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- 2026-03-10 08:28:09
- Opinion
- [Desk View] Dual pricing for the sake of our own citizens
- by Eo, Yun-Ho Nov 24, 2025 06:19am
- The government intends to expand the number of dual-priced listed drugs to prevent disclosure of actual transaction prices. By raising reference prices through higher public list prices, it aims to improve access to new drugs. The government has announced a major overhaul of Korea’s drug pricing system. The forthcoming reform plan, which the government plans to reveal concrete details soon, is drawing significant attention from the pharmaceutical industry. It is expected to include adjustments to the generic drug pricing calculation rate, reform of the tiered drug pricing system, consolidation of post-market management systems, expansion of the Risk Sharing Agreement (RSA) and dual pricing scheme, and R&D investment-linked drug price premiums. Multinational pharmaceutical companies are particularly focused on expanding the dual pricing system. Among RSAs, the refund-type model—which assigns dual prices by separating the actual transaction price from the listed price—has consistently been the preferred contract type since its introduction. However, calls for improvements to its scope have been persistent. Many even suggested excluding the refund-type from RSAs altogether. The government has also partially accommodated these opinions, making minor adjustments to the system. Initially applied under a strict criterion, only to ‘anticancer drugs or rare disease treatments with no equivalent substitutes or therapeutically equivalent alternatives’, the ‘life-threatening’ qualifier has now successfully been removed from the criteria. Yet, the prevailing sentiment remains that its application conditions are still stringent. However, this time appears to be different. Pressure from the U.S. Trump administration’s Most-Favored-Nation (MFN) drug pricing policy served as a trigger, and the health authorities appear to have internalized growing alarm over the long-discussed but uncomfortable issue of “Korea passing” within the global pharma industry. Given the circumstances, the upcoming expansion of RSA and dual pricing will likely loosen at least the criteria tied to disease severity. Whether the current price cap, “below the A7 adjusted average price,” will be modified is another point to watch. It is never right for a game of brinkmanship to unfold over reference prices, leading to the bypassing phenomenon. The products sold by multinational pharmaceutical companies are not luxury goods like Mercedes-Benz or Chanel. It is also true that drug prices are set higher in relatively poorer countries—those with weaker negotiating power. Still, many countries are expanding the share of non-public drug pricing—a second-best solution, though not ideal— to secure access to new therapies for their own citizens. While the global moral imperative of ‘transparent drug pricing’ is commendable, the government must also make decisive choices for the sake of patients in our country.
- Policy
- Price of Jardiance, Xeljanz cut 30% with entry of generics
- by Lee, Tak-Sun Nov 24, 2025 06:19am
- The diabetes treatment Jardiance (empagliflozin, Boehringer Ingelheim) and the rheumatoid arthritis treatment Xeljanz (tofacitinib citrate, Pfizer) will have their maximum insurance prices officially reduced due to the listing of generic versions. When a therapeutically equivalent product is newly listed, the price ceiling is adjusted to 53.55%, and a one-year 70% add-on premium is applied. As a result, starting in December, the previous prices will drop by 30 percentage points. According to industry sources on the 21st, starting December, the price of Xeljanz 5mg Tab will decrease from KRW 10,996 to KRW 7,697, and Xeljanz 10mg Tab will decrease from KRW 18,250 to KRW 12,775. Additionally, the price of Jardiance 10mg Tab will be adjusted from KRW 582 to KRW 408, and Jardiance 25mg Tab from KRW 762 to KRW 533. This price adjustment is due to the inclusion of generic drugs in the reimbursement list. With the substance patent for Xeljanz expiring on the 22nd of this month, 17 products from 12 companies, including those from Daewoong Pharmaceutical and Chong Kun Dang, will be reimbursed starting on the 23rd. Generic versions of Jardiance also entered the market en masse in October. Following the expiration of the substance patent, 235 products from 37 companies were listed for reimbursement on October 24. Both products are achieving high sales in the market. Jardiance recorded KRW 66.3 billion last year based on UBIST data, while the combination product Jardiance Duo recorded KRW 41.8 billion, boasting a combined market size exceeding KRW 100 billion. Xeljanz also secured market presence with KRW 14.3 billion in outpatient prescriptions. The ex officio price reductions made for the extended-release and combination formulations are expected to cause significant concern for Pfizer and Boehringer. Starting December, the price ceiling of Xeljanz XR 11mg will drop from KRW 22,169 to KRW 17,071, and Xeljanz Syrup 1mg/mL will decrease from KRW 527,808 to KRW 369,443. Additionally, the price ceiling of Jardiance Duo Tab 5/1000mg will decrease from KRW 301 won to KRW 284, Jardiance Duo Tab 5/500mg from KRW 301 to KRW 278, and Jardiance Duo Tab 5/850mg from KRW 301 to KRW 278. Among the items subject to this ex officio adjustment, Xeljanz 5mg Tab, Xeljanz 10mg Tab, Xeljanz XR 11mg Tab, and Xeljanz syrup will see an additional price reduction on November 23 next year, once the one-year add-on premium ends, dropping to 53.55%, equal to the generic price. Jardiance 10 mg and 25 mg will undergo the same adjustment on October 24 next year, one year after generic entry. For both original manufacturers, generic competition and reimbursement price cuts will inevitably impact sales, prompting intense efforts to defend market share. Pharmacies are advised to take note of returns and settlement procedures following price changes for these frequently prescribed original products. Meanwhile, drug prices will also be adjusted for the menopausal hormone therapy drug Angelic Tab (drospirenone/estradiol, Bayer) and the antifungal agent Ambisome Inj (liposomal amphotericin B, Gilead) with the entry of their respective generics. The price of Angelic Tab will be adjusted from KRW 10,393 to KRW 5,565 starting in December. The price of Ambisome Inj will be reduced by 30% from KRW 129,392 to KRW 113,218, and after the add-on premium ends on October 1 next year, the price will drop to KRW 86,612.
- Opinion
- [Reporter’s View] K-Pharma bets its survival on new drug R&
- by Choi, Da-eun Nov 24, 2025 06:18am
- The R&D direction of major Korean pharmaceutical companies is shifting from generics to new drug development. This shift comes as the perception grows that generics, long the mainstay of domestic pharma growth, are no longer a safe bet. With tighter price regulations, intensified competition, and shrinking distribution margins, the generic ecosystem is being pushed into relentless price pressure. As the sense of crisis deepens that generics alone cannot guarantee the future, leading pharmaceutical companies are increasingly willing to bear the cost burden to secure mid-to-long-term growth engines. Hanmi Pharmaceutical is aggressively investing in R&D, raising expectations that it may be the first Korean company to launch a homegrown obesity drug. Hanmi's R&D expenditure for the third quarter of this year reached KRW 169.1 billion, a KRW 15.5 billion increase year-on-year, accounting for 15% of its sales. CKD (Chong Kun Dang) is moving away from a generic-centric model toward a bio-focused structure, expanding its pipeline from ADC (antibody-drug conjugate) oncology drugs to advanced biopharmaceuticals. It recently announced a KRW 2.2 trillion investment, making a major ‘bet’ by constructing a large-scale biopharmaceutical complex R&D center in Siheung. Its R&D expenses are on the rise - from KRW 151.2 billion in 2023, KRW 157.4 billion in 2024, to KRW 126.5 billion in the third quarter of this year. JW Pharmaceutical is also steadily increasing its annual R&D spending. Its third-quarter R&D expenses this year reached KRW 74.9 billion, a 26.9% increase compared to KRW 59.0 billion in the same period last year. It is currently conducting a Phase III multinational clinical trial in Asia for its core pipeline, the gout treatment ‘epaminurad (URC102)’. Considering the growth potential of the gout treatment market and the limitations of existing uric acid-lowering drugs, analysts view it as having significant mid-to-long-term pipeline value. Even manufacturing-oriented giants like Celltrion and Samsung Biologics are jumping into the R&D competition, expanding their own pipelines as new growth pillars. Celltrion emphasized ambitions beyond biosimilars, outlining plans to develop ADCs, multi-specific antibodies, and obesity drugs. Samsung Biologics launched Samsung Epis Holdings, a bio-investment holding company, through a spin-off. Samsung Epis Holdings plans to strengthen new drug development based on EPIS NexLab’s biopharmaceutical development platform. Behind these bold future investments by domestic companies lies a shared understanding that sustainable growth is difficult to achieve, relying solely on generic drug profits. The global M&A market, policy direction, and investment capital all operate based on ‘innovation’. This means that companies unable to break free from a domestic-focused, generic-centric structure will inevitably fall behind. Of course, strengthening R&D does not guarantee immediate success. The risk of clinical failure is significant for any company, and securing funding grows increasingly difficult. Risks clearly exist behind the banner of ‘investment for the future’. However, it is becoming increasingly clear that competitiveness in the pharmaceutical industry is shifting from price to technology. These days, the phrase “We will increase our R&D investment” appears like a motto in all pharmaceutical companies' new year business plans. To the reporter, it reads as a strategic declaration directly tied to survival. The reality that generic drugs alone cannot defend corporate value is pushing companies harder for reinvestment in R&D. As the market landscape shifts, clinging solely to safe strategies leads only to regression. The direction is becoming clearer: decisively shedding inefficient businesses and concentrating resources on next-generation drug development. This is why domestic pharmaceutical companies have chosen the difficult path of restructuring toward high-value-added focus, and why their ‘long-term’ challenge deserves close attention.
- Opinion
- [Reporter’s View] K-BIO needs strength to go the distance
- by Cha, Jihyun Nov 21, 2025 06:12am
- New drug development is a war of capital. The amount of money and time required to develop a drug candidate, push it through clinical trials, and finally reach approval is beyond imagination. It is widely known that developing a single new drug typically takes 10–15 years and costs KRW 1–2 trillion. When developing high-complexity modalities such as antibody–drug conjugates (ADCs) or bispecific antibodies, the initial R&D cost grows exponentially. This is why biotechs inevitably rely on early-stage technology out-licensing models. Without a revenue base, it is difficult to independently conduct late-stage clinical trials that require hundreds of billions to trillions of won. As a result, secure preclinical or early clinical data and quickly move to out-license the technology. For drug development biotechs, technology transfer is not a choice but a survival strategy. But recently, a shift is emerging. Rather than out-licensing technologies at early stages, some leading biotechs are now moving to carry their core pipelines into late-stage clinical trials themselves. LigaChem Bio, which strengthened its capital base after Orion Group became its largest shareholder, has declared plans to push certain ADC pipelines into late-stage clinical trials independently. ABL Bio, which signed two major licensing deals with global big pharma this year alone, has also indicated its intention to take its key pipeline into late-stage trials on its own. This trend is noteworthy as it signifies that domestic companies are moving into a phase where they directly secure control over new drug development. Under the traditional licensing model, the fate of development was effectively handed over the moment the license was transferred. If the partner changed strategy or de-prioritized the project, the original developer had no way to intervene or revive it. Conversely, by directly advancing into late-stage clinical trials, the company itself can determine the value and direction of the new drug. The decision to take a pipeline into late-stage development is also a major shift in terms of corporate value. Licensing deals grow larger the further the pipeline progresses. While early-stage technology exports typically result in contracts worth tens to hundreds of billions of won, the contract size jumps to at least hundreds of billions of won, and can reach trillions of won, by the time late-stage clinical trials commence. Behind the decision to “carry it all the way through” lies the calculation that taking on additional risk is worth it if it means the results and rewards remain with the company. Above all, the attempt to directly navigate through to the late-stage clinical phase holds significant meaning in terms of accumulating the ‘core know-how involved with new drug development’ that Korea has been lacking. Under the license-out-centric structure, most late-stage experiences determining a drug's success—such as Phase 2b/3 trials, global regulatory strategies, FDA meetings, and commercialization preparation—were largely ceded to overseas partners. The recent move by some companies to take their pipelines through late-stage clinical trials into their own hands holds value in internalizing the experience and know-how that previously flowed overseas, thereby elevating Korea's drug development capabilities to the next level. Technology exports remain necessary and will continue to be a vital survival strategy. However, companies aiming to compete on the global stage should resolve to “see at least a few pipelines through to the end.” While not every biotech company can conduct late-stage clinical trials directly, simply accumulating one or two more companies with ‘full-cycle experience’ will undoubtedly elevate the standing of Korea's biotech sector. May technology transfer become not the final destination for survival, but the starting point toward completing the full cycle.
- Policy
- Scope of use for Kisqali, Imfinzi expanded for combo use
- by Jung, Heung-Jun Nov 21, 2025 06:12am
- Use of combination therapies for breast cancer, endometrial cancer, urothelial carcinoma, and prostate cancer has been newly approved, expanding the expected treatment scope for drugs such as Kisqali and Imfinzi. Starting December, 5 new combination therapies for breast cancer, 2 for endometrial cancer, and 1 each for urothelial and prostate cancer will be established. The Health Insurance Review and Assessment Service (HIRA) is collecting industry opinion on the revision of the notification regarding drugs prescribed and administered to cancer patients until the 24th. For breast cancer, four new combination therapies using Novartis Korea's breast cancer treatment Kisqali (ribociclib) tablets will be added. Newly established methods include ribociclib + anastrozole, ribociclib + letrozole, and adding leuprorelin (LHRH agonist). Additionally, the non-reimbursed triple combination of inavolisib + palbociclib + fulvestrant—will also be added.. This option is used when cancer progresses despite treatment with other targeted therapies. Combination therapies using AstraZeneca's immunotherapy Imfinzi (durvalumab) for endometrial cancer and urothelial carcinoma will also be expanded. For endometrial cancer, two new regimens are introduced: either durvalumab monotherapy following combination therapy with durvalumab + carboplatin + paclitaxel, or durvalumab + Olaparib combination therapy. For urothelial carcinoma, the approach involves combination therapy with durvalumab + gemcitabine + cisplatin followed by radical cystectomy, with durvalumab used as adjuvant therapy. For both endometrial cancer and urothelial carcinoma, the addition of durvalumab to existing reimbursed regimens (carboplatin + paclitaxel, gemcitabine + cisplatin) will be added. For prostate cancer, a new combination therapy combining the non-reimbursed talazoparib with the reimbursed enzalutamide has been newly established. The newly established combination therapies expand treatment options using targeted therapies and immunotherapies based on genetic mutations and DNA repair capabilities. HIRA also revised reimbursement criteria for 19 items among Groups 1-2 anticancer drugs. This aims to clarify reimbursement standards for therapies that are not considered standard treatments. Changes, such as adding or deleting phrases, were made to the reimbursement criteria for anticancer drugs used in malignant melanoma, rhabdomyosarcoma, neuroblastoma, Wilms tumor, and retinoblastoma. HIRA stated, “We have announced additional combination therapies requested by academic societies that were deemed to comply with the general principles of the official notice and announcement.”
- Company
- Cosentyx gains reimbursement for hidradenitis suppurativa
- by Eo, Yun-Ho Nov 21, 2025 06:12am
- Cosentyx, the first new treatment option for hidradenitis suppurativa in 10 years since Humira, has succeeded in expanding its reimbursement one year after reapplying for reimbursement in Korea. The Ministry of Health and Welfare recently announced that it will expand the reimbursment criteria for Novartis Korea's interleukin (IL)-17A inhibitor Cosentyx (secukinumab) for hidradenitis suppurativa (HS) starting next month (December), through a partial amendment to the ‘Detailed Rules on the Standards and Methods for Applying Health Insurance Benefits.’ Specifically, hidradenitis suppurativa patients can use Cosentyx with reimbursement if they satisfy one of the following criteria: ▲ Adults with a diagnosis of over 1 year ▲ Lesions in two or more distinct areas, with a total of three or more abscesses and inflammatory nodules ▲ Insufficient therapeutic effect or adverse effects despite at least 3 months of antibiotic treatment. The process of expanding Cosentyx’s reimbursement was not smooth. Novartis originally submitted a reimbursement application after expanding its indication for Cosentyx to hidradenitis suppurativa in 2023, but voluntarily withdrew the application due to a lack of progress. Subsequently, in the European Hidradenitis Suppurativa Foundation (EHSF) practice guidelines presented at the 2024 European Academy of Dermatology and Venereology (EADV) Annual Congress, the EHSF recommended Cosentyx as a first-line biologic treatment option for patients with moderate-to-severe hidradenitis suppurativa (HS) and those with an inadequate response to prior systemic therapies. This led to the resubmission of the reimbursement expansion application in November of the same year, and the company gained success 1 year after resubmitting the application. Until now, AbbVie Korea’s Humira (adalimumab) has been virtually the only treatment option available for hidradenitis suppurativa in Korea. The introduction of Cosentyx, an IL inhibitor with a different mechanism of action that is also recommended as a first-line therapy, can become a viable option in managing hidradenitis suppurativa. Meanwhile, Cosentyx has demonstrated its clinical utility through the Phase III SUNNY (SUNSHINE, SUNRISE) trial, which was conducted on 1,084 patients with moderate-to-severe hidradenitis suppurativa. Results showed that the HiSCR achievement rate in the Cosentyx group was 45% in the SUNSHINE study and 42% in the SUNRISE study when the drug was administered every 2 weeks at 16 weeks of treatment, which was a significant improvement compared to the placebo group’s 34% and 31%, respectively. In the SUNRISE study, even when the drug was administered every 4 weeks, the HiSCR achievement rate for Cosentyx was 46%, which was significantly higher than the 31% in the placebo group, and the HiSCR achievement rate of Cosentyx improved steadily until the 52nd week of treatment. Cosentyx also showed significant effects in improving patients' pain. According to the results of the SUNNY study, the NRS30 achievement rate at Week 16 of treatment was 39% in the group that received Cosentyx every 2 weeks and 36% in the group that received it every 4 weeks. On the other hand, only 27% of the placebo group achieved NRS30. Also, by week 52 of treatment, 79.6% of the Cosentyx arm, who were administered Cosentyx every 2 weeks, and 72.7% of those who were administered every 4 weeks, did not experience disease exacerbation.
- Company
- "Yescarta leads DLBCL Tx…CAR-T therapy in earlier lines"
- by Son, Hyung Min Nov 21, 2025 06:11am
- The market position of CAR-T cell therapy in the treatment of relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) is rapidly expanding. Notably, Yescarta has secured approval in Korea for both second- and third-line treatment, drawing attention as a treatment option that has proven survival benefits over the conventional standard therapy. On November 20, Gilead Sciences Korea held a press conference at its headquarters in Jung-gu, Seoul, to share the role and clinical value of Yescarta (axicabtagene ciloleucel) in the treatment of DLBCL. Yescarta received approval last August for: ▲adult patients with DLBCL who relapsed or were refractory within 12 months of first-line chemoimmunotherapy ▲patients with relapsed or refractory DLBCL and Primary Mediastinal B-cell Lymphoma (PMBCL) after two or more lines of systemic therapy. Yescarta is a CAR-T cell therapy that involves harvesting a patient's T cells, genetically reprogramming them to target CD19 on cancer cells, and then reinfusing them. It is the first CAR-T therapy approved in Korea for both second and third-line treatment. Since its first approval for follicular lymphoma in 2021, Yescarta has successfully secured market adoption by rapidly expanding its indications to DLBCL, leukemia, and others. Its global sales reached $1.57 billion (approximately KRW 2 trillion) last year, making it the only CAR-T therapy to surpass $1 billion in annual revenue. Sungeun Kim, Medical Lead at Gilead Sciences KoreaThe domestic approval of Yescarta is based on the ZUMA-7 clinical trial, which compared the efficacy and safety of CAR-T against conventional standard therapy. The clinical results showed that the median Event-Free Survival (EFS) in the Yescarta group was 8.3 months, which was more than 4 times longer than in the high-dose chemotherapy and autologous hematopoietic stem cell transplantation (ASCT) group. The percentage of patients surviving without disease progression or additional treatment at two years was also 41% in the Yescarta group, 2.5 times higher than the 16% in the standard therapy group. The efficacy was consistently observed even in high-risk subgroups, including elderly patients, first-line refractory patients, and patients with double-hit or triple-hit lymphoma. Sungeun Kim, Medical Lead at Gilead Sciences Korea, said, "Yescarta has been supplied to over 31,000 patients worldwide and is a treatment with a stable foundation in terms of manufacturing success rate," and added, "We have submitted the application for reimbursement listing and will do our best to ensure supply in the first half of next year." High unmet need in relapsed/refractory DLBCL…will CAR-T be the solution? DLBCL is a disease where B cells, which protect the body, grow or proliferate uncontrollably. It is the most common B-cell lymphoma, accounting for approximately 40% of non-Hodgkin lymphomas, and is characterized by aggressive, rapid progression. The number of DLBCL patients in Korea was 14,183 as of last year, up 36% from 10,428 in 2018. Up to 15% of patients fail treatment after the first-line standard therapy, and even 25% of patients who achieve complete response (CR) experience relapse within 18 months. Patients with relapsed or refractory DLBCL typically see a rapid worsening of prognosis as the number of treatment lines increases. The current first-line treatment for DLBCL is the chemotherapy 'R-CHOP' (rituximab, cyclophosphamide, vincristine, prednisone), which uses a monoclonal antibody combination. While R-CHOP offers curative potential for about half of patients, the remainder are refractory or relapse due to poor prognostic factors. Professor Gi June Min of Seoul St. MarySubsequent treatment options include high-dose chemotherapy or ASCT. However, due to the physical burden, these options are difficult for elderly or frail patients. In reality, only about 30-40% of patients who respond to salvage chemotherapy can even be considered for ASCT, and half of those are known to relapse after the transplant. Although CAR-T therapies like Kymriah and bispecific antibodies are used after second-line treatment, Yescarta is the only treatment in Korea to secure the second-line indication. This has intensified calls from experts to apply CAR-T therapy as early as possible in patients at high risk of relapse or refractoriness. Professor Gi June Min of Seoul St. Mary's Hospital's Division of Hematology said, "CAR-T therapy is a priority recommended treatment for patients who relapse within 12 months," and emphasized, "Yescarta, which has confirmed improvement in OS, is a good drug that should be used earlier in the treatment sequence to maximize its effect."
- Company
- Gov't-Pharma meet for drug pricing system reform
- by Kim, Jin-Gu Nov 21, 2025 06:11am
- The Ministry of Health and Welfare (MOHW) and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA) Board of Directors have shared the direction for the upcoming reform of the drug pricing system. This initial meeting between the government and the pharmaceutical industry is expected to accelerate future discussions regarding the reform. According to the pharmaceutical industry on November 19, MOHW officials, including Lee Joong-kyu, Director-General of the Health Insurance Policy Bureau, attended the KBPMA Board of Directors meeting on the afternoon of November 18. It was the first meeting discussing the drug pricing system reform. During the meeting, the fundamental objectives and broad direction of the reform were shared. The government explained its policy to actively incentivize R&D investment by pharmaceutical and biotech companies and enhance access to new drugs. It was also mentioned that an adjustment to the generic drug price criteria must be made. Additionally, details on measures to stabilize the supply of essential medicines and to reorganize the post-market management system were shared. With the reform's general direction now shared with the industry, there is anticipation that discussions regarding the drug pricing system overhaul will gain momentum. The MOHW plans to finalize the draft reform plan based on the content shared at the meeting. The relevant agenda is expected to be reported to the Health Insurance Policy Review Committee scheduled for November 28. The discussions are expected to proceed after the Health Insurance Policy Review Committee report. While the report will outline the overall direction of the reform, subsequent discussions regarding detailed aspects, such as the generic drug pricing calculation rate, are expected to continue with the pharmaceutical industry's working-level consultative body. Considering the necessary procedures, a concrete outline of the drug pricing system reform is anticipated to emerge by the end of this year or early next year. The government is reportedly contemplating several changes, including adjusting the generic drug pricing calculation rate, reforming the tiered drug pricing system, merging post-market management systems, expanding the Risk-Sharing Agreement (RSA) and Dual Pricing systems, and implementing drug price bonuses linked to R&D investment ratios. First, there is a review to lower the generic drug calculation rate from the current 53.55% to below 50%. Under the current system, the price of a generic drug is set at 59.5% of the original drug's maximum price for the first year of listing, and this price is lowered to 53.55% thereafter. To receive the 53.55% rate, companies must meet both conditions: conduct their own 'bioequivalence test' and use a 'registered Active Pharmaceutical Ingredient (DMF)'. If only one condition is met, the price is reduced by an additional 15% (to 45.52% of the original price). If neither condition is met, it is reduced by another 15% (to 38.69% of the original). The government judges that the current 53.55% calculation rate is too high. Although the specific adjustment range has not been disclosed, industry forecasts suggest the rate could drop to around 40%. The tiered drug pricing structure is also an item for reform. Currently, the 53.55% rate applies to the first 20 generics listed, after which the price is reduced by 15% sequentially. Regarding this, there is discussion about narrowing the listing bracket from the current 20th generic to around the 10th, while simultaneously easing the drug price reduction rate to below 15%. The post-market management systems are expected to be merged and reorganized. This addresses criticism that various systems, such as the Actual Transaction Price-Based Drug Price Reduction, the Drug Reimbursement Appropriateness Re-evaluation, and the Price-Volume Agreement, operate in a complicated manner, reducing predictability. Discussions about integrated systems are expected to begin soon after the 'Research on a Integrated Mechanism for Post-market Drug Price Management' results are released. The drug price incentive system is likely to be reorganized to link preferential treatment to each pharmaceutical and biotech company's R&D investment ratio. An official from the pharmaceutical industry stated, "The government is clearly communicating that the market centered solely on generics has limitations for growth," and added, "I understand that discussions are proceeding toward simplifying the system and ensuring compensation for corporate innovation."
- Policy
- Ineffective dual pricing system to be revised
- by Jung, Heung-Jun Nov 20, 2025 06:16am
- The government has acknowledged the failure of the 'Separate Contracting System: Dual Pricing System', implemented last March to support the export of domestically developed new drugs. It will soon introduce a revised plan under a new name. The revised plan is expected to be submitted as an agenda item to the Health Insurance Policy Review Committee meeting on November 28 of this month, with the option to allow dual pricing for drugs other than those for severe and rare diseases being strongly considered. According to industry sources November 19, the government plans to significantly relax requirements for the dual pricing system, including conditions for ▲new drugs developed by companies that received Innovative Pharmaceutical Companies designation ▲eligibility for expedited review ▲domestic clinical trial requirements. Currently, no product meets all three requirements to use the dual pricing system. The system, though well-intentioned to support the development of domestic new drugs, has essentially remained a regulation without practical use. An official from pharmaceutical company A explained, "There were many restrictions. The number of new drug developments by domestic companies is at a low point, and few multinational pharmaceutical companies have received innovativeness designation," and added, "Moreover, the target for expedited review is often narrowed to severe and rare disease drugs, meaning ultimately, there are no drugs utilizing the dual pricing system." Currently, 45 domestic pharmaceutical and biotechnology companies of South Korea and four multinational pharmaceutical companies have received the innovativeness designation. Only drugs held by these companies that are also eligible for expedited review and have undergone domestic clinical trials could apply for the dual pricing system. Multinational pharmaceutical companies also assessed the original dual pricing system as insufficiently incentivizing. Since many multinational companies already utilize the refund-type Risk-Sharing Agreement (RSA), they were not interested in the dual pricing system, which offered no additional benefit. An official from multinational pharmaceutical company B assessed, "When the policy direction came out, we thought it would be widely used, but when we actually looked into it, there was no major advantage," and added, "There was many opportunity to utilize the RSA refund type, and since (applying the dual pricing system) did not grant an exemption from health-economic evaluation, it was difficult to see any added value." Following criticism in the National Assembly that the system lacked practical effectiveness due to zero uptake, the government is revising the regulation and renaming it the 'Flexible Drug Pricing Contracting System'. To avoid repeating the mistake of merely changing the name without addressing the lack of efficacy, incorporating field feedback is critical. The National Health Insurance Service (NHIS) is currently conducting internal reviews and gathering industry opinions for the introduction of the Flexible Drug Pricing Contracting System. Prospective expansion for eligible drugs for the dual pricing...will be gradually introduced to RSA drugs Even before the government announced the finalized plan, there was already discussion about the prospective expansion of the drugs eligible for the dual pricing system. Some predict that market-entry hurdles, such as the requirement for innovativeness designation and eligibility for expedited review, will be entirely removed. A multinational company official said, "The direction will likely be to allow it even for companies outside of the innovativeness designation. We anticipate that a wide range of products from pharmaceutical companies that show commitment will be permitted." The official also predicted, "We expect that RSA drugs will switch to the dual pricing system when their cost-sharing period ends or when the listing of a subsequent drug mandates the disclosure of their official listed price." Domestic pharmaceutical companies preparing for overseas export are also awaiting the government's detailed plan. They are, however, optimistic about the decision to expand eligibility. A domestic company official stated, "Since there are countries that reference our drug prices, it is beneficial if the official external price is higher. If implemented, we plan to enter the flexible contract system," and added, "Although the number of items for domestic companies is limited, it is much better than nothing. We will have to wait and see exactly how much they relax the rules, but I understand they are going to expand the scope of application proactively." This official estimated, "They seem to be aiming for implementation around the second half of next year, after consulting with the industry for necessary adjustments." Another industry official commented, "Given the external issues, the Lee Jae Myung administration is also interested in the dual pricing system, so I think it will be discussed as a priority item in the drug pricing reform." The commenter strongly suggested that the plan be submitted to the committee on the 28th of this month. The Ministry of Health and Welfare (MOHW) is being cautious ahead of the official announcement. A MOHW official said, "We are preparing improvements, and because the announcement will be made soon, it is difficult to disclose the details," and added, "We are discussing with the personnel in charge at the executive agency (NHIS) and are in the process of gathering opinions from stakeholders regarding the system improvement."
- Company
- Topical JAK inhibitor 'Anzupgo cream' submitted for reimb
- by Eo, Yun-Ho Nov 20, 2025 06:16am
- Product photo of Topical JAK inhibitor 'Anzupgo cream' has been submitted for insurance reimbursement listing. According to industry sources, LEO Pharma Korea recently submitted a reimbursement application for Anzupgo (delgocitinib), a new drug for Chronic Hand Eczema (CHE). Attention is drawn to whether this first and only cream-formulation JAK inhibitor option will gain reimbursement option. Anzuupgo is the only non-steroidal topical cream formulation approved for the treatment of moderate-to-severe CHE in adult patients who have not responded to, or for whom topical corticosteroids are not advisable. Anzupgo does not contain parabens or steroids. It works by suppressing the JAK-STAT signaling pathway, which is involved in various inflammatory reactions, by inhibiting the activity of JAK1, JAK2, JAK3, and TYK2, thereby helping to alleviate skin inflammation and pruritus. Until now, treatment options for CHE have been limited, with strong topical corticosteroids primarily being used. However, prolonged use of these agents can carry various risks, including skin barrier damage, skin atrophy, and dilated blood vessels. For cases where treatment effects did not appear in a short period, Korean treatment guidelines also recommended combining them with topical calcineurin inhibitors or systemic steroids. GSK's 'Alitoc (alitretinoin)', currently the only approved oral treatment for severe CHE, is used in patients who have not responded to at least 4 weeks of potent topical corticosteroid therapy. It improves symptoms through its skin-regulatory, anti-inflammatory, and immunomodulatory actions. It is known to be effective for the long-term management of chronic, severe hand eczema with a high risk of relapse. However, its continued use has been limited by concerns over various side effects, including hepatotoxicity, hypothyroidism, dyslipidemia, and fetal malformation. Anzuupgo's efficacy was proven through the DELTA FORCE and DELTA 2 clinical studies, which included a direct comparison with GSK's Alitoc (alitretinoin). In the DELTA FORCE study, the primary objective was met, showing superiority over alitretinoin capsules when delgocitinib was evaluated at baseline and at Week 12 using the Hand Eczema Severity Index (HECSI) score. The DELTA 2 study enrolled 473 patients with moderate-to-severe CHE. Participants were randomized to either the delgocitinib cream or placebo cream application group, receiving treatment twice daily for 16 weeks. The primary endpoint was an Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 0/1 measured at Week 16. Key secondary endpoints included the IGA-CHE score and the Hand Eczema Symptom Diary (HESD) score, both evaluated at Weeks 4 and 8. The results showed that the delgocitinib group significantly improved chronic hand eczema at Week 16 compared to the placebo group, meeting the primary and key secondary endpoints.
