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- 2025-12-21 23:26:11
- Policy
- Will there be progress in introducing a checkup for Hep C?
- by Jung, Sae-Im Feb 20, 2023 05:52am
- Attention is focusing on whether the introduction of national screening for hepatitis C, which has been idle for eight years, will be able to make progress this year. At APASL 2023, which was held in Taipei, Taiwan for five days from the 15th, in-depth discussions were held on preparing national policies to combat hepatitis C. The forum examined the situation in Korea, where hepatitis C was still not included in the national examination. The WHO declared the eradication of hepatitis C by 2030 and called for international efforts. As hepatitis C has opened the era of cure due to the development of treatments, the most important goal is to find patients who have not been diagnosed. Several countries around the world, including Germany, Japan, and Taiwan, are reducing the number of patients through active diagnosis and treatment, including hepatitis C, in national checkups. Discussions on hepatitis C, which began in 2016, are still "in progress." Although cost-effectiveness has been consistently proven through feasibility studies and pilot projects centered on the Korean Liver Association, the government has not responded positively. Korean health officials who attended the forum made an optimistic prediction that "If positive results are obtained from this year's expert review, hepatitis C could be included in the national examination as early as next year." Kwak Jin, head of the infectious disease management department of the Korea Centers for Disease Control and Prevention, said, "The first expert review conducted in 2018 judged that there was not enough evidence to meet the qualifications for national screening." "If we pass the review successfully, we predict that national screening of hepatitis C could be possible next year or the year after next," he said. He also suggested other aspects to consider to combat hepatitis C. This means that a system from diagnosis to treatment and management, such as post-diagnosis treatment and high-risk group management, should be established organically. Manager Kwak said, "If a public or private examination confirms the infection, a system should be established that can be performed as treatment." It is also important to establish management and screening systems for high-risk groups of infection, such as correctional facility inmates, refugees, and injection drug users, and to establish a comprehensive public-private cooperation system including the hepatitis Policy Advisory Committee. Park Ji-min, a health promotion officer at the Ministry of Health and Welfare, said, "Since the Korean government is well aware of the importance of eradicating hepatitis C, two large-scale pilot studies have been conducted. However, Park took a cautious stance, saying, "Korea has a national health examination system, which is a program for all Korean citizens, and the inclusion of hepatitis C in the national examination has a great impact. Therefore, the careful and conservative application is needed according to the principles mentioned by Kwak." This is seen as a remark in consideration of whether it is right to include hepatitis C, which has a domestic prevalence of only 0.8%, in the screening system for all citizens. The prevalence of hepatitis C, which has met cost-effectiveness through various pilot projects, has been mentioned as the reason for failing to enter the national examination. The Korean Liver Association has reaffirmed the validity of the hepatitis C screening test through further research. According to the report on the study's final results on the feasibility analysis of hepatitis C screening and follow-up management of screening among the national health screening items released by the Korea Centers for Disease Control and Prevention, hepatitis C met all five conditions for introducing national screening items. The five conditions will be important health problems, diseases that can be detected and treated early, acceptable to the screening method, more profitable than loss, and effective against cost. The report relates to prevalence. In 2020, medical expenses due to hepatitis and related diseases were confirmed to be 11.5% of the total annual medical expenses," it stressed. At the forum, domestic specialists reiterated the need to introduce a rapid national screening of hepatitis C. Jang Jae-young, a professor of gastroenterology at Soonchunhyang University Seoul Hospital, said, "As a result of the study, the incidence of major liver diseases was significantly reduced when all people aged 40 to 65 were examined for hepatitis C through national checkups and was cost-effective at all ages. In particular, screening in the 60s is the most cost-effective, and when conducting hepatitis C screening tests at the age of 56 to 65, the savings have been greater than the input cost since 12 years ago. After 20 years, 20 billion won can be saved, and 30 billion won can be saved after 30 years."
- Policy
- Skyrizi benefit will be expanded from next month
- by Lee, Jeong-Hwan Feb 17, 2023 05:50am
- Expanded standards for oral hepatitis B drugs. From March 1, the scope of recognition of drug care benefits by Skyrizi PFS is expected to expand from existing psoriasis to active and progressive psoriatic arthritis. Reva-K and Reba-eye 2% are listed as new benefits, and medical benefits are recognized when administered to "improve corneal epithelial disorders in adult ocular anterior patients." The criteria for recognition of medical care benefits for oral chronic hepatitis B treatment will also be expanded compared to the previous one. The phrase of the Argatroban component injection is changed so that the detailed recognition criteria for medical care benefits are administered within the scope of permits for each drug. The hemostatic oxidative regenerative cellulose benefit item is changed from Equtamp to Surgicel. On the 15th, the Ministry of Health and Welfare will announce the administrative notice of "partial revision of the criteria and methods for applying for medical care benefits" and conduct a related opinion inquiry until the 24th. First, the standard of the AbbVie interleukin (IL)-23 inhibitor Skyrizi PFS will be expanded. Skyrizi, which is an indication of plate psoriasis and psoriatic arthritis, is currently only reimbursed for psoriasis. The Ministry of Health and Welfare adds 'active and progressive psoriatic arthritis' to the Skyrizi standard. Skyrich will also be added to the replacement pay standard for Tremfya, Taltz PFS, Cosentyx, and Stelara. 2% Reva-K and Reba-ye, are newly registered and a new standard will be established. Nursing benefits are recognized if administered within the scope of the permit, "Improvement of corneal epithelial disorders in adult dry eye patients." However, benefits are not recognized when administered in combination with mucin secretion promoters such as Diquasol Eye drops. Oral chronic hepatitis B drugs expand the liver enzyme (AST/ALT) numerical standard that recognizes drug benefits. The HBV-DNA numerical standard, which recognizes benefits even in chronic hepatitis B patients accompanied by targeted cirrhosis, is expanded. Specifically, "Patients with 40-80 units of AST or ALT and showing stages of liver biopsy or fibrosis of illiterate periphery" will be added to the initial treatment benefit standard. Patients with chronic active hepatitis B with cirrhosis and hepatocellular carcinoma are recognized for benefits if they are HBV-DNA positive. The standard item of Agastroban injection, an antithrombotic component used to treat chronic arterial obstruction, will be revised from "Argaron Inj" to "Argaron Inj, etc." Considering that each drug has different permits, the statement of the administration discussion will be changed within the scope of each drug. The standard item for hemostatic oxidatively regenerated cellulose is changed from Equtamp to Surgicel. This is to make it current as an item on the list of drug benefits.
- Policy
- NHIS President “will improve the PVA system"
- by Lee, Tak-Sun Feb 17, 2023 05:49am
- NHIS President Do-Tae Kang is explaining NHIS Do-Tae Kang, President of the National Health Insurance Service expressed plans to continue managing pharmaceutical expenditures by preparing a plan to improve the price-volume agreement (PVA) negotiation system within the year. Also, Kang added that the NHIS will be applying the refund type of the performance-based risk-sharing agreement (RSA) system that was applied to Kymriah and Zolgensma to high-priced drugs that cost over KRW 300 million and reduce the reimbursement negotiation period for new anticancer or severe and rare disease drugs. At a new year’s roundtable meeting with industry journalists that was held at a Korean-Chinese restaurant in Mapo-gu on the 16th, Kang explained that he would promote such policies this year as part of HIRA’s plan to manage drug expenditures. Kang said, “Our research service results showed that the PVA system has produced great outcomes in reducing NHIS’s drug expenditures and had a positive impact from a social and industrial aspect. Based on the results, we will work with pharmaceutical companies and the working group to prepare improvement plans to continue managing pharmaceutical expenditures this year by adjusting the maximum discount rate, improving the negotiation reference formula, and deriving a plan to expand the exclusion criteria, etc.” The refund type of the performance-based RSA system is expected to be mainly used as a measure to manage high-priced new drugs. Kang said, “Drug expenditures have been soaring every year in line with the rising social demand for high-priced new drugs. However, the mechanism for predicting and controlling drug expenditures is yet inadequate. We plan to apply the ‘expenditure cap type’ and ‘performance-based refund type’ RSA to new drugs with high prices that were recently developed and have unverified treatment efficacy and cost-effectiveness to consider both the accessibility to essential drugs and fiscal health of Korea’s national health insurance.” He added, “We introduced a ‘performance-based refund type’ of RSA where pharmaceutical companies bear a portion of the expenditures according to treatment performance to reimburse the ultra-high-priced drugs Kymriah and Zolgensma. This year, we plan to expand the performance-based refund type RSA to drugs that cost over KRW 300 million and shorten the negotiation period for anticancer drugs or new severe or rare disease drugs for prompt listing.” The NHIS also plans to prepare a plan to improve the fee negotiation system and find the right balance between the parties. Kang said, “Despite the difficult economic situation, Korea’s national health insurance finances are expected to see a surplus for the second year in a row, therefore fee negotiations are expected to be quite difficult this year. While the subscribers are expected to request a minimum raise in fees, the suppliers are expected to demand a bigger raise in fees as a compensatory measure in consideration of the companies’ management difficulties." He added, “As NHIS is in charge of managing NHI finances, we will comprehensively consider the fiscal soundness, essential medical reinforcement policies, and the subscribers’ insurance premium level to find a reasonable balance between parties. Based on the results of the research service, we will conduct a multilateral analysis and discuss with the ‘system development consultative body' that subscribers and suppliers are involved in to prepare an agreeable model and apply it to fee negotiations." NHIS will also continue to manage chronic diseases and promote the big data business this year. Kang said, “We have been promoting a 'Pilot project on primary care for chronic disease', which provides annual care plans and services for patients with hypertension and diabetes in neighborhood clinics and have advanced the chronic disease management model by managing service quality and improving the project participation process. This year, we will consult with stakeholders and the government to reach an agreement on the appropriate fee level and copayment rate, conduct a pilot project, and then promote its conversion to a main project." Regarding the big data business, the NHIS has been providing customized health information for individuals on their health status and life cycle through mobile apps and will develop a new personal health record (PHR) service to promote public health and manage the disease with a ‘QR Electronic Prescription System’ among others in the future. Also, as a data integration institution, the NHIS will develop a guideline for the provision of combined data and expand the analysis center to promptly provide data necessary for drug development and research. Kang said, “The health insurance finances are being stably operated so far. We expect a current account surplus that exceeds what was made in 2021 to occur in 2022." “However, fiscal expenditures are continuing to increase due to the aging population and the introduction of new health technologies. Therefore, we will do our best to responsibly carry out key tasks by independently operating the 'fiscal consolidation promotion team,’ and find new tasks to pursue in line with the mid-term fiscal consolidation plan.” On this, the NHIS opened a ‘Proposal and report center to protect the fiscal soundness of NHI finances’ in December last year to reinforce the management of financial leakage factors by directly collecting public opinion. After the operation of the report center, reports were filed on illegal medical institutions and unfair claims, for which an investigation is underway. Lastly, regarding the embezzlement of its employee last year, “Many people must have been shocked and disappointed by the disreputable incident. The NHIS announced comprehensive measures last November to fundamentally prevent the recurrence of such events, and consulting with external specialized institutions is currently underway for a more professional inspection. After the consultations are complete, we will prepare improvement plans for each work type and implement them immediately.” He added, "In addition, we plan to support insurance premiums for the low-income and the vulnerable class whose insurance premiums are significantly less likely to be collected, by using donations voluntarily collected from NHIS executives and staff.”
- Policy
- Rebamipide eye drops will be reimb next month
- by Lee, Tak-Sun Feb 16, 2023 05:51am
- Mucosta ophathalmic solution (Rebamipide) being currently sold in Japan Whether the reimbursement of Samil Pharmaceutical and Kukje Pharma’s rebamipide eye drop solutions that were developed as a treatment for dry eye will reorganize the artificial tears market is gaining attention. In particular, with reimbursement reevaluations set to be conducted for hyaluronic acid eye drops that occupy the largest share of the artificial tears market this year, the possibility of changes made in the market share and rank has also been raised. On the 15th, the Ministry of Health and Welfare issued an administrative notice of an amendment to newly establish a reimbursement standard for Rebamifide 0.1/5ml. The drugs subject to the amendment are Samil Phamraceutical’s ‘Reva-K Eye Drops’ and Kukje Pharma’s ‘Reba-eye Eye Drops 2%.’ The Health Insurance Review and Assessment Service decided to approve the drugs for reimbursement within its approved indication, for the ‘improvement of corneal and conjunctival epithelial damage in adult patients with dry eye syndrome.’ However, its combined administration with mucin secretagogue (diquafosol sodium) will not be allowed reimbursement. The reimbursement will be add a rebamipide option to the dry eye treatment market. Rebamipide eye drops have already been released in Japan in 2012 by Otsuka Pharmaceutical as 'Mucosta ophthalmic suspension UD 2%', but Samil and Kukje’s products are the first to be introduced to Korea. Rebamipide is known to stabilize the tear film by increasing ocular mucin secretion and contribute to the improvement of corneal and conjunctival epithelial damage to improve dry eye symptoms. Samil and Kukje demonstrated the drug's improved outcomes through a clinical trial. In a clinical trial that was conducted on a total of 220 patients with dry eye symptoms (74 patients in the 2% Rebamipide ophthalmic suspension arm, 74 patients in the placebo arm), patients were administered the drug or placebo in each eye four times (every 4 hours). At week 12, outcomes in the 2% Rebamipide ophthalmic suspension arm were superior to the placebo arm. With the drug demonstrating an effect in improving dry eye syndrome when administered just 4 times a day, Rebamipide has been evaluated to have an improved convenience compared to existing artificial tear products that require administration 5-6 times per day. Reimbursed eye drop options currently in use for dry eye include hyaluronic acid, diquafosol sodium, and cyclosporine. Among the options, hyaluronic acid boasts the largest share in the market, which is estimated to bring in an annual sales of KRW 230 billion. These hyaluronic acid eye drops will be receiving reevaluation on their adequacy of reimbursement this year. According to HIRA, as of January 2022, reimbursement is being applied to 427 items from 51 companies, and the average annual claims amount of the drugs for the past three years was estimated to be around KRW 231.5 billion. Controversy over the reimbursement adequacy of hyaluronic acid eye drops, which were reimbursed since 1997, has been raised for some time. In 2000, the National Evidence-based healthcare Collaborating Agency (NECA) argued for the need to improve the reimbursement standards for dry eye, saying that it was too early to conclude that hyaluronic acid ophthalmic solutions are clinically significantly different from other treatment alternatives. Hyaluronic acid eye drops are currently used both for specialized and general drugs in Korea, however, most are used with a doctor's prescription, putting pressure on Korea’s national insurance finances. On the other hand reimbursement for hyaluronic acid is not applied in major developed countries and is only reimbursed in Japan. If the reevaluation concludes that hyaluronic acid eye drops are not eligible for reimbursement, the artificial tears market will inevitably be reorganized. The analysis is that the existing diquafosol sodium and cyclosporine products will reap reflective benefit, and the rebamipide eye drops that are reimbursed this time may also serve as an alternative. Recently, Daewoo Pharm is also known to be preparing a same-ingredient drug with Samil Pharmaceutical and Kukje Pharma for approval. An industry official said, “Rebamipide eye drops that will be reimbursed this time, developed by Samil and Kukje, have improved marketability. It offers an improvement in the irritability experienced using the original Japanese product. Therefore, I believe the products will settle as new options in the dry eye syndrome treatment market upon release.
- Policy
- Paxlovid's expiration date has been extended
- by Lee, Hye-Kyung Feb 14, 2023 05:48am
- While the expiration date of Pfizer's COVID-19 treatment Paxlovid has been changed from 12 months to 18 months, experts said that a six-month extension is reasonable for the volume purchased after approval. According to the minutes of the Central Pharmaceutical Review Committee recently released by the Ministry of Food and Drug Safety, there was a feasibility consultation on the extension of the validity of Paxlovid, and all members agreed to increase the validity of medical field distribution. At the meeting, the Korea Centers for Disease Control and Prevention explained that 1.7 million COVID-19 treatments were introduced as of the end of October last year, leaving 500,000 people in stock, of which Paxlovid accounts for 400,000 to 450,000. Based on the stability test data in December 2021, Paxlovid has been recognized for 18 months as a previous submission data in August last year after initial approval with a validity period of 12 months. However, if the expiration date of the emergency use approved product is extended, the product imported before the change approval is not retroactively applied, so Celltrion submitted additional data on the amount that was suitable for up to 12 months at the time of Paxlovid import. The Korea Centers for Disease Control and Prevention said, "The amount purchased after the approval of the change has an expiration date of 18 months, but the previous purchase is applied to 12 months, so we need a six-month extension," adding, "As of the end of October last year, 380,000 people need to be extended." Currently, about 4,000 pharmacies and medical institutions are storing Paxlovid in a packaged state by tablet, and the Korea Centers for Disease Control and Prevention said it has conducted a full document survey and on-site inspection of pharmacies to see if it is properly stored and managed. When asked by the committee whether it is possible to purchase a new product with an 18-month validity period instead of extending the validity period of Paxlovid, the Korea Centers for Disease Control and Prevention said, "It is important to prevent budget waste with expensive drugs. If there is no safety problem, we will reduce disposal." The Korea Centers for Disease Control and Prevention said, "If a re-test is necessary to extend the validity period, we will proceed with the test as much as possible," adding, "However, there is a concern that the test will take a lot of time and cannot be extended." In response, a member of the committee said, "The key is what data to replace the appropriateness of the storage of on-site supplies," and stressed, "There should be sufficient explanation for the public afterward." The Korea Centers for Disease Control and Prevention said, "If it is extended, we will check the storage condition again, and if the storage is appropriate, we will label the expiration date and check whether it is working." The Commission agreed that the validity period of medical field distribution can be extended by applying the requirements for detailed submissions under the Pharmaceutical Affairs Act to extend the validity period of crisis-responsive medical products.
- Policy
- MFDS prepares a cost-sharing plan
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- The Ministry of Food and Drug Safety plans to prepare measures to disperse risk responsibility in preparation for the occurrence of drug safety accidents such as unintentional impurity generation and mixed drugs. According to the 4th plan for drug safety management recently released by the Ministry of Food and Drug Safety, related industries such as pharmaceutical organizations and user organizations will be discussed to compensate for costs incurred in exchanging drugs. This is to come up with social sharing measures for costs incurred due to the exchange of drugs that are feared to be harmful as unintentional impurity accidents may continue to occur in the future following NDMA detection accidents such as Valsartan and Ranitidine. In 2021, according to the re-prescription, re-prescription, or exchange procedure prepared by the Ministry of Health and Welfare and related associations, the remaining amount of impurities produced by consumers can be re-prescribed, re-prescribed, or exchanged for normal products of the same drug at hospitals, clinics, and pharmacies. Hospitals and clinics have been charging pharmaceutical companies for the cost of re-prescribing and re-preparing impurities-producing drugs as normal manufactured products through the Korea Appraisal Board and the Health Insurance Corporation. However, 36 companies are responding to a lawsuit to confirm the absence of debt when the National Health Insurance Service requested 69 companies to make up 2.03 billion won for the loss of health insurance related to valsartan. At the time of the Valsartan impurity accident, the Pharmaceutical Affairs Act was revised, and after consultation between ministries through the Legislative Policy Council of the Ministry of Government Legislation, the Pharmaceutical Affairs Act was revised. Accordingly, the Ministry of Food and Drug Safety plans to provide legal grounds by reflecting on the discussions of the consultative body and the results of research services this year. When revising the Pharmaceutical Affairs Act, the goal is to prepare and revise sub-laws that set details such as applications for compensation for the operation of the Deliberation Committee for the calculation and collection of the cost compensation charges. The Ministry of Food and Drug Safety said, "We plan to establish a social safety net to protect public health and create a safe use environment for drugs by preparing measures to disperse risk in case of drug safety accidents such as unintentional impurity generation."
- Policy
- MenQuadfi has entered the licensing process
- by Lee, Hye-Kyung Feb 10, 2023 05:53am
- MenQuadfi, Sanofi Pasteur's tetravalent meningococcal vaccine, is expected to be released soon. According to the pharmaceutical industry on the 7th, Sanofi Pasteur completed receiving product licenses from the Ministry of Food and Drug Safety, including clinical trials of MenQuadfi, a vaccine for meningococcal (A, C, Y, W) to prevent invasive meningococcal infections in children and adults over the age of 2. MenQuadfi is designed to induce high immune responses for four serum groups across a wide range of ages from 2 to 56 and was FDA-approved as the first and only tetravalent meningococcal vaccine in the United States using tetanus toxoid as a protein carrier in April 2020. FDA approval was based on clinical data from five double-blind, random, multi-organ, phase 2, and phase 3 trials conducted on 5,000 children and adults over the age of 2. Tests have shown that MenQuadfi-induced immune responses are inferior to other approved tetravalent meningococcal vaccines. Four clinical trials were conducted on those who have not been vaccinated against the meningococcal vaccine and one on those who have been vaccinated against the meningococcal vaccine. In a study of those who have not been vaccinated against the meningococcal vaccine, most (55.4-97.2%) were confirmed to have an immune response after 30 days of vaccination.
- Policy
- Rosuvastatin 2.5mg/Ezetimibe, Hanmi from Daewoong,& Yuhan
- by Lee, Tak-Sun Feb 10, 2023 05:53am
- Rosuzet 10/2.5 mg (left) and Daewoong Crezet 10/2.5 mg (right)The combination market, which combines low-dose (2.5 mg) Rosuvastatin + Ezetimibe, is fluctuating with the addition of large pharmaceutical companies. Yuhan Corporation will also join the market, which Hanmi Pharmaceutical first entered at the end of 2021, following Daewoong Pharmaceutical. As the market size is not expected to be small, competition between the three pharmaceutical companies is expected to intensify. According to the industry on the 9th, Yuhan received a license for Rosuvastatin 2.5mg + Ezetimibe complex developed by its affiliate Addpharma and received a license for Rosuvamibe 10/2.5mg on the 7th. Earlier, the original developer Addpharma has also licensed for Addrose 10/2.5mg in December last year. However, it is said that this product has not yet been applied. Rosuvastatin + Ezetimibe complex has become a trend in the treatment market for dyslipidemia. It is characterized by the combination of statins and Ezetimibe to increase the therapeutic effect. However, there has been a steady demand for low capacity due to the burden of existing statins. The Rosuvastatin 2.5 mg + Ezetimibe complex has the advantage of reducing side effects of high-dose statins such as diabetes-induced and muscular dystrophy while having a similar effect to a single drug, high-dose Rosuvastatin. Accordingly, it is becoming a new prescription option for patients with low and moderate-risk groups and elderly patients. Hanmi Pharmaceutical pioneered the market by launching Rosuzet 10/2.5 for the first time in Korea in December 2021. This product is known to have shown a blockbuster aspect as its monthly prescription (based on Ubist) has recently risen to about 1.4 billion won. Daewoong Pharmaceutical then joined the market by releasing Crezet 10/2.5mg in November last year. There is little difference in the drug prices of the two products. Rosuzet 10/2.5 mg is 751 won and Crezet 10/2.5 mg is 750 won. It's only a one-won difference. Yuhan is expected to be on the payroll list in May with permission this time. As the three pharmaceutical companies have a high market share in the Rosuvastatin+Ezetimibe combination market, market reactions are expected to be high. Last year, Rosuzet recorded 140.3 billion won, Crezet 25.8 billion won, and Rosuvamibe 66.8 billion won in outpatient prescriptions. They are expected to implement a strategy to maximize sales through the Rosuvastatin+Ezetimibe. Meanwhile, in addition to these three companies, other pharmaceutical companies such as NVP Healthcare are also said to have jumped into the development of Rosuvastatin 2.5mg + Ezetimibe complex. It is also leading to the development of Atorvastatin low-dose + Ezetimibe complex.
- Policy
- MOHW opposes legislating premium pricing for KIPC drugs
- by Lee, Jeong-Hwan Feb 10, 2023 05:53am
- The Ministry of Health and Welfare virtually opposed the bill that legislates preferential treatment for drugs manufactured by accredited Korea Innovative Pharmaceutical Companies. The MOHW’s position is that drugs manufactured by Korea Innovative Pharmaceutical Companies already receive preferential treatment, such as premiums provided on insurance price ceilings as well as other support such as additional points for R&D, levy discounts, etc.” On the 9th, the MOHW submitted the opinion above regarding the bill for the ‘Partial Amendment of the Special Act to Foster and Support for the Pharmaceutical Industry’ that was submitted by NA Rep. Jung-sook Suh of the People Power Party. Suh’s bill contains a clause that changes the official name of the Pharmaceutical-Bio Industry Innovation Committee and upgrades its status, as well as a clause that obligates the provision of preferential treatment on drugs manufactured by Korea Innovative Pharmaceutical Companies. Pharmaceutical companies have shown interest in the bill as the bill seeks to obligate the existing arbitrary regulation on preferential treatments for drugs manufactured by Korea Innovative Pharmaceutical Companies, including those that provide premiums on price ceilings set for reimbursement, etc. The industry is also in favor of upgrading the status of the Pharmaceutical-Bio Industry Innovation Committee to an agency directly operated by the Prime Minister. However, the MOHW expressed caution in reviewing the two provisions. Although the ministry agreed on the need to systematically support and foster the pharmaceutical and bio-industry, it opposed the provision of preferential drug pricing. The MOHW said, “Drugs manufactured by Korea Innovative Pharmaceutical Companies are already receiving preferential treatment with premiums provided on the reimbursed price ceilings of their drugs. Also, additional points for R&D, and payment discounts are also provided as support." Regarding upgrading the status of the committee, the MOHW explained, “The government plans to discuss the establishment of a pan-ministerial governance body that not only covers the pharmaceutical industry but also medical devices and digital healthcare. During legislative discussions for that agenda, it will be necessary to review the scope of jurisdiction of each committee, as well as their function, system, and operation method.” However, the Health and Welfare Expert Committee deemed it necessary to revise the mandatory regulations on preferential drug prices for Korea Innovative Pharmaceutical Companies. Article 17-2 of the current Act that stipulates preferential treatment such as providing a premium to the ceiling price of reimbursed drugs was newly established in December 2018 and is an arbitrary rule that provides preferential treatment for drugs manufactured by Korea Innovative Pharmaceutical Companies. However, due to the lack of follow-up legislation, it has been criticized that no preferential treatment other than the price ceiling is being provided under the clause. In other words, the committee believes the optional regulation alone is not enough for the preferential system to be properly applied to drugs manufactured by Korea Innovative Pharmaceutical Companies. The Health and Welfare Expert Committee said, “Effective support measures for drugs manufactured by Korea Innovative Pharmaceutical Companies are needed to increase incentives to attract investment into R&D in the pharmaceutical industry. Therefore measure to provide preferential treatment to benefiting companies and drugs should be specified and stipulated as legislations through discussion with the public-private consultative body.”
- Policy
- Drugs subject to 2nd evaluations may submit data by Oct
- by Lee, Tak-Sun Feb 09, 2023 05:50am
- Drugs that were to receive the 2nd series of reevaluations by HIRA and were required to submit data by July will also be deemed to have met their requirements even if they exceed their submission deadline and submit the Ministry of Food and Drug Safety review completion notice by the end of the objection period. This will allow companies an additional 3 months of time, until October, to submit data. The measure has been made in consideration of the unavoidable circumstances, just as the first series of drugs that were subject to receive evaluations this year. According to the Health Insurance Review and Assessment Service on the 7th, oral and sterile preparations that were subject to receive evaluations in the second review were required to submit data by July 31 will be deemed to have satisfied their requirements if they submit their MFDS review completion notice within the objection period in consideration of the delay in MFDS review. A total of 5,905 oral and sterile preparations that were expanded and designated to conduct bioequivalence tests were set to receive the second set of evaluations. Some of the items have not even started bioequivalence tests , being unable to designate reference drugs. The authorities had previously announced that it will register priority review requests from drugs subject to receive the first set of evaluations and need to submit their data by February, and deem those companies that submit MFDS review completion notice within the objection period to have satisfied standard requirements. Therefore, relevant companies will first submit review requests to the MFDS by February, then submit their review completion notice by May. The data submission deadline had been extended in consideration of the COVID-19 situation, and HIRA explained that the same consideration will be provided to drugs subject to the second series of evaluations. Therefore, drugs subject to receive the second series of evaluations will be allowed to first submit review requests by July and submit the review completion notice by October to satisfy the standard requirements. HIRA believes that the 3-month addition to the deadline of the drugs subject to receive the second series of evaluations will allow drugs whose bioequivalence tests have been delayed due to reasons including non-announcement of reference drugs or difference in the sorbitol additive with its reference drug, to fully conduct reevaluations. A HIRA official explained, “Although discussions will still need to be made with the MFDS, we believe most drugs will be able to submit data within the evaluation period." Meanwhile, HIRA will hold a briefing session on its reevaluation of standard requirements on reimbursed ceiling price of listed drugs at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association office from 3:30 p.m. on the 10th and provide guidance on frequently asked questions in a Q&A format. Afterward, after collecting the opinions of the pharmaceutical industry on the series of evaluation subjects that will follow, the final list of drugs subject to evaluation will be released on HIRA’s webpage once again.
