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- 2026-05-06 15:23:52
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- SK pneumococcal conjugate vaccine nears global entry
- by Chon, Seung-Hyun Dec 15, 2023 05:51am
- SK Bioscience is fast-tracking its global market strategy for its next-generation pneumococcal vaccine. Nine years following the start of their joint development with Sanofi, the company has now progressed to the last phase of clinical trials for commercialization. SK Bioscience has also been improving its vaccine production facilities to prepare for the commercial manufacturing of pneumococcal vaccines. SK Boscience announced on 11th that SK Bioscience and Sanofi have submitted a Phase 3 Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for its jointly developed 21-valent pneumococcal conjugate vaccine candidate, GBP410 (Sanofi’s project name: SP0202). SK Bioscience and Sanofi aim to enroll infants from various nations including the US, Europe, and Korea and complete Phase III clinical trials by 2027. In March 2014, SK Bioscience signed an agreement with Sanofi to jointly develop and commercialize an next-generation pneumococcal vaccine. The companies have rogressed to the last phase of clinical studies for the vaccine’s commercialization, nine years after signing the joint development agreement. GBP410 is a protein conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumonia and invasive pneumococcal disease. The conjugate vaccines are well known to provide superior protection among pneumococcal vaccines developed to date. GBP410s anticipated to offer broader protection over existing pneumococcal vaccines, given that it includes 21 serotypes. Serotypes are one of the key pathogenic factors in pneumococcal bacteria, and different serotypes are associated with varying pathogenicity. The newly introduced pneumococcal vaccine in Korea helps protect against 15 serotypes. SK Bioscience and Sanofi are preparing to commence the Phase 3 clinical study based on the successful completion of their Phase 2 clinical study of GBP410, The Phase 2 study by SK Bioscience and Sanofi was commenced in May 2020, enrolling 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89days from the US, Canada, and Honduras. GBP410 and a comparator vaccine were given to the cohorts as primary vaccination (2·4·6 months of age) and then as a booster vaccination (12-15 months of age). The results demonstrated comparable immunogenicity of GBP410 compared to the comparator vaccine. In terms of safety, no serious vaccine-related adverse reactions were reported in the GBP410-vaccinated group. GBP410 demonstrated equivalent immunogenicity and safety compared to the comparator vaccine when co-administered with recommended vaccines for infants and children, such as those for tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type B. SK Bioscience SK Bioscience has also started securing production facilities for GBP410. Last month, the company's board of directors agreed to invest approximately 81.5 billion won to expand their Andong L House vaccine production facility. This expansion, supported by a joint-investment with Sanofi, will lead to the construction of a roughly 45,208 square feet production facility. Once the FDA approves GBP410, SK Bioscience aims to manufacture the vaccine at Andong L House and distribute it to the global market . Once the commercialization of GBP410 is finalized, SK Bioscience plans to also launch the vaccine in Korea. Previously, SK Bioscience suffered defeat in the pneumococcal vaccine market in Korea. In 2016, SK Bioscience gained approval from the Ministry of Food and Drug Safety (MFDS) to market its pneumococcal vaccine, SKYPneumo Prefilled Syringe. SKYPneumo Prefilled Syringe is SK Bioscience's first premium vaccine. The company is positioning premium, next-generation vaccines as a pivotal element in its growth strategy. To achieve this, SK Bioscience has invested approximately 400 billion won in enhancing vaccine business infrastructure and R&D efforts. A significant step in this direction was the completion of the L House in Gyeongbuk Andong, in 2012. This facility stands as the largest vaccine factory in Korea, with an investment of about 200 billion won solely for its construction. After losing a patent lawsuit against Pfizer, SK Bioscience failed to launch SKYPneumo Prefilled Syringe. SK Bioscience had contested the validity of Pfizer's patent for PREVENAR 13 Inj by filing a lawsuit. In December 2018, the Supreme Court rejected the suit. Consequently, SKYPneumo Prefilled Syringe cannot be marketed until the Prevnar 13's patent expires in 2026. In response, SK Bioscience voluntarily withdrew the license for SKYPneumo Prefilled Syringe in 2020 but reacquired it the following year. “We are getting closer to successfully developing the pneumococcal conjugate vaccine that only few of the world’s top vaccine companies have succeeded in,” said Ahn Jaeyong, CEO of SK Bioscience. With 740,000 infants, children, and adolescents dying from pneumonia every year, we seek to contribute to global public health and rise to become a market-leading company by successfully developing GVP410."
- Policy
- Global orphan drug Lamzede receives GIFT designation
- by Lee, Hye-Kyung Dec 15, 2023 05:51am
- 'Lamzede Inj (velmanase)’ received the Global Innovative Products on Fast Track (GIFT) designation and will receive an expedited review in Korea. Lamzede is an orphan drug for which Kwang Dong Pharmaceutical signed an exclusive sales and distribution agreement with Italy's Chiesi Farmaceutical in July this year. As the GIFT program seeks to shorten the review period by at least 25%, the drug could be granted within 90 working days if Kwang Dong Pharmaceutical thoroughly submits the required supplementary materials. The Ministry of Food and Drug Safety recently announced that it had designated Lamzede, an enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis (AM) to receive review through the GIFT program. The MFDS grants the GIFT designation and the expedited review to ▲ drugs aimed at treating serious life-threatening diseases such as cancer or rare diseases ▲ drugs aimed at preventing or treating infectious diseases that may cause serious harm to public health, such as bioterrorism infectious diseases or pandemics, ▲ new drugs developed by Korea Innovative Pharmaceutical Companies designated by the Ministry of Health and Welfare, ▲ drugs used in combination with medical devices subject to expedited review, ▲ drugs that showed clinically significant improvements in effect over existing treatments or for which no existing treatment exists. Lamzede is a global orphan drug for which there are no existing therapies and was granted Priority Review (PR) by the US FDA on February 16, and was granted approval under the Marketing Authorisation Under Exceptional Circumstances (MAEC) program by the European Medicines Agency (EMA) in March 2018. Kwang Dong Pharmaceutical signed an exclusive domestic sales and distribution contract with the Italy-based global pharmaceutical company Chiesi Farmaceutical in July this year. Under the agreement, Kwangdong Pharmaceutical partnered with Chiesi Farmaceutici, for the exclusive sales distribution of Chiesi’s three rare disease drugs – Lamzede, Leber's neuropathy drug Raxone, and Fabry disease treatment Elfabrio – in Korea. The company plans to introduce Chiesi’s diverse lineup to the Korean market through the partnership agreement. In March, before partnering with Chiesi, the company had also signed an agreement with a Hong Kong opathamology drug company Zhaoke Ophthalmology to introduce the latter’s new drug candidate for pediatric myopia, 'NVK002,’ to Korea. Since the commencement of the program in September last year, a total of 23 products have been designated as GIFT products until now. Meanwhile, the first GIFT drug, Lunsumio (mosunetuzumab)’ has been approved in November this year. Drug subject to GIFT receives various support for the rapid commercialization of its product including at least a 25% reduction in the review period (ex: 120 working days → 90 working days), support for preparing approval data, rolling review support, and opportunities for close communication between the reviewer and developer and expert consulting on regulatory affairs, etc.
- Policy
- HER2-positive metastatic breast cancer drug Tukysa approved
- by Lee, Hye-Kyung Dec 15, 2023 05:51am
- The Ministry of Food and Drug Safety (MInister: Yu-kyoung Oh) approved two dosage forms (50mg, 150mg) of MSD Korea’s new breast cancer drug Tukysa (tucatinib) on the 14th. The drug is used in combination with trastuzumab and capecitabine, for patients with locally advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Tucatinib is a tyrosine kinase inhibitor (TKI) that is a selective and potent inhibitor of the HER2 receptor overexpressed on cancer cells. It blocks the intracellular signaling pathway of HER2 to inhibit the survival, proliferation, and metastasis of tumor cells and induce cellular apoptosis The drug is expected to provide new treatment opportunities for HER2-positive patients who have been difficult to treat with existing therapies. MFDS said, "Based on our expertise in regulatory science, we will continue to make our best efforts to ensure that therapies with sufficiently confirmed safety and effectiveness are promptly supplied to expand treatment opportunities for our patients in Korea.”
- Company
- Reimb for Cold Agglutinin Disease drug Enjaymo starts in KOR
- by Eo, Yun-Ho Dec 15, 2023 05:51am
- The cold agglutinin disease treatment ‘Enjaymo’ is seeking reimbursement listing in Korea. According to industry sources, Sanofi Korea has filed a reimbursement application for its Enjaymo (sutimlimab) as a treatment for hemolysis in adult patients with Cold Agglutinin Disease (CAD) Enjaymo’ is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway-specific serine protease, C1s. The drug was found to increase the CAD patients’ hemoglobin level and reduce profound fatigue. CAD is a very rare type of autoimmune blood disorder where part of the body’s immune system mistakenly continues to attack and destroy the body’s healthy red blood cells. When patients with CAD are exposed to a temperature below body temperature, they can experience▲ anemia due to chronic hemolysis, ▲ extreme fatigue, ▲ dyspnea, ▲ hemoglobinuria, ▲ acrocyanosis, and ▲ thromboembolism, with a median survival of 8.5 years after diagnosis. CAD is a very rare disease that develops in 1 in 1 million individuals. The number of CAD patients in Korea cannot be accounted for as the disease does not even have a disease code in Korea yet. Enjaymo has been approved in Korea based on the results of 2 clinical trials that demonstrated the drug’s efficacy and safety profile in adult patients with CAD. In the 26-week open-label, single-arm pivotal Phase III CARDINAL study that was conducted on 24 patients over 18 years of age, 54% of the patients (13/24) met the composite primary endpoint criteria - achieved normalization of hemoglobin (Hgb) level ≥12 g/dL or demonstrated an increase from baseline in Hgb level ≥2 g/dL at the treatment assessment time point and no blood transfusion from weeks 5 through 26 or medications prohibited per the protocol from weeks 5 through 26. Also in the 26-week randomized, placebo-controlled Phase III CADENZA study that was conducted on 42 adult CAD patients with one or less transfusion history within 12 months or no transfusion history within 6 months before enrollment, 42 patients were randomized to the Enjaymo arm (22) and placebo arm (20.) Study results showed that 73% of the Enjaymo arm (16/22) had showed an hemoglobin increase ≥1.5 g/dL at treatment assessment timepoint, avoidance of transfusion, and study-prohibited CAD therapy, whereas only 15% (3/20) achieved the same in the placebo arm. Based on the drug’s proven efficacy and safety profile, Enjaymo received the Orphan Drug designation, Priority Review, Breakthrough Therapy designation, and then officially approved the drug in February 2022. The drug was approved by the Japanese Ministry of Health, Labor and Welfare in June 2022, and by the European Medicines Agency (EMA) in November 2022.
- Company
- US-expanded Cresemba faces reimb challenges in KOR
- by Son, Hyung-Min Dec 15, 2023 05:51am
- The antibiotic Cresemba has received expanded indications in the US to include pediatric patients. However, in Korea, the reimbursement for Cresemba is being delayed because of challenges in economic evaluations, limiting patient access to this medication. According to the industry on the 15th, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Cresemba (isavuconazonium sulfate) for use in pediatric patients 1 to 17 years of age. Cresemba’s prescribed injection is indicated for 1 year and older, whereas the prescribed capsule is indicated for children 6 years of age and older (weight of 16kg or more). PfizerDue to the approval, Cresemba is now the only azole antifungal treatment approved by the FDA for use in pediatric patients with invasive aspergillosis and invasive mucormycotic. Cresemba is an antibiotic (antifungal agent) jointly developed by Switzerland's Basilea Pharmaceutica and Japan's Astellas Pharma. Pfizer holds the rights for commercial release in the European region and the distribution rights in Asia-Pacific regions, including Korea. Astellas has received approval for Cresemba in the US and Japan. The expanded indication approval for Cresemba was based on findings from the two Phase II clinical studies. The researchers assessed the safety and efficacy of Cresemba for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in 31 patients aged 1 to 17. The clinical result has shown that 54.8% of patients were able to achieve a successful response rate. In terms of safety, the most common adverse effects observed in Cresemba-treated pediatric patients were abdominal pain, rash, and injection site reaction. All-cause mortality rates through days 42 and 84 were 6.5% and 9.7%, respectively. There have been no reports of death related to the treatments. In addition, the FDA granted pediatric exclusivity for CRESEMBA, extending its period of market exclusivity in the US by an additional six months. Despite expanded use of Cresemba, the reimbursement of antifungal drugs is pending. While the indication for Cresemba is expanding overseas, its reimbursement is challenging in Korea. Cresemba has been approved in Korea in 2020 for the treatment of IA and IM in adults aged 18 and older. MSDYet, the discussion for reimbursement approval is still pending. Antibiotics include antibacterial drugs effective against bacteria, antifungal drugs effective against fungal infections, and antiviral drugs effective against viruses. Currently, antifungal and antiviral drugs are not included in the range of drugs exempted from the economic evaluation (cost-effectiveness assessment exemption). The government has granted cost-effectiveness assessment exemption to antibacterial products, but it views the inclusion of antifungal products as not aligning with the criteria of severity and urgency. However, there is an increasing demand for the inclusion of new antifungal drugs in reimbursement. This is in response to the escalating global prevalence of fungal infections. Despite this need, there have been no recent cases of new antifungal drugs being reimbursed. Since 2014, MSD's Zerbaxa (ceftolozane·tazobactam), Dong-A ST's Sivextro (tedizolid), Cresemba, and Pfizer's Zavicefta (ceftazidime·avibactam) have been approved in Korea. Among these, only Zerbaxa has been included in the reimbursement. Zavicefta, an antibacterial drug, is currently in pricing negotiations with the National Health Insurance Service. Sivextro, also an antibacterial drug, was withdrawn from the market in 2020, primarily due to challenges such as low pricing and the absence of insurance coverage.
- Policy
- Non-inferior drugs likely to receive preferential pricing
- by Lee, Tak-Sun Dec 15, 2023 05:51am
- Non-inferior drugs from Korea innovative pharmaceutical companies will likely be eligible for preferential drug pricing starting next year. Previously, non-inferior drugs were priced below the weighted average of alternative drugs. However, through improvement measures, if the patent of an alternative drug is still active, non-inferior drugs are now likely to be priced within a range between the weighted average price and the highest price of alternative drugs. According to the industry, the government and the pharmaceutical industry held a meeting for ‘Measures to Recognize the Appropriate Value of Innovative Drugs,’ and shared these updates. The improved measure states that if a drug of a Korea innovative pharmaceutical company receives approval through the Ministry of Food and Drug Safety (MFDS)'s GIFT system (Global Innovative Products on Fast Track, GIFT), it will be included and be applied the existing preferential treatment measures used during reimbursement review. The existing preferential treatment measures that will be used during reimbursement review for the GIFT drugs refer to the article, ‘1.7. Medicines in need of preferential treatment when considering its effects on public healthcare,‘ in the Health Insurance Review and Assessment Service (HIRA)’s ‘Specific evaluation criteria for new drugs and medicines subject to pricing negotiations.’ Specifically, the existing criteria contain preferential drug pricing measures for essential medicines endorsed by the WHO or national essential medicines, globally first-approved innovative drugs, and cell therapy products that satisfy the criteria. If the candidate drug’s clinical utility was similar to (or non-inferior to) an alternative, its price was set as ▲either an amount between the weighted average price and the highest price of the alternative drugs, or ▲the weighted average price of its alternative multiplied by (100/53.55), whichever was lower. The criteria has now been expanded to include drugs from Korea innovative pharmaceutical companies approved through the GIFT system. Whereas previously, non-inferior drugs from these companies were priced below the weighted average price if the alternative drug's patent had not expired, they can now be potentially priced at an amount between the weighted average price and the highest price of the alternative drugs. Since most new drugs developed domestically are non-inferior drugs from Korea innovative pharmaceutical companies, these homegrown new drugs will likely receive better drug prices in the future. Meanwhile, it has been reported that the agenda of including natural product-derived new drugs like cell therapy products as a subject to the preferential measures is set to be discussed in the future. Although this item was omitted from discussions in the meeting held on the 12th, it might be included again as an agenda for the Health Insurance Policy Deliberation Committee's subcommittee, which is scheduled to meet on the 14th. Additionally, it has been reported that for new drugs meeting the criteria for innovative drugs, there will be flexible application of the ICER (Incremental Cost-Effectiveness Ratio), and implementation of a risk-sharing plan to provide eased measures such as removing the final 3 negotiations if a drug has already received 3 three PVA negotiations during the past five years. The improvement measures are scheduled to be reported at the meeting of the Health Insurance Policy Deliberation Committee planned for the 20th, and the measures are expected to be sequentially applied from next year.
- Company
- Domestic market withdrawal of Forxiga remains a mystery
- by Kim, Jin-Gu Dec 14, 2023 05:47am
- Pic of ForxigaAstraZeneca’s decision to withdraw its SGLT-2 inhibitor diabetes drug Forxiga (dapagliflozin) from the Korean market is being considered an unusual move by the industry. This is because the decision to pull out of the Korean market would essentially mean giving up KRW 50 billion in annual sales for AstraZeneca. While AstraZeneca's official position is that the decision is part of the company’s "portfolio overhaul," the mysteries surrounding the decision are not expected to be resolved anytime soon. Therefore, the industry's eyes are on AstraZeneca's next move, especially as it has been in stark contrast with MSD’s treatment of Januvia (sitagliptin). MSD Korea, which had faced a similar situation with Januvia, had sold its domestic sales rights for a large sum to a Korean company. #SB Company suddenly decides to withdraw ‘Forxiga,’ whose prescription sales exceed KRW 50 billion from the Korean market#EB According to industry sources on the 12th, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. The withdrawal is limited to the single-agent drug Forxiga. Its metformin combination Xigduo, sitagliptin combination Sidapvia, and saxagliptin combination Qtern will continue to be supplied through local pharmaceutical companies. Forxiga is an SGLT-2 inhibitor class diabetes drug. It was approved in Korea in 2013. Since then, it has rapidly increased its prescription sales. The annual prescription amount for the drug exceeded 30 billion won in 2019 and reached the 50 billion won mark last year. Yearly prescriptions of Forxiga (Unit: KRW 100 million, Data: UBIST). In Korea, it had dominated the SGLT-2 inhibitor market with Boehringer Ingelheim Korea’s 'Jardiance empagliflozin).’ Among single-agent drugs, prescriptions had been KRW 51 billion for Forxiga and KRW 48.3 billion for Jardiance last year. Sales of Astellas' Suglet (ipragliflozin) and MSD's Steglatro (ertugliflozin) accounted for less than KRW 5 billion during the same period. The joint sales agreement AstraZeneca had made with Daewoong Pharmaceutical is said to have contributed to the increase in prescription performance in Korea. Daewoong has been jointly selling Forxiga since 2018. The agreement between the two companies will end at the end of this year. Forxiga's rise to prominence hit a major inflection point earlier this year. Forxiga’s substance patent expired in April. More than 60 pharmaceutical companies launched generic versions of Forxiga upon patent expiry. This coincided with reimbursement for the use of SGLT-2 and DPP-4 inhibitor combinations, heralding a very fierce competition between the original and generic companies. AstraZeneca Korea deployed an aggressive defense strategy to maintain Forxiga’s position in the market. It filed an administrative appeal against the price reduction made upon entry of the generic version. At the same time, it applied for an injunction for the stay of execution of the government's price reduction. The court granted the request. As a result, the price of Forxiga is set to remain at the same level until February next year. AZ "Drug price reduction disposition unreasonable”…U-turns its stance after half a year The enforcement order was cited on June 1. However, just over 6 months later, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. This is a 180-degree turnaround for the company, as this means the company decided to abandon Forxiga just half a year after it challenged the Ministry of Health and Welfare's decision to lower the drug's price with an administrative lawsuit. AstraZeneca's official position is that it is "discontinuing the domestic supply of Forxiga to realign the company's portfolio." On the surface, this seems to indicate that the company intends to reorganize its portfolio around anti-cancer drugs such as Tagrisso, Imfinzi, and Lynparza and focus on related businesses. In the industry, there are also assumptions that the market withdrawal decision was driven by the rush of generics that entered upon patent expiry and the pressure of excessive competition. Others argue that AstraZeneca Korea has exhausted resources and accumulated fatigue negotiating with the government to expand reimbursement for its Forxiga and other key products such as Tagrisso. However, those who believe otherwise point to how Forxiga's influence in the market remains strong even though more than 60 companies have launched generic versions of the drug. In fact, Forxiga's outpatient prescription performance has increased slightly YoY after the release of its generics. In Q2, Forxiga's prescriptions totaled to KRW 14.1 billion, up 15% YoY. In Q3, prescriptions increased 4% YoY to reach KRW 13.7 billion. While generic products generated KRW 3.9 billion in prescriptions in Q2 and KRW 6.8 billion in Q3, they did so by opening up new markets rather than by taking over Forxiga's share. Moreover, Forxiga’s indication was being expanded to not only diabetes but also heart failure and kidney disease. Forxiga has recently added a series of indications. They were for ▲ the treatment of heart failure with reduced ejection fraction (HFrEF), ▲ left ventricular ejection fraction/ heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), and ▲ chronic kidney disease (CKD). Of these, the company had applied for the drug’s reimbursement in HFrEF and CKD. The company was also reportedly conducting negotiations with the government for reimbursement extensions until recently. From AstraZeneca's point of view, extending Forxiga's reimbursement to heart failure could have further increased the prescription amount. In contrast with MSD's sale of Januvia rights … Competition will intensify to close the KRW 50 billion void The pharma industry focused on how MSD decided to sell Januvia’s domestic sales rights before patent expiry. Pic of JanuviaJanuvia is a DPP-4 inhibitor class diabetes drug. Januvia has various similarities to Forxiga, such as the fact that it is a flagship item with a prescription value of KRW 42.6 billion last year and a large number of generics were launched after its patent expiry in July this year. In May, Chong Kun Dang signed a licensing agreement with MSD to acquire domestic rights for 3 products - Januvia, Janumet, and Janumet XR. Chong Kun Dang will acquire all domestic sales, distribution, licensing, trademark, and manufacturing rights for the 3 Januvia series drugs. The contract amount was 45.5 billion won. Chong Kun Dang paid MSD an upfront payment of KRW 23 billion and additional milestone payments of KRW 22.5 billion based on sales performance. MSD made a considerable profit by handing over all domestic rights for the antidiabetic drugs to Chong Kun Dang ahead of Januvia's patent expiration, at a time when generics were expected to be launched. The deal was seen as a win-win, as MSD could focus on sales and marketing of its other products instead of competing with domestic drugmakers, and Chong Kun Dang could secure a stable cash cow that brings in over KRW 100 billion a year. On the other hand, AstraZeneca made a contrasting move, deciding to withdraw from the Korean market instead of selling the rights for Forxiga to a Korean company. The company had made no moves to sell Forxiga's domestic rights to any company. AstraZeneca also drew the line regarding its plans to resupply Forxiga in Korea. An AstraZeneca Korea official said, "We have secured enough domestic supply to last until the first half of next year. We are discussing patient protection measures with the Ministry of Food and Drug Safety. However, at this time, we are not considering resupplying the drug after the first half of next year."
- Company
- Rinvoq is granted reimb for ankylosing spondylitis
- by Son, Hyung-Min Dec 14, 2023 05:47am
- AbbVie Korea holds press conference in celebration of Rinvoq’s reimbursement approval in ankylosing spondylitis on the 13th The use of JAK inhibitors, which had been used for rheumatoid arthritis and atopic dermatitis, has been expanded to ankylosing spondylitis. On the 13th, AbbVie Korea held a press conference at Andaz Seoul Gangnam in Gangnam-gu, Seoul to celebrate the reimbursement of its Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib) for severe active ankylosing spondylitis. Rinvoq was granted reimbursement for the treatment of adults with severe active ankylosing spondylitis on the 1st. Rinvoq is reimbursed for use in patients with severe active ankylosing spondylitis who have had an inadequate response to or had to discontinue treatment with tumor necrosis factor-alpha (TNF-α) blockers or interleukin (IL)-17 inhibitors. With the reimbursement extension, Rinvoq can now be used to treat patients with ankylosing spondylitis in addition to other inflammatory diseases such as atopic dermatitis, rheumatoid arthritis, and ulcerative colitis. Its efficacy and safety were confirmed in adult patients with active ankylosing spondylitis through the SELECT-AXIS 1 Phase II/III study and the SELECT-AXIS 2 Phase III study. In the SELECT-AXIS 1 study, which included patients naïve to biologic disease-modifying drugs, the Rinvoq arm achieved a 52% response rate at Week 14 in terms of ASAS40 (defined as a ≥40% improvement in response per Assessment of SpondyloArthritis International Society standards), which was higher than the placebo arm. In the SELECT-AXIS2 study, which observed patients who had failed biologic therapy, the ASAS40 response in the Rinvoq arm was 45% at week 14, demonstrating an efficacy compared to the 18% in the placebo arm. The mean reduction in pain was -3.00 in the Rinvoq arm and -1.47 in the placebo arm. Unmet needs remain in ankylosing spondylitis…Rinvoq and other JAK inhibitors emerge as alternatives #I2Ankylosing spondylitis is an autoimmune disease in which the spine joint becomes inflamed and gradually stiffens. Inflammation of the spinal joints causes pain, stiffness, and other symptoms. If left untreated, the joints can become stiff and become immobile. The number of affected patients has been increasing steadily every year. According to the Health Insurance Review and Assessment Service’s Healthcare Big Data, the number of patients with ankylosing spondylitis in Korea was 52,616 in 2022, showing a steady increase over the past 5 years. Results of a treatment satisfaction survey conducted on patients with ankylosing spondylitis showed that about half of patients are dissatisfied with their current treatment. Despite significant improvements in clinical outcomes, unmet needs remain in achieving remission, pain control, fatigue, and psychological issues (anxiety, depression). Therefore, it is analyzed that the reimbursement of JAK inhibitors, such as Xeljanz (tofacitinib) and Rinvoq, will be able to improve patient outcomes. Seung-Jae Hong, Professor of Rheumatology at Kyung Hee University Hospital, said, "I believe that the introduction of oral agents such as Rinvoq for the treatment of ankylosing spondylitis will greatly benefit patients. As Xeljanz is considered to be associated with a high risk of cardiovascular disease (CVD) based on the clinical results, we believe Rinvoq would become a more popular reimbursed choice in the field."
- Company
- Reimb of latecomer leukemia drug Bosulif imminent
- by Eo, Yun-Ho Dec 14, 2023 05:47am
- Bosulif, a new leukemia treatment, is expected to receive reimbursement next year. According to the pharmaceutical industry, Pfizer Korea successfully completed drug pricing negotiations with the National Health Insurance Service for Bosulif (bosutinib), a Chronic Myelogenous Leukemia (CML) treatment. Bosulif will be presented to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare, and if approved, it will be reimbursed starting in January 2024. Following its FDA approval in 2012, Bosulif was authorized for use much later in Korea, in last January. Bosulif is a second-generation targeted therapy similar to Novartis Korea’s Tasigna (Nilotinib), BMS Korea’s Sprycel (Dasatinib), and Il-Yang Pharmaceutical’s Supect (Radotinib). Given that there are already established drugs in the same category, no difficulties are expected in the course of its reimbursement approval. The efficacy and safety of Bosulif has been confirmed in Phase 3 NCT02130557 study, which enrolled newly-diagnosed CML patients. The primary endpoint of Bosulif was major molecular response (MMR) by 12 months. Bosulif-treated patients had MMR of 47%. Patients treated with the comparator drug, first generation drug Gleevec (imatinib), had MMR of 36%. MMR by Month 60 was 74% for Bosulif versus 66% for Gleevec. After 60 months of follow-up, the median time to MMR in responders was 9.0 months for bosutinib and 11.9 months for Gleevec. Many next-generation targeted therapies are already available in the field. These include the third-generation Korea Otsuka Pharmaceutical's Iclusig (Ponatinib), and a fourth-generation Norvatis’ Scemblix (Asciminib).
- Policy
- Will Enhertu be reimbursed using flexible ICER threshold?
- by Lee, Tak-Sun Dec 14, 2023 05:47am
- With the government reportedly planning to flexibly apply the Incremental Cost-Effective Ratio (ICER) threshold, whether the breast cancer treatment Enhertu (fam-trastuzumab deruxtecan, Daiichi Sankyo) will finally find its way to reimbursement is gaining attention in Korea. The drug’s reimbursement review is currently stuck in HIRA’s pharmacoeconomic evaluation stage. The drug was unable to pass the stage due to the longer period of administration, which rather increased drug cost, despite its significantly better effect than existing drugs. Therefore, a more flexible application of the ICER threshold during pharmacoeconomic evaluation is expected to allow Enhertu’s passage. According to the industry on the 13th, a plan to flexibly apply the ICER threshold for innovative new drugs in consideration of their innovative value was shared at the public-private consultative body meeting for 'Measures to recognize the appropriate value of innovative new drugs’ that was held on the 12th. The current ICER threshold is flexibly used to evaluate the cost-effectiveness of drugs in consideration of the severity of the disease, impact on quality of life, and innovativeness of a new drug. As the criteria used to evaluate the economic feasibility of a new drug with an improved effect, it determines the additional cost spent by a new drug compared to its comparator for the improved efficacy or each unit of use. If a drug’s ICER threshold is less than or equal to a certain level, the drug is interpreted as being cost-effective to its comparator. In general, the level is set at around KRW 50 million for anti-cancer and rare disease drugs and around KRW 30 million for other general drugs. Enhertu’s price had reportedly exceeded the ICER threshold of KRW 50 million. The industry believes that if the threshold is flexibly applied according to the characteristics of each drug, it could serve as a breakthrough for Enhertu’s reimbursement which is stuck in the pharmacoeconomic evaluation process. However, concerns have been raised about the strict standards set on which innovative new drugs may receive flexible application of the ICER threshold. To be eligible for flexible application of the ICER threshold, a new drug must meet all of the following criteria: ▲ has a new mechanism of action or substance, ▲ has no alternative treatments (including drugs) available, ▲ has shown clinically significant improvement, such as a significant extension in survival, ▲ received a Breakthrough Therapy Designation (BTD) from the U.S. FDA or approved as a Priority Medicines (PRIME) by the European Medicines Agency (EMA), and ▲ is a treatment for a rare disease or an anti-cancer drug. Enhertu must also meet all of the criteria above to receive preferential treatment in its pharmacoeconomic evaluation process. The industry believes Enhertu can meet the criteria for innovative new drugs and receive preferential treatment. Although Enhertu’s reimbursement passed the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Deliberation Committee’s review after redeliberation in May and set reimbursement standards, it has been unable to pass the Drug Reimbursement Evaluation Committee evaluation ever since. The agenda is said to be stuck in the pharmacoeconomic evaluation stage.
