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- 2026-05-09 19:28:29
- Policy
- Industry burdened but accepting of mandatory DSUR
- by Byun Kyung A Oct 31, 2019 09:59am
- Pharmaceutical industry initially complained of administrative strain when the government issued a notice on enforcing mandatory drug safety update report (DSUR)’, as advised by the National Assembly. But the industry also agrees with Korean government’s intention to enforce the pre-marketing regulation, which now has become a global trend. The pharmaceutical industry sees why the government would rather tighten the pre-marketing regulation than to cause actual corporate loss and public confusion over post-marketing recall and reimbursement and approval revocation. According to the lawmakers and pharmaceutical industry on October 27, Ministry of Food and Drug Safety (MFDS) plans to enforce mandatory submission of DSUR to strengthen clinical trial safety control. Currently, the Pharmaceutical Affairs Act does not stipulate mandatory DSUR submission. Along with post-marketing periodic safety update report (PSUR), DSUR has been an issue as a whistleblower from MFDS reported how “the ministry neglects its most basic job and does not even review submitted drug safety materials”. Criticism on MFDS neglecting drug review expertise grew intensely as drug quality and safety issues, such as ranitidine impurity incident and Invossa-K approval revocation, surfaced all at once. Accordingly, the lawmakers tackled the ministry on DSUR and PSUR management at the recent National Assembly Annual Audit. MFDS accepted the criticism and vowed to reinforce related regulation. MFDS official stated, “The ministry reviewed a total of 2,823 PSUR materials in last five years, and drug safety information reported from around the world were evaluated and reflected during the reexamination period”, and “mandatory DSUR would be enforced from 2020 based on the five-year National Health Insurance Comprehensive Plan announced last August”. Starting with new drug, MFDS is to phase in mandatory DSUR submission from next year considering pharmaceutical industry’s human resource, cost and other preparation procedure. Pharmaceutical industry showed mixed feelings of burden and need of the tightened regulation. Many also saw DSUR as unavoidable task the industry should take in as it is a pre-marketing regulation in clinical trial phase. “It is difficult to happily accept the new regulation as a company. DSUR submission, despite the phase-in introduction, would inevitably burden the industry with development cost and time,” but “we do agree the regulation is needed. Already many pharmaceutically advanced countries have enforced mandatory DSUR and it is now a global trend Korea cannot avoid,” a pharmaceutical administrative personnel from Korean pharmaceutical company commented. The Korean company associate also added, “Time would not be much of an issue, as it would be applied to new drug first, and give plenty of preparation time. The regulation aims to reinforce drug safety measures before commercialization, and not to be an excessive over-regulation. MFDS officials would probably convene a regulatory seminar for companies”. A multinational pharmaceutical company insider predicted DSUR would be less of a problem, as it regulates pre-marketing phase and not post-marketing. The multinational company associate said, “The authority has been trying to swiftly solve recent drug safety and approval revocation issues with strict regulation, retrospectively. Meanwhile, DSUR is a pre-marketing regulation that minimizes post-marketing measures but raises the bar for drug safety management. The actual strain on the industry would be relatively insignificant”.
- Policy
- Weighted pricing benefit abused as permanent price booster
- by Byun Kyung A Oct 31, 2019 09:58am
- The government evaluated the current weighted drug pricing system has been digressed as a permanent pricing benefit. Apparently, 96 percent of items have maintained the benefitted pricing for more than three years, and the authority sees that such practice has distanced itself from the initial objective to secure stable supply. Ministry of Health and Welfare (MOHW) submitted a statement answering the National Assembly Health and Welfare Committee Audit addressing the issue. Previously, Liberty Korea Party Lawmaker Kim Soon-Rye questioned the ministry about revising drug pricing system and strengthening competitiveness of Korean companies. In summer, MOHW presented revised 'Decision-making and Modification Standard for Drug Item' and unveiled weighted pricing system revision plan as a part of generic pricing system revision. The system was revised to set one year period of weighted pricing for synthetics and biopharmaceuticals, but provides maximum two years in case number of companies supplying the equivalent generics is less than three. The revision also established generic drug pricing standard and pricing for multi and single-use eye drops. On the revised weighted pricing system, MOHW explained “The initial objective of the system was to stabilize drug supply (weighted pricing for generics with less than three suppliers) and to induce soft landing for a generic entering the market where the original is lowering its price, from 100 percent to 70, and then to 50 percent.” “The revision was planned to keep the regulation faithful to its original objective maintaining stable drug distribution”, the ministry added. And the government emphasized its justification of drug pricing system revision as “244 out of 254 items, or 95 percent of the benefited items have been maintaining its increased price for more than three years, abusing the system as a permanent price boosting tool”. The ministry also ensured it would thoroughly review individual cases that need special support to stabilize drug supply. The statement added MOHW’s commitment to contribute strengthening Korean pharmaceutical company’s global competitiveness by executing the Biohealth Industry Innovation Strategy and Pharmaceutical Industry Fostering and Support Master Plan.
- Policy
- For reimbursed drug, efficacy and cost-efficiency come first
- by Byun Kyung A Oct 31, 2019 09:34am
- On the last day of the 20th National Assembly Annual Audit for the Health Insurance Review and Assessment Service (HIRA), half the questions were dedicated to pharmaceutical affairs. The lawmakers of the NA Health and Welfare Committee questioned HIRA about NHI reimbursement reevaluation on dementia treatment choline alfoscerate, reimbursement expansion on NOAC Xarelto, and reimbursement expansion on the anticancer treatment reflecting its frequent non-reimbursed off-label use as ophthalmic solution. Some lawmakers claimed the General Principle of Healthcare Reimbursement on liquid solutions, like syrup and suspensions, should be revised and expand utilization cap eligible for reimbursement. As always, however, HIRA had a strictly basic answer for the said topics and stated, “The issues addressed would be sufficiently reviewed when clinical efficacy and cost-efficiency are proven”. Below is Daily Pharm’s summary of HIRA’s written answer submitted to the NA on Oct. 28. ◆Reimbursement reevaluation on choline alfoscerate: The current system does not stipulate a reevaluation for NHI reimbursement based on clinical efficacy, except for special cases of Ministry of Food and Drug Safety (MFDS) revoking an approval. The government's National Health Insurance Comprehensive Plan is to establish a pharmaceutical reevaluation system considering clinical efficacy of listed drug, financial impact and healthcare coverage listing status in foreign countries. HIRA, then, plans to have Drug Post-evaluation Subcommittee under Drug Reimbursement Evaluation Committee (DREC) to conduct NHI reimbursement feasibility reevaluation with the new system. Particularly, HIRA official stressed uncertainty of choline alfoscerate “has been questioned constantly” and that the agency would “establish reevaluation system promptly for it”. The dementia treatment is usually sold as a health functional food in other countries. ◆Expanded reimbursement benefit on Xarelto: Medical industry urges the health authority to grant NHI benefit on new oral anticoagulant (NOAC) Xarelto (rivaroxaban) to high-risk patients with coronary artery disease (CAD), specifically for cases of atrial fibrillation (AF) before and after catheter ablation and electrical cardiodiversion, nonvalvular AF with hypertrophic cardiomyopathy, and nonvalvular AF with CHA₂DS₂-VASc score 1. At the moment, Brilinta (ticagrelor) and Xarelto are listed for reimbursement as antiplatelets, and the benefit for Xarelto only covers high-risk patients with nonvalvular AF. HIRA answered, “As medical academic society has requested expanding reimbursement benefit on Xarelto, the agency plans to promptly review additional clinical evidences, such as revised guideline in foreign countries”, and the treatment’s “reimbursement would be expanded depending on clinically proven efficacy”. ◆Revising General Principle for syrup and suspensions: The current General Principle on Healthcare Reimbursement Criteria and Method stipulates granting NHI reimbursement benefit on pharmaceutical syrup and suspensions, also available in types of table or capsule with equivalent ingredient, in following cases; prescribed to patients younger than 13; patients with old age, dementia or other dysfunctional esophagus unable to swallow; prescribed with antacid, sucralfate, and sodium alginate under approved indication. The National Assembly pointed out the General Principle regarding pharmaceutical liquid solution should be amended and provide healthcare benefit for all Koreans to consume drug more conveniently. But HIRA official explained, “Liquid solution tends to be more expensive than tablet or capsule drugs”, therefore, “the General Principle, on Oct. 1, 2011, stipulated providing benefit to subject drugs meeting cost-efficiency standard under certain medical state and patient condition”. Since 2011, some syrup and suspension with proven cost-efficiency have received reimbursement as an exception to the General Principle. HIRA official added, “The agency would accordingly review the need to amend general reimbursement criteria based on cost-efficiency standard”. ◆Listing Avastin for reimbursement: This year’s National Assembly Audit addressed promptly providing reimbursement for non-reimbursed off-label treatment approved to be used. The issue refers to the use of anticancer treatment Avastin in ophthalmology as a non-reimbursed off-label treatment for macular generation. After consulting with Ministry of Food and Drug Safety (MFDS), HIRA allowed request for use of non-reimbursed treatment at clinics without an institutional review board (IRB) by revising ‘Standard and Procedure of Requesting Usage Approval of Non-reimbursed Off-label Drug’ this month. HIRA stated it would consider providing healthcare reimbursement benefit in the future, when the legitimately used off-label drugs meet clinical efficacy and cost-efficiency standards. ◆Expanding RSA for follow-on drugs: As the RSA subject regulation for severe disease has been revised in last July, HIRA plans to positively review feasibility of expanding RSA subject for follow-on drugs after collecting public opinions. ◆Preventing illegal drug distribution: HIRA has decided to upgrade monitoring system to better manage all drug distribution information and to utilize the collected information properly through the serialization system. HIRA currently requires a serial number to be labeled on minimal drug distribution unit container for the health authority to track individual unit in all phase of distribution, from manufacturing to import, distribution, and consumption. In last May, HIRA cooperated with Seoul city community police to investigate illegal distribution of a weight-loss medicine Saxenda injection. ◆Drug pricing standard for the revised Generic Pricing Policy: The latest revision in the Generic Drug Pricing Policy stipulates drug pricing differentiated with compensation for cost, time and investment spent on generic development, and revised weighted pricing system. Nonetheless, the pricing standard for incrementally modified new drug is same as before. As the new weighted pricing policy could bring down prices of some incrementally modified drugs (IMD), HIRA plans to adequately amend the standard with Ministry of Health and Welfare. HIRA official said, “IMDs are mostly developed by Korean pharmaceutical companies, so drug pricing benefit without limitation on IMD could cause international trade discrepancy as unfairly favorable benefit for Korean companies only”, but “the agency would continue to talk to other related ministries and industry about other means to promote development of IMD with better clinical efficacy”. ◆Revising PE analysis review process: In Australia and Canada, a company is responsible for submitting pharmaco-economic analysis and a public agency is responsible for reviewing the submitted material. But in Korea, pharmaceutical companies have difficulties editing submitted PE analysis report. Lawmakers claimed Korea should adopt ‘Application Registration System’ to prevent such inconvenience. HIRA official answered, “it would be reviewed in detail, surveying overseas cases and current conditions in Korea”.
- Policy
- Jext, only distributed to KOEDC for profits
- by Lee, Jeong-Hwan
- The company that exclusively deals with one of urgent drugs, Jext used for allergic reaction Shock (Anaphylaxis) was criticized for distributing drugs only through KOEDC( Korea orphan & Essential Drug Centers ) for profit. Even though Jext was listed insurance registration last July and it is possible for the company to make direct distribution, The price between general reimbursement and KOEDC reimbursement has big difference. So, Jext distributed only to KOEDC. According to the patients and KOEDC on the 11th, Jext has been distributed and sold patients only through KOEDC since domestic reimbursement listed. It is in patients and KOEDC view that KOEDC reimbursement is much higher than general reimbursement, and it makes economic burden to patients. The company says it is not for profit at all. The headquarters regulates the distribution of general reimbursement items, so the company is inevitably unable to distribute the supply. In fact, KOEDC reimbursement price of Jext is ₩134,933 more than double the general reimbursement price is ₩56,670. The company distributes Jext only through KOEDC until insurance registration listed. But it is still on sale only through KOEDC, even though Jext got general reimbursement listed and can be distributed at clinics or retail pharmacies. The reimbursement price of KOEDC is calculated based on the import cost, whereas the general reimbursement price is meticulously formulated through registraion procedure of Health Insurance Review & Assessment Services. It is the majority opinion of reimbursement specialists that it is much more profitable to sell at KOEDC than to distribute Jext at the general imbursement. Furthermore, the distribution of Jext through KOEDC significantly reduces additional marketing and management tasks such as account management costs required for direct distribution. That's one of the reasons why the direct distribution is delayed. However, if the distributor don't handle the medicine reimbursement listed directly for 6 months, the regulatory action is removed. It even raises doubts that the company deliberately distributes Jext only to KOEDC. Regardless of the company's intentions, as a result, patients need to get Jext ony by paying more expensive money through KOEDC because thiere is no distribution volume, even though there is a way to purchase Jext at significantly lower reimbursement. KOEDC official said, the prodcut is not in shortage of distribution, but the the company distributes medicines only to KOEDC and dose not supply them directly. It's reluctant. In the end, patients have to go and buy through KOEDC with higher price for almost 6 months even after reimbursement listed, there has never been a company using this trick so far. The deliberate coordination disregards the purpose of establishing KOEDC and the policy of expanding access to ER medicines for patients. In response to such criticism, the company said that it is not a distribution control for profitability, and will start direct distribution as soon as possible. The company official said, It was true that Jext was distributed only to KOEDC after July when reimbursement listed, but it was not intended. It was a supply disruption at the headquarters in preparation for improved Korean insert, etc. The official added, "The company will import Jext products within this month and supply them directly from next January after our own quality inspection".
