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- 2026-07-03 08:28:51
- Policy
- Chong Kun Dang salt modified Entresto will be released soon
- by Lee, Hye-Kyung Apr 25, 2022 06:07am
- The market launch of Sacubitril/Valsartan Calcium, developed by Chong Kun Dang is imminent. According to the pharmaceutical industry on the 21st, Chong Kun Dang filed an application with the MFDS for permission for the drug developed by changing Valsartan Sodium, the main ingredient of Novartis' chronic heart failure treatment Entresto. This drug is likely to be a candidate substance called CKD-349, which was completed in June and October last year by conducting phase 1 clinical trials at Chungnam National University Hospital and H Plus Yangji Hospital, respectively. CKD-349 was tested with Entresto as a control drug. Entresto is the first double-inhibitor ARNI-based treatment that combines ARBI Valsartan and Sacubitril that inhibits Neprilsysin, and is currently recommended as a standard treatment in domestic and foreign heart failure treatment guidelines. As Entresto, which was approved for items in April 2016, was officially released in October 2017 after being listed, 13 domestic companies, including Hanmi Pharmaceutical and Chong Kun Dang, filed for patent judgment last year. On December 23, 2020, the Korean Intellectual Property Tribunal sided with generic companies by making a judgment on the establishment of the claim in a passive confirmation of the scope of rights of Entresto's crystalline patents filed against Novartis by 13 companies, including Hanmi Pharmaceutical and Chong Kun Dang. Entresto is protected by a total of five patents, including salt patents expiring in November 2026, use patent expiring in July 2027, crystalline patent expiring in September 2027, composition patent expiring in November 2028, and composition patents expiring in January 2029. If domestic companies succeed in targeting patents for use, they will be able to launch generics for Entresto early, which will end PMS on April 13. Entresto's outpatient prescription amounted to 32.3 billion won last year, up 37.3% from 23.5 billion won last year. This is the first achievement in four years since its release in October 2017.
- Company
- COVID-19 Tx Lagevrio lands in tertiary hospitals in Korea
- by Eo, Yun-Ho Apr 25, 2022 06:07am
- The oral COVID-19 treatment ‘Lagevrio’ has officially landed for prescriptions at general hospitals in Korea. According to industry sources, MSD Korea’s Lagevrio (molnupiravir) has passed the drug committees of tertiary hospitals including the Seoul National University Hospital in Korea. With the approval, the drug may be prescribed for in-hospital dispensing at tertiary hospitals and for in-hospital and out-hospital dispensing at general hospitals. Lagevrio, which is directly supplied by the Korea Disease Control and Prevention Agency through direct contracts, has been prescribed at dispensed at frontline convalescent hospitals, medical institutions, and designated pharmacies until now. The World Health Organization had issued conditional recommendations for the use of Lagevrio for patients at very high risk of hospitalization such as ▲those who haven’t received vaccinations for COVID-19, ▲those severely immunocompromised due to immunotherapy, etc., and ▲those with chronic diseases such as diabetes and published this revised COVID-19 treatment guideline in the British Medical Journal in March. Lagevrio is a ribonucleoside analog that is inserted in the place of the normal RNA needed in the viral replication process to induce lethal mutagenesis. As the first oral antiviral to be included in the WHO’s COVID-19 treatment guideline, the metanalysis of 6 clinical trials on Lagevrio in 4,827 patients showed that the drug reduced the rate of hospitalization by 36% compared to its comparator and showed a 3.4 day faster symptom improvement. Also, an interim and full analysis of a Phase III trial on Lagevrio showed that the drug demonstrated a reduction in the risk of hospitalization and death in outpatients with mild-to-moderate COVID-19 who were at risk of progressing to severe disease. In the planned interim analysis at 29 days after treatment, 14.1% (53/377) of the randomized patients had been hospitalized or died (8 cases) in the placebo group, whereas 7.3% (28/385) of the randomized patients were hospitalized with no deaths recorded in the Lagevrio group. The absolute risk reduction between the Lagevrio and placebo group was 6.8%, in which Lagevrio reduced the risk of hospitalization or death by around 50% by Day 29. Meanwhile, Lagevrio was approved for use in the UK as the first oral antiviral treatment for COVID-19 in November last year and then received emergency use authorization from the US Food and Drug Administration in December of the same year. MSD has signed supply agreements for the drug in 30 countries including Korea, the US, the UK, Germany, Australia, and Japan, and has been supplying Lagevrio to the countries.
- Company
- Sales of Expectants & antibiotic have increased
- by Chon, Seung-Hyun Apr 25, 2022 06:07am
- Sales in the outpatient prescription market have been rising sharply this year. Sales in the prescription market have been rising as the number of COVID-19 confirmed cases has soared since late last year. The Expectant and antibiotic prescription market, which is used for colds and infectious disease diseases, recovered to the level before the outbreak of COVID-19 as it emerged from the sluggishness of the past two years. According to UBIST, a pharmaceutical research institute, on the 20th, the amount of outpatient prescriptions for medicines in the first quarter was 4.1248 trillion won, up 6.5% from the same period last year. This is the second time after 4.22 trillion won in the fourth quarter of last year. The outpatient prescription market showed a pattern of slowing growth after the spread of COVID-19. The prescription amount in 2019 was 15.2318 trillion won, up 8.2% from the previous year, but the growth rate in 2020 and last year was only 2.7% and 3.0%, respectively. In the first quarter of last year, the prescription amount increased 2.0% from the previous year to 3.8746 trillion won, but this year is the first time since the third quarter of 2019 that the quarterly prescription growth rate exceeded 6% compared to the same period last year. In more than two years, the growth before the outbreak of COVID-19 has recovered. The slowdown in the prescription market growth over the past two years is pointed out as the direct cause of COVID-19. After the spread of COVID-19, the market for related treatments also shrank significantly as the number of patients with infectious diseases such as flu and colds plunged due to strengthening personal hygiene management such as washing hands and wearing masks. This year, if there are many COVID-19 confirmed cases, hundreds of thousands of people poured out a day, and the demand for COVID-19 symptom-relieving treatments such as cold medicine surged. The government also encouraged pharmaceutical companies to increase production as the supply of cold medicines and anti-inflammatory analgesics failed to keep up with demand. In the first quarter, the amount of outpatient prescriptions for expectorants was 53.3 billion won, up 116.6% from 24.6 billion won during the same period last year. It is the first time in more than two years that the quarterly prescription performance of expectorants has exceeded 50 billion won since the fourth quarter of 2019 Prescription market of expectorants has been on the decline since recording KRW 54.5 billion in the fourth quarter of 2019. In the second quarter of 2020, the amount of prescription for expectorants was 26.5 billion won, down 43.8% from the previous year, and remained at 20 billion won for six consecutive quarters until the third quarter of last year. After the spread of COVID-19, the prescription market was directly hit by a sharp drop in cold patients. However, in the fourth quarter of last year, the prescription amount of expectorants began to rebound to 33.8 billion won, and this year, the market size recovered to the level before the spread of COVID-19. The amount of prescriptions for expectants in the first quarter was 33.2 billion won, up 164.4% from a year-on- Expectants decreased from 37.1 billion won in prescriptions in the fourth quarter of 2019 to 14.3 billion won in the second quarter of 2020, when COVID-19 began to spread in earnest. The amount of outpatient prescriptions for oral cephalosporin drugs in the first quarter was 65.1 billion won, up 49.6% from the previous year. Cephalosporin drugs, also called "Cepha antibiotics," are antibiotics widely used for pneumonia, sore throat, tonsillitis, and bronchitis. The amount of oral cephalosporin prescription in the first quarter is the largest since it recorded 75.6 billion won in the fourth quarter of 2019. Sales of Cephalosporin drugs have also shrunk significantly over the past two years due to a sharp drop in flu or cold patients due to the prolonged COVID-19. In recent years, it has recovered to the level of previous years due to a surge in the number of COVID-19 confirmed patients. In the case of oral PCN preparations, it recorded 52.7 billion won in the fourth quarter of 2019, but it was reduced by more than half to 20 billion won from the second quarter of 2020 to the third quarter of last year. It recorded 34.3 billion won in the fourth quarter of last year and showed a higher increase in recent years.
- Company
- LDL-C target for cardiovascular dz will be lowered in Korea
- by Apr 25, 2022 06:07am
- The LDL-C target figure for South Korea's ultra-high-risk group for cardiovascular diseases is expected to be lowered to a similar level to global guidelines. The Korean Society of Lipid and Atherosclerosis held the Spring Cardiovascular Integration Academic Conference online and offline at the HICO on the 15th and 16th and unveiled some of the latest revised versions of the Dyslipidemia Treatment Guidelines. This amendment (the 5th edition) is the first revision of the guidelines for treating dyslipidemia in 4 years since 2018. In the meantime, in the United States and Europe, LDL-C targets for ultra-high-risk groups for cardiovascular diseases were lowered simultaneously. The ESC recommended lowering the target LDL-C level of the ultra-high-risk group for cardiovascular disease to 55 mg/dL, and considering less than 40 for extreme risk groups, such as patients who have experienced a second cardiovascular event. The AACE also recommends the LDL-C target value of the extreme risk group for cardiovascular disease at 55. This is because the premise that "the lower the LDL-C level, the higher the cardiovascular disease-related benefits" is accepted internationally. Korea, which remained in the 2018 guidelines, still sets the LDL-C target value for the ultra-high-risk group below 70. As the revision was made for the first time in four years, Korea also included changes in global guidelines in the new revision. The main focus of the amendment is a stronger LDL-C treatment strategy than before. Kim Sang-hyun, a professor of circulatory internal medicine at Seoul National University Hospital, introduced the framework and direction of the revision being prepared this year under the theme of "the goal of LDL-C treatment for ultra-high-risk/high-risk groups for cardiovascular diseases." According to the revised bill released by Professor Kim, the society classified the clinical situation into five according to the patient's risk level by judging the presence or absence of cardiovascular risk factors, and recommended lowering the LDL-C target overall by risk group. If the existing guidelines consisted of four groups: ultra-high-risk, high-risk, medium-risk, and low-risk, the revision is characterized by more detailed groups. Among the five groups according to the clinical situation, the highest risk group is coronary artery disease and diabetes (with targeted organ damage or three or more major cardiovascular disease risk factors). The amendment presented the group with the lowest LDL-C target of less than 55. The second group is a case of atherosclerosis ischemic stroke/daily cerebral ischemic stroke, carotid artery disease, peripheral artery disease, abdominal aneurysm, diabetes (with risk factors for cardiovascular disease over 10 years of illness or one or two). It was recommended that the group be targeted below LDL-C 70. The third group is a group of patients with less than 10 years of diabetes and no major risk factors for cardiovascular disease, with a target figure of less than 100. The other two groups were moderate risk groups (more than two major risk factors) and low risk groups (less than one major risk factor), respectively, with LDL-C targets of less than 130 and 160. It is noteworthy that LDL-C target values of coronary artery disease patients who have experienced myocardial infarction and angina were adjusted to be less than 55 and at least 50% lower than the baseline (Recommended grade 1, Evidence level A). Existing medical guidelines recommended reducing the LDL-C target for these patients by less than 70 or 50% or more. The association plans to unveil the final revision within the first half of this year. It is because it is still judged that expert discussion is necessary. In the case of diabetic patients, it was agreed that more discussion is needed on what to do with the LDL-C target value depending on the risk. A domestic data base to be used in determining patient risk should also be established.
- Policy
- Expansion of benefit standards such as Tenofovir/Baricitinib
- by Kim, Jung-Ju Apr 24, 2022 06:33pm
- As the scope of benefit of registered drugs such as chronic hepatitis B oral drug Vemlidy expands, the benefit standards for these drugs will also be expanded and changed. In addition, the standards for Baricitinib PO such as oluminant 2mg will be expanded to patients with chronic severe atopic dermatitis. The MOHW unveiled the "revised notification of details on the standards and methods of applying medical care benefits" and began to inquire about opinions until the 27th. ◆As the permission of the MFDS for= Tenofovir, an oral chronic hepatitis B treatment such as Vemlidy, is changed, the insurance benefit standards will also be expanded. Insurance authorities will expand and apply standards to non-target liver cirrhosis and liver cancer in consideration of excluding country permits, textbooks, clinical treatment guidelines, clinical research documents, and related academic opinions (expert opinions). In detail, the standard of "Besifovir and Tenofovir do not recognize non-subjective cirrhosis and liver cancer" among the benefit clues is changed to the phrase "Besifovir does not recognize non-subjective cirrhosis," and Tenofovir recognizes medical care benefits in patients with non-subjective cirrhosis. ◆ Antibiotics, PPI PO, Bismuth PO, Clarithromycin PO, Levofloxacin PO= Antibiotics, as well as Bismuth PO such as PPI PO and Denol, Clarithromycin PO, and Levofexin PO will be expanded. Insurance authorities were required to apply benefits to "after endoscopic resection of gastric adenoma" by referring to domestic and foreign permits, related literature, and academic opinions. ◆The benefits of Baricitinib PO will also be expanded to patients with Upadacitinib PO= chronic severe atopic dermatitis such as Olumiant 2mg and Rinvoq SR. However, the authorities may change the standards depending on the results of the MFDS review related to the safety of JAK I. In addition, due to insufficient grounds for replacement administration, it was decided not to admit replacement administration between Dupilumab and JAKI and replacement administration between JAK I. ◆ Everolimus PO such as Certican and Sirolimus PO= will also be applied to kidney transplant patients in the future. In addition, benefits are recognized for combination therapy with Tacrolimus for renal transplant patients beyond the scope of the MFDS' permission. ◆Guselkumab injections such as Tremfya Prefilled Syringe, etc.,= will be added to the MFDS' permission, and related standards will be expanded accordingly. In March last year, the drug added indications of "psoriatic arthritis." As a result, standards are also extended. Specifically, it is active and progressive healthy arthritis. A combination of newly listed items will be added to the benefit standard of the oral system for high blood pressure and hyperlipidemia. Starting next month, five Atorvastatin compound PO products such as Amlodipine, Candesartan, and Cantabell, and Telmisartan, Rosuvastatin and eight items of Ezetimbe PO complex such as Duowell Plus are scheduled to be listed, the combination of the drug ingredients will be added. ◆Tenofovir oral drugs such as K-Cab and K-CAB ODT 50mg will be newly registered next month, and this drug will also be added to the relevant benefit standards. The MOHW plans to implement the revision of the notice from May 1st if there is nothing unusual.
- Company
- Samsung BioLogics acquired all of its shares in Epis
- by Chon, Seung-Hyun Apr 24, 2022 06:33pm
- View of Samsung Bioepis buildingSamsung BioLogics will incorporate Samsung Bioepis as a 100% subsidiary and operate a separate management system. Samsung BioLogics announced on the 20th that it has completed the first payment of $1 billion in the acquisition of Epis shares to Biogen. From the day the first payment was completed under the contract between the two companies, Epis was officially converted into a 100% subsidiary of Samsung BioLogics. Earlier in January, Samsung BioLogics signed a contract with Biogen to acquire 10,341,852 shares of Epis (50%-1 share) for 2.7655 trillion won. Of the total amount, $50 million is equivalent to an additional "Earn-out" cost if certain conditions are met, and the remaining $2.25 billion will be paid in installments over the next two years. Samsung BioLogics raised a total of 3.2008 trillion won through a paid-in capital increase in shareholders' allocation to raise the cost of acquiring Epis shares. It achieved a high subscription rate of more than 100% in the paid-in capital increase public subscription for shareholders. The public offering of 400 billion won worth of shares for executives and employees recorded a subscription rate of nearly 100%, while existing shareholders such as Samsung C&T and Samsung Electronics made 100% subscriptions. As a result, Samsung BioLogics ended its partnership with Biogen for the first time in 10 years. Samsung BioLogics established Epis in 2012 in the form of a joint venture with Biogen. Epis was launched in February 2012 with a capital of 164.7 billion won. At this time, Biogen invested 24.7 billion won, or 15% of its capital. In 2018, Biogen raised its stake to 50% when it exercised its call option for Samsung Epis. Initially, Biogen established Samsung Biologics and signed a call option contract to transfer shares of Samsung Bioepis up to 50% - 1 share by June 29, 2018. Biogen decided to acquire shares when the call option contract expired. In June 2018, Samsung BioLogics took over 9,226,068 shares of Epis 19,567,921 shares for $700 million (748.6 billion won). Samsung BioLogics said, "As the joint management system with Biogen is transformed into Samsung BioLogics' sole management system, independent and rapid decision-making on Epis is expected to be possible. Through this, we believe that we will be able to push for mid- to long-term growth strategies such as the development of new pipelines, open innovation, and new drugs more quickly and flexibly." Starting with the acquisition of Epis, Samsung BioLogics plans to take a leap forward toward global bio companies. It is expected to internalize Epis' R&D capabilities in biopharmaceutical and expand its business portfolio to the development of new drugs in the long run. Samsung BioLogics plans to continue its bold and preemptive investment to secure future growth engines by using the investment funds secured by the paid-in capital increase to build its fourth plant and purchase additional sites. John Lim, president of Samsung Biologics, said, "Epis' capabilities and know-how will as an opportunity to making Samsung's bio business a global top tier."
- Company
- Tecentriq, first immunotherapy reimbursed in liver cancer
- by jung, sae-im Apr 22, 2022 06:07am
- Roche’s Tecentriq(atezolizumab) became the first cancer immunotherapy to be approved for reimbursement in liver cancer. Analysts have assessed that it had prepared the footsold to expand its sales with the first expansion in its scope of reimbursement in 3 years since 2019. Tecentriq is continuing its stride to overcome the stronghold of Keytruda, the current leader in the cancer immunotherapy market. The National Health Insurance Service had preannounced the posting of the ‘Revision to the notice for drugs prescribed and administered to cancer patients’ that contains a new category created to establish reimbursement standards for Tecentriq in liver cancer. The reimbursement will be applied from May 1st. According to the amendment, Tecentriq will be reimbursed as monotherapy in first-line for patients with metastatic NSCLC whose tumors are PD-L1 positive (TC≥50% or IC≥ 10%) and do not have EGFR of ALK mutations. Also, the drug will become the first immunotherapy to be approved for liver cancer (patocellular carcinoma, HCC). Among patients with advanced or unresectable hepatocellular carcinoma (HCC), those satisfy all of the following conditions: ▲who are Stage III or higher ▲Child-Pugh class A and ▲have a ECOG PS (performance status) 0-1, may receive reimbursement for Tecentriq in the first-line in combination with Avastin (bevacizumab). The drug is approved for reimbursement for basically one year in liver cancer, and when no clinical results are announced on the optimal period of administration within the year, reimbursement can be approved for up to 2 years at the most. As a latecomer in cancer immunotherapy, the company has been hurrying to extend its reimbursement to expand its share in the market. Although the agenda had made slow progress after passing the Cancer Drug Deliberation Committee in February last year, the agenda gained momentum this year and was finally approved after 1 year and 2 months. Source: IQVIA In terms of reimbursement, Tecentriq’s scope has neared that of the immunotherapy leader Keytruda. Keytruda currently owns the broadest indication among all cancer immunotherapies. The drug was approved for 18 indications in 14 cancer types including lung cancer, head and neck cancer, melanoma, and gastric cancer. However, among the approved indications, Keytruda is only reimbursed for NSCLC, Hodgkin lymphoma., and melanoma. It took the drug 4 years just to extend the scope of reimbursement (both monotherapy and combination therapy) to first-line from second-line in NSCLC. This goes to show how difficult reimbursement extensions are for the costly immunotherapies. Roche has been expanding its reimbursement relatively quickly by actively accepting government proposals. It succeeded in entering reimbursement in one year since its approval, and in 2019, it became the first immuno-oncology drug to remove the PD-L1 expression rate restriction and broaden its scope of reimbursement. Based on this, Tecentriq posted ₩67.2 billion in sales last year based on the drug research institution IQVIA. This is an 81.6% increase from the ₩37 billion made in the previous year. It is only one-third of the sales of Keytruda, which is posted nearly ₩200 billion won, but Tecentriq’s sales are increasing at a rapid pace. The drug significantly narrowed its gap with Opdivo (₩85 billion), the runner-up in the market. The extended reimbursement approval this year has laid the grounds for Tecentriq’s sales expansion. In particular, Tecentriq is the only drug that entered reimbursement among cancer immunotherapies, and is expected to bring a significant impact on the drug’s sales growth. The Tecentriq and Avastin combination extended the survival period of liver cancer patients by about 6 months compared to Nexavar (sorafenib), the only first-line drug that had been available for 10 years.
- Company
- The opinions of the pharmaceutical community vary widely
- by jung, sae-im Apr 22, 2022 06:07am
- Employees of pharmaceutical companies who have entered the era of post-COVID-19 due to the end of social distancing are divided. Various opinions are coming out as it is divided into pharmaceutical companies that maintain telecommuting and pharmaceutical companies that terminate. Pros and cons also followed group meetings such as company dinners and workshops. According to the pharmaceutical industry on the 21st, as social distancing has been completely lifted, pharmaceutical companies are also preparing to return to their daily lives. They would like to reduce or end telecommuting, and gradually promote suspended dinners and workshops. However, employees who have been satisfied with telecommuting and reduced company dinners for two years have recognized that commuting and company dinners are unnecessary hours. They look upset at the news that they can return to their old company culture. A, an employee of a multinational company, said, "I've had enough meetings and work from home, and my work efficiency has increased," adding, "Now I feel like commuting time is a waste. It's better to take care of one more task at that time," he said. B, an employee of a domestic company, said, "When there was a business hour limit, it ended at 9-10 o'clock even if we had a company dinner, but now there is no time limit, so the burden has increased. I'm already stressed out because I can have a company dinner until after midnight like before." C, an employee of a domestic company, also said, "There are already talks about having a company dinner in the department. During the COVID-19 period, I was able to enjoy a "life with dinner" while doing personal hobby activities, but I think it will be difficult to enjoy hobbies now, he confessed. Pharmaceutical salespeople, who had become a daily routine to go to work in the local area, are also worried that the number of office workers will increase. D, a sales employee at a domestic company, said, "As the number of office visits decreased due to COVID-19, the movement path was efficient, but the lifting of distance is likely to double the time to go to work again." There are some people who welcome going to work. This is because they felt limited in communication through telecommuting. E, an employee of a multinational company, said, "I moved during the COVID-19 period, but it took a while to identify employees in each department because I was working from home," adding, "It is not easy to communicate because there are still a lot of people out of touch. It seems that face-to-face communication is much more helpful in handling tasks with a lot of collaboration between departments," he said. F, an employee of a multinational company, said, "I have a hard time staying at home for a long time, so I feel lonely and depressed because I had to work from home when COVID-19 was serious, but now I have autonomy to go to work on purpose." In fact, the preference was also mixed in a survey conducted by commercial real estate data company Rsquare on career tech platform people and 2,625 office workers in their 20s and 50s or older last month. 37% of the respondents preferred the form of "going to work at the office and working in a designated seat," while half of them cited "the necessity and efficiency of face-to-face work" as the reason. Respondents in their 30s preferred "hybrid work," a mixture of commuting and telecommuting. The company's workshop, which had been suspended for a while, is also showing signs of reviving. There are opinions that a workshop is needed for unity and opinions that it is unnecessary. G, an employee of a domestic company, said, "In particular, after COVID-19, new employees do not know who belongs to which department because OJT (on the job training) is also online. In the past, collaboration was smooth through workshops and interdepartmental dinners, but since it was suspended for more than two years, we often had difficulty knowing each other, he said. "I hope there will be a chance to get together once in a while, even if not often." H, a domestic company employee, said, "I don't know if I really need to go to a group workshop. It is possible to communicate smoothly through tea meetings between collaborative departments, he said. "It has been suspended due to COVID-19, but if we make good use of small meetings such as company clubs, we will be able to produce better effects than workshops."
- InterView
- We are making all efforts to reimburse ‘Vyndamax’
- by Eo, Yun-Ho Apr 21, 2022 06:03am
- 김희정 전무 Rare disease patients suffer more due to the 'rarity' of their condition. Due to the small number of affected patients, even drugs that are already available cannot be easily listed for reimbursement due to difficulty in demonstrating cost-effectiveness or predicting their fiscal impact on the NHI budget. Rare diseases are diseases that affect fewer than 20,000 people or those for which the number of affected patients cannot be estimated due to difficulties in diagnosis. As rare diseases are difficult to diagnose and treat and have a significant impact on the life expectancy of the patients, it is imperative to ensure patient access to the treatments. However, due to the small number of affected patients, initiating clinical trials for such treatments in itself is quite difficult. In this context, Pfizer's Rare Disease Busines Unit has been currently exerting all its efforts to list its ‘Vyndamax (tafamidis 61mg),’ a treatment for ATTR-CM (ATTR amyloidosis with cardiomyopathy) for reimbursement in Korea. However, the process has not been so smooth. The company has already failed twice and is now making its third attempt at reimbursing the drug. Dailypharm met with Hee-Jeong Kim, Rare Disease Lead of Pfizer Korea to hear about the company’s position and state of affairs. -In Korea, it is not an exaggeration to say that reimbursement determines the success or failure of a new drug. As much as the government provides good coverage for the reimbursed drugs, this also makes it more difficult for drugs to be listed for reimbursement. Have you felt this while leading the Rare Disease BU at Pfizer? Korea’s strength is in its coverage (range of coverage). Patients in Korea can receive broader benefits in the course of their treatment due to Korea’s consistent policy and predictable supply under the single-payer system, once the drug is listed. Other markets abroad operate under various schemes. Access to new drugs is a little more difficult in Asia than in other regions. In Europe, new drugs are introduced at a relatively faster rate. In Spain, separate funding is operated for each region, and in the UK, the NHS has allocated alternative funding schemes for necessary drugs. The prompt introduction of new drugs is indeed difficult in Korea due to the wide scope of use of NHI finances from the patient’s perspective. The advantages of the single-payer system that I mentioned previously are partially offset by the strict standards set for new drugs. -This is the third attempt at reimbursement for ‘Vyndamax.’ It seems that the company’s determination will be as important as the government's will in obtaining the reimbursement approval. What efforts have Pfizer been making for the reimbursement?’ All employees at Pfizer Rare Disease have a strong desire to deliver the value of Vyndamax’ to patients in Korea. We plan to continue making attempts through various tracks available in Korea. ATTR-CM is a rare disease that lacks studies and trials to identify the exact prevalence of the condition itself. We fully understand the government’s concerns regarding this ambiguity and have continuously been in discussions with our head office to prepare an innovative risk-sharing plan as requested by the government. However, the agenda has not even passed the Drug Reimbursement Standard Subcommittee, therefore, we are not at the stage to discuss the risk-sharing plan being prepared by the company. We did not expect the drug to fail at setting the reimbursement standard stage so many times, therefore, our prime focus is on passing the Drug Reimbursement Standard Subcommittee this time. We will continue exerting our utmost effort at every stage that follows. -What about collaboration with academic societies and patient groups? The academic societies and patients groups recognize the need for the prompt reimbursement of ‘Vyndamax’ and have expressed their opinion to the government several times. Due to the small number of affected patients, it takes a significant time for HCPs to accumulate the expertise required. The Rare Disease BU cannot exist if the company only considers performance and numbers. In this perspective, having a sense of mission seems to be more important in our line of work. Our drug is necessary for further diagnosis of rare diseases, and we are sorry that there is no treatment currently available for use for HCPs and patients in Korea after the patients are diagnosed with ATTR-CM.
- Opinion
- [Reporter’s View] 1st oral abortion pill approval difficult
- by Lee, Hye-Kyung Apr 21, 2022 06:03am
- A year has passed since the decriminalization of the abortion ban has taken effect. The Korean Health and Medical Workers’ Union distributed a press release on the 11th on ‘ensuring safe abortion of the people 1 year after the decriminalization of abortion in Korea.’ The press release contained the request for marketing authorization of the oral abortion inducer Mifegymiso (Mifepristone·Misoprostol) and the preparation of an alternative legislation following the decriminalization of abortion under the criminal law in Korea. On April 11, 2019, the Constitutional Court made a constitutional discordance adjudication on the provision on abortion under the Criminal Act. The ruling took effect on January 1st, 2021, after which Hyundai Pharm applied for the marketing authorization of Mifegymiso in July of that year. Hyundai Pham has signed an exclusive marketing and distribution agreement for the supply of Mifegymiso in Korea with the UK-based Linepharma International. The drug is being used in 75 countries after the World Health Organization designated the drug as an essential medicine in 2005, The Ministry of Food and Drug Safety had assured expedited review of the drug to Hyundai Pham before the company applied for the marketing authorization of Mifegymiso. Since then, the drug went through a preliminary review process for 4 months from February last year, during which it was implied that the drug may be commercialized within the year with an expedited review. The Mifegymiso that Hyundai Pharm applied for is a combination pack that contains one 200mg Mifepristone tablet and four Misoprostol 200ug tablets. 10 months have passed since the marketing approval, but there is still no news of its approval in Korea, with the drug still under review. The MFDS is known to have requested supplementary data to Hyundai Pharm in the review process, but the company requested a postponement of the deadline for submitting supplementary data, which has rendered the approval schedule unpredictable. In addition, the need to create a legislative environment in which abortion drugs can be used stably was emphasized. As controversies continue to arise over the approval of the abortion drug, the MFDS is having trouble promptly proceeding with the approval of the product. In November last year, the MFDS and MOHW held an expert advisory meeting on the issue, but the meeting ended fruitlessly due to strong objections by obstetricians and gynecologists. While civic groups are urging for the prompt approval of Mifegymiso, the medical community, mainly the Korean Association of Obstetricians and Gynecologists, is pointing out the dangers of Mifegymiso and insisting that it must undergo a bridging study in accordance with the principle of drug introductions in Korea. In addition, it seems difficult for domestic pharmaceutical companies to expedite the marketing of abortion drugs in the absence of revisions to legislation such as the Criminal Act and Maternal and Child Health Act that would contain specific conditions and regulations for allowing abortions. Ultimately, it seems that the approval of the first abortion drug in Korea will not be granted until all controversies in legislation and safety are revised and resolved.
