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- 2026-03-11 21:57:55
- Policy
- Daewoong starts developing XR formulation of tofacitinib
- by Lee, Tak-Sun Nov 08, 2023 05:37am
- Pfizer Daewoong Pharmaceutical has begun developing a product that can rival Pfizer's oral JAK inhibitor 'Xeljanz XR 11mg'. Xeljanz XR (tofacitinib citrate) is Prizer's latest tofacitinib product approved in December 2020. Daewoong Pharmaceutical, like the original company Pfizer, is building a lineup of immediate-release and extended-release tablets before entering the tofacitinib generic drug market. On the 3rd, the Ministry of Food and Drug Safety approved the Phase 1 clinical trial plan for DWJ1431, for intake with and without food. DWJ1431 is known to contain 10mg of tofacitinib. The trial will focus on confirming DWJ1431’s pharmacokinetic properties and safety compared with tofacitinib 11mg. The reference drug, tofacitinib 11mg appears to be Pfizer's Xeljanz XR Tab 11mg. Pfizer received approval for the once-daily Xeljanz XR Tab 11mg on December 1, 2020. With its approval, the company secured various prescription options, in addition to the twice-daily Xeljanz 5mg Tab (approved in April 2014) and Xeljanz 10mg Tab (approved in December 2018). Xeljanz XR Tab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. In particular, its extended-release tablet is expected to play a major role in protecting the market from its generics, which are scheduled to be released in November 2025. As of now, 56 generic versions of Xeljanz have been approved by the Ministry of Food and Drug Safety, most of which are tofacitinib 5 mg salt-modified drugs that have overcome the Xeljanz composition patent, and are immediate-acting tablets that are taken twice a day. Daewoong Pharmaceutical also received approval for its Zeltopa Tab 5mg, which contains tofacitinib aspartate, in September 2020 and is waiting to release the product. If it receives approval for its XR formulation as well, the company’s competitiveness is expected to double when the market for generics opens. Meanwhile, Pfizer's Xeljanz recorded outpatient prescriptions worth KRW 12.3 billion in Korea in 2022 based on UBIST.
- Policy
- PN injection benefit restriction suddenly halted
- by Nho, Byung Chul Nov 08, 2023 05:37am
- Intra-articular injection of PN ingredients reduces knee cartilage friction by maintaining physical restoration and high elasticity With the advent of the reevaluation period for selective coverage of intraarticular injections containing PN (sodium polynucleotide), health authorities are planning to adjust the patient copayment upward. Manufacturers and sellers have recently submitted opinions to HIRA, drawing attention to the future direction. The opinion is based on supporting papers and clinical evaluations, and it is expected that the issue of 'restrictions on reimbursement of related products' will be quickly resolved. According to the industry on the 7th, HIRA held a suitability evaluation committee and treatment material expert evaluation committee from early this year to September with the advent of the selective reimbursement period for PN preparations and agreed to increase the patient copayment from the existing 80 to 90%. The key issue in the selective reimbursement of PN drugs is evaluated as 'restriction of administration after 6 months from the start of treatment,' and if such a measure is actually realized, the related market may be in danger of virtually drying up. Currently, there are approximately 20 pharmaceutical companies manufacturing and selling intra-articular injections containing PN ingredients, and the market size alone amounts to a whopping 80 to 100 billion won. If all went as planned, the measure to restrict coverage of PN drugs around October to December would likely have been submitted to the review committee and then notified, but the brakes were put on hold as pharmaceutical companies' written opinions based on clinical usefulness, feasibility, and cost-effectiveness were delivered. The PN preparation is a new medical technology that has entered insurance coverage and has secured clinical results that are not inferior to the safety and effectiveness of the pharmaceutical collagen/sodium hyaluronate injection. The industry and academic community also believe that ex officio adjustments related to ‘withdrawal of insurance benefits’ are an abuse of administrative power when there is clinical data that is comparatively inferior to alternative drugs, regardless of whether it is a drug or medical device. An industry official said, "PN, collagen, and hyaluronic acid injections are usually administered 1 to 5 times every 6 months, and it is known that there is no significant difference in their effectiveness and safety. However, with the advent of selective coverage, PN injections are now available for life. He pointed out, “Limiting benefits to only one vaccination per cycle is highly problematic.” Regarding the overall situation, the legal profession's position is citing the precedent of Dong-A ST's Styrene Tablet, and it is highly likely that PN preparations and intraarticular injections will also present conditional clinical trials related to securing effectiveness within the next 2 to 3 years. In the case of Stillen, there is a precedent in 2011 of receiving reimbursement for about 2.5 years on the condition of securing an indication for the prevention of gastritis due to the administration of non-steroidal anti-inflammatory drugs (NSAIDs). At the time, the dispute over the reduction of styrene tablets' benefits, although it failed to secure clinical trial data to prove its usefulness, was evaluated as an exemplary case of protecting the authority and pride of an 80 billion won blockbuster domestic natural medicine, including indications for the treatment of acute and chronic gastritis, against the ex officio adjustment of health authorities. there is. The introduction of health insurance coverage for new medical technologies is an active patient consideration policy that limits the upper limit of indiscriminate treatment fees for similar non-covered products and can also be expected to have a savings effect on health insurance finances. In other words, with the development of private actual cost insurance, out-of-pocket expenses can be minimized, and the national health insurance financial loss can be reduced to only 1/4 of the level of registered drugs, killing two birds with one stone. This raises questions about the current benefit restriction measure. PN preparations have been proven to be safe and effective using DNA components, a safe biomaterial extracted from salmonid fish, and are a biomaterial for tissue repair recommended for patients whose knee cartilage is worn out due to aging or overweight by reducing knee joint friction. all.
- Policy
- A draft for reevaluation of overseas drug prices
- by Lee, Tak-Sun Nov 08, 2023 05:37am
- Advantages and disadvantages depending on the re-evaluation method. The HIRA has prepared a draft plan for comparative and reevaluation of overseas drug prices and will begin collecting opinions in earnest with the pharmaceutical industry starting this month. As the HIRA plans to conduct re-evaluation sequentially starting next year, it is expected to prepare a final plan by at least next month, and intensive discussions are expected to take place this month. According to the industry on the 7th, HIRA plans to hold working-level discussions with the pharmaceutical industry on the 10th to discuss ways to compare and reevaluate overseas drug prices. Depending on the method of reevaluating overseas drug prices, there is a high possibility that it will have a disadvantageous effect on the domestic pharmaceutical industry, so it is expected that it will be difficult to come up with a final plan during this working-level discussion. The overseas countries subject to comparison are eight: the United States, the United Kingdom, Germany, France, Italy, Switzerland, Japan, and Canada. The HIRA plans to sequentially re-evaluate chronic disease drugs whose patents have expired starting next year. In a recent government audit, he said, "We plan to carry out re-evaluation sequentially by the year starting in 2024," and added, "We will strive to secure the sustainability of health insurance finances by managing the drug costs of products listed with high drug prices compared to foreign countries." He said. Considering this, it is highly likely that a reevaluation will be carried out with the goal of reducing drug costs, so it is possible that the overseas drug price standard will be lowered and the upper limit amount may be adjusted. However, it appears that some modifications will be made while gathering opinions from the pharmaceutical industry, so we will have to watch the future discussion process. A HIRA official also explained, “The internal draft has been prepared, but the final draft may be revised during discussions with the pharmaceutical industry.” It is expected that some of the contents of the HIRA draft will be made public once the opinion collection process begins. In order for the reevaluation to proceed next year, the final draft must be confirmed in December, so intensive discussions with the pharmaceutical industry are scheduled to take place this month. A HIRA official added, “We plan to hold discussions with the pharmaceutical industry throughout November,” adding, “I don’t think it will end with one or two meetings.”
- Policy
- Drug price reduction delayed due to suspension of execution
- by Lee, Jeong-Hwan Nov 07, 2023 05:34am
- As the so-called 'Drug Price Reduction Litigation Recovery and Refund System' is about to be implemented in earnest from the 20th, it is expected that some pharmaceutical companies will be put on hold in their tricks to preserve the prices of their own drugs by nullifying or delaying the effect of the government's drug price reduction disposition. According to the Ministry of Health and Welfare on the 6th, according to the results of administrative litigation on drug price reduction, the amendment to the Health Insurance Act and subordinate laws to post-settlement the recovery and refund of drug costs between pharmaceutical companies and insurance authorities will take effect from the 20th. The amendment requires domestic and foreign pharmaceutical companies to collect losses and interest if they obtain unreasonable profits, such as collecting drug costs without reducing the litigation period by suing to suspend the execution of drug price cuts decided by the government through litigation procedures. Conversely, if the government loses the case and is found to have illegally lowered drug prices to a pharmaceutical company, it will be required to refund the pharmaceutical company's drug cost losses along with interest. This regulation applies to administrative trials or administrative lawsuits filed after November 20, when the amendment goes into effect. With the implementation of the system, the number of cases in which pharmaceutical companies protest against government drug price cuts and file 'applications for suspension of execution' and 'lawsuits for cancellation of administrative dispositions' without considering whether they win or not is expected to decrease. Until now, in most cases, suspension of execution of drug price reduction measures was cited until the court's final ruling, which resulted in drug prices not being reduced or only after the lawsuit was completed several years later. This is why criticism has been raised that patients had to take medicine at high prices during the period when drug prices were not reduced due to lawsuits, leading to a waste of health insurance funds. According to the health insurance authorities, the financial loss of health insurance resulting from the suspension of drug price cuts in 47 lawsuits in which suspension of execution was cited since 2018 amounted to approximately 573 billion won as of the end of March 2022. The Ministry of Health and Welfare plans to minimize health insurance financial losses by implementing the system and using related funds to strengthen patient access to rare disease treatments.
- Policy
- Lunsumio receives marketing authorization in Korea
- by Lee, Hye-Kyung Nov 06, 2023 05:27am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that it had approved ‘Lunsumio (mosunetuzumab),’ which is used to treat follicular lymphoma, on the 3rd of this month. Lunsumio is used to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Lunsumio is an anti-CD20/CD3 T-cell engaging bispecific antibody that binds to CD3 on the surface of T cells and CD20 on the surface of B cells, and provides a new treatment opportunity for patients with relapsed or refractory follicular lymphoma. When it binds to CD3, T cells are activated, and when it binds to CD20, it positions B cells next to the activated T cells and induces lysis of B cells. In November last year, Lunsumio was designated as the first product subject to the Global Innovative Product on Fast Track (GIFT) program the MFDS has been operating. Drug subject to GIFT receives various support for the rapid commercialization of its product including shortening the review period by at least 25% (e.g. 120 → 90 working days), as well as rolling review that allows for the review of prepared materials first and provides opportunities for close communication between the reviewer and developer, as well as expert consulting on regulatory affairs, etc. MFDS said, “We will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.”
- Policy
- Pulmican & Pulmicort price increase discussed on the 9th
- by Lee, Tak-Sun Nov 06, 2023 05:26am
- The agenda to increase the prices of asthma drugs Pulmican and Pulmicort, suffering from supply and demand problems, will be discussed at the 12th Pharmaceutical Reimbursement Evaluation Committee held on the 9th. On this day, the appropriateness of the drug price increase will be reviewed. If it passes the Pharmaceutical Review Committee, it is expected that the drug price increase will be realized as early as December through adjustment negotiations with NHIS. Attention is being paid to whether supply will increase due to drug price increases and whether the supply-demand problem will be resolved. According to the industry on the 5th, Kunil Pharmaceutical and AstraZeneca Korea, suppliers of Pulmican and Pulmicort, applied to HIRA for adjustment of the upper limit of the drug, and the final review of the suitability of the application for adjustment will be held by the committee on the 9th. Both drugs are used as a suspension and nebulizer for treating bronchial asthma and acute laryngotracheobronchitis in infants and children. This is a representative drug whose supply and demand have been disrupted since last year as the number of respiratory patients has increased rapidly due to the impact of COVID-19. Recently, the need to increase the prices of two drugs was raised in a public-private consultative body in response to the unstable supply and demand of medicines, and the adjustment process began. The procedure for adjusting the upper limit amount is set when ▲ there is no alternative drug, ▲ a drug that is essential for medical treatment, ▲ a drug that is necessary for medical treatment but has a lower administration cost than a drug that can be replaced, ▲ or there is only one company in the drug with the same administration route and ingredients. The committee plans to review whether the two drugs meet the conditions. If it passes the committee, it will undergo adjustment negotiations with NHIS regarding the specific ceiling amount increase rate. Currently, the upper prices for Pulmican and Pulmicort are 946 won and 1,000 won per bottle, respectively. In the NHIS negotiations, an increase in supply is expected to be presented as a condition for increasing drug prices. Considering that the previous negotiations for adjustment of acetaminophen and pseudoephedrine preparations were concluded in a short period of time, this price increase for budesonide preparations is also expected to be applied as early as December after completing the negotiations this month if passed by the Pharmaceutical Review Committee. In the case of acetaminophen, for which a drug price increase was decided in December last year, the drug price increase is considered the most effective policy as a solution to the out-of-stock problem in that the supply and demand problem has gradually escaped after the upper limit amount was adjusted.
- Policy
- Prevenar competitor Vaxneuvance is approved in KOR
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- MSD Korea’s 15-valent pneumococcal vaccine ‘Vaxneuvance Prefilled Syringe (Pneumococcal/diphtheria CRM197 Protein conjugate vaccine) has been granted marketing authorization in Korea. Vaxneuvance, which is expected to rise as a strong competitor to ‘Prevenar 13,’ is a 15-valent pneumococcal conjugate vaccine, that induces active immunization for the prevention of invasive pneumococcal disease caused by streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F. Vaxneuvance holds significance in demonstrating its effect in preventing serotypes 22F and 33F, the common serotypes that cause invasive pneumococcal disease (IPD) in adults. Serotypes 22F and 33F are not contained in Prevenar 13. The vaccine must be administered by intramuscular injection in children aged 6 weeks or older. Infants under 6 months of age who have previously received one or more doses of Prevenar 13 can complete their vaccination schedule with this drug. In the clinical trial, Vaxneuvance was non-inferior to Prevenar 13 (PCV13) for the 13 shared serotypes as assessed by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs). Also, its immune responses were superior to Prevenar 13 shared serotype 3 and for the two serotypes unique to Vaxneuvance, 22F and 33F. In particular, in the Phase III PNEU-AGE (V114-019) trial, Vaxneuvance demonstrated greater OPA GMT ratios for serotypes 22F and 33F. However, randomized controlled trials assessing the clinical efficacy of Vaxneuvance compared to Prevenar 13 have not been conducted. Meanwhile, Vaxneuvance was approved by the U.S. Food and Drug Administration (FDA) in October 2021 to prevent pneumococcal disease in adults 18 years of age or older. According to MSD, Vaxneuvance's sales last year amounted to $138 million. Meanwhile, Pfizer is also working to extend its indications by launching Prevenar 20, its successor to Prevenar 13, in the United States.
- Policy
- Tramadol classified as narcotics abroad but not in KOR
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- The Ministry of Food and Drug Safety stated that there is insufficient evidence to designate tramadol, a so-called narcotic painkiller, as a controlled narcotic in Korea. On the 1st, the MFDS submitted a written response to the written inquiry issued by Rep. Sun-Woo Kang of the Democratic Party of Korea regarding the need to designate tramadol as a narcotic. Since the Korean Pharmacists for Democratic Society proposed the designation of tramadol as a psychotropic drug in 2014, there has been ongoing controversy over the need for its designation as a narcotic. Accordingly, the Ministry of Food and Drug Safety recently conducted a 'Study on the misuse and abuse of opioids’ and concluded that there is insufficient evidence to designate tramadol as a narcotic based on the results. However, considering how some countries including the United States and the United Kingdom designate the drug as a narcotic, the MFDS said they will continue to monitor its misuse and abuse and whether it should designated as a controlled substance at the United Nations level and will consider designating it as a narcotic if necessary. However, as the survey in the research study was conducted only on doctors, Rep. Kang pointed out, "Talks on their side effects were raised by patients and pharmacists' groups. How credible would a survey only on doctors be from that aspect?” The MFDS responded, "Products containing tramadol are prescription drugs that can only be used with doctor's prescriptions, so the survey was conducted on doctors who regularly treat actual patients and prescribe tramadol. We will monitor adverse events including drug dependence and regulatory trends overseas and review the need to conduct a research service to survey various groups including pharmacists and patients if necessary.” Tramadol is a painkiller used for moderate-to-severe acute and chronic pain, but due to its structure, which is similar to narcotics, it can cause dependence, withdrawal symptoms, and respiratory depression. This is why it is classified and managed as 'Schedule IV' drug in the US. Recently, according to the monitoring group of the Seoul Pharmaceutical Association, one patient received prescriptions for a total of more than 200 tablets of the narcotic painkiller Tritol (Tramadol) and cough and phlegm medicine Cough Tab from 4 to 5 clinics over a period of 5 days under the names of several family members, raising the issue of misuse and abuse. Rep. Kang requested an explanation at the very least on the drug’s precautions, saying, “It is inconsistent to strengthen the labeling requirements by deleting the phrase ‘tramadol is less dependent’ from its precautions for use while stating that there is no need to designate it as a narcotic.” In the precautions for tramadol use, there is a phrase that goes 'mental and physical dependence may occur due to intolerance from long-term administration. For patients with drug abuse or dependence, it should be administered for a short period of time under strict supervision.’ To this, MFDS stated, “Tramadol can cause mental and physical dependence, so we believe that safety management for the drug should be conducted even though there is insufficient evidence to designate it as a narcotic. We strengthened its safety management by deleting the phrase on its dependence due to worry that it may raise misconceptions that it causes no problem due to low dependence.”
- Policy
- SR version of gabapentin enters Korean market
- by Lee, Tak-Sun Nov 02, 2023 05:35am
- The first sustained-release formulation of gabapentin, which is used for nerve pain, has been introduced to Korea. The drug is Alvogen Korea’s Gralise SR Tab. The drug will be reimbursed from November and is expected to improve the convenience of intake for patients. According to industry sources on the 1st, Gralise SR Tab 600mg will be listed at KRW 648/tablet. It has improved the dosage guidelines from the 3 times a day with existing immediate-release tablets to once a day. The drug may be taken once daily with dinner. The Gralise SR was recognized as a drug that offers a new dosing method and strength, and the drug price was calculated at 110% of the insurance price ceiling set for the development target products. Therefore, its listed price became 10% higher than the highest price of KRW 589 given to the existing gabapentin immediate-release tablet 600 mg. However, its scope of indication is narrower than those for existing immediate-release tablets. Gralise SR 600 mg is only indicated for pain associated with postherpetic neuralgia. The immediate-release versions were also allowed used for epilepsy and neuropathic pain. The original gabapentin is Neurontin from Viatris Korea. The drug was introduced to Korea in 2000, and 174 products are currently approved on the market, indicating the highly competitive market. Based on UBIST last year, the original Neurontin's outpatient prescriptions amounted to KRW 21.4 billion. In a clinical trial on 359 patients with postherpetic neuralgia, Gralise SR showed a higher Cmax (highest blood concentration after drug administration) and a lower steady-state AUC (blood drug concentration) than its immediate-release version. The time to reach maximum plasma concentration (Tmax) was 8 hours, about 4 to 6 hours longer than immediate-release gabapentin. Graliz SR is an imported product developed by the US pharmaceutical company Almatica Pharma. It was approved by the FDA in 2011. Attention is rising on whether this drug, which offers an improved convenience, will rise to become a rival to Neurontin.
- Policy
- There were more than 20 doses of Dapagliflozin 5mg
- by Lee, Tak-Sun Nov 02, 2023 05:35am
- Forxiga 5mg, it was withdrawn from the domestic market Even though there are 21 SGLT-2 series Dapagliflozin propanediol hydrate 5mg products listed for reimbursement, the stepped drug price was not applied to the newly listed items in November. Why? This is because all 21 products were viewed as first-time registered products. According to the industry on the 1st, Nexpharm Korea's 'Floga 5mg' met the standard requirements when it was listed for reimbursement in November, and was added to the 59.5% given to first generics to the existing highest price of the same drug, setting a price of 291 won per tablet. Even though there are already 21 generics on the benefit list, they were calculated using the highest price formula. The stepped drug price system implemented in 2020 is such that when generics enter the market with more than 20 already listed identical products, the price is capped at 85% of the lowest price for the same drug or 38.69%. However, this time, the stepped drug price was not applied. This is because, in the case of a first-registered product, multiple products are considered one. Dapagliflozin 5mg was listed for the first time in Korea on April 8. AstraZeneca's original drug, Forxiga 5mg, was listed on the reimbursement list in 2014 but was deleted in 2018, so there was no identical drug on the reimbursement list at the time of listing the generics. Therefore, all 21 products listed for reimbursement on April 8 were recognized as first-listed. However, for the same drug that will be registered in the future, a stepped drug price will be applied. From now on, drug prices will be calculated based on the total number of registered items, including the first listed products. Therefore, the next item listed for benefit is calculated at 85% of the lower of the lowest price for the same product or 38.69%, regardless of whether the standard requirements are met. Nexpharm Korea's Floga 5mg was listed for reimbursement 7 months later than competing drugs, but was fortunate enough to receive a high price. An industry official said, "The generic calculation standards themselves were complicated, so in the case of Dapagliflozin 5mg, it was not possible to know whether the stepped drug price would be applied in the field." He explained, “It was only later that I understood why Nexpharm products received the highest price plus extra.”
