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- 2026-05-11 14:34:43
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- PharmaEssentia attempts to reimb its first new drug BESREMi
- by Eo, Yun-Ho Apr 12, 2023 05:53am
- The Taiwanese pharmaceutical company PharmaEssentia is attempting to list its first new drug ‘Besremi’ for reimbursement. According to industry sources, PharmaEssentia submitted an application for the reimbursement of its polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) on March 28th. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be reimbursed is gaining attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The response rates at 72 months were high at 80.4% and 65.3% in low-risk and high-risk patients, respectively, and showed high hematologic and molecular responses. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in terms of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment options available for use and had no option but to wait for their condition to progress further. He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera by the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
- Policy
- The alternative drug pricing system will be improved
- by Nho, Byung Chul Apr 12, 2023 05:53am
- It is expected that the specific direction of the public-private consultative body for rational drug price calculation of domestically developed innovative new drugs will be set, and system improvements will be promoted from May at the earliest. According to the industry, the public-private consultative body for improving the drug pricing system, composed of officials from the Ministry of Health and Welfare, KPBMA, and KRPIA, has held five rounds of discussions since last December and is expected to give positive incentives to new drugs. The drug price system improvement classification plan that the health authorities and the industry have formed a consensus on ▲innovative value for new drugs, ▲recognition of appropriate value for natural medicines (formerly new natural medicines), ▲derived system improvement for raw material self-sufficiency, and ▲stabilization of pharmaceutical supply maintenance of the period of accrual of the amount, etc. This proposal is a point of convergence in the larger framework, and the specific calculation method needs to be narrowed down through a general meeting of the public-private consultative body around the middle of this month. The most noteworthy part is the method of assigning value to new drugs and IMDs, and it is expected to be able to receive up to 10% higher drug prices than existing ones. If the alternative drug was reduced to 53.55% due to patent expiration, an additional 86.8% (100% 53.55%) is requested. IMD is expected to be recognized for up to 110% of development target products, including drugs for which the Ministry of Food and Drug Safety has approved data submission, as well as new usage and dosage. It is also eye-catching to prepare measures to strengthen its status as the originator of oriental medicine and to promote herbal medicine and herbal preparations. In the case of herbal medicines with improved clinical usefulness, it is likely to apply an additional 110% of the highest price of alternative medicines. For drugs using domestically produced drug substances, the additional period will be extended from 1 year to 5 years, and an exception to the follow-up management system will be applied. It is expected that the system will be improved so that if the number of companies for administration routes and products of the same dosage form is two or less, the addition of already-listed products will be maintained until there are three or more.
- Policy
- Leukemia Scemblix·Onureg passed the Evaluation Committee
- by Lee, Tak-Sun Apr 11, 2023 06:11am
- Leukemia treatments Scemblix and Onureg are recognized for their suitability for reimbursement and will move on to drug price negotiations with the NHIS. The HIRA held the 4th Pharmaceutical Reimbursement Evaluation Committee and reviewed the appropriateness of reimbursement for the six drugs for which the decision was applied. As a result of the deliberation, two out of six items passed, one item conditionally passed, two items failed, and one item decided to be re-discussed. The items that passed the committee first were Scemblix and Onureg. Scemblix 20, 40 mg is indicated for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) previously treated with 2 or more TKIs. At the beginning of the year, the Cancer Disease Review Committee succeeded in setting the reimbursement standard. Onureg 200, 300 mg is used for maintenance therapy after induction therapy in adult patients with AML. The item that passed conditionally was Nephoxil 500mg (ferric citrate monohydrate) from Kyowa Kirin Korea. This drug is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Tabrecta 150 and 200mg and Vyndamax 61mg are items that have not passed the committee due to non-reimbursement decisions. Tabrecta is a drug used for locally advanced or metastatic non-small cell lung cancer in which MET exon 14 skippings have been confirmed, and Vyndamax is a rare disease treatment used for ATTR-CM. Meanwhile, Lilly's RET-targeted anti-cancer drug Retevmo 40, 80mg will be discussed again. This drug has efficacy and effectiveness in RET fusion-positive non-small cell lung cancer, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer.
- Company
- Luxturna, a one-shot retinal disease treatment
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- Luxturna, a one-shot retinal disease treatment, is once again aiming to enter insurance coverage. As a result of the coverage, Novartis Korea recently resubmitted a reimbursement application for Luxturna, a treatment for Inherited Retinal Dystrophy. This is a quick resumption of the process after the HIRA's non-reimbursed decision last month. As the company's will to be listed on the salary is firm, it remains to be seen whether this re-challenge will be successful. This drug submitted an application for reimbursement in September 2021, but there was no progress in the listing process so far, and it was first introduced this year. Although it is expensive one-shot gene therapy, it seemed difficult to register because the disease is not directly related to life. Luxturna restores the function of the defective or defective RPE65 gene, one of the causes of IRD, by replacing it with a normal gene with just one administration. This means that the fundamental treatment of the disease is possible. Therefore, the key is how much Luxturna can achieve the value of preventing blindness. This drug was designated by the US FDA as Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained expedited approval in 2017. IRD is a rare and intractable disease in which vision loss occurs due to mutations in the gene responsible for the structure and function of retinal photoreceptors. It includes more than 20 different eye diseases, and there are about 300 causative genes. IRD caused by RPE65 gene mutation causes an abnormality in the visual cycle in the retina, which converts visual information entering the eye into nerve signals and transmits them to the brain. RPE65 gene mutation reduces the RPE65 protein, which is essential for visual circuitry, and destroys retinal cells, gradually narrowing the field of vision and eventually leading to blindness. Luxturna proved its effectiveness through a phase 3 clinical trial targeting patients with hereditary retinal diseases in which a biallelic mutation in the RPE65 gene was confirmed. As a clinical result, the functional vision of patients treated with Luxturna improved statistically significantly compared to the control group who did not receive treatment at 1 year of treatment. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT), which evaluates the ability to pass through an obstacle course of various heights in various levels of illumination by recreating a daily walking environment, as the primary evaluation variable at 1 year of treatment, Luxturna treatment group The score change of was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.
- InterView
- CDK4/6 latecomer Kisqali exudes confidence in its effect
- by Jung, Sae-Im Apr 11, 2023 06:11am
- Novartis’s Kisqali (rivociclib), a latecomer CDK4/6 inhibitor used in metastatic breast cancer, is taking on an unexplored path, away from other CDK4/6 inhibitors. The drug has demonstrated efficacy in aggressive forms of breast cancer, which had not been attempted by other CDK 4/6 inhibitors. Aggressive breast cancers appear relatively often in Korea where the proportion of younger aged patients is large, but the patients’ only available option was to use highly toxic chemotherapy. In a recent interview with Dailypharm, Seock-Ah Im, Professor of Hemato-Oncology at Seoul National University Hospital said, “Younger breast cancer patients have a higher probability of accompanying visceral metastasis because of their rapid cancer growth and aggressive clinical pattern. However, due to the clinical practice guidelines that recommended using chemotherapy for the past 20 to 30 years, there were doubts about whether to use CDK4/6 inhibitors. However, Kisqali's recent study convinced me of the viability of using CDK4/6 therapies." The recent study mentioned by Professor Im is the RIGHT Choice trial that was released in December last year. The trial studied aggressive hormone receptor–positive, HER2-negative advanced breast cancer patients that had symptomatic visceral metastasis, rapid disease progression or impending visceral compromise, or marked symptomatic nonvisceral disease. Although the CDK4/6 inhibitor+ endocrine therapy is currently used as the standard treatment for breast cancer in the first line, chemotherapy was still used in patients with rapid disease progression or visceral metastasis. Metastatic breast cancer often spreads to the lungs, liver, or brain, and when metastasis occurs, symptoms such as shortness of breath and pain may arise. In such cases, it is difficult to quickly reduce tumor size with hormone therapy alone. CDK4/6 inhibitors have been introduced as a new option in this field, but no data existed demonstrating their effectiveness in these patients. Kisqali is the only CDK4/6 inhibitor class drug to demonstrate an improved effect over combined chemotherapy in aggressive breast cancer. Results showed that the median progression-free survival (PFS) of the Kisqali + endocrine therapy combination was 24.0 months, a 1-year extension over the 12.4 months recorded by the control group (HR=0.54). The median time to treatment failure in the Kisqali combination group was 18.6 months, which was at least 10 months longer than that of the control group (HR=0.45). In terms of safety as well, the Kisqali combination group had a lower rate of treatment-related serious adverse reactions and treatment discontinuation rate compared to the combination chemotherapy group. Professor Lim said, "The scope of use of CDK4/6 inhibitors including Kisqali in HR+ breast cancer has increased significantly over the past two years. In line with the broadened scope of use of CDK4/6 inhibitors that changed the treatment paradigm of HR+ breast cancer, the ground is being laid to allow their more active use.” Professor Seock-Ah Im-I heard that Asian doctors first suggested the initiation of the RIGHT Choice trial = I am a member of a group of researchers that seek to improve the treatment of young breast cancer patients. As members, specialists from Asian countries, including Korea, Taiwan, Hong Kong, and Singapore, gather together to discuss and study how to improve the treatment environment for young breast cancer patients. During a meeting, the researchers suggested that a combination therapy that uses a CDK4/6 inhibitor could improve the quality of life and have a better antitumor effect than combination chemotherapy, and a research proposal was sent to pharmaceutical companies based on the suggestion. We proposed a study because young patients in their 40s and 50s occupy the majority population in Asia, compared to the West, which is dominated by elderly patients in their 60s and 70s. Breast cancer often takes on an aggressive form among young patients due to the fast cancer growth rate and relatively faster cell division. This means patients are highly likely to have accompanied liver or lung metastases. These doctors had been using chemotherapy as the first-line treatment for HR+ patients because it takes a long time to improve the patient’s symptoms by reducing cancer size with hormone treatment. Chemotherapy allows the tumor size to reduce within 1 to 2 months and the symptoms improve. However, it is also highly toxic. Therefore, a consensus was reached on how combining hormone therapy and targeted therapy instead of chemotherapy, which is difficult to be approved, would yield better results. Novarits’s Kisqalit team accepted the request, and so the RIGHT Choice study was conducted to demonstrate the actual improvement effect.. -How would you interpret the RIGHT Choice trial results? s= There had been clinical trials comparing hormone therapy and CDK4/6 inhibitors with oral anticancer drugs. However, this study is the first to show improvement compared to a combination therapy that is administered in two injections of cytotoxic anticancer drugs. In general, if a patient starts anticancer therapy, the tumor size is first reduced and then starts to grow again. The time until disease progression, that is, the time to symptom relief after chemotherapy and relapse is about 5 to 6 months. In clinical practice, the median time to treatment failure in the Kisqali combination group was 18.6 months, about twice as large as 8.5 months in the control group. Median progression-free survival was also extended by about 1 year compared to the control group. In particular, this study brings more significance because it includes premenopausal women and proves that a more comfortable initial treatment can be performed in premenopausal patients with more aggressive liver cancers or those with lung metastases. The limitation is that the study enrolled patients whose control group could be either one of two cytotoxic anticancer drugs and have a normal range of liver function and daily performance ability to some extent. The study did not include patients whose daily performance is so poor that they are almost bedridden. There are some cases we feel it’s inappropriate to conduct chemotherapy in some patients with visceral metastasis. However, on the other hand, there were many questions about whether it was really okay to use CDK4/6 inhibitor combination therapies. The study convinced me of the potential held by 'CDK4/6 therapy.’ -Kisqality was the last of the three CDK4/6 inhibitors to be introduced to the market. However, if you look at the recent sales records reported by the market research institution IQVIA, Kisqali made notable sales. How reliable are new drugs like Kisqali? =The data was interesting. Having participated in the trial of all three CDK4/6 inhibitors, Ibrance, Verzenio, and Kisqali, I am well aware of the benefits and disadvantages of each drug. Therefore, doctors tend to select drugs after comprehensively considering each patient’s safety, the patient's environment, and condition. In the case of postmenopausal women, side effects such as age, presence or absence of pulmonary embolism or venous thrombosis, and probability of pneumonia are considered. In addition, bone marrow function, liver function, electrocardiogram abnormality, and diarrhea are also considered. However, re-menopausal breast cancer patients didn't have as many options to choose from. Before Ibrance, the patient had to first remove both ovaries to use Ibrance. Fortunately, the combination therapy with Ibrance after ovariectomy did not require chemotherapy, and had only a few side effects other than a slight decrease in white blood cell count, so this method was mainly used. Later, the MONALEESA-7 study played a significant role.in allowing premenopausal women to use Kisqali combination therapy without ovarian resection.
- Company
- One-shot CAR-T tx, approved for domestic items
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- According to related industries, Janssen Korea's Kavicty was approved last month, and Novartis Korea's Kymriah obtained additional approval for indications on the 5th. The second domestically approved CAR-T new drug, Kavicty, is an anticancer drug that inserts genetic information to recognize BCMA into the patient's immune cells (T cells) and then injects these T cells into the patient's body. B-cell maturation antigen, which is selectively expressed during plasma cell differentiation and not expressed in other major organs, represents an ideal target for plasma cell cancer (multiple myeloma). This drug is indicated for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including ▲proteasome inhibitors ▲immunomodulators, and ▲anti-CD38 antibodies. In the case of Kymriah, the indication was expanded to treat adult patients with recurrent or follicular lymphoma after two or more treatments. With this expansion of the indication, Kymriah ▲relapses or secondary relapses after transplantation and subsequent relapses or refractory B-cell ALL (Acute lymphoblastic leukemia) and ▲ in pediatric and young adult patients under the age of 25 A third indication was obtained following recurrent or diffuse large B-cell lymphoma after two or more systemic treatments. Kymriah's new indication was based on ELARA, a phase 2 clinical trial targeting adult patients with relapsed or refractory follicular lymphoma (n=97). As a result of the study, the Overall Response Rate was 86.2%, including 69.1% of Complete Remission. Meanwhile, in March 2021, it was approved as a domestic advanced regenerative medicine bio law No. 1 treatment, and in April 2022, insurance benefits are applied to the two previously approved indications.
- Company
- Roche and Korea BIO offers opportunity to domestic companies
- by Hwang, Jin-joon Apr 11, 2023 06:08am
- KoreaBIO and Roche are hosting an open innovation event(Pic: KoreaBIO) The Korea Biotechnology Industry Organization will be providing opportunities for technology transfer and overseas expansion of domestic biopharmaceutical companies. For this purpose, Korea Bio plans to first cooperate with the multinational pharmaceutical company Roche. According to industry sources on the 10th, Korea BIO is planning to hold a ‘Korea BIO x Roche Partnering’ open innovation event on the 9th of next month. The event will be held on and offline at Roche Korea’s head office in Gangnam, Seoul, and be attended by groups wishing to partner with Roche. The event will offer one-on-one meetings between global pharmaceutical companies and domestic biopharmaceutical companies. Korea BIO planned the event to provide opportunities for domestic pharmaceutical and biohealth companies to receive a diagnosis on their commercialization potential for technology transfer and overseas expansion, etc. Domestic pharmaceutical and biohealth companies wishing to engage in technology transfer and joint research with Roche can submit an application, and prepare nonconfidential company introduction materials, personal information consent form, and company introduction material consent form to Korea Bio by the 24th of this month. The company introduction materials should only include only publicly available data. When the domestic pharmaceutical and biohealth companies submit the required documents, Roche Asia Partnering will select companies after review. Select companies will have on/offline meeting opportunities with Roche, and receive feedback related to the contents discussed. Then, a select few that wish to partner with Roche will receive the opportunity to have face-to-face meetings at Roche headquarters, global branches, and subsidiary research institutes. As collaboration areas, Roche suggested immunology, oncology, neurological disorders, research and development technology, personalized digital healthcare, rare diseases, and infectious diseases. If approved, the collaboration will be carried out with its Genentech Research Center, Roche Innovation Center Basel, Roche’s Shanghai Innovation Center, Global Product Development Department, and Product Strategy Department, etc. The industry believes that Korea BIO's open innovation project will be an opportunity for domestic companies to receive feedback from multinational pharmaceutical companies on their direction of pipeline research, further required research, and the marketability of their candidate substances. Starting with Bayer in 2021, Korea BIO had held open innovation partnering events with Boehringer Ingelheim, Novartis, French Healthcare Club, and CJ in the same year.
- Policy
- 3 combination DM drug is cheaper than the 2 combi
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- 2-drug combination therapy should also be provided with reimbursement standards From this month, as it is applied to the three-drug combination therapy of SGLT2 inhibitors, prescriptions for the existing two-drug therapy (SGLT2i + DPP4i) are expected to decrease significantly. The HIRA said on the 5th through a Q&A related to the reimbursement standards for diabetes medications that will change from this month, “The two-drug combination therapy of a combination of a DPP-4 inhibitor and an SGLT-2 inhibitor is only one type of combination within the scope of approval, as is the case at present. You can apply it with a burden,” he explained. DPP4i+SGLT2i that are currently within the scope of approval are Januvia and Forxiga. The amount the patient will pay is 987 won, which is the sum of 734 won (Forxiga, fully paid by the patient) and 253 won (Januvia, 30% of 846 won). If Metformin is included in the prescription, the drug cost will decrease. This is because from this month, regardless of the ingredients, benefits will be applied to the combined use of met+DPP4i+SGLT2i. This is because if Forxiga 10mg + Januvia 100mg plus Metformin 500mg (highest price 119 won), which is taken daily, the patient's co-payment is only 509 won because 30% is applied. From the patient's point of view, the cost of three drugs has become cheaper than the cost of two drugs. Accordingly, it is analyzed that there is a high possibility that the medical field will prescribe a 3-drug containing metformin instead of an expensive 2-drug. Some experts are concerned that prescriptions for metformin will increase even for patients who do not need to take metformin, and social costs may only increase if prescribed Metformin is not accepted. There is also an opinion of regret that the DPP4i + SGLT2i two-drug regimen is not provided in this reimbursement standard. However, as the reimbursement review for the two-drug combinations is underway, some say that the reimbursement criteria for the two-drug regimen will be established sooner or later.
- Policy
- Reimb review for Pompe disease drug Nexviazyme underway
- by Lee, Tak-Sun Apr 10, 2023 05:53am
- Reimbursement review is underway in Korea for Nexviazyme Inj (avalglucosidase alfa-ngpt), Sanofi’s Pompe disease drug that had been approved by the Ministry of Food and Drug Safety on the 29th. Nexviazyme is the first biobetter among rare disease drugs to be approved in Korea. According to industry sources on the 7th, the Health Insurance Review and Assessment Service started the reimbursement review for Nexviazyme and requested the Ministry of Food and Drug Safety to confirm the drug’s Target Product Profile. Nexviazyme is regarded an upgraded version of the company's Myozyme. The MFDS has been approving products with improved safety, efficacy, and use over existing approved biodrugs or those that were recognized for their progressive technology, as biobetters. Nexviazyme is the first drug among rare disease drugs to obtain marketing authorization as a biobetter drug. Pompe’s disease is caused by a genetic deficiency or dysfunction of the lysosomal enzyme acid alpha-glucosidase (GAA). When left untreated, it may lead to muscle damage, respiratory failure, movement disorders, and even premature death. The company has implemented innovative technology to increase the amount of mannose-6-phosphate (M6P), which plays a major role in the drug's cellular enzyme uptake, in Nexviazyme by 15 times compared with Myozyme. The company added, the increase in M6P also improves immunogenicity and provides safety benefits. Myozyme is currently reimbursed at KRW 653,000 per vial. In 2021, USD 7.7 million's worth of Myozyme was imported to Korea.
- Company
- Two types of RET-targeted anti-cancer drugs for minority pts
- by Eo, Yun-Ho Apr 10, 2023 05:52am
- It does not seem easy to enter the insurance coverage of RET-targeted anti-cancer drugs targeting a very small number of patients. According to related industries, Retevmo of Lilly Korea failed to pass the HIRA held on the 6th, and Roche Korea's Gavreto submitted an application for benefits last year, but it has not yet been presented to the Cancer Disease Review Committee, and discussions are slow. However, in the case of Retevmo, as the decision to re-discuss was made, there is room for hope. Although the application for Gavreto was delayed compared to Retevmo, there is no news about it, despite the strong tendency of the government to evaluate drugs with the same mechanism. Retevmo and Gavreto both obtained FDA approval in March. Retevmo was a bit early for global first permission. Retevmo obtained marketing approval from the US FDA in May last year and Gavreto in September last year. Retevmo was approved for two indications of non-small cell lung cancer and thyroid cancer, and for indications of Gavreto, thyroid cancer was added in December of the same year after approval as a lung cancer treatment. Since these drugs suppress not only the primary mutation of the RET gene but also the secondary mutation that causes resistance to chemotherapy, it was expected that they would be able to solve the unmet demand in various types of cancer, but they are experiencing difficulties in the insurance coverage process. Cho Byung-cheol, a professor at the Lung Cancer Center at Yonsei Cancer Center, said, "Until now, there were no chemotherapy options for patients with RET gene mutation cancer, so we had no choice but to undergo chemotherapy in the same way as general cancer patients. It can be an alternative for patients who have had difficulties with relatively low anti-cancer toxicity.” Meanwhile, in the LIBRETTO-001 clinical trial, Retevmo recorded a response rate of 64% in non-small cell lung cancer patients who had previously received platinum chemotherapy and an 85% response rate in the newly diagnosed group. Gavreto significantly reduced tumors by 58.8% in non-small cell lung cancer patients who had previously received chemotherapy in the Arrow trial. In patients diagnosed for the first time, the response rate was 72%.
