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- 2026-04-04 13:41:29
- Policy
- Reimb discussions restart for BMS’s Camzyos in KOR
- by Lee, Tak-Sun Oct 25, 2024 05:48am
- The National Health Insurance Service was found to have restarted reimbursement discussions for the obstructive hypertrophic cardiomyopathy treatment Camzyos (mavacamten, BMS). BMS and the NHIS entered into drug price negotiations for Camzyos in August but failed to reach an agreement within the 60-day deadline. However, the deadline has been extended, and it is expected that the company may be able to list the drug for reimbursement as early as next month. In particular, there are opinions that the criticisms made during the NA audit may have accelerated the drug’s reimbursement discussions. Lorviqua, whose reimbursement progress was also criticized during the NA Audit, may likely skip the Drug Reimbursement Evaluation Committee review and re-enter into negotiations with the NHIS. According to industry sources on the 24th, during the NA Health and Welfare Committee’s Audit that ended on the 23rd, Democratic Party of Korea Rep. Hee-Seung Park inquired about the Camzyos’s reimbursement progress and requested its prompt reimbursement. Camzyos’s reimbursement has been in the drug price negotiation stage since early August. The deadline for negotiations was 60 days, so an agreement was supposed to be reached in early October. In response to Park's inquiry, the NHISon explained, “Based on DREC’s review results, we are in the process of negotiating with the company to set an appropriate drug price and expected claims amounts, and signing the risk-sharing agreement. However, during the current negotiation process, the pharmaceutical company requested a pause in the negotiation as it needed time to submit additional data, upon which the NHIS accepted the request and extended the negotiation deadline.” In other words, the period needed to submit the additional data was excluded from the negotiation period, which was why the deadline was extended. “In order to ensure access to new drugs for the active treatment of cardiomyopathy patients while minimizing the financial burden, we plan to closely review the financial impact data such as patient size and market share submitted by pharmaceutical companies and clinical literature to reflect the financial impact and clinical value of the drug under negotiation,” said the NHIS. Camzyos had been the focus of recent media coverage, as well as the NA audit, to ensure expedited access for the patients. As a result, payers are also reportedly considering expediting its reimbursement. As such, negotiations have resumed, raising the possibility of the drug being listed as early as next month. However, time is running out to finalize and report the negotiation results to the Health Insurance Policy Review Committee meeting that will be held next week. If not next month, there is still a good chance of reimbursement by December. Also, industry eyes are on whether Lorviqua (lorlatinib, Pfizer), which had failed negotiations with them in June, will enter into negotiations again. Lorviqua is a treatment for ALK (anaplastic lymphoma kinase)-positive NSCLC that was in the process of extending its reimbursement to first-line treatment. Initially, the company submitted an application to extend the drug’s reimbursement standards as an Expenditure Cap type RSA, but after negotiations broke down, the company reapplied for the drug’s reimbursement through the general listing pathway. According to the regular procedure, the drug must be first reviewed by HIRA’s Drug Reimbursement Evaluation Committee to start negotiations with the NHIS, but as it is a special case where the drug is switching its status from RSA to general listing, there is a high possibility that the government will simplify the procedure. during the NA Audit on the 16th of this month, Dong-Kyu Lee, Director General of MOHW’s Bureau of Health Insurance Policy, said, “We are currently in negotiations with the pharmaceutical company,’ and showed a proactive stance, saying, “We will complete negotiation as soon as possible for the benefit of the patients.’ As a result, the industry expects Lorviqua’s reimbursement agenda may skip the DREC stage and restart negotiations with the NHIS.
- Policy
- MFDS says 'no procedural issues' regarding 'Leqembi'
- by Lee, Hye-Kyung Oct 24, 2024 05:52am
- Product photo of Leqembi. The Ministry of Food and Drug Safety (MFDS) stated that there was no procedural issue during the approval of 'Leqembi (lecanemab),' a dementia treatment, that omitted the review by the Central Pharmaceutical Affairs Advisory Committee (hereafter referred to as the "Advisory Committee"). Out of 33 active ingredients of new drugs that received domestic approval since 2023, only 6 active ingredients were reviewed by the Advisory Committee. The final approval of Leqembi was based on its effects, treatment options, and monitoring plans. In answering the questions from media reporters on October 22nd, the MFDS stated that regarding the procedural issue of Leqembi approval, "The specialists in the MFDS had reviewed thoroughly based on science-based expert analysis." The MFDS explained that they had made a comprehensive assessment. In particular, the drug demonstrated a reduction in cognitive impairment (27%) in patients with mild Alzheimer's disease and the potential to provide new treatment option by targeting the removal of the significant cause of the disease (amyloid beta), unlike conventional drugs. Additionally, the drug's company established a stringent monitoring method (such as MRI monitoring) to follow ARIA, a potential side effect of treatment. Leqembi's ARIA has been identified as cerebral edema and microhemorrhage confirmed by MRI imaging test. Also, the MFDS emphasized that they could seek consultation from the Advisory Committee when they decide outside consultation is needed, but it is not a mandatory procedure during the approval process. During the National Assembly's parliamentary audit of the Health and Welfare Committee, held on October 10th, Rep. Jeon Jin-sook, a member of the Democratic Party of Korea, questioned the approval process of a new dementia drug that received a recommendation for non-approval from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) due to side effects. "Although it is a new drug, approval has been granted without seeking expert opinion," Rep. Jeon said. "In the United States, this drug was approved with the required warning label statement in the prescribing information after the FDA's advisory committee meeting. Europe postponed approval," Rep. Jeon explained. In answering this question, the MFDS said, "The Pharmaceutical Affairs Act guides that the Advisory Committee shall be established to respond to inquiries from the Minister of the MFDS, but it does not mandate the Advisory Committee's review." They explained, "We request consultation from the Advisory Committee when we decide outside consultation is necessary, such as making conditional approval (requiring submission of Phase 3 clinical trial data) or marketing authorization·review." The MFDS further added that as part of Leqembi's risk-assessment plan, they will conduct a post-marketing survey (patient registration research, 6 years) and thoroughly monitor the occurrence of ARIA in Korean patients. "In the approval detail, we required management of ARIA by checking ARIA occurrences by MRI testing before and during the drug administration and suspending administration based on disease severity," the MFDS said. "Since ARIA tends to occur in the early course of treatment, we required testing before 1st, 5th, 7th, and 14th drug administration, and the administration will be suspended when the disease severity is found as moderate to severe during the testing." Meanwhile, Leqembi is intravenously administered in a sing-dose every two weeks. It is a new drug known to delay the cognitive impairment due to Alzheimer's disease by 27%. The drug eliminates 'amyloid beta' aggregates, abnormal protein in neurons, and amyloid fibrils.
- Company
- Biktarvy’s indication expanded to patients 6yrs and older
- by Whang, byung-woo Oct 24, 2024 05:52am
- Pic of Biktarvy The indication for the HIV-1 treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) has been expanded to include children and adolescents aged 6 years and older. Gilead Sciences Korea announced on the 23rd that its Biktarvy has been approved by the Ministry of Food and Drug Safety for the treatment of HIV-1 infection in children or adolescents 6 years of age and older. The approval allows Biktarvy’s use in adults and pediatric patients aged 6 years and older weighing 25 kg or more who are antiretroviral treatment-naïve or who have achieved stable viral suppression (HIV-1 RNA
- Company
- Reimb of the dyslipidemia drug Leqvio at a halt?
- by Eo, Yun-Ho Oct 24, 2024 05:52am
- The dyslipidemia drug that received industry attention as a first-in-class siRNA drug is facing difficulties in obtaining insurance reimbursement coverage in Korea. According to Dailpharm’s coverage, Novartis Korea's Leqvio (inclisiran) applied for new drug reimbursement after receiving approval from the Ministry of Food and Drug Safety in June, but during the Health Insurance Review and Assessment’s review process, the company and the government, especially the medical community and the government, were found to have major differences in opinion in setting the reimbursement standards. The government is considering reimbursing the drug for the rare disease, familial hypercholesterolemia, not for the treatment of dyslipidemia, the main indication. This is similar to when the PCSK9 inhibitor Repatha (evolocumab) was initially listed. Furthermore, as Leqvio’s competitor Repatha, which is in the same therapeutic position, is already being reimbursed, it is possible that the government feels delaying Leqvio’s reimbursement as long as possible would not pose a problem. However, it is worth noting that this does not take into account the fact that Leqvio is administered by a healthcare provider in a hospital just twice a year. This will improve adherence, not just because of the reduced number of doses, but because it is administered by a healthcare professional in a hospital rather than by self-injection. In fact, 78.4% of patients in the study population, including those with ASCVD who received Leqvio for up to 6.8 years or more, achieved their target LDL-C levels. In the US real-world study, patients with ASCVD, including myocardial infarction, who were fully adherent had a 27% lower risk of major adverse cardiovascular events (MACE) compared to those who were not fully adherent. In addition, the fully adherent group had lower annual healthcare costs than the less adherent group, confirming that high adherence not only reduces the risk of recurrent cardiovascular events but also the economic burden of ASCVD patients. Cardiovascular disease accounts for 18% of all deaths in Korea. Over the past decade, this rate has been rising steadily, and the incidence of cardiovascular disease has recently spread to affect younger people. In a market that amounts to KRW 1 trillion for statin and ezetimibe combination drugs alone, it is estimated that the financial expenditure being spent on LDL-C lowering alone would be between KRW 1.5 trillion to KRW 2 trillion in Korea if we add the financial expenditure for statins and pcsk9 inhibitors. However, the LDL-C target achievement rate for ASCVD patients in Korea is a mere 24%. At the policy session of the Korean Society of Cardiology's Fall Meeting that was held on the 18th, Jang-hwan Bae, Chief of Good Samsun Hospital, mentioned Leqvio while pointing out the issue of restricting the reimbursement standards for new drugs, “Leqvio, which is approved in Korea as a bi-annual treatment, is currently being discussed for reimbursement, but just for familial hypercholesterolemia.” Meanwhile, Repatha is reimbursed in 41 countries, including major countries, and Leqvio is reimbursed in 39 countries.
- Policy
- 'Preferential drug pricing for K-made new drugs' revision
- by Lee, Jeong-Hwan Oct 24, 2024 05:52am
- Rep. Baek Jong-heon It was pointed out that upon receiving criticism that the recently announced amendment plan for drug pricing system lacked provision to provide preferential drug pricing for new drugs made by Korean pharmaceutical companies, the Ministry of Health and Welfare (MOHW) posted an administrative notice detailing amendment to be made for 'Pharmaceutical Approval and Adjustment Criteria.' Previously, the amendment plan had been criticized for making a reverse discrimination against Korean pharmaceutical companies. According to the MOHW's notice, the amendment plan included implementing a 68% drug pricing increase applied to national essential medicines for up to 10 years (5+5 years), preferential drug pricing of new drugs manufactured by pharmaceutical companies with significant R&D contribution, and a double pricing system to support exports. On October 23rd, Rep. Baek Jong-heon, a member of the People Power Party, stated that during the parliamentary audit held on October 8th, he raised an issue with the Health Insurance Review and Assessment Service (HIRA)'s amendment plan for the pharmaceutical pricing system. The criticism concerned that the amendment plan excluded the core clause to benefit Korean pharmaceutical companies. Baek emphasized that the amendment plan could reverse discrimination against Korean pharmaceutical companies because most of the revision details for the drug pricing system favored multinational companies. In response to this criticism, the MOHW's Pharmaceutical Benefits division proceeded with revising the drug pricing system, aiming to reflect the new drug's innovative value and public health security. They have notified an administrative action for 'Pharmaceutical Approval and Adjustment Criteria.' MOHW's plan will be officially announced in 2025 after being reviewed by the Ministry of Government Legislation and evaluated by the Regulatory Reform Committee. Earilier, Baek questioned Cho Kyoo-hong, Minister of Health and Welfare, about the rationale for excluding a measure that provides practical benefits to Korean pharmaceutical companies from the revised plan, despite Korean pharmaceutical companies requesting improvements to the current policy related to new drug development and exports. "As part of the 120th national agenda, the Yoon Suk Yeol government has decided to foster bio-health business as the core export business, aiming to leap as a leading global country in the bio·digital health field," Baek said. "However, the MOHW announced the revised plan without considering practical supporting measures." "MOHW's role is to lead the growth and development of the Korean biopharmaceutical industry and enhance international competitiveness, thereby contributing to the nation's health and welfare improvement," Beak emphasized.
- Policy
- Will non-face-to-face prescriptions of Wegovy be banned?
- by Lee, Jeong-Hwan Oct 24, 2024 05:51am
- Yu-Kyoung Oh, Minister of the Ministry of Food and Drug Safety, said the ministry will discuss the issue of Wegovy, a new obesity drug, being prescribed through non-face-to-face treatment with the Ministry of Health and Welfare. The MOHW Minister Kyoo-hong Cho also responded that he would actively engage in Oh's request for discussions. On the 23rd, Rep. Joo Young Lee, a lawmaker from the Reform Party, asked Oh about the misuse of obesity drugs through non-face-to-face prescriptions. Rep Lee said, ‘The anticipated concerns regarding obesity treatment have become a reality. After the release of Wegovy on the 15th, in addition to the illegal sales and advertisements of the drug online, but also the issue of the drug being prescribed through non-face-to-face treatment platforms even if they are normal or underweight arose. The MFDS’s promotion is not enough, and I believe it is necessary to make it institutionally difficult to make the inappropriate access itself.” “There is a precedent of post-partum contraceptives being excluded from the list of possible prescriptions from non-face-to-face treatment platforms,” said Lee, adding, “Obesity management should start with lifestyle improvement. Adding Wegovy prescriptions to the list of allowed non-face-to-face prescription servrequiresquire more sensitivity and expertise. Bad practices such as using them in smaller doses are arising. Is there a countermeasure?” Oh replied that the ministry would seek measures to address the misuse of Wegovy and limit non-face-to-face treatment prescriptions. “The purchase of Wegovy online is a problem, and the cyber investigation team has been intensively monitoring this for a month,’ Oh said, adding, ’Overseas direct sales are also a concern due to poor temperature control. Since yesterday, we have been cooperating with the Korea Customs Service to block overseas direct sales and purchases of Wegovy.’ “Non-face-to-face treatment prescriptions are also a problem. We sent a letter asking them to refrain from excessively advertising the prescription of obesity drugs,” said Oh, adding, ’We will discuss whether to include prescriptions for non-face-to-face treatment (such as Wigobi) as it is the responsibility of the Ministry of Welfare.’ Minister Cho Kyu-hong also briefly responded to Oh's comment, saying that the MOHW would “cooperate.”
- Policy
- Overseas direct purchases of GLP-1 obesity drugs banned
- by Lee, Hye-Kyung Oct 23, 2024 05:50am
- The government has begun blocking direct purchases of GLP-1 obesity drugs overseas in the wake of the ‘Wegovy’ craze. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) and Korea Customs Service (Comissioner: Kwanghyo Ko) announced on the 22nd that they would block the direct purchase of recently launched GLP-1-based obesity drugs via overseas online platforms and bringing them into Korea. They also said they are actively cracking down on illegal sales and advertisements online and via social media. The MFDS has asked major online shopping malls to set ‘Wegovy,’ ‘Saxenda,’ ‘diet pills,’ and ‘slimming pills’ as prohibited words and requested their cooperation in self-monitoring and regulating the illegal imports. GLP-1-class obesity drugs such as Wegovy must be administered following a doctor’s prescription at a hospital and dispensing and medication guidance of a pharmacist at a pharmacy, according to the set dosage and administration method. If purchased directly from overseas, it is difficult to check the authenticity of the drug due to unclear manufacturing and distribution routes, and if it is an illegal counterfeit product, its safety cannot be guaranteed as it may contain harmful ingredients and is dangerous due to the possibility of misuse. The Ministry of Food and Drug Safety has requested major online shopping malls to prohibit the sales of obesity treatment drugs and conduct self-monitoring and requested the Korea Communications Commission to block access to posts on social media and online shopping malls that illegally promote or advertise sales of such drugs. Since Wegovy was released on the 15th to the 21st of this month, 12 violative posts were detected and taken action against. The Ministry of Food and Drug Safety and the Korea Customs Service will continue to share relevant information to prevent consumer damage caused by illegal direct purchases and advertisement of obesity treatment drugs overseas. They also warned that the obesity drugs sold on online platforms should never be purchased or administered and that they will do their best to strengthen the monitoring system for illegal sales and bait advertising in the future for the safe use of drugs by people in Korea.
- Company
- Moderna’s keyword for post-COVID vaccination is ‘RWE’
- by Whang, byung-woo Oct 23, 2024 05:50am
- With the COVID-19 pandemic transitioning to the post-COVID-19 era, Moderna is putting forward ‘real-world evidence (RWE)’ as the keyword for its vaccines. As the seasonal vaccination of COVID-19 vaccines has become the norm, the company has been promoting the accumulated effectiveness and safety of its vaccines. (from the left) Jae-Kap Lee, Professor of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital, Piyali Mukherjee, Executive Vice President, Medical Affairs, Moderna Asia Pacific Since the pandemic, the Korea Disease Control and Prevention Agency (KDCA) has designated COVID-19 as an infectious disease that requires annual vaccination along with influenza (flu). As a result, this year, as in previous years, the KDCA is recommending people aged 65 and older, who are at higher risk of both COVID-19 and influenza, receive both vaccines at the same time. However, there is still a lack of awareness of the disease compared to the flu. According to a survey of 1,003 adults in Korea, only 14.5% of the respondents perceived COVID-19 vaccination as important to protect their health, which is over 3 times lower than the 54.2% for the flu. COVID-19 awareness lower than flu, emphasizing the need for vaccination At a conference hosted by Moderna Korea on the 22nd, Jae-Kap Lee, Professor of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital, emphasized the lingering dangers of COVID-19. “COVID-19 is a dangerous disease that causes higher hospitalization and mortality rates than influenza due to the constant rise of new variants,” said Professor Lee. “Among elderly patients, hospitalization rates for COVID-19 were 5 times higher than influenza, and in-hospital mortality rates were 3 times higher for COVID-19 than influenza among those with underlying medical conditions.’ Given this, Lee believes high-risk groups, including those aged 65 and older, should be vaccinated against COVID-19 alongside the flu to protect them from health deterioration and disease burden. Moderna is supplying the COVID-19 vaccine, ‘Spikevax JN,’ in line with the government's 2024-2025 seasonal vaccination plan, which began on the 11th of this month. Jae-Kap Lee, Professor of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital In Korea, there are currently 7.55 million doses of COVID-19 vaccine available in the country for this season, including 5.23 million doses of Pfizer, 2 million doses of Moderna, and 320,000 doses of Novavax vaccines. With multiple COVID-19 vaccine options, Moderna emphasized the accumulation of real-world experience (RWE) as its vaccine’s strength. ‘With more than 1 billion doses of Moderna's COVID-19 vaccine supplied, its RWE continues to confirm its effectiveness and safety. In a real-world study evaluating its COVID-19 prevention effect, the Moderna vaccine booster arm reduced hospitalization rates by 89%,’ said Piyali Mukherjee, Executive Vice President, Medical Affairs, Moderna Asia Pacific. She added, “Moderna’s Spikevax is available in single-dose vials to help both healthcare providers and patients in the country, increasing the likelihood of required dose administration and reducing the chance of contamination. Moderna's vaccine is the only mRNA vaccine manufactured in Korea in partnership with Samsung Biologics.” Most importantly, Vice President Mukherjee said, Moderna's vaccine has proven its value in the current situation where concurrent vaccination for COVID-19 and flu is recommended. “In a Phase III study evaluating the combination of a quadrivalent influenza vaccine and Moderna's COVID-19 vaccine, the combination resulted in a high immune response and a tolerable safety profile.” ‘Flu+COVID-19’ combo vaccine is on the horizon...domestic clinical trials to start next March Another hot topic related to COVID-19 vaccination at the event was the rise of a ‘combo vaccine’ that protects against both flu and COVID-19. Moderna has completed clinical trials on the combo vaccine and plans to submit data to regulatory authorities in Europe and the United States, which is expected to be a game changer in the future. In Korea, the company plans to start enrolling patients for a bridging trial in March next year. “The combo vaccine will first be approved abroad, and patient enrolment in Korea will start in March next year. We expect discussions on approval will take place after 2-3 years of clinical trials,” said Professor Lee. “Many companies are conducting clinical trials on mechanisms that prevent both COVID-19 and influenza at the same time with interest.” While cost remains an issue in the long term, there is no doubt that a combo vaccine that protects against both COVID-19 and flu would be a game-changer, said Lee. “Currently, two doses are administered separately, but the combo vaccine is only one dose. When you look at the cases of children, the market share changes when the combo vaccine comes out,’ he said, adding, ’If the price of the combo vaccine becomes affordable for the government to supply, I don't think there will be much of a problem with its marketability.”
- Policy
- New drug expenditure is 13.5% of NHI finance's drug spending
- by Whang, byung-woo Oct 23, 2024 05:49am
- It was found that the total expenditure on new drugs listed in the past six years since the Positive List System policy was implemented amounted to 13.5% of the National Health Insurance pharmaceutical spending, which is the lowest compared to the averages of A8 countries and OECD countries. The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced the research outcome of 'Analysis of pharmaceutical spending on new drugs by disease,' conducted by Seung-Rae Yu, a Professor at Dongduk Women's University's College of Pharmacy, on October 22nd. The research evaluated new drugs listed from 2007 to 2022 when the Positive List System policy was implemented to allocate financial resources to drugs. The document compared the performance to 25 OECD countries besides South Korea. The research aimed to set the analysis period to the past 6 years (2017-2022) and to investigate financial analysis reflecting the outcome of the government's policy implementation to strengthen patient access to new drugs. It researched disease types contributing to patient deaths and compared domestic and overseas new drug expenditures in diseases with the highest financial burden, by analyzing pharmaceutical costs by disease. The percentage of new drug expenditures in South Korea (red), OECD countries (green), and A8 countries (blue). The percentage of new drug expenditure in South Korea Based on the research, the percentage of new drug expenditure in South Korea's total pharmaceutical cost amounted to 13.5%, which was below half of those in A8 countries, 38.0% on average, and in OECD countries, 33.9% on average. The analysis suggests that the figure would be the lowest among 26 countries. The analysis of the trend in the percentage of new drug expenditure from 2017 to 2022 indicates that the differences between Korea and the average for A8 countries grew significantly, amounting to almost a threefold difference in 2022. In particular, the total expenditure on new drugs was merely 15-25% of those in A8 countries, including the U.K., France, Italy, and Canada, which are similar in population and GDP per capita. The research analyzed the financial cost of disease by comparing a weighted index of disease·injury·risk factor, including death·disorder, by country, and new drug expenditure through the analysis of pharmaceutical cost by disease. The percentage of expenditure on new drugs for treating tumors was 46.2% for South Korea, not significantly different from 54.4% in the OECD on average. However, the percentage of expenditure on new drugs for treating cardiovascular diseases was 20.2% for the OECD on average and 2.4% for South Korea. Furthermore, the neurological disease category was 30.1% and 4%, respectively. The respiratory system category was 43% and 6.7%, respectively. They showed that Korea's percentages were merely 1/10th of the OECD countries' average, indicating relatively poor patient access to treatments. In other words, Korea showed significantly lower expenditures in the top-costing disease category, including the cardiovascular system, neurological system, and respiratory system, compared to those of the OECD and A8 countries. The analysis of the trend in the percentage of new drug expenditures in South Korea (red) and the average for A8 countries (blue). The research pointed out that despite a continuous increase in National Health Insurance reimbursement in the past, reimbursement for severe·high cost diseases started to decrease since 2022. The expenditure index of the number of new drugs and pharmaceutical cost by reimbursement category shows that the number of new drugs listed under the economic evaluation exemption program or essential program amounts to merely 11.6% and 3.6%, respectively. These drugs are needed to enhance patient access to severe disease treatments. The percentages of these drugs in the total pharmaceutical cost were 0.6% and 0.3%, which is relatively low. Additionally, the percentage of new drugs listed after undergoing economic evaluation out of the total number of listed new drugs was 26.8%. Excluding drugs in the antitumor category, it is merely 14.5%, indicating that the percentage of listed new drugs that are found to have values for improving clinical effectiveness is relatively small. "After implementing the Positive List System policy, the percentage of pharmaceutical cost in the total medical cost was aimed at about 24%, and it has been maintained. However, it seems that setting the new drug expenditure in the total pharmaceutical cost lacked specific aim and direction," said Yu. "From a financial viewpoint, we need to consider differences in the percentage of new drugs in Korea to other major countries and set the priority to strengthen reimbursement of treatments, including reimbursement of innovative new drugs, for diseases with high cost." "The percentage of new drugs in National Health Insurance-supported pharmaceutical cost is significantly lower than those of overseas, indicating that Korean patients are not fully benefiting from new drug treatments," Lee Young-shin, vice chairman of the KRPIA, said. "The system may need improvements, including the economic evaluation and expanding economic evaluation exemption and risk sharing agreement system, to enhance patient access to innovative new drugs and to allow them to have a better lifestyle."
- Product
- Stockpiled COVID-19 drugs soon to expire in KOR
- by Kim JiEun Oct 23, 2024 05:49am
- A corona drug that caused a crisis due to its shortage has become a nuisance, an inventory glut, in just 3-4 months. In August, the government additionally distributed large quantities of the treatments, but the number of confirmed COVID-19 cases plummeted. The expiry date of the supply is approaching, raising the possibility of mass discarding of the high-priced drugs. As of the 23rd, the drug distribution industry and pharmacies are closely monitoring the change in the supply of COVID-19 drugs such as Paxlovid Tab and Veklury Inj, as these will be reimbursed through national health insurance from the 25th. It has been confirmed that there are still some stocks of Paxlovid and Lagevrio that were supplied to pharmacies by the government in late August. The issue is that the expiry date of the government’s additional supply is nearing. The extra supply was provided via an emergency purchase by the government and is due to expire in January next year. This means that the stockpiles of COVID-19 drugs in COVID-19 dedicated pharmacies have less than 3 months left. In some pharmacy communities, pharmacy-to-pharmacy exchanges are being attempted, but there is currently no demand. “The demand was so high that the dedicated pharmacies had taken as much extra supply as they could, which coincidentally coincided with the drop in confirmed COVID-19 cases, which has left them with excess stock,” said a local pharmacist. “I think it's safe to say that there has been virtually no prescribing since September. We've had very little response to posts on our local dedicated pharmacy group chat for pharmacies in need of stock.” The pharmacist added, ”‘The extra supplies have a short expiration date, set to expire in less than two to three months, so if the outbreak doesn't resurface in November or December, the expiration date of the drugs will either have to be extended or be discarded.” The distribution industry believes that despite the change in the supply system from government supply to commercial distribution upon reimbursement of COVID-19 drugs with national health insurance finances, it would not be easy to commercially distribute the drug immediately. This is because the government is reportedly aiming to first exhaust the existing supply from the market. A pharmaceutical wholesaler said, “There is no set date for the commercial distribution of COVID-19 drugs. Drug distributors are also checking with interest due to their reimbursement listing, but I heard that the KDCA recently requested pharmaceutical companies to delay the release of the general distribution as much as possible. I know that there is a lot of stock left in existing pharmacies, so using it up first is being discussed. The current stock on the market has an expiration date of only about 3 months, which is why the government has decided to use it up first.” The wholesaler added, “I believe the drugs for commercial distribution will be released when the current stock is exhausted. When I asked the pharmaceutical company, they said that the timing is not clear and that they need to see the trend, such as whether the existing stock is exhausted. We can't rule out the possibility of the existing stock being mixed up with the commercially distributed items.”
