will not pose any problem based on the modeling result. However, the applications below the age of 4 or 2 must need further discussion." Another committee member stated, "The CYP cell maturity is similar after age 2, larger liver size and hepatic clearance. We believe that this has been incorporated in the modeling." Once patients start taking medication, they are likely to continue treatment. Therefore, concerns have arisen that administration should only begin after safety results are reviewed. However, the committee chair noted that data collection could be challenging since the target population comprises children with rare diseases. Regarding this, "The medication has been designated as an orphan drug in both the U.S. and Korea, with four additional approved cases," the MFDS stated. "We need consultation on whether the clinical trial data from U.S. approval, submitted as evidence of safety and efficacy, along with the modeling data and case studies from 10 patients, can substitute for therapeutic confirmatory or exploratory clinical trial results." Consequently, it was concluded that CPAC must give a green light, as the unapproved status in South Korea and CPAC's opposition to access would deny Korean patients treatment opportunities. Meanwhile, since the currently available 70 mg product is a film-coated tablet that children may be unable to swallow, the company plans to provide the medication in 10 mg and 30 mg tablets.
- Policy
- Linking 'Prior review-performance evaluation-reevaluation'
- by Lee, Tak-Sun Dec 06, 2024 05:56am
- HIRA The Health Insurance Review and Assessment Service announced that it has been reviewing a measure that links preliminary review, performance evaluation, and reevaluation for newly listed high-priced drugs. In other words, for newly listed high-priced drugs, the authorities will conduct a proper cost-effectiveness evaluation through a preliminary review process. In this way, the new system will build a virtuous cycle with the existing preliminary review system. HIRA's Healthcare Review and Assessment Committee (HCRAC)’s Review Department and Review Division explained so at a press conference with press corp reporters on the 3rd. The Review Department and the Review Division are TF-type departments that were established this year to improve HIRA’s review standards. Min-Sun Kim, Head of the HCRAC Department, said, “The HCRAC Department was newly established earlier this year when a new task of overseeing and improving the general review standards was added to the committee’s preliminary review task.” Kim explained that the HCRAC's key achievements this year were the voluntary efforts it had made to improve the review standards and the establishment of a virtuous cycle of the preliminary review system. “As the need for preliminary review has increased with the increase in the number of high-priced drugs, we have established and operated a monitoring and return system that switches items that have been under review for a long time to post-review and quickly introduce newly listed high-priced drugs through preliminary review,” explained Kim. Of the 12 preliminary review items, 5 items, including a treatment for paroxysmal nocturnal hemoglobinuria, were stably transitioned to items for post-review, and a new treatment for the inherited retinal disease was introduced. In addition, the committee improved and expanded the reimbursement standards for 6 items through analysis of the review status and expert discussions. This year, HIRA switched the preliminary review status of Strensiq, Soliris Inj (paroxysmal nocturnal hemoglobinuria), Ultomiris Inj, ICD (implantable cardioverter-defibrillator), and CRT (cardiac resynchronization therapy) as subject to post review. Kim added, “In the case of preliminary review, we will promote the introduction of high-priced new drugs, and consider ways to utilize data that can be linked from preliminary review to performance evaluation and re-evaluation for a solid reimbursement management system of high-priced drugs." Jung Gu Kang, President of HIRA who also attended the conference, added, “Drugs whose data has not been verified at the time of their introduction should be objectively verified for cost-effectiveness through post-evaluations. Newly introduced drugs should undergo preliminary review to reduce unnecessary spending.” However, he said there are no plans to move the atypical hemolytic-uraemic syndrome treatment, which has been receiving many requests to transition the item to post-review due to its low pre-approval rate. “The reason we switched paroxysmal nocturnal hemoglobinuria treatments to post-review is because they are stable in terms of reimbursement coverage, but atypical hemolytic uremic syndrome treatments are not so,” added Kim, ”The Anti-Corruption & Civil Rights Commission did not recommend abolishment of the drug’s preliminary review status.” In addition to the reorganization of the preliminary review system, the HCRAC’s review office said it has improved the review standards for 114 applications. Kim explained, “At the end of last year, we reviewed a total of 410 cases, including spine surgeries that clinical societies and associations filed appeals and opinions on improving the review criteria and revised and reflected their opinion on 114 cases into review guidelines and notices, and improved the review process. We met and discussed with academic societies and held advisory meetings more than 50 times.” “Of the 410 cases, 58%, or 238 cases, were resolved within the year. For 124 cases where the medical community misunderstood the review and criteria, we provided detailed guidance to clinical societies and associations for better understanding of the medical community, and 114 cases with medical grounds were reflected in the review guidelines and notices.” “For the other 172 cases that have not yet been resolved, some cannot be resolved immediately due to lack of clinical evidence, while others need to be improved, but may take several months to a year or more to resolve due to equity issues between medical departments or financial requirements. We have shared these situations with clinical societies and associations, and we ask for the understanding and cooperation of the medical community and the government for their resolution.”
- Policy
- Astellas’s Xtandi Tab 40mg and 80mg approved in KOR
- by Lee, Hye-Kyung Dec 05, 2024 05:53am
- Pic of Xtandi Soft Cap Astellas, the original company of the oral androgen receptor inhibitor (ARTA) class prostate cancer treatment, became the first company to receive marketing authorization for the tablet formulation of Xtandi in Korea. The Ministry of Food and Drug Safety approved two dosage forms of Astellas' Xtandi Tab - 40 mg and 80 mg – on March 3. Since Astellas received approval for ‘Xtandi Soft Capsules 40 mg (enzalutamide)’ in Korea in 2013, the company has only been supplying the soft capsule formulation until now. Soft capsule formulations have a disadvantage in that increasing the dose increases the size of the capsule itself, which can reduce patient convenience, making it difficult to develop higher-strength products. Astellas has been developing Xtandi Tab since 2020, increasing the dose to 80 mg and selling them alongside its soft capsule product after receiving approval for the tablet formulation in the US and Europe. However, in Korea, only the soft capsules have been released due to delays in approval, and domestic pharmaceutical companies have been developing tablet formulations of enzalutamide, the main ingredient of Xtandi. Recently, Ildong Pharmaceutical and Boryung Pharmaceutical have been developing tablet formulations of enzalutamide. However, Astellas registered its patent technology for Xtandi’s tablet formulation with the Korean Intellectual Property Office in July, and then recently received approval for Xtandi Tab. According to IQVIA, domestic sales of Xtandi Soft Capsules have increased from KRW 29.1 billion in 2022 to KRW 43.2 billion in 2023, accounting for one-fifth of Astellas' sales. Xtandi's growth has been largely driven by the drug’s reimbursement extension. In August 2022, Xtandi was granted reimbursement for patients with advanced prostate cancer with distant metastases when used in combination with androgen blockade therapy (ADT), and in November last year, it became reimbursable regardless of the patient’s prior use of other ADTs. In addition, the reimbursement was extended to non-metastatic hormone-sensitive prostate cancer (nmHSPC) in June, leaving room for further growth. Meanwhile, Astellas Pharma Korea's sales reached KRW 251.1 billion last year, up 7.5% from KRW 232.2 billion in 2022.
- Policy
- 30-day negotiation window for essential medicines
- by Lee, Tak-Sun Dec 04, 2024 05:57am
- The National Health Insurance Service (NHIS) has started revising guidelines related to the government's initiative to improve the drug pricing system to 'reflect on the new drug innovative value.' First, the NHIS announced to introduce Risk Sharing Agreement (RSA) types and has reduced the time required to negotiate pricing adjustments for national essential medicines. The NHIS has recently drafted a revision to the guidelines for drug price negotiations and detailed matters for RSA drug price negotiations, collecting public opinions. The deadline for submitting opinions is December 4. Regarding revision to the guidelines for drug price negotiations, the NHIS established a basis for shortening the time required for drug price negotiation and pre-negotiating the national essential medicines. In detail, the NHIS decided that the negotiating period for drugs evaluated at the Drug Reimbursement Evaluation Committee (DREC) to require assistance from the central administrative agency for drug supply issues, such as crisis for infectious diseases or emergency drug shortages, will be 60 days instead of 30 days. Also, pre-negotiation is possible, and the pre-negotiation application will be the same as a submitted document to the Health Insurance Review and Assessment Service (HIRA). For detailed matters for RSA drug price negotiations, the NHIS announced introducing an early-stage treatment cost refund type and an achievement-based refund type. The early-stage treatment cost refund type is for applicants seeking refunds from NHIS for a portion of the initial administration cost. Also, the achievement-based refund type is for applicants requesting refunds of a portion of the total claim amount of the drug from NHIS when an individual does not meet the predetermined treatment effects after a follow-up·monitoring for a specified time. Recently, these two types have been applied to high-priced drugs. With the newly added types, contract additions·changes will be permitted during negotiations, and post-management procedures will be officially incorporated. Additionally, the current revision will simplify the procedure required at RSA termination. Previously, the NHIS requested an evaluation of the RSA-approved drug's clinical usefulness and cost-effectiveness before the contract termination. The current revision will skip the drug procedure under the third contract for RSA. Also, the NHIS will request confirmation from the HIRA director related to changes to RSA drugs, including substitute drugs or reimbursement criteria. "The revision has been established to bring improvements to the drug pricing system to reflect on new drug innovative value and to ensure healthcare security," the NHIS explained regarding the current revision. "To promote innovative new drug value and incentivize innovative growth, the NHIS aims to support sustainable, innovative systems for the pharmaceutical and biotech industry. This includes ensuring stable drug supplies by setting reasonable drug prices for essential pharmaceuticals required by patient treatments and establishing a foundation for essential healthcare." The current revision is a follow-up to the 'Specific evaluation criteria of new drugs and medicines in consideration for negotiation,' which was established by the HIRA in August, and the 'Pharmaceutical Approval and Adjustment Criteria,' which was announced in October. The government plans to promote new drugs' innovative value and to improve the drug pricing system to ensure healthcare safety by favoring the national essential medicine. The government will expand the number of pharmaceuticals for RSA and provide benefits for the drug pricing of the national essential medicines that use domestic raw materials. An NHIS employee explained, "We plan to implement the revised draft by hearing public opinions alongside the announced draft by the Ministry of Health and Welfare (MOHW).
- Policy
- Legislation of ‘INN prescriptions’ for drugs begin
- by Lee, Jeong-Hwan Dec 04, 2024 05:56am
- The government is promoting legislation to recommend international non-proprietary name prescriptions for national essential medicines and drugs with unstable supply and demand and to encourage the use of 'product name and the international non-proprietary name’ when obtaining a marketing authorization. The bill also includes a provision that requires the government to establish a policy to resolve stockouts by legislating the definition of unstable drugs and giving them the same status as national essential medicines. The legislation recommends that the government prescribe and approve the use of ingredient names only for drugs with unstable supply and national essential medicines, which are frequently out of stock and cause inconvenience to pharmacies and patients. On the 2nd, Rep. Yoon Kim, a member of the Democratic Party of Korea, introduced a bill as representative to amend the Pharmaceutical Affairs Act. First, the bill defines an unstable supply drug as a drug designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation as a drug that needs to secure a stable supply due to unstable supply and demand. The amendment puts unstable drugs on the same level as national essential medicines. The Minister of Welfare and the Minister of Food and Drug Safety are obligated to carry out support tasks to promote the production and utilization of drugs with the same ingredients as drugs with unstable supply and demand. The Minister of Welfare and the Minister of Food and Drug Safety are required to establish and promote comprehensive measures to stabilize the supply of drugs with unstable supply and demand and to support the establishment of a stable supply base, research and development, and safe use. Recommendation of international non-proprietary name prescriptions and approving ingredient-containing product names In particular, the law recommends doctors prescribe ingredient names for national essential medicines and drugs with unstable supply and demand and encourages pharmaceutical companies to receive marketing authorization based on ingredient-containing product names. Specifically, the Minister of Welfare is required to establish a policy to activate the use of ingredient names for nationally essential medicines and drugs with unstable supply and demand in prescriptions. This provision has the effect of encouraging the prescription of nationally essential medicines and drugs with unstable supply and demand. In addition, the Minister of Food and Drug Safety recommends the use of international non-proprietary names for those who intend to sell or import national essential medicines and drugs with unstable supply and demand. The Minister of Food and Drug Safety can provide administrative and financial support for those who want to sell and import nationally essential medicines, etc. Through the provision, the government recommends pharmaceutical companies planning to sell and import drugs with domestic marketing authorizations to include the names of ingredients in the product names. The law also stipulates that the MFDS National Council for Stable Supply of Essential Drugs shall consult on matters related to national essential medicines. The Korea Orphan & Essential Drug Center will manage drugs with unstable supply along with national essential medicines. The amendment is expected to create a government organization dedicated to drugs with unstable supply and demand. “In recent years, the problem of unstable supply and demand of certain drugs has not been easily resolved and is often prolonged,” said Rep Yoon Kim. ”This causes problems within the drug supply process, from distribution to consumer purchases, such as stockpiling, issuing long-term prescriptions, and over-the-top trading between pharmacies.” “Therefore, the government will establish a stable supply mechanism for drugs with unstable supply and demand and promote the use of international proprietary names for nationally essential medicines to lay the foundation for stable and timely supply of drugs to consumers.” Yoon Kim was joined in the bill by Democratic Party members Gi-Pyo Kim, Nam-Geun Kim, Nam-Hee Kim, Seung-won Kim, In-soon Nam, Ji-won Park, Hae-Cheol Park, Hee-Seung Park, Seung-A Bak, Hoon-Gi Lee, and Mi-ae Lim.
