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- 2026-04-10 15:36:42
- Policy
- Obizur will be evaluated for reimbursement upon approval
- by Lee, Tak-Sun Mar 30, 2023 05:41am
- Obizur, a treatment for acquired hemophilia A for adults, approved on the 20th, immediately began a benefit evaluation. This drug is attracting attention as it is the first treatment to replace blood coagulation factor 8 with an indication for acquired hemophilia A. According to the industry on the 29th, the HIRA received an application for Obizur benefits and entered the evaluation. Obizur received approval from the MFDS on the 20th. This drug was designated as an orphan drug in July 2021. US FDA approval was obtained in 2014. Acquired hemophilia A is a rare disease in which autoimmune antibodies cause antibodies to coagulation factor VIII, and bleeding cannot be stopped like in hemophilia patients. The prevalence rate is 0.2 to 1.48 per year per 1 million people, and it is known that there are about 60 patients in Korea. Takeda explains that Obizur is a genetically engineered product made by removing the B-domain from pig coagulation VIII, which is similar to human, and replaces inactivated human VIII, which is not easily recognized by autoimmune antibodies, to help blood coagulation and help control bleeding. did. In phase 2/3 for 28 patients with acquired hemophilia A, Obizur stopped or reduced bleeding in all early bleeding episodes, showed clinical improvement, or showed VIII activity above the target 24 hours after the first administration. The treatment success rate at the time of final administration was 85.7%, and the success rate was higher in the patient group using Obizur as the first treatment at 94%. The patient group using the second-line medicine showed a 73% treatment success rate. It seems that Obizur applied for reimbursement to the HIRA immediately after passing the safety and efficacy verification of the Ministry of Food and Drug Safety.
- Policy
- Govt seeks to improve the drug price reduction system
- by Lee, Tak-Sun Mar 29, 2023 06:02am
- The Korean government will be working together with the pharmaceutical industry to come up with plans to improve the price reduction system that discounts the actual transaction price of drugs. The Health Insurance Review and Assessment Service plans to hold a roundtable meeting with the pharmaceutical industry to improve the actual drug transaction price reduction system based on the recently disclosed research service results. However, whether the improvements will be received with content by both the authorities and the industry remains in question as some of the research service results may be difficult for the pharmaceutical industry to accept. According to industry sources on the 21st, the results of the 'Study to Prepare a Comprehensive Improvement Plan through an Effect Evaluation of the Transaction Drug Price Reduction System' that was led by principal investigator Jin-Hyun Kim, a Seoul National University professor, was disclosed through the public institution management disclosure system on the 9th. The research team proposed short-term, mid-term, and long-term measures for improvement in its final report. As for the short-term measures, ▲abolishing the 10% upper limit in the price ceiling system and ▲reflecting the low purchasing price paid by national and public hospitals in the drug price cuts were proposed. As mid-term measures, ▲ identifying the actual transaction price including rebates ▲ tougher punishments for false reporting, ▲ real financial savings, and ▲ promoting low-price purchases, etc. were proposed. As long-term measures, ▲ switching to a list price reimbursement system rather than the currently ineffective actual transaction price reimbursement system, ▲reducing the insurance price ceiling based on the actual transaction price, ▲changing the drug price structure including the dispensing fee, and ▲ maximizing pharmaceutical expense saving effect on outpatient pharmaceutical expenditures were proposed. As the proposed mid-to long-term measures are difficult to apply immediately, the short-term plans proposed by the research team are highly likely to be discussed with the pharmaceutical industry as a promotion task. However, predictions are that it will be difficult to reflect the low purchasing price paid by national and public hospitals in the drug price cuts due to strong opposition from the industry. Therefore, realistic measures such as the abolition of the 10% upper limit in the price ceiling system are expected to be discussed. A HIRA official said, “The actual drug transaction price reduction system has been in effect for a long time, and there had been criticism on its low effect, therefore, we plan to come up with an improvement plan. If discussions progress well, measures may even be derived within the year.” The reductions to the actual drug transaction price had been carried out every year in line with the separation of prescribing and dispensing system in 2000 to reflect the actual transaction price of drugs in the drug price, and then has been conducted every two years since 2016. However, the prevailing opinion was that an improvement was needed as its drug cost reduction effect was poor and it was difficult to identify the actual transaction price. This was why HIRA set out to derive an improvement plan through a research service last year.
- Company
- JW Pharma registers the first overseas patent for JW0061
- by Mar 29, 2023 06:02am
- A researcher at JW Pharmaceutical is conducting a candidate substance test. (Photo by JW Pharma)JW Pharmaceutical announced on the 27th that it has obtained a patent for 'JW0061', a treatment for hair loss targeting Wnt, from the Russian Intellectual Property Office. This patent is for JW0061, a new drug candidate for hair loss treatment based on the Wnt signaling pathway. The patent protects the composition of JW0061. This is the first time that the JW0061 material patent has been registered. JW Pharmaceutical has applied for patents in more than 10 countries including the US, Europe, Japan, and China as well as in Korea. JW0061 is a first-in-class candidate substance that promotes hair follicle proliferation and hair regeneration by activating the Wnt signaling pathway in skin and hair follicle stem cells. It is effective for hair loss symptoms such as androgenetic alopecia and alopecia areata and is expected to have excellent hair loss prevention effects. JW Pharmaceutical participated in the 'Wnt2022' conference held in Japan last November and disclosed the results of the preclinical study of JW0061. JW Pharmaceutical also disclosed the results of animal experiments that confirmed the superior hair growth and hair follicle generation effect of JW0061 compared to the placebo group. As a result of animal experiments where JW0061 was applied, the time to enter the hair growth phase, which took an average of more than 50 days, was advanced by more than 15 days (30%). JW Pharmaceutical is conducting GLP non-clinical toxicity evaluation with the goal of starting clinical trials of JW0061 in the first half of 2024. We are also conducting joint research with medical staff in the field of dermatology in the United States.
- Company
- Bridge Biotherapeutics applies to FDA for the phase 1/2 plan
- by Mar 29, 2023 06:02am
- Bridge BiotherapeuticsBridge Biotherapeutics announced on the 27th that it had applied to the FDA for a phase 1/2 clinical trial plan for 'BBT-207', a 4th generation non-small cell lung cancer drug candidate. BBT207 is a new drug candidate that targets the C797S mutation that can occur after using third-generation non-small cell lung cancer treatments such as Tagrisso. Bridge Biotherapeutics plans to conduct clinical trials at 15 to 20 institutions in the US and Korea when the phase 1/2 clinical trial plan is approved. This clinical trial is a study to evaluate the safety, pharmacokinetic/pharmacodynamic properties, and efficacy of BBT-207 in patients with advanced non-small cell lung cancer with EGFR mutation after EGFR TKI treatment. The dosage will be increased through a phase 1/2 study targeting 112 patients, and an appropriate phase 2 dose will be explored. Capacity expansion will follow. Bridge Biotherapeutics plans to attend AACR on the 18th (local time) and present the preclinical data of BBT-207 as a poster. Based on the results of additional animal experiments, the company plans to publish data related to antitumor efficacy, survival rate improvement in brain metastasis animal models, and brain metastasis inhibitory activity, which study the potential of BBT-207 for targeted treatment for C797S-positive mutations.
- Company
- TB treatment Dovprela lands in general hospitals in Korea
- by Eo, Yun-Ho Mar 29, 2023 06:02am
- ‘Dovprela,’ the first new drug introduced in the field of tuberculosis in half a century can now be prescribed at general hospitals in Korea. Viatris Korea's multidrug-resistant tuberculosis treatment Dobprela (pretomanid) passed the Drug Committees (DCs) of Seoul National University Hospital and Seoul Asan Medical Center. Dovprela, which was first approved in September 2019 in the US and in October 2021 in Korea, is indicated in combination with bedaquiline and linezolid to treat adult patients with extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). Pretomanid is the first new drug introduced in the field in 50 years. The field of TB has been neglected by front-line pharmaceutical companies due to its lack of economic feasibility. In fact, Viatris developed the drug in collaboration with a non-profit organization, ‘TB Alliance,’ rather than a general pharmaceutical company. Multi-drug resistant tuberculosis is a type of TB that cannot be treated with two or more TB treatments due to intolerance including isoniazid and rifampicin, the two most effective anti-TB treatments. Its cause can be divided into primary resistance and acquired resistance. Primary resistance develops when a patient is infected with drug-resistant MTB or during the course of treatment due to arbitrary discontinuation of treatment or irregular administration, etc. The treatment success rate of multi-drug resistant tuberculosis is around 50%, therefore, the condition's treatment efficiency is low, and an increased number of adverse events occur with their use in the second-line compared to first-line drugs. Moreover, due to its longer treatment period of 18 to 24 months, its cost burden is high and may even require surgical operations to remove lesions. Also, the seven-drug combination therapy that includes bedaquiline (Bdq) that is used as the current standard treatment for multidrug-resistant tuberculosis is not well used in Korea due to its high drug resistance rate and long treatment period of 9 to 12 months. Due to the long treatment period, the 7-drug combination is difficult to manage and has a high failure rate. Meanwhile, Dovprela demonstrated its efficacy through the Phase III Nix-TB trial. Dovprela, in combination with bedaquiline and linezolid (BPaL), demonstrated 92% effect in patients with treatment-intolerant or nonresponsive multidrug-resistant TB and an 89% effect in patients with extensively drug-resistant TB within 6 months and demonstrated its potential as a new short-term combination therapy in the field. Also, it reduced the treatment period from 18-24 months to 6 months, and almost all patients with treatment-intolerant or nonresponsive multidrug-resistant TB and extensively drug-resistant TB were found to be sputum culture-negative within 16 weeks. As the first ready-to-use combination that consists solely of oral treatments, the BPaL regimen reported a 90% cure rate in patients with extensively drug-resistant tuberculosis when used for 6 months compared to the standard treatment that recommends the use of at least 4 drugs in the initial intensive phase.
- Policy
- 87.5% of anticancer/rare drugs, evaluated as drugs w/o PE
- by Lee, Tak-Sun Mar 29, 2023 06:01am
- Yoo Mi-yeong, head of the HIRAAs the PE drug standard expands, the HIRA is seeking a reasonable management plan. This year, we plan to improve and supplement the PE system by deriving detailed plans through research services. Yoo Mi-young, head of the Pharmaceutical Management Office at the Health Insurance Review and Assessment Service, explained this at a meeting with the Professional Reporters Association held on the 28th. "In the case of anti-cancer drugs and rare disease drugs that were listed as new drugs last year, 87.5% of the total were evaluated as drugs without PE," said Director Yoo. We plan to prepare management plans based on this.” The research service is planned to start in April and end around the end of the year, and it is a policy to come up with a reasonable plan to improve health insurance financial sustainability and patient accessibility. The system that allows PE data submission to be omitted began in May 2015 with drugs for treating rare diseases for which there is no alternative or that threatens survival, and anticancer drugs, and in October 2020, it was expanded to drugs for tuberculosis, antibacterial drugs, and emergency antidotes among essential national medicines. From January of this year, it has been applied to drugs that have been proven to improve the quality of life of pediatric patients with rare diseases. Accordingly, CRYSViTA, a pediatric rickets treatment, falls under this category, passed the HIRA review stage without PE, and is currently negotiating with the NHIS. This PE omission system is being used to advance the drug evaluation period in order to increase patient access to treatment. Starting in the second half of this year, full-scale pilot projects linking permission-evaluation-negotiation For the same purpose, the MFDS, the HIRA, and the NHIS are starting this year to shorten the registration period for treatments for severe diseases such as cancer and rare diseases. are promoting Director Yoo explained, "We are currently in discussions with the MFDS related departments on target selection and related procedures to promote the pilot project." However, since the three institutions have different evaluation methods and conditions, and the beneficiary pharmaceutical companies also have burdens in preparing data at the same time, it is expected that only a few pharmaceutical companies will actually benefit from the system. Participation in the NHIS Pharmaceutical Evaluation Committee, there are concerns that fairness and objectivity issues may be raised. On the 7th, Lee Sang-il, executive director of the NHIS, said at a Korea Special Press Association meeting, “Secure the benefit adequacy and consistency of financial impact when listing a new drug, and evaluate the uncertainty of risk-sharing new drugs through organic linkage of negotiations. In order to support the decision, participation in the Pharmaceutical Reimbursement Evaluation Committee of the NHIS is necessary, so we plan to review a plan for NHIS members to participate in the Pharmaceutical Reimbursement Evaluation Committee through consultation with the Ministry of Health and Welfare and related organizations such as the HIRA." Director Yoo said, "Currently, the NHIS attends and monitors every meeting, and regularly holds meetings with the Ministry of Health and Welfare and the NHIS to discuss the contents of the committee's deliberations and issues for each individual agenda, and shares related data from time to time." Negative views were made on the need for NHIS to participate in the committee.
- Policy
- Erleada is listed
- by Lee, Tak-Sun Mar 28, 2023 05:56am
- Janssen Erleada, a new drug for the treatment of prostate cancerJanssen Korea, which succeeded in listing Erleada, a new prostate cancer treatment drug, voluntarily lowers the upper limit on Zytiga, an existing prostate cancer treatment drug. The industry believes that another so-called 'trade-off' case appeared last year when MSD lowered the upper limit on its drug while expanding reimbursement for the immuno-oncology drug 'Keytruda'. According to the industry on the 22nd, Janssen Erleada will be listed next month at a marked price of 20,045 won as a risk-sharing agreement (RSA) reimbursement type. In terms of the market price alone, it is slightly cheaper than the competing drug, Xtandi, which costs 20,882 won. However, it is evaluated that Erleada is economical for patients in that Xtandi is a selective benefit with a co-payment of 30%, while Erleada is a mandatory benefit with a co-payment of 5%. Some predicted that Erleada would not be easy to apply for benefits while receiving PE, unlike Xtandi. In fact, Erleada and Xtandi passed the HIRA in February of last year, but Xtandi, which omitted PE and accepted selective benefits, applied for benefits in August of that year, but Erleada had to pass the year. As a result, Erleada's benefit is also evaluated as a strategic success on the part of Janssen. It is interpreted as suggesting a trade-off as one of the strategies. It appears that the company negotiated with the insurance authorities by lowering the upper limit on Zytiga, an existing prostate cancer treatment, as a condition for Erleada's insurance coverage. Zytiga will cut 4.7% from next month from 17,606 won to 16,780 won. An industry insider said, “Trade-off negotiations in the form of drug price cuts for existing treatments through new drug reimbursement are gradually expanding following Keytruda last year.” It can be seen as a kind of trade-off negotiation in that it is intertwined with
- Company
- Daewoong succeeds in Entresto's unregistered patent
- by Kim, Jin-Gu Mar 28, 2023 05:56am
- A generic company succeeded in invalidating the unregistered patent of Novartis' heart failure treatment 'Entresto'. This patent was one of the hurdles that must be overcome for the early release of generics. As such, it is analyzed that generic companies are one step closer to the release of generic for Entresto. According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board made a ruling on the invalidation of the Entresto salt/hydrate patent recently filed by Daewoong Pharmaceutical against Novartis. This patent is not listed in the Ministry of Food and Drug Safety patent catalog. However, from the perspective of generic companies, it was a patent that must be overcome in order to release later drugs early. Novartis obtained approval for the crystalline form of sacubitril/valsartan, the main ingredient of Entresto, as '2.5 hydrates'. In the patent catalog, only 2.5 hydrates, which are directly related, are listed. Generic companies supplied crystalline raw materials as 'trihydrate' and 'tetrahydrate' instead of 2.5 hydrates. The problem is that Novartis did not register it in the patent catalog, but separately registered the trihydrate patent with the Korean Intellectual Property Office. From the perspective of a generic company, the unregistered patent trihydrate patent must be avoided or invalidated in order to release a trihydrate-based generic. In response, Daewoong Pharmaceutical filed an invalidation trial on this unregistered patent in April 2021. Afterwards, Erison Pharmaceuticals and Hanmi Pharmaceuticals joined by requesting the same judgment. The Intellectual Property Tribunal sided with Daewoong Pharmaceutical. It is expected that the same result will come out in the judgment of Hanmi Pharmaceutical and Erison Pharmaceutical, which has not yet been concluded. As a result, generic companies have succeeded in overcoming 5 out of 6 patents related to Entresto. The remaining patent that has not yet been overcome is 'Use Patent 2' related to heart failure, which preserves the ejection fraction, which Novartis registered after generic companies applied for product approval. Since Novartis registered the patent a step later, it does not have a big impact on the early release of generics by patent challengers. Generic companies have already applied for Entresto generic product approval since April of last year. In addition, in December of last year, Novartis' request for an injunction to ban the sale of generics was also rejected by the court. The remaining risk factor is the second trial of the patent dispute with Novartis. Novartis appealed to the Patent Court in December 2021 after a first-instance defeat for the crystalline patent. Then, in July of last year, after losing in the first trial related to patents, the case was similarly brought to the second trial. No conclusion has been reached yet. If generic companies win the second trial following the first trial, the timing of the release of Entresto's generics is expected to accelerate. According to UBIST, a pharmaceutical market research institute, Entresto's outpatient prescription performance last year was 40.6 billion won. Since its launch in 2017, Entresto's prescription performance has soared from 6.3 billion won in 2018 to 15 billion won in 2019, 23.5 billion won in 2020, and 32.3 billion won in 2021.
- Company
- Sam Chun Dang Pharm’s biosimilar equivalent to Eylea
- by Nho, Byung Chul Mar 28, 2023 05:56am
- On the 27th, Sam Chun Dang Pharm announced that it had received the final result report for its Phase III trial for SCD411 (Eylea biosimilar). The results are from a global phase III clinical trial that had been conducted on 576 patients at 132 hospitals in 14 countries from September 2020 to September 2022. Through the global Phase III trial, the company demonstrated the equivalence of SCD411 to the original Eylea in terms of efficacy (primary endpoint & secondary endpoint), safety, tolerance, effectiveness, and immunogenicity. The primary outcome measure, change from baseline in BCVA (best corrected visual acuity) measured from baseline to Week 8, fell within the equivalence limit interval set by the US FDA (Food and Drug Administration), EMA (European Medicines Agency), and Japan’s PDMA (Pharmaceuticals and Medical Devices Agency) compared to the original. UF FDA set the equivalence limit interval as a confidence interval of 90% with a treatment difference with the original between -3.0 to 3.0 characters, Europe’s EMA and Japan’s PMDA as a confidence interval of 95%, and a difference between -3.8 to 3.8 characters. The results of the primary outcome measure analysis showed that the differences in effect were between -1.6 to 0.9 characters under the US standards, and between -1.8 to 1.1 characters under the European and Japanese standards. Based on the results, Sam Chun Dang Pharm plans to apply for marketing approval of SCD411 in major countries such as the United States, Europe, and Japan and will supply and market the products through its partners as soon as it receives authorization.
- Company
- Erleada's reimb and lower coinsurance rate raise issue
- by Eo, Yun-Ho Mar 28, 2023 05:56am
- Most latecomer drugs are priced at a lower level than first-comer. This is an essential element in Korea's reimbursement listing system. However, a rare occasion occurred where patients are complaining over the lower price set for a latecomer drug. The drugs that arose as an issue were Janssen Korea’s prostate cancer treatment ‘Erleada (apalutamide),’ and Astellas Korea’s ‘Xtandi (enzalutamide)’ which was listed for reimbursement before Erleada. The situation goes as follows. The price difference (list price) between the two drugs is not large. However, the problem lies in the listing registration system the two drug companies selected and the patient's coinsurance. In August of last year, reimbursement for Xtandi was extended through a selective reimbursement system. Xtandi was first listed in 2014 as a treatment for metastatic castration-resistant prostate cancer (mCRPC). The selective reimbursement system is a system for listed drugs that authorities determine is urgent to expand coverage. To rapidly extend the scope of reimbursement for such drugs, the authorities waive the economic feasibility evaluation process but differentiate the copayment rate for the drug. Xtandi met the purpose of the system for the 'metastatic hormone-sensitive prostate cancer (mHSPC)' indication, which was why Astellas chose to receive reimbursement through the system. However, the situation was different for Erleada. As a newly listed new drug, Erleada did not have the option to choose selective reimbursement, therefore, it had to undergo the essential reimbursement processes, including the pharmacoeconomic evaluation process. This was why the time to the listing of the two drugs differed significantly. The two drugs passed review by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February last year, but Erleada is only being listed for reimbursement starting next month. Applying selective reimbursement to new drugs has remained a long-cherished desire in the industry. The different reimbursement tracks taken by the two companies led to the difference in the amount paid by patients as coinsurance. Xtandi’s coinsurance rate under the selective reimbursement system is 30%, whereas the rate is a mere 5% for Erleada which is applied essential reimbursement and special calculation of exemptions. If so, it would seem that existing patients can opt to use the cheaper Erleada, but it is impossible for patients taking Xtandi to switch to Erleada under the current reimbursement standards. In other words, dissatisfaction is arising among patients as existing patients could not benefit from the use of a cheaper drug option that became available. However, no one is to blame for the situation. Aside from the company's strategy, Astellas quickly offered a reimbursed treatment option in mHSPC through the selective benefit system. Janssen also has no fault. The prevailing view had been that it would be difficult for anticancer drugs with the mHSPC indication to be listed for reimbursement in Korea. This was why the news that Janssen completed final negotiations and successfully receive reimbursement after receiving pharmacoeconomic evaluations was received with surprise in the industry. Also, a solution does exist. The gap caused by the difference in coinsurance rates can be resolved if Xtandi also receives pharmacoeconomic evaluations and switches to an essential reimbursement like Erleada. However, it is unclear whether such a decision can be made quickly due to the nature of multinational pharmaceutical companies. A pricing official in the industry said, “Although it is uncommon, we should not overlook the fact that this can happen again in the future. Institutional improvement is needed to resolve the out-of-pocket burden that occurs with the entry of latecomers for selective benefit-applied items.”
