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- 2026-04-17 00:26:11
- Policy
- “Neglecting cost-effectiveness is dereliction of duty"
- by Kim, Jung-Ju May 19, 2020 06:07am
- Answering to the criticism that National Health Insurance (NHI) coverage enhancement initiative is toughening the barrier of pharmaceutical reimbursement listing and standard, Korean health authority officials urged the cost-effectiveness should be further reinforced. Recently appointed Director Yang Yoon Seok of the Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW) hinted, “We want to put more filters, if possible.” The ministry officials also noted the government would pay a close attention to what pharmaceutical and bio industry, as well as patient groups, have to say, but they are planning to make policies weighing more on rationality and predictability. Regarding the listed drug reevaluation pilot program announcing last week that choline alfoscerate would be the first, the government officials stressed unlike the approval system, the cost-effectiveness comes first in listed drug reevaluation. On the questions directed to the final outcome of reevaluation—reimbursement removal or reduction, the officials shortly commented adequate actions would be taken and avoided providing further details. Director Yang elaborated during a press conference held immediately after the Health Insurance Policy Deliberation Committee (HIPDC) meeting on May 15. Appearing for the first time at an official press conference, Director Yang expressed his philosophy in insured drug policy, prospective approach, and his commitment to them. Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho, playing significant roles in the Pharmaceutical Benefits Division, also joined Director Yang during the question and answer session. (From left) Senior Deputy Director Lee Seon-joo, Director Yang Yoon Seok and Deputy Director Choi Kyung-ho ▶The Ministry of Food and Drug Safety (MFDS) is reportedly considering on reevaluating the approval standards on choline alfoscerate. Has the listed drug reevaluation been discussed with MFDS? If not, then it could cause confusion when reevaluations each conducted by MFDS and MOHW (Health Insurance Review and Assessment Service, HIRA) result in contrasting outcomes. Deputy Director Choi Kyung-ho (“Choi”) “MFDS’ approval evaluation and MOHW’s reimbursement listing evaluation are different. The previous negative listing system used to list most of the approved drugs, but the current positive listing system reviews cost-effectiveness. The listed drug reevaluation is to be introduced within the framework, and such reevaluation, specifically for the price, is nothing new.” ▶Can the listed drug reevaluation ultimately result in reimbursement standard reduction or removal? Director Yang Yoon Seok (“Yang”) “Depending on the outcome, adequate actions would be taken accordingly.” ▶The reevaluation mentioned in the first NHI Comprehensive Plan was about introducing more general drug reevaluation covering clinical efficacy, financial impact and contract compliance. While selecting choline alfoscerate for the pilot program does not exactly explain how it is covering the said factors. Is there a possibility that the pilot program could include other subject drugs during or after the first pilot program? And what is the reason behind only selecting choline alfoscerate? Yang “The lawmakers and media have raised issues over choline alfoscerate last year, and even civic health organizations have requested for an audit. As we have already promised for a reevaluation, it cannot be delayed anymore. The actual regulation would be set down based on the pilot program, but the pharmaceutical industry seems to be concerned about the [government policy] being spontaneous or arbitrary. [By understanding those concerns] the Ministry intends to enhance predictability.” Choi “A number of pharmaceutical substances were listed up as the pilot program candidates. Selecting the urgently demanded choline alfoscerate seemed appropriate. In fact, differentiating the pilot evaluation and the actual evaluation would be meaningless.” ▶According to the information from HIPDC, the pharmaceutical expenditure saved from the reevaluation would be used for listing severe and rare disease treatments. The previous director of Pharmaceutical Benefits Division mentioned about opening an account for pharmaceutical expenditure on severe disease treatment. Has it been reviewed any further? Choi “The limited resources, despite so many expenditures to cover, is our concern for the system. So basically, the talk came about as a means to accumulate resources for coverage on severe disease treatment by cutting out expenditure on drugs with weak efficacy or unnecessary reimbursement. Regardless, if the pharmaceutical expenditure can be saved, the ministry would have more resource to utilize on much needed reimbursement to cover severe disease treatments. The issue is still under review.” ▶Again, the HIPDC information explains the reason behind choosing choline alfoscerate for the pilot program, which referred to A8 external pricing reference countries. Does this mean that the existing list of A7 countries would be updated to A8 countries including Canada? Choi “[The external pricing reference countries] is set by HIRA. The A8 mentioned here is not so significant. The eight countries were picked as reasonable references. It would be better to interpreted like that.” ▶Some criticize that the financial issue of anticancer treatment reimbursement listing or expansion have been evaluated through ‘triple-filtering (Cancer Deliberation Committee, DREC and drug pricing negotiation)’ as the Cancer Committee started reinforcing financial impact management. Some even go further and say the triple-filtering is deferring deliberation on many of anticancer treatment coverage and affecting the patient’s access to treatment. Yang “They call it the ‘triple-filtering,’ but to be honest, we want more filtering if possible. For this time around, we had the applicant company to submit a financial impact management plan on their immunotherapy. Nevertheless, we would need to construct a system for the patients to receive more benefits.” Choi “It does not mean the previous evaluations were insufficiently done. Anyway, healthcare reimbursement review has to take account of cost-effectiveness at each step. “In some cases, HIRA first projects comparatively lower cost, when NHIS projects the cost higher. As a health authority, such cases should be prevented. Neglecting cost-effectiveness is as irresponsible as dereliction of duty. “Attempting to catch a mosquito with a sword would be nonsensical, but the related experts can talk about it at every step. And if each step can be a filter, we expect the next step would be able to bring even better outcome. “Pharmaceutical companies may feel these steps are excessively straining them, but demanding the health authority to review listing without the filtering would mean they are demanding us to work blindly. And in clinical scene, doctors judge the use of a drug, and these doctors are part of the committees. Financial experts are there to add more on the financial aspect. We are definitely not putting down one-fifth resource for the necessary expenditure.”
- Policy
- Reimbursement on Ibrance-Faslodex available from June
- by Lee, Hye-Kyung May 19, 2020 06:07am
- From June 1, the healthcare reimbursement would be granted on the combined use of Pfizer Pharmaceutical Korea’s HER2-negative breast cancer treatment Ibrance (palbociclib) capsule and Faslodex (fulvestrant). National Health Insurance Service (NHIS) has settled on a negotiation over an indication expansion of the already listed drug and listed Ibrance 75 mg, 100 mg and 125 mg under refund type risk sharing agreement (RSA). Each capsule would be priced at 125,900 won with the healthcare benefit. On May 15, Korea’s Ministry of Health and Welfare (MOHW) held the seventh Health Insurance Policy Deliberation Committee (HIPDC) meeting of the year. Convened for the first time in the year, the HIPDC members passed the Ibrance listing as a part of the revised list of reimbursed drugs and maximum reimbursement price. The negotiation on Ibrance was not a new drug pricing negotiation, but a reimbursement standard expansion according to the change in indication. Initially indicated to treat postmenopausal female patients with hormone receptor positive (HR+) or human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer as an endocrine therapy, Ibrance is additionally indicated to treat, in combination with Faslodex, female patients with hormone receptor positive (HR+) or human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer who has been treated with endocrine therapy. The indication expansion on Ibrance’ combination therapy has been demanded for over three years, as its indication was expanded to a first-line endocrine therapy combined with letrozole to treat postmenopausal women in 2017. Since Pfizer applied for the new indication to treat female patient with advanced breast cancer after endocrine therapy as a combination therapy with Faslodex on Apr. 26 last year, Health Insurance Review and Assessment Service (HIRA) has been reviewing the revised reimbursement standard. The revised reimbursement standard on Ibrance has undergone deliberations by Cancer Deliberation Committee in last September and Drug Reimbursement Evaluation Committee (DREC) in last February, and was negotiated for reimbursement pricing with NHIS from Mar. 7 to May 6. Due to the cost-effectiveness issue raised by NHIS, Pfizer has agreed to refund a set ratio of claimed cost of Ibrance to NHIS, and also to lower the reimbursed price by 10.8 percent to lessen the financial impact. The Korean health authority projected the expanded reimbursement standard on Ibrance, in effect from June 1, would additionally cost them 16.5 billion won a year.
- Company
- Bispecific antibody by Yuhan & ABL BIO debuts at the AACR 20
- by An, Kyung-Jin May 19, 2020 06:06am
- YH32367/ABL-105, which Yuhan & ABL Bio are jointly developing, debuts on the international stage. Yuhan announced on the 15th that it will announce the results of the preclinical efficacy test of the bispecific antibodies for cancer immunotherapy 'YH32367 (ABL-105)' at the American Association of Cancer Research's 2nd online academic conference (AACR 2020). YH32367 / ABL-105 is a Pipeline drug under joint research by Yuhan & ABL Bio. By specifically binding to tumor cells and stimulating T-immune cell activation receptor 4-1BB, it increases the anticancer activity of immune cells and suppresses the growth of tumor cells. In September 2018, Yuhan Corporation secured global rights for two bispecific antibodies for cancer immunotherapy under preclinical stage through a contract with ABS Bio. The contract amount without obligation to return is ₩200 million, and the total contract size combined with milestones is up to ₩59 billion. This was achieved in one year and eight months of technology introduction. According to the abstract published on the 15th (local time) AACR website, YH32367 increased apoptosis cytokine secretion such as interferon gamma (IFN-γ) in human T-immune cells and induced tumor cell death. Animal experiments using humanized mice and human 4-1BB-expressing mice also showed superior anticancer efficacy compared to the control group. In particular, it explained that safety has been proven without identifying side effects of hepatotoxicity, which is one of the disadvantages of competitive drugs. Yuhan expects YH32367 to be effective against patients with resistance to existing anticancer drugs among a number of solid cancers such as breast cancer, stomach cancer, and lung cancer. The goal is to complete pre-clinical toxicity studies next year and start clinical trials.
- Company
- Will Hanmi also target Stivarga's patent?
- by Kim, Jin-Gu May 19, 2020 06:06am
- Hanmi's generic launch of Nexavar (Sorafenib) is imminent. Hanmi is considering internally reviewing a plan to target the patent of 'Stivarga (Legorafenib)', a secondary target treatment for liver cancer. If Hanmi succeeds in overcoming patents to Nexavar and Stivarga, it is expected that a lineup of targeted treatments for liver cancer will be established. According to the pharmaceutical industry on the 14th, Hanmi recently submitted an application of generic for Nexevar to the MFDS. Unless there is a special variable, the approval of an item for “Hanmisorafenib (tentative name)” is expected to be made soon. It is confirmed that Hanmi is already in the process of planning for the next step as the launch of Generic for Nexavar is imminent. Hanmi intends to target the patent of Stivarga, following to Nexava. Stivarga is a targeted anticancer drug that can be used as a secondary treatment for patients who fail to treat Nexavar. Bayer has a patent right. An official from Hanmi said in a call with Dailypharm, "With the imminent approval of generic for Nexavar, we are considering a new way to re-challenge the patent in the next step." In fact, Hanmi had previously tried the patents. However, the results were not good. It ended in defeat or self-dismissal. In April 2015, Hanmi, together with Huons, Yuhan, and Chong Kun Dang, requested invalidated trials for Stivarga's material patent (expired in March 2025), formulation patent (expired in August 2025), and hydrate patent (expired in September 2027). In June 2017, the Patent Tribunal sided with the original company on a trial of “partial dismissal” against the invalidation trial for a formulation patent. Subsequently, in August, domestic companies voluntarily canceled the trial for invalidating a patent. Although domestic companies seemed to have failed to acquire Stivarga's patent, Boryung requested a judgment to confirm the scope of passive rights alone in the hydrate patent. In the end, after two years of fighting, Boryung succeeded in pursuing patents in April 2019, leading to a trial. The decision was confirmed in May of the same year. Hanmi's strategy is no different from Boryung. It intends to re-challenge by raising a judgment on the passive scope of rights to Stivarga's hydrate patent. If Hanmi targets patents following Nexavar and Stivarga, it is expected to generate considerable synergy in that it will have both generics of primary targeted treatments for liver cancer. The original company, Bayer, also has the advantage of being able to perform continuous treatment and has an advantage over Lenvima. According to drug research agency IQVIA, sales of each drug amounted to ₩25.4 billion in Nexavar and 23.6 billion in Stivarga as of last year.
- Company
- Pfizer launches Vyndaqel followed by Vyndamax in Korea
- by Eo, Yun-Ho May 18, 2020 06:16am
- Pfizer is expecting to introduce 'Vyndamax' following 'Vyndaqel'. According to the related industry, Pfizer is in the process of approving for Vyndamax (Tafamidis meglumine) by the MFDS, a treatment for cardiomyopathy caused by hereditary transthyretin amyloid polyneuropathy (hATTR-PN) and transthyretin mediated amyloidosis (ATTR-CM). It is expected in the second half of the year. Vyndaqel (Tafamidis meglumine) and Vyndamax have the same active ingredients but differ in indication and dosage. In the case of Vyndaqel, it was already approved in Korea in 2015, and it is currently undergoing an expanded indication for cardiomyopathy indications by ATTR-CM. Both drugs added an indication for cardiomyopathy caused by ATTR-CM following hATTR-PN from the US FDA last year. The efficacy of ATTR-CM has been demonstrated in a phase III study. The primary endpoint of the study was a comprehensive assessment of mortality for all causes and frequency of hospitalization for cardiovascular disease, and the secondary endpoint was a Kansas City survey of 6-minute walking distance tests and quality of life for patients with heart failure. As a result of the study, the two drugs showed statistically significant results in both the mortality rate according to all causes and the hospitalization period due to heart disease compared to the placebo. On the other hand, hATTR-PN is a genetic disease, whereas ATTR-CM is not the only cause. There is a non-genetic factor, and it is more common in men than in women as age increases. The incidence of non-genotype hATTR-CM is higher than that of PN. It is estimated that there are more patients in the world.
- Opinion
- [Reporter’s View] COVID-19 and vaccine self-sufficiency
- by An, Kyung-Jin May 18, 2020 06:15am
- The U.S. and Europe have sparked a conflict over COVID-19 vaccine still in development. The tension arose when a multinational pharmaceutical company Sanofi announced its intention to prioritize the distribution of the vaccine to the U.S., in case the company successfully completes the development. During an interview with Bloomberg, Sanofi’s British CEO Paul Hudson who newly took over the office in last September said, “The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” so “the Americans will likely get Sanofi’s COVID-19 vaccine before the rest of the world.” Along with its competitor GlaxoSmithKline (GSK), the French-based multinational company has initiated COVID-19 vaccine co-development project. And apparently, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has provided USD 30 million (approximately 36.8 billion won) for the project Immediately after the news was released, the whole of Europe was shaken. Particularly, the reaction from France, where Sanofi’s headquarters and manufacturing plants are housed, was rough. The French government was infuriated by the pharmaceutical company’s public comment as the country and the EU have been often giving direct and indirect support for the company’s R&D programs. French Prime Minister Édouard Philippe reproached by twitting “A #COVID19 vaccine should be a global public good. And the equal access to the vaccine is not negotiable.” The European Commission official also published a statement insisting that “The vaccine against COVID-19 should be a global public good and its access needs to be equitable and universal.” The pharmaceutical industry experts are claiming the international cooperation has worsened as the EU intervened the U.S. and China’s race for the COVID-19 vaccine. Some are concerned that a war on exclusive pre-ordering of the vaccine in development may break out. Eventually, CEO Hudson took back his words, as his ‘America-first’ comment has inflicted a firestorm. When the vaccine is fully developed, he said all countries around the world would have an equal access to the vaccine. But the CEO also urged “the European countries should also assertively take risks on the vaccine development like the U.S.” He pointed out how the U.S. is taking a risk even before scientifically confirming the success of the vaccine development, whereas the European countries have not. The CEO also argued the risk should be shared among European countries and the U.S. Sanofi CEO’s comment also rings in a grave tone in Korea as well, where the country has not yet fully resolved the vaccine self-sufficiency issue. When Green Cross established the Hwasun vaccine plant in 2009, South Korea has become the 12th country in the world to locally procure flu vaccine. The locally made vaccine is viewed as the top contributor in overcoming the 2010 flu pandemic. Although it has been a decade since then, Korea’s self-sufficiency rate in vaccine has not improved much. Out of 19 National Immunization Program (NIP) vaccine types, only six types—hepatitis B virus, hemorrhagic fever with renal syndrome (HFRS), varicella, influenza, tetanus, diphtheria, and pertussis (Td), Haemophilus influenzae type b (Hib)—are locally produced without importing the vaccine strain. Other three vaccine types are locally produced with imported strain, and the rest of the nine types are imported as finished products. In case of a pandemic or biologic terrorism, Korea has to unavoidably rely on other countries for vaccine. When the country cannot even self-procure vaccines long demanded, it is skeptical if Korea would be able to promptly produce vaccine during a novel infectious disease outbreak. According to the World Health Organization’s (WHO) update, total eight cases of clinical studies in COVID-19 vaccine have started their global trial phase. Four of them are funded by Chinese government and corporations. Partnered with a biotechnology company Moderna, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), associated under the National Institute of Health (NIH), has started a clinical trial for a vaccine against COVID-19 from last month. The U.S. government body aims to report the immunological reaction in around coming July or August. In Korea, a number of pharmaceutical companies like SK Bioscience, GC Pharma and Genexine are seeking for a vaccine against COVID-19, but the progress is far behind compared to the U.S. or China. The country was able to put the limelight on its promising global level biotechnology as the world highly evaluated Korea’s ability to test the disease. To maintain the outstanding disease control capacity, the Korean government would need to invest and support the vaccine and treatment development, bottomlessly. Korea should let the latest pandemic be the reminder of the necessity of ‘vaccine self-sufficiency.’
- Policy
- The mechanism by SGLT2 inhibitors was first identified
- by Lee, Hye-Kyung May 18, 2020 06:15am
- Research has shown that the 'diabetes treatment agent' SGLT2 inhibitor lowers the risk of cardiovascular disease by inhibiting inflammatory cytokine secretion. Jung-Sun Kim, Professor of cardiology, Yong-ho Lee Professor of endocrinology, and Sang-Guk Lee Professor of laboratory medicine at Severance Hospital and So Ra Kim, Professor of hospital medicine at Yongin Severance Hospital said on the 14th that SGLT2 inhibitors significantly reduced inflammatory cytokine secretion in macrophages. This is the first study to show that SGLT2 inhibitors reduce cytokine secretion in the human body, and was published in the latest issue from Nature Communications, a world-renowned international academic journal. Diabetes is closely related to abnormal metabolic conditions, including inflammation, dyslipidemia, and insulin resistance. Among these, inflammatory cytokines involved in inflammatory reactions are being identified as causes of various cardiovascular disease (CVD) such as myocardial infarction, heart failure, and angina. Inflammatory cytokines are secreted from NLRP3 inflammasomes present in macrophages. SGLT2 inhibitors are known to reduce cardiovascular disease or mortality in diabetic patients by inhibiting reuptake of glucose from the kidneys. The American Heart Association, the ESC, and the EASD recommends that SGLT2 inhibitors be given priority to other medications for diabetics at high risk of cardiovascular disease. However, the mechanism by which SGLT2 inhibitors lower the risk of cardiovascular disease has not been determined. The research team randomly selected type II diabetes patients admitted to Severance Hospital from November 2016 to July 2017, and divided them into groups A and B. Group A (29 patients) assigned to treatment with SGLT2 inhibitors and group B (32 patients) received a sulfone urea drug, a diabetes drug that promotes insulin secretion. As a result of analyzing macrophages isolated from blood after 1 month, group A significantly decreased secretion of inflammatory cytokines than group B. SGLT2 inhibitors inhibited NLRP3 inflammasome activity by 83% more than group B by lowering blood sugar and reducing uric acid and insulin hormone. Particularly, in group A, NLRP3 inflammasome activity and inflammatory cytokine secretion were decreased in the body compared to before administration of the drug, but group B had no such effect. In the group A taking the SGLT2 inhibitor, the blood ketone body (β-hydroxybutyric acid) also increased from 0.06 mM to 0.20 mM. Increased blood ketone bodies inhibited the activity of NLRP3 inflammasomes, resulting in decreased secretion of inflammatory cytokines. Professor Yong-ho Lee said, "While large-scale studies have been reported that SGLT2 inhibitors reduce cardiovascular disease, researchers around the world are very interested because the mechanism by which cardiovascular disease is reduced is not yet clear." Professor Lee said that this is the first study that revealed that SGLT2 inhibitors reduce NLRP3 inflammasome activity and inflammatory cytokine secretion in the human body, and further studies will be conducted in the future.
- Policy
- Patients suffer from quarrels between companies & the HIRA
- by Lee, Jeong-Hwan May 18, 2020 06:15am
- Patients urged Ono Pharma Korea, BMS Korea, and MSD Korea to come up with a reasonable burden-sharing plan that the health authorities could accept. Patients have been urging to expand the health benefits of Opdivo (Nivolumab) and Keytruda (Pembrolizumab), which have various therapeutic indications, such as lung cancer and kidney cancer. It is a request to urgently improve the reality that Opdivo and Keytruda have failed in the HIRA’s Cancer Drug Review Committee due to controversy over the financial burden of health insurance due to high prices. On the 14th, at 10 am, the Korea Alliance of Patients Organization held a press conference in front of Ono Pharma Korea, urging the expansion of health benefit for immune cancer drugs. At 1 pm on the same day, the Korea Alliance of Patients Organization will hold a press conference with the same purpose at the Seoul Women's Plaza. The Korea Alliance of Patients Organization was scheduled to hold an interview in front of Ono Pharma Korea and MSD Korea, the developer of Opdivo and Keytruda respectively. Changes in place were inevitable as meetings and interviews became impossible due to the occurrence of COVID-19 confirmed patients in Seoul Square, where MSD resides. The patient's demand is that the developer & the HIRA should stop negotiating drug prices and prepare a reasonable level of financial sharing that the financial authorities will accept. The domestically approved immune anticancer drugs include Ono Pharma·BMS' Opdivo, MSD's Keytruda, Roche's Tecentriq (Atezolizumab), AstraZeneca's Imfinzi (Durvalumab), and BMS' Yervoy (Ipilimumab). Indications are rapidly expanding from non-small cell lung cancer, Hodgkin's lymphoma, head and neck cancer, kidney cancer, bladder cancer, gastric cancer, esophageal cancer, breast cancer, etc., Looking at the health insurance coverage, Opdivo, Keytruda and Tecentriq were reimbursed as non-small cell lung cancer, Opdivo and Keytruda as melanoma, and Tecentriq as bladder cancer. In order to receive treatment with immunosuppressive drugs for indications other than the indications is reimbursed, it costs from ₩ tens of millions to more than ₩100 million. The Korea Alliance of Patients Organization said to improve this reality. "The quality of life of terminally ill cancer patients living in the era of targeted anti-cancer drugs, followed by targeted anti-cancer drugs, has improved in a different dimension than when the first chemotherapy was administered," the organization said. "It is an urgent reason to increase the supply of immuno-cancer drugs." The organization said, “Pharmaceutical companies seeking to get high drug prices and financial authorities trying to save money on health insurance are not making any concession over the expansion of the benefits of anti-cancer drugs.” "We only accepted two indications for head and neck cancer and eliminated indications for kidney and stomach cancer." The organization said that Keytruda’s company also did not accept the expansion of the primary treatment reimbursement standard for non-small cell lung cancer. The HIRA’s Cancer Drug Review Committee asked pharmaceutical companies to prepare a rational financial sharing plan. The organization criticized the patient for dying of life-sustaining or cure-out opportunities while governments and pharmaceutical companies struggled with the price of drugs, such as a proverb saying when elephants fight, it is the grass that suffers. The Korea Kidneycancer association also issued a statement saying that the HIRA’s Cancer Drug Review Committee would speed up the registration of Opdivo for disqualification due to the financial burden. The organization also said that it was difficult to understand that Opdivo did not get kidney cancer benefits from the HIRA’s Cancer Drug Review Committee. According to the organization, the cost of the immuno-cancer drug is close to ₩6 million to ₩10 million per month, but it is also important for the health and financial benefits of the health insurance company, but the most important thing is patient’s life. The organization said that it is necessary to extend the patient's life by using the resources used in the patient support program that is conducted before the reimbursement to reduce the price.
- Company
- Hanmi on legal action against Sanofi returning efpeglenatide
- by Chon, Seung-Hyun May 18, 2020 06:14am
- A multinational pharmaceutical company Sanofi has decided to return the rights on antidiabetic candidate medicine efpeglenatide back to Hanmi Pharmaceutical. Apparently, the French-based company is putting an abrupt brake on the development of efpeglenatide, licensed out as the biggest Korean-developed pipeline in 2015. Hanmi Pharmaceutical explains “The decision was solely made by Sanofi with their shift in business plan,” and stated it would review taking a legal response. A view over Hanmi Pharmaceutical headquarters On May 14, Hanmi Pharmaceutical released news that Sanofi has notified the intention to return the licensed out efpeglenatide, currently undergoing a series of phase 3 clinical trials. According to the contract terms, the two companies are to finalize the decision on the retuning of the rights after 120 days of negotiation. Even if the French company returns the right, the Korean company is not subjected to return EUR 200 million (approximately 260 billion won) already received from the partner company. Hanmi Pharmaceutical official elaborated, “We have decided to negotiate with Sanofi to complete the ongoing phase 3 global study on efpeglenatide as it is close to the end,” and said the company “plans to seek for a new global partner company.” A glucagon-like peptide-1 (GLP-1) receptor agonist, efpeglenatide is an innovative bio drug candidate to treat patients with diabetes by administering the drug once-weekly or once-monthly at most. The candidate drug is based on Hanmi Pharmaceutical’s core platform technology ‘Labscovery,’ which prolongs the short half-life period of biologics and reduces administration frequency and dose to lessen the adverse reaction and improve effect. In November 2015, Hanmi Pharmaceutical and Sanofi had signed a license-out deal valued at 390 million euros on the Quantum Project (efpeglenatide, long-acting insulin, efpeglenatide plus long-acting insulin combination). Although the contract terms have been revised twice since then, the deal is still the biggest license out deal a Korean pharmaceutical company holds to the date. Hanmi Pharmaceutical claims Sanofi’s decision to return their rights over efpeglenatide were unreasonable, because the global company is dropping the already agreed upon phase 3 clinical study. Intending to take a legal action, Hanmi Pharmaceutical official said, “Sanofi’s decision was made without discussing with Hanmi Pharmaceutical.” After a new CEO took over the office in last September, Sanofi has unveiled a widely reformed R&D plan to halt diabetes and cardiovascular related research but to strategically concentrate on four main sectors including oncology, hematology, rare disease and neurology. When the announcement was made, Sanofi officially noted the multinational company would give up the rights to commercialize and distribute the antidiabetic pipeline efpeglenatide and search for a new partner, however, the ongoing phase 3 clinical trials would be completed with the company. At the moment, Sanofi is conducting five global phase 3 clinical trials related to efpeglenatide. Hanmi Pharmaceutical stressed Sanofi giving up on the efpeglenatide rights is unrelated to the medicine’s efficacy and safety. Hanmi Pharmaceutical official stated, “As Sanofi has publicly promised affected patients, investigators and Hanmi Pharmaceutical that the global phase 3 clinical trials would be fully conducted, we would demand Sanofi to keep their word,” and “Further legal actions pursuing litigation would be reviewed, if need be.” The Korean company official stressed, “Efpeglenatide is a promising pipeline, as the global GLP-1 receptor agonist market would be worth approximately USD 10 billion by the time the candidate medicine is commercialized,” and “the biologic would be able to find a new global partner at around the end of the year or the beginning of next year, when the outcomes of the superiority trial against efpeglenatide’s competitor Trulicity would be released.”
- Policy
- Xeljanz was rejected for the uninsured benefit
- by Lee, Hye-Kyung May 18, 2020 06:14am
- The application to use 'Xeljanz (Tofacitinib citrate)' from Pfizer Korea, which has been approved for rheumatoid arthritis and ulcerative colitis, was rejected for the uninsured benefit for patients with dermatomyositis or severe alopecia. The HIRA is applying in advance for the uninsured benefit that is not approved by the MFDS in order to prevent the use of drugs that lack medical basis or are concerned about safety. According to the details of the 'disapproval of the uninsured benefit' recently released by the HIRA, 10 new cases of disapproval, including Xeljanz, have been added, resulting in a total of 183 cases of disapproval of the uninsured benefit. First of all, in the case of Xeljanz, a medical institution applied to prescribe 5mg twice a day for 6 months to refractory dermatomyositis patients, but was rejected due to insufficient medical evidence. Another medical institution has requested that Xeljanz be used in patients with severe alopecia areata who have failed to continue treatment with systemic steroids or Cyclosporine for 3 months or cannot continue treatment due to side effects (alopecia over 80% of the entire scalp area). This institution evaluated the area of hair loss every 6 months and compared to the first time, if the area of hair loss decreased by more than 50% (SALT 50), it will be administered continuously, and the drug will be discontinued if hair loss improves with an SALT score of 10 or less. However, due to insufficient evidence, it was rejected. In this case, 'Olumiant (Baricitinib)', a treatment for rheumatoid arthritis in Lilly Korea, has been newly added. A medical institution said that it would administer Olumiant once a day to patients in 2019-nCoV acute respiratory disease, among patients undergoing inpatient treatment, fever, elevated inflammatory values, pneumonia findings and hypoxia in chest radiographs not improving or worsening. However, the HIRA said, "The data presented suggests the theoretical possibilities screened by artificial intelligence, and medical evidence is insufficient to support clinical use." In addition, it is not permitted to use the uninsured benefit because there are warnings that infection patients should not be used, and that the infection rate will be increased.” In addition, 'Botox', Carmine Injection 0.8%, Tuberculin PPD RT , Diabex XR, Luphere Depot, Enbrel, Enbrel Myclic Pen 50mg, Eucept Prefilled Syringe, Eucept autoinjector which have been applied for the uninsured benefit, were also not approved for use due to insufficient medical evidence of the submitted data.
