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- 2026-04-15 22:52:05
- Company
- Ninlaro starts pricing negotiation after three long years
- by Eo, Yun-Ho Dec 04, 2020 05:55am
- An oral multiple myeloma treatment, Ninlaro is initiating the drug pricing negotiation to seek for the National Health Insurance (NHI) reimbursement. The pharmaceutical industry sources reported the drug has started the pricing negotiation with the National Health Insurance Service (NHIS) on the only oral option in multiple myeloma treatment, Ninlaro (ixazomib), according to the Ministry of Health and Welfare’s (MOHW) order to negotiate given on Nov. 30, as the drug passed the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). The treatment was designated as an orphan drug in May 2017, and was approved for the South Korean market in July same year. But its reimbursement application has been pending for over three years. The supplier, Takeda Pharmaceutical, has been providing the treatment to the South Korean market for free of charge since October last year. Although the drug could not utilize risk sharing agreement (RSA) with its competitor already in the market first, the multiple myeloma drug was able to sign the refund type RSA and receive clearance from the DREC as a law was passed recently to stipulate RSA on follow-on drugs as well. Ninlaro, combined with lenalidomide and dexamethasone, can be prescribed to treat multiple myeloma patients who have not responded to at least one standard therapy. The proteasome inhibiting drug Ninlaro confirmed its efficacy and safety I Phase III TOURMALINE-MM1 clinical trial conducted with 722 patients with relapsed or refractory multiple myeloma. The study found the triplet regimen of ixazomib, lenalidomide, and dexamethasone had significantly improved the duration of progression-free survival (PFS) to average 20.6 months, 14.7 months longer than a combination of placebo, lenalidomide and dexamethasone. Meanwhile, the triple combination therapy with Revlimid is the most recommended multiple myeloma treatment option according to the U.S. National Comprehensive Cancer Network (NCCN) guideline and the European Society for Medical Oncology (ESMO). And Revlimid (lenalidomide) is the backbone for all triple combination therapies. Following are some of major triple combination therapy options for second line and later treatments; Amgen’s Kyprolis (carfilzomib) KRd combination (Kyprolis, Revlimid, dexamethasone); BMS’ Empliciti (elotuzumab) ERd combination (Empliciti, Revlimid, dexamethasone); Takeda’s Ninlaro (ixazomib) IRd combination (ixazomib, Revlimid, dexamethasone); and Janssen’s Darzalex (daratumumab) DRd combination (Darzalex, Revlimid, dexamethasone).
- Opinion
- [Reporter’s View] Haste makes waste
- by Dec 04, 2020 05:55am
- The commercialization of the COVID-19 vaccine is approaching. The UK has already announced that the Pfizer vaccine will be approved for emergency use for the first time in the world and will be supplied early next week. Excluding vaccines from Russia and China that are not internationally recognized, this is the fastest action. The British government has also secured a dose for 20 million people. Other countries are in a hurry as the UK preemptively commercializes vaccines. It is reported that the United States will also receive vaccines by Pfizer/Modena within this month. According to CNN, the United States will go through a meeting of the FDA (Food and Drug Administration) advisory committee on the 10th to decide whether to approve it, and receive Pfizer on the 15th and Modena vaccine on the 22nd. It will be vaccinated as soon as the vaccine is available. In addition, there are many opinions in Korea asking for a vaccine. Some say that in the third epidemic of COVID-19, the government must quickly approve, contract, and proceed with vaccination. Currently, the Korean government has completed a purchase contract with AstraZeneca, signed an MOU with Johnson & Johnson and Pfizer, and is known to be negotiating with Modena. I agree with the opinion that amid the COVID-19 pandemic that continues for the first year, the situation should be pacified with rapid vaccination. However, it seems that a more careful approach is needed at times like this. This is because the current vaccine is not the absolute thing to end COVDI-19. Rushing has no advantage in negotiations. Currently, the vaccine manufacturers hold all the cards. They said they demanded a 'side-effect immunity' from all countries that the manufacturer is not responsible for any side effects from those who received the vaccine. It is a condition that is unthinkable under normal circumstances, but in the COVID-19 outbreak, the development period, which took more than 10 years, had to be drastically reduced, so this demand can also be raised. In this situation, if the government is in a hurry, there is a possibility that negotiations will proceed on more unfavorable terms. Getting the vaccine quickly doesn't mean everything The confusion is even greater if unexpected side effects occur one after another or if the vaccine's effectiveness is less than expected. Rather, it is much more stable to proceed with vaccination while taking a closer look at the trends of other countries where vaccination was started. Currently, there are 400~500 confirmed cases in Korea every day, but the situation is not urgent enough to urgently introduce a new substance whose efficacy and safety are not fully guaranteed. In addition, there are not one or two guidelines to be established before the vaccine is introduced, such as distribution method, the institutions, and order of vaccination. We already had already suffered from an urgent vaccination schedule just a few months ago, and the flu vaccines were exposed to room temperature during delivery. The process of delivering about 10 million doses of the flu vaccine, which is said to be easy to manage, was also difficult. Can we safely deliver tens of millions of doses of a much more difficult mRNA vaccine? It is necessary to prepare the cold chain thoroughly over time. What makes the confusing situation worse is the unpredictable factor. We need to be able to put the new variable, the vaccine, into the most predictable range. Vaccines are neither absolute nor complete solutions to COVID-19 outbreak. "Vaccines are just one tool for controlling disease," said Albert Bourla, CEO of vaccine maker Pfizer. "We have to be on the lookout for absolute belief in vaccines," he said.
- Policy
- HIRA completes selective reimbursement listing
- by Lee, Hye-Kyung Dec 04, 2020 05:54am
- To reinforce the National Health Insurance (NHI) coverage, the South Korean health authority granted selective reimbursement on 16 out of 23 anticancer therapies without the healthcare reimbursement standard or left as a non-reimbursement with 100-percent copayment rate. According to the list of anticancer treatments with selective reimbursement as of Oct. 31 the Health Insurance Review and Assessment Service (HIRA) submitted to the National Assembly, the selective reimbursement has given to 23 therapies including Halaven injection (July 1, 2017) to Blincyto injection (Apr. 1, 2020). Since the government has announced the Moon Jae-in Care initiative on Aug. 9, 2017, the government has been expanding coverage standard on insured drug and turned non-reimbursed drugs as selectively reimbursed drugs to lessen the financial burden for the medically vulnerable community. At a meeting convened in June 2018, the Health Insurance Policy Deliberation Committee (HIPDC) of the Ministry of Health and Welfare (MOHW) announced 48 anticancer therapies would undergo standard expansion or selective reimbursement listing for three years to come From 2017 through 2018, the health authority reviewed providing selective reimbursement on anticancer treatments used in rare cancer and female-specific cancer, which gave the benefits to nine items in 11 therapies, including Halaven injection, Vidaza injection, Revlimid capsule, Afinitor injection, Imbruvica capsule, Avastin injection, Blincyto injection, Votrient tablet and Sutene capsule. Besides the rare and female-specific cancers, the selective reimbursement was given to eight out of 12 anticancer therapies, starting from Xtandi soft capsule on May 20, 2019 to Blincyto injection on last Apr. 1. The items covered with selective reimbursement from last year are managed according to HIRA’s revised notice on drug prescribed to patients with cancer. ◆ Perjeta: The copayment ratio has changed from 100/100 to 30/100 for the combination of Perjeta and Herceptin for the adjuvant treatment of patients with locally advanced, inflammatory or HER2-positive early breast cancer (over 2 cm). It was turned essential reimbursement (partial copayment rate 5 percent), because the therapy was decided for the patients to cover the entire cost as the effect was insignificant compared to the cost, regardless of the proven clinical efficacy. However, it was applied with selective reimbursement (30 percent), as the therapy has superior improvement in clinical efficacy but no other alternative with same level of treatment. ◆ Halaven injection: The selective reimbursement with 50/100 patient’s copayment was granted on the Halaven monotherapy that demonstrates clinically improved effect, compared to Xeloda (capecitabine) monotherapy used as a standard of care. The therapy has substitutable therapies like Xeloda, Gemcitabine and Vinorelbine monotherapies and paclitaxel-based combination therapies. ◆Xtandi: The reimbursement standard was to be adjusted as the treatment expanded indication to treat patients with non-metastatic castration-resistant prostate cancer (CRPC) with no or mild symptoms. A Phase III clinical study reported the Xtandi-administered group showed improved median progression-free survival compared to placebo group. But the selective reimbursement with copayment rate of 30 percent was set as the treatment is too expensive for the benefit targeting patients with no or mild symptoms. ◆Caelyx: The committee decided granting the essential reimbursement (patient copayment 5 percent) would not be adequate for the treatment as it shows similar value of overall survival, compared to the currently reimbursed capecitabine monotherapy in metastatic breast cancer patients. But the committee granted selective reimbursement with patient copayment of 50 percent, because liposomal doxorubicin monotherapy is the only treatment that lowers heart damage while maintaining the antitumor effect, but the high-cost treatment shows similar results with the capecitabine monotherapy. Regardless, the treatment is covered with the essential reimbursement, when treating patients with AIDS-relevant Kaposi's sarcoma (KS), as it costs about the same as the off-label use of paclitaxel monotherapy. ◆ Thalidomide capsule and Velcade injection: As the healthcare reimbursement standard on the hematopoietic stem-cell transplantation (HSCT) regarding the target age group expanded from ‘age 65 or lower’ to ‘age 70 or lower,’ the age limit in the remission-induction therapy reimbursement standard for multiple myeloma was removed. ◆ Gazyva: Although the evidence to prove the clinical efficacy in maintenance therapy for follicular lymphoma is insufficient, the treatment received selective reimbursement with patient copayment of 30 percent, considering the absence of other alternative option to use when relapsed or show no response after using an anticancer treatment including rituximab. ◆ Nexavar tablet: The reimbursement was expanded to Child-Pugh class B7, as a large-scale prospective observational study on patients with hepatocellular carcinoma confirmed improved survival period at Child-Pugh class B7. ◆ Blincyto: The committee has decided to give reimbursement (5/100) for remission-induction therapy (two cycles) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. The committee evaluated the reimbursement (partial copayment 5/100) would not be adequate for the remission-consolidation therapy administering extra three cycles, because the high-cost treatment was clinically effective when only HSCT is difficult immediately after the remission-induction therapy.
- Company
- The liver cancer treatment market is fluctuating
- by Kim, Jin-Gu Dec 04, 2020 05:53am
- Nexavar (left) and Lenvima The liver cancer treatment market is fluctuating greatly. Sales of Nexavar (Sorafenib), which occupied an absolute position in the market, declined significantly, while sales of Lenvima (Lenvatinib) increased. Hanmi's Soranib, which succeeded in overcoming Nexavar's patent, is scheduled to be released, and attention is focused on whether the change in this market will be faster in the future. According to the drug market research agency IQVIA on the 3rd, the cumulative sales of Nexavar in the third quarter of this year is ₩15 billion. Compared to the cumulative ₩20 billion in the third quarter of last year, it decreased by 25%. Lenvima, another liver cancer treatment, surged from ₩4.6 billion to ₩8.8 billion over the same period. The gap in sales between the two treatments sharply decreased from ₩15.3 billion to ₩6.3 billion in a year. In this situation, Nexavar's generic 'Soranib' will be released soon. The MFDS approved Hanmi’s Soranib on October 30th. Hanmi can sell generic for Nexavar exclusively until July 29, next year. Nexavar's sales may further decline further. Changes in cumulative sales in the third quarter of Nexavar and Lenvima, the primary tx for liver cancer (left) and quarterly sales (unit: ₩billion, data IQVIA) Currently, the only first-line treatments for liver cancer that have been released in Korea are Nexavar and Lenvima. The advantages and disadvantages of both drugs are clear. When analyzing clinical data, Lenvima precedes Nexavar. As a result of conducting a one-to-one comparative clinical trial with Nexavar, it was found that the objective response rate (ORR) and progression-free survival (PFS) were improved. The advantage of Nexavar is that it has a follow-up drug. Stivarga (Regorafenib) and Cabometyx (Cabozantinib) can be used as follow-up drugs. Lenvima cannot use Stivarga or Cabometyx as a follow-up drug if the first-line treatment fails. In the case of both treatments, indications and benefit standards are also limited to patients who have failed Nexavar treatment. Even though Lenvima was released with better data after 10 years of Nexavar's release, the reason why Lenvima still struggles is that there is no follow-up drug. Accordingly, opinions on allowing Stivarga to be used even for patients who have failed Lenvima treatment have been steadily raised by the medical community and patients, but the discussion is still in the beginning. If Lenvima solves the problem of follow-up drugs, future sales are expected to increase even more rapidly.
- Company
- Sanofi's multiple myeloma tx Sarclisa was approved in Korea
- by Dec 04, 2020 05:53am
- Sanofi-Aventis Korea (CEO Kyung-Eun Bae) announced on the 2nd that its relapsed and refractory multiple myeloma treatment Sarclisa (Isatuximab-irfc) was approval from the MFDS on the 1st. Sarclisa was previously approved as a combination therapy with Pomalidomide and Dexamethasone in patients with multiple myeloma who received more than one treatment, including Lenalidomide and proteasome inhibitors. Sarclisa is a monoclonal antibody treatment that induces tumor cell death by binding to a specific epitope of the CD38 receptor present in multiple myeloma cells. Despite receiving more than two treatments, it is expected to provide better treatment benefits to patients with advanced myeloma in Korea. The Phase III clinical ICARIA-MM study, which was the basis for approval, was conducted in 307 adult patients with relapsed and refractory multiple myeloma who previously received two or more treatments including Lenalidomide and proteasome inhibitors. Clinical results showed that the Sarclisa + Pomalidomide + Dexamethasone combined treatment group (hereinafter referred to as Isa-Pd therapy) reduced the risk of disease progression or death by 40% compared to the standard therapy, Pomalidomide + Dexamethasone combination administration group (hereinafter referred to as Pd therapy). Progression-free survival (PFS), was extended by 5 months. President of Sanofi Genzyme, Park Hee-kyung said that the approval of Sarclisa will provide another treatment option to patients with multiple myeloma in Korea who are suffering from recurrence despite two or more treatments. Sarclisa is a combination therapy with Pomalidomide and Dexamethasone in adult patients with relapsed and refractory multiple myeloma who previously received two or more treatments including Lenalidomide and proteasome inhibitors from the US Food and Drug Administration (FDA) in March 2020. Licensed. In May 2020, the European Medicines Agency (EMA) had experience of two or more treatments, including Lenalidomide and proteasome inhibitors. In addition, it was approved as a combination therapy with Pomalidomide and Dexamethasone in adult patients with advanced relapsed and refractory multiple myeloma.
- Company
- Joint venture Akijen withdrew in 6 years
- by An, Kyung-Jin Dec 04, 2020 05:53am
- Samsung Biologics Akijen, a joint venture established by Samsung Biologics and multinational pharmaceutical company AstraZeneca, is going through the process of rearranging the business in six years. According to Samsung Biologics' quarterly report submitted to the Financial Supervisory Service on the 2nd, the company decided to stop research and development (R&D) activities of AstraZeneca and Akijen Biotech in September. a SAIT101, biosimilar of Mabthera (Rituximab), which ended earlier this year, has been completed with a phase III clinical trial. An official from Samsung Biologics said, "We decided to suspend the business in September under discussion with our partners. We are in the process of finalizing clinical trials that have been underway." "We will announce again it when a specific schedule comes out," he said. Akijen is a joint venture established by Samsung Biologics in June 2014 by investing 50% of each with AstraZeneca. Samsung Biologics first invested ₩71.3 billion in Akijen Biotech. Since 2016, it is reported that a total of about ₩250 billion has been invested while conducting clinical development related to SAIT101 which is prescribed for rheumatoid arthritis and lymphoma. SAIT101 is a project that Samsung Advanced Institute of Technology stopped after 8 months after entering the global phase III clinical trial in 2012. As Akijen resumed clinical development after 4 years, it attracted industry attention, but after 6 years, the development was discontinued again. The results of the Phase III clinical trial ended earlier this year were valid, but the fact that Rituxan's biosimilars are already on sale is confirmed to have had a decisive effect. This is because it was judged that the competitiveness of the original drug would fall if it missed the position of 'First Mover' that enters the market first after the patent expiration. Currently, in the US and Europe, a number of Rituximab biosimilar products such as Celltrion's Truxima and Pfizer's Rexience have been released and are competing.
- Company
- Rob Kempton inaugurated as the new president of GSK
- by Dec 03, 2020 11:32am
- GSK announced on the 30th that it will appoint Rob Kempton as the president of GSK's Korean subsidiary on Dec 1st. New president Rob Kempton is a healthcare professional with over 20 years of pharmaceutical experience in the US, UK and Asia. After joining GSK in 2013, he was in charge of sales management in the United States of Viiv Healthcare, a company specializing in HIV, and then in charge of marketing of Dolutegravi in the United States. As Vice President of Field Sales, he led the launch of Trelegy Ellipta, a single COPD (chronic obstructive pulmonary disease) treatment in the United States, and recently served as Vice President of Global Sales for GSK's follow-up pipeline. New President Rob Kempton said, "Based on the foundation so far, the goal is to establish GSK's Korean subsidiary as a leading pharmaceutical and vaccine company in Korea, and we will do our best for the continuous growth of our business with them." Meanwhile, President Julien Samson, who has been leading GSK's Korean subsidiary since 2018, was appointed Vice President of Global Vaccine Sales and Head of Sales Strategy Division at GSK headquarters.
- Policy
- Life expectancy regulations for RSA drugs will be maintained
- by Lee, Jeong-Hwan Dec 03, 2020 06:01am
- The MOHW has announced that it will not change the two-year life expectancy rule applied to the 'risk sharing system (RSA)' applied to high-priced new drugs such as the latest anticancer drugs and rare disease treatment drugs. This regulation was established by referring to similar overseas systems such as the UK and Australia, and it is based on the fact that it is applied flexibly in the evaluation process of expert members. On the 30th, the MOHW made such a statement in a written inquiry by Choi Hye-young, a member of Democratic Party of Korea. Risk-sharing drugs are anti-cancer drugs or rare disease treatments that do not have a cure, and there are regulations that are applied in consideration of whether drugs are used for serious diseases that threaten survival, that is, diseases with a life expectancy of only two years. Choi Hye-young, a member of Democratic Party of Korea inquired, "There is a need to amend the two-year life expectancy rule." The Ministry of Health and Welfare said it would keep it as it is. The MOHW said, "The criteria for determining serious diseases that threaten survival,' in case of progressive serious diseases or life expectancy of less than 2 years', were set by referring to similar systems abroad (UK and Australia). The HIRA's expert committee considers the characteristics of the disease comprehensively and applies it flexibly when evaluated. The MOHW added, "For matters that need to be supplemented so that the guarantee of patient access to treatment can continue to be improved, the system will be supplemented by collecting opinions from pharmaceuticals, patients, and related organizations."
- Company
- Celltrion completes acquisition of Takeda APAC products
- by An, Kyung-Jin Dec 03, 2020 06:00am
- On Dec. 1, Celltrion announced it completed the acquisition for the Asia-Pacific market products from a multinational pharmaceutical company Takeda Pharmaceutical Company (“Takeda”). In last June, the South Korean company signed a deal to take over the rights to Takeda’s 18 Primary Care product assets from the Asia-Pacific markets for a total of USD 278 million (approximately 307.4 billion won). The company’s subsidiary in Singapore, ‘Celltrion APAC,’ has been in charge of the acquisition process. With the completed acquisition, Celltrion APAC would be able to directly and indirectly practice rights over the 18 products available in nine markets including South Korea, Thailand, Taiwan, Hong Kong, Macao, the Philippines, Singapore, Malaysia and Australia. The list of the product assets ranges from prescription drugs like antidiabetes drug ‘Nesina’ and ‘Actos,’ antihypertensive drug ‘Edarbi,’ to OTC drugs like cold drug ‘Whituben’ and stomatitis drug ‘Albothyl.’ Considering Nesia and Ebarbi are protected by their substance patents until 2026 and 2027, respectively, Celltrion expects to see stable growth in sales for a while. Celltrion Healthcare is to utilize its own sales network for the global market, while Celltrion Pharm is to lead the local sales in South Korea. For the mean time, Celltrion plans to use the existing manufacturing facilities owned by Takeda under a manufacturing and supply deal with the multinational company to maintain the stable supply. In the future, some of the drugs would be manufactured in Celltrion Pharm’s cGMP level manufacturing facility for local and global markets. Celltrion says the acquisition has created a momentum for the company to leap as an integrated global biopharmaceutical firm by strengthening the chemical drug business on top of the company’s already competitive biopharmaceutical business. Based on the R&D capacity and newly secured substance patent, the South Korean company plans to reinforce the incrementally modified drug (IMD) and insulin biosimilar line-ups in extended release and combination drug form, and also to complete the line-ups in antidiabetic and antihypertensive products. Moreover, the headquarters have set a plan for the new subsidiary Celltrion APAC to gradually expand the businesses by seeking deals for contract development and manufacturing organization (CDMO) and contract research organization (CRO) and establishing biopharmaceutical cold chain in Asia-Pacific region. A Celltrion official stated, “By successfully completing the acquisition process, the company has created a stepping stone to develop IMDs and to expand market share to penetrate the APAC markets. Celltrion would also do its best to grow as an integrated global biopharmaceutical company by expanding the R&D and CDMO businesses in the APAC biopharmaceutical markets.”
- Policy
- 16 new drugs listed including Kisqali, Verzenio & Ibrance
- by Kim, Jung-Ju Dec 03, 2020 06:00am
- A total of 16 major new drugs for which insurance benefit coverage was initiated this year were counted. A total of 4 drugs have lowered the burden on patients due to lower benefit standards. Regardless of the estimated size of insurance finance, the tendency to expand flexible coverage was established according to social importance and patient needs. From January this year until recently, new drugs that were newly listed on the drug benefit list and drugs with enhanced coverage among the new drugs already registered were expanded, resulting in a total of 20 drugs, and it is more than doubled when all items by content are summed. Penciclovir Cream, Rinvoq 15mg, and Kisqali 200mg were newly listed as of this month. Penciclovir Cream, a treatment for herpes simplex virus, is expected to be used by about 18,000 patients in Korea. The annual insurance budget is 34 million won, which is relatively small, but the satisfaction level of coverage is expected to be high. Rinvoq15mg, a treatment for rheumatoid arthritis, is expected to cost about ₩4.2 billion per year for 800 domestic patients. Kisqali 200mg, a new drug for advanced or metastatic breast cancer, is expected to cost about ₩12.2 billion as it is covered by approximately 400 patients in Korea. This year, the government and insurers used about ₩164.6 billion per year to grant access to expensive new drugs to approximately 262,907 patients.
