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- 2026-04-09 09:45:00
- Policy
- Bioequivalence reevals speed up in line with drug price reev
- by Lee, Hye-Kyung Sep 21, 2023 05:24am
- With the number of items requiring equivalence tests expanded as such, the Ministry of Food and Drug Safety is also accelerating the reevaluation of those that were previously approved. In particular, it is said that the review is being further accelerated this year as its timing overlaps with the reevaluation of the insurance price ceiling amount, which requires self-bioequivalence tests. So-Hee Kim, Director of the Bioequivalence Evaluation Division at the Ministry of Food and Drug Safety's National Institute of Food and Drug Safety Evaluation, said so at a press briefing it had held together with the Drug Evaluation Department. Director Kim explained, "The initial results of the Ministry of Health and Welfare's 'insurance price ceiling reevaluations (standard requirements)' have come out, and pharmaceutical companies are showing mixed responses based on their results. At the time of the drug pricing reevaluations that were conducted, the MFDS reviewed the equivalence reevaluation of many items in a short period of time, and have completed the first review and are reviewing the data again,” The MFDS has expanded the scope of equivalence reevaluations to include all prescription drug generics, starting with oral tablets (uncoated tablets) this year, tablets (film-coated tablets) in 2024, and capsules, granules, and syrups in 2025. For the equivalence reevaluation, subject companies would have to submit a bioequivalence testing result or plan by March of every year. If the companies find it difficult to submit the test result report by then, they may first submit a plan, and submit the results by December after completing the test according to plan. The reevaluation results will be released around February of the following year. The problem was the drug price reevaluations that took place this year. Generic drugs subject to drug price reevaluations had to satisfy both requirements - conducting bioequivalence tests and using registered raw drug substances - to receive the highest insurance price. For items that are subject to both equivalence reevaluations and drug price reevaluations, it was difficult for the companies to submit a notice of completion of their bioequivalence tests in accordance with the drug pricing reevaluation schedule under the Ministry of Food and Drug Safety’s plan. Kim explained, “ The MFDS also had to conduct many equivalence reevaluations in a short period to meet the pricing reevaluation schedule. The review of the items subject to drug price re-evaluation has been completed, and we are now reviewing the remaining equivalence re-evaluation data.” For companies to receive the highest price, the MFDS had to submit a notice of completion of the equivalence reevaluation review to HIRA within the drug pricing reevaluation period, which forced the MFDS to also accelerate its review. Kim said, “Pharmaceutical companies have been expressing difficulties. We have been guiding ways to resolve their issues to help them follow the government’s policies.” (from the left) Sang-Ae Park, Director of the Advanced Drug Quality Division, Mi-Jung Kim, Director of the Pharmaceutical Standardization Division, Young-Rim Kim, Director-General of the Drug Evaluation Department, Ho-Jung Oh, Director of the Oncology and Antimicrobial Products Division, So-Hee Kim, Director of the Pharmaceutical Standardization Division Regarding the need to engage in continuous communication with the pharmaceutical industry to respond to various issues including the recent reevaluations, Young-Rim Kim, Director-General of the Drug Evaluation Department, explained the plan. Director-General Kim said, "Last March, we launched CHORUS (CHannel On RegUlatory Submission & Review) to discover two-way agendas between the industry and the MFDS industry, and we are forming and have been operating five branches to allow various companies to cooperate with working-level members that directly carry out the actual work.” He added that CHORUS plans to announce the performance of each branch this year and establish a plan for next year at the H2 CHORUS workshop. In addition to related associations and industry meetings, it plans to strengthen communication with companies that directly meet reviewers. Director-General Kim said, “We have procedures in place so that companies can officially request a supplementary meeting or in-person consultation when applying for marketing authorizations. The temporary restrictions made on phone consultations for relevant departments due to COVID-19 have been lifted. Now, companies can call for consultation without any time limit.” However, as only 124 review personnel are available in the Institute which needs 135, the institute lacks the manpower to address the absolute number of civil complaints. For example, the U.S. FDA has 8,000 review personnel. Director-General Kim said, “We will take the domestic pharmaceutical industry environment into consideration, adjust the timing, and approach it step by step to ensure that the policy is well established and implemented, and we will fully listen to the industry’s opinions during the process.”
- Policy
- Pseudoephedrine price negotiations have been concluded
- by Lee, Tak-Sun Sep 21, 2023 05:24am
- Quick agreement reached after a week of negotiations, likely to be implemented in October It appears that the single agent for colds, Pseudoephedrine, will be subject to increased drug prices starting in October. There is news that drug price adjustment negotiations with the NHIS, which have been ongoing since last week, have been concluded. Attention is being paid to whether this drug price increase will increase the supply of products from pharmaceutical companies and alleviate supply and demand difficulties. According to the industry on the 19th, the corporation and pharmaceutical companies agreed to increase the price of 60mg of single drug Pseudoephedrine HCl. It is said that negotiations were concluded around 30 won, an increase from the current 23 won. Pseudoephedrine HCl 60mg products are sold as Cosue by Kolon, Schdafen by Sam-A, Sudafed by Samil, and Pseudoephedrine by Shinil. Among these, Pseudoephedrine is worth 20 won, and the rest are worth 23 won. This ingredient has been in short supply since last year. This is because, as the number of respiratory patients as well as COVID-19 increases, prescriptions for medications containing Pseudoephedrine, which are used for colds, sinusitis, and upper respiratory allergies, have increased. Accordingly, pharmacies have requested increased supply. Last May, the Pharmaceutical Association supplied one bottle of 500 tablets to each pharmacy to solve the supply shortage. Supply shortages continued, and recently, the ‘Public-Private Response Consultative Group on Instability in Pharmaceutical Supply and Demand’ composed of the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the Pharmaceutical Association, the Pharmaceutical and Biopharmaceutical Association, and the Pharmaceutical Distribution Association decided to push for an increase in drug prices. After the drug price increase agenda passed the HIRA on the 6th, the NHIS began drug price negotiations last week and announced a settlement within a week. Accordingly, the agenda for increasing the price of pseudoephedrine will be reported to the Health Policy Review Committee of the Ministry of Health and Welfare, which will be held soon, and the adjusted drug price is expected to be applied from October 1. The NHIS appears to have received confirmation from pharmaceutical companies regarding drug price increases as well as supply expansion. Accordingly, it is expected that the problem of a supply shortage of Pseudoephedrine single drugs will be resolved.
- Policy
- ‘Introduce a Korean Cancer Moonshot Plan for patients'
- by Lee, Jeong-Hwan Sep 21, 2023 05:24am
- It has been pointed out that Korea also needs a policy that can improve the quality of life of cancer patients by providing reasonable compensation for cancer treatment technologies such as robot-assisted surgery and advanced radiation therapy to improve the quality of life of cancer patients in Korea, like in the case of the U.S. Cancer Moonshot Initiative or the EU’s Beating Cancer Plan. On the 20th, the AI law, regulation, and policy platform CODIT’s (Jeong Ji-eun Chung) Global Policy Empirical Research Institute pointed out in an issue paper called 'Implications of the development of advanced cancer treatment technology - Focusing on improving the quality of life of cancer patients.’.' According to the issue paper, countries around the world have been making national efforts with the explicit goal of improving the quality of life of cancer patients and their families, with plans such as U.S. President Biden's 'Cancer Moonshot Initiative' and the EU's ‘Beating Cancer Plan.’ On the other hand, the paper criticized that in Korea, improving the quality of life of cancer patients is being pushed back from the priority list of health authorities due to frequent transfers of officials from the relevant ministries and seasonal changes in national health issues. The issue paper introduced examples of advanced treatment technologies that have a significant impact on improving the quality of life of cancer patients and emphasized the need for the government to contemplate on an institutional level on improving the quality of life of cancer patients. The paper pointed to robot-assisted surgery reducing bleeding and complications by enabling sophisticated surgery based on hand tremor correction, wide joint range of motion, and delicate joint movements, as well as advanced radiation that maximizes effectiveness through customized radiation therapy using artificial intelligence (AI) as examples. Such advanced treatment technology can greatly contribute to improving the quality of life of patients during the treatment process by increasing the likelihood of their successful return to society after surgery. However, in the current healthcare system, it is not easy for people to receive the benefits of advanced treatment technologies due to cost issues, and the paper stressed that the government needs to actively make considerations on that aspect. In addition, the issue paper emphasized that the government needs to improve social and emotional awareness to prevent having been or being a cancer patient or from acting as an invisible stigma in this society, which is ranked among the Top 10 in regards to its economic achievement in the world, while at the same time actively improving healthcare policies to build a healthcare system that allows patients to enjoy a better quality of life physically.
- Opinion
- [Reporter’s View] Biobetters to prosper with better prices
- by Eo, Yun-Ho Sep 21, 2023 05:23am
- A series of cases where preferential pricing has been applied to biobetter drugs are being introduced to Korea. In 2016, the government announced a plan to provide preferential pricing for biosimilars and biobetters, which are improved versions of already approved biopharmaceuticals, that have contributed to the improvement of Korea’s healthcare. Considering how biobetters are more difficult to develop compared to incrementally modified drugs (chemical drugs), the government decided to set the overall price of biobetters at the 100-120% range of the original drug. However, no drug had reaped the benefit until recently. And then in September, Sanofi-Aventis Korea’s Nexviazyme (avalglucosidase alfa-ngpt) made the start. Nexviazyme is an improved biological drug that offers improved dosing and administration compared to Myozyme (alglucosidase alfa), a recombinant human acid alpha-glucosidase (rhGAA), that is developed by the same company, Sanofi. The drug has increased the amount of M6P, which plays an important role in the intracellular uptake of drugs, by about 15-fold compared to Myozyme through the glycol-engineering technology. Nexviazyme’s increased M6P increases drug uptake over Myozyme and GAA activity to enable more effective glycogenolysis and less damage to muscle cells. Also, the increase in surface M6P contributes to improved immunogenicity, providing benefits in terms of safety. And another drug is soon to be added to the list. The second to benefit is expected to be Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab), which combines the company’s ‘Perjeta’ and ‘Herceptin.’ The drug passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review last month. If listed, Phesgo will become the first anticancer drug and the second drug to benefit from the biobetter preferential treatment plan. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named as the first biobetter approved for cancer in Korea. Metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. Also, as Phesgo is a subcutaneous formulation injected in the thigh rather than into the veins, it can reduce blood vessel and nerve damage that can be caused by repeated intravenous injections. Biobetters are much more difficult to develop than IMDs. It mainly offers improved convenience over the existing original drugs, but the improvement in convenience of injectable drugs has a greater impact on patients compared to orally administered synthetic drugs. Although the first case had been implemented so late, it is encouraging that more cases are starting to emerge. In addition, domestic companies are also developing biobetters. As the likelihood of success is higher for biobetters than new drugs, we expect more to benefit in the future. Amid the many imminent patent expiries of blockbuster drugs, this is now the time for companies to take the opportunity.
- Policy
- Generics for Janumet competition begins in earnest in Oct.
- by Lee, Tak-Sun Sep 21, 2023 05:23am
- MSD DPP-4 inhibitory diabetes treatment The diabetes treatment market is expected to remain active in October. This is because salt-modifying complex drugs that were not registered in September are hitting the market all at once. According to the industry on the 20th, generics of MSD's DPP-4 inhibitory diabetes combination drug 'Janumet and Janumet XR' will be listed in large numbers next month. These are salt-modifying drugs, and due to the calculation criteria, they were not released when the patent expired on September 2nd. This is because salt-modified complex drugs can only be calculated if a single salt-modified drug with the same ingredient is registered first. Sitagliptin hydrochloride hydrate complex drugs are scheduled to be registered in October. On the 2nd of this month, 134 single products were registered. There are 304 combination drugs on the approved list that combine Sitagliptin HCl and Metformin. If there are no production issues, most of these are expected to be registered in October. A combination drug combining Sitagliptin phosphate and Metformin is expected to be released in October. Accordingly, the follow-up drugs of Janumet and Janumet XR are expected to enter into full-scale competition starting in October. Looking at last year's outpatient prescriptions based on UBIST, Januvia's single drug was 40.5 billion won, Janumet and Janumet XR combination drugs were 68.9 billion won and 48.2 billion won, respectively, totaling 117.1 billion won, forming a much larger market than single drugs. The key appears to be the speed with which Hanmi Pharmaceutical and Chong Kun Dang can dominate the market. Both companies were the only ones to list Janumet and Janumet XR generics on September 2nd. This was possible because only both companies obtained generic for exclusivity as a generic with the same ingredient. The entry speed of other generics is expected to be determined by how well the two companies with large sales forces dominate the market within a month. An official in the pharmaceutical industry said, "In the Janumet and Janumet XR generics market, only Hanmi and Chong Kun Dang had the opportunity to dominate the market due to the salary standards, and other generic companies entered the market a month late." He explained, “The key for other generic companies is how much of the overall market share the two companies that released a month early have taken.”
- Opinion
- [Reporter’s View] Industry suffers from ‘Re-eval Neurosis'
- by Kim, Jin-Gu Sep 20, 2023 05:36am
- The era of reevaluations has dawned on Korea. Reevaluation of reimbursement adequacy, clinical reevaluations, and generic drug pricing reevaluations are being carried out simultaneously. The Ministry of Health and Welfare and its affiliated organizations appear to be scrambling to reevaluate and reduce drug pricing expenditures as if they have received orders from somewhere. The reevaluation of the reimbursement adequacy began with choline alfoscerate preparations in 2020, and then reviewed 4 ingredients including silymarin and avocado-soya in 2021, then 7 ingredients including streptokinase in 2022, and then 8 ingredients including hyaluronic acid eye drops, and rebamipide this year. In addition, the reimbursement adequacy of 7 ingredients, including sarpogrelate and mosapride will be reevaluated next year. At the same time, the Ministry of Food and Drug Safety is conducting its clinical reevaluations. Clinical safety and efficacy reevaluation of choline alfoscerate, acetyl L-carnitine, oxiracetam, streptokinase, and streptodornase has been conducted or is in progress. Not long ago, reevaluations on the reimbursement ceiling price of drugs, also known as the reevaluation of generic drug prices, had been carried out. This reevaluation was conducted to apply the new drug pricing system implemented in July 2020 to already listed generics. More than 20,000 items were subject to reevaluation. As a result, as of the 5th of this month, the prices of 7,355 generic drugs were reduced by up to 28%. Due to so many items being reevaluated at the same time, much confusion has been occurring in the field. The biggest problem pointed out was the redundancy of reevaluation targets. Choline alfoscerate, streptokinase, streptodornase, acetyl L-carnitine, and oxiracetam were selected simultaneously as subjects for clinical reevaluation and the reevaluation of reimbursement adequacy. As a result, acetyl L-carnitine and oxiracetam were withdrawn from the market after failing to prove clinical utility and were naturally excluded from receiving reevaluation on their reimbursement adequacy. In the case of streptokinase, some indications that failed to prove clinical usefulness were removed, and there is a high possibility that the remaining indications will also be deleted following the other reevaluations. Employees in charge of related affairs express extreme fatigue caused by the excessive and redundant reevaluations. Although the government claims that the legal basis and purpose of each reassessment are clearly different, the pharmaceutical industry's criticism is that there is no significant difference in the methods each uses to select subject drugs, assess the adequacy of reimbursement, and prove clinical usefulness. In addition, the officials had to painstakingly reevaluate the prices of 20,000 generic drugs. Even though these drugs were legally approved and listed for reimbursement, the pharmaceutical industry had no choice but to conduct bioequivalence tests for the sole purpose of maintaining drug prices. Even though the generic drug pricing re-evaluation is not complete, pharmaceutical industry officials say they have no time to rest. This is because a bigger wave of ‘overseas drug price comparison reevaluation’ is expected to land soon. The MOHW had announced that it will conduct a reevaluation and compare the price of listed drugs with their overseas prices next year. The MOHW plans to finalize the reevaluation criteria within the year, report it to the Health Insurance Policy Deliberation Committee, and implement it in earnest next year. This means that next year, in addition to the ongoing reimbursement adequacy reevaluations and clinical reevaluations, a reevaluation for comparison with overseas drug prices will also be carried out simultaneously. In particular, anxiety appears to be rising as the scope and range of drug price cuts are expected to be larger than that made by the existing reevaluations. In addition to anxiety, uncertainty is also rising due to repeated reevaluations every year and the various accompanying measures that follow. But above all, constant reevaluations are serving as the largest barrier. Complaints are rising constantly on how so many reevaluations are taking place simultaneously. The data that must be submitted amounts to hundreds or thousands of pages. Some have been cynically joking that a department dedicated to reevaluation should be established. And so it seems fair to say that the pharmaceutical industry is indeed suffering from reevaluation neurosis.
- Policy
- High-priced drugs need adjustment from the approval stage
- by Lee, Tak-Sun Sep 20, 2023 05:36am
- He also explained that he would conduct a pilot project to curb multi-drug prescriptions to reduce usage. Chairman Jeong made this announcement at a press conference for a health magazine held at a restaurant in Gwanghwamun, Seoul on the 15th. He said, “It is true that as income increases, prescriptions switch to more expensive drugs even if they have similar efficacy.” He said, “Moreover, doctors prefer original drugs with extensive research rather than generic drugs that have only received BA evaluation.” He said, "The authorities are continuing to set prices for generic drugs and are using a savings policy of refunding half of the money after verifying the efficacy of expensive drugs for a year, but I personally believe that the trend of rising drug prices is inevitable." Accordingly, as a policy to suppress drug prices, he emphasized that adjustments must be made from the start of approval. Chairman Jeong explained, “In the past, there were many high blood pressure medicines priced at 5 won, but now the old, cheap medicines that are no longer used are naturally being eliminated, and their place is being filled by expensive medicines.” He emphasized, “Therefore, there must be coordination from the start of approval with the Ministry of Food and Drug Safety and HIRA.” This was also said to be the reason for participating in the HIRA Pharmaceutical Reimbursement Evaluation Committee. Chairman Jeong said, "If NHIS participates in the drug evaluation committee, the listing period can be shortened through prompt negotiations linked to evaluation, and insurance finances can be reduced by preemptively reviewing the financial impact." He added, "Patient groups also believe that NHIS is for this reason. “I understand that they expressed the opinion that there is a need to participate in the committee,” he explained. “Although NHIS did not participate in this 9th committee, we will continue to discuss this issue with HIRA and the Ministry of Health and Welfare for the benefit of the public,” he said. “We will strengthen the public’s access to medicines through smooth communication and mutual cooperation, including data sharing with related organizations.” “We will strive to manage drug costs more efficiently,” he emphasized. Chairman Jeong emphasized that he will make various efforts to ensure the sustainability of health insurance and that he will pay particular attention to encouraging appropriate treatment. He said, "The Ministry of Health and Welfare, NHIS, and HIRA will cooperate to reduce medical expenses by establishing 'standard treatment guidelines' to prevent citizens from receiving unnecessary excessive tests or treatment," and added, "In order to prevent leakage of health insurance funds, a special judicial police officer system will be introduced in NHIS." “We will strengthen the detection of illegally opened institutions.” In addition, in order to prevent foreign dependents from entering the country for medical purposes, the plan is to strengthen subscription criteria, such as stipulating a 'required period of stay (6 months)' for health insurance applications. Chairman Jeong emphasized, "We will fundamentally work to normalize the fee structure and establish a proper medical delivery system to address the shortage of doctors and improve the labor intensity of medical staff." Chairman Jeong was inaugurated as the 10th Chairman of NHIS last July. He graduated from Seoul National University and served as Chairman of the Academic Research Committee of Hallym University Medical Center, Director of Hallym University Sacred Heart Hospital, and Director of Hallym University Medical Center. He also served as Director of the Korea Centers for Disease Control and Prevention. In this administration, he served as the head of the COVID-19 Special Response Team and contributed to the transition to routine management of COVID-19.
- Policy
- The NHIS begins negotiations to increase the size of PSE
- by Lee, Tak-Sun Sep 20, 2023 05:36am
- The NHIS has started negotiations to adjust the drug price increase for the ingredient formulation of the nose cold medicine Pseudoephedrine (PSE), which is struggling with supply and demand. The deadline for this negotiation is 60 days, but it is said to be targeting an agreement this month. If this month's negotiations are signed, it is highly likely that the drug prices raised from next month will be applied. According to the NHIS and the industry on the 18th, the NHIS has been negotiating a drug price adjustment with manufacturers of 60 mg of Pseudoephedrine HCl since last week. This ingredient was recognized for the validity of the adjustment of the drug price increase by the Pharmaceutical Benefits Evaluation Committee of the HIRA held on the 6th. Soon after that, the Ministry of Health and Welfare reportedly issued a negotiating order. The deadline for negotiations is 60 days. However, the government aims to speed up adjustment negotiations like acetaminophen, which was a drug price increase last year. The Acetaminophen adjustment negotiations were completed in about 20 days. If this month's negotiations is completed as targeted and a resolution from the Ministry of Health Insurance Policy Review Committee at the end of the month is received, the adjusted drug price will be applied from the 1st of next month. Currently, manufacturers are said to want to double the current drug price. Currently, the upper limit is 20 won for one item, and the remaining 3 items are all 23 won. Kolon , Sam-A , Samil, and Shinil are selling it. The key to negotiating speed is a cost analysis. It is analyzed that if the two opinions differ in the cost analysis, the negotiation is likely to be longer. Pharmaceutical companies are reportedly doing a cost analysis using the cost of production opportunities early in the negotiations. However, the NHIS is of the opinion that cost analysis should be done through more practical data. Pseudoephedrine HCl formulation has been a supply problem since last year due to COVID-19. Therefore, in May, the Pharmaceutical Society also provided an equal supply of one bottle per pharmacy to solve the supply and demand instability. The industry argues that a drug price increase is essential for additional production power.
- Company
- A new drug for optic shylomyelitis is necessary
- by Eo, Yun-Ho Sep 20, 2023 05:35am
- Professor Kim, Ji-eun Off labels refer to the act of prescribing a medicine for an indication other than a use approved by the Ministry of Food and Drug Safety. In general, the use of the drug has been determined by the health authorities, and the question may arise as to why it is necessary. However, there is an area of disease where this Off label prescription is covered by insurance benefits. It is NMOSD. Currently, the immunosuppressant Azathioprine is used for primary maintenance treatment for optic vesical schomyelitis, and Mycophenolate or Mapthera are prescribed as the second treatment after the failure of Azachioprine treatment. Mycophenolate and Rituximab Offlabel drugs that do not have indications for optic nerve lingualism. The cause is simple.These drugs did not formally obtain indications through clinical studies of optic severe, but were confirmed to be effective through presumed efficacy and long-term accumulated prescription experience. However, there is a more bizarre situation in the area of optic sever. Immediately through phase 3 clinical trials, its effectiveness is confirmed, and officially approved new drugs are not eligible. Dailypharm met with Kim Ji-eun, the insurance director of the Korean Neurological Society (Professor of Neurology at Eo University Seoul Hospital), and heard about the current treatment environment of optic scurveitis and the need for new drugs. The drug used in the treatment of the optic sbellomyelitis category is known as an off label drug. I wonder if there are any side effects to the use of these drugs, and what their characteristics are. Of course, it must be the necessary medicines. However, as it is not a drug that has been proven to be effective and safe in the disease based on systematic clinical research, there are concerns in terms of side effects and effects. In particular, there are many reports that the primary treatment, Azathioprine, is low compared to other drugs, along with the risk of side effects such as bone marrow suppression, elevated liver levels, and increased cancer incidence during long-term use. In fact, about 50% of patients who used Azathioprine stopped treatment due to side effects within 18 months of treatment, of which 15% were due to lack of effects such as recurrence, and 62% were due to side effects of the drug. When following the current domestic benefit standards, Rituximab is used as a tertiary drug if there is a recurrence in the primary and secondary drugs. In the case of Rituximab, it is off label, but compared to other drugs, it has a better recurrence effect, and it is excellent in terms of effectiveness and safety, so in some patients with severe severity, it is increasingly skipping the first and second drug and administering it right away. In some countries abroad, Rituximab can be used as a primary treatment. The effect of Rituximab is not bad, but do we still need a new drug? It's excellent compared to existing drugs. There are patients who still have a relapse even after using Rituximab, so a new drug is needed for them. It is reported that about 10% of patients experience recurrence even after using Rituximab and as the accessibility of new drugs is reduced, these patients have no choice but to maintain their existing treatment even after recurrence. New drugs include monoclonal antibodies that directly act on the main inflammatory immune response targets of optic spondylomyelitis pathology, such as Soliris, Enspring and Uprizuna. Some of them are currently in the process of applying their benefit. Eculizumab is a prote suppressant, and Enspryngg is an interleukin-6 resuppressant with other mechanisms, so that patients who have recurrent in existing drugs can have the opportunity for treatment without being marginalized. In particular, these new drugs are very effective against conventional drugs, and in the case of ekulizumab, it has been found to reduce the risk of recurrence by 94%. - Among the drugs to be said, Soliris and Enspryngg are going through the process. However, there is a disagreement between the pharmaceutical company and the government over the standard, so I know it is not easy to discuss. After prescribing all the drugs that can be used now, it is the direction to recognize the benefit only at the back end (4th or more). The desperate thing for the medical staff is to first offer a new treatment option to patients who don't have a treatment option, and then the best treatment option to prevent irreversible recurrence. However, new drugs are somewhat expensive, and considering the social costs, I think that even patients who have failed to treat ritukshimab need urgent benefits. -As the drug price is high and the non-reimbursed status continues, the expiration date of the drug's PMS is getting closer. If the PMS is not completed under the regulations, the permit will be withdrawn. These new drugs are not enough to come in or not to come in. It was a disease that had not been diagnosed before, but it became possible to diagnose it through anti-quaporin-4 antibody tests, etc., and treatment that can reduce the disorder through drugs became possible. I hope that access to drugs will improve as soon as possible so that patients in need can receive treatment. Have you ever given an opinion to the government at the society level? The conference has also submitted several submissions of opinions on new drugs so that alternative options can be quickly arranged, and it continues to be of interest. I hope the benefit will be made quickly so that even a small number of patients can provide treatment options to those who really need it. Also, the disease itself has a very big impact on the patient's life. In addition, we hope that various new drugs targeting various mechanisms will be available in clinical practice as soon as possible so that an environment where customized treatment can be created for patients can be created.
- Policy
- Reimbursement imminent for some anticancer drugs in KOR
- by Lee, Tak-Sun Sep 20, 2023 05:35am
- Jeperli Inj (dostarlimab, GSK) and Braftovi Cap 75mg (encorafenib, Ono), which passed the Drug Reimbursement Evaluation Committee meeting last month, are currently in drug price negotiations with the National Health Insurance Service. According to industry sources on the 19th, the National Health Insurance Service recently updated the list of drugs receiving new drug pricing negotiations. According to the update, the drugs currently subject to negotiation are the asthma antibody treatment Cinqair Inj (Teva), Braftovi Cap 75mg, and Jeperli Inj. On the other hand, ‘Evrysdi Dry Syrup (risdiplam, Roche)', a spinal muscular atrophy (SMA) treatment that had been under negotiation for some time, was removed from the list after its company and the NHIS reached an agreement. Drug pricing negotiations with the NHIS are usually conducted for 60 days. Braftovi and Jemperli were deemed adequate for reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Review Committee held on the 3rd of last month and entered the price negotiation stage with the NHIS thereafter. Braftovi is an anticancer drug used for metastatic colorectal cancer with a confirmed BRAF V600E mutation and is used in combination with Erbitux (cetuximab). In the Phase III BEACON CRC, the Braftovi+cetuximab combination demonstrated a statistically significant overall survival (OS) improvement to the irinotecan+ cetuximab combination (HR 0.60, p=0.0003). Median OS was 8.4 months for Braftovi and 5.4 months for the control group. Jemperli is used to treat mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer. It is the third PD-1 inhibitor to be approved in Korea, following Opdivo (nivolumab, Ono·BMS), and Keytruda (pembrolizumab, MSD). However, among these immuno-oncology drugs, Jemperli is the first to be approved for endometrial cancer and is expected to greatly benefit patients in Korea. Jemperli’s approval was based on the cohort A1 analysis results of the Phase I multicohort GARNET trial. As a result of analyzing a total of 108 patients for a median follow-up period of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile, and the ORR of the Jemperli group was 43.5%
