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- 2026-04-12 22:51:50
- Policy
- Keytruda to be reimbursed as first-line treatment for NSCLC
- by Lee, Tak-Sun Feb 22, 2022 05:54am
- A new category will be added to reimburse MSD’s NSCLC treatment ‘Keytruda’ as a first-line treatment. This is the first anticancer immunotherapy released in Korea to be reimbursed for NSCLC, five years into its approval as a first-line treatment for non-small-cell lung cancer in Korea. The drug passed deliberations by the Health Insurance Reimbursement and Assessment’s Drug Reimbursement Evaluation Committee, which decided to extend the national health insurance coverage for Keytruda as first-line treatment for NSCLC. HIRA announced the results above while collecting opinions on the 'revisions on the announcement made for drugs prescribed and administered to cancer patients' on the 18th. The revisions showed that a new reimbursement category has been added for Keytruda as first-line therapy and will take effect from March. Keytruda is a cancer immunotherapy drug that specifically binds to PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 proteins existing on the surface of tumor cells and induces T cells to attack the tumor cells. Therefore, the drug can be used in various cancer patients with PD-L1 expression and was approved as a first-line treatment in Korea in March 2017 for the treatment of metastatic NSCLC. However, its reimbursement did not gain momentum until last year, when the agenda passed HIRA’s Cancer Disease Review Committee and then passed DREC review in January this year. In the proposed revision, Keytruda can now be reimbursed as ▲first-line treatment for PD-L1 positive (Tumor Proportion Score (TPS)≥50%), advanced NSCLC (Stage IV) patients with no EGFR or ALK mutation, ▲ first-line treatment of metastatic nonsquamous NSCLC patients with no EGFR or ALK mutation in combination with pemetrexed platinum-based chemotherapy, ▲ first-line treatment of metastatic squamous NSCLC patients in combination with pemetrexed or paclitaxel (or albumin-bound paclitaxel), ▲as monotherapy for the treatment of adult patients and pediatric patients aged 2 years or older with relapsed or refractory classical Hodgkin lymphoma (cHL) who have relapsed after at least two types of therapy or failed or is ineligible for allogeneic hematopoietic stem cell transplantation (HSCT). This is the first time a cancer immunotherapy is reimbursed as a first-line treatment for NSCLC. A clinical trial conducted on NSCLC patients as monotherapy for the reimbursed indication showed that its median OS was 30 months and median PFS 10.3 months, both better than the control group (14.2 months, 6.0 months), raising expectations on the treatment effect the drug will bring to the field. The ORR in the Keytruda-treated group was 69%, higher than the 42% of the control group. A qualitative improvement is expected in the field of NSCLC treatment in general with the increased treatment options and the improved patient access to new options. Meanwhile, the revision also added a new reimbursement standard for the acute myeloid leukemia (AML) treatment ‘Xospata (Astellas, gilteritinib).’ A new reimbursement standard will be added for the second-line or higher use of Xospata as monotherapy in patients with FLT3 mutation-positive relapsed or refractory AML.
- Company
- Endless evolution of cancer immunotherapy
- by Eo, Yun-Ho Feb 22, 2022 05:54am
- According to related industries, news of approval for the expansion of domestic indications of cancer immunotherapy Opdivo (Nivolumab) and Keytruda (Pembrolizumab) in PD-1 inhibition mechanisms continues. Although it is the same mechanism, it is competing by securing different indications. In the case of Opdivo, two postoperative adjuvant therapy and three combined therapy indications were added. Postoperative adjuvant therapy in patients with esophageal cancer or gastroesophageal junction cancer with residual pathological diseases after receiving chemotherapy (CRT) as a preoperative adjuvant therapy and Postoperative adjuvant therapy in patients with root resection were added. Combination therapy with Carboplatin, Paclitaxel, and Bevacizumab as the primary treatment for metastatic or recurrent non-small cell lung cancer patients without EGFR or ALK mutation and combination therapy with Cabozantinib as the primary treatment of advanced Neoplasmine, and Fluoropyrimidine, Oxaliplatin and combination therapy with Yervoy (Ipilimumab) was also added to the treatment of adult patients with metastatic direct bowel cancer with microsatellite instability-high (MSI-H) or dMMR that recurred after Irinotecan treatment. As a result, Opdivo can be used alone or with other treatments such as melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell cancer, typical Hodgkin lymphoma, head and neck squamous cell cancer, urinary epithelial cell cancer, gastric cancer, gastroesophageal adenocarcinoma, esophageal cancer, and direct bowel cancer. In the case of Keytruda, it entered the field of renal and endometrial cancer through Lenvima combination therapy. The permission for the first-line treatment indication for renal cell cancer was based on data from the CLEAR study (KEYNOTE-581/Study 307), a phase 3 clinical trial. In the CLEAR study, Keytruda-Lenvima combination therapy demonstrated statistically significant Progression-Free Survival (PFS) and Overall Survival (OS) improvements over the existing treatments Sunitinib. Keytruda-Lenvima combination therapy reduced the risk of disease progression or death by 61% and the risk of death by 34% compared to Sunitinib.
- Company
- Samsung Bioepis' biosimilar had ₩1.5 trillion
- by Chon, Seung-Hyun Feb 22, 2022 05:54am
- Samsung Bioepis products sold overseasBiosimilar products developed by Samsung Bioepis generated 1.5 trillion won in sales overseas last year. It increased by more than 10% from the previous year, the largest ever. According to Samsung Bioepis on the 18th, five biosimilars recorded a total of $1.255.1 billion (about 1.5 trillion won) in overseas markets last year. It achieved maximum sales, up 11% from $1.125.8 billion in 2020. With Samsung Bioepis' marketing partner Biogen, it is a statistic that collects Organon's performance. Biogen sells three types of biosimilars in Europe: Enbrel, Remicade, and Humira for autoimmune diseases. Organon sells these three products in the rest of the country except Europe and Korea. In the United States, only Remicade biosimilar are sold. Organon is also in charge of overseas sales of two types of biosimilars, Herceptin and Avastin. Last year, sales of biosimilars sold by Biogen reached $831.1 million, up 4% from the previous year. Sales of organon rose 28% year-on-year to $424 million. Samsung Bioepis explained, "We achieved the largest annual product sales in overseas markets last year based on close marketing cooperation with partners and thorough supply chain management." Samsung Bioepis was approved for sale of biosimilar SB11 of Lucentis, an ophthalmic disease treatment, in Europe and the United States last year. SB11 will be sold by Biogen under the product name Byooviztm in the United States and Europe. Under the license agreement with Genentech, Samsung Bioepis can sell its products in the United States from June 2022 before Genentech's expiration of the relevant SPC (Additional Protection Certification, Supplementary Protection Certification). In other regions, it can be sold after Genentech's SPC expires. An official from Samsung Bioepis said, "Based on last year's results, we plan to work closely with our partners this year to expand product sales," adding, "We will further strengthen our position as a leading company in the global biosimilar industry by expanding our product portfolio to eye diseases."
- Company
- Kymriah is expected to be able to register insurance benefit
- by Eo, Yun-Ho Feb 21, 2022 05:59am
- Kymriah, an ultra-high-priced one-shot treatment, is expected to be covered by insurance benefits as early as April. According to related industries, Novartis Korea's CAR-T new drug Kymriah officially began drug price negotiations with NHIS in the last week of the same month after passing the Drug Benefit Evaluation Committee of the HIRA on January 13. Considering that the drug price negotiation deadline is 60 days, the negotiations should be completed at the end of March. If so, the Health Insurance Policy Committee, the final decision body for drug benefits, is usually held at the beginning of each month, and if Kymriah's price negotiations are concluded in March, it will be possible to register them in April. Pharmaceutical price negotiations themselves may break down, and the possibility cannot be ruled out that discussions will not end within the negotiation deadline. Recently, more and more cases are extending the deadline for negotiations. Since Kymriah is ultra-high-priced, it is not expected that it will be smooth to find an agreement between the government and pharmaceutical companies. Kymriah's indications are ▲Diffuse Large-B-Cell Lympoma (DLBCL) adult patient treatment after two or more systemic treatments and ▲ post-transplantation recurrence or secondary recurrence in children and young adult patients under the age of 25 and subsequent B-Acute Lymphoblastic leukemia (B-ALL). There is a difference in standards for Kymriah's two indications. B-ALL applies only to Expenditure Cap, but in the case of DLBLC, a performance-based type was added. This means that pharmaceutical companies share part of the drug price according to treatment performance for all DLBCL patients. The problem is that unlike conventional drugs that are mass-produced, the manufacturing cost is astronomically high due to the nature of Kymriah, which produces one batch of cells extracted from patients, and the cost burden of pharmaceutical companies increases in the event of a patient with an Expenditure Cap or higher. Novartis Korea's efforts are essential to the goal of conclusion of drug price negotiations, but it remains to be seen whether this will lead to achievement. About 200 DLBCL and B-ALL patients who have refused or recurred to existing treatment are in critical condition, with only six months of life expectancy due to no alternative treatment options or no standard treatment until Kymriah is approved. The median survival period of DLBCL patients who failed secondary treatment in Korea is around 4.73 months, and about 70% of patients who failed secondary treatment repeatedly perform rescue chemotherapy.
- Price of ‘Vesicare’ drops below its generics
- by Lee, Tak-Sun Feb 21, 2022 05:58am
- The voluntary price cut made by the overactive bladder treatment Vesicare (solifenacin succinate) is expected to reduce its drug price to a level lower than its generic versions. On what tactic the generic companies will take after losing their price competitivity remains the focus of attention. According to industry sources on the 20th, Astellas Korea has voluntarily applied to lower the reimbursement ceiling for Vesicare from ₩533 to ₩516, which will become effective as of March 1st. The price will be applied to both the 5mg and 10mg doses. The price ceiling of the discounted Vesicare 5mg will be set at the third-lowest level among the 78 products with the same active ingredient, dose, and formulation. In other words, only 2 of the 77 Vesicare generics will be cheaper than the original. Based on the February drug reimbursement list, the two drugs cheaper than Vesicare are Pharmbio Korea’s ‘OAB tab. 5mg' at ₩490, and Hanall Biopharma’s ‘Vesigad tab. 5mg’ at ₩500. The other 75 products cost between ₩532 to ₩534, priced around ₩16-18 more expensive than the ₩516 of Vesicare. The generic versions of Vesicare were released in July 2017. At the time, most generic companies in Korea have launched generic versions of Vesicare that had been leading the OAB treatment market. However, Betmiga (mirabegron), which Astellas had released in October 2015 in preparation for Vesicare’s patent expiry took over the OAB treatment market, leaving Vesicare generics little room for success. 45 products have already withdrawn from the market after revoking their licenses. Moreover, Hanmi Pharmaceutical and Ahngook Pharm had released their salt-modified drugs 7 months before other generics, so the other companies were unable to reap the benefits of preoccupying the market. According to UBIST, outpatient prescriptions of Vesicare last year recorded ₩13.7 billion, the salt-modified Hanmi’s ‘Besigum (solifenacin tartrate)’ recorded ₩1.7 billion, and Ahngook Pharm’s ‘A-care (solifenacin fumarate)’ recorded ₩2.9 billion. Other generic products have sold less than ₩1 billion and have been making an insignificant presence in the market. The reimbursement ceiling price set for Besigum and A-care is ₩698, which is relatively more expensive than the price-adjusted solifenacin succinate drugs. With the price gap widening to ₩182 with Vesicare’s voluntary price cut, Hanmi Pharmaceutical and Ahngook Pharm would also need to pay attention to consider price competitivity. Accordingly, what strategies the latecomers would take to respond to the voluntary price cut of its original is receiving attention. The industry expects generics with low competition to withdraw from the market, and those who wish to remain in the market would consider price adjustments.
- Policy
- Required PMS case reports reduced for Genvoya and Descovy
- by Lee, Hye-Kyung Feb 21, 2022 05:58am
- The number of evidence cases reported for post-marketing surveillance of HIV treatments ‘Genvoya tab (emtricitabine / tenofovir alafenamide/ cobicistat / elvitegravir)’ and ‘Descovy tab (emtricitabine / tenofovir alafenamide) that are subject to reevaluation will be adjusted. Genvoya and Descovy, which received marketing authorization from the Ministry of Food and Drug Safety in September 2016 and February 2017, respectively, are up for reexamination by September 12th and have been conducting post-marketing surveillance for 6 years since their release. The PMS cases that were required for the report are 3000 cases for Genvoya and 600 for Descovy, but the Central Pharmaceutical Affairs Council saw consensus on the need for the number of cases to be adjusted to 1,430 and 460 for each. The results were detailed in the minutes of the CPAC meeting disclosed recently by the Ministry of Food and Drug Safety. The committee members have judged that the number of evidence cases reported should be adjusted in consideration of the indications and the reduced sales for Genvoya, and the refunds and characteristics of its indication for Descovy. ◆Descovy = In detail, the committee chair of the safety and pharmaceutical reexamination review subcommittee explained that when a new standard-of-care is introduced, the number of new patients taking the drug decreases while the number of HIV-positive patients remains the same, the 600 PMS cases required for Descovy may not be realistic. The MFDS said, “The drug was not designated an orphan drug due to the availability of various alternatives. As setting a fixed number, 3,000 or 600, unilaterally on drugs rose as an issue, the company is allowed to present an appropriate number of evidence cases for the report in the process of determinations, but as the actual market situation may change, the number is often later adjusted according to the market situation. The explanation came after the inquiry on why AIDS treatments do not fall into the category of rare diseases when the number of AIDS patients was 14,000. A committee member said, “The number of PMS cases for submission should be reviewed and applied consistently within the ministry. A standard should be set internally to adjust the number of PMS cases.” Some had raised the opinion that AIDS treatments should be reviewed from a different standard than other general medicines when setting the number of required evidence cases for examinations. Another committee member said, “Due to the small number of patients and short duration of the drugs, it is hard to collect cases according to regulations. The short duration of action of the drug and the number of patients are not being considered. Since the additional investigation period will not help increase the number of collected cases, it would be better to close the re-examination within the set period and sort out the side effects as soon as possible.” ◆Genvoya = Both Descovy and Genvoya are Gilead Science Korea’s products, and the committee members focused on the fact that was the same company has been supplying improved follow-on STR formulation. The committee saw that the fact that the company supplies both the product subject to case number adjustments and follow-on products was an important factor and that the pharmaceutical company is leading the market by focusing on marketing its follow-on drug. The committee members weighted on the fact that the reason why Descovy and Genvoya cannot collect the number of required cases is that the market share has shifted with the release of its follow-on drugs. Another member said, “The follow-on drug will also be subject to reexaminations, and we should require the company to fill the number of evidence cases early on in those subject to the PMS. As the PMS should be conducted in patients who are new users of the drug, the company may apply for another adjustment without the allowance of retrospective studies." To this, some members had suggested that cases in the retrospective studies should also be included as PMS cases for submission. A member said, “There may be distortions in the retrospective survey depending on the patient's memory, but as the collection of results for the retrospective study is based on medical records, there will be no major distortions. We need to accept retrospective study results.” However, the MFDS said, “The PMS is conducted to monitor all adverse events. There is still room for data distortion with retrospective investigations.” The committee was able to reach an agreement on adjusting the number of cases, the members were unable to reach an agreement due to discord on filling the number of cases with retrospective studies. The chair of the committee said, “We ask the MFDS for more thorough supervision of the latecomer drugs developed and prepared by the pharmaceutical companies that developed the originals so that the companies could fully concentrate on PMS in the early stages after release.”
- Policy
- Pre-registration of Novavax vaccination will begin
- by Kim, Jung-Ju Feb 21, 2022 05:58am
- The quarantine authorities will start pre-registration of Novavax vaccinations for adults over the age of 18. According to the COVID-19 vaccination promotion team, adults over the age of 18 who want to receive Novavax can make reservations through (http://ncvr.kdca.go.kr). Elderly people who have difficulty making reservations on their own can make proxy reservations through the website or make phone reservations (1339, local government call centers). Those who have completed the pre-booking will be able to get vaccinated on the day of reservation at consigned medical institutions nationwide (about 12,900 locations) from March 7, and the second inoculation date will be automatically booked three weeks after the first inoculation. However, the inoculation date cannot be selected as a date two weeks before the reservation date. For example, if people make a reservation on February 21, they can choose after March 7, and if people make a reservation on February 22, they can choose after March 8. People can get vaccinated on the same day by booking a remaining vaccine on Kakao Talk and Naver, or putting the name on the preliminary list after checking by wire with a medical institution. The authorities plan to allow vaccinations on the same day through the amount held by all consignment agencies after March 7 so that vaccinations can be conveniently received without prior reservations. Cross-vaccination and 3rd vaccination using Novavax vaccine are also possible. 2nd vaccination should be inoculated with the same vaccine as primary vaccination, but cross-vaccination through Novavax vaccine is exceptionally possible if MD determines. In the case of basic vaccination with Novavax vaccine, the third vaccination is based on Novavax vaccine, and the vaccination interval is three months after the completion of the second vaccination. However, there are two exceptional cases. In the first case, a person who has received a basic vaccination with Novavax vaccine wishes to receive 3rd vaccination with mRNA vaccine, and can be vaccinated without any special reason. The second is the case where a person who received basic vaccination with a vaccine other than the Novavax vaccine has a reason for contraindication or postponement during the basic vaccination, and a third vaccination is possible with an exception under the judgment of a doctor. The authorities are conducting door-to-door vaccinations for non-invaccinated people such as ▲ hospitalized patients, ▲ residents of nursing facilities, ▲ elderly people with severe disabilities, etc. It is expected to contribute to reducing the number of severely ill patients and protecting high-risk groups by eliminating vaccination blind spots for high-risk groups that were not vaccinated due to physical constraints. The promotion team said, "As vaccination can reduce the risk of COVID-19 infection in the community and effectively prevent severe progression, we ask those who have not yet been vaccinated to actively participate in the pre-reservation for Novavax vaccination."
- Company
- Development of Xolair biosimilars is in full swing
- by Ji Yong Jun Feb 21, 2022 05:58am
- Xolair (Novartis)Domestic and foreign bio companies have started to develop Xolair (Omalizumab) biosimilars which patents expire in two years. The development stage of Celltrion, a domestic company, is the fastest. According to Clinical Trials, a clinical registration site of the NIH on the 17th, six clinical trials of Xolair biosimilars are currently registered. Three companies, Celltrion, Theba in the UK, and CSPC in China, are conducting phase 3 clinical trials, while three are in phase 1 clinical trials, including Zhejiang Huahai Pharmaceutical in China, Generium in Russia, and Syneos Health in the United States. Xolair is a treatment for allergic asthma and chronic urticaria. It was jointly developed by Genentech and Novartis, subsidiaries of Roche. Based on the two companies' earnings announcements, Xolair's sales last year amounted to 4.2 trillion won, up 10.5% from the previous year. Xolair will be challenged by biosimilars from 2024. Xolair patents expire in Europe in 2024 and in the United States in 2025, respectively. Celltrion is analyzed as the fastest place to develop Xolair biosimilars. Celltrion is conducting phase 3 clinical trials of the Xolair biosimilar CT-P39. The end of the clinical trial is expected to be January next year. Considering the period of the European licensing process, it is expected that biosimilars will be released in time for Xolair's patent expiration. Teva, a British pharmaceutical company, is closely chasing this. Teva is conducting phase 3 clinical trials of the Xolair biosimilar TEV-45779. However, the end of the clinical trial is expected to be June 2024, later than Celltrion. China's CSPC entered phase 3 clinical trials of the Xolair biosimilar SYN008 earlier than Teva, but it is still in the pre-patient recruitment stage. In addition, Generium's GNR-044 has ended phase 1 clinical trials, while Zhejiang Huahai Pharmaceutical's HS632 and Synos' BP11 are undergoing phase 1 clinical trials. Due to the clinical progress of companies, Celltrion is likely to take over the first mover of Xolair biosimilars. First mover is considered a top priority when evaluating the competitiveness of biosimilars. This is because biosimilars generate profits by bringing the market share of the original market. Celltrion's biosimilars Remsima and Truxima, which were released as first movers, are prominent in the European market. According to Celltrion, as of the third quarter of last year, the European market share was 54% for Remsima and 34% for Truxima.
- Company
- Vitrakvi's price negotiation has been extended
- by Eo, Yun-Ho Feb 18, 2022 05:55am
- According to related industries, both Roche's Rozlytrek (NTRK) anticancer drugs, Roche Korea's Rozlytrek and Bayer Korea's Vitrakvi, failed to conclude discussions with the NHIS (60 days) in January. The two drugs seeking the PE system passed the HIRA's Drug Benefit Evaluation Committee last year, but are in the final stage. If the extended negotiations are concluded as soon as possible, both drugs can be applied in March, but as they are the first drugs to be applied to multiple solid cancers only for certain genetic mutations, it remains to be seen whether the government and pharmaceutical companies can reach an agreement. Among adult and pediatric patients with NTRK gene fusion without acquisition-resistant mutations, Rozlytrek and Vitrakvi are highly likely to undergo severe morbidity during local progression, metastasis, or surgical resection, and can be used to treat solid cancer patients who have progressed after conventional therapy or do not have suitable treatments currently available. Meanwhile, Rozlytrek's approval was determined based on experimental data from phase 1/2 STARTRK-NG trials and phase 2 clinical trials in pediatric patients, STARTRK-1, and ALKA-372-001. In the STARTRK-2 study, Rozlytrek reduced tumors in more than half to 56.9% of patients with solid cancer (ORR) positive for NTRK fusion genes. Patients were conducted in 10 different solid cancer patients, and the duration of the reaction was observed to be 10.4 months. Vitrakvi's approval was based on a phase 1 test for adults aged 18 or older, a phase 2 NAVIGATE test for adults and children aged 12 or older, and a phase 1/2 SCOOT study for pediatric patients aged 1 month to 21 years old, including primary CNS tumors. According to the efficacy evaluation of a total of 55 people whose NTRK gene fusion was confirmed from three studies,Vitrakvi achieved an objective response rate (ORR) of 75% and 53% in various carcinomas (soft tissue sarcoma, infant fibroma, salivary gland cancer, lung cancer, melanoma, colon cancer, bile duct cancer, breast cancer, and pancreatic cancer).
- Policy
- Tagrisso’s succeeds in RSA renewal… 3% price cut per dose
- by Kim, Jung-Ju Feb 18, 2022 05:55am
- AstraZeneca’s NSCLC treatment Tagrisso (Osimertinib) succeeded in renewing its risk-sharing agreement (RSA) with the National Health Insurance Service, and the price of the drugs will be adjusted and discounted by 3% per dose. According to industry sources, AstraZeneca has agreed to discount the insurance price of Tagrisso during RSA renegotiations with the NHIS. With the MOHW working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement these changes. If the amendment is finalized, it can be applied from March 1st. Leclaza is reimbursed for second-line treatment of lung cancer, for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with positive EGFR T790M mutation who have been previously treated with an EGFR-TKI. The drug also has indications as first-line therapy and as adjuvant therapy after complete tumor resection. With the expiry of the first RSA term, the price of the drugs will be discounted by 3% each. The 30mg dose will be discounted from ₩116,563 to ₩113,066, and the 80mg dose from ₩217,782 to ₩211,248.
