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- 2026-04-04 07:31:06
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- Three months after Pluvicto launch
- by Moon, sung-ho Nov 19, 2024 06:13am
- Novartis Korea's prostate cancer treatment, Pluvicto, which has garnered attention since its approval by the Ministry of Food and Drug Safety (MFDS), has now been administered to Korean patients for three months. Pluvicto is a blockbuster drug that generated over KRW 1 trillion in global sales last year and is recognized as a product initiating the so-called "radioactive missile" era. Pluvicto can primarily be prescribed in large hospitals in South Korea, leading to a growing number of patients receiving the treatment. However, its high cost and non-reimbursable status remain significant barriers to patient access. As the use of radiopharmaceuticals becomes more widespread in domestic clinical settings, competition among local pharmaceutical‧biotech companies developing similar treatments is intensifying once again. According to the medical community on November 14, since the MFDS approved Novartis Korea's prostate cancer treatment Pluvicto (Lutetium (177Lu) vipivotide tetraxetan injection) at the end of May, six medical institutions, including the National Cancer Center, have administered or plan to administer the treatment as of November. Pluvicto is a radioligand therapy that targets prostate-specific membrane antigen (PSMA), which is overexpressed in prostate cancer, by binding the radioactive isotope Lutetium-177 (177Lu) to PSMA to eliminate cancer cells. Radioligands are therapies that combine a ligand (a targeting molecule) with a therapeutic radioactive isotope. When the radioligand binds to the target cell, it emits therapeutic radiation, which suppresses cancer cell proliferation. The basis of domestic approval was the Phase 3 VISION clinical tiral. The trial involved 831 patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). It was designed to compare the efficacy and safety of Pluvicto combined with standard therapy versus standard therapy alone. The clinical trial results showed that the Pluvicto group recorded a median radiographic progression-free survival (PFS) of 8.7 months, significantly longer than 3.4 months in the control group. The median overall survival (OS) was 15.3 months for the Pluvicto group, compared to 11.3 months for the control group. Administration of Pluvicto reduced the risk of disease progression or death by 60%. To introduce Pluvicto, medical institutions must have dedicated PSMA PET-CT equipment for prostate cancer and facilities for preparation, quality control, and separate spaces for patient administration. Additionally, multidisciplinary collaboration involving nuclear medicine, oncology, and urology specialists is essential. The treament requires significant investment in medical institutions' facilities, equipment, and personnel. Currently, 15 medical institutions nationwide, including major hospitals in South Korea, have adopted PSMA PET-CT for diagnostic purposes. As of November, six of these institutions are providing treatment using Pluvicto. The remaining issue is the cost. The recommended dose of Pluvicto is 7.4 GBq (200 mCi), administered intravenously every six weeks (±1 week) for up to six doses. Each dose costs KRW 30-40 million out-of-pocket in clinical practices, bringing the total treatment cost to approximately KRW 200 million. However, despite the high cost, the clinical efficacy of Pluvicto has been proven to surpass existing treatments. Nearly 20 patients have completed or are undergoing Pluvicto therapy within three months after launch. Considering the expense, this is a significant number of patients. Dr. Inkeun Park from the Oncology Department at Asan Medical Center in Seoul said, "From a medical professional's perspective, the introduction of Pluvicto sheds a positive light as it provides an additional effective treatment option with manageable side effects." Park added, "The challenge lies in its high cost, the limited number of institutions equipped to perform PSMA PET-CT, and the restricted availability of facilities capable of administering the treatment." Novartis, fully aware of these challenges, has set reimbursement for Pluvicto as a chief objective for next year. A representative from Novartis Korea said, "We are currently conducting internal reviews to secure reimbursement for Pluvicto." Adding, "Given its role in transforming the prostate cancer treatment paradigm, we aim to improve patient accessibility by obtaining reimbursement approval next year."
- Company
- Imfinzi passes first step to reimb in KOR… key is the price
- by Whang, byung-woo Nov 19, 2024 06:13am
- With the reimbursement standard set for the immuno-oncology drug Imfinzi (durvalumab), which is under review for reimbursement extensions, how the discussions will develop thereafter is gaining attention. Although the first step has been taken, attention is being paid to the future process as the matter was mentioned during the National Assembly’s Health Insurance Review and Assessment Service National Audit. The drug price is the key issue. Consensus on the cost is expected to be crucial amid the rising health insurance expenses being spent on anticancer drugs. Pic of Imfinzi According to industry sources on the 18th, the Health Insurance Review and Assessment Service recently held the 8th Cancer Disease Deliberation Committee (CDDC) meeting in 2024 to deliberate on whether to establish reimbursement standards for major anticancer drugs. As a result, Imfinzi was set reimbursement standards in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic biliary tract cancer. In addition, AstraZeneca's Imjudo (tremelimumab) has also been set reimbursement standards in combination with Imfinzi in liver cancer, raising expectations for further coverage of the drug. In a response to a written inquiry during the NA Audit, HIRA had said, “As a result of the CDDC review that was held in November last year, the committee decided Imfinzi’s cost should fully be borne by patients due to its high price and high financial spending compared to clinical benefits.” However, the CDDC changed its decision and recognized Imfinzi’s clinical benefits this time around. In fact, a Korean subgroup analysis of TOPAZ-1, Imfinzi’s Phase 3 trial in biliary tract cancer, which was presented at the Korean Society of Medical Oncology (KSMO) International Conference in September, showed improved median overall survival (mOS) and 3-year OS rate in Korean patients. Korean patients treated with the Imfinzi combination showed an mOS of 16.6 months, compared to the 11.3 months found in Korean patients treated with conventional therapy, which is a 5.3-month extension in overall survival. The OS rate at 3 years also improved over twofold, being 21.0% in the Imfinzi combination arm and 8.8% in the conventional therapy arm. ▲ Key Results of the TOPAZ-1 overall patient and Korean subgroup analysis The industry also believes that AstraZeneca's improved financial proposal to the government for Imfinzi would have played a role during the CDDC review. The key question is whether it will pass the next stage, the Drug Reimbursement Evaluation Committee review. Although the company has succeeded in expanding the reimbursement standard for Imfinzi and setting the reimbursement standards for Imjudo in biliary tract cancer and liver cancer, respectively, there is also the burden of increased use for Imfinzi that would affect the drug’s price. Currently, Imfinzi costs around KRW3.34 million per bottle, and the cost of administering the drug is even higher for liver cancer patients who receive the drug in combination with Imjudo. In the end, it will be important to find a compromise between the fact that Imfinzi has become the global standard of care for biliary tract cancer in 12 years and its increasing burden on health insurance finances. In the U.S., U.K., and Japan, Imfinzi was reimbursed within a year of its approval. The industry believes the U.K.’s case would provide clues for Korea’s implementation. During reimbursement discussions, the U.K. used a quality-adjusted life years (QALYs) weight of 1.2 and a flexible ICER in recognition of the fact that Imfinzi was the first immuno-oncology drug approved for the first-line treatment of biliary tract cancer. However, as Imfinzi’s ICER does not meet the criteria for the Korean government's 'preferential treatment for innovative new drugs', it remains to be seen how the discussions will unfold. The industry analyzes that it will come down to what the pharmaceutical companies will propose in terms of financial sharing and whether the government will accept the proposal. “AstraZeneca Korea is committed to providing innovative treatment options for biliary tract cancer patients in Korea. We will continue to do our best in the coming process,” said an AstraZeneca official.
- Policy
- Samil voluntarily cuts price of its Vemlino to lowest price
- by Lee, Tak-Sun Nov 19, 2024 06:13am
- Samil Pharm is voluntarily reducing the price of its hepatitis B drug Vemlino (Tenofovir Alafenamide Hemimalate). This will render the drug to be the lowest-priced drug among tenofovir alafenamide drugs, increasing its price competitiveness. According to industry sources on the 18th, the price of Vemlino will be reduced from KRW 2,425 to KRW 2,358 starting next month. There are currently 9 tenofovir alafenamide-based hepatitis B treatments, including the original Vemlidy (tenofovir alafenamide hemifumarate, Gilead). The other 8 are salt-modified agents. Vemlidy is an upgraded version of Gilead's Viread. Viread was associated with side effects of decreased kidney function or bone density in some patients, so the upgraded Vemlidy has become the most commonly recommended initial treatment on site as it contains one-tenth the active ingredient dose of Viread while providing the same level of viral suppression. The salt-modified versions of Vemlidy have been sequentially released to the market starting with Dong-A ST’s ‘Vemlia Tab (tenofovir alafenamide citrate). The companies were able to enter the market by avoiding patents through salt modification. However, even with the introduction of such versions, the original's status remained unchanged. Vemlidy’s sales continued to soar, reaching KRW 27.9 billion in 2021, KRW 39.3 billion in 2022, and KRW 49.2 billion in 2023, according to UBIST. This is the third consecutive year that the drug’s upper limit has been reduced through the price-volume agreement negotiations due to increased usage. The price of Vemlino, whose price was lowered this time, was only KRW 300 million (UBIST) last year. Samil had listed its drug at KTW 2,425, lower than the calculated amount when it was listed in July last year, to gain price competitiveness. However, the lowest price title went to Dongkook Pharmaceutical’s Alfoterin Tab (Tenofovir Alafenamide Hemimalate). The upper limit for Alfoterin is KRW 2,424. This time, Samil lowered the price of Vemlino to KRW 2,328 and took over the lowest price title. The highest price for tenofovir alafenamide is currently KRW 3,235 for the original Vemlidy Tab, and the difference between Vemlidy and Vemlino is KRW 887. HBV patients are sensitive to the price because they need to take medications for life. Therefore, it will be interesting to see if Vemlino can gain market share with its competitive price. An industry insider said, “The market for tenofovir alafenamide preparations has only 8 generic contestants that entered the market through patent evasions, so there is less competition and the companies can take more of the market share. However, the generic companies are struggling due to high dependence on the original, and the eyes are on whether the low-price competition can break this pattern.”
- Company
- Mounjaro aims for 'diabetes·obesity' synergy
- by Whang, byung-woo Nov 19, 2024 06:12am
- Eli Lily's Mounjaro (tirzepatide), the first once-weekly GIP·GLP-1 receptor agonist, will enter the market with its diabetes and obesity indications. Unlike already launched Wegovy (semaglutide), Mounjaro has two indications: diabetes and obesity. Experts anticipate that Mounjaro's sales strategy will be focused on diabetes treatment although a separate indication is not a chief factor for medication choice in clinical practices. Product photo of Mounjaro. Mounjaro is a single molecule that activates both GIP and GLP-1 receptors, which are primary incretin hormones that stimulate insulin secretion in the body. Mounjaro received the Ministry of Food and Drug Safety (MFDS) approval for the treatment of type 2 diabetes in June 2023. In August, it added an indication to treat chronic weight management, resulting in two indications. Mounjaro generated significant sales in the global market, so it has high expectations for the Korean market. Mounjaro's sales in Q3 amounted to US$3.11 billion (KRW 4.29 trillion), an increase from US$1.41 billion (KRW 1.9683 trillion) last year. Zepbound recorded US$1.26 billion (KRW 1.73 trillion). In South Korea, 73.6% of patients with diabetes are overweight and obesity patients. Therefore, the analysis suggests that Mounjaro has a high potential. Hyuk-Sang Kwon, Korean Diabetes Association (Endocrinology at The Catholic University of Korea Yeouido St. Mary's Hospital), said that "Type 2 diabetes patients with obesity must be treated with a goal of improving glycated hemoglobin and weight loss." Kwon explained, "Still, many type 2 diabetes in South Korea have difficulty managing glycated hemoglobin (HbA1c) and body mass index (BMI). We need a proactive treatment to improve treatment prognosis." SungHee Choi, Korean Diabetes Association (Endocrinology at Seoul National University Bundang Hospital), said, "Mounjaro is administered as an adjuvant treatment to dietary therapy and physical therapy to improve regulation of blood sugar in adult patients with type 2 diabetes." Choi said, "Wegovy with semaglutide was recently launched. It is said that Mounjaro is positioned as the treatment for obesity rather than diabetes, but in my opinion, it must be focused as a diabetes treatment." Lily Korea says that the company is preparing for reimbursement before announcing the launch date. "We are closely discussing with the Ministry of Health and Welfare (MOHW) for reimbursement, and we have invested over US$20 billion in the past four years to expand production and distribution capacities," Lily's representative said. "In South Korea, we are putting our best efforts into supplying Mounjaro stably." Clinical practices point out high costs as a barrier. The company is expected to determine a launch date after weighing the options for reimbursement strategy and the possibility of a non-reimbursement. As the domestic distributor candidates for Mounjaro are being discussed, the industry anticipates the launch date of Mounjaro in the first half of 2025. It is said that Mounjaro will enter the market before Wegovy launches and has a market-dominating effect. Meanwhile, the latest Mounjaro's SURMOUNT-1 study results will positiviely affect obtaining reimbursement. Sub-group analysis of adults who participated in the randomized Phase 3 SURMOUNT-1 trial showed that the risk of diabetes progression was reduced by 94% after patients were treated with Mounjaro for about 3 years. The average rate of weight loss during the treatment was 15.4-22.9% for the Mounjaro group, and the average weight was reduced by 34.6~54.2lb from about 236.8lb. Mounjaro's weight loss effects observed in the early treatment stage were maintained throughout the study period.
- Company
- Academia pushes for Tagrisso’s reimbursement expansion
- by Moon, sung-ho Nov 19, 2024 06:12am
- Less than a year after AstraZeneca's lung cancer drug Tagrisso (osimertinib) was granted expanded reimbursement coverage, another round of discussions on its further expansion has begun, drawing attention to its background. As the expansion request came from the medical community, not pharmaceutical companies, it will be interesting to see if the experts' request will be granted. #On the 18th, according to the pharmaceutical industry and medical community, the Health Insurance Review and Assessment Service recently held the 8th Cancer Disease Deliberation Committee meeting in 2024 to deliberate on whether to set a reimbursement standard for Tagrisso. The committee discussed the need to set a reimbursement standard for ‘Tagrisso in combination with pemetrexed and platinum-based chemotherapy’ as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small-cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation. In other words, less than a year after the drug’s reimbursement was expanded to its use as a monotherapy, the authorities are reviewing extending its reimbursement as a combination therapy as a first-line treatment for NSCLC. The review is based on the results of the FLAURA2 study, which compared the efficacy of the Tagrisso+chemotherapy combination therapy with Tagrisso monotherapy. Study results showed that the Tagrisso+chemotherapy combination reduced the risk of disease progression or death by 38% compared to Tagrisso alone. Median investigator-assessed PFS was 25.5 months, an 8.8-month extension compared to 16.7 months with Tagrisso monotherapy. Median PFS by blinded independent central review (BICR) was 29.4 months, compared with 19.9 months in the Tagrisso monotherapy arm. This led to a reimbursement discussion, but the outcome was a 'reimbursement standard not established’ decision However, it is worth noting the background of why CDDC decided to discuss Tagrisso's reimbursement extension. Usually, a “pharmaceutical company” applies to expand the reimbursement of anticancer drugs, but this time, the Korean Lung Cancer Society applied for the reimbursement expansion upon which the cancer review was held. The Korean Association For Lung Cancer applied to expand the reimbursement of the Tagrisso+chemotherapy combination, and AstraZeneca supported it. This means that the need to use the Tagrisso+chemotherapy combination has been recognized in clinical practice. “Pemetrexed plus cisplatin or carboplatin, which is used as combination therapy, is relatively well tolerated by patients,” said Professor Sang-We Kim (Medical Oncology) from Seoul Asan Medical Center. ”It can be relatively difficult because you have to receive chemotherapy for four cycles, but from the fifth cycle, you receive only pemetrexed. Given the positive outcomes, including PFS in the FLAURA2 study, the combination may be a viable first-line treatment option compared to Tagrisso monotherapy.” As such, AstraZeneca is expected to further review the data and decide whether to reapply for reimbursement expansions. However, there is a possibility that AstraZeneca may not pursue the reimbursement expansions, given that any additional reimbursement would require further price cuts for Tagrisso. A HIRA official said, “The regulations allow medical societies to apply for reimbursement of drugs. This is what happened to Tagrisso. There have been many such cases before. However, even if a medical society applies for a reimbursement expansion, it may not be possible to discuss it without the cooperation of the pharmaceutical company because the drug’s cost-effectiveness must be verified.” “For new drugs that are applied the risk-sharing agreement, it is more often the pharmaceutical company that applies for reimbursement coverage, as they have to prove the drug’s cost-effectiveness. However, it has always been possible for academic societies to apply for reimbursement expansions, like in this case.”
- Company
- Premium meningitis vaccine Bexsero lands in hospitals in KOR
- by Eo, Yun-Ho Nov 18, 2024 05:49am
- The next-generation meningococcal vaccine, ‘Bexsero’ can now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea’s Bexsero, the first meningococcal B vaccine introduced to Korea, has passed the drug committees (DCs) of the Big 5 tertiary hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. Kyungpook National University Hospital, Korea University Anam Hospital, Korea University Ansan Hospital, Inje University Paik Hospital, Seoul National University Bundang Hospital, Seogwipo Medical Center, Ajou University Hospital, and Pusan National University Yangsan Hospital. Meningococcal infections can cause invasive meningococcal infections, meningitis, and sepsis. Invasive meningococcal infection progresses rapidly and can cause death within 24 to 48 hours of the onset of symptoms. Even with treatment, the disease is deadly, with a fatality rate of 8-15%. Typical serogroups of meningococci that cause invasive meningococcal infections in humans include A, B, C, W, X, and Y. The most predominant meningococcal serogroup in Korea, the United States, and Europe are serogroup B, with high levels found in infancy and adolescence. From 2010 to 2016, the proportion of meningococcal B serogroup cases identified in Korea was 28%, but from 2017 to 2020, the rate increased significantly to 78%. Meningococcal B's capsular polysaccharide is structurally similar to human tissue, which has made vaccine development challenging due to the risk of autoimmune damage. GSK developed Bexsero by applying novel technologies that employ genome sequencing. Since its initial European approval in 2013, GSK has accumulated over a decade of experience in preventing meningococcal B infections, conducting 17 studies on subjects aged 2 months to adults. Professor Hyunmi Kang, Department of Pediatrics at St. Mary's Hospital in Seoul, said, "The prevalence of meningococcal serogroups varies across countries and time periods, so it is not easy to predict. In Korea, serogroup B meningococcal infection cases have increased in recent years, increasing the need for its prevention.”
- Company
- 'Tevimbra' can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 18, 2024 05:49am
- 'Tevimbra,' a type of immune checkpoint inhibitor, is becoming more widely available for prescription at general hospitals. According to industry sources, BeiGene's PD-1 inhibitor Tevimbra (tislelizumab), which has applied for reimbursement for its esophageal cancer indication, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Asan Medical Center. Tevimbra is a PD-1 inhibitory immune checkpoint inhibitor that demonstrated clinical usefulness as the second-line therapy for esophageal squamous cell carcinoma. It was approved in South Korea in November 2023. The drug passed the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) in August in its second attempt and is awaiting consideration for the Drug Reimbursement Evaluation Committee (DREC) review. Since there haven't been any immune checkpoint inhibitors with reimbursement for esophageal cancer, it remains to be watched whether Tevimbra will become available as the new treatment option. Currently, seven immune checkpoint inhibitors have been approved or authorized for marketing in South Korea, including ▲Keytruda ▲Opdivo ▲Tecentriq ▲Imfinzi ▲Bavencio ▲Jemperli ▲Tevimbra. The number of indications for these drugs totals 64. However, only 21 therapies are reimbursement-listed (about 33%). None of these drugs are included on the reimbursement list for the treatment of esgophageal cancer. In South Korea, platinum-based anticancer chemotherapy is approved for reimbursement as both first-line therapy and second-line therapy or higher for esophageal squamous cell carcinoma. The low reimbursement rate for immune checkpoint inhibitors in each indication, such as esophageal cancer, is due to drug price and finance. It has been known that after drugs were reimbursed for treating several cancer types, such as lung cancer, the overall claim amount for immune checkpoint inhibitors and the percentage of anticancer agents under the National Health Insurance significantly increased, resulting in a financial burden. Based on the 2023 report, the claim amount of anticancer agents was KRW 2.4 trillion. The claim amount for immune checkpoint inhibitors was about KRW 500 billion, accounting for 20% of the anticancer agents' claims. Patients have high hopes for BeiGene's Tevimbra because the company announced the drug supply at a relatively lower price. BeiGene has already demonstrated its 'Fair pricing of innovative new drugs' philosophy to eliminate potentially excluded patients through the reimbursement procedure for the blood cancer treatment, 'Brukinsa (zanubrutinib).' Meanwhile, the global Phase 3 clinical RATIONALE-302 study showed Tevimbra prolonged the median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs. 6.3 months), statistically reducing the death risk by 30%. The response rate was twofold higher in Tevimbra compared to chemotherapy (20% vs. 10%), and Tevimbra extended the median duration of response (DOR) by approximately three months, from 4.0 months to 7.1 months. As a result, the National Comprehensive Cancer Network (NCCN) Guidelines were revised, detailing Category 1 recommendation for Tevimbra as a favorable option for second-line therapy for esophageal squamous cell carcinoma.
- Policy
- HK Inno.N to distribute Tamiflu as Roche’s new partner
- by Lee, Tak-Sun Nov 18, 2024 05:49am
- HK Inno.N will be responsible for the domestic distribution of ‘Tamiflu Cap’ in addition to the distribution of the antiviral drug ‘Xofluza.’ The company is expected to gain external growth with the distribution of Tamiflu, which has an annual sales volume of KRW 15 billion. According to industry sources on the 15th, HK Inno.N sent a letter to its business partners and announced that it will distribute Roche Korea’s Tamiflu Cap. 30/45/75mg from the 14th. Tamiflu is “the” antiviral flu drug. Its sales were sluggish in 2020 and 2021 during the height of the COVID-19 pandemic, but have risen significantly since last year with the rise of the flu epidemic. Last year, its outpatient prescriptions amounted to KRW 15 billion based on UBIST. Its previous distributor, Chong Kun Dang had distributed Tamiflu in Korea since 2012, but the companies’ partnership ended last year and Roche has been seeking a new domestic partner since. Last year, HK Inno.N signed an exclusive domestic distribution and commercialization agreement with Roche Korea for the antiviral flu drug Xofluza (baloxavir marboxil). Under the agreement, HK Inno.N will distribute Xofluza for 2 years and jointly conduct marketing and sales activities with Roche Korea. Xofluza is a new drug that can treat influenza with just one dose, unlike other oral influenza treatments that require 5 days of administration. It is the first flu antiviral drug to be developed in 20 years. However, Xofluza is still non-reimbursed in Korea, so it has not been able to raise significant domestic sales. If it succeeds in being reimbursed in Korea, it is expected to take over Tamiflu's sales. Roche had shown its trust in HK Inno.N, signing for Tamiflu following Xofluza. HK Inno.N is expected to become Roche's new partner in Korea after Chong Kun Dang. “HK Inno.N has recently emerged as a key player in the domestic respiratory virus drug market, supplying Pfizer's new COVID-19 vaccine,” said a pharmaceutical industry insider. ”Its distribution of Tamiflu will help accelerate the company's external growth and raise company awareness in the antiviral drug market.”
- Company
- Demand rises for reform of the cancer drug reimb system
- by Moon, sung-ho Nov 18, 2024 05:49am
- With the presence of new anticancer drugs increasing in the clinical field, the pharmaceutical industry has been demanding the authorities apply a new reimbursement model in Korea. In addition to the existing immuno-oncology drugs, the emergence of antibody-drug conjugates (ADCs), which have proven effective in various cancers, has led to calls for different drug prices for each 'indication.’ # These calls have been mainly coming from multinational pharmaceutical companies that own new anticancer drugs, but they have been met with a lukewarm response in the field. The reason is that the system they requested considers the profitability of companies rather than the patients. According to industry sources on the 9th, as immuno-oncology drugs or ADCs with indications for various cancer types have recently been introduced to the field, the opinion has been raised on how different drug prices should be applied to the same drug by indication. The system, indication-based pricing (IBP), is a further subdivision of value-based pricing (VBP), which states that drug prices should reflect the actual value of drugs. Currently, the single-price policy used by Korea’s health insurance system bases a drug’s price on the initial indication. For each additional indication that is covered, the existing drug’s price must be reduced to reflect the expanded scope of coverage. For example, if an immuno-oncology drug called A is initially approved for lung cancer, and then expands its indication to gastric and breast cancer, the existing price must be reduced through negotiation to reflect the increased use in practice. The problem is that an increasing number of drugs have indications for multiple cancers, including major immuno-oncology drugs and ADCs, and as demand for their reimbursement is rising, the current single-price system cannot accommodate all the indications. One such treatment is MSD Korea's immuno-oncology drug Keytruda (pembrolizumab). As of August, Keytruda was approved in Korea for 33 indications in 17 different cancers. Since last year company has been pushing to expand reimbursement for Keytruda. It has applied for reimbursement of a total of 17 indications in Korea but has not been able to cross the Cancer Disease Deliberation Committee’s threshold. After applying for reimbursement for 13 of its indications last year, the company has added 4 more indications this year: ▲MSI-H gastric cancer, ▲MSI-H biliary tract cancer, ▲HER2-positive gastric cancer, and ▲HER2-negative gastric cancer. MSD Korea recently submitted an additional financial-sharing proposal that included a gastric cancer indication and is reportedly making every effort to cross the CDDC threshold. The multinational pharmaceutical industry is of the opinion that the government should consider treatments with multiple indications, including immuno-oncology drugs such as Ono Pharmaceutical’s Opdivo (nivolumab), Roche’s Tecentriq (atezolizumab), AstraZeneca’s Imfinzi (durvalumab), and ADCs represented by Enhertu (trastuzumab deruxtecan), and the autoimmune disease treatment, Sanofi’s Dupixent (dupilumab). “In the current system, we have to apply for the reimbursement of each indication separately, which means that we have to continuously conduct negotiations with the government,” said one multinational pharmaceutical industry official. ”I think the need for indication-specific pricing, which is being adopted in some countries overseas, is a reference to the need that we need to find a more efficient way to work the system.” In fact, major countries such as the United Kingdom, France, Germany, Italy, Japan, Switzerland, and the United States have adopted indication-specific pricing, said the official. “The use of a single drug for multiple indications will be increasing not only in cancer but also in other diseases,” said the official. “We need a more comprehensive approach.” Then how do clinicians who actually use the drugs on-site feel about the need? First of all, the pharmaceutical industry’s dominant opinion is that IBP is necessary for 'multinational pharmaceutical companies,' but believes in the need for a cautious approach in implementing the system. This means that while the need is acknowledged, patient consent should be prioritized. For now, the demand is more focused on the profit logic of pharmaceutical companies than an improvement on the patient’s part. “With the rising number of anticancer drugs that hold multiple indications, I do agree on the need to calculate drug prices by indication,” said Dr. Shin-kyo Yoon, Professor of Oncology at Asan Medical Center, ”but the opinions of patients are more important than ours. It is not easy because the entire system would need to be reorganized.” Another professor of oncology at a university hospital said, “It's not an easy problem, as the price cuts in the current system are entirely borne by the drug companies. The IBP seems to have come about because they have to apply for reimbursement while avoiding drug price reductions and receive approval for the additional indications. In the end, it's a problem that the government should need to address.” As such, introducing IBP has been mentioned during the National Assembly's audit, which ended last month. However, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service did not specifically mention the need for such a system, saying that the necessity of the system should be reviewed first. At the same time, the authorities stated that it is time to think about how too much of Korea’s health insurance finances are being spent on reimbursing anticancer drugs. The MOHW said, “We will review the necessity of introducing a Korean-style IBP system that reflects the value of each indication by comprehensively considering various factors such as expanding access to new drugs and the impact on health insurance finances. However, we would need to conduct literature reviews, explore domestic and foreign cases, evaluate its operability within the current drug pricing system and the national health insurance system, and calculate the benefits of introducing the system comprehensively.” It added, “The post-settlement method, in which the actual price is set differently for each indication and then settled between the payer and pharmaceutical companies, requires sufficient review and public discussion on the method of calculating drug prices by indication and the reimbursement method between the payer and pharmaceutical companies.” “In the case of anticancer drugs, many good drugs are being released, but at a higher than we expected,” said Kook-hee Kim, Director of the Pharmaceutical Management Division at HIRA. ”Recently, we have been managing finances by adjusting the reimbursement standards for artificial tears and choline alfoscerate drugs, but there is a concern on whether such saved finances should be solely invested in anticancer drugs.”
- Company
- Six reimbursement revaluations fail in 4 years
- by Chon, Seung-Hyun Nov 15, 2024 05:49am
- Six items have been removed from the reimbursement list after reimbursement reevaluations during the past 4 years. Silymarin bilberry fruit dried powder, followed by itopride, failed the reimbursement reevaluations. Streptokinase - streptodornase, oxiracetam, and acetylcarnitine were also removed due to reimbursement reevaluation failures. Pharmaceutical companies are facing annual losses of up to KRW 240 billion as a result of the 6 drugs' reimbursement reevaluation failures. According to the Ministry of Health and Welfare on the 14th, 55 itopride-based drugs have been removed from the reimbursement list as of this month. The move follows the government's reimbursement revaluation. The health authorities selected 7 ingredients, including thioctic acid, pranlukast, itopride, sarpogrelate, levodropropizine, mosapride, and formoterol, to be reevaluated this year. As a result, the authorities concluded that itopride lacked clinical efficacy and was removed from the benefit. Three components - thioctic acid, pranlukast, and mosapride - were recognized as clinically useful and will remain on the reimbursement list. In the case of sarpogrelate and levodropropizine, the two will be removed from the reimbursement list but will remain covered if pharmaceutical companies voluntarily reduce their prices. The decision of formoterol was deferred pending clinical reevaluation by the MFDS, with the condition that the NHIS will recollect a portion of their reimbursement costs if the drugs fail to prove clinical efficacy. This means that only itopride fully failed the reimbursement reevaluations, and all products containing itopride will be removed from the reimbursement list. Itopride products from JW Life Science, JW Pharmaceutical, Kuhnil Biopharm, KyungDong Pharm, Kwangdong Pharmaceutical, Kukje Pharm, Nexpharm Korea, Novem Healthcare, NEWGEN Pharma, Daewon Biotech, Daewon Pharmaceutical, Dongsung Pharm, Dongwha Pharmaceutical, Mother’s Pharmaceutical, Medix Pharm, Bukwang Pharmaceutical, Samsung Pharm, Celltrion Pharm, Sinil Pahramcetucial, Shinpoong Pharmaceutical, iCure Pharmacueticals, Ahngook New Pharm, Ahngook Pharmaceutical, Alvogen Korea, SPC, Neo Bio Korea Pharm, Youngil Pharm, Young Poong Pharmaceutical, Yuyu Pharma, Yuhan Corp, Eden Pharma, Reyon Pharmaceutical, Intro Biopharma, Il-Yang Pharmaceutical, Ilwha, Jeil Pharmaceutical, Chong Kun Dang, Jinyang Pharmaceutical, Cosmax Pharma, PharmaKing, Poonglim Pharmatech, Hana Pharm, BMI Korea, Abbott Korea, Union Korea Pharm, Korus Korea, Korea Pharma, Pharmbio Korea, PMG Korea, Hutecs Korea Pharmaceutical, Han Wha Pharma, Whan In Pharm, Huons Meditech, Huons Life Sciences, will be withdrawn from the reimbursement market. Itopride is used to treat digestive symptoms caused by functional dyspepsia. According to the drug research institution UBIST, it generated KRW 23.6 billion in outpatient prescriptions last year. Itopride's prescription volume has decreased 18.7% in 5 years from KRW 29.1 billion in 2019 but has maintained prescription sales of over KRW 20 billion annually. From the pharmaceutical companies’ perspective, the reimbursement cut for itopride means a loss of more than KRW 20 billion a year. During the various reimbursement reevaluations that were conducted since 2021, a total of 6 ingredients were removed from the reimbursement list. In 2021, the health authorities announced a plan to reevaluate the reimbursement adequacy of 5 ingredients, including ▲grape seed extract Vitis vinifera (grape seed and grape leaf extract), ▲avocado soya, ▲ginkgo biloba dried extract, ▲bilberry dry extract, and ▲ silymarin. Among them, silymarin and bilberry dry extract were concluded to be inadequate for reimbursement and were removed from the health insurance reimbursement list. For both silymarin and bilberry dry extract, the prescription market has not been eliminated as some products that have filed administrative lawsuits have retained their reimbursed status. However, the prescription market has shrunk significantly due to the mass breakaway of products that accepted the reimbursement deletion. Silymarin's prescription market size grew 44.6% over 3 years, from KRW 23.6 billion in 2019 to KRW 34.1 billion in 2022, showing a significant increase in demand in the prescription market. Silymarin is an OTC drug used for toxic liver disease, hepatocyte protection, chronic hepatitis, and cirrhosis. However, after failing reimbursement reevaluations, sales fell to KRW 26.7 billion in 2022, down 21.5% from the previous year, and then to KRW 25.7 billion last year, down 24.8% from 2 years ago. Last year, the prescription amount of bilberry dry extract was KRW 13.3 billion, down 30.3% from the previous year. Bilberry dry extract is a drug used to improve retinal degeneration and vascular disorders of the eye caused by diabetes. The prescription market for bilberry dry extract was worth KRW 31 billion in 2021, but after the government deleted its reimbursement status, sales dropped 38.5% to KRW 19.1 billion in 2022 and shrank further last year. Prescriptions for bilberry dry extract last year shrank by 57.1% compared to two years ago. Streptokinase - streptodornase (Strepto preparations), oxiracetam, and acetyl L-carnitine, which were eligible for reimbursement but failed to pass the MFDS’s clinical reassessment, have seen their prescription market decline to the point of extinction. Last year, the prescription market for strepto preparations was KRW 16.1 billion, down 41.0% from the previous year. In 2022, the MFDS determined the strepto preparations lacked clinical efficacy during reimbursement reevaluations. However, given the ongoing clinical reassessment, conditional reimbursement was offered to defer the reimbursement reevaluation results only for items that agreed to refund the reimbursed costs based on the outcome of the clinical reevaluation. Strepto preparations are used for the “relief of acute inflammatory edema caused by ankle surgery or trauma to the ankle” and “difficulty in bile drainage accompanying respiratory diseases.” In 2017, the MFDS ordered a clinical reevaluation of strepto preparations after controversy arose over their efficacy. However, the clinical reevaluation failed to prove their efficacy, and the drug was excluded from the health insurance reimbursement list in December last year, the the indications were also deleted. Oxiracetam and acetyl L-carnitine were selected for reimbursement reevaluations last year but failed clinical reevaluations and were unable to proceed to reimbursement reevaluations. In January, the prescription and dispensing of oxiracetam was discontinued after the clinical reevaluation failed to verify the drug’s efficacy. Oxiracetam was approved for the treatment of cognitive impairment caused by Alzheimer's disease, multiple sclerosis, and temperamental brain syndrome due to brain dysfunction. Oxiracetam generated KRW 23.2 billion in prescription sales in 2022, but its clinical reevaluation failure wiped out the prescription market. Acetyl-L-carnitine was subject to reimbursement reevaluations in 2023 but was not evaluated due to its failure to pass clinical reevaluations. Acetyl-L-carnitine is licensed for use in “primary degenerative diseases” or “degenerative diseases secondary to cerebrovascular diseases.” In 2013, the MFDS ordered a clinical reevaluation of acetyl-L-carnitine preparations. However, in 2022, the indications were removed due to the drug’s failure to demonstrate efficacy in both indications. Acetyl-L-carnitine had a prescription market worth KRW 77.9 billion in 2019, but its removal from both the approval and reimbursement list led to losses for pharmaceutical companies. The 6 ingredients that were removed from the reimbursement list among those subject to reimbursement reevaluations over the past 4 years since 2021 had a combined prescription volume of KRW 242.3 billion in 2019. Pharmaceutical companies have realized an annual loss of KRW 242.4 billion in prescription sales due to the removal of the 6 ingredients.
