- LOGIN
- MemberShip
- 2026-05-07 06:48:02
- Company
- Will Padcev be deemed cost-effective and receive DREC review
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- Whether the reimbursement discussions for Padcev, a new antibody-drug conjugate for bladder cancer, will make progress is gaining attention. According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin), which passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in February, has completed pharmacoeconomic evaluations and is being reviewed by the subcommittee. Whether the agenda will pass the subcommittee review and be presented to the Drug Reimbursement Evaluation Committee remains to be seen. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. The key to Padcev’s successful reimbursement is in receiving a beneficial ICER threshold from the government in recognition of its innovativeness, like Enhertu (trastuzumab deruxtecan), which was listed in April. Padcev is also known to meet the government's preferential treatment standards for innovative new drugs. The standards are ▲ there is no substitute or therapeutically equivalent product or treatment ▲ demonstrated clinically meaningful improvement, such as a significant extension in survival ▲ the new drug has been approved by the Ministry of Food and Drug Safety under Article 35(4)(2) of the Pharmaceutical Affairs Act (designation of priority review) and were approved through the fast-track (GIFT) or received a breakthrough therapy designation (BTD) by the US FDA or a priority review (PRIME) by the European Union’s EMA. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 39% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of Oncology at Seoul National University Hospital, explained, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later line therapies after using immunotherapy in the second-line due to the lack of a standard later line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and will open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.”
- Policy
- Reimb expansions of Keytruda have failed the 4th CDRC
- by Lee, Tak-Sun Apr 19, 2024 06:24am
- MSD Korea’s cancer immunotherapy drug Keytruda’s reimbursement expansion item did not cross the Cancer Disease Review Committee (CDRC) threshold for the fourth time following its expansion in June last year. The analysis is that this attempt is particularly significant as all 15 indications were reviewed by the CDRC, and MSD’s financial contribution proposal was discussed for the first time. During the 3rd CDRC in 2024, held on April 17th, the reimbursement expansion of MSD Korea’s cancer immunotherapy drug 'Keytruda (pembrolizumab)' was reviewed but failed in securing reimbursement expansion. The CDRC announced during the meeting, it decided to postpone setting reimbursement criteria for 15 indications, including endometrial cancer. It was decided that the setting of reimbursement criteria would be reconsidered upon the additional submission of financial contribution proposal. All 15 indications included in the reimbursement expansion application were reviewed. In June of last year, MSD Korea submitted Keytruda’s reimbursement expansion application to the Health Insurance Review and Assessment Service (HIRA) for 13 indications with high unmet needs in medical fields in Korea. MSD's application includes 13 indications: ▲ Early-stage triple-negative breast cancer ▲ Metastatic or recurrent triple-negative breast cancer ▲ Metastatic or recurrent head and neck cancer ▲ Advanced or metastatic esophageal cancer ▲ Adjuvant therapy after renal cell carcinoma surgery ▲ Non-invasive bladder cancer ▲ Persistent, recurrent, or metastatic cervical cancer ▲ Advanced endometrial cancer ▲ Metastatic endometrial cancer with MSI-H or dMMR ▲ Metastatic rectal cancer with MSI-H or dMMR that cannot be removed with surgery ▲ Metastatic small intestine cancer with MSI-H or dMMR ▲ Metastatic ovarian cancer with MSI-H or dMMR ▲ Metastatic pancreatic cancer with MSI-H or dMMR. The company recently added two additional indications. It was reported that MSD applied for the reimbursement expansion of two indications last December: gastric cancer with MSI-H and bile duct cancer with MSI-H. Three indications were assessed at the CDRC meeting in October last year, where Keytruda's reimbursement expansion was first discussed. Then, 4 indications were assessed in November of the same year, and 6 indications were assessed in January of this year. The CDRC said at each review, “We will prioritize reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion. Upon receiving the pharmaceutical companies' financial contribution proposal towards proven indications, we have decided to analyze its impacts to establish reimbursement criteria.” Furthermore, during this CDRC review, 15 indications, including the previously discussed 13 and the two additional indications applied for in December, were all brought to the review table. This indicates that the CDRC prioritized reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion. In other words, the initial assessment of indication has been completed. The committee will discuss establishing final reimbursement criteria for the next step after reviewing the pharmaceutical companies' financial contribution proposal. It was reported that the financial contribution proposal submitted by MSD Korea was added as an additional agenda item just two days before the CDRC review. This suggests that pharmaceutical companies deliberated on their financial contribution proposals until the last minute. However, it has been reported that members of the CDRC were not satisfied with the financial contribution proposal submitted by MSD. Keytruda's reimbursement expansion in the future depends on how much MSD is willing to compromise in their financial proposal. “Keytruda is reimbursed for 7 indications, and its domestic sales reach KRW 400 billion,” an industry expert explained. He added, “If the pharmaceutical company does not submit a new financial contribution proposal, it may not be possible to reimburse all 15 indications at once.”
- Company
- Global companies are affected by doctors’ resignation
- by Moon, sung-ho Apr 19, 2024 06:24am
- Two months have passed since the government announced its plan to raise the medical school quota by '2,000' students. Pharmaceutical companies are facing more marketing challenges amin the ongoing dispute between the medical community and the government. In particular, global pharmacies that launched new drugs after overcoming reimbursement hurdles face challenges as new patients decline. In addition to local pharmaceutical companies, global companies are also impacted by doctors’ strikes. According to industry sources on April 6th, the Ministry of Health and Welfare (MOHW) approved the new listing and reimbursement expansion of 18 drugs until April. Due to the new listing and reimbursement expansion, approximately KRW 434.2 billion from the annual health insurance budget will be allocated toward these items this year. Last year, approximately KRW 381.5 was spent in 32 reimbursed drugs (24 newly listed and 8 reimbursement expanded drugs), whereas this year’s expenditure has already surpassed last year’s even before the end of the first half of the year. Breaking down the pricing by drugs, there are items that have gathered attention in the clinical field in South Korea. For example, the list includes Tagrisso (osimertinib) and Leclaza (lazertinib, Yuhan), which competed for reimbursement expansion for the first-line treatment of non-small cell lung cancer (NSCLC). According to estimates from the MOHW, Tagrisso and Leclaza will receive KRW 204.6 billion and KRW 137.7 billion, respectively, in finances this year. Both drugs were approved for reimbursement expansion in January. Out of the total finance, the expected increase due to reimbursement expansion would be KRW 92 billion and KRW 88.1 billion for these two drugs, and 2634 patients are expected to benefit from coverage of the first-line treatment. For these two drugs, an increase in financial spending by KRW 180 billion is expected. Among the drugs newly listed up to April, the antibody-drug conjugate (ADC) 'Enhertu (trastuzumab deruxtecan, Daiichi Sankyo Korea, AstraZeneca)' accounted for the largest part of the financial spending. The MOHW has calculated the expected financial spending for Enhertu, which is reimbursed for breast cancer and gastric cancer, to be KRW 134.7 billion. Among the reimbursement expanded and newly listed drugs, this is the single item with the highest financial spending. In addition to anticancer drugs, drugs for chronic diseases, such as the 'chronic kidney disease' drug Kerendia (finerenone, Bayer), are among the drugs gaining attention. As it can be prescribed in endocrinology and nephrology departments within university hospitals, it is considered a notable new drug from a global pharmaceutical company. This is supported by the government’s estimate that 29,350 patients can benefit from the reimbursement listing. Since the announcement on February 6th of an increase in medical school quotas, there have been mass resignations extending beyond resident physicians to professors at nationwide university hospitals, resulting in continued disruptions in medical services. The pharmaceutical industry, which must actively engage in sales and marketing following successful new drug approvals or reimbursement expansion, is in a challenging environment. As a result, they remain cautiousness about holding medical symposiums after new drug launches. So far, challenges have primarily been experienced by suppliers of surgical materials, pharmaceuticals, medical devices, wholesalers, and domestic pharmaceutical companies. However, this situation could also impact global big pharma with new drugs. AstraZeneca and Yuhan have been proactively preparing through prior processes, such as clearing the Drug Committees (DC) at hospitals for Tagrisso and Leclaza in line with the reimbursement expansion in January. This effort was aimed at gaining an advantage in the non-small cell lung cancer market through medical institution coding work. As a result, by the end of March, AstraZeneca cleared the DC review of Tagrisso in 94 hospitals, and Yuhan cleared the DC review of Leclaza in 103 hospitals. However, university hospitals face difficulties treating new patients with prolonged medical service disruptions. As a result, the expansion of the field for these two treatments, Tagrisso and Leclaza, is unfolding differently than anticipated. Enhertu, which became reimbursed in April, may have faced similar circumstances in a clinical setting specializing in oncology. Daiichi Sankyo and AstraZeneca, in joint sales and marketing, have obtained approval from the DC in 60 hospitals for Enhertu. “Due to structural challenges, our focus is currently on existing patients, but we must see new patients,” a professor of Hematology-Oncology at Hospital A commented. He added, “Despite efforts to prioritize patient care as much as possible, there has been a decline in the number of new patient treatments, which may result in reduced drug usage.” “Because leukemia patients are still being accepted through the emergency room, new patient intake has not stopped. The problem is that it is now becoming a chronic situation,” another professor of Hematology at a different university hospital stated. He added, “Even if the range of treatments expands, it will be challenging for pharmaceutical companies due to the structural constraints in the clinical setting, making it difficult to utilize them effectively.” Global big pharma headquarters are now increasingly concerned about the consequences of the increase in medical school quotas for the clinical field in South Korea. At the same time, there is a sense of urgency to evaluate the extent of revenue decline in the first quarter of this year due to the controversy surrounding the expansion of medical school quotas. "The headquarters closely monitors the long-term treatment disruption issue in the domestic clinical field. This issue is a major topic in every video conference," an anonymous executive from the Korean subsidiary of a global pharmaceutical company stated. He added, "As we are in a situation where the introduction of new drugs or their reimbursement is at stake, we are proactively evaluating and communicating the potential consequences of this situation."
- Policy
- Impurity detected in single-agent entacapones
- by Kang, Shin-Kook Apr 19, 2024 06:24am
- t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease. According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based on the submitted test and inspection results, following a company report that nitrosamine impurities (NDEA, N-nitrosodiethylamine) were detected in its entacapone-containing drugs. In other words, if there is a medical need for the drug or there is a concern about supply interruptions (shortage), the government plans to apply a temporary permissible limits for the drugs’ distributions for a certain period of time. For this, the MFDS is collecting opinions from doctors to prepare for the possibility of unstable supply and demand of entacapone-containing drugs if recall measures or suspension of production and import measures are applied due to necessity until impurities are reduced. This is a preliminary investigation into the medical necessity of entacapone, the impact on patient care in the event of a supply interruption (shortage) of entacapone single-agent drugs, the current status of substitute drugs, and the establishment of temporary permissible limits. The entacapone single tablets currently approved in Korea include Comtan Tab 200 mg, Myungin Entacapone Tab 200 mg, and Entapone Tab 200 mg.
- Policy
- Four Otezla generics were authorized simultaneously in Korea
- by Lee, Hye-Kyung Apr 19, 2024 06:24am
- Amgen Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea. With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent seem to have applied for approval of their generic versions at once. On the 17th, the Ministry of Food and Drug Safety approved four apremilast-based formulations, including Dong-A ST's ‘Otelia Tab,’ Daewoong Pharmaceutical's ‘Apsola Tab,’ Dongkoo Biopharm’s ‘Otemila Tab,’ and Chong Kun Dang’s ‘Otebell Tab.’ Otezla, the original apremilast formulation of these generics, was the first oral psoriasis treatment to be approved by the MFDS in November 2017, but the company voluntarily withdrew the drug’s license in June 2022 after failing to cross the reimbursement threshold. In the process, domestic pharmaceutical companies began filing patent suits to launch their generic versions of Otezla. Otezla has 3 registered patents, including a use patent (10-0997001) and two formulation patents (10-2035362 and 10-2232154). In the case of the 2 formulation patents, 7 companies, including Daewoong Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, Huons, Chong Kun Dang, Mothers Pharm, and Cosmax, filed to confirm the passive scope of rights in May 2021 and November 2022 and succeeded in avoiding the patents. However, the companies still had to overcome the use of patents to launch their generic versions. Otezla’s use patent was set to expire on March 18, 2028. The companies must invalidate the use patent as well to launch their generic versions, and on August 24 last year, the court decided to ‘partially reject and dismiss’ the use patent’s invalidation trial. Despite withdrawing from the Korean market, Amgen appeared to be vigorously defending its patent rights, leading to criticism that it was blocking the entry of generics that were preparing to launch in Korea. And with no further news of the domestic pharmaceutical companies filing appeals to evade the use of patents since August last year, the news of the 4 generic Otezla approvals drew attention to their background. A representative from a relevant Korean pharmaceutical company said, "We have been continuously making an agreement with Amgen regarding the use of the patent. Amgen withdrew its license for Otezla in 2022 and had no intention of launching it in the future, so there was no reason to prevent generics from entering the market." "Amgen said that it didn't want to continue litigating a product that they had no intention of launching in the country. They agreed that the patent would not be a barrier to generic entry in the future, which is why we went through the process." Currently, the legal status of Otezla's use patent, (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, and methods of synthesis and compositions thereof" is indicated as “revoked," according to Korea’s Intellectual Property Trial and Appeal Board bulletin. An industry official said, "The Otezla generics have not been jointly developed by the companies, but seem to have been approved at the same time upon the resolution of the patent issue. We plan to apply for reimbursement immediately upon approval and start drug price negotiations."
- Company
- Adcetris’s IPS requirement for reimb may be removed
- by Eo, Yun-Ho Apr 19, 2024 06:23am
- A green light has been given for the removal of the IPS score requirement for Adcetris, which had been a long-standing wish of the patients. According to industry sources, Takeda Pharmaceutical Korea’s reimbursement expansion application to remove the International Prognostic Score (IPS) score criteria for prescribing its Adcetris (brentuximab vedotin) in combination with chemotherapy (AVD, adriamycin+bleomycin+dacarbazine) in Hodgkin's lymphoma passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee review on the 17th. Adcetris )’ was granted reimbursement as a first-line treatment for Hodgkin’s lymphoma in 2021, but a restriction of "IPS score of 4" was applied, meaning that the drug was only reimbursable for patients with severe disease. As a result, patients with an IPS score of 2-3 have been prescribed an existing chemotherapy combination, ABVD (adriamycin+bleomycin+vinblastine+dacarbazine), instead of Adcetris. Even patients with stage IV disease were unable to benefit from Adcetris and its better efficacy if they had a low IPS score. However, when analyzing the results of the 1,344 patients in the ECHELON-1 trial, Adcetris demonstrated efficacy in high-risk patients who were Stage IV, male, younger, and had an IPS score of 4-7. The National Comprehensive Cancer Network (NCCN) guidelines recommend Adcetris+AVD for the treatment of patients with stage III and IV disease, and the European guidelines allow Stage IV patients to be treated with Adcetris regardless of the IPS score. Therefore, the medical community has been pushing for the removal of the IPS score requirement from Adcetris’s reimbursement criteria, and expectations are rising with its passage of the CDDC review this time. However, it remains to be seen if Adcetris can clear the remaining hurdles, including the Drug Reimbursement Evaluation Committee and drug price negotiations, and remove the IPS score requirement from its reimbursement criteria. In the Phase III ECHELON-1 trial, Adcetris demonstrated superior clinical efficacy compared to ABVD in previously untreated patients with stage III or IV classical Hodgkin lymphoma. Its three-year progression-free survival (PFS) analysis showed that the Adcetris combination therapy (PFS rate 83.1%) reduced the risk of disease progression by 30%, compared with ABVD (PFS rate 76%).
- Company
- Drug exports escape ‘COVID-19 endemic slumps’ with botox
- by Kim, Jin-Gu Apr 19, 2024 06:23am
- The export values of drugs developed by Korean pharmaceutical companies increased 16% year-over-year in Q1. Compared to other quarters, it is the highest amount two years after Q1 of 2022. The export performances of domestic drugs had stagnated after the announcement of the endemic. However, the pharmaceutical industry has a positive outlook, as exports have started to recover since Q3 last year. According to the Korea Customs Service, exports of domestic drugs amounted to US$1.72 billion (approximately KRW 2.38 trillion). This is an increase of 16.1% over a year, compared to US$1.4 billion in Q1 of 2023. Around the same period, drug imports amounted to US$2.24 billion (approximately KRW 3.1 trillion), down 6.7%. As exports increased while imports decreased, the trade balance improved from KRW 925.38 million at loss to KRW 527.21 million at loss. Domestic drug exports have skyrocketed during the prolonged COVID-19 pandemic. In Q4 of 2020 and Q1 and Q4 of 2021, export values increased to over US$2 billion. Domestically produced COVID-19 vaccines played a significant role in boosting the export performance at that time. Quarterly drug exports (Unit: US$1 million, Source: Korea Customs Service). After the announcement of the COVID-19 endemic, export values declined due to decreased exports of domestically produced vaccines. Since Q4 of 2022, the export value has been consistently around US$1.5 billion, gradually decreasing. However, it was KRW 1.27 billion in Q3 of last year, the lowest after the endemic, but rebounded. The export value increased to US$1.6 billion in Q4 last year and over US$1.7 billion in Q1 of this year. It is the highest quarterly value since Q1 of 2022. Among major items, Botolinum toxin exports increased while vaccine exports decreased. Botolinum toxin exports in Q1 amounted to US$87.95 million (approximately KRW 120 billion), up 16.3% compared to US$75.64 million in Q1 of last year. In terms of countries, the export of botulinum toxin to the United States increased by 16.4% from US$14.5 million to US$16.88 million. Exports to China doubled from US$7.26 million to US$14.65 million. Exports to Japan increased by 64.1% from US$4.11 million to US$6.74 million. However, exports to Brazil decreased by 31.1% from US$9.73 million to US$6.71 million, and exports to Thailand decreased by 18.2% from US$6.53 million to US$5.34 million. Quarterly export values of vaccines and botolinum toxin (Unit: KRW 100 million, Source: Korea Customs Service). Vaccine exports decreased by 40.5% from US$135.6 million in Q1 of last year to US$61.59 million (approximately KRW 85 billion) in Q1 this year. The last export of domestically produced COVID-19 vaccines was in Q1 last year. However, COVID-19 vaccine exports sharply declined, steadily decreasing until Q4 and rebounding in Q1 this year.
- Company
- Korean pharma companies accelerate global market entry
- by Heo, sung-kyu Apr 18, 2024 05:54am
- Domestic pharmaceutical companies are targeting the Southeast Asian and Latin American markets as a bridgehead to their entry into the global market. As these are still emerging markets, the companies believe that they can secure relative competitiveness in those markets. For this, the companies are exploring the market through various strategies such as seeking local approvals or indirect entry through agreements, among others. According to industry sources on the 15th, pharmaceutical companies in Korea have recently started to accelerate their efforts to enter the Southeast Asian and Latin American markets. The reason the companies are primarily targeting these emerging markets is due to their high growth potential, as they point of entry for the companies’ global expansion. As these markets show high growth potential, domestic pharmaceutical companies have been prioritizing entry into these regions as a starting point for their global expansion. To this end, domestic pharmaceutical companies have already confirmed their entry into various Southeast Asian countries such as Thailand, Vietnam, and Indonesia. The need for companies to enter emerging markets in addition to markets such as the U.S. and Europe have been rising, sparking interest in the so-called ‘pharmerging’ markets. Pharmerging is a new term that combines 'Pharma' and 'Emerging' and refers to emerging pharmaceutical markets such as the Middle East, Latin America, and Southeast Asia. Due to the companies’ continued interest in emerging markets, the entry of pharmaceutical companies – especially mid-sized pharmaceutical companies - into the Southeast Asian market has risen further. In fact, companies that have recently accelerated their entry into the Southeast Asian market include Yuyu Pharma and Jeil Pharmaceutical, which have been receiving marketing authorizations and signing related agreements. First of all, Yuyu Pharma has received approval for its ‘Yuhylys Soft Cap (dutasteride)’ from the Philippines Food and Drug Administration and the Myanmar Food and Drug Administration. Yuhylys is sold under the brand name ‘Armadart’ in the Philippines and the same as Yuhylys in Myanmar. Jeil Pharmaceutical recently signed a memorandum of understanding with Universiti Kebangsaan Malaysia (UKM) University Hospital for the exclusive supply of pharmaceuticals and R&D cooperation, and plans to promote technology transfer and local production with UKM through the agreement. In addition, companies that have already entered the market are also making further inroads. For example, LG Chem held a symposium on its 'Zemiglo Tab' at the Philippine College of Endocrinology, Diabetes & Metabolism conference. LG Chem has been working to penetrate the global market since 2017 and had already entered the Philippines in 2019. LG Chem plans to continue holding symposiums with Korean endocrinology professors in Thailand later this month and then in Latin America, including Mexico, in the second half of the year. As the company has already entered the markets of all these countries, the symposium held will help expand the company's presence in the exporting countries. In addition, Daewoong Pharmaceutical has recently applied for marketing authorization for its ‘Envlo Tab’ in Mexico. Daewoong's Envlo has already entered Southeast Asian markets such as Indonesia, the Philippines, Thailand, and Vietnam, and is expanding its area to Latin America, seeking approval in Brazil and Mexico. In addition, Hugel recently received marketing authorization for its PDO (polydioxanone) suture brand ‘Licellivi’ in Brazil and announced that it will establish a strategy for its rapid market settlement. Korean companies are entering the Southeast Asian and Latin American markets because they are expecting growth in these markets. According to an export support report released by the Korean Health Industry Development Institute, the pharmaceutical market in 6 major emerging countries (Indonesia, Vietnam, the Philippines, Thailand, Malaysia, and Singapore) is worth about USD 20 billion, or KRW 26 trillion. In particular, the per capita cost of drugs in the countries was about USD 36 last year, an increase of 6.6% YoY, and is expected to reach USD 46 by 2026 at an average annual growth rate of 7.4%. In addition, in Latin America, the pharmaceutical market is growing rapidly due to the high demand for products and high prevalence of hypertension and gastrointestinal diseases. The market is expected to grow at an average of 7% per year through 2023 to reach a total value of USD 76 billion. As such, more companies are also expected to take on the challenge of entering these emerging markets.
- Policy
- PVA exemptions expanded to drugs below KRW 3 billion
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Effective this year, the price-volume agreement (PVA) criteria will be expanded to provide an exemption to products with a claim amount below KRW 3 billion. This amount represents an increase from the previous criteria, which was below KRW 2 billion. Also, any product that has undergone more than two price reductions in the last five years will receive a 30% cuts. The reduction rate will be differentially applied depending on the claimed amount. Since April 15th, the National Health Insurance Service (NHIS) has been collecting opinions regarding the partial revision of the 'Detailed Matters regarding PVA negotiation’s operational guidelines.' The revised program will be implemented starting on May 1st. ◆Expansion of drugs eligible for exemption·Addition of drugs eligible for reduction =Exempted drugs from negotiations will be expanded from same-class products with an annual claim amount of less than KRW 2 billion to less than KRW 3 billion. If a product has undergone more than two price reductions in the last five years before the end of the analysis period, it will be eligible for a reduction. However, drugs that have already received a reduction rate during the two negotiations with agreements before the end of the analysis period will not be eligible for the reduction. Drugs eligible for reduction will include those developed by innovative pharmaceutical companies or companies with R&D expenses to sales as of the year preceding the end of the analysis period, with a ratio of 10% or more and recognized by NHIS. The reduction rate is set to 30%. ◆Differential reduction rate based on claimed amounts = A formula for reference price for negotiation will be differentially calculated based on the claim amount. A higher reduction rate will be applied to drugs with a larger claim amount. For example, if the claim amount of 'Drug-type Ga' during the analysis period is more than KRW 3 billion and less than KRW 5 billion, the formula will be 'Reference price for negotiation = 0.95×(Price ceiling)+(1-0.95)×{Price ceiling×(Expected claim amount/Claimed amount by same-class product during the analysis period)}'. If the claim amount is more than KRW 5 billion and less than KRW 30 billion, the formula of 'Reference price for negotiation = 0.9×(Price ceiling)+(1-0.9)×{Price ceiling×(Expected claim amount/Claimed amount by same-class product during the analysis period)}' will be applied. If the claim amount is more than KRW 30 billion, the formula of 'Reference price for negotiation = 0.85×(Price ceiling)+(1-0.85)×{Price ceiling×(Expected claim amount/Claimed amount by same-class product during the analysis period)}' will be applied. The differential formula will be used for 'Drug-type Na' and 'Drug-type Da'. If the claim amount is more than KRW 3 billion and less than KRW 5 billion, the formula of 'Reference price for negotiation = 0.9×(Price ceiling)+(1-0.9)×{Price ceiling×(Claimed amount by same-class product during the analysis period)}' will be applied. If the claim amount is more than KRW 5 billion and less than KRW 30 billion, the formula of 'Reference price for negotiation = 0.85×(Price ceiling)+(1-0.85)×{Price ceiling×(Claimed amount by same-class product during the analysis period)}' will be applied. If the claim amount is more than KRW 30 billion, the formula of 'Reference price for negotiation = 0.8×(Price ceiling)+(1-0.8)×{Price ceiling×(Claimed amount by same-class product during the analysis period)}' will be applied. ◆Expanded refund contracted drugs = Drugs eligible for a refund contract instead of a drug reduction will be expanded. Drugs with multiple indications for the initial listing will be eligible for a refund contract. A one-time refund contract is also possible. The NHIS can enter into a one-time refund contract with a company instead of adjusting the reference price for negotiation when there is a temporary increase in the volume and upon the company’s request. The new guidelines will be implemented starting on May 1st, 2024. Drugs undergoing PVA monitoring or negotiations will be applied first. Therefore, any drugs subjected to this year’s 'Drug-type Da' monitoring will be eligible for the new guidelines.
- Policy
- KRW 10 Bil antiemetic drug Akynzeo seeks reimb for injection
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Akynzeo Inj has applied for reimbursement. HK inno.N is expanding the lineup of 'Akynzeo,' a medicine used to prevent vomiting in cancer patients. In addition to the capsule formulation currently covered by health insurance, the company has applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) for Akynzeo inj. According to industry sources on the 17th, Akynzeo inj, approved in October 2022, has applied for HIRA review. Akynzeo was introduced to South Korea by HK inno.N from the Swiss pharmaceutical company Helsinn. It is used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. It is a combination of netupitant and palonosetron hydrochloride, with a mechanism of action inhibiting the nerve pathway associated with causing nausea and vomiting. According to analysis, the two active ingredients have a long plasma half-life, which makes them effective antiemetics. The capsule formulation was already available in South Korea. Akynzeo cap was approved in 2018 and listed for reimbursement in December of the same year. After the listing, the sales of the drug have skyrocketed. According to IQVIA, its sales of KRW 1.8 billion in 2019 increased to KRW 4.5 billion in 2020, KRW 6.4 billion in 2021, KRW 7.3 billion in 2022, and recorded KRW 9.8 billion last year (KRW 2 billion shy of KRW 10 billion). Akynzeo cap usage was expanded after the approval of reimbursement expansion in June 2022. Before the expansion, it could be used as a combination therapy with corticosteroids in patients who fell into the high-risk group (over 90%). After the reimbursement expansion, it can now be administered to severe patient groups (30~90%) without combination with corticosteroids. Akynzeo Inj, which has applied for reimbursement, is an IV injection. It is expected to benefit cancer patients who have difficulty ingesting oral medicines. Akynzeo Inj will undergo HIRA review for reimbursement appropriateness and seek health insurance listing.
