- LOGIN
- MemberShip
- 2026-04-12 22:51:49
- Company
- BRAF I Braftovi can be prescribed at the Big 5
- by Eo, Yun-Ho Mar 03, 2022 06:01am
- Along with the progress of the insurance benefit procedure, "Braftovi," which lowers the BRAF, will be prescribed at general hospitals. According to related industries, Braftovi (Encorafenib), a treatment for colorectal cancer in Ono Pharmaceutical Industry, passed the Pharmaceutical Affairs Committee (DC) of Korea University Anam Hospital, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center. Braftovi can be used as a combination therapy with Erbitux (Cetuximab) of Merck Korea in adult patients with direct bowel cancer with previous treatment experience and confirmed BRAF V600E mutation. It is currently in the process of registering benfits, and has passed the HIRA Cancer Disease Review Committee for the first time this year in January. It will be the first drug that can be prescribed for metastatic colorectal cancer with confirmed mutations in BRAF V600E with previous treatment experience. Combination therapy with Braftovi was confirmed to be effective through a phase 3 clinical BEACON CRC study in patients with non-removable progressive or recurrent direct bowel cancer with BRAF V600E mutations after primary or secondary treatment. In the study, combination therapy of Braftovi-Cetuximab showed statistically significant extensions (HR 0.60, p=0.0003) in the overall survival period (OS) compared to the control, Irinotecan-Cetuximab-based combination therapy. The median OS value was 8.4 months in the Braftovi group and 5.4 months in the control group. In the objective response rate (ORR) according to the independent central review (BICR), the combination therapy of Braftov-Cetuximab was 20%, showing a statistically significant improvement compared to 2% of the control group. The median progression-free survival period (PFS) was 4.2 months for combination therapy of Braftov-Cetuximab and 1.5 months for the control group. In this study, there was no unexpected toxicity of combination therapy of Braftov-Cetuximab. Positive BRAF V600E gene mutation occurs in 4.7% of patients with direct bowel cancer in Korea. If there is a BRAF V600E mutation, the prognosis is known to be worse than that of patients who do not. There was no approved drug based on its efficacy and effectiveness in direct bowel cancer with BRAF gene mutation, so a new treatment option was needed.
- Company
- Entresto settles in as early-stage heart failure treatment
- by Eo, Yun-Ho Mar 03, 2022 06:01am
- The heart failure treatment ‘Entresto’ will now be covered by insurance benefits in the first line as well. According to industry sources, reimbursement for Novartis Korea’s chronic heart failure treatment ‘Entresto (sacubitril)’ will be expanded to cover patients with acute decompensated heart failure who are in a stable hemodynamic condition after hospitalization regardless of their administration of ACE inhibitors or angiotensin II receptor blockers from March 1st. On the 14th, the authorities approved an additional indication for Entresto in patients with chronic heart failure whose left ventricular ejection fraction (LVEF) level is below normal to ‘reduce risk of cardiovascular deaths and hospitalization from heart failures.’ The reimbursement expansion this time is based on the PIONEER-HF study that was conducted on the indicated patient group as well as references from textbooks, guidelines from Korea and overseas, and academic opinion. In the PIONEER-HF study, a significant reduction of NT-proBNP was identified from Week 1 of treatment, and the clinical efficacy of Entresto was consistent among various patient groups including patients newly diagnosed with heart failure and RASi-naïve patients. Also, the 12-week open-label extension results that were presented at JAMA Cardiology 2019, the drug demonstrated consistent treatment effect and safety at Week 12. The difference between the two treatment groups, such as readmission within 8 weeks, was not narrowed for 4 weeks, confirming the clinical necessity on the initial use of Entresto. Entresto is currently recommended as the standard-of-care in heart failure treatment guidelines in Korea and abroad. The European Society of Cardiology (ESC) and the American College of Cardiology (ACC) recommends Entresto as a first-line treatment option, and in January 2021, the 2021 update to the ACC Expert Consensus Decision Pathway amended the guidelines to recommend Entresto ahead of ARB or ACE inhibitors. Also, the ESC’s Heart Failure Guidelines that was updated in August 2021 emphasizes a combined treatment strategy that simultaneous initiates the use of 4 essential drugs including ARNI-class drugs (Entresto) that reduce the risk of death from heart failures Meanwhile, Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNI) that directly works on the heart. It works on two hormonal pathways, to activate the NP nerve hormones that benefit the cardiovascular system while inhibiting RAAS which is harmful to the cardiovascular system.
- Policy
- Ahn Cheol Soo, promised for Vaccine Sovereignty
- by Lee, Jeong-Hwan Mar 03, 2022 06:00am
- Like other party candidates, the presidential candidate of the People's Party Ahn Cheol Soo also put securing vaccine sovereignty and fostering the pharmaceutical bio-industry at the forefront of health care pledges. It also announced specific pledges such as half-price hair loss drugs, free vaccination against rotavirus in newborns, support for vaccination against HPV, and strengthening support for essential medical care. This is the result of examining health and welfare pledges in the policy pledge book released by candidate Ahn Cheol Soo on the 28th. Candidate Ahn, also promised to "take a leap forward as a vaccine sovereign state" through national investment in the bio industry. With the will not to repeat the current government's policy practice, which caused public confusion and anxiety due to the failure to secure the COVID-19 vaccine early, the government intends to implement policies to prepare for infectious diseases that will occur periodically in the future. Specifically, candidate Ahn drastically improved unreasonable regulations on vaccine development, creating an ecosystem for the vaccine industry that is good for business, and strengthening support for clinical trials. He also revealed his vision to foster the vaccine industry into our future industry by discovering and actively supporting companies with super-gap technologies in the pharmaceutical bio sector. He also specified the half-price hair loss pledge he promised earlier Candidate Ahn explained that the application of health insurance increases the financial burden because there is currently little difference in price between the original and generic hair loss drugs. He directly criticized Democratic Party candidate Lee Jae-myung's pledge to pay health insurance for hair loss. He declared that he would reduce the burden of hair loss and secure the soundness of health insurance finances by lowering the price of generic hair loss drug to 600 to 800 won. He said he would introduce incentives to revitalize generics of hair loss and adjust them with little financial input, including them in preliminary benefits, if necessary. It pledged to significantly expand R&D support for the health industry for hair loss drugs. The neonatal rota vaccine is a household burden with an inoculation cost of about 300,000 won, and the government plans to support all newborns, including the national vaccination. Like the United States, the United Kingdom, and Germany, the government and local governments provide full support for vaccination costs. He plans to expand the number of free HPV vaccines that cause cervical cancer than now. Currently, the free vaccination standard for girls under the age of 12 will be greatly expanded to men and women under the age of 26, while women under the age of 45 will be provided with vaccination fees if desired. The government-supported vaccine will be changed from Cervarix and Gardasil, the current 2-valent and 4-valent vaccines, to Gardasil 9, the 9-valent vaccine, to expand the scope of prevention. It also included policies to reduce the medical gap between regions by strengthening support for essential medical fields Candidate Ahn expressed concern that the proportion of surgeons, pediatrics, and obstetrics and gynecologists among all doctors is on the decline, and that there may be no supply due to insufficient number of majors. As a result, the government will provide indirect expenses such as wages and education expenses for training in essential medical subjects, improve the number of unpopular subjects, and take incentives to eliminate avoidance factors such as resolving disputes over medical accidents. The project to support vulnerable delivery areas will be expanded to obstetrics and gynecology medical institutions to support facilities, equipment, operating expenses, and labor costs of delivery medical institutions, and a mandatory placement system for obstetricians with more than 200 beds will be introduced.
- Policy
- To establish a pharmaceutical bio-innovation committee
- by Lee, Jeong-Hwan Mar 03, 2022 06:00am
- Yoon Suk-youl, presidential candidate for the presidential election, pledged to establish a "pharmaceutical bio-innovation committee" directly under the Prime Minister, while creating an ecosystem that can establish sovereignty in pharmaceutical bio and foster key talents and jobs in the pharmaceutical bio industry. It is said that it will overhaul the COVID-19 response system within 100 days immediately after taking office and implement the national responsibility system for vaccine side effects. The pledge also included strengthening access to medicines for patients by diversifying the rapid benefit registration system for drugs with severe rare diseases such as ultra-high-priced anticancer drugs compared to the previous one. On the 24th, Candidate Yoon Suk-youl announced a policy pledge for the power of the people in the 20th presidential election. Candidate Yoon said he would use the health care and pharmaceutical bio-industry as a new path to establishing health security and creating national wealth. He specified in his pledge the establishment of a "pharmaceutical bio-innovation committee" directly under the Prime Minister in line with the establishment of a pharmaceutical bio-control tower directly under the Blue House demanded by the KRPIA. In addition, the vision is to support national R&D to establish vaccine sovereignty and global vaccine hubs and to establish an environment to expand talent and jobs in the pharmaceutical bio industry. ◆ Reorganization of the Infectious Disease Response System = Yoon said the current government failed to respond to COVID-19. They say that they have failed to establish a proper treatment system while causing unnecessary economic damage and prolonging damage to small business owners and self-employed people by keeping distance without principles. In response, candidate Yoon plans to completely reorganize the COVID-19 response system within 100 days. The pledges include scientific and data-based quarantine measures, reorganization of the manual for responding to new infectious diseases, and conversion of public medical institutions to hospitals dedicated to COVID-19. It also declared that it will open the era of biohealth and become a vaccine and treatment powerhouse. He criticized that six domestic vaccines are currently undergoing clinical trials, but have nothing to do with government support. It is pointed out that the SK Bioscience vaccine, which is in phase 3 of clinical trials, is also being developed with technical cooperation and the CEPI support at the University of Washington in the United States. He promised to expand the overall national R&D, including high-speed vaccine development and manufacturing technology, post-corona vaccines and treatments, essential vaccines, and digital quarantine. The government's responsibility system for essential medical care and the national responsibility system for side effects of COVID-19 vaccination were included in the pledge. Under the public policy fee system, policy fees added compared to usual times are paid to doctors and nurses in emergency situations such as COVID-19, and public policy fees are also paid to severe trauma centers, delivery rooms, and newborn rooms. ◆ National Health Protection = Candidate Yoon also pledged to expand support for disaster medical expenses, ease the burden of national nursing expenses, and introduce a rapid registration system for expensive anticancer drugs and new drugs for severe and rare diseases. Among them, the rapid registration system of expensive anticancer drugs and new drugs for severe and rare diseases is a policy proposal that the KRPIA strongly appealed to when it met with party leader Lee Joon-seok. Candidate Yoon said that it takes about two years to pay health insurance benefits for new drugs with severe rare diseases such as cancer, and patients are paying high prices and administering new drugs. RSA also pointed out that it was applied only to 41 drugs, and 32 of them were concentrated on anticancer drugs. Candidate Yoon promised to shorten the health insurance registration process for anticancer drugs and treatments for severe rare diseases. It also said it will use RSA to reduce drug price negotiations and the burden on patients and insurers. In order to secure insufficient emergency and essential medical care and medical personnel in the region, the government will strengthen the publicity of local national university hospitals and upper-level general hospitals and expand them to cities and provinces without upper-level general hospitals.
- Company
- Omicron confirmed cases continue to occur in companies
- by Ji Yong Jun Mar 02, 2022 05:55am
- Due to the spread of COVID-19 Omicron, there are a series of in-house confirmed cases within pharmaceutical bio companies. Pharmaceutical bio companies are responding by operating the Omicron emergency system and granting additional telecommuting to close contacts. According to the Central Disease Control Headquarters on the 2nd, the number of new confirmed cases as of the 1st was 138,993. Compared to last week (February 25), the number of confirmed patients increased 1.4 times and more than 6.0 times from four weeks ago (February 1st). As a result, the cumulative number of confirmed patients in Korea is 3,273,449. As the spread of Omicron increases, it is known that confirmed cases occur one after another in pharmaceutical bio companies. Pharmaceutical Company A reportedly had a commotion in which all employees classified as close contacts at the time left work after an in-office employee was recently confirmed. Pharmaceutical B is also known to have returned home to all those who worked in the same department the previous day after an in-office employee was confirmed by a self-diagnosis test before going to work. An official from a pharmaceutical company said, "All of the contacts have been converted to telecommuting because the number of employees on duty has been confirmed," adding, "Some pharmaceutical companies also know that the number of confirmed cases by employees is increasing." There have been no reports of mass infections in pharmaceutical bio companies yet, but there are confirmed cases all over the company, so we are paying attention to the management of confirmed cases. According to the guidelines of the quarantine authorities, they are paying more attention to the corporate quarantine system as it enters self-management according to the situation. Hanmi Pharmaceutical operates an emergency situation room in the CSR team to manage confirmed patients at work. The emergency room manages employees who have symptoms such as fever, cough, and body aches, or who have been in close contact with confirmed patients in their families. Even if an employee classified as a close contact is tested negative in a self-diagnosis test, additional telecommuting is given according to the health status and intention of the employee. Dong-A Socio Group has increased the proportion of telecommuters among its in-house workers to 50%. This is to reduce unnecessary contact between employees. In addition, in the event of an in-house confirmed patient, the scope is set and managed larger than the government's close contact standard (more than 15 minutes within 2m). In addition, the government is taking measures to reduce contact between employees by varying the hours of use of the cafeteria or to support diagnostic tests and work from home for employees with suspected COVID-19 symptoms. HK inno.N recommends telecommuting for all employees except for essential field workers to reduce contact with employees at workplaces nationwide, which has been underway since January. It also established a system in which each department creates an emergency contact network to report symptoms or to the head of the department when the cohabitant is confirmed. If a confirmed patient comes out in-house, it is conducting its own quarantine guidelines to check close contacts and return home along with internal sharing. However, pharmaceutical companies are also concerned about work disruptions as a series of self-quarantine people follow due to close contact. Concerns are growing that telecommuting on a large scale in essential field groups such as factories and research institutes could disrupt production schedules. Since the 1st, the government has applied eased self-quarantine guidelines that require the government to exempt families living with confirmed patients from quarantine regardless of whether they are vaccinated or not. Most pharmaceutical bio companies recommend working from home if their cohabitants are confirmed, and the key is whether employees will reorganize their quarantine standards to minimize work gaps. An official from a large pharmaceutical company said, "In addition to the flexible work system and wearing regular masks, we are striving for internal quarantine in a stronger way than the government guidelines." However, as the government's quarantine guidelines are easing, there are many cautious parts about how to set the number of quarantine personnel in case of in-house confirmed patients, he said.
- Company
- Keytruda may make ₩300 billion with 1st-line reimb
- by Mar 02, 2022 05:55am
- The reimbursement expansion approval of Keytruda is expected to add wings to the sales growth of an already leading product in the domestic pharmaceutical market. It is expected that the company may achieve ₩300 billion in sales with its reimbursement expansion to the first-line, which has more patients, from the ₩200 billion sold last year. According to industry sources, the insurance benefit for MSD’s PD-1 inhibitor Keytruda (pembrolizumab) will be expanded to first-line treatment of NSCLC. This is the first time an immunotherapy drug was granted reimbursement for the first-line treatment of cancer. Also, a new reimbursement category was prepared for the drug’s use as second or higher-line monotherapy in Hodgkin’s lymphoma. Patient groups that will be newly benefitting from the reimbursement expansion are ▲ Patients with advanced (Stage IV) NSCLC (PD-L1 positive (TPS≥50%) without EGFR or ALK mutations, ▲ patients with metastatic non-squamous NSCLC without EGFR or ALK mutations (in combination with chemotherapy) ▲ metastatic non-squamous cell lung cancer without EGFR or ALK mutation (in combination with chemotherapy) ▲ adult and ages 2 or older patients who have relapsed/refractory typical Hodgkin’s lymphoma and have failed two or more therapies and failed or cannot receive autologous stem cell transplants (ASCT). The reimbursement expansion this time is expected to become a ‘catalyst’ for the explosive growth of Keytruda’s sales. Based on IQVIA, Ketyruda’s sales had surpassed ₩200 billion for the first time last year. This is a 28.5% increase from the ₩155.7 billion made in the previous year. The drug has topped the ranks with its sales for the second consecutive year. With its reimbursement expanded to first-line treatment, an area with relatively more patients, Keytruda is expected to be the first to exceed ₩300 billion in annual sales. The health authorities believe 4,000 additional metastatic NSCLC and Hodgkin lymphoma patients will receive insurance benefits with the expanded reimbursement. Simple calculation of once every three weeks (2 vials) administration at the discounted price (₩2,107,642) will bring around ₩72 million in annual sales per patient. In other words, even if only half of these potential patients are treated with Keytruda, this will bring in ₩140 billion in sales. Quarterly sales of Keytruda (Source=IQVIA) Keytruda's sales had surged when it was initially approved for reimbursement. Its sales, which stayed at ₩10 billion after its release in Korea in 2015, skyrocketed to ₩70.4 billion after it started being reimbursed as a second-line treatment for NSCLC in August 2017. In 2019, its sales exceeded ₩100 billion. It has been analyzed that the reimbursement approval played a big part in Keytruda's sales exceeding ₩200 billion only 6 years since its release. Less than 10 products including Lipitor, Avastin, Tagrisso, and Humira, had made over ₩100 billion in annual sales in the domestic prescription drug market. Among the products, Keytruday was the only product that recorded over ₩200 billion in sales as a single product. If patients start using Keytruda for first-line treatment, its annual sales may easily reach ₩400 billion. Of course, due to the expenditure-cap type RSA that was agreed upon for the reimbursement, the company’s profit may not be proportional to the increased sales. This is because the company and the authorities agreed to increase the company's share of the cost burden after undergoing 9 deliberations by the Cancer Disease Deliberation Committee. The reimbursement extension was also good news for the patients. The immune checkpoint inhibitor Keytruda treats cancer with a different mechanism of action than other existing anticancer drugs. It inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The introduction of Keytruda had changed the treatment paradigm for NSCLC, which was untreatable using targeted therapies. However, its high cost had acted as a high barrier in its access. Until now, the non-reimbursed use of Keytruda had cost nearly ₩100 million, an amount difficult to come up with unless you have private medical indemnity insurance or go to hospitals that are applied the new DRG system. However, with the reimbursement expansion, its price had fallen 25.6%, and patients will now only need to bear 5% of the cost as a copayment, which is around ₩3.5 million a year.
- Company
- Tylenol's sales amounted to ₩83.1 billion last year
- by Chon, Seung-Hyun Mar 02, 2022 05:54am
- OTC Tylenol recorded the highest sales ever. Sales more than doubled last year from the previous year due to a surge in demand for COVID-19 vaccinations. However, growth slowed in the second half of last year as demand for Tylenol was resolved. According to IQVIA, a pharmaceutical research institute, sales of the Tylenol series last year amounted to 83.1 billion won, up 118.4% from 38.1 billion won a year earlier. It is sales of four types: Tylenol, Tylenol 8-hour ER, Tylenol Cold, and Women's Tylenol. Sales of the Tylenol series did not change much from 20 billion won to 30 billion won every year, but soared suddenly last year. Sales of Tylenol and Tylenol 8-hour ER, which are used as antipyretic analgesics, surged. Sales of Tylenol and Tylenol 8-hour ER totaled 80.2 billion won last year, up 133.4% from the previous year. Tylenol's sales surged 159.4% from 24.3 billion won in 2020 to 62.9 billion won last year, while Tylenol's 8-hour ER sales rose 71.1% from the previous year to 17.3 billion won last year. It is analyzed that sales have increased significantly as COVID-19 vaccinations started purchasing Tylenol in preparation for fever and muscle pain. As COVID-19 vaccinations began in earnest in Korea from the beginning of last year, demand for Tylenol surged. Tylenol ranked first in sales among all OTCs last year. It was also pointed out that the government contributed to the surge in Tylenol's sales. The quarantine authorities informed those subject to vaccination in March last year, "If side effects such as fever occur, it is better to take Tylenol." Since then, the demand for purchasing Tylenol has soared, leading to a shortage. According to quarterly sales of acetaminophen single-drug Tylenol, it surged in the first half of last year and slowed down somewhat in the second half. Sales of Tylenol and Tylenol 8-hour ER more than tripled from the previous quarter from 10.7 billion won in the first quarter of last year to 32.9 billion won in the second quarter. In the case of Tylenol, sales more than tripled from 8.1 billion won in the first quarter of last year to 25.5 billion won in the second quarter, while Tylenol 8-hour Al also expanded from 2.6 billion won to 7.5 billion won during the same period. Sales of Tylenol and Tylenol 8-hour ER jumped sharply from the previous year to 20.4 billion won and 16.2 billion won in the third and fourth quarters of last year, respectively, but decreased from the second quarter. Sales in the fourth quarter of last year fell by half compared to the second quarter. It is analyzed that the unstable supply and demand of Tylenol has been resolved and sales of Tylenol have been on the decline through the purchase of generics. In May last year, the MFDS disclosed information that more than 60 acetaminophen single agents were on sale in addition to Tylenol, inducing the purchase of other products with the same ingredients. In June last year, the MFDS decided to cooperate with KPA, KPBMA, and KPDA in the smooth supply of Acetaminophen. KPDA also urgently implemented a plan to supply Acetaminophen drugs, which are supplied first from producers, to pharmacies nationwide.
- Policy
- Negotiations with NHIS on Actemra have been completed
- by Lee, Tak-Sun Mar 02, 2022 05:54am
- Actemra (Tocilizumab), a treatment for rheumatoid arthritis by JW Pharma, has been officially recognized as a treatment for COVID-19 in Korea. The drug, which has been used in patients with severe COVID-19 for purposes other than permission, will also be covered by health insurance benefits from March. On the 24th, the MOHW announced that Actemra is preparing to revise the regulations so that benefits can be applied as a treatment for COVID-19. Earlier, the NHIS negotiated with JW Pharma, a domestic importer and seller, to apply benefits. Through this, it is possible to apply benefits to severely ill patients with COVID-19. According to the revision of the MOHW, medical care benefits are recognized when administered to COVID-19 patients aged 2 or older beyond the scope of the existing permits of Actemra (excluding SC injections). "If a patient is admitted to an intensive care unit or a hospital room within 48 hours and needs respiratory treatment of HFNC (High Flow Nasal Canula) or higher," alternatively, it corresponds to "the case of administration to patients who rapidly deteriorate to a state in which respiratory treatment above High Flow Nasal Cannula (HFNC) is required even though they have been treated with steroid therapy and low flow oxygen therapy." Full support is provided through health insurance without the patient's copayment. Actemra, unlike in Korea, is already used as a treatment for COVID-19 abroad. The U.S. FDA decided on Actemra as a treatment for COVID-19 in June last year. The European Commission also approved it as a treatment for COVID-19 in December last year. Recently, the WHO also added Actemra to the Pre-qualification Review List for COVID-19 Treatment for reference by middle and low-income countries that have difficulty in independent drug screening. It has been used as an offline in Korea, but the problem is that the patient had to pay the full price of the drug because it was not paid. Other COVID-19 treatments approved in Korea are purchased entirely by the state and have no Pt's payment. Therefore, the medical community also requested the purchase of Actemra to the state in terms of equity. Actemra achieved 20 billion won in domestic sales last year, up 24.9% year-on-year. Currently, Actemra 80mg's price is 134,263 won, Actemra 200mg's price is 306,166 won, and Actemra 400mg's price is 537,060 won, while SC (subcutaneous injection) product is 345,682 won. Until now, patients have paid all the drug prices, but if health insurance benefits are applied, the patient will not be burdened with the drug prices. Actemra is also pushing for a change in permission to expand manufacturing sources limited to Japan due to the recent shortage of supply. It is also known that EUA plans as a treatment for COVID-19 are being considered. Meanwhile, JW Pharma also announced on the 25th that Actemra's benefit range will be expanded for the purpose of treating COVID-19 (COVID-19) in accordance with the revision announced by the MOHW. The company explained that the new revision, which will take effect on March 1, has changed its standards to reflect the status of overseas permits such as FDA EUA, clinical research literature, and related academic opinions. An official from JW Pharma said, "Considering the recent surge in confirmed cases of Omikron mutant virus, we have been closely discussing with health authorities to expand the benefits of Actemra. The EUA is also quickly proceeding with the MFDS." Actemra is an antibody treatment that treats diseases such as rheumatoid arthritis and pediatric idiopathic arthritis by inhibiting the binding of IL-6 and its receptors, a protein that causes inflammation in the body. It has been shown that it effectively lowers the mortality rate of severely ill and critically ill patients with COVID-19 and reduces hospitalization time in global clinical trials, a complication of excessive immune responses. JW Pharma acquired Actemra's domestic development and exclusive sales authority from Chugai under Roche Group in 2009 and has since been selling it since 2013 through phase 3 clinical trials for rheumatoid arthritis patients.
- Opinion
- [Reporter’s View] Why Big Pharmas 'select and focus'
- by Mar 02, 2022 05:54am
- In the famous TV show ‘Backstreet,’ CEO Baek Jong-won’s main advice and solution for small eateries suffering from slow business was to ‘reduce menus.’ Paik tells the restaurant owners to concentrate on their main menus instead of trying everything. Due to his consistent act of reducing menus in every restaurant he consults, he was fondly dubbed ‘BBunos,’ a combination of his nickname ‘BBu the homemaker’ and the ‘Avengers’ villain ‘Thanos’ who eradicated half of all life in the universe. Global big pharmas are also busy ‘reducing their menus.’ The companies are letting go of their main sources of income, in particular, products in their Consumer Health care units that are mainly consumer goods. In this sense, Johnson & Johnson’s announcement of its plan to spin off its consumer division had received much attention. The spin-off will not only transfer the baby powder product that imprinted the J&J brand on the public, but also many familiar brands including Aveeno, Neutrogena, Listerine, etc. The company had also said that the planned separation was a “momentous event” and the “biggest change in direction in J&J's 135-year history.” GSK is also spinning off its consumer healthcare unit. The spin-off, newly named ‘Haleon’ does not contain the GSK name. GSK Consumer Healthcare had been in charge of OTC drugs and consumer goods including popular products such as Sensodyne, Otrivin, and Theraflu. GSK Consumer Healthcare, which had been formed as a joint venture with Novartis, increased its size by adding Pfizer’s Consumer Healthcare business in 2018. However, the company seems to have intended to separate from the business. The company announced its plans to sell the business last year and is known to be considering its acquisition offers. The same trend is evident in other big pharmas as well. Sanofi had transferred all of its OTC drugs to its newly established spin-off of its Healthcare ‘Opella Healthcare.’ Going further, MSD had even transferred its off-patent chronic disease business to its spin-off, Organon. The global pharmaceutical companies are making such decisions to 'select and focus' on their specialty drugs, especially those in the field of oncology, immunology, and rare diseases. Of course, J&J’s decision is being suspected as a sort of ‘sham’ to pass on its responsibility for compensation for its baby powder product, which caused controversy due to the detection of carcinogens. However, the global perception in the industry is that they may survive only by focusing on severe and rare diseases. Also, it has been evaluated the industry reached a limit in growing using OTC drugs and consumer goods. On the other hand, once commercialized, innovative new drugs for severe and rare diseases bring big profit to companies. This is because these drugs may be sold at a high price due to little or no competition and the use of next-generation technology. Such restructuring of businesses through reorganizations of their business units has recently begun in earnest. J&J promised to strengthen its pharmaceutical division at the JP Morgan Health Care Conference in January and aims to achieve sales of ₩70 trillion in its pharmaceutical division by 2025 with next-generation new drugs such as anticancer drugs and CAR-T therapies. GSK also plans to focus on developing innovative new drugs and vaccines. Sanofi also stopped investing in chronic diseases and is broadening its autoimmune diseases and vaccines portfolio. For this, the company bought several early-stage research biotechs rather than those that can generate immediate sales. Last year alone, the company carried out 6 M&As with biotechs. The domestic pharmaceutical industry should eye this trend and movement of global pharmaceutical companies. Although it is impossible to directly compare companies due to the different size and focus areas, domestic pharmaceutical companies are still mainly pursuing the business strategy of providing 'many generics' rather than a single ‘wise drug'. Cash cows are necessary to develop new drugs as this costs an astronomical amount of resources, but everyone knows that it cannot be a long-term survival strategy. It's time for Korean companies to devise their own differentiation strategy on what and which areas to ‘select and focus.'
- Company
- Pfizer's 3rd attempt to reimburse ATTR-CM drug ‘Vyndamax'
- by Eo, Yun-Ho Feb 28, 2022 05:55am
- The third attempt at reimbursement for Vyndamax, a new drug for transthyretin amyloid cardiomyopathy, has been made by its company. According to industry sources, Pfizer Korea had again applied for the insurance reimbursement of its new drug that is indicated for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). This is the company’s third attempt. Earlier last year, Pfizer failed to first designate Vyndamax as an essential medicine. In the first half of the same year, the company made the second attempt at reimbursement using the Risk-sharing Agreement but failed again. With perseverance, the company made its third attempt in 2022. Vyndamax is virtually the only treatment option available for ATTR-CM. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. In this area with a dire need, Vyndamax had demonstrated a reduction of cardiovascular events in ATTR-CM patients and improvement in their functional athletic ability in the six-minute walk through the Phase III ATTR-ACT study. Based on these results, healthcare professionals in Korea are also insisting on the necessity of prescribing Vyndamax. Due to its high cost, the decision lies in the will of the government and company. As the less attention paid to reimbursement listing of rare disease treatments is emerging as an issue, whether Vyndamax will bring a different result this time remains to be seen. In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive the tafamidis 80 mg dose, tafamidis 20 mg dose, or placebo, respectively. The primary endpoint of the study was the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations. The key secondary endpoints were the change from baseline to month 30 for the 6-minute walk test and the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS), in which higher scores indicate better health status. Study results showed that the tafamidis demonstrated a statistically significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo.
