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- 2026-04-09 03:05:55
- Company
- Will Lixiana hit the 100 billion won mark for the NOAC RX?
- by Kim, Jin-Gu Nov 10, 2023 05:19am
- Attention is focused on whether Daiichi Sanko Lixiana will become the first NOAC drug to exceed 100 billion won in annual prescription sales. As of the third quarter, the cumulative prescription amount was 78.2 billion won, and if this trend continues, it is expected that prescriptions will easily exceed 100 billion won by the end of the year. Lixiana's annual prescription volume exceeded KRW 100 billion, making it the only original company to grow According to UBIST, a pharmaceutical market research firm, on the 9th, Lixiana's outpatient prescription volume in the third quarter was 26.8 billion won. Compared to 24.9 billion won in the third quarter of last year, it increased by 8% in one year. Lixiana's cumulative prescription amount in the third quarter was 78.2 billion won. The pharmaceutical industry predicts that if this trend continues, the number of prescriptions will increase to more than 100 billion won by the end of the year. Lixiana recorded prescriptions worth 96.7 billion won last year. In Korea, products that recorded over 100 billion won in prescriptions last year include Viatris 'Lipitor', Hanmi Pharmaceutical 'Rosuzet', HK inno. N 'K-CAB', Daewoong Bio Gliatamin, Handok 'Plavix', Chongkundang Gliatirin, LG Chemical Zemimet, etc. There are only 7. Even though the domestic NOAC market has reached a plateau, Lixiana is the only original drug that continues to see an upward trend in prescription performance. The NOAC market continued to grow rapidly until last year. The NOAC market, which was 147.2 billion won in 2018, reached 225.9 billion won in 2021, reaching the 200 billion won mark. Last year, the market size further expanded to 242.5 billion won. However, on a quarterly basis, it appears to have slowed down since peaking in the second quarter of last year. The NOAC market, which was 61.8 billion won in the second quarter of last year, decreased to 58.3 billion won in the 4th quarter. This year, it stagnated at 59.3 billion won in the first quarter, 60.2 billion won in the second quarter, and 60.9 billion won in the third quarter. BMS Eliquis, the second-largest product in the market, recorded prescription sales of 19.2 billion won in the third quarter. It remained at a similar level to the third quarter of last year. Eliquis has been recording prescription sales of around 19 billion won every quarter since the third quarter of last year. Xarelto's prescription performance decreased significantly due to the release of generics and the subsequent price reduction. Xarelto prescriptions in the third quarter amounted to 7.6 billion won, a 36% decrease from 11.8 billion won in the same period last year. Xarelto had issued quarterly prescriptions worth more than 15 billion won until the third quarter of 2021, but prescriptions have plummeted since the launch of generics. In the fourth quarter of last year, the quarterly prescription amount fell below 10 billion won and has been steadily decreasing since then. Boehringer Ingelheim Pradaxa's slump is prolonged. Pradaxa's prescription volume in the third quarter was 2.5 billion won, a 19% decrease compared to the same period last year. Generics for Xarelto are rapidly expanding their influence. The combined prescription amount for generics for Xarelto in the third quarter was 4.7 billion won. It increased by 72% compared to 2.7 billion won in the third quarter of last year. Its share in the rivaroxaban treatment market increased to 38%. Compared to 18% in the third quarter of last year, the market share has more than doubled in one year. Xarelto generics were released in large numbers in the third quarter of that year following the release of Chong Kun Dang's Riroxia in the second quarter of 2021. Chong Kun Dang's Riroxia, Hanmi Pharmaceutical's Riroxban, and Samjin Pharmaceutical's Rivoxaban are competing. As of the third quarter of this year, Riroxia's cumulative prescriptions were the highest at 3.3 billion won. Riroxban follows this at 2.4 billion won and Rivoxaban at 2.1 billion won. The remaining 30 companies had cumulative prescriptions of less than 1 billion won in the third quarter.
- Company
- Will Trodelbi become a second-line standard tx
- by Nov 09, 2023 05:43am
- Gilead Sciences Korea held a press conference at the Plaza Hotel in Seoul on the 7th to commemorate the domestic launch of Trodelbi, a treatment for metastatic triple-negative breast cancer Antibody Drug Conjugate (ADC) anticancer drugs first appeared in the domestic triple-negative breast cancer treatment market. To date, there have been no treatment options targeting triple-negative breast cancer treatment other than immunotherapy drugs and PARP inhibitors. Gilead is aiming to make Trodelbi the standard treatment option in this area. Gilead Sciences Korea held a press conference at the Plaza Hotel in Seoul on the 7th to commemorate the domestic launch of Trodelbi, a treatment for metastatic triple-negative breast cancer. Trodelbi is an ADC that targets Trop-2 protein, which is frequently observed on the surface of breast cancer cells and is used as a treatment for advanced or metastatic triple-negative breast cancer. Last May, Trodelbi was approved in Korea for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer that has previously received two or more systemic treatments, at least one of which was for metastatic disease, and was launched in Korea last month. The phase 3 ASCENT study served as the basis for approval. The study was conducted to compare the effectiveness and safety of Trodelbi and chemotherapy in 529 patients with locally advanced or metastatic triple-negative breast cancer who had previously received chemotherapy twice or more. 12% of all patients had brain metastases. The primary endpoint was PFS in patients without brain metastases compared to baseline. Secondary endpoints included overall patient PFS, OS, and ORR. As for clinical results, the median PFS in patients without brain metastases, which was set as the primary endpoint, was recorded by Trodelbi at 5.6 months. This was a higher figure than the 1.7 months recorded for chemotherapy. The OS, measured regardless of the secondary endpoint of brain metastasis, was 11.8 months for Trodelbi and 6.9 months for chemotherapy in the entire patient group. There was a significant difference in ORR, with Trodelbi being 31% and chemotherapy being 4%. In terms of safety, serious adverse reactions such as neutropenia (7%), diarrhea (4%), and pneumonia (3%) occurred during Trodelbi administration. Treatment discontinuation due to adverse reactions was calculated to be 5% for Trodelbi and chemotherapy. Professor Son Joo-hyuk of the Department of Oncology at Yonsei Cancer Hospital said, “Trodelbi is considered a docile anticancer drug. The basic principle is that cytotoxic anticancer drugs kill cancer cells, and as they bind to antibodies, we confirmed a good safety profile without severe toxicity,” he said. “Trodelbi is an anticancer drug that should be used as a standard treatment for metastatic triple-negative breast cancer.” “I think it should be included not only in ESMO or NCCN but also in our country’s treatment guidelines,” he said. According to the NCCN guidelines, Trodelbi is classified as Category 1 for the second-line or higher treatment of adult patients with metastatic triple-negative breast cancer. Rare cancer, triple-negative breast cancer, need for secondary treatment options after treatment failure. Triple-negative breast cancer is classified as a rare cancer among breast cancers. Triple-negative breast cancer, which is negative for human epidermal growth factor receptor type 2 (HER2), hormone receptor (HR), and estrogen, is experiencing difficulties in developing targeted treatments. In particular, compared to HR- and HER2-positive breast cancer, there is a shortage of treatments and treatment outcomes are not as good. In the case of early triple-negative breast cancer, immunotherapy drugs can be used without biomarker analysis. However, in metastatic triple-negative breast cancer, it can only be used if there is PD-L1 expression. If BRCA mutation is confirmed, PARP inhibitors can be used, but if there is no corresponding biomarker mutation, there is no treatment. Professor Kim Ji-hyung of the Department of Oncology at Gangnam Severance Hospital said, “Triple-negative breast cancer has aggressive clinical manifestations and there are almost no targeted therapies available. “The disease-free survival rate is usually only 2 to 3 months, and there is no standard treatment,” he said. “Immunotherapy drugs also require confirmation of the PD-L1 expression rate, so treatment options are limited. “An effective treatment is needed for patients with metastatic triple-negative breast cancer who have failed primary treatment,” he said.
- Policy
- Korean researchers develop 1st new substance for Alzheimer's
- by Lee, Hye-Kyung Nov 09, 2023 05:43am
- A Korean research team has developed a new substance (ALT001) that promotes mitophagy, and the recycling of damaged mitochondria, and presented a new door to treating Alzheimer's type dementia. The Korea Health Industry Development Institute (President: Soon-Do Cho) announced that a joint research team that consists of Jin-ho Yoon (College of Medicine, Dong-A University), Jong-Hyun Cho (Department of Medicinal Biotechnology, College of Health Sciences, Dong-A University), Ji-Hoon Jo (Chonnam National University), and Alt Medical (CEO: Eun-Hee Yoo) has succeeded in developing a new mitophagy promoting substance (ALT001) that can treat Alzheimer's type dementia. Summary of ALT001 ALT001 demonstrated low toxicity and safety that does not interfere with cell growth. Also, animal testing in vivo showed that the substance effectively improved damaged cognitive function, proving its value as a clinically applicable treatment substance for dementia. Previously, most studies for the treatment of Alzheimer's type dementia had focused on amyloid beta and tau proteins, but recent study results showed that mitochondrial dysfunction plays an important role in the development of dementia by interacting with amyloid beta, and promoting the mitophagy process that maintains mitochondrial function has been attracting attention as a new treatment strategy. However, due to the absence of mitophagy-promoting substances with proven clinical applicability, dementia treatment through mitophagy has not been implemented in practice. To improve this situation, the joint research team conducted a chemical library screening using an in-house mitophagy activity analysis system. Through the screening, the research team identified an isoquinolium scaffold for mitophagy induction and generated ALT001 through chemical optimization of the isoquinolium scaffold. ALT001 effectively promotes mitophagy and is safe as it does not interfere with cell growth, demonstrating its clinical applicability. The result of an experiment conducted to evaluate the learning and memory ability when using ALT001 for Alzheimer's type dementia in mouse models showed surprising results, where the learning and memory ability of the dementia mouse model was restored, and this therapeutic effect was also identified in a mouse model widely used in other dementia research. Professor Jin-ho Yoon, who led the research, said, “Thanks to the national support and helping hands, we researchers in Korea were able to develop a dementia treatment substance that can be clinically applied in the highly competitive mitophagy-based treatment development field. We are very grateful for the support. Our research will allow the development of a mitophagy-based dementia treatment that has been difficult to commercialize due to the lack of a drug with defined molecular mechanisms. We will devote ourselves to follow-up research with the goal of commercializing a dementia treatment using the results of this research.” The study was conducted with the support of the Korea Dementia Research Center, and its results were published in Theranostics, a world-renowned academic journal ranked among the top 5.8% in the field of medical research.
- Company
- Prescriptions of HCV market leader Mavyret halves in 1 yr
- by Kim, Jin-Gu Nov 09, 2023 05:43am
- Pic of Outpatient prescription performance of ‘Mavyret,’ the No. 1 product in the hepatitis C treatment market, has shrunk to less than half in just 1 year. In addition to the decrease in overall market size due to the decline in hepatitis C patients, Mavyret’s newly released competitors 'Epclusa' and ‘Vosevi’ have been rapidly expanding their influence in the market. According to the market research institution UBIST on the 8th, outpatient prescriptions of Mavyret in Q3 amounted to KRW 3.7 billion. This is a 52% decrease in 1 year compared to the KRW 7.8 billion it had posted in Q3 last year. Mavyret is a pan-genotypic hepatitis C treatment that was released by AbbVie. Since its release in Q3 2018, it quickly replaced Sovaldi and Harvoni which previously led the market. ‘Mavyret.’ can be used for patients with hepatitis C virus types 1 to 6, while Harvoni cannot be used for types 3 and Sovaldi cannot be used for types 5 and 6. The long treatment period of 12 weeks for Harvoni and Sovladi, compared to 8 weeks for Mavyret, also served as a weakness for Harvoni and Sovaldi. Mavyret’s share in the HCV treatment market share rose vertically from 3% in Q3 2018 to 56% in Q4. Subsequently, its market share exceeded 60% in Q1 2019 and then 70% in Q2 of the same year. Subsequently, its market share steadily increased and expanded to more than 80% in Q3 last year. Contrary to its expanded market share, prescription performance has been declining since 2019. Mavyret’s prescription performance, which recorded KRW 41.5 billion in 2019, decreased for 3 consecutive years to KRW 34.4 billion in 2020, KRW 32.8 billion in 2021, then to 31.2 billion won in 2022. Quarterly prescription performance of major hepatitis C treatments (Unit: KRW 100 million, Data UBIST) The analysis is that this is due to the steadily shrinking overall market size. The size of the HCV treatment market has steadily decreased from KRW 135.3 billion in 2017 to KRW 73.7 billion in 2018, then to KRW 65.1 billion in 2019, and KRW 47.4 billion in 2020, KRW 35.1 billion in 2021, then to KRW 34.2 billion in 2022. Compared to 2017, when the market had expanded to its maximum, the market had shrunk to a quarter in 5 years. The industry pointed to the characteristics held by the HCV treatments as a cause of the market contraction. Before the introduction of direct-acting antivirals (DAAs) like Mavyret, HCV had been a very critical disease. However, the treatment effect of HCV drugs had increased dramatically with the introduction of BMS’s Daklinza and Sunvepra. With Gilead Sciences' Sovaldi and Harvoni, MSD’s Zepatier, and Abbvie’s Mavyret that followed, the treatment effect had further increased. Ironically, as these new treatments offer an effect high enough to be close to a complete cure, the market size quickly contracted with the number of patients being prescribed the drug increasing within the finite number of patients in the market. As a result, the market size is shrinking. Pic of The entry of its competitors also affected the decline in Mavyret’s prescription performance. Gilead Sciences released Epclusa and Vosevi as next-generation hepatitis C treatments in November last year. The combined prescription performance of the two products is on the rise, reaching KRW 300 million in Q4 last year, then KRW 1.6 billion in Q1 of this year, KRW 2.7 billion in Q2, then to KRW 2.5 billion in Q3. During the same period, the market share of the two products had rapidly expanded from 4% to 19%, 34%, then 39%. If the current trend continues, it is predicted that it will surpass Mavyret and become a leader in the hepatitis C treatment market within the next year. However, like Mavyret, the fact that the overall market size is shrinking is expected to become a concern for Epclusa and Vosevi as well.
- Company
- Velexbru can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 09, 2023 05:43am
- Velexbru, a new drug for lymphoma, can be prescribed at general hospitals. According to related industries, Ono Pharmaceutical's BTK (Brutons Tyrosine Kinase) inhibitor Velexbru recently passed the Drug Committee of top general hospitals such as AMC and Sinchon Severance Hospital. In addition, major medical institutions, including Samsung Seoul Hospital, are also conducting landing procedures. Velexbru was approved domestically in 2021 by the Ministry of Food and Drug Safety as a monotherapy for patients with Primary Central Nervous System Lymphoma. This drug is the first BTK inhibitor approved in Korea for the treatment of patients with relapsed or refractory B-cell primary central nervous system lymphoma for which there is no standard treatment. The effectiveness of Velexbru was confirmed through ONO-4059-02, a non-blinded, uncontrolled phase 1/2 clinical study of Velexbru conducted in Japan in patients with relapsed or refractory primary central nervous system lymphoma. A total of 44 patients were enrolled in the study and were administered Velexbru 320 mg (80 mg per tablet, n = 20), 480 mg (n = 7), and 480 mg (n = 17) on an empty stomach orally once daily. Drug administration continued until the disease progressed or unacceptable toxicity occurred. The primary endpoint was ORR according to BICR. As a result of the study, the ORR for the approved dosage and dosage of 480 mg (fasting) was 52.9%. Major adverse reactions corresponding to grades 3 and 4 included neutropenia, leukopenia, and hypertriglyceridemia, which occurred in 11.8% of patients each. PCNSL is a very rare disease, so it is quite difficult to estimate the nationwide patient population. In general, it is reported that approximately 6,000 lymphoma patients occur annually in Korea, and about 2,000 primary brain tumors occur annually. Among these, PCNSL is known to account for approximately 2% of all brain tumor patients. Considering that PCNSL is reported to occur at 0.44 cases per 100,000 people in Western countries, it is estimated that approximately 200 to 250 new PCNSL patients will occur annually in Korea.
- Policy
- Drug pricing nego start in earnest for Tagrisso·Leclaza
- by Lee, Tak-Sun Nov 09, 2023 05:43am
- With drug pricing negotiations ongoing for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as a first-line treatment for non-small cell lung cancer, whether the two drugs will be applied the initial treatment refund-type RSA (risk-sharing agreement system) remains a variable. Leclaza, which is being supplied for free through the early access program (EAP), is not applied to the initial treatment refund type RSA and the National Health Insurance Service is conducting negotiations in consideration of this. According to industry sources on the 8th, Leclaza began drug pricing negotiations with the National Health Insurance Service at the end of last month. Leclaza was previously recognized as adequate for reimbursement in the first line at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that was held on the 12th. Tagrisso had been conducting negotiations with the corporation since the end of September. Given that drug price negotiations are carried out within a 60-day deadline, Tagrisso and Leclaza are expected to complete negotiations in December at the earliest receive reimbursement listing in January. However, a tense tug-of-war between the government and companies is expected over the RSA refund rate. In particular, in the case of Leclaza, as the initial treatment refund type is not included in its RSA, the government is expected to adjust the other refund rates while taking this into account. The initial treatment reimbursement type RSA takes into account uncertainties in effect among others for the initial treatment period. The initial treatment reimbursement type RSA was not applied for Leclaza because the full amount is being supported without limit to patients until its reimbursement listing through the Early Access Program (EAP). However, from the NHIS’s perspective, the authorities would need to adjust the other refund rates as it has no choice but to consider treatment uncertainty and the required finances. Moreover, they also must consider equity with Tagrisso, which is also under negotiation. Due to high interest in the reimbursement of the two drugs, including the National Assembly, the NHIS is expected to speed up negotiations. However, it remains to be seen whether both drugs will succeed in receiving reimbursement together or whether only one drug will be listed for reimbursement. An industry official said, “Their reimbursement depends on how much the pharmaceutical company is willing to give up on the RSA refund rate. Since the government and pharmaceutical companies are all willing to reimburse both drugs, it is highly likely that negotiations will be concluded at an appropriate level.”
- Policy
- MFDS approves P3T for talquetamab in MM patients
- by Lee, Hye-Kyung Nov 08, 2023 05:37am
- Janssen Korea Janssen Korea received approval to initiate a Phase III trial for its first-in-class investigational bispecific antibody ‘talquetamab’ for multiple myeloma in Korea. The drug is ‘Talvey,’ which was approved by the US FDA in August. The FDA granted accelerated approval to Talvey based on its overall response rate and duration of response. Its continued approval will depend on the results of the Phase III confirmatory trial. The phase 3 drug trial approved in Korea this time is for the indication approved by the FDA. The FDA approved Talvay for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The randomized Phase III conducted in Korea will enroll adults patients with relapsed or refractory multiple myeloma who have received one to four prior lines of therapy, and compare the effect of talquetamab+pomalidomide, talquetamab+ teclistamab, and investigator’s choice of elotuzumab combined with pomalidomide dexamethasone(EPd) or pomalidomide, bortezomib, and dexamethasone (PVd). The trial will be conducted at seven sites, including Seoul National University Hospital, Samsung Medical Center Chonnam National University Hwasun Hospital, Ulsan University Hospital, Seoul St. Mary's Hospital, and Pusan National University Hospital. Talvay is a bispecific T-cell engaging antibody that binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, non-malignant plasma cells and healthy tissue such as epithelial cells in keratinized tissues of the skin and tongue. The Phase 2 MonumenTAL-1 study, which became the basis for its accelerated approval, was conducted on 187 patients who had received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy Results showed that patients who received a biweekly dose of Talvay 0.8 mg/kg, 73.6% of patients achieved an ORR. At a median follow-up of nearly 6 months from the first response among responders, 58% of patients achieved a very good partial response (VGPR) or better, including 33% of patients achieving a complete response (CR) or better 73.0% of patients who received a once-weekly subcutaneous injection (0.4mg/kg) of Talvay also achieved an ORR, but their CR rate was 35%, lower than the biweekly arm. The duration of response was also favorable for the biweekly arm, which was why the drug was approved as a biweekly subcutaneous injection.
- 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.
- Company
- Whether Ilaris for 10 will receive reimb gains attention
- by Eo, Yun-Ho Nov 08, 2023 05:37am
- Attention is focused on whether progress will be made on discussions for the insurance reimbursement of 'Ilaris', a treatment that is used by around ten patients in Korea. According to industry sources, reimbursement discussions for Novartis Korea’s Ilaris (canakinumab) are currently being negotiated between the government and pharmaceutical companies at the Drug Reimbursement Standards Subcommittee stage. Half a year had passed since the company reapplied for reimbursement in line with the addition of its pediatric indications in April at registration. The company had failed to list the drug for reimbursement two times. A bumpy road lies ahead for its reimbursement still. The current focus of Ilaris’s reimbursement discussion is whether or not the drug can be applied the pharmacoeconomic evaluation exemption system. Ilaris's listing will become more difficult if its reimbursement evaluation is not carried out through the PE exemption track, Ilaris was initially approved in 2015 as a hereditary recurrent fever syndrome treatment. Its disease type is specified according to the mutated gene. Among the various specific syndromes that accompany hereditary recurrent fever, Ilaris is approved in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF), and ▲ Systemic juvenile idiopathic arthritis (JIA). Among these, CAPS is further classified into ▲Familial Cold Autoinflammatory Syndrome FCAS)/ Familial Cold Urticaria (FCU), ▲Muckle-Wells Syndrome (MWS), ▲Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurologic Cutaneous and Articular. Due to the very small number of subject patients and complex indications, it was difficult to progress discussions for its reimbursement. The number of patients who are applied the various indications for Ilaris is extremely small. Some indications for Ilaris do not even have disease codes or are only recently registered. In fact, the number of domestic patients that can use Ilaris is estimated to be around 13. Due to Ilaris’s non-reimbursement, patients have been receiving a treatment they can with an alternative that is not really an alternative. Patients with CAPS have been using ‘Kineret’ which is being supplied through the Korea Orphan & Essential Drug Center. As this drug has not been officially approved by the Ministry of Food and Drug Safety and is being supplied through the center, when supply disruptions occur, no entity in Korea has the obligation to ensure its supply, rendering the communication channel unclear and limits to improving its supply. In the case of FMF, colchicine is recommended as a first-line treatment but is not available in Korea. Ilaris is approved for use in patients with FMF who are contraindicated, intolerant, or achieved inadequate response with the highest-dose colchicine. However, since colchicine has not been introduced domestically, it will be difficult for FMF patients to use Ilaris, even if it receives reimbursement if colchicine's approval and reimbursement issues are not resolved. To solve this problem, an academic society applied for non-reimbursed off-label use of colchicine and reimbursement extension for the drug. In addition, voices calling for Ilaris’s reimbursement listing had risen in the recent NA audit. The National Assembly’s Health and Welfare Committee audit of the National Health Insurance Service and the Health Insurance Review and Assessment Service, Rep Sun-woo Kang of the Democratic Party of Korea, said, "Patients are spending KRW 80 million to as much as KRW 100 million a year to purchase non-reimbursed drugs. We ask the government to promptly list the drug for reimbursement to improve the quality of life for children and ease the financial burden borne by the patients' families.” Therefore, it remains to be seen whether the company and health authorities can reach a consensus and achieve reimbursement listing for ‘Ilaris’, a drug for a very small number of patients.
