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- 2026-04-14 13:28:25
- Policy
- Objections to post-marketing premium reevaluation submitted
- by Lee, Hye-Kyung May 31, 2021 06:02am
- The Health Insurance Review & Assessment Service’s reevaluations of premiums applied to listed drugs are being finalized. On the 28th, HIRA held a post-marketing drug management subcommittee meeting to finalize its decision on the items for which the premiums would be terminated (products for price ceiling recalculation) according to the reorganized drug premium pricing system. 가산재평가 기준 The subcommittee meeting was held to review items that companies submitted objections to, among candidates for reevaluation that was first selected at the Drug Reimbursement Evaluation Committee’s meeting on April 8th. The specific number of items that would undergo re-evaluation will be disclosed after the DREC meeting on the 3rd of next month. HIRA had announced that companies submitted objections to 180 items among the 500 that were first selected during the submission period. After the next DREC meeting, the National Health Insurance Service will conduct a drug pricing negotiation for 60 days under the order of the Minister of Health and Welfare, then implement the notice around August or September after passing the Health Insurance Policy Deliberative Committee meeting. The premium re-evaluation was modified according to the ‘Rules on Criteria for Medical Care Benefits of the National Health Insurance’ and ‘Standards for Decisions and Adjustments for Drugs' that were announced by the Ministry of Food and Drug Safety on November 9th of last year. The rules were modified so that premiums applied to drugs that fall under the following criteria may be terminated after deliberation by DREC: ▲ a biologic that had been applied a premium for 1-2 years that is being manufactured by 4 or more companies; ▲when the premium was applied for 3-5 years; and ▲When the premium was applied for over 5 years HIRA has been receiving data submissions from pharmaceutical companies since January this year to finalize the items subject to reevaluation. In the process, premiums for drugs that had been applied for over 5 years were terminated. For drugs that were applied premiums over 3 years but less than 5 years, the authorities decided to maintain the premium if the drug satisfied at least one of the following criteria: ▲the non-existence of alternative drugs ▲clinical necessity ▲superiority in additional costs incurred ▲listing status of same ingredient drugs ▲IMD (Incrementally modified drug)
- Policy
- Leukemia treatment ‘Venclexta’ to be reimbursed
- by Lee, Hye-Kyung May 31, 2021 06:02am
- ‘Venclexta (venetoclax)’ in combination with ‘MabThera (rituximab)’ will be reimbursed as second-line treatment for patients with chronic lymphocytic leukemia. The Health Insurance Review and Assessment Service (HIRA) has been conducting an opinion inquiry on its proposed revision of the ‘Notices required according to drugs prescribed and administered to cancer patients.’ If no objections are raised during this period, the revision will be applied and enforced from June 7th. Venclexta was approved in combination with rituximab for ‘adult patients with chronic lymphocytic leukemia (CLL) who had at least one prior treatment.’ HIRA reviewed the reimbursement expansion based on information from textbooks, guidelines, and clinical papers. As a result, the combination’s clinical efficacy was demonstrated in the randomly assigned, open-label, Phase III MURANO trial through progression-free survival (PFS), etc., in adult patients with relapsed or refractory chronic lymphocytic leukemia. In addition, the interval required for response evaluation of Afinitor (everolimus), a treatment for central nervous system cancer, was extended. Under general principles, the response of patients with solid cancers and malignant lymphoma should be evaluated every 2-3 cycles or 2-3 months. However, a request had been filed to extend the evaluation interval for Afinitor in tuberous sclerosis complex (TSC) patients who are in need of therapeutic interventions but have a brain tumor called subependymal giant cell astrocytoma (SEGA), in which the tumor cannot be removed completely by surgery. HIRA's textbook review showed that the interval should be 3-6 months for the first 3-5 years, followed by at least once a year. The U.K. guidelines also recommend patients to check responses in 1-3 years if they are asymptomatic, and more frequently so if they have symptoms. Considering the evidence that shows that the imaging tests may be conducted in an interval of 1 year at maximum, HIRA decided to recognize the 3 to 12 month interval as the response evaluation interval for Afinitor depending on the patient's condition.
- Company
- Sales of Gaviscon and Strepsil continue to be sluggish
- by Kim, Jin-Gu May 31, 2021 06:01am
- Gaviscon & StrepsilsSales of Gaviscon and Strepsils have been sluggish for five years since Reckitt's boycott. It is shown that sales of two products decreased by 46% and 74% respectively in first quarter compared to before boycotting. Competitive items are found to benefit from the long-term sluggishness of the two products. According to IQVIA, a pharmaceutical market research company, Strepsil's sales in first quarter of last year were ₩600 million. The figure is down 74% from ₩2.2 billion in the first quarter of 2016, just before the boycott of the entire Reckitt product began in earnest. The boycott of Reckitt products began in earnest after the second quarter of 2016. At that time, the humidifier disinfectant incident caused a lot of controversy, and as public opinion deteriorated sharply, it spread to a boycott of the entire product. The company changed its name from Oxy Reckitt to Reckitt, but it was not enough. Strepsils was ranked first in the sore throat treatment market with quarterly sales of about ₩2 billion before the boycott. However, since the boycott began in earnest, it has only generated ₩600 million to ₩1.2 billion in sales so far. Competing products are enjoying reflective benefits due to Strepsil's sluggishness. The representative product is Boryung's Younggaksan. Immediately after the boycott, it beat Strepsils and became the No. 1 item in the market. Its quarterly sales are about ₩2 billion. Since the fourth quarter of last year, sales have risen significantly on the basis of COVID-19 prevention issues. Its sales in fourth quarter of last year are ₩3.5 billion and its sales in first quarter of this year are ₩4 billion. In the case of Gaviscon, the company generated ₩2.3 billion in sales in the first quarter of 2016, just before the boycott began, but has since maintained sales of around ₩1 billion. Its sales in first quarter of this year are ₩1.2 billion. In five years, it has fallen by 46%. Gaviscon's rival, Yuhan's Almagel, has seen a modest rise in sales since the boycott. Its first quarter sales were ₩3.2 billion and it was the highest ever. Another competitor, Boryung's Gelfos, had sales similar overall to those before the start of the Gaviscon boycott. Its first quarter of this year's sales were about ₩2.4 billion. Analysts say that the sluggish sales of Gaviscon & Strepsils are due to the company's passive advertising and marketing activities. In fact, Reckitt Benckiser had been actively advertising and marketing both products before the boycott began. According to the KFAA's Advertising Information Center statistics, Reckitt Benckiser was included in the top 100 advertisers, spending ₩2.2 billion as of January 2016, but has disappeared since 2017.
- Company
- Keytruda, passed the committee except for lung cancer
- by Eo, Yun-Ho May 31, 2021 06:01am
- According to the industry, yesterday (26th) the HIRA's Cancer Drugs Benefit Appraisal Committee recognized the appropriateness of immuno-cancer drug Keytruda (Pembrolizumab)'s ▲ bladder cancer 2nd or higher ▲ typical Hodgkin lymphoma solo therapy that recurred after 3rd treatment. In fact, NSCLC, Non-small Cell Lung Cancer's indication of primary solo and combined therapy failed to pass the Cancer Drugs Benefit Appraisal Committee on the eighth challenge. This is likely to make it virtually difficult to expand the benefit of Keytruda's indications of lung cancer. It has been discussing the benefit expansion since September 2017. It's been almost four years now. The biggest challenge at the time was the "burden of pharmaceutical companies for the initial third cycle of medication," which the government presented as a condition for expanding the benefit to pharmaceutical companies with immuno-cancer drugs. Roche, a company with "Tecentriq(Atezolizumab)" which was generic at the time, accepted the proposal, and failed to accept two types of PD-1 inhibitors, including Keytruda and "Opdivo(Nivolumab)." The MSD then repeatedly proposed and revised compromises. The final discussion was in August last year. At that time, the Cancer Drugs Benefit Application Committee held off because it believed there was a lack of compromise. The HIRA then resubmitted the financial contributions discussed at the Cancer Drugs Benefit Appraisal Committee to MSD in September of the same year, demanding a revision. MSD submitted the revised bill a month later and handed it over to the Cancer Drugs Benefit Appraisal Committee for discussion. Eventually, the introduction of the Cancer Drugs Benefit Appraisal Committee was delayed, and the MSD persuaded the government directly by the new CEO Kevin Peters, but the answer was NO. There may be a reason, but even the failure of third-generation EGFR TKI 'Tagrisso' (Osimertinib) and Keytruda in April, the expansion of the benefits of the first treatment for lung cancer is facing difficulties.
- Company
- ‘No-show vaccines’ as the way out of COVID-19
- by An, Kyung-Jin May 28, 2021 06:08am
- J, who works as a medical representative in A Pharmaceuticals, has been struggling with his smartphone for 3 hours. J had finished his lunch early to try and reserve the no-show vaccines. However, both the Naver and Kakao applications on his phone were not working. Even after the server was restored, both maps were full of ‘0’s. He expanded the search area to all of Seoul and renewed the page several times. One hospital popped up, but the 10 shots that were available immediately turned to 0 as he pressed the reservation button. Dispirited, he pressed the notification services in various nearby hospitals, then put down his smartphone According to industry sources on the 27th, pharmaceutical companies have been internally encouraging vaccination with the ‘no-show vaccines’ to their employees. By hastening the vaccination of their employees, the companies sought to reduce group infections and normalize their business activities that have shrunk down due to the prolonged COVID-19 pandemic. In other words, the companies are seeing the leftover vaccines as an exit strategy-the fastest way out of the COVID-19 pandemic. One year and three months have passed since the World Health Organization (WHO) declared the 'COVID-19' pandemic. Industry’s fatigue is accumulating with the repeated ups and downs in the prescription drug market. Medical representatives who were unable to conduct normal sales activities for nearly a year since the entry into clinics and hospitals were restricted are at the end of their tether. The prescription drug market has not shown signs of recovery after the social distancing level was raised at the end of last year. With pressure for sales performance rising, the atmosphere in the companies for MRs to receive COVID-19 vaccinations as soon as possible’ have been tacitly created. If the number of vaccinated employees increase, the companies could reduce the proportion of telecommuters and boost sales activities that have been shrinking. ▲ Hospitals that have remaining vaccines in the whole Seoul area on the afternoon of the 27th, after the reservation of no-show vaccines have started (Source: captured screen of Naver and Kakao no-show vaccine reservation page) The COVID-19 vaccination response task force made the decision to disclose the information on leftover vaccines to the public in a bid to minimize the waste of COVID-19 vaccines. AstraZeneca’s COVID-19 vaccine can inoculate up to ten people per one vial, but once opened, the vial must be used within six hours or be discarded. Until now, people who wish to receive the vaccine had to directly call the commissioned medical institutions and put their name on a waiting list. A search and real-time reservation function was developed as a pilot program so that people could search for leftover vaccines through the Naver and Kakao map platform from 1 p.m. on the 27th, and will be operated for 2 weeks. As the reservation for ‘leftover vaccines,’ or no-show vaccines started at 1 p.m. on the 27th, pharmaceutical MRs were busy attempting reservations of the vaccines. However, it was difficult to find success stories in the Seoul area. An MR from A pharmaceuticals said, “I did the authentication process in advance and was fully prepared to reserve the no-show vaccines, but I also failed. Our Kakaotalk chat room was busy all day with the talk about reserving no-show vaccines. Other than those who had reserved vaccines in advance in noncapital regions like Busan, none of my colleagues were able to succeed in making the reservations.” The situation does not only apply to MRs. Attempts to reserve the no-show vaccines have increased greatly among pharmaceutical employees working at manufacturing plants and research sites. These employees who hold manufacturing and research duties at the pharmaceutical companies are those that can cause enormous damage to the company in the case of shutdowns. The opinion is that by completing inoculation, the employees can be free from the risk of becoming the first infected in their companies. Also, the ‘incentive’ policy to ease restrictions for those vaccinated with COVId-19 is seen to have had some influence on raising interest in the no-show vaccine. An employee from a plant at B Pharmaceuticals said, “No formal instructions were given, but most of my colleagues have already listed their names on the waiting list for leftover vaccines. Many have already completed their first vaccinations. As more and more colleagues joining in for the reservation, we have applied for the reservation at a nearby hospital and are awaiting their notification.”
- Policy
- It's necessary to go through the social consensus
- by Lee, Jeong-Hwan May 28, 2021 06:08am
- It is argued that conflicts between doctors and pharmacists were not be resolved despite government intervention in order to legislate for the activation of the generic substitution, and that they should go through the social consensus process that took place at the time of the separation of prescribing and dispensing. They say that citizens, doctors, pharmacists, and the government should come up with an agreement together because they are divided between doctors and pharmacists and repeatedly make unyielding claims. In particular, the formation of a social consensus is inevitable because the issue of "prescribing active ingredient" is in conflict with the revitalization bill of the generic substitution. The MOHW held a meeting of the KMA, the KHA and the Korean Pharmaceutical Association on the 26th, but failed to agree. Eventually, the first subcommittee of the National Assembly's Health and Welfare Committee reviewed the agenda for revitalizing the generic substitution, which broke down the agreement between doctors and pharmacists. Therefore, the National Assembly reviewed legislation to activate the generic substitution. In 1999, the KMA and the Korean Pharmaceutical Association agreed on a generic substitution and the same level of social consensus that the agreement council had worked on in order to implement the separation of prescribing and dispensing. Furthermore, the bill, which changes the name of the system from generic substitution to "same active patient dispensing" and extends pharmacists from doctors to the HIRA's DUR system, suggests that there is a serious conflict between the division of prescribing and dispensing. It is unreasonable for doctors and pharmacists to simply try to resolve the same active dispensing, separation of prescribing and dispensing bill, which affects social consensus, with parliamentary legislation. "From a doctor's point of view, changing a generic substitution to a same active ingredient dispensing is perceived as generic prescribing. In particular, the generic substitution is a system that is deeply related to the separation of prescribing and dispensing. "If the bill is passed right now, it will be a problem. "How many doctors will agree to the bill that the National Assembly or the government hastily decided without an agreement?" "The general substitution issue is not a matter that can be proposed by a member of Parliament from a pharmacist and decided unilaterally by the National Assembly. "We need to discuss more issues that have differences of opinion between professions." Professor Lee Jae-hyun of Sungkyunkwan University of Medicine said, "The perspective of the generic substitution depends on whether it is a job problem between doctors and pharmacists or a drug inventory problem at pharmacies.If looking at as a matter of doctors and pharmacists to operate a a social consensus on the impossibly difficult. Regardless of the generic substitution, doctors and pharmacists had different opinions," he said, adding, "In terms of pharmacy drug inventory, we can find common ground." The arrangement of a list of local prescriptions was agreed upon at the time of the separation of prescribing and dispensing. "It depends on which issue we focus on." An official from the Korean Pharmaceutical Association said, "The idea of a generic substitution as an active ingredient prescribing is too contradictory. "The goal of the bill is to secure the finances of health insurance and promote national benefits by increasing the use of drugs already licensed through biological equivalence tests," he said. "The general substitution sub-consultation ended without reaching an agreement, and theMOHW plans to report the details to the National Assembly." "It is not a matter of conflict between professional organizations, but a policy that the government should decide for the sake of the people." The official said, "The Ministry of Health and Welfare agreed to a clause that would expand the scope of post-notification. "It is time for the National Assembly to pass even a partial passage of the extension of post-notification clause," he said. "I think the Korean Pharmaceutical Association should join the discussion in that the formation of a social consensus is a division of preservation and dispensing revaluation." But it's going to take too long.
- Company
- NA bill to guarantee labor succession following M&A
- by May 28, 2021 06:08am
- A bill that guarantees the succession of labor relations in changing businesses such as mergers or business transfers is being promoted. With the introduction of such a bill soon expected, eyes are on whether and how the pharmaceutical industry will also be affected by the bill. In particular, the bill is expected to pull the brakes on the unilateral notifications given by multinational pharmaceutical companies that undergo frequent mergers and divisions. Ok-Joo Song (Democratic Party of Korea), member of the Environment and Labor Committee of the National Assembly, submitted the ‘Act on the protection of workers changing business, etc.’ as a representative, which is the first bill to stipulate the succession of labor relations following changes in business, such as corporate spinoffs, merger, and changes in subcontractors. Specifically, the business owner must undergo consultation processes with the labor representative before the change of business, and notify the workers subject to succession, and stipulates the worker's right to refuse succession and right to object. Also, the bill contains measures to prevent the existing employment rules and working conditions from changing unfavorably with an individual worker’s consent during changing business and restricts layoffs from the change of business. In the case where a change of business happens, the collective agreement made between the previous company and labor union is to be succeeded as well. In particular, the bill stipulates the laws of labor succession and protection take precedence over other laws. On the background for proposing such a bill, Song said, “There has been criticism that the current system lacks legal stability as the succession of labor relations left to the interpretation of the court. The EU has guidelines on change of business that stipulate labor succession as a principle. The proposed bill intends to provide significant protection to workers that may be left unstable due to changes in the workplace by stipulating the succession of labor relations following change of business.” The bill was proposed as a result of the group dismissal of cleaning workers that happened at the LG Twin Tower, however, it is expected to have a significant impact on the pharmaceutical industry as well. In particular, multinational pharmaceutical companies have been seeing much labor-management conflict due to frequent mergers and split-ups. For example, Pfizer spun off its off-patent business to a separate corporation, Pfizer Upjohn, and then combined with Mylan only 2 months after the division and renamed the company to Viatris. MSD has also spun off its women’s health·off-patent drug·biosimilar business with Organon. Takeda Pharmaceutical also acquired Shire and sold off its primary care business (chronic disease business) in the Asia-Pacific region. In the process, many employees have suffered labor instability, worried that they might be notified to move to the spin-off or become subject to voluntary retirement due to redundancies. Protests were led by labor unions opposing the unilateral decisions made by companies. With mergers and divisions expected to continue at the global level, similar issues are expected to continue to arise. The problem is that there is no law stipulating the succession of labor relations following changes of business under the current law and relies solely on case law precedents. Workers have difficulty exercising their ‘right to refuse transfers,’ and in reality, cannot assert their rights to refuse relocation during labor negotiations. If the bill is passed, the consultation process between the company and workers would play an important role in the sale or mergers of its businesses. Labor consultant Kyung-Rak Kim of the Daesang Labor Law Firm said, “The bill will make it mandatory for the management to undergo a consultation procedure with worker representatives in advance in the process of making corporate changes such as mergers, business transfer, or divisions. The bill stipulates the right to refuse succession or raise objections of workers in the process. If the bill is passed as it is, it will be able to provide significant protection to workers in the process of corporations’ reckless business changes."
- Company
- Olumiant's indication for atopic dermatitis has expanded
- by May 28, 2021 06:08am
- Lilly's Olumiant (Baricitinib) is the first Korean JAK inhibitor to acquire atopic dermatitis. Lilly Korea announced on the 26th that Olumiant received approval from the MFDS to expand its indications to treat secondary or severe atopic dermatitis in adult patients subject to systemic therapy on the 24th. Olumiant has acquired two indication for diseases, following severe active rheumatoid arthritis, which was previously recognized in Korea. Atopic dermatitis is a chronic inflammatory disease that is typical of itching. This causes scratching, leading to worsening skin inflammation and skin pain. In addition, the majority of patients suffer from itching and accompanying symptoms such as sleep disorders and poor quality of life, and mental symptoms such as stress and depression due to apparent skin lesions. JAK inhibitors contain inflammatory cytokines, which block inflammation, pain and cell activation. Olumiant, a selective inhibitor of JAK1 and JAK2, has confirmed the efficacy and safety of the drug on a combination of sole and local corticosteroid (TCS) administrations in three clinical studies. In particular, Olumiant has been shown to improve itching rapidly from day 2 of treatment, which seriously undermines patients' overall health and quality of life. Olumiant's recommended dose for treatment of atopic dermatitis is 4 mg once a day. It can be administered alone or in combination with TCS, and its effectiveness can be increased when administered in combination with TCS.
- InterView
- Leclaza's ASCO data is like a global champion
- by An, Kyung-Jin May 28, 2021 06:08am
- Cho Byung-chul, a professor at Yonsei UniversityThe response rate for 'Lazertinib+Amivantamab' is the same as when ESMO was announced? It's ridiculous. The data is incomparably more complete than it was 7 months ago. " Professor Cho Byung-chul (oncology at Yonsei Cancer Hospital) commented on Leclaza (Lazertinib) combined data. A number of questions have been asked since the opening of the American Society of Clinical Oncology (ASCO 2021) and some misinterpretations need to be corrected. Professor Cho will introduce the latest clinical results related to combined therapy of Leclaza and Amivantamab at the ASCO 2021 online conference on the 5th of next month. This is the follow-up announcement of CHRYSALIS 1b, which drew much attention at the European Oncology Society (ESMO 2020) last year. The purpose is to evaluate the response rate of 'Lazertinib+Amivantamab' combined therapy in patients with resistant non-small cell lung cancer. The published objective response rate (ORR) is 36%. Fifteen out of 45 Tagrisso-resistant patients reached a partial reaction (PR) that reduced the tumor size by more than 30%, and one showed a complete reaction (CR) that completely disappeared. Because ORR figures are the same as when ESMO 2020 was announced, it can be accepted as the same data. "Even if the ORR values are the same, the maturity of clinical data has completely changed," Professor Cho added. The key is the difference in follow-up periods. Data released at the time of ESMO showed a follow-up period of only about four months after medication. On the other hand, the tracking period of ASCO's announcement increased to 11.8 months. In other words, the same response rate was maintained even though the tracking period has more than doubled.The duration of the reaction in patients who responded to the drug administration was more than 10 months. When the concept of biomarker is combined, the reaction rate increases further. Eight out of 17 patients with EGFR and MET mutations, known as Tagrisso's most common cause of resistance, showed treatment responses, achieving ORR 47%. However, the absence of biomarkers does not mean that the response rate is low. Of the remaining 28 people whose biomarkers were not identified, eight showed tumor responses to combined Lazertinib+Amivantamab administration. In terms of ORR, it is 29%. "There is a group of patients who are good at responding to Lazertinib+Amivantamab combined therapy," Professor Cho said. "However, the data alone when there is no biomarker is far more competitive than the existing treatment." Previously, there were no lung cancer treatments that demonstrated a 30% response rate and a duration of 10 months in patients who failed Tagrisso treatment. For example, the most prescribed combination of Tagrisso and MET inhibitor Savolitinib is 30% response rate and 7.9 months response duration when only MET patients are selected. Professor Cho compared this data to boxing. It's nothing short of winning Mike Tyson.Treatment of non-small cell lung cancer, which has developed new resistance after Tagrisso administration, is quite difficult due to tumor heterogenicity. This means that the data has increased over a long period of tracking for cancer patients with such malignant conditions. Professor Cho said that there is a good chance that Lazertinib+Amivantamab combined therapy will be designated as a U.S. FDA innovative therapy (BTD) within this year. If similar levels of data are reproduced in Janssen's ongoing CHRYSALIS-2 clinical trial, FDA approval will not be long.
- Policy
- One-time ￦2 billion therapy Zolgensma to be soon approved
- by Lee, Tak-Sun May 27, 2021 05:56am
- Zolgensma (onasemnogene abeparvovec-xioi), a new gene therapy drug that attracted attention due to its high price of nearly 2 billion won per single shot, is soon to be approved in Korea. As a spinal muscular atrophy gene therapy, Zolgensma is also called a ‘one-shot treatment’ as only a single dose is required during a patient’s lifetime. As the drug is about to be approved, whether the drug will be allowed reimbursement is expected to be the key issue. On the 26th, industry sources said that the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review for Zolgensma. The results are expected to be announced soon. Zolgensma was designated as an orphan drug in December 2018 but was not formally approved in Korea. The drug has gained much attention as a treatment for SMA that needs to be administered only once. SMA is caused by a defect or mutation in the SMN1 gene that leads to a deficiency of motor neuron protein. Without proper treatment, patients with SMA would need to depend on assistive devices and even result in death. When administered, For Zolgensma, an SMN1 gene is inserted inside a virus vector, which is then injected into the patient's body to induce the production of SMN1 protein. Various SMA treatments such as Spinraza (nusinersen, Biogen) and Evrysdi (risdiplam, Roche) have been recently released in Korea; however, the demand for the one-shot Zolgensma stays strong. The issue at hand is its price. The price of a single shot of Zolgensma is 2.5 billion won in the U.S. and 1.89 billion won in Japan. Experts say that the reimbursement standards in Korea are not sufficient to evaluate ultra high-priced drugs and that a new evaluation model needs to be designed for such drugs. In a forum held on the 13th, Professor Hye-Young Kang of the Department of Pharmacy at Yonsei University said, “The optimal plan for each country should be prepared in consideration of each country’s history, culture, and economy.” She continued, “Adopting a reimbursement model from other countries may be dangerous as we cannot fully implement or understand the details or backgrounds of the models used in other countries.” On this, Yoon-Seok Yang, head of the Division of Pharmaceutical Benefits at MOHW said, “We can apply the current risk-sharing agreement scheme to evaluate the reimbursement of Zolgensma.” Explaining that the drug may be evaluated under current reimbursement standards, he added that “However, the payment structure needs to be deeply considered.” Meanwhile, Novartis’s ‘Kymriah,’ another ‘one-shot treatment’ indicated for the treatment of acute lymphoblastic leukemia (ALL), was approved in March and is in the process of being evaluated for reimbursement.
