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- Policy
- Erleada is listed
- by Lee, Tak-Sun Mar 28, 2023 05:56am
- Janssen 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
- 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.”
- Opinion
- [Reporter's view] The goal of global new drug development
- by Hwang, Jin-joon Mar 28, 2023 05:54am
- When the government announced the 'Third Five-Year Comprehensive Plan to Foster and Support the Pharmaceutical Bio Industry', it was emphasized that it would create three new blockbuster drugs that record global sales of more than 1 trillion won by 2030. For this purpose, strategic R&D investment was selected as a key task. In the development of new drugs, it is planned to significantly increase public and private R&D investment. Looking at the detailed support measures, the government plans to promote R&D investment of a total of 25 trillion won jointly with the private sector for 5 years with 10 global new drug development goals. The government also expects to invest 4 trillion won in government R&D and 21 trillion won in private R&D from this year to 2027. Based on the national new drug development project that inherited the results of the pan-governmental new drug development project from 2011 to 2020, a joint public-private investment of 2.2 trillion won was invested to develop one new blockbuster drug and three new drugs by 2035. A plan for development was also established. The government's will to foster the industry is positive, but the problem with new drug development is that speed is not important. As of last year, there were zero blockbuster new drugs recognized by the government. The government expects to secure two by 2027. Under the current circumstances, only Yuhan's non-small cell lung cancer drug Leclaza and SK Biopharmaceuticals' epilepsy drug Xcopri appear to be the only drugs developed by domestic biopharmaceutical companies by 2027 that have the potential to become global blockbusters. Leclaza was transferred from Genosco/Oscotec to Yuhan Corporation in July 2015 when preclinical development was underway. In November 2018, the technology was transferred from Yuhan to Janssen, a subsidiary of J&J, a global pharmaceutical company. Yuhan received conditional approval for Leclaza as a treatment for secondary mutations in non-small cell lung cancer in Korea in 2021. In other words, it took five and a half years from preclinical trials to conditional approval. It seems that it will take more time for Leclaza to rise to prominence as a global blockbuster. Janssen, which holds the global copyright, is conducting a phase 3 trial of Leclaza alone and Rybrevant as an indication for non-small cell lung cancer. Cenobamate started with basic research in 2001, went through clinical trials and licensing, and was approved by the U.S. Food and Drug Administration (FDA) in 2019. It took 18 years from the first research to enter the large-scale US pharmaceutical market. Last year, US sales of Cenobamate more than doubled from the previous year to 169.2 billion won, but it will take more time to get on the list of global blockbuster new drugs. Moderna's Corona 19 mRNA vaccine, which recorded $18.4 billion in sales last year, was praised for succeeding in developing it in about a year, but the actual situation is different. Moderna's COVID-19 mRNA vaccine is the product of 30 years of RNA research, 20 years of LNP development that protects mRNA, and 10 years of Moderna's own research and development. The government recognized the biopharmaceutical industry as a 'future food in a low-growth period', a 'key field for securing jobs', and an 'essential national strategic industry for overcoming infectious diseases and other diseases and guaranteeing public health'. In order to realize this, not only R&D support measures such as active support for global clinical trials but also support measures for basic research fields such as chemistry and biotechnology from a long-term perspective must be prepared.
- Opinion
- [Reporter's view] Tagrisso's first benefit
- by Mar 27, 2023 05:56am
- AstraZeneca's lung cancer drug Tagrisso has begun receiving benefits for first-line treatment. After 5 challenges, he passed the HIRA Cancer Disease Review Board. After adding the first treatment indication in December 2018, Tagrisso actively tried to expand benefits but was rejected by the review committee every time. The reason was that looking at the data of the phase 3 sub-analysis, the effect of improving overall survival in Asians could not be confirmed. The controversy over the efficacy of Tagrisso was started by Japan and ended by Japan. In the phase 3 FLAURA clinical trial, Japan had the greatest impact in making the OS values of Asians insignificantly different from those of the control group. The medical environment where drug switching is free is a crazy aftermath. The real damage was seen by Korean patients. In Japan, the first benefit is applied regardless of the results of the sub-analysis, but in Korea, because of this data, they had to receive treatment without benefit for more than 4 years. It is also Japan that has quelled OS doubts in Asia. Last year, Japan's large-scale real-world data came out. Real-world data is not clinical in a controlled environment, so it is generally less effective than data from clinical practice. However, Tagrisso showed a longer progression-free survival period and an overall survival period of more than 3 years compared to the phase 3 trial in the Japanese real world. There is no longer any need to argue over phase 3 sub-data. Already, the first-line Tagrisso therapy has fully established itself as a global trend for EGFR-mutated non-small cell lung cancer. A German professor of hemato-oncology whom I met in an interview last year expressed some disapproval at the reporter's question, "What do you think of the sequential treatment that uses the first and second generations first and then the third generation?" This is because I had never thought about sequential therapy after Tagrisso. His answer was, "I heard that even in Germany, a small number of hospitals choose sequential treatment. However, since Tagrisso has already become the clear first-line standard treatment, to be honest, I have never thought about sequential treatment. I'm sorry I couldn't give you an answer. it was" It will take a little longer for Tagrisso to become the standard first-line therapy in Korea. Concern about cancer is just the beginning of reimbursement for anticancer drugs, and in the future, drug price negotiations with the HIRA and the NHIS, and the Ministry of Health and Welfare must all pass. Now it's a speed battle. Depending on how long it stays on the drug rating, the Tagrisso benefit expansion could be over the year or within the year. First of all, AstraZeneca has a very high will to cooperate with the government as much as possible and expedite the process. The HIRA also has many new drugs to review for reimbursement adequacy. But it's only 4 years. The fact that the first petition for Tagrisso's salary exceeded 50,000 people can be said to have reached its maximum level of desperation. I hope that their wait will not exceed 5 years.
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