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- 2026-04-16 14:43:37
- Company
- HCV drug Mavyret prescription goes down by 31% amid COVID-19
- by Kim, Jin-Gu Jul 29, 2020 06:33am
- Although Mavyret (glecaprevir) dominated the hepatitis C treatment market as soon as it was launched, the treatment took a steep fall in prescription volume. The pharmaceutical industry sources argue the 31-percent drop compared to last year would have been impacted by decreased number of patients and COVID-19. According to the pharmaceutical market research firm UBIST on July 27, Mavyret’s outpatient prescription sales from last January through June marked 16.4 billion won. Still the treatment is accounted for 74 percent of the Korean hepatitis C treatment market, but the situation is not exactly rosy. Compared to last year, the prescription sales have gone by down 31 percent. In the first half of 2019, Mavyret generated 23.7 billion won. In 12 months time, the figure plummeted by 7.3 billion won. The fall has continued for five consecutive months. After peaking at 13.1 billion won in the second quarter of 2019, the prescription has been sliding down from 12 billion won in third quarter last year, 8.8 billion won in fourth quarter last year, 8.8 billion won in last first quarter, and 7.7 billion won in last second quarter. Hepatitis C treatment prescription volume in 2020 H1 and Mavyret’s quarterly prescription volume (Source: UBIST) The research firm claims two complicated causes have affected the state. First, the hepatitis C patient size has shrunk. Direct-acting antiviral (DAA) medications treating hepatitis C, such as Mavyret, demonstrates high cure rates and has short therapy duration. Naturally, the overall patient size is constantly narrowing as increasing number of patients are cured. Korea’s Health Insurance Review and Assessment Service (HIRA) reported the number of hepatitis C patients last year was at 44,483, which went down by 10 percent in three years from 49,569 in 2016. The hepatitis C treatment market has been following the descending curve since the third quarter in 2016. The market volume valued at 68.5 billion won has dwindled to 10.3 billion won in the last second quarter. The current market is now at about one-seventh of its peak. The last quarter actually hit the historic low since the DAA medication entered the market. In last month, Bristol Myers Squibb (BMS) that first opened the hepatitis C treatment market withdrew ‘Daklinza plus Sunvepra’ combination therapy from the Korean market. The company explained it was because the competition has gotten increasingly intense, while the demand lessened. Yearly count of hepatitis C patients (Source: HIRA) and quarterly trend in hepatitis C treatment market volume (Source: UBIST) Moreover, this year has been rough for the market amid COVID-19. As patients have been refraining from visiting hospitals and clinics due to COVID-19, they were less exposed to the main cause of hepatitis C like infection through blood transfusion and syringe. Regardless of blood borne infection, the hepatitis C infection transmission was apparently impacted by social distancing.
- Company
- Eight generic companies for Lixiana are expected to compete
- by Kim, Jin-Gu Jul 29, 2020 06:31am
- LixianaHanmi and Boryung overcome the patent of oral anticoagulant (NOAC) 'Lixiana' (Edoxaban). Eight generic companies, including those, are expected to compete after the patent expires in November 2026. The Intellectual Property Trial and Appeal Board recently decided on 'claims established'' at a trial to confirm the passive scope of rights to Lixiana composition patent claimed by Hanmi Pharmaceutical and Boryeong Pharmaceutical. As a result, eight companies have overcome Lixiana composition patent. Previously, in April, Samjin, HK inno.N, Chong Kun Dang, Kolmar pharma Hutecs Kolmar Korea received the same trial. However, they failed to overcome Lixiana's material patent. Accordingly, eight companies can enter the generic competition after November 10, 2026, when the material patent expires. They met two of the three requirements for generic for exclusivity right. If the requirements are met until the first application for permission, it is expected that there will be no difficulty in winning generic exclusivity. Lixiana is the representative product of the NOAC market. It was the latest release compared to other items, but It is superior to the results of JXarelto (Rivaroxaban), Eliquis(Apixaban), and Pradaxa (Dabigatran). According to UBIST, Lixiana's outpatient prescription amounted to ₩59.9 billion last year. This year, only ₩31.7 billion was prescribed in the first half.
- Company
- [Photo]“Dismissal is a murder” Sanofi Labor Union protests
- by An, Kyung-Jin Jul 29, 2020 06:30am
- On July 27, the Sanofi-Aventis Korea Labor Union Chapter of Federation of Korean Chemical Workers' Unions (FKCU) was gathered in front of the company’s Seoul headquarters to denounce the management’s unfair disciplinary action Sanofi-Aventis Korea’s Disciplinary Committee meeting was scheduled in the afternoon to deliberate a salesperson, who made false reports of calls and received a ‘letter of recommended dismissal.’ Two other salespeople who were accused the same have reportedly ‘resigned by recommendation.’ The labor union claims the two employees have been intervened by the management unjustly. And the union plans to continue their protest against the company to defend the job security of the other one employee that refused the management’s offer and received a letter of dismissal. The chief of Sanofi-Aventis Korea Labor Union, Park Young stated, “An unfair treatment by the Disciplinary Committee is as cruel as committing a murder. Hopefully, the committee would make a fair decision,” while “we would fight against the management until it stops repeating the same action of imposing excessive penalty and dismissing employees.”
- Policy
- Tecentriq combo wins coverage as first-line on NSCLC
- by Lee, Hye-Kyung Jul 28, 2020 06:37am
- Roche Korea’s Tecentriq (atezolizumab) is to receive coverage on treating patients with non-small cell lung cancer (NSCLC) as a first-line treatment. South Korea’s Health Insurance Review and Assessment Service (HIRA) disclosed the revised notice on anticancer treatment with the said update, which would accept public opinion on the revision until July 28. Combined with carboplatin and etoposide, Tecentriq has been indicated as a first-line treatment in patients with extensive NSCLC. HIRA apparently reviewed textbook, guideline and clinical literature to expand the reimbursement standard. The government body confirmed the National Comprehensive Cancer Network (NCCN) guideline prefers (Category 1) the combination therapy as a first-line treatment in patients with extensive NSCLC. Moreover, Phase III trial ‘IMpower 133’ confirmed the combination therapy showing statistical improvement in the median overall survival (mOS) by two months (12.3 months vs. 10.3 months) and median progression-free survival (mPFS) by 0.9 months (5.2 months vs. 4.3 months) compared to the control group. The coverage expansion was granted as most of patients with extensive NSCLC have short survival time (eight to ten months) and extremely limited anticancer treatment options. But in Korea, immunotherapy can be used only in healthcare institutes capable of responding on emergency cases of unpredicted adverse reaction, and administered by a well-experienced doctor with sufficient knowledge in anticancer therapies. Accordingly, a healthcare institute and patient using Tecentriq would have to submit information on using the treatment with coverage to the president of HIRA. A patient’s coverage would last for a year. HIRA has also decided to approve reimbursement on on-label use of Casodex (bicalutamide) in patients with prostate cancer as Category 1 single or combination anticancer treatment. As a measure to improve review expertise and transparency standard, a Category 1 single or combination therapy in prostate cancer newly added bicalutamide.
- Company
- Generics for Betmiga competition gets fierce
- by Kim, Jin-Gu Jul 28, 2020 06:37am
- BetmigaFull-fledged competition began in the generic market of “Betmiga (Mirabegron),” which has annual outpatient prescriptions of ₩65 billion. Hanmi and Chong Kun Dang, which received generic for exclusivity, recently released generics. The two companies plan to focus on expanding the market until February next year when the trial period expires. According to the pharmaceutical industry on the 24th, Chong Kun Dang has released "Selebeta", which is a generic for Betmiga, from the 1st of this month. Hanmi has been launching and selling “Mirabek” since June, a month earlier. The overall prescription amount is a little higher than that of Hanmi, which was released a step ahead, but the two companies are said to be very similar. As the original market was so large, the officials said that the prescription performance was good. Since the launch of Betmiga, more than 40 domestic companies have filed for patent evasion. Since 2015, invalidity trials and passive judgments on the scope of rights have been requested for material patents, formulation patents, crystalline patents, and use patents. As a result, 11 companies succeeded in overcoming formulation patents, crystalline patents, and use patents excluding material patents. These are Hanmi, Chong Kun Dang, JW Pharma, Daewoong, Ildong, Intropharm, Alvogen Korea, Kyung Dong, Sinil, Hanwha, and Shinpoong. Only Chong Kun Dang and Hanmi have won the right of generic for exclusivity. They received the right of copyright in April. As the material patent expired on May 3, the two companies launched a series of products. Other pharmaceutical companies that have evaded patents are said to have been disrupted in bioequivalence tests. It is expected that the generic competition will get hotter after February next year. Other generic companies such as Kyung Dong, Sinil, and Shinpoong, which are currently undergoing bioequivalence testing, are predicting to join after February 3, next year, when the trial period ends. According to UBIST, Betmiga's outpatient prescription amounted to ₩65.7 billion last year. Betmiga became a blockbuster drug shortly after its release in October 2015. In 2016, it posted sales of ₩28.8 billion, ₩41.7 billion in 2017, and ₩54.8 billion in 2018.
- Policy
- Copayment of Choline alfoscerate other than dementia is 80%
- by Kim, Jung-Ju Jul 28, 2020 06:36am
- The government's commitment to the re-evaluation of the already listed Choline alfoscerate was clear, and the results of the re-evaluation of Choline alfoscerate, which had strong social demands, eventually ended up maintaining the benefits only for dementia. The government left only the task of applying the revision after making an administrative notice to revise the relevant notice. If it proceeds sequentially, it may be implemented at the end of next month. The MOHW held the 13th general meeting of the Health Insurance Policy Deliberation Committee this afternoon (24th), and proposed and reported the Amendment of the Pharmaceutical reimbursed list and the upper limit table. The Pharmaceutical Benefits Evaluation Committee conducted a deliberation by the Pharmaceuticals Post-Assessment Subcommittee on the 4th of June and the 11th of the Committee, gathered industry opinions such as pharmaceutical companies from the 12th to the 13th of this month, held a round-table meeting with the Pharmaceuticals Association on the 16th In addition to 81 pharmaceutical companies, the Korean Neurological Association, the Korean Neurosurgical Society, and the Pharmaceutical Society for Health Society submitted different opinions surrounding Choline alfoscerate to the HIRA. Pharmaceutical companies generally lowered the copayment for selective benefit from 80% to 50% for brain-related diseases in consideration of social needs ▲submitted severe brain-related disease literature ▲high-priced alternatives had no effect on financial savings ▲Procedure lack of transparency ▲After deriving the results of clinical re-evaluation from the MFDS, it was suggested to adjust insurance benefits. Subsequently, the HIRA hled a subcommittee on the 21st of this month and decided to maintain the re-evaluation and put it up on the 23rd. As a result of the review by the Pharmaceutical Evaluation Committee ▲selective benefit is considered in social needs, but the minimum benefit rate is required because the clinical usefulness is insufficient. ▲The submitted documents are already reviewed as data on patients with dementia that may occur due to stroke, etc. Data ▲ Among 5~6 prescriptions for inexpensive alternative drugs ▲Procedures such as public hearings, deliberation and review of health ratings, and opinions from pharmaceutical companies are undergoing legal procedures. The MOHW plans to announce and revise the proposed amendment to 'a partial revision of Criteria for Adjustment and Method on Reimbursed services' during next month as the report of the Deliberation Committee is completed. In this case, it can be applied even at the end of August. Therefore, according to the government's will, it is expected that the reduction of Choline alfoscerate benefit will be implemented in late August or September. On the other hand, the efficacy of this drug is ▲ secondary symptoms due to cerebrovascular defects and deterioration in memory, confusion, and decreased concentration due to degenerative or degenerative cerebral stromal syndrome ▲ emotional and behavioral changes ▲ sensible pseudodepressiveness, for clinical usefulness. The dementia-related disease with evidence (within the efficacy effect) maintains benefit, and other diseases with insufficient evidence are converted into selective benefit (copayment rate: 30→80%) and reevaluate the appropriateness of reimbursed services for selective benefit after 3 years. Choline alfoscerate has a high rate of increase in claims, but there are social controversies over clinical evidence and are sold as health functional foods in major foreign countries. This ingredient, listed in 2007, has 232 items listed as of May this year. In 2016, it was claimed to be ₩167.6 billion, and in 2019, it exploded to ₩352.5 billion. So far, the National Assembly and civic groups have constantly raised concerns about the abuse of this drug and the appropriateness of insurance benefits.
- Policy
- Multiple myeloma drug Farydak was revoked after approval
- by Lee, Jeong-Hwan Jul 28, 2020 06:33am
- Farydak (Panobinostat), which can be used for patients who have failed to administer Velcade (Bortezomib), was revoked after three years of domestic marketing approval. There are many domestically licensed multiple myeloma medications, and the track listings, such as Risk-Sharing Agreement (RSA), have had an effect on the cancellation of the permit. On the 27th, the MFDS announced that Novartis Korea's approval for three items of 'Farydak capsules 10, 15, and 20 mg' has been revoked. Farydak was approved by the MFDS on February 6, 2017. Farydak is used as a combination therapy of Bortezomib and Dexamethasone in the treatment of patients with multiple myeloma who have previously received at least two treatments, including Bortezomib and an immunomodulatory agent. At the time of marketing approval, Farydak was evaluated as the first drug approved as a 'Histone Deactylase Inhibitor' that restores cellular function in patients with multiple myeloma with epigenetic activity. Nevertheless, the drug was not officially administered because it was not listed for health insurance for three years after the approval, and it was finally canceled. There were 7 multiple myeloma drugs that were marketed in Korea, including Janssen’s Darzalex (Daratumumab), Takeda’s Ninlaro (Ixazomib), Celgene’s Revlimid (Lenalidomide), Pomalyst (Pomalidomide), Amgen’s Kyprolis (Carfilzomib), BMS’ Empliciti (Elotuzumab), and Farydak. Of these, Revlimid, Pomalyst, Kyprolis, and Darzalex are being applied as risk-sharing (RSA) benefits. Empliciti, Farydak, and Ninlaro were not listed, and Farydak was canceled on the list of multiple myeloma drug approvals in Korea. Currently, RSA benefits are excluded from drugs that are considered as alternatives compared to existing drugs. Some point to this as a monopoly on the benefits. Farydak also seemed to lead to withdrawal of permission because it was difficult to launch market
- Company
- MFDS collects acetaminophen to confirm impurity
- by Chon, Seung-Hyun Jul 28, 2020 06:33am
- 식품의약품안전처 전경 The South Korean government is initiating an investigation on impurity contamination in an active pharmaceutical ingredient (API), acetaminophen. As the risk of impurity contamination in API manufactured by a Chinese manufacturer was raised recently, the government started proactively collecting and testing the API used in Korea. If the widely used acetaminophen were to be found with unacceptable level of impurity, the pharmaceutical industry would be unable to avoid a heavy blow. According to pharmaceutical industry sources on July 27, Ministry of Food and Drug Safety (MFDS) has recently visited pharmaceutical companies and taken samples of acetaminophen to confirm the impurity contamination in the API. The government’s action seems to be a follow-up of the concern raised of impurity risk in acetaminophen manufactured and supplied by a Chinese-based bulk pharmaceuticals manufacturer Anqiu Luan Pharmaceutical. A Dutch daily newspaper NRC has reported a few weeks ago that three batches of acetaminophen Anqiu Luan Pharmaceutical manufactured last year have been found with carcinogenic substance, 4-chloroaniline. The substance is apparently genetoxic. Regarding the accusation, Anqiu Luan Pharmaceutical disseminated an official statement to their clients on 15 explaining “4-chloroaniline was not found in the samples from the batch the Dutch client received in the first quarter of last year.” The Chinese manufacturer official said the voluntary investigation result was sent to European Directorate for the Quality of Medicines (EDQM) and elaborated “The acetaminophen manufacturing procedure does not create a chemical condition to generate 4-chloroaniline, and the level of impurity risk can be managed during the procedure.” According to the manufacturer’s explanation, the carcinogen can hardly generate during the acetaminophen API production line. But MFDS presumably has decided to take a deeper look into the API used in Korea to proactively check the impurity risk. Sources confirmed a significant volume of acetaminophen manufactured by the Chinese company has been exported to Korea. MFDS’ Drug Master File (DMF) registration shows that total 100 items of acetaminophen are available in the Korean market. And 20 of the items use API supplied by Anqiu Luan Pharmaceutical. DMF registration of products using acetaminophen manufactured by Anqiu Luan Pharmaceutical (Source: MFDS) If the ministry’s investigation find impurity in Anqiu Luan Pharmaceutical’s API, the impact on the Korean industry would be inevitable. MFDS has reportedly collected acetaminophen manufactured by other Korean and global companies as well. Analgesic substance acetaminophen is widely used in OTC drugs, such as Tylenol, Penzal and Geworin. And for prescription drugs, the API is used in brands like Ultracet. Curretnly, total 120 Korean companies are in the Ultracet market. In worst case scenario, the general Korean pharmaceutical industry would be shaken to the core by the Korean ministry discovering unacceptable level of impurity in acetaminophen. Since the impurity risk incident with valsartan in July 2018, the substance contamination issue has been spreading through ranitidine, nizatidine and metformin. All the incidents started from a foreign country sources addressing an impurity risk in specific pharmaceutical substance, which led to MFDS investigating the collected API and finished products and banning the sales of certain product in the Korean market. This is why the pharmaceutical companies are closely watching the MFDS’ investigation and following actions. MFDS official said, “The ministry is collecting and investigating acetaminophen to proactively confirm the risk of impurity.”
- Policy
- Government “Concerned of COVID-19 vaccine monopolization”
- by Lee, Hye-Kyung Jul 27, 2020 09:41am
- The South Korean government says it is closely following up with international sources to timely access the COVID-19 treatment and vaccine. At a regular briefing on July 23, Kwon Jun-wook, a deputy director of the Central Disease Control Headquarters, said “The disease control authority is paying a close attention to the global cases of COVID-19, because of unpredictable difficulty in accessing COVID-19 treatment and vaccine due to possibility of countries with high number of confirmed cases or pharmaceutical manufacturing countries attempting to monopolize the pharmaceuticals when they are developed.” Deputy Director Kwon added, “The headquarters is following up with the global situation also to strictly evaluate risk and to control special immigration to block off international inbound travelers infecting the local community.” Although remdesivir and some other drugs are currently used as treatment, the director stressed the importance of individual effort to prevent infection until an effective vaccine is available. The deputy director elaborated, “The disease control authority would continue to track confirmed patients and warn people of relying on misguided precautions,” and “the country can manage to have the daily life and disease control at the same time, if we maintain the effort to keep the masks on and follow the correct precautions.” Moreover, the disease control headquarters official mentioned of ongoing R&D. The government is currently collecting the second batch of the outstanding convalescent plasma from nationwide regions including Daegu, Daejeon and Sejong, initially excluded from the first Korea National Health Nutrition Examination Survey (KHANES). When the plasma collection is completed, the antibody count result would be unveiled in late August. The government is also conducting a cosigned research on antibody investigation in 3,300 people from Daegu and Gyeongsan region in August. As of July 23, the number of new COVID-19 confirmed cases in Korea marked 39. Including 20 new cases confirmed from overseas traveler, the accumulated number of confirmed cases reached 13,938. 60 people have been lifted from quarantine, while 883 people are still in quarantine. Total 18 are in serious state requiring intensive care.
- Policy
- Betmiga’s price is temporarily on hold due to lawsuits
- by Kim, Jung-Ju Jul 27, 2020 09:41am
- Betmiga products by Astellas Korea, which are at risk of dropping more than 30%, are temporarily on hold due to lawsuits filed by Astellas. The court decided to keep the price before the adjustment for the time being until the ruling of Betmiga trial is over as requested by the company. The Seoul Administrative Court decided to extend the suspension of the decision on the Betmiga's ruling in the 'Pharmaceutical reimbursed list and the upper limit table (Notification No. 2020-124)' promoted by the MOHW in June. The government lowers the upper limit of the product with the same route, ingredient, and formulation as the first listed product. Originally, the drug was decided to be cut by 30.1% every year due to the adjustment of authority on July 1st. Betmiga 50mg was expected to drop by 30.1% to ₩498 and Betmiga 25mg to ₩332, respectively. the company raised the government's decision, and the court will finally decide. According to the suspension of execution, the drug price of Betmiga 50mg per tablet is ₩712, and Betmiga 25mg per tablet is ₩475. It will remain temporarily until the 30th day from the date of the court decision. The final date has not been set.
