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- 2026-04-04 16:36:47
- Policy
- Prolia’s drug price cut 30% before the entry of biosimilars
- by Lee, Tak-Sun Sep 03, 2024 05:53am
- Prolia, the No. 1 product in the domestic osteoporosis treatment market, has had its upper insurance price limit adjusted this month through price-volume agreement (PVA) negotiations. The drug underwent 4 PVA negotiations in total, which led to a price drop of nearly 30% from the initial price it received in October 2017 upon reimbursement. According to industry sources on the 2nd, the upper limit for Prolia Prefilled Syringe (denosumab, Amgen Korea) was lowered from KRW 156,100 to KRW 154,700 from the 1st of this month under ‘Type B’ PVA negotiations with the National Health Insurance Service. The rate of reduction this time was -0.9% Type B negotiations are applied when the expected claims amount of a drug that has been previously adjusted through Type A negotiations or has not been adjusted for 4 years since its initial date of listing or price adjustment increased by 60% or more compared to the previous year, or increased by 10% or more but the total amount exceeds KRW 5 billion. This is the 4th time Prolia’s insurance price ceiling has already been adjusted through PVA negotiations. In December 2020, the cap was reduced by 6.5% due to an increase in expected claims amount of over 30%, which qualifies the drug for ‘Type A’ PVA negotiations. In August 2022, the price was reduced by 5.0% under Type A negotiations. And in August 2023, the cap was adjusted by 3.7%, also through Type A negotiations. Prolia’s sales have been on the rise ever since it was applied reimbursement benefit in October 2017. In particular, since April 2019, when reimbursement coverage was expanded to first-line therapies, its sales have grown to exceed KRW 100 billion in annual sales. The synergies of Amgen and Chong Kun Dang’s copromotion have also contributed to the steep rise. According to IQVIA, Prolia posted sales of KRW 47.3 billion in 2019, KRW 75.1 billion in 2020, KRW 92.1 billion in 2021, KRW 115.7 billion in 2022, and then KRW 151.1 billion in 2023. Sales in 2023 increased by 219% compared to 2019. The steep rise in performance has inevitably led the company to receive PVA negotiations 3 years in a row. In May, Prolia received reimbursement extensions in Korea. Prior to the reimbursement extension, patients with a bone mineral density measurement of -2.5 (T-score) or less were eligible for 1 year of benefits, but after the reimbursement extension, patients with a T-score of -2.0 or less and to -.2.5 are eligible for up to 2 years of reimbursement. At the time, Amgen had voluntarily reduced the price ceiling of its drug upon the reimbursement extension. That voluntary reduction likely reduced the reduction rate during this year’s PVA negotiations. Even so, the price is already down -28.3% compared to the price at the time of the October 2017 reimbursement (KRW 215,678). This is a further reduction in price than the 20% ex officio reduction an original drug would receive the first year a biosimilar is listed. Prolia's patent is scheduled to expire next March. Celltrion and other biotechs are preparing to receive approval for its biosimilars. Therefore, the price of Prolia is expected to drop further once a biosimilar enters the market. “Prolia is a biologic drug that targets the RANKL protein, which forms osteoclasts that destroy the bone. Its use in the field will continue to increase in the future due to its high compliance that is provided by its longer dosing interval of every 6 months, and has clinical results that have proven its effect even after 10 years of treatment,” said an industry official.
- Policy
- Rival party heads discuss pending issue in NA
- by Lee, Jeong-Hwan Sep 03, 2024 05:53am
- Dong-hoon Han, Chairman of the People Power Party, and Jae-Myung Lee, Chairman of the Democratic Party of Korea met at the National Assembly on the afternoon of the 1st and reached a consensus on resolving the parliamentary conflicts and medical gap. Han mentioned the need to resolve the public's anxiety over the medical gap, while Lee suggested that the National Assembly seek a solution to the parliamentary conflict. Although healthcare reform was not on the official agenda of the ruling and opposition parties' talks, due to the Corporal Chae’s Special Prosecutor Act, the abolition of the financial investment income tax, and the public KRW 250,000 support law, it was reportedly mentioned by Lee in the closed-door meeting. “I would like to say that healthcare reform is also ultimately for the people,” Han said in his remarks, ”but it is also the task of us politicians to resolve the people's anxiety about the medical gap in the immediate future.” Han had previously proposed to the President's Office to suspend the increase in medical school enrollment for the 2026 academic year as an intervention. However, the President's Office rejected the proposal and confirmed that the healthcare reform implementation plan, including the 2026 medical school enrollment quota, remains unchanged. In his meeting with Lee, Han reaffirmed the need for an alternative solution to the healthcare gap. “As party leader, I will make further efforts to address the concerns and anxieties of the people at this time while maintaining the essence and drive for the healthcare reform,” said Han. In his remarks, Lee also said, “It is unfortunate that the healthcare crisis is not on the official agenda. The medical crisis is linked to people's lives, which is why Mr. Han proposed certain alternatives even at the risk of gathering conflict with the government. It will not disappear just because we cover it with our palms and avoid it.” “I agree with the basic direction of healthcare reform, which is to increase the number of doctors and strengthen essential, public, and local medical care, as Mr. Han said,” said Lee, ”but it is essential to have sufficient dialog and seek compromise among groups with conflicting interests in the policy implementation process.” “If you use force to force people to give in, even if you succeed, the aftermath and damage are too great,” he said. ”If the policy implementation is as harsh, urgent, and excessive as it is now, inevitable side effects would have to appear“ “These side effects have led to a crisis in one of the world's best healthcare systems, and the number of people dying in emergency rooms who shouldn't have is already exceeding last year's total. We look forward to having sufficient dialogue with Mr. Han about this issue. First of all, let's seek a solution for the medical crisis in the National Assembly, the ruling and opposition parties together, through discussions and dialogues to accurately identify the current situation, recognize the problem, and reach a consensus.”
- Policy
- Usage recommendations for 3 JAK inhibitors to be changed
- by Lee, Tak-Sun Sep 03, 2024 05:53am
- After collecting opinions, the MFDS will change the usage·dosages section for PfizerAfter collecting opinions, the MFDS will change the usage·dosages section for Pfizer The Ministry of Food and Drug Safety (MFDS) will implement changes to approval for Janus Kinase (JAK) inhibitors, recommending low dosages when used to treat high-risk patients. This is a follow-up measure to the changes to the efficacy and effectiveness section for high-risk patient treatment in 2022. On August 30th, the MFDS posted on the website that it has started collecting opinions on the revised approval for JAK inhibitors based on reviewing the safety information from the European Medicines Agency (EMA). The posting indicates that the updated guidelines for tofacitinib in ulcerative colitis now include a recommendation against using the 10 mg maintenance dose in patients with major cardiovascular adverse events (MACE) or malignancy risk factors, regardless of the availability of alternative treatments. Baricitinib usage·dosages in the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata will include "a recommendation for a daily dose of 2 mg for patients at high risk of venous thromboembolism (VTE), MACE, malignancy, those aged 65 or older, and those with a history of chronic or recurrent infections." Additionally, new guidelines for upadacitinib in treating atopic dermatitis, ulcerative colitis, and Crohn's disease will be updated. A clause such as "A daily dose of 15 mg is advised for patients at high risk of VTE, MACE, and malignancy" will be added. The revisions will be made to 18 products, including the original drugs such as Pfizer's Xeljanz tab, AbbVie's Rinvoq, and Lily's Olumiant. In June 2022, the MFDS added a guideline specifying that high-risk patients aged 65 and older, those with cardiovascular risks, and those at risk of malignancies could use the existing treatments only if they were deemed ineffective. This update was based on safety information from international data. In September 2021, the MFDS issued a safety communication based on international safety information, warning that the three substances, tofacitinib, baricitinib, and upadacitinib, could increase the risk of severe cardiovascular events, including heart attacks. As a follow-up measure, the MFDS is revising the approval requirements. JAK inhibitors are drugs used to treat various autoimmune diseases, including rheumatoid arthritis. It works by inhibiting JAK, a kinase regulating immune responses and inflammation. The JAK inhibitors sales in South Korea are high. Last year's IQVIA data show that Pfizer's Xeljanz tab recorded KRW 12.9 billion, AbbVie's Rinvoq recorded KRW 20.7 billion, and Lily's Olumiant recorded KRW 17.9 billion in sales.
- Policy
- Pfizer's new COVID-19 vaccine wins nod in KOR
- by Lee, Hye-Kyung Sep 02, 2024 05:48am
- Pfizer Korea The new vaccine, JN.1, developed against emerging COVID-19 subvariant, received approval in South Korea. The Ministry of Food and Drug Safety (MFDS) announced on August 30th that it had completed approval just under two and a half months after application was submitted. A designated review team was formed following the plan announced by the Korea Disease Control and Prevention Agency (KDCA) to initiate COVID-19 vaccination. The approved vaccine is Pfizer Korea's 'Comirnaty (bretovameran),' containing an mRNA molecule designed to produce a protein from JN.1 subvariant. Because the SARS-CoV-2 virus mutates over time, vaccines that target subvariants are being developed. The efficacy and effectiveness of Comirnaty are for COVID-19 prevention in people aged 12 and above. A single 0.3 mL dose injection is given in the muscle. People previously vaccinated with COVID-19 can be vaccinated after at least three months. The MFDS stated that it has reviewed the safety, effectiveness, and quality of Comirnaty through a designated review team. After hearing expert opinions, including infectious disease specialists, for a comprehensive review, the final marketing authorization has been granted. The MFDS stated, "The current COVID-19 vaccine approval in South Korea is expected to help reduce the spread of COVID-19 and the progression to severe cases. We will ensure people to get vaccinated safely by thoroughly checking the vaccine quality in the authorization process after approval and strengthening the collection of adverse reaction cases and the management of the safety system." Meanwhile, the KDCA announced on July 4th that as COVID-19 new variant (JN.1) vaccine to be used for '2024-2025 seasonal COVID-19 vaccination' targeting the high-risk group of aged 65 and above, it has secured a total of 7.55 million doses of vaccines (7.23 million doses of mRNA vaccines and 320,000 doses of synthetic antigen vaccine), including 5.23 million doses of Pfizer, 2 million doses of Moderna, and 320,000 doses of Novavax. Among these, Pfizer vaccine has been approved first. The MFDS plans to approve Moderna and Novavax within September.
- Company
- Biological drug options for psoriasis treatment increase
- by Son, Hyung-Min Sep 02, 2024 05:48am
- Domestic and foreign pharmaceutical companies are expanding psoriasis treatment options through the development of biological agents. Recently, Korea's UCB Pharma succeeded in obtaining domestic marketing authorization for a biological drug with a new mechanism of action, sparking competition in the field. Other domestic pharmaceutical and biotech companies such as HK Inn.N and AprilBio have also entered the market by developing new biologics. Celltrion, Samsung Bioepis, and others are planning to expand their influence in the psoriasis treatment market by manufacturing biosimilars of biological drugs. #According to industry sources, the Ministry of Food and Drug Safety approved Korea's UCB Pharma’s interleukin-17 dual inhibitor Bimzelex on the 29th. Bimzelex is the first biologic to simultaneously target interleukin (IL)-17A and F. While biologics targeting IL-17A, such as Lilly's Taltz and Novartis' Cosentyx, have been available in the market, Bimzelex is the first drug to target IL-17F as well. IL-17 is an inflammatory cytokine that causes psoriasis. By targeting both IL-17A and IL-17F simultaneously, it is believed to be able to inhibit the inflammatory cytokines in higher doses and with greater potency. Psoriasis is a chronic, systemic skin disease caused by an abnormality in the immune system, and is characterized by erythema, a reddening of the skin, and psoriasis, which is white, scaly patches of the skin. Bimzelex’s approval is based on the Phase III BE READY study. The study compared the efficacy and safety of Bimzelex versus placebo in patients with plaque psoriasis. Results showed that the primary endpoint, a Psoriasis Area and Severity Index (PASI) score of 90 or greater at Week 16, was 90.8% in the Bimzelex arm. The proportion of patients achieving a PASI score of 100 was 68.2%, and the proportion of patients achieving an overall clinical response (IGA) score of 0 or 1 was 92.6% in the Bimzelex arm, significantly higher than the 1.2% in the placebo arm. Bimzelex also achieved significant PASI score improvements compared to other biologics. Bimzelex achieved significantly higher PASI 100 rates compared to Janssen's Stelara, AbbVie's Humira, and Cosentyx. Bimzelex’s PASI 100 achievement rate was also shown to have been maintained at a high level for 3 years in the BE BRIGHT open-label extension study. Bimzelex is the only IL-17 biologic introduced in Korea that can be dosed once every 8 weeks as maintenance therapy. It can also be self-injected by patients with education. Development of biologics active...competition heats up for psoriasis The domestic pharma and biotech industry is also developing biologics for psoriasis. Currently, biologics with psoriasis treatment indications include Abbvie’s Humira-Skyrizi, Cosentyx, and Taltz. Domestic biotech companies have also signaled their entry into the market by developing the drugs’ biosimilar versions. Celltrion recently received approval from the U.S. Food and Drug Administration (FDA) for a global Phase III trial of Cosentyx’s biosimilar, ‘CT-P55.’ Cosentyx is a biological drug developed by Novartis that inhibits IL-17A and is effective in a variety of inflammatory diseases, including psoriasis and ankylosing spondylitis. The study will enroll a total of 375 patients with plaque psoriasis. A comparative study will be conducted to demonstrate equivalence in efficacy and safety between the original drug and CT-P55. CT-P55 received Phase I IND approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in December of last year. In addition to Cosentyx, Celltrion has developed a number of other biologics, including biosimilars of Humira and Stelara. The company plans to expand its footprint in inflammatory diseases such as psoriasis with the Cosentyx biosimilar. Samsung Bioepis is challenging this market with the commercialization of its Stelara biosimilars. In April, Samsung Bioepis received approval from the European Medicines Agency (EMA) for Pyzchiva, a biosimilar of Janssen's autoimmune disease treatment Stelara. Pyzchiva is a biologic that treats plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with annual global sales near KRW 14 trillion. HK Inno.N and AprilBio will develop biologics targeting novel mechanisms of action. HK Inno.N, YBiologics, and IMBiologics recently licensed-out IMB-101, a new drug candidate for autoimmune diseases, to US pharmaceutical company Navigator Medicines. MB-101 is a dual antibody drug candidate that simultaneously controls innate and adaptive immune responses by dual-targeting OX40L and tumor necrosis factor (TNF). The OX40L pathway is involved in the activation of T-cells, and immune cells, and TNF is a cell signaling protein involved in inflammatory responses. IMBiologics received IND approval from the U.S. Food and Drug Administration (FDA) in August last year and is currently conducting Phase I clinical trials. AprilBio has also successfully licensed out its technology for its autoimmune disease drug candidate 'APB-R3' to U.S. new drug developer Evommune. APB-R3 is a biological drug candidate that targets interleukin (IL)-18. IL-18-targeting candidates are known to be effective in various diseases including psoriasis, inflammatory bowel disease, atopic dermatitis associated with metabolic syndrome-related steatohepatitis, and sepsis. AprilBio has confirmed the tolerability and safety of APB-R3 in a Phase I clinical trial. Evommune plans to initiate a Phase II clinical trial for APB-R3 in the first half of next year.
- Company
- Yuhan’s Leclaza targets US mkt based on its clinical effect
- by Hwang, Byung-woo Sep 02, 2024 05:48am
- The non-small cell lung cancer drug Leclaza (lasertinib) in combination with Ryvrevant(amivantamab) has gained competitivity in the U.S., based on data presented at the World Congress on Lung Cancer (WCLC 2024). Additional data on Leclaza monotherapy and Leclaza in combination with Ryvrevantare is expected to be presented to further increase the drug’s clinical value. WCLC 2024 will be held from September 7 in San Diego, U.S. According to industry sources on the 31st, results from a study comparing the efficacy and safety of Leclaza+Ryvrevant and Leclaza monotherapy to Tagrisso monotherapy will be presented at WCLC 2024, which will be held from September 7 in San Diego, U.S. The data to be presented at WCLC 2024 are from the interim follow-up results of the study, which evaluated the clinical efficacy of Leclaza monotherapy (216 patients) versus Tagrisso monotherapy (429 patients) and Leclaza+Ryvrevant combination therapy (429 patients). In the results that were first disclosed through its abstract, the study showed that Leclaza monotherapy achieved a median progression-free survival (PFS) of 18.5 months by a blinded independent centralized review (BICR) over a median follow-up of 22 months. Also, the Leclaza monotherapy arm was associated with a 2% reduction in the risk of disease recurrence, progression, or death compared with the 16.6 months confirmed in the Tagrisso arm. In addition, an analysis of a high-risk subgroup showed that Leclaza improved PFS even further compared with Tagrisso. In patients with a history of brain metastases, the median PFS was 16.4 months with Leclaza versus 13.0 months with Tagrisso. The median PFS of patients with circulating tumor DNA (ctDNA) was also superior with Leclaza (18.4 months) versus Tagrisso (14.8 months). While more detailed results will be presented at WCLC 2024, experts believe that these results will support the drug settle in the U.S. market. “I think the argument for Janssen will be in providing a stronger rationale for why they chose Leclaza for combination therapy,” said Professor A, a hematologist-oncologist at a Big 5 hospital who asked for anonymity. ”The abstract shows that the efficacy was as expected and that Leclaza was better in terms of side effects, which is one reason why the company chose to use Leclaza as its partner.” Pic of Leclaza With the rising need to prescribe new treatments, the research presented at WCLC 2024 is expected to support the use of Leclaza. The congress will also feature a follow-up of the MARIPOSA trial presented at the European Society of Clinical Medical Oncology Annual Congress (ESMO 2023) last year. According to the abstract, at a median follow-up of 31.1 months, 44% (185/421) of patients in the Leclaza+Ryvrevant arm and 34% (145/428) in the Tagrisso arm were still on treatment. Overall survival (OS) data at a median follow-up of 31.1 months were also presented. At 24 months, 75% and 70% of patients were alive in the Leclaza+Ryvrevantand Tagrisso arms, respectively, and at 36 months, the corresponding figures were 61% and 53%, respectively. the interim analysis of the OS results showed a positive trend in favor of the Leclaza+Ryvrevantarm over the Tagrisso monotherapy arm as in last year but showed no statistical significance. On this, the researchers commented, “OS continues to show a trend toward improvement in the Leclaza+Ryvrevant arm compared to Tagrisso, reaffirming how the Leclaza+Ryvrevant combination is the standard first-line therapy for advanced EGFRm NSCLC.”
- Company
- Tevimbra may be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Sep 02, 2024 05:48am
- The immuno-oncology drug 'Tevimbra' may now be prescribed in general hospitals in Korea. According to industry sources, BeiGene Korea's PD-1 inhibitor Tevimbra (tiselizumab) has passed the drug committees (DCs) of tertiary hospitals, including Samsung Medical Center and Seoul National University Hospital. In addition, the company succeeded in reapplying for Tevimbra’s reimbursement to the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee, raising the possibility of its insurance reimbursement. Tevimbra had previously received the ‘reimbursement standards not set' decision by the CDDC in March. The company had resubmitted its reimbursement application in May. Tevimbra (tiselizumab), which was approved in Korea last November, is an immuno-oncology drug indicated as a monotherapy for patients with unresectable, relapsed, locally advanced, or metastatic oesophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or who have relapsed or progressed after receiving prior platinum-based chemotherapy. In the global Phase III RATIONALE-302 trial, Tevimbra prolonged median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs. 6.3 months), with a statistically significant 30% reduction in the risk of death, and did not show any crossover, unlike existing immuno-oncology monotherapies in the OS graph. In the trial, Tevimbra’s OS improvement was consistent across predefined subgroups, including baseline PD-L1 status, region, and race. Compared to chemotherapy, Tevimbra resulted in more than twice as many patients responding to treatment (20% vs. 10%), and showed an improvement in the median duration of response of approximately 3 months, from 4.0 months to 7.1 months, with sustained responses and a reduction in tumor size, which is directly related to quality of life for esophageal cancer patients. Furthermore, Tevimbra was associated with a 17% lower risk of disease progression or death in progression-free survival (PFS) (HR=0.83, 95% CI 0.67-1.01) and improved health-related quality of life (HRQoL) compared to chemotherapy. In April, the U.S. National Comprehensive Cancer Network (NCCN) revised its guidelines to recommend Tevimbra as a Category 1, preferred option for second-line treatment of esophageal squamous cell carcinoma.
- Policy
- Nicergoline for dementia listed at 50% of the highest-priced
- by Lee, Tak-Sun Sep 02, 2024 05:48am
- Sermion, the original drug containing the ingredient nicergoline.Before March this year, there were only two products containing the active ingredient nicergoline available. However, the number quickly increased, resulting in nearly a 50% difference between the highest and lowest prices. The prices of the listed products are getting cheaper with a stepwise pricing system applied. This reflects that more products are being listed for reimbursement listing. According to industry sources on September 1st, Korea Pharma's Pharma Nicergoline Tab 30mg was listed for reimbursement with a ceiling price of KRW 221 per tablet. Because there are already over 20 existing drugs in the same class, it was priced at around 85% of the prices of those, which is the lowest price. The price KRW 221 is nearly 50% of the highest price, KRW 424. Just last year, no one predicted that such many products containing nicergoline would be listed for reimbursement. In February, the products containing nicergoline 30mg were the original Il Dong's Sermion Tab 30 mg and Hanmi Pharm's Nicegoline Tab 30mg. After three pharmaceutical companies released their products in March, 20 products became available by March. The products listed since June have applied a stepwise pricing system, and the price is set at 85% of the lower price between the lowest price for the same medicine and the price calculated at 38.69% of the original drug price. Consequently, Hutecs Korea Pharmaceutical's Sarminon Tab 30mg, initially priced at 38.69% of the original price, was calculated at around 85%, now KRW 260 per tablet. Therefore, Pharma Nicergoline Tab 30mg's price was set at KRW 221, 85% of the lowest priced Sarminon Tab 30mg. The ceiling price will become even lower for products that will be listed and priced at 85% of the lowest price. Since 20 products became available in just under three months, latecomer products will, in turn, experience a price burden. Nearly 37 Nicergoline Tab 30mg are listed for reimbursement until now. The number of products containing the active ingredient nicergoline approvals by year (unit:#, source: the Ministry of Food and Drug Safety (MFDS), excluding products set for import or API). The products containing nicergoline is used for the first-line treatment of dementia symptoms, including memory impairment, concentration difficulties, judgment issues, and lack of initiative, related to primary degenerative vascular dementia and complex dementia. Korean pharmaceutical companies have jumped into this market this year because previously listed preventative drugs for dementia have failed to show efficacy and are being withdrawn. First, products containing acetyl-L-carnitine and oxiracetam were removed from the market after clinical trial reassessment failed. Clinical trial reassessment for the active ingredient choline alfoscerate is also underway, but the results are not promising. During the reimbursement reassessment review, it was decided that choline alfoscerate cannot be covered by reimbursement when used for mild cognitive disorder, an earlier stage of dementia. However, pharmaceutical companies have filed a lawsuit to seek nullification of reimbursement reduction for choline alfoscerate and received cancellation of the administration order, thus maintaining the reimbursement criteria. However, after losing the appeal court, pharmaceutical companies will likely face sales reductions. The annual prescription sales of choline alfoscerate amount to KRW 622.6 billion (based on UBIST). The market impact is expected to be substantial when reimbursement coverage for the mild cognitive impairment indication is no longer available because such use amounts to 80% of the sales. In countermeasures, pharmaceutical companies quickly released products containing nicergoline. The first product to be launched in South Korea was in 1978. The safety of the drug has been confirmed since it was launched 46 years ago. However, the National Health Insurance Service (NHIS) may attempt to reassess reimbursements. Even if that is the case, pharmaceutical companies can use products containing nicergoline as quick cards to fill the sales gap for drugs that provide cognitive benefits. An employee of a Korean pharmaceutical company said, "Nicergoline is categorized as an alpha-blocker and is effective in increasing blood flow in the brain and peripheral nervous system through vasodilation,' and added, "Because it is commonly used as a preventative measure for senile dementia or cognitive dementia, it is the most suitable drug to replace cognitive enhancers."
- Policy
- Lily's orphan drug 'Jaypirca' receives conditional approval
- by Lee, Hye-Kyung Aug 30, 2024 05:50am
- Product photo of Lily 'Jaypirca,' a designated orphan drug for the treatment of Mantle Cell Lymphoma that recently received marketing authorization in South Korea, is expected to submit the Phase 3 trial results showing therapeutic confirmation by March 2027. As it received conditional approval based on Phase ½ clinical trial results, the company must compare Jaypirca to existing Bruton tyrosine kinase (BTK) inhibitors and confirm clinical benefits. According to the meeting notes of the Central Pharmacist Review Committee, disclosed by the Ministry of Food and Drug Safety (MFDS) on August 27th, the committee members exchanged opinions on conditional approval of Jaypirca, an orphan drug for treating Mantle Cell Lymphoma (MCL). Jaypirca has received domestic approval for its efficacy and effects as a 'monotherapy for adult patients with relapsed or refractory MCL previously received at least two treatments.' Because this drug works differently in BTK-binding compared to existing treatments, Jaypirca has the advantage of treating MCL patients who are difficult to treat with existing treatments, such as 'Imbruvica (ibrutinib)' and 'Brukinsa (zanubrutinib).' However, similar to drugs of the same type, Jaypirca's Phase 2 clinical trial outcomes did not lead to improved survival in the Phase 3 trial. The expert opinion suggested that the decision on the clinical effectiveness of Jaypirca cannot be made based on the current outcomes. Jaypirca received marketing authorization based on Phase ½ clinical trial outcome as an orphan drug. It has been suggested that additional clinical trials are needed to confirm clinical effectiveness for the consideration of approval. A Central Pharmacist Review Committee member commented, "Although the global Phase 3 trial is being conducted to secure therapeutic confirmation, the trial's patient group differs from the target indication for approval. Thus, it is difficult to use the outcomes as the basis of approval," and added, "Objective response rate is not sufficient to decide on the final clinical effectiveness. Therefore, we need to grant conditional approval requesting the Phase 3 clinical trial showing therapeutic confirmation." Another member stated, "The drug meets the requirement for orphan drug designation. However, additional documents are needed to evaluate the final clinical effectiveness and benefits," and added, "As a condition of approval, we must require Phase 3 clinical trial showing the final clinical effectiveness and clinical benefits over existing BTK treatments." However, some argue that the drug's marketing authorization is necessary because existing BTK inhibitors target MCL patients who do not have alternative treatment options. A committed member said, "There are no existing treatment methods using BTK inhibitors in South Korea. The submitted Phase 1/2 clinical trial results show an overall response rate (ORR) of 57.8% and a duration of response (DOR) close to one year, meeting the efficacy targets and showing no significant issues in safety evaluations." Some argue that Jaypirca's approval is necessary because CAR-T for blood cancer treatments is expensive and has not been approved as an MCL treatment. A committee member said, "Previously, there were no treatment methods using BTK inhibitors in South Korea," and emphasized, "While there are no significant issues with safety evaluations, it is advisable to grant conditional approval based on the submission of Phase 3 data, as Phase 2 clinical trials alone cannot definitively establish the stability and efficacy of the treatment." Consequently, Jaypirca received conditional approval despite not having the Phase 3 document. The approval has been made due to the patient's need for treatments, with the expectations that the company will submit the clinical outcomes showing therapeutic confirmation by March 2027."
- Policy
- Reimb standards set for biliary tract cancer drug Pemazyre
- by Lee, Tak-Sun Aug 30, 2024 05:50am
- Pemazyre (pemigatinib), a targeted therapy for biliary tract cancer supplied to Korea by Handok, has successfully received reimbursement standards from the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDDC). The reimbursement standards for the immuno-oncology drug Tevimbra were also set at the meeting. Merck's Erbitux has been granted an extended reimbursement. The CDDC held a meeting on the 28th to review reimbursement for new anti-cancer drugs and extend reimbursement for listed drugs. As a result, Handok’s Pemazyre may be reimbursed for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. Also, Tevimbra may be reimbursed as monotherapy in adult patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma who are unable to continue prior platinum-based chemotherapy or who have relapsed or progressed after receiving prior therapy. In the case of Erbitux, which is primarily used to treat colorectal cancer, the application to extend its reimbursement as combination therapy with encorafenib (with bi-weekly Erbitux) as a treatment for adult patients with previously treated metastatic colorectal cancer with a confirmed BRAF V600E mutation was approved by CDDC. On the other hand, MSD Korea's rare disease drug ‘Welireg Tab’ failed to set reimbursement standards. In addition, Ipsen Korea's ‘Cabometyx Tab,’ Ono Pharmaceutical Korea’s ‘Opdivo Inj,’ and drugs containing anastrozole and letrozole also failed to establish reimbursement standards. In addition, the CDDC reviewed the use of prophylactic G-CSF for dose-dense MVAC/CMV therapy for urothelial cancer, TIP therapy for testicular cancer, and cabazitaxel therapy for prostate cancer with drugs such as Neulasta, reflecting the opinions of the medical community, but decided to maintain the current state.
