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- 2026-03-18 20:22:39
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- Rinvoq is in the process of prescribing general hospitals
- by Eo, Yun-Ho Oct 23, 2020 09:44am
- The third JAK inhibitor Rinvoq was received for prescription in general hospital. The synergy is expected as the application of insurance benefits became visible from November. According to related industries, AbbVie Korea recently concluded a drug price negotiation between the NHIS and the oral autoimmune disease treatment Rinvoq (Upadacitinib), and listed. Applications of DC to major general hospitals including Big 5 are in progress from October. It recently concluded a drug price negotiation with the NHIS, and listed. AbbVie focused on the pace of Rinvoq's listing by accepting the weighted average price of alternative drugs because Pfizer's Xeljanz (Tofacitinib citrate) and Lilly's Olumiant (Baricitinib), which have the same mechanism, are already listed. Rinvoq's permit-reimbursement linkage system was also very useful. As a result, the drug, which was approved in Korea in June, was put on the reimbursement list in about five months. Janus kinase (JAK) inhibitors, such as Xeljanz, Olumiant, and Rinvoq, were the first oral options that proved equivalent to anti-TNF drugs in the area of autoimmune diseases, and have received a lot of attention. However, it has not yet exerted as much influence as biological agents in the market. Anti-TNF drugs and anti-interleukin drugs are also active, but the indications for JAK inhibitors were relatively narrow in areas other than rheumatoid arthritis. JAK inhibitors have potential. Xeljanz, which was first developed last year, secured additional indications such as ulcerative colitis and psoriatic arthritis, and generics, including Rinvoq, are also conducting research to expand indications for autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. Rinvoq proved its effectiveness through five phase III SELECT clinical trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE, SELECT-EARLY) in which 4,443 patients with moderate to severe active rheumatoid arthritis participated. In phase III clinical results, Rinvoq showed lower disease activity and improved clinical response rate compared to placebo, MTX or Humira(Adalimumab) group when used alone or in combination with a conventional synthetic antirheumatic drug (csDMARD). Seong-Hwan Park, a professor of rheumatology at Seoul St. Mary's Hospital, said, "Rinvoq shows a 20% higher remission rate compared to MTX at week 12 in SELECT-COMPARE, a phase III clinical trial administered in combination with MTX, which is a standard therapy. and he said that it will be used as a new treatment option that provides an opportunity to improve the quality of life.
- Company
- Kisqali to be listed November starting three-way competition
- by Eo, Yun-Ho Oct 22, 2020 06:32am
- The cyclin-dependent kinase 4/6 (CDK4/6) inhibitor market is expanded to a three-way competition. A pharmaceutical industry source reported, Novartis’ hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer treatment Kisqali (ribociclib) has concluded the pricing negotiation with National Health Insurance Service (NHIS). The drug is expected to get listed for reimbursement through a refund type risk sharing agreement (RSA). As a third CDK4/6 inhibitor, Kisqali entered the market the last but its position is not completely negative. The main competition in the market centers the Faslodex (fulvestrant) combination therapy, in which Pfizer’s Ibrance (palbociclib) and Lilly’s Verzenio (abemaciclib) are already in the game with five months gap apart from the point of reimbursement listing. Ibrance and Verzenio were approved in South Korea in August 2016 and May last year, respectively. But considering Kisqali was approved last year October, its gap of reimbursement listing with those two drugs was relatively short. Moreover, Kisqali’s reimbursement standard is looser than the first two drugs. The drug can be prescribed not only to postmenopausal patients who have never had an oophorectomy, but also to premenopausal patients, which would make Kisqali a favorable option. Professor Im Seock-ah of Hemato Oncology Department at Seoul National University Hospital explained, “The MONALEESA-7 study was mainly proposed and led by an Asian researcher, and had 30 percent of Asian patients as registered sample. These findings reflect how Asian region still has a great need for a new treatment option in premenopausal women with breast cancer”. The Phase 3 MONALEESA-7 clinical trial evaluated Kisqali combined with endocrine therapy (either an aromatase inhibitor or ovarian function suppression) as a first-line treatment in pre and perimenopausal women with HR+/HER2- advanced or metastatic breast cancer, and confirmed the drug’s effect of significantly extending patient’s overall survival (OS). Specifically, the Kisqali combination group demonstrated median progression-free survival (mPFS) of 23.8 months, whereas endocrine therapy only group had 13 months. In a subset analysis on Asian patients only, the Kisqali combination group’s mPFS was at 24.7 months, which was about 14 months longer than the endocrine therapy only group’s. Also in Phase 3 MONALEESA-3 study, Kisqali confirmed its effect of extending the OS in pre and postmenopausal women. At the point of 42 months, the OS in Kisqali combination group was at 58 percent, and fulvestrant only group was at 46 percent.
- Company
- Samsung-AZ joint venture contemplates on Mabthera biosimilar
- by Kim, Jin-Gu Oct 22, 2020 06:30am
- Mabthera product image. A subsidiary of Samsung Biologics, Archigen Biotech (“Archigen”) has successfully completed clinical trials but it has not yet disclosed its further plan on the product in development. While Archigen’s sole portfolio is a Mabthera (rituximab) biosimilar in development, the industry is paying attention to the correlation between Archigen’s silence and the saturated Mabthera biosimilar market. A source from the pharmaceutical industry told on Oct. 19, Archigen has completed a Phase III trial on 'SAIT101' treating patients with follicular lymphoma and published the outcome. The study was conducted in the U.S., Europe, Japan and South Korea. According to the clinical trial information website ‘ClinicalTrials.gov’ managed by the U.S. National Institutes of Health (NIH), the study started from June 2016 and ended in last January. The outcome of the study was presented in last August after data analysis. The trial had total 315 participating patients with follicular lymphoma, in which 158 patients were treated with Mabthera and the rest of 157 patients treated with SAIT101. The outcome seemed generally successful. The primary endpoint, overall response rate (ORR) in the Mabthera group marked 70.6 percent and the SAIT101 group marked 66.3 percent. Prior to the disclosure, a Phase I trial outcome comparing the Korean-made biosimilar against Mabthera in treating rheumatoid arthritis was published in last February. The outcome was also deemed successful as the biosimilar’s efficacy was on par with Mabthera. Disclosed information on Archigen’s Phase III trial on SAIT101 treating patients with follicular lymphoma (top) and Phase I trial on treating rheumatoid arthritis (Source: ClinicalTrials.gov) However, the company has not spoke of any prospective plan on the drug for two months and even for eight months. The industry sources say it is an exceptional case. Usually, a company would announce additional clinical trial or item approval plan around the point of announcing the clinical trial result. Archigen’s parent company, Samsung Biologics gave an explanation in principle only. The company official said, “We would have an opportunity in the future to speak of the prospective plan.” Archigen is a biosimilar-specializing company established in 2014 as Samsung Biologics and AstraZeneca’s joint venture with 50/50 partnership. With that in mind, the South Korean company would not be able to make a prospective plan by itself. Regardless, the pharmaceutical industry has a different view in why Archigen is contemplating for a long time. It is a convincing story that SAIT101, as a latecomer, would not have a favorable position entering the market. At the moment, Celltrion, Pfizer and Sandoz are having a heated competition in the Mabthera biosimilar market. In the European market, Celltrion’s Truxima, Sandoz’ Rixathon, and Pfizer’s Ruxience have been released. And due to the series of biosimilars launched in the market, the original Mabthera’s sales have been halved. Meanwhile, Sandoz has decided to pursue sales in the world’s biggest market, the U.S. with low marketability expected. The industry experts analyze the company felt the strain to enter the market after Celltrion promptly expanded its market share. When launching its latecomer drug Ruxience in the biosimilar market, Pfizer lowered 15 percent of Truxima’s price. On the contrary, some claim Samsung Biologics and AstraZeneca would push ahead with the product launch to retrieve the investment made so far, worth approximately 250 billion won. A pharmaceutical industry source explained, “The Mabthera biosimilar market is a tough one as even Sandoz, considered as the biggest competitor of Celltrion, backed out from the U.S. market and Pfizer also had to lower the price of its follow-on drug by 15 percent,” so “Samsung Biologics would have to make a difficult decision to break through the challenging market.”
- Company
- Submission of α-GPC clinical reevaluation plan is imminent
- by Chon, Seung-Hyun Oct 20, 2020 06:35am
- Pharmaceutical companies are preparing in earnest with two months ahead of the deadline for submitting data for the clinical reevaluation plan of Choline alfoscerate. They are contemplating the indications for clinical trials and clinical work. The method of paying the cost of clinical trials and the process of selecting participating companies will not be easy. According to industry sources on the 19th, the MFDS announced in June that it would conduct a clinical reevaluation of Choline alfoscerate. The MFDS requested that 134 companies submit the results of domestic clinical trials for 255 items. In case of conducting a clinical trial, it was instructed to submit a clinical trial protocol by December 23rd. Accordingly, companies that hold Choline alfoscerate are busy preparing clinical trial plans. According to the existing clinical re-evaluation practice, it is highly likely that companies with large sales will take the lead in conducting clinical trials and other companies will participate in a way that shares the cost. Companies such as Chong Kun Dang and Daewoong Bio have started to set up a full-fledged clinical trial plan. It is said that these companies will soon meet with the MFDS representative to discuss clinical trial design, etc. Choline alfoscerate is a drug that has three indications: ▲Secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral temperamental syndrome ▲Emotional and behavioral changes, and ▲senile pseudodepression. In principle, clinical trials for each indication should be conducted and data proving efficacy should be submitted. However, pharmaceutical companies are also considering how to set targets and conduct clinical trials by slightly changing existing indications. The MOHW acknowledged that it is effective against 'secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal syndrome' of patients diagnosed with dementia, and determined the positive list system for patients diagnosed with dementia and other patients. The method of separating and conducting clinical trials was also being considered. A method of separately conducting clinical trials by dividing the indication area for each pharmaceutical company could also be promoted. Another brain function improvement agent 'Acetyl-L-Carnitine' was also divided by company and clinical reevaluation was conducted. Acetyl-L-Carnitine, generic for Dong-A ST's Nicetile, has been approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular disease'. When The MFDS ordered a clinical re-evaluation in 2013, Dong-A ST took the lead in conducting a “primary degenerative disease” clinical trial. Hanmi was in charge of the clinical trial for "secondary degenerative diseases caused by cerebrovascular disease." In July last year, Acetyl-L-Carnitine was removed from the indication for a “primary a degenerative disease” because the clinical results conducted by Dong-A ST did not meet the efficacy. Hanmi is still undergoing clinical trials. When the clinical trial design and clinical method of Choline alfoscerate are determined, the recruitment process for participating companies is expected to proceed. At this time, it is also an issue of how each company will bear the cost of clinical trials. If each company decides to pay the same clinical cost, companies with small sales volume of Choline alfoscerate will have to consider participating in reevaluation. If the submission of clinical reevaluation data is abandoned, the authorization will be revoked. The risk of redemption due to the price-volume agreement is also a burden for pharmaceutical companies. Recently, some pharmaceutical companies with Choline alfoscerate agreed to adjust drug prices according to the price-volume agreement negotiation system. The agreement stipulated that when a clinical trial is conducted for the renewal of the MFDS's product license and re-evaluation of drugs, the relevant facts should be notified to the NHIS. If the approval is withdrawn as a result of reevaluation, etc., the pharmaceutical company has a clause that requires the NHIS to return the full amount of the bill from the date the MFDS makes the clinical trial to the date of the removal of the list. If a pharmaceutical company has agreed to reduce the drug price of Choline alfoscerate according to the price-volume agreement negotiation system, and withdrawal from the market as a result of a re-evaluation later, all sales sold so far must be returned to the NHIS. If pharmaceutical companies fail to demonstrate the efficacy of Choline alfoscerate in clinical trials, approval may be revoked in the worst case. At this time, for products that have undergone the price-volume agreement negotiation system, all prescription amounts must be returned from negotiation to cancellation of the license. For example, if Choline alfoscerate with an annual prescription amount of ₩10 billion is canceled due to a clinical trial failure 5 years after the price-volume agreement negotiation system, ₩50 billion will be required. Drug price agreement based on the Price-Volume agreement Pharmaceutical companies are inevitably burdened with clinical reevaluation. An industry official said that there are a lot of homework from setting up clinical design to recruiting participating companies with about two months left until the submission of the clinical reevaluation plan. He said, "With the burden of uncertainty about the revaluation results, a lot of pain between pharmaceutical companies is inevitable."
- Company
- Can novel bone-builder Evenity win reimbursement this year?
- by Eo, Yun-Ho Oct 20, 2020 06:34am
- Apparently, a novel bone-builder Evenity is making its last push to nab the National Health Insurance (NHI) benefit by the end of the year. The South Korean pharmaceutical industry sources reported, Amgen Korea and National Health Insurance Service (NHIS) have recently initiated a pricing negotiation on an osteoporosis drug Evenity (romososumab) indicated to promote bone formation and inhibit bone resorption. As the 60-day negotiation is due next month, the drug could be listed for reimbursement within this year if the administrative procedure rushes on. After receiving an approval for the South Korean market in May last year, the drug applied for reimbursement listing after a year. The Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) green lit the listing after confirming the feasibility. The drug is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, and for bone formation in men with osteoporosis at high risk for fracture. The specialists have been anticipating for the novel drug as it is the only bone-builder to have proven the effect of lessening hip fracture. As any of novel osteoporosis drugs had struggled through most of their reimbursement listing process in South Korea, Evenity would have to see if it could successfully get listed. For about a decade, 70 percent to 80 percent of osteoporosis patients in South Korea have been using bisphosphonate, which was tackled on its strict limitation for drug administration and efficacy lacking sufficient data. In fact, a bone formation medicine Forsteo (teriparatide) has taken a decade from item approval to reimbursement listing. Amgen’s Prolia was also approved for the South Korean market in 2014 and launched as a non-reimbursed treatment in November 2016, but finally got to list its name in October 2017. President of Korean Society for Bone and Mineral Research (KSBMR) Chung Ho-yeon noted, “Osteoporosis treatment prioritizes prevention of bone fracture. So a treatment option preventing bone loss while forming new bone would induce prompt treatment benefit.” The efficacy of Evenity has been confirmed during Phase III FRAME and ARCH studies, as well as in Phase III 3 BRDIGE study for the indication treating male patients. In the Phase III placebo-controlled FRAME study, Evenity has demonstrated effect of reducing the risk of new vertebral fracture in postmenopausal women with osteoporosis at risk for fracture resulting in bone mineral density (BMD) T-score of -2.5 to -3.5 at the total hip or femoral neck. Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture. The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia. And in Phase III alendronate-controlled study ARCH, Evenity confirmed preventive effect of reducing risk of vertebral fracture and clinical fracture superior than alendronate. Compared to the patient group treated only with alendronate, the patient group switched to alendronate after being treated with Evenity for 12 months had 50 percent lower risk of new vertebral fracture at 24 months.
- Company
- The government restricted the exemption to antibacterials
- by Eo, Yun-Ho Oct 19, 2020 06:19am
- The government restricted the exemption from economic evaluation to only antibacterial agents. There is great backlash. The HIRA confirmed the amendment to the regulations regarding evaluation standards and procedures, such as whether or not drugs are eligible for medical care benefits, by publicizing internal regulations on the 8th. The revised bill was announced, narrowing the scope of exemption from economic evaluation from 'antibiotics' to 'antibacterials'. Initially, the plan to expand the exemption from economic evaluation related to antibiotics was supported by both industry and academia. However, there was controversy in terms of 'the definition of antibiotics'. The medical concept of antibiotics refers to 'antimicrobial medicines' that encompass antibacterial agents (treatment of bacterial infections), antifungal agents (treatment of fungal infections), and antiviral agents (treatment of viral infections). The continued increase in antimicrobial resistance (AMR) is one of the most important public health agendas worldwide. The issue is that the concept of antibiotics is generally confined to 'antibacterial agents'. In fact, the government clarified the definition of antibiotics as the government announced its intention to apply limited inquiries to the related inquiries of the Korean Research-based Pharmaceutical Industry Association (KRPIA). ◆Antibiotic Resistance Problems and the International Community's Approach=The WHO defines the concept of AMR as 'a threat to effective prevention and treatment of continuously increasing infections caused by bacteria, parasites, viruses and fungi'. AMR is not limited to the well-known superbacterial outbreak. Antibiotic resistance, also called ``superbugs,'' is a change that occurs when microorganisms (fungi, viruses, parasites, etc.) that cause infection, including bacteria, are exposed to antibiotics and antibacterial drugs such as antifungal and antiviral drugs. AMR is a public health agenda that should be approached, including the risk of resistance to fungi such as Candida and Aspergillus, as well as so-called 'super bacteria' such as Carbapenem-resistant bacteria and Vancomycin-resistant bacteria. The revelation of AMR makes it difficult to treat infections, increases the risk of spread of infectious diseases, occurrence of severe infectious diseases, and death. As a result, the effectiveness of the drug decreases, and the risk of continued infection in the body increases the risk of transmission to others. Worrying about the mutation of COVID-19 even before the development of COVID-19 vaccine is in the same as worrying about the emergence of resistant bacteria that are currently being developed or the treatment does not work. In fact, in the early days of the 'Global Antimicrobial Resistance Surveillance System (GLASS)', which was started to implement the Global Action Plan for AMR in 2016, the focus was on human bacterial (bacteria) infection, but in 2018 Since then, efforts have been made to narrow the information gap in other types of AMR, such as the development of a global surveillance frame for AMR of invasive fungal infections. ◆ Increased risk of secondary infection in COVID-19 confirmed patients = Cases and results of secondary infections caused by these fungi are being published in patients with COVID-19. It is known that the risk of secondary infection in the hospital increases when long-term hospitalization or long-term use of a ventilator, such as a severe COVID-19 patient. There is a need to secure sufficient infectious disease drugs in preparation for new infectious diseases and secondary infections in hospitals. Analysis of the results of a retrospective multicenter cohort study of 191 COVID-19 patients at two hospitals in Wuhan, China, found that 15% of all patients (28/191) and about 50% (27/54) of deaths were secondary infections. According to a study analyzing the prevalence of invasive aspergillosis in COVID-19 patients, about 5% of COVID-19 patients were in critical condition requiring intensive treatment, and these severely ill patients have been shown to have an increased risk of secondary infection with Invasive Aspergillosis. Jeong-Hyun Choi, Chairman of the Korean Society for Antimicrobial Therapy (Department of Infection and Internal Medicine, Eunpyeong St. Mary's Hospital, Catholic University) said, "If patients are hospitalized for a long time or use a ventilator for a long time, such as a severely ill patient with COVID-19, the risk of secondary infection in the hospital increases. In contrast to the opinion of the Society, it is very unfortunate that the concept of antibiotics has been arbitrarily reduced, contrary to the opinion of the Society, while the necessity of securing sufficient drugs for infectious diseases in preparation for new infectious diseases and secondary infections in hospitals is being raised. In addition, he expected that the 'Antibiotic Resistance Management Division' within the Korea Disease Control and Prevention Agency would be established to enable active management of antibiotic resistance. However, the problem of accessibility is on the contrary. I hope that the government will listen to the voices of the infection control site so that it is not limited to only antibacterials.”
- Company
- Issues to look into when pricing drug by each indication
- by Eo, Yun-Ho Oct 17, 2020 06:37am
- Amending a regulatory system is not a simple work. Moreover, introducing the indication-specific drug pricing would have to entirely change the premise of the National Health Insurance (NHI) system that grants ‘unified insured pricing on a single drug.’ Regardless of the final result, the government would need to have detailed discussions and survey the public opinion. As for the industry, it is positive that the government is still open to the idea to discuss it further. In fact, Vice Minister Kang Do-tae at Ministry of Health and Welfare (MOHW) spoke during an interview with the industry news media and noted, “The indication-specific pricing could help strengthening the treatment access in severe disease patients. But the feasibility of realizing the novel payment system within the current billing structure and payment system the NHI system uses should be confirmed. And also various views of stakeholders, such as related government bodies, pharmaceutical industry and civic group, should be sufficiently surveyed as well.” And there is already a number of issues raised regarding the subject. Following are the concerned voices on adopting the indication-specific pricing; ◆Issuing a variety of drug codes and the risk of abuse: Inconvenience in administration work is inevitable. Using the indication-specific pricing would mean giving two to three unique codes on a single drug. And the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) would undergo big changes in their billing system, which could cause confusion in healthcare institutes when inputting the main or sub disease code. Nevertheless, these are literally some ‘inconvenience’ that can be handled. When the government implemented the NHI coverage enhancement initiative and lowered the copayment rate of anticancer treatment expense to 5 percent and differentiated the billing, unique code for the variant copayment rate code was issued. In other words, issuing unique code for each indication on a single drug could be bothersome, but not impossible. However, the issue of the system abuse should be looked into. For instance, a drug could be priced at 100,000 won or 150,000 won when prescribed as a stomach cancer or liver cancer treatment, respectively, according to the indication-specific pricing. Then a healthcare institute may falsely report the drug as a prescription for treating liver cancer, when it was prescribed to a patient with stomach cancer to make profit from the difference. Actually, there are drugs containing same substance but priced individually. Regardless of the same substance, each item is approved under different name with a variety of doses and formulation. An immunosuppressant Certican and anticancer treatment Afinitor both containing everolimus, and enlarged prostate treatment Proscar and hair loss treatment Propecia sharing finasteride are prescribed under different pricing. Recently, Pfizer won separate approvals on Vyndaqel and Vyndamax sharing tafamidis and started the reimbursement listing procedure (Vyndamax). But even with these drugs, there were reported cases of abusing the drugs. People with hair loss receiving prescription of Proscar, instead of non-reimbursed Propecia, are apparently breaking the tablet into pieces to take them in smaller dose. But considering the anticancer treatment prescription scene and the initial talks on indication-specific pricing limited to RSA drugs only, it would be unlikely for the system abuse to be apparent widely. Nevertheless, the regulatory measures to manage such system abuse would be accompanied when implementing the indication-specific pricing. An official from NHIS said, “Even if it is a same drug, a pricing reasonable in one country or payment model could be inappropriate in other countries. Ultimately, it would be wise to select optimized payment model taking in account of unique situations in each countries. We need to have talks on the possibility of realizing the novel payment system within the current billing data structure and payment system.” ◆Patient acceptance and social consensus: The most fundamental issue and the core of the conflict is the patients’ reaction. Literally, the indication-specific pricing would differentiate the price of a drug a patient has to pay depending on the disease they have. And for a cancer patient, it may be difficult to accept the fact that the specific cancer they are fighting against is costing them more. In the end, the public should be aware and create a social consensus recognizing that the indication-specific pricing would ‘accelerate the reimbursement listing for anticancer treatment, and be a solution to drugs struggling to expand reimbursement on additional indication after its first.’ Patients could feel the burden of pricing, but ultimately receiving reimbursed treatment would be a better than no option at all. Also the actual price is subject to change when adjusting refund rate, but the gap would be narrowed when the copayment rate is applied. A market access personnel in a multinational pharmaceutical company urged, “Beyond the issue regarding the international reference pricing (IRP) system, the Korean offices are having more difficulties in getting the headquarters’ approval during the reimbursement expansion process. A company has to give up on expanding the coverage when a drug’s actual price, despite the labeled price, is making a loss. We want the public to understand that what the industry wants from the indication-specific pricing is not to burden the patients, but to improve treatment access for them.”
- Company
- Different use different price for same substance drugs?
- by Eo, Yun-Ho Oct 15, 2020 06:06am
- One says “Why should drugs cost the same when their effects, target patient sizes and values are different?” Another argues, “Why should I pay more for a drug that shares a common substance with other drugs?” In some way, both of those arguments make sense. And it is considered a conventional conflict of interest between a seller and a consumer. An ‘indication-specific drug pricing’ means granting a pricing on a drug based on each indication with different value of innovation the drug owns to reflect the recent changes in drugs having various indications. So far, an organization representing multinational pharmaceutical companies, the Korean Research-based Pharmaceutical Industry Association (KRPIA), has been focusing on expanding risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption eligibility. But now it is advocating differentiated pricing based on specific indication of the drug. The industry trend of one drug having numerous indications has been apparent for at least five years, considering the South Korean market only. Lately, various indications not only applicable for different lines of treatment, but also for different disease treatments have been added constantly. But why now? ◆Reactions on expanded RSA: The revised RSA system is the reason why KRPIA and multinational pharmaceutical companies have been closely following the indication-specific drug pricing. On Oct. 8, the industry was relieved to see a follow-on drug now eligible for RSA. The revised regulation provides an option of RSA to cost-effective drug (latecomer) with treatment level equivalent to first-in-class drug. However, the South Korean government also added another clause as well. Although the regulation was alleviated on follow-on drugs, the government now demands for cost-effectiveness confirming evidence (administration cost comparison or PE) from a RSA drug when expanding its reimbursement regardless of having RSA-eligible indication or not. After the said revision was disclosed, KRPIA officially addressed of ‘indication-specific drug pricing’ in an official statement submitted. At the time, KRPIA claimed “The cost-effectiveness evaluation standard’s consistency and predictability of the final price could be improved, if the drug pricing was decided based on indication. The labeled price could be kept the same, but the patients’ treatment access could improve if the contract is signed to apply differentiated indication-specific refund rate based on the actual cost-effective price for each indication.” At a glance, the indication-specific drug pricing and regulation to confirm cost-effectiveness in a drug seeking to expand RSA reimbursement, but it is far from it. Previously, RSA-applied drug coverage expansion was processed by the Health Insurance Review and Assessment Service (HIRA) setting the reimbursement standard without reviewing cost-effectiveness evidence and the National Health Insurance Service (NHIS) negotiating based on increasing patient size and use volume and adjusting the refund rate. Of course, nowadays the Cancer Deliberation Committee is the biggest hurdle for the pharmaceutical companies, but the said course of action was considered typical. But basically, it means the latecomer drugs’ pricing are lowered with the same standard as the first-in-class drug, because the authority grants minimum pricing after comparing against alternative options’ administration cost and PE results. And it creates a synergy effect when overlapped with latecomer’s drug approval, because the lowest pricing goes down as the number of follow-on drug listed with RSA goes up and listed indication expands. In other words, the industry is complaining “Why should the drug pricing always fall and never get raised? If the cost-effectiveness of an added indication is higher than the previously listed induction, then the pricing should be adjusted accordingly.” Various types of novel payment models in other countries◆The basic frame of indication-specific drug pricing as explained by the industry: Their argument is actually not a farfetched idea. The background of KRPIA and the industry’s claim is that the introduction of the indication-specific drug pricing in South Korea would highly likely to be limited to RSA-applied drugs (preferentially considered) that also adjust the refund rate. Currently, Australia, Switzerland and the U.S. are using the indication-specific pricing that mostly maintains the initial labeled price but adjusts the refund rate. And other types of novel payment models (NPM), such as combination-based pricing and over-time payments are used in Australia, Switzerland, the U.S. and Italy to improve access to new drug. The industry experts seem to agree the indication-specific pricing is the most suitable model in the South Korean market. And from the government’s perspective, the notion is not to be dismissed blindly. The self-explanatory term, ‘indication-specific pricing,’ literally means pricing a drug based on the value of each indication. If the system, as described by KRPIA, adjusts the refund rate based on the value of the indication assessed through PE while maintaining the labeled price, the government could find more grounds to lower the drug pricing. It is also important to note that most of new drug’s additional indications tend to be less innovative than their first indication. The industry’s market access associate commented, “At this point, the reimbursement listing of a latecomer drug’s first indication may be easy, but growing number of companies has started to give up on listing additional indications with complications they face. And now the patients are left behind only to watch their access to treatment get further out of reach.”
- Company
- The patent dispute over Otezla is expected to be fierce
- by Kim, Jin-Gu Oct 15, 2020 06:06am
- OtezlaThe patent dispute over the psoriasis treatment 'Otezla (Apremilast)' is expected to be fierce. In 15 days, eight companies had a patent challenge. Considering the fact that this treatment has not yet been officially released in Korea, it is evaluated that it is receiving great attention from domestic companies. According to the pharmaceutical industry on the 14th, four companies including Mothers Pharm, Yuyu, Huons, and Cosmaxpharma challenged two patents related to Otezla on the 13th. A trial for invalidation was filed for use patents expiring in March 2028, and a trial for passive confirmation of scope of rights for formulation patents expiring in December 2032. As a result, a total of eight pharmaceutical companies challenging Otezla patents have increased. After Daewoong and Dong-A ST challenged two patents on the 29th of last month, Chong Kun Dang (5th) and Dongkoo Bio & Pharma (8th) joined. In 15 days, eight companies had a patent challenge. In the industry, there is also a possibility that more pharmaceutical companies will challenge this patent. Interestingly, Otezla has not yet been officially released in the domestic market. Otezla was originally Celgene's item. In November 2017, it was approved in Korea. At the same time, it failed to get on the reimbursed list due to the difference on the price between the insurance authority and the company. With BMS' acquisition of Celgene earlier last year, Otezla's plans to launch in Korea began to become more entangled. Initially, BMS tried to bring Otezla's copyright to it, but the Federal Trade Commission (FTC) caught up. This was the reason that BMS would be concerned about monopoly in the psoriasis treatment market if it acquired the copyright to Otezla. Eventually, BMS sold the Otezla copyright to Amgen. In August of last year, Amgen acquired global copyright for the drug for $13.4 billion. Accordingly, the domestic copyright was transferred to Amgen. It is still unclear whether the reimbursement will be applied. Even though it has not been officially released in the domestic market, companies that have challenged the patent are expecting this treatment to be sufficiently possible in Korea. It is an evaluation that it has already been verified in the global market. Otezla's global sales in 2018 were $1.6 billion (about ₩1.83 trillion). In the industry, global sales are expected to expand to $2.5 billion (about ₩2.86 trillion) by 2023.
- Company
- SK Biopharm, to export technology for XCOPRI to Japan
- by An, Kyung-Jin Oct 15, 2020 06:05am
- XCOPRI SK Biopharm announced on the 13th that it has signed a technology export contract for the development and commercialization of XCOPRI (Cenobamate), a new epilepsy drug, in Japan with Ono Pharma. With this contract, SK Biopharm secured ¥5 billion (approximately ₩54.5 billion) in a down payment without obligation to return it. It is worth ¥48.1 billion (approximately ₩524.3 billion) for technical fees (milestone) by stages according to the achievement of permission and commercialization. Separately guaranteed royalties equivalent to two-digit percent of sales. XCOPRI is a brand for Cenobamate that was independently developed by SK Biopharm and received approval for sale by the US Food and Drug Administration (FDA) in 2019. It is prescribed for adult epilepsy patients with partial seizure symptoms. As a positive allosteric modulator of γ-Aminobutyric acid type A (GABAA) ion channel, it is known to reduce repetitive firing of nerve cells through blocking voltage-translating sodium current, thereby reducing seizure symptoms. SK Biopharm is currently pursuing large-scale phase III clinical trial to commercialize Cenobamate in three Asian countries, including Japan, China, and Korea. In the Japanese market, SK Biopharm plans to perform phase III clinical trial, and the two companies will cooperate in development and product approval. Through this contract, SK Biopharm has also secured a co-promotion option to jointly carry out commercialization with Ono Pharm. Ono Pharm is a research and development-oriented pharmaceutical company headquartered in Osaka, Japan. The main item is 'Opdivo' (Nivolumab), an immune checkpoint inhibitor, and it is focusing on the development of First-in-class drugs for diseases with cancer, immune diseases, and nervous system diseases. CEO Jo Jung-woo of SK Biopharm said, "With this contract, we are expanding SK Biopharm's position in Japan, one of the largest pharmaceutical markets in Asia." Sagara Gyo, CEO of Ono Pharma Korea said, "We are very pleased to be able to cooperate with SK Biopharm to commercialize Cenobamate. We believe that Cenobamate will be a new treatment option for Japanese patients suffering from epilepsy. "
