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- 2026-04-09 03:05:54
- Policy
- A draft for reevaluation of overseas drug prices
- by Lee, Tak-Sun Nov 08, 2023 05:37am
- Advantages and disadvantages depending on the re-evaluation method. The HIRA has prepared a draft plan for comparative and reevaluation of overseas drug prices and will begin collecting opinions in earnest with the pharmaceutical industry starting this month. As the HIRA plans to conduct re-evaluation sequentially starting next year, it is expected to prepare a final plan by at least next month, and intensive discussions are expected to take place this month. According to the industry on the 7th, HIRA plans to hold working-level discussions with the pharmaceutical industry on the 10th to discuss ways to compare and reevaluate overseas drug prices. Depending on the method of reevaluating overseas drug prices, there is a high possibility that it will have a disadvantageous effect on the domestic pharmaceutical industry, so it is expected that it will be difficult to come up with a final plan during this working-level discussion. The overseas countries subject to comparison are eight: the United States, the United Kingdom, Germany, France, Italy, Switzerland, Japan, and Canada. The HIRA plans to sequentially re-evaluate chronic disease drugs whose patents have expired starting next year. In a recent government audit, he said, "We plan to carry out re-evaluation sequentially by the year starting in 2024," and added, "We will strive to secure the sustainability of health insurance finances by managing the drug costs of products listed with high drug prices compared to foreign countries." He said. Considering this, it is highly likely that a reevaluation will be carried out with the goal of reducing drug costs, so it is possible that the overseas drug price standard will be lowered and the upper limit amount may be adjusted. However, it appears that some modifications will be made while gathering opinions from the pharmaceutical industry, so we will have to watch the future discussion process. A HIRA official also explained, “The internal draft has been prepared, but the final draft may be revised during discussions with the pharmaceutical industry.” It is expected that some of the contents of the HIRA draft will be made public once the opinion collection process begins. In order for the reevaluation to proceed next year, the final draft must be confirmed in December, so intensive discussions with the pharmaceutical industry are scheduled to take place this month. A HIRA official added, “We plan to hold discussions with the pharmaceutical industry throughout November,” adding, “I don’t think it will end with one or two meetings.”
- Company
- Budesonide’s price to be raised due to increased demand
- by Chon, Seung-Hyun Nov 07, 2023 05:34am
- Health authorities are working to increase the price of asthma medications containing ‘budesonide’, which have been experiencing supply shortages. Quarterly prescriptions of budesonide, which was less than KRW 1 billion, more than tripled after the COVID-19 pandemic, intensifying the supply and demand imbalance. According to industry sources on the 6th, the Korean health authorities have been reportedly working to increase the prices of two drugs that contain the asthma treatment ingredient budesonide. The authorities are known to be reviewing a price increase due to the recent surge in their demand. Budesonide is used to treat bronchial asthma and acute laryngotracheobronchitis in infants and children. Two products, AstraZeneca's Pulmicort and Kuhnil Pharmaceutical's Pulmican, are currently available in the Korean market. According to the pharmaceutical research institution UBIST, the prescription amount for Pulmicort and Pulmican in Q3 this year was KRW 1.6 billion. The amount decreased by 0.2% from Q3 last year but is 155.8% in 2 years from the KRW 600 million in Q3 2021. In 2020, the prescription market for budesonide was only KRW 3.8 billion. The average quarterly prescription amount was less than KRW 1 billion. In 2021, prescription performance was less than KRW 1 billion from Q1 to Q3. Quarterly outpatient prescriptions of Pulmicort(grey) and Pulmican(green) Budesonide prescriptions increased 39.0% YoY to KRW 1.4 billion in Q4 2021, then soared again to KRW 3 billion in Q4 last year, recording an over threefold increase from 2 years ago. This year, budesonide continued to increase in sales, recording KRW 2.5 billion and KRW 2.8 billion in Q1 and Q2, respectively. The cumulative prescription amount for budesonide in Q3 this year was KRW 6.9 billion, approximately 3 times higher than KRW 2.3 billion during the same period in 2021. The prescription market for budesonide has also increased significantly with the surge in the number of confirmed COVID-19 cases since the end of 2021. Recently, the demand for asthma drugs has increased due to the increase in not only confirmed cases of COVID-19 but also cold and flu patients, resulting in a supply-demand imbalance where supply cannot meet demand Prescriptions for Pulmican and Pulmicort both surged from the end of 2021. Pulmicort’s quarterly prescriptions from 2020 to Q3 2021 ranged around KRW 300 million to 500 million. It jumped 36.6% YoY to KRW 800 million in Q4 2021 and exceeded KRW 1 billion in the of last year. The cumulative prescription amount for Pulmicort in Q3 this year was KRW 3.4 billion, up 194.7% from the cumulative KRW 1.2 billion in Q3 2021. Pulmican’s quarterly prescriptions from Q1 2020 to Q3 last year fell below KRW 1 billion. However, sales surged to KRW 1.8 billion in Q4 last year, and recorded KRW 1.5 billion and KRW 1.4 billion in Q1 and Q2 this year, respectively. The cumulative prescription amount of Pulmican in Q3 this year was KRW 3.4 billion, a threefold increase from 2 years ago. If raised, budesonide will become the fourth drug to receive a price increase since last year, following acetaminophen, magnesium hydroxide, and pseudoephedrine. The Ministry of Health and Welfare raised the insurance price ceiling of 18 acetaminophen 650mg items by up to 76.5% in December last year. The insurance price limit for 650mg acetaminophen, which ranged between KRW 43 to 51 before then, was raised to KRW 90. The government made an unprecedented decision to raise the price of all acetaminophen together when pharmaceutical companies expressed reluctance to increase production due to the drug’s poor cost structure. However, it is a temporary increase that will be adjusted to KRW 70 from December this year. Pharmaceutical companies had promised to increase production of acetaminophen in line with the price hike. The Ministry of Health and Welfare has also raised the price of magnesium hydroxide-based laxatives since last June. The price of Magmil was raised by 27.8% from KRW 18 to KRW 23. Cho-A Pharmaceutical's Marogel was raised from KRW 15 to KRW 22, and Sinil Pharm’s M Tab Sinil was raised from KRW 16 to KRW 22. Last month, the prices of the 4 types of pseudoephedrine single-agent drugs were increased by up to 45%. The insurance price of Sinil Pharm’s Pseudoephedrine Tab Sinil increased by 45% from KRW 20 to KRW 29. The price of Sam Il Pharmaceutical's Sudafed rose 39% from KRW 23 to KRW 32. The insurance drug price of Sama Pharm’s Schdafen and Kolon Pharmaceutical's Cosue was raised by more than 30% from KRW 23 to KRW 30 and KRW 31, respectively.
- Policy
- Drug price reduction delayed due to suspension of execution
- by Lee, Jeong-Hwan Nov 07, 2023 05:34am
- As the so-called 'Drug Price Reduction Litigation Recovery and Refund System' is about to be implemented in earnest from the 20th, it is expected that some pharmaceutical companies will be put on hold in their tricks to preserve the prices of their own drugs by nullifying or delaying the effect of the government's drug price reduction disposition. According to the Ministry of Health and Welfare on the 6th, according to the results of administrative litigation on drug price reduction, the amendment to the Health Insurance Act and subordinate laws to post-settlement the recovery and refund of drug costs between pharmaceutical companies and insurance authorities will take effect from the 20th. The amendment requires domestic and foreign pharmaceutical companies to collect losses and interest if they obtain unreasonable profits, such as collecting drug costs without reducing the litigation period by suing to suspend the execution of drug price cuts decided by the government through litigation procedures. Conversely, if the government loses the case and is found to have illegally lowered drug prices to a pharmaceutical company, it will be required to refund the pharmaceutical company's drug cost losses along with interest. This regulation applies to administrative trials or administrative lawsuits filed after November 20, when the amendment goes into effect. With the implementation of the system, the number of cases in which pharmaceutical companies protest against government drug price cuts and file 'applications for suspension of execution' and 'lawsuits for cancellation of administrative dispositions' without considering whether they win or not is expected to decrease. Until now, in most cases, suspension of execution of drug price reduction measures was cited until the court's final ruling, which resulted in drug prices not being reduced or only after the lawsuit was completed several years later. This is why criticism has been raised that patients had to take medicine at high prices during the period when drug prices were not reduced due to lawsuits, leading to a waste of health insurance funds. According to the health insurance authorities, the financial loss of health insurance resulting from the suspension of drug price cuts in 47 lawsuits in which suspension of execution was cited since 2018 amounted to approximately 573 billion won as of the end of March 2022. The Ministry of Health and Welfare plans to minimize health insurance financial losses by implementing the system and using related funds to strengthen patient access to rare disease treatments.
- Company
- Chong Kun Dang signs KRW 1.7 tril deal with Novartis
- by Kim, Jin-Gu Nov 07, 2023 05:34am
- On the 6th, Chong Kun Dang Pharm announced on the 6th that it signed a licensing out agreement worth KRW 1.7 trillion for its new drug candidate 'CKD-510' with the global pharmaceutical company Novartis. Under the agreement, Novartis will have exclusive rights to the development and commercialization of CKD Pharm’s CKD-510 worldwide, excluding Korea. CKD Pharm will first receive an upfront payment of USD 80 million (approximately KRW 106.1 billion), followed by milestone payments of USD 1,225 billion (approximately KRW 1.624 trillion) for future development and approval milestones, in addition to sales royalties based on net sales CKD-510 is a new drug candidate in the low molecular substance histone deacetylase 6 (HDAC6) inhibitor class being developed by CKD Pharm. It has applied a highly selective non-hydroxamic acid (NHA) platform technology. It had confirmed its efficacy in a preclinical study in several HDAC6-related diseases including cardiovascular disease. Also, it demonstrated safety and tolerability in Phase 1 trials conducted in Europe and the United States. Young-Joo Kim, CEO of CKD Pharm, said, “We have previously licensed out the anemia drug biosimilar ‘Nesbell,’ and new antidiabetic drug ‘Duvie’ in Japan and the US, respectively. This is the largest agreement ever made by the company and is the result of our continuous investment with over 12% R&D to sales.” Mi-Yeop Lee, Head of CKD Pharm’s Product Development Division, said, “We expect Novartis will develop CKD-510 into a global new drug based on Novarits’s long new drug development know-how and commercialization capabilities. Using the agreement as momentum, CKD Pharm will spur clinical development of its new drug candidates to achieve a result as soon as possible.” CKD Pharm plans to use its own HDAC6 platform to continue developing treatments for various diseases in the future. In addition, the company is speeding up the development of a new bispecific antibody anti-cancer bio drug 'CKD-702' and a dyslipidemia treatment 'CKD-508', which are currently in Phase 1 trials. In addition, the company plans to expand the scope of new drug development to advanced biopharmaceuticals such as gene therapy and ADC anticancer drugs to develop first-in-class new drugs and drugs with unmet needs.
- Opinion
- [Reporter's view] Preferential pharmaceutical alternative
- by Lee, Jeong-Hwan Nov 07, 2023 05:34am
- The government appears to be slow to announce a plan to reform the drug pricing system, which includes measures to give preferential prices for drugs that reflect the value of innovation. Although we have already held several consultative meetings with representatives of domestic and foreign pharmaceutical and biopharmaceutical companies, it is becoming increasingly late to present results on how to specifically evaluate innovation value and provide preferential drug prices. Initially, it was expected that the government would announce a plan to improve the drug price system in September last September for new drugs. The Ministry of Health and Welfare's plan was to make a final announcement as soon as possible based on the results of five public-private consultations on drug price system reform from February to June of this year. However, since there was no specific plan, the release was further delayed due to reasons such as a government audit. The establishment of preferential drug price regulations that reflect the value of innovation is an issue that the National Assembly has also proposed for several years, raising the need for improvement. The special bill on the pharmaceutical industry, proposed by People Power Party lawmaker Seo Jeong-sook, is the core of the bill, which establishes a pharmaceutical and bio innovation committee under the Prime Minister's direct control and mandates additional preferential treatment of the upper salary limit for drugs manufactured by innovative pharmaceutical companies. Park Min-soo, Second Vice Minister of Health and Welfare, has promised to establish and implement a practical system since the beginning of this year since taking office in relation to the plan to reform the drug price system to reflect innovation values. At a meeting held in person with the Professional Journalists Association in February of this year, Vice Minister Park Min-soo said, "Like the U.S. bio executive order, our country will create an incentive system to convert essential medicines and medicines using domestic raw materials to domestic production and reflect them in drug prices." It was revealed. Even during the review of Rep. Seo Jeong-sook's bill, Vice Minister Park expressed concern over converting the drug price preferential clause for innovative pharmaceutical companies into a mandatory/mandatory regulation and announced plans to clearly create and implement a policy of preferential drug prices for drugs that have proven their innovative value even if not converted. there is. Furthermore, this year's National Assembly inspection is reviewing a plan to improve the drug price system to appropriately compensate for the innovation value of new drugs in order to prevent 'Korea passing' and promote the overseas expansion of new domestic drugs and has responded that it will create a policy of preferential drug prices for drugs using domestic raw materials. In the end, the Ministry of Health and Welfare has announced throughout this year that it will prepare a plan to reform the drug price system to reflect innovation values, but it is regrettable that it is still difficult to examine the specific implications. In the past, in response to criticism that the drug price system needed to be reformed, the Ministry of Health and Welfare repeatedly stated that it would be difficult to come up with a drug price reform plan that would only give preference to domestic industries due to reasons such as WTO trade friction. However, after realizing that the pharmaceutical industry is directly linked to national security due to the prolongation of the COVID-19 pandemic, a signal was sent to protect the domestic industry without any trade friction and to provide corresponding compensation to medicines that showed innovative levels of efficacy and safety. Sent several times. Domestic and foreign biopharmaceutical companies that are manufacturing and importing pharmaceuticals in Korea may also have participated in public-private consultative meetings amid this signal. It is understandable at first glance that the Ministry of Health and Welfare is delaying the release of the inevitable reform plan in the process of designing a more detailed and practical drug price preferential policy based on the results of the consultative body discussions. However, from the perspective of the pharmaceutical industry, which is anxiously awaiting the improvement plan, the delay in the release of the Ministry of Health and Welfare's reform plan without any mention is hopeless. It can be torture. Complaints regarding pharmaceutical companies' drug price system reform have already been submitted to the Ministry of Health and Welfare after several meetings. The government's will to prepare a plan to reform the drug price system should not be weakened due to the end of the COVID-19 pandemic. We hope that the drug pricing system reform plan, which will encourage pharmaceutical companies to develop new and improved drugs, increase their chances of entering the global market, and motivate them to manufacture drugs using domestic raw materials instead of cheap Indian and Chinese raw materials, will be revealed before the end of the fall.
- Company
- First GIFT drug Lunsumio in reimb process after approval
- by Eo, Yun-Ho Nov 07, 2023 05:33am
- The new lymphoma drug ‘Lunsumio' started the insurance reimbursement process immediately after its approval in Korea. According to industry sources, the anti-CD20/CD3 T-cell engaging bispecific antibody Lunsumio (mosunetuzumab) is starting the listing process using the approval-reimbursement evaluation linkage system. Lunsumio is the first product that was designated for the Global Innovative Product on Fast Track (GIFT) program. It received approval by the Ministry of Food and Drug Safety on the 3rd. The GIFT system supports the rapid commercialization of drugs for which there are no other existing treatment options, such as those aimed at treating life-threatening serious diseases or rare diseases. Lunsumio was considered a 'drug without an existing treatment’ and was designated as the first product for the GIFT program in November 2022. In addition to the GIFT designation, Roche sought more efficient market access by applying for an approval-reimbursement linkage system. Accordingly, attention is being paid to whether Lunsumio, the first GIFT drug, can produce significant results. Lunsumio can be prescribed to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Follicular lymphoma is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymphoid tissue become malignant. Because the symptoms are mild and progress slowly, approximately 80% of cases are discovered in Stage 3 or 4 after disease progression and show worse progression with relapse. Although the median progression-free survival (mPFS) for first-line treatment patients is 10.6 years but is reduced to 2 years in third-line treatment patients. Lunsumio is a first-in-class anti-CD20/CD3 T-cell engaging bispecific antibody for relapsed or refractory follicular lymphoma and is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. The dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. It was released as a finished product and can be administered immediately without waiting for the treatment manufacturing process, and outpatient treatment is possible without the need for hospitalization. The administration period is fixed to 8 cycles, and if the patient does not achieve complete remission during this period, it can be administered up to 17 cycles. Seok Won Kim, Professor of Hematology-Oncology, said, “Follicular lymphoma is considered a benign lymphoma with a life expectancy of up to 20 years, but the disease becomes more aggressive and the prognosis worsens with repeated relapses. Therefore, there is an urgent need for an effective treatment option that can provide a cure for patients who have relapsed more than twice.
- Policy
- Lunsumio receives marketing authorization in Korea
- by Lee, Hye-Kyung Nov 06, 2023 05:27am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that it had approved ‘Lunsumio (mosunetuzumab),’ which is used to treat follicular lymphoma, on the 3rd of this month. Lunsumio is used to treat adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Lunsumio is an anti-CD20/CD3 T-cell engaging bispecific antibody that binds to CD3 on the surface of T cells and CD20 on the surface of B cells, and provides a new treatment opportunity for patients with relapsed or refractory follicular lymphoma. When it binds to CD3, T cells are activated, and when it binds to CD20, it positions B cells next to the activated T cells and induces lysis of B cells. In November last year, Lunsumio was designated as the first product subject to the Global Innovative Product on Fast Track (GIFT) program the MFDS has been operating. Drug subject to GIFT receives various support for the rapid commercialization of its product including shortening the review period by at least 25% (e.g. 120 → 90 working days), as well as rolling review that allows for the review of prepared materials first and provides opportunities for close communication between the reviewer and developer, as well as expert consulting on regulatory affairs, etc. MFDS said, “We will continue being committed to the rapid provision of safe and effective treatment for the Korean people based on its expertise in regulatory science.”
- Company
- Scemblix may be prescribed at Big 5 Hospitals in KOR
- by Eo, Yun-Ho Nov 06, 2023 05:27am
- The next-generation chronic myeloid leukemia drug ‘Scemblix’ can now be prescribed at general hospitals in Korea. According to the industry sources, Novartis Korea's Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) treatment ‘Scemblix (asciminib)' has passed the drug committees of the Big 5 tertiary hospitals in Korea- Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, Sinchon Severance Hospital – as well as major medical institutions nationwide. As the drug was listed for reimbursement in June, the prescription environment seems to have been created quite quickly. Scemblix is reimbursed as a treatment for patients aged 18 and older with Ph+ CML in the chronic phase who are resistant or intolerant to two or more prior tyrosine kinase inhibitors (TKIs). However, Scemblix is only allowed reimbursed for patients without the T315I or V299L mutations in Korea. Meanwhile, Scemblix was approved in June last year as a treatment for adult patients with Ph+ CML in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs). Chronic myeloid leukemia is a malignant blood disorder that occurs when myeloid cells produce white blood cells. Although it progresses slowly, if left untreated, it can gradually progress to acute leukemia, and result in spleen enlargement and frequent infections as well as bleeding. Currently, TKIs are used to treat patients with chronic myeloid leukemia, but treatment may be limited due to intolerance or resistance, and the longer the treatment period, the higher the failure rate. Research results show that up to 70% of patients treated in the second line did not achieve major molecular response (MMR) within 2 years. Contrary to existing TKIs that had the potential to develop resistance due to mutations in the ATP binding site, Scemblix specifically binds to the ABL1 myristoyl pocket to overcome mutations at the defective BCR::ABL1 gene, which is associated with the over-production of leukemic cells., and is also called the STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. Through the mechanism of action, it shows high specificity for BRC-ABL1 and is unlikely to cause resistance due to mutations in the BCR-ABL1 gene, which is associated with resistance and intolerance in patients with chronic myeloid leukemia that used to occur with existing treatments. Meanwhile, Scemblix demonstrated its efficacy through the Phase III ASCEMBL study, which confirmed its clinical utility and safety profile in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia who received at least two or more TKI treatments. Study results showed that Scemblix improved the rate of major molecular response (MMR) compared to its comparator bosutinib by 2 times. Also, the rate of treatment discontinuation due to adverse reactions in the Scemblix group was 5.8%, about one-fourth of the control group's 21.1%, confirming its overall safety profile.
- Company
- Wegovy and Mounjaro begin to dominate the obesity market
- by Kim, Jin-Gu Nov 06, 2023 05:27am
- Wegovy and Mounjaro Novo Nordisk Wegovy and Eli Lilly Mounjaro have grown explosively in the global market. The two products together generated sales of close to 4 trillion won by the third quarter. In the future, if Mounjaro officially obtains an obesity treatment indication from the FDA, competition between the two products is expected to become more intense. The obesity market rises vertically to Wegovy 4.1 trillion won and Mounjaro 3.9 trillion won According to the pharmaceutical industry on the 4th, Novo Nordisk's obesity treatment Wegovy recorded cumulative sales of approximately 4.1248 trillion won in the third quarter of this year. Sales increased nearly six times compared to the same period last year. Wegovy is a Semaglutide GLP-1 receptor agonist drug. Novo Nordisk first developed Ozempic as a diabetes treatment with the same ingredient and then relaunched it as Wigobi after proving its effectiveness in treating obesity. Since its launch, Wegovy has received a lot of attention. In the U.S. market, demand was high enough to cause shortages within a few months of launch. Thanks to Wegovy's sensation, Novo Nordisk's sales also increased significantly. Novo Nordisk's total cumulative sales in the third quarter amounted to approximately 31.67 trillion won, an increase of 33% in one year. Eli Lilly Mounjaro, which is considered a potential competitor to Wegovy, also posted sales close to 4 trillion won. According to the third-quarter performance data released by Eli Lilly on the 2nd (US local time), Mounjaro's cumulative sales in the third quarter amounted to $2.957.5 billion (approximately 3.91 trillion won). Compared to the same period last year, sales rose vertically by more than 14 times. It is estimated that most of the sales come from off-label prescriptions aimed at treating obesity. Currently, Mounjaro has been approved by the U.S. FDA as a treatment for diabetes. However, as the effectiveness of this product in treating obesity became known, it received great attention and was widely prescribed off-label in the United States. It contributed significantly to Lilly's overall sales growth. Lilly's cumulative sales in the third quarter were $24.77 billion (about 32.77 trillion won), a 16% increase compared to $21.2936 billion in the third quarter of last year. It is analyzed that although the sales of Trulicity, Lilly's highest-selling product, decreased by 7% due to supply instability, this was offset by the significant increase in sales of Mounjaro. Mounjaro will compete with Wegovy in earnest once its official obesity treatment is approved. Attention is focused on the timing of Mounjaro's official approval as an obesity treatment. Lilly has proven its weight loss effect through a separate phase 3 obesity clinical trial and is currently going through the approval process for obesity indications. Lilly expects to receive additional approval for obesity indications from the U.S. FDA within this year. If Mounjaro is officially approved as an obesity treatment within the year as Lilly plans, full-scale competition with WeGobee is expected after next year. Although there are no studies directly comparing the two drugs, looking at each clinical trial alone, Maunzaro's weight loss effect is evaluated to be slightly superior. In Mounjaro's SURMOUNT-1 study, the weight loss effect was found to be 15.0-20.9% depending on the drug dose. This study was conducted on 2,539 adults with a body mass index (BMI) of 30 or higher or a BMI of 27 or higher who suffered from one or more weight-related complications other than diabetes. When they were administered 5mg, 10mg, and 15mg of Mounjaro for 72 weeks, the weight loss rates were 15.0%, 19.5%, and 20.9%, respectively. Wegovy's STEP study showed a weight loss effect of 14.9%. The study was conducted on 1,961 adults with a BMI of 30 or higher or a BMI of 27 or higher who suffered from one or more weight-related diseases other than diabetes. When these people were administered Wegovy 2.4mg for 68 weeks, the weight loss rate was 14.9%. Additionally, the proportion of people who lost more than 5% of their body weight was 86.4%.
- Company
- Polivy’s reimb soon to receive CDDC review
- by Eo, Yun-Ho Nov 06, 2023 05:26am
- Whether progress will be made for the reimbursement of the lymphoma treatment ‘Polivy,’ which has applied for reimbursement again after changing its indication to the first-line, is gaining attention. According to industry sources, schedule coordination is underway for the review of the agenda of reimbursing Roche Korea’s Diffuse Large B-Cell Lymphoma (DLBCL) treatment Polivy (polatuzumab vedotin) by the Cancer Disease Deliberation Committee (CDDC), after completing opinion collection from academic societies. Polivy is the first-in-class ADC targeting CD79b that binds to CD89b, a protein expressed in the majority of B-cells, to induce apoptosis. The drug had applied for reimbursement with its first indication, as a third-line treatment in combination with standard BR therapy (rituximab-cyclophosphamide), in 2021, but failed to pass review by the Cancer Disease Deliberation Committee. The company resubmitted an application for its reimbursement in the first half of this year after extending its indication to the first line in November last year. In addition, the patient group Korea Alliance of Patient Organizations added its support, urging that for the prompt review of Polivy’s reimbursement at the CDDC level. On the 2nd, KAPO submitted a written opinion to the HIRA, requesting rapid CDDC review and reimbursement adequacy revaluation for Polivy. Therefore, whether Polivy’s reimbursement agenda will be submitted for review at the CDDC meeting scheduled for the 22nd remains to be seen. Diffuse large B-cell lymphoma is an aggressive type of hematological cancer and the most common form of non-Hodgkin's lymphoma. In Korea, the number of new patients diagnosed with DLBCL is estimated to be near 5,000 each year. As the most common form of non-Hodgkin lymphoma, DLBCL is an aggressive (fast-growing) type of lymphoma that requires immediate treatment. DLBCL is generally responsive to treatment as over half of the patients reach remission, however, 30% to 40% of the patients do not respond to the standard-of-care, R-CHOP, or experience relapse after first-line treatment. Its first-line indication was approved based on the Phase III POLARIX trial. In the POLARIX trial, all patients were followed for over 24 months, and at a median follow-up of 28.2 months, the risk of disease progression, relapse, or death was reduced by 27% with Polivy + R-CHP compared with R-CHOP alone.
