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- 2026-03-10 00:46:46
- Policy
- The implications of Keytruda’s reimb expansion
- by Jung, Heung-Jun Dec 24, 2025 08:06am
- MSD Korea’s immune checkpoint inhibitor Keytruda (pembrolizumab) is expected to complete the process of expanding its reimbursed indications at the Health Insurance Policy Deliberation Committee (HIPDC) meeting scheduled for today (the 23rd).Following approval by the committee, Keytruda’s reimbursement will be significantly expanded from January next year, increasing from the current 7 indications across 4 cancer types to 18 indications spanning 13 cancer types.This marks the culmination of a process that began with the reimbursement application in 2023—nearly three years in the making. Beyond the numerical addition of reimbursement for 9 additional cancer types and 11 new indications at once, the decision signifies enhanced treatment accessibility for previously underserved cancer types.It also stands as a significant precedent, having found a breakthrough for expanding reimbursement indications under the existing RSA framework before the government’s formal introduction of its indication-specific drug pricing system.According to industry sources on the 23rd, the National Health Insurance Service's Health Insurance Review and Assessment Service (HIRA) will vote on expanding Keytruda's reimbursement indications at its meeting today at 2 PM.Starting next January, Keytruda will be reimbursed for gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small cell lung cancer, and bile duct cancer. Previously, reimbursement was applied to 7 indications across 4 cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma.While coverage was previously concentrated on non-small cell lung cancer, the expansion will now allow insurance coverage for a broader range of patients, including those with women’s cancers such as endometrial, breast, and cervical cancer.Furthermore, for several cancer types, including endometrial cancer, small cell lung cancer, and bile duct cancer, reimbursement will be extended to patients with MSI-H (microsatellite instability-high) tumors, significantly improving access for patient groups that had previously been excluded from treatment options.A milestone in multi-indication coverage ahead of indication-based pricingKeytruda, which received a multi-indication approval, has long been at the center of discussions surrounding the potential introduction of an indication-based pricing (IBP) system in Korea.While the government recently announced plans to introduce IBP through a drug pricing system reform, concrete measures have yet to be finalized. In this context, Keytruda's case can be seen as an example where the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and the pharmaceutical company found a broad solution for expanding coverage within the current Reimbursement Strategy Agreement (RSA) framework.With several other multi-indication therapies awaiting reimbursement review, this case is expected to serve as a reference model for future reimbursement decisions, regardless of whether IBP is formally adopted.Keytruda currently holds approvals for 18 cancer types and 35 indications, so further attempts to expand reimbursement coverage are anticipated going forward.Of course, this expansion of Keytruda's indications does not eliminate the need for IBP. How the government's drug pricing system will accommodate blockbuster drugs with multiple indications remains an unresolved policy challenge.However, the significance of Keytruda's recent coverage expansion lies in its active use of RSA to achieve results effectively approaching an indication-based pricing system. The case is meaningful not only for enhancing patient access to treatment but also for clarifying the extent to which existing reimbursement mechanisms can be leveraged to address complex multi-indication therapies.
- Policy
- 3 supply shortage drugs set to receive a price premium
- by Jung, Heung-Jun Dec 23, 2025 08:00am
- Hanmi Pharm's Vildagle Tab and Kyongbo Pharm's Vilda TabWhile drug prices for approximately 4,000 items will be reduced next January, including those affected by the Actual Transaction Price adjustment, prices for certain products at risk of supply shortage will be increased.These adjustments apply to drugs for which the government is either extending price premiums due to low profitability or raising prices to offset production costs for 'discontinuation-prevention drugs'.According to industry sources on December 22, the price premium period for two salt-modified vildagliptin products, scheduled to expire in January, will be extended for another year.Hanmi Pharmaceutical's Vildagle Tab 50mg (vildagliptin hydrochloride) and Kyongbo Pharm's Vilda Tab 50mg (vildagliptin nitrate), both DPP-4 inhibitor diabetes treatments, were initially set to lose their four-year price premiums next month.However, in line with the Drug Reimbursement Evaluation Committee (DREC)'s opinion on stable supply, the premium period will be extended by 1 year.Currently, Vildagle Tab receives a premium of KRW 300 from KRW 240, and Vilda Tab receives KRW 314 from KRW 240, a premium of 25%-30% at the ceiling price.These two products entered the market in 2022 through salt modifications, before the expiration of the Novartis patent on its original drug, Galvus (vildagliptin).While prices typically drop following patent expiration and the entry of generics, these salt-modified products successfully defended their pricing. By continuously raising their price premiums, they are now priced above the KRW 240 ceiling price of the original Galvus.Additionally, the ceiling price for Bukwang Pharmaceutical's Antiroid Tab (propylthiouracil), an antithyroid agent designated as a 'discontinuation-prevention drug', will increase by approximately 11% next month, from KRW 34 to KRW 38.Price compensation for 'discontinuation-prevention drug' is granted to medicines that are essential for clinical treatment but are at risk of production stoppage due to low profitability.As an ingredient designated as a 'National Essential Drug', it has faced concerns about supply instability amid rising raw material costs, given its low drug pricing. The 11% price hike for Antiroid Tab will take effect on the 1st of next month.Meanwhile, the products undergoing price reductions next month total around 4,000 items, including 3,940 drugs whose prices are being adjusted following the government's Actual Transaction Price investigation.
- Policy
- Celltrion has added 'Omlyclo' Pen Inj…rival Xolair
- by Lee, Tak-Sun Dec 23, 2025 07:59am
- Celltrion's 'Omlyclo'Celltrion has started chasing the original product in the Korean market through the expanded formulation of 'Omlyclo (omalizumab)', used to treat allergic asthma and chronic spontaneous urticaria.The original drug is Novartis' Xolair, an injectable generating KRW 20 billion in the domestic market (KRW 21.1 billion according to the 2023 IQVIA). Omlyclo is a biosimilar to Xolair, and it was added to the reimbursement list in September of last year.The Ministry of Food and Drug Safety (MFDS) approved Omlyclo Pen Inj in September. This product is a pen formulation, a different formulation from Omlyclo PFS Inj approved in June of last year.The difference between a pre-filled pen and a pre-filled syringe is whether the needle tip is exposed. A pre-filled syringe is injected with a needle exposed, while a pre-filled pen may reduce fear due to its hidden needle tip. Both formulations can be self-injected.The original drug Xolair has no pen formulation approved in South Korea. Only the conventional injectable and pre-filled syringe formulations are available.Considering these factors, Celltrion may be one step ahead in the future competition against Xolair.When it comes to prices, Celltrion has a competitive edge. Xolair is priced at KRW 216,755 per 150mg. In contrast, Omlyclo costs KRW 173,404, approximately KRW 40,000 less.However, Omlyclo 300mg of higher strength has not yet been added to the reimbursement list, thereby constituting the current weakness.Product sales overseas are also at full scale. In September, it was launched in Europe. In Europe, Omlyclo is reportedly the sole biosimilar to omalizumab.Omlyclo obtained U.S. FDA approval in March, thereby beginning to target the North American market on a full-scale basis.However, due to the patent expiration of Xolair in November, other biosimilars, such as one from Teva Pharmaceutical, are about to enter the market. Celltrion taking the market lead in the early race is expected to drive sustained sales.Xolair's global sales amounted to approximately KRW 5 trillion as of 2023.
- Policy
- Moderna’s RSV vaccine gains expedited approval
- by Lee, Tak-Sun Dec 19, 2025 09:08am
- The Ministry of Food and Drug Safety (MFDS) announced on the 18th that it has approved mRESVIA Prefilled Syringe (respiratory syncytial virus [RSV] mRNA vaccine, Moderna Korea) as the first biologic drug to be authorized under the newly implemented ‘New Drug Marketing Authorization and Review Procedures’ implemented this year.The revised New Drug Marketing Authorization and Review Procedures, introduced earlier this year, include expedited review measures such as the formation of dedicated product review teams and prioritizing GMP reviews. These measures were established as follow-up actions to the increase in new drug approval review fees.For the approval of mRESVIA, the MFDS formed a dedicated review team consisting of 18 members, including specialists in new drug evaluation, conducted priority GMP reviews, and held individualized face-to-face meetings before and after the marketing authorization application. Through close communication with the applicant, the MFDS was able to complete the approval process in an expedited manner.The newly approved imported drug, mRESVIA Prefilled Syringe, is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older, as well as in high-risk individuals aged 18 to under 60 years. It is the first RSV preventive vaccine in Korea approved using an mRNA platform.Respiratory syncytial virus (RSV) is a virus that causes acute respiratory infections with symptoms similar to those of the common cold.Meanwhile, the first small-molecule drug approved under the new fast-track review system was Xcopri Tab (cenobamate) developed by Dong-A ST, which received marketing authorization in November.The MFDS stated that it plans to further enhance the new drug review system through in-depth preliminary assessments, item-by-item parallel reviews, and stage-specific tailored meetings during the new drug approval process. These efforts aim to facilitate rapid market entry of innovative medicines, provide patients with quicker access to treatment options, and support the growth of the biopharmaceutical industry.
- Policy
- Support grows for reform of aHUS reimb pre-approval system
- by Jung, Heung-Jun Dec 19, 2025 09:08am
- Concerns about improving the pre-approval review process for Soliris, a treatment for aHUS, has also been raised during last year's NA auditCalls to improve reimbursement access for treatments for atypical hemolytic uremic syndrome (aHUS) are gaining momentum, with the Anti-Corruption and Civil Rights Commission (ACRC) joining the National Assembly in pressing for institutional reform.Previously, the National Assembly had criticized the low approval rate of prior authorization for Soliris, an aHUS treatment, and urged regulatory relaxation.On the 17th, the ACRC has recommended system-wide improvements, including designating aHUS and other “ultra-urgent rare diseases” as a separate category and improving the system to ensure prior reviews are completed within 2-3 days.It ordered the establishment of a 48-hour fast-track review process for prior approval and the creation of a ‘Rare Disease Drug Review Committee (tentative name)’ to ensure such reviews are conducted swiftly.The ACRC has given the Health Insurance Review and Assessment Service (HIRA) an implementation deadline of December next year. If the recommendations are not implemented, the Commission plans to continue monitoring progress.ACRC investigator Joon-hyung Kim said, “We are aware of the issues raised by the National Assembly. We listened to the voices of medical professionals, patients with rare and severe diseases, and patient organizations. We also conducted an on-site investigation at HIRA this summer. Through stakeholder meetings, we consolidated opinions and finalized our recommendations. This is not limited to aHUS alone. There are several other ultra-rare diseases requiring immediate emergency care.“Kim added, ”HIRA is likely aware of the need for improvement, having conducted its own investigation. We have now communicated the recommendations along with a deadline for implementation by December next year."While these are recommendations without legal enforceability, the ACRC stated that it will actively follow up and encourage implementation if reforms are not carried out.Investigator Kim conveyed, “Even if it goes beyond December next year, we will continuously monitor whether implementation occurs and manage the situation to ensure improvements are made.”The prior approval system is a mechanism designed to obtain reimbursement approval before administering ultra-high-priced new drugs, considering the financial stability of the National Health Insurance budget.Last year's National Assembly audit pointed out low approval rates and review delays for treatments like atypical hemolytic uremic syndrome (aHUS) and spinal muscular atrophy (SMA).Meanwhile, the reimbursement criteria for aHUS treatments were partially relaxed this October.
- Policy
- Keytruda completes price negotiations for reimb in KOR
- by Jung, Heung-Jun Dec 17, 2025 09:50am
- MSD Korea’s immunotherapy drug Keytruda (pembrolizumab) has completed price negotiations with the National Health Insurance Service (NHIS), with reimbursement coverage expected to expand to additional indications starting next month.Keytruda previously received approval for reimbursement appropriateness for 11 indications, including gastric cancer and esophageal cancer, at the 9th Drug Reimbursement Evaluation Committee meetingAccording to industry sources on the 16th, MSD Korea has finalized a drug price agreement with the NHIS regarding the reimbursement expansion for Keytruda. Following review by the Health Insurance Policy Deliberation Committee (HIPDC), the Ministry of Health and Welfare is expected to issue a formal notice next month.The 11 additional indications approved by the Drug Reimbursement Evaluation Committee this time include gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and biliary tract cancer. Approximately 2 years after the initial reimbursement expansion request in 2023, the decision now awaits only the Health Insurance Review and Assessment Service (HIRA) resolution.Previously, Keytruda was granted reimbursement for seven indications across four cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma.For metastatic or unresectable recurrent head and neck squamous cell carcinoma, reimbursement was granted for first-line treatment as ▲ monotherapy in PD-L1-positive patients, ▲ combination therapy with platinum and fluorouracil-based chemotherapy.Keytruda to show strong momentum in both regulatory approvals and reimbursement expansion in head and neck cancer.In October, the Ministry of Food and Drug Safety approved an expanded indication for Keytruda as perioperative therapy (pre- and post-surgery) in patients with resectable locally advanced head and neck squamous cell carcinoma.Given this expanded approval in head and neck cancer, MSD is expected to pursue further reimbursement expansion for the approved indications. Beyond head and neck cancer, it holds 35 indications across 18 cancer types, leaving significant potential for additional reimbursement expansion.Keytruda’s annual claims exceed KRW 400 billion, and claims are expected to increase starting next year as additional reimbursed indications start being prescribed.
- Policy
- President Lee "Review reimb of hair loss·obesity drugs"
- by Lee, Jeong-Hwan Dec 17, 2025 09:50am
- President Lee Jae Myung has drawn attention by instructing the Minister of Health and Welfare, Jeong Eun Kyeong, to specifically review the possibility of extending National Health Insurance (NHI) coverage to hair loss and obesity treatments.President Lee stated, "I previously made a campaign pledge to support hair loss medication. Isn't hair loss also part of a disease? I hear many young people use it, so have you reviewed the possibility of coverage?" He added, "I would like you to examine the potential costs, and if unlimited support poses a financial burden, consider limiting the number of doses or imposing a total expenditure cap."President Lee asked, "I assume the reason for the lack of coverage is that genetic factors cause baldness. But isn't a genetic disease also caused by genetics? It becomes a matter of defining whether something is a disease or not." He concluded, "This does not seem logical."President Lee further added, "In the past, hair loss was viewed as a cosmetic issue, but these days, it seems to be perceived as a matter of survival." He then asked, "The same seems to be true for obesity treatment. Is coverage for severe obesity medication under review?"Minister Jeong responded that it is necessary to consider medical urgency or priority when covering hair loss medication.Minister Jeong explained, "NHI supports treatment for alopecia areata caused by medical reasons. NHI does not cover hair loss due to genetic factors because its link to medical treatment is considered low." She added, "It is true that many non-covered medical services include treatments for hair loss, acne, and obesity."Minister Jeong said, "Since they are not life-threatening diseases, other treatments deemed cosmetic are also not covered by the NHI," and added, "We will review [NHI coverage] for these conditions."Regarding coverage for obesity medication, Lee Jung-kyu, Director of the NHIS Bureau, replied, "For severe obesity, we currently provide partial coverage for surgical treatments based on the Body Mass Index (BMI) criteria."Minister Jeong further explained, "We are still reviewing these medications. Since an application for reimbursement has just been submitted, we need to proceed with the review for reimbursement appropriateness.
- Policy
- ‘Expand 1st line reimb for anabolic agents to reduce healthcare costs’
- by Jung, Heung-Jun Dec 16, 2025 08:36am
- Calls have been raised for expanding reimbursement coverage for anabolic agents as first-line therapy in order to prevent osteoporotic fractures and the resulting rise in direct and indirect healthcare costs.As reimbursement for bone-forming agents is limited to second-line treatment only, experts argue that coverage should be expanded to include first-line use. Representative agents in this class include Evenity (romosozumab) and Forteo (teriparatide).Seung-hoon Baek, Director of Insurance and Policy at the Korean Society for Bone and Mineral ResearchOn the 15th, Seung-hoon Baek, Director of Insurance and Policy at the Korean Society for Bone and Mineral Research, emphasized the need for a first-line treatment strategy using anabolic agents at a National Assembly policy forum on osteoporosis fracture prevention held on the 15th.Director Baek stated, “Recent domestic and international guidelines recommend anabolic agents as a first-line treatment strategy for the very high-risk group. Global guidelines, including those from the American Association of Clinical Endocrinology, also position them as first-line treatment options.”The KSBMR also established guidelines in 2024 recommending the use of anabolic agents as first-line therapy in high-risk groups meeting criteria such as: ▲ a fragility fracture within the past year ▲ multiple fractures ▲ a bone mineral density T-score below -3.0.Director Baek explained, “If bone resorption inhibitors are administered first, there is a risk that bone formation may also be suppressed. Therefore, administering anabolic agents first is more effective for improving bone density."A study involving 1,000 women aged 75 showed that 43 fractures occurred when antiresorptive agents were used first, compared with 22 fractures when anabolic agents were used as first-line therapy, confirming a significant fracture-reduction effect.However, in Korea, reimbursement for anabolic agents is granted only if they are used after bone resorption inhibitors prove ineffective, which has been cited as a major limitation.Furthermore, the target population must meet all of the following conditions: ▲ Age 65 or older (or postmenopausal women aged 65 or older for romosozumab) ▲ T-score ≤ -2.5 ▲ History of two or more osteoporotic fractures.Director Baek emphasized, “Korea's reimbursement criteria are excessively restrictive compared to major countries overseas. Following the UK and Japan, Australia also expanded reimbursement for romosozumab as a first-line treatment for high-risk groups in early November last year. While there may be an increase in drug costs in the short term, a reduction in healthcare costs is expected in the long term. Overseas, this is the basis for its use in the first-line.”He further elaborated, “Patients who experience osteoporotic fractures incur approximately 80% higher per-patient medical costs compared to those without fractures. Preventing fractures is key to curbing rising healthcare expenditures.”Specifically, experts proposed recognizing it as a first-line treatment and expanding the target population from postmenopausal women aged 65 and over to include those aged 50 and over. The proposed eligibility criteria include: ▲ Relaxing the bone density test requirement from ≤-2.5 to <-3.0 ▲ Expanding from patients with two or more fractures to those with a fracture within the past year ▲ Patients meeting any one of the following: bone density ≤-2.5 and two or more fractures.
- Policy
- ‘Allowing drug wholesaling via platform creates conflicts of interest’
- by Lee, Jeong-Hwan Dec 16, 2025 08:35am
- Joon-Hyuk Kang, Director of Pharmaceutical Policy Division, MOHW"Just as it is clearly a conflict of interest and therefore prohibited for public officials such as lawmakers and ministers to purchase stocks in sectors related to their official duties, it is equally a clear conflict of interest and should be prohibited for platforms to engage in distribution and sales by also operating as pharmaceutical wholesalers. Doctors, pharmacists, and platforms must fulfill their distinct roles in the telemedicine process, and for this, the amendment to the Pharmaceutical Affairs Act must pass the National Assembly."The Ministry of Health and Welfare stated that allowing telemedicine platforms to operate as pharmaceutical wholesalers is not a solution to the ‘pharmacy hopping’ crisis.The Ministry directly challenged the main argument currently being used by some lawmakers and Presidential Chief of Staff Hoon-sik Kang to block the plenary session and processing of the amendment to the Pharmaceutical Affairs Act, which passed the National Assembly's Health and Welfare Committee and Legislation and Judiciary Committee with bipartisan agreement, stating it is factually incorrect. This has drawn intense attention from political circles and the healthcare and pharmaceutical sectors.Regarding how the bill banning platform wholesalers is commonly referred to as the ‘Doctornow Prevention Act,’ the Ministry stated, “It could easily be misinterpreted as a law banning platform brokerage itself. A more accurate description would be a platform conflict-of-interest prevention bill or a ban on collusion between Doctornow and drug wholesalers,” the ministry said.”On the 14th, Joon-Hyuk Kang, Director of Pharmaceutical Policy at the Ministry of Health and Welfare, met with the press corps to explain the ministry's position on the delayed plenary processing of the Pharmaceutical Affairs Act amendment proposed by Rep. Yoon Kim of the Democratic Party of Korea, which has already passed both the Health and Welfare Committee and the Legislation and Judiciary Committee review.Yoon Kim’s bill for the amendment to the Pharmaceutical Affairs Act faces plenary delay due to opposition from some lawmakers across parties and Chief of Staff Hoon-sik Kang.The Ministry maintains that, to establish a safe non-face-to-face medical environment free from platform dependency for patients, medical institutions, and pharmacies, safeguard a fair pharmaceutical distribution system, and prevent patient medication misuse, both the Medical Service Act amendment institutionalizing non-face-to-face care (already passed by the National Assembly) and the Pharmaceutical Affairs Act amendment banning platform wholesalers require urgent plenary session processing.Minister of Health and Welfare Eun-kyeong Jeong also strongly expressed her view during the previous Judiciary Committee meeting regarding the platform wholesaler ban bill. She stated that, similar to doctors and pharmacists, the amendment of the Pharmaceutical Affairs Act is necessary to prohibit platforms from abusing their monopolistic position to engage in specific pharmaceutical distribution and sales activities.Nevertheless, several lawmakers from both major parties, including So-young Lee, Han-kyu Kim, Bo-yoon Choi, and So-hee Kim, argued that “Banning platform wholesaling based solely on concerns over illegal rebates would stifle startup innovation.” Presidential Chief of Staff Hoon-sik Kang also supports these lawmakers’ position.Doctornow, which positions itself as Korea’s leading telemedicine platform, claimed that “operating a wholesaling business is merely a practical measure to resolve pharmacy hopping” and has actively lobbied against the legislation.“Allowing platform wholesalers cannot be the solution to the pharmacy hopping issue”The Ministry of Health and Welfare has fully refuted these arguments from some lawmakers, the Presidential Office, and Doctornow. First, it stated that allowing Doctornow to operate a wholesaler and directly or indirectly intervene in drug distribution and sales cannot be considered a solution to the patient pharmacy hopping crisis.The MOHW believes the claim that platforms should be allowed to operate as wholesalers to address the issue of patients using telemedicine services having to go from pharmacy to pharmacy due to lack of medication is flawed.The ministry questioned why resolving pharmacy hopping must necessarily involve allowing platforms to operate as wholesalers, suggesting that this logic itself requires serious reconsideration by policymakers.While approximately 30,000 pharmaceutical products are distributed in Korea, Doctornow reportedly handles only about 90 products—an imbalance that, according to the MOHW, demonstrates how platform-operated wholesaling could promote illegal or distorted practices.Director Kang explained, “Allowing platforms to operate as wholesalers won't solve the ‘pharmacy hopping’ issue for pharmacies. If frontline pharmacies could freely share their inventory and stock of medicines via platform apps, the ‘pharmacy hopping’ issue could be resolved.”Kang added, “With over 30,000 pharmaceuticals circulating in the market, can platforms like Doctornow, which operate wholesalers, distribute, and sell all 30,000 drugs? Currently, Doctornow handles only about. When a specific platform distributes only 90 out of 30,000 drugs, it can distort prescriptions and dispensing at affiliated medical institutions and pharmacies.“He added, ”But does that mean we should turn the platform into a large wholesaler distributing all 30,000 drugs? This would also create problems in itself. The dual role of platform and wholesaler has clear limitations.“”Serious conflict of interest issues will arise among large capital platforms if legislation fails"The MOHW warned that if the bill fails, conflicts of interest arising from platform involvement in drug distribution and sales could spiral out of control.Beyond Doctornow, larger capital-backed platforms, corporations, or even pharmaceutical companies could collude with platforms to distribute and promote drugs that serve their own interests, the ministry cautioned.Kang stated, “The purpose of the amendment is not to target a specific company like Doctornow, but to prevent broader conflicts of interest that could lead to medication misuse or collusion. Therefore, the bill needs to be reviewed during the plenary session. Just as public officials are prohibited from purchasing stocks related to their official duties due to conflicts of interest, platform-operated wholesaling presents the same problem.”He added, “The potential for illegal rebates by platform wholesalers is merely a tool. The core issue is the potential for patient medication misuse or collusion that could arise if conflicts of interest are left unresolved. During non-face-to-face consultations, platforms should only be granted and exercise authority within their specific roles, just like doctors and pharmacists.”“Platforms hold prescription/dispensing authority equivalent to doctors/pharmacists... reason for wholesaler ban”The Ministry of Health and Welfare judges that platforms like Doctor Now hold influence equal to or greater than that of doctors holding prescription authority and pharmacists holding dispensing authority in the distribution and sale of pharmaceuticals.Because physicians and pharmacists are legally prohibited from engaging in wholesaling, the ministry argues that platforms should be subject to the same restrictions.Director Kang emphasized the urgent need for consensus among the MOHW, the Ministry of SMEs and Startups, and relevant National Assembly committees that platforms can exercise pharmaceutical influence equivalent to healthcare professionals.Kang said, “The MOHW’s position is that platforms exercise prescribing and dispensing influence comparable to physicians and pharmacists. Therefore, they require equivalent regulatory restrictions, including a ban on wholesaling. The ministry had actually proposed amendments to the original bill to better protect legitimate platform functions, leading to its passage through the Health and Welfare Committee and the Legislation and Judiciary Committee.”Kang explained, “The original bill defined even the act of posting drug inventory or price information on platforms as patient solicitation and banned it outright. The Ministry views such information provision as a basic platform function and excluded it during the Welfare Committee review. The provision prohibiting pharmacy owners from offering economic incentives to platforms for patient solicitation was also removed. This was because it was difficult to distinguish between legitimate compensation for pharmacy services and other forms of inducement."He added, “Rather than getting bogged down in peripheral issues like the potential for illegal rebates or the interests of specific companies like Doctornow, I urge politicians and the media to focus on the fact that allowing platforms to operate as wholesalers themselves creates a conflict of interest. We must look toward the passage of the amendment to the Pharmaceutical Affairs Act in the National Assembly as necessary to protect public health in medicines and ensure safe telemedicine.”
- Policy
- Vial formulation of Mounjaro approved only for diabetes in KOR
- by Lee, Tak-Sun Dec 15, 2025 09:16am
- Lilly’s ‘Mounjaro Prefilled Pen Inj’Lilly has obtained Korean regulatory approval for a vial formulation of Mounjaro in Korea. Mounjaro is a GLP-1 and GIP dual agonist, and its prefilled pen formulation was launched in August as an obesity treatment.The Ministry of Food and Drug Safety approved six dosage strengths of Mounjaro Vial Inj (tirzepatide) on the 12th. Like the previously approved pre-filled pen, it comes in 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml, and 15mg/0.5ml doses.However, its indication for chronic weight management in adults was excluded. The newly approved Mounjaro vial formulation is indicated solely as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, either as monotherapy or in combination therapy.Earlier this month, Mounjaro Prefilled Pen received a positive reimbursement assessment as a diabetes treatment from the Drug Reimbursement Evaluation Committee (DREC) under Korea’s Health Insurance Review & Assessment Service (HIRA). Products that pass the DREC review proceed to price negotiations with the National Health Insurance Service (NHIS), followed by final listing approval by the Health Insurance Policy Deliberation Committee.With reimbursement listing now highly likely for the prefilled pen formulation, Lilly is expected to pursue reimbursement for the vial injection formulation as well.Lilly secured three formulations: Mounjaro Prefilled Pen in June 2023, Mounjaro QuickPen in September this year, and now Mounjaro vial formulation.The currently marketed formulation is the prefilled pen formulation, supplied without reimbursement as an obesity treatment. Mounjaro generated sales of KRW 28.4 billion (IQVIA) within two months of launch, fueling strong market momentum alongside Wegovy.Tirzepatide, the active ingredient in Mounjaro, selectively binds to and activates both GIP and GLP-1 receptors, which are targets of endogenous incretin hormones. Through this mechanism of action, it enhances first- and second-phase insulin secretion in a glucose-dependent manner and suppresses glucagon secretion. GLP-1 is a key physiological regulator of appetite and calorie intake.
