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- 2026-04-15 11:06:06
- Policy
- New standard for Adcetris combination has been established
- by Lee, Hye-Kyung Mar 22, 2021 06:17am
- Takeda's antibody-drug conjugate (ADC) and Adcetris (Brentuximab) are now available in combination with chemotherapy during the first-line administration of patients with non-Hodgkin lymphoma and Hodgkin lymphoma. The HIRA announced on the 17th that the revised bill 'Details on the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients' was released and that opinion inquiry will be conducted by the 25th. The scheduled enforcement date is April 1. The revised bill of this announcement contains the new and changed reimbursement standards for combination therapy including Adcetris, a lymphoma treatment. ◆Non-Hodgkin's lymphoma= It is recognized when Adcetris and chemotherapy drugs (Cyclophosphamide, Doxorubicin, Prednisone) are administered in combination with CD30-positive peripheral T-cell lymphoma that have not been treated before (sALCL). In the case of ALK-positive sALCL, it is possible by limiting to 'IPI (international prognostic index) ≥ 2 points' included in the clinical literature. As a result of reviewing textbooks, there is a mention of a clinical study of Adcetris combination therapy for sALCL, and NCCN recommends ALK-positive sALCL as a preferred regimen category 1A and other peripheral T-cell lymphoma as category 2A. In a randomized phase 3 clinical trial, it was confirmed that progression-free survival was increased as a result of comparison with CHOP (Cyclophosphamide, Doxorubicin, Vinblastine, Prednisone), an alternative therapy. ◆Hodgkin's lymphoma= Adcetris and chemotherapy drugs (Doxorubicin, Vinblastine, Dacarbazine) in combination therapy for stage 3 or 4 Hodgkin lymphoma that have not been treated before are recommended for NCCN. Reflecting the expert opinion that it is difficult to establish objective standards and prove relevance as symptomatic improvement, it was decided to be reimbursed only for 'IPS (international prognostic score) ≥ 4 points'. In the case of non-Hodgkin's lymphoma and Hodgkin's lymphoma combination therapy, it was decided to classify it as a therapy with a risk of febrile neutropenia exceeding 20%, reflecting the NCCN guidelines, related clinical trials (ECHELON-2), and expert opinions.
- Product
- This situation of mixing Lyrica with other doses is absurd
- by Kang, Shin-Kook Mar 22, 2021 06:16am
- When it was confirmed that Pfizer Korea's Lyrica had mixed drugs with different doses, The Korean Pharmaceutical Association urged a countermeasure to prevent recurrence. The KPA(Chairman Dae-eop Kim) made a statement on the 17th, saying, "The case where different doses of pharmaceuticals are mixed & packaging in the bottle is a serious problem that should not exist in the GMP process." "The basics of quality control have not been observed," he pointed out. The KPA said, "The government has achieved success in joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to enhance the international reliability of the quality of domestic drugs, but paradoxically, the management of overseas manufacturing facilities of multinational pharmaceuticals has been neglected. In the year, the quality problems of imported medicines have been constantly being raised.” The KPA said, "As the manufacturing facilities for imported drugs are overseas, it is limited to check the problems of the manufacturing process. It is necessary to prepare intensive measures related to imported drugs, such as expanding due diligence at overseas manufacturing facilities and strengthening customs clearance procedures. As the 20th National Assembly has implemented a registration system for overseas manufacturing companies to strengthen safety management of imported drugs, and amendments to the Pharmaceutical Affairs Act, which established the grounds for taking measures to suspend imports according to the results of local due diligence, thorough supervision and expansion of specialized overseas investigators." In addition, The KPA said that it was necessary to improve the quality of imported drugs and to cooperate in prompt handling of complaints with the suspension of the sale and collection of imported drugs. The MFDS confirmed that Pfizer imported and distributed Lyrica bottles with different doses mixed with medicines, and issued an urgent sales suspension and recall order.
- Company
- Keytruda is expected to expand its indications
- by Eo, Yun-Ho Mar 19, 2021 06:29am
- Keytruda, an immune anticancer drug, is expected to expand its indications for the first-line therapy for colon cancer and esophageal cancer. According to industry sources, MSD Korea recently submitted an application for additional indications about PD-1 inhibitor Keytruda's (Pembrolizumab) ▲MSI-H, microsatellite instability high or dMMR, first-line therapy in patients with advanced colorectal cancer with mismatch repair deficient and ▲ combination therapy of first-line platinum-based chemotherapy drugs for unresectable, locally advanced or metastatic esophageal cancer and gastroesophageal junction cancer (GEJ). The study was conducted in 307 patients with advanced colorectal cancer with MSI-H/dMMR with poor prognosis. Keytruda alone and conventional chemotherapy (5-FU-based therapy ± Bevacizumab or Cetuximab) was compared and evaluated. As a result of the interim analysis, the median follow-up period was 32.4 months, the median progression-free survival (mPFS) of the Keytruda-treated group was 16.5 months, and more than twice that of 8.2 months of the chemotherapy group, and reduced the risk of disease progression and death by 40%. The objective response rate (ORR) was 43.8% in the Keytruda-treated group and 33.1% in the chemotherapy group. In these patients, 83% of the Keytruda-treated group and 35% of the chemotherapy group maintained a response even in the second year. In the case of stomach cancer, the efficacy was proven through the KEYNOTE-590 study. As a result of interim analysis, the combination of Keytruda and platinum-based chemotherapy improved both overall survival (OS) and PFS compared to standard therapy, and passed safety indicators such as duration of response (DOR) and ORR. Keytruda is also in the process of approving indications for first-line therapy for metastatic triple-negative breast cancer (TNBC) in Korea. The effectiveness of Keytruda in triple-negative breast cancer was proven through the KEYNOTE-355 study. In this study, Keytruda improved progression free survival (PFS) and an objective response rate of 53% (17% for complete, 36% for partial) in the entire patient group including patients with poor prognosis who recurred rapidly for more than 6 months.), with a high rate of complete relevance, suggesting the possibility of cure in metastatic triple-negative breast cancer.
- Opinion
- [Reporter’s Eye] For unbiased KPBMA ethics committee
- by Mar 19, 2021 06:28am
- Industry-representing associations are often perplexed among various opinions of businesses of all sizes. Unlike small and medium-sized companies urging the regulation to be versatile for the survival of many companies, large corporations focus more on industry support and advancement. Often, the companies express contrasting opinions on a same regulation. The industry association, supposed to generally cover all member companies, gets into an internal dispute when it loses balance among them. And pharmaceutical industry associations were no exception. When the industry was sensitive with the drug pricing system revision in early 2019, many of small and medium-sized companies talked of collectively leaving the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) as they complained the association has turned its back on the small and medium-sized companies and represented the large corporations’ benefit. The association’s ethics committee has to maintain a fine balance as well. The association consists of 10 committees to research for or deliberate about businesses, and the ethics committee reviews misdemeanor by a member company and takes appropriate disciplinary action. In other words, the penalty on a member company’s misconduct imposed by the ethics committee provides an opportunity for the industry to self-reflect on itself. The committee’s disciplinary action would not hurt a company financially, but it would take a detrimental hit on the corporate image. For instance, the ethics committee imposed a penalty of disqualification on Pharma King for the charge of providing illegal rebate in 2016. The same disciplinary action was taken on Binex and Vivozon lately for manufacturing drugs for not following the authorized label. Since the news broke out on Mar. 8 of the allegation, the association moved fast. On Mar. 11, it issued an official statement that the companies would be “strictly penalized to set an example,” and convened an emergency ethics committee a week after. But the issue with the ethics committee is that it distances itself from consistency. The ethics committee seems to be biased towards small and medium-sized companies, compared against large corporations. Back in October 2019, Dong-A ST was sentenced for illegal rebate and decided to voluntarily leave the association. In the case of Parma King, Binex and Vivozone, the association, which preemptively opened the ethics committee before the results of the trial came out, waited patiently until the Supreme Court sentence was confirmed in the Dong-A ST case. At that time, Dong-A ST was the chairman company of the association. A year after the incident, Dong-A ST rejoined the origination in November 2020. On top of everything, the company was once again designated as a chairman company. Currently, the JW Group, under an investigation for the allegation of providing illegal rebates, is also favored by the association. Some cases of misconduct are dealt by the ethics committee, while others do not. Even for the same issue, smaller scale of misdemeanor faces worse penalty. The reason for the inconsistent standard is because the ethics committee is convened without clear regulations. .Members committing misconduct may or may not be penalized .Reprimanding a member charged with the wrongdoing is also a duty the association has .However, the committee should clarify the grounds when taking a disciplinary action .Only when everyone is on the same page as to when the ethics committee is convened for what kind of misconduct and in what scale, the penalty on the responsible member would be agreeable and acceptable .Based on the precedents, it feels like the ethics committee, firmly conservative on large corporation, tends to open promptly for small and medium-sized companies .Hopefully, the association to become more well-trusted by the pharmaceutical and bio industry and better represent the whole of the industry .
- Policy
- AZ vaccine plan can be updated after reviewing EMA's results
- by Lee, Jeong-Hwan Mar 19, 2021 06:28am
- Commissioner Jeong Eun Kyeong (left) & Rep. Jong-heon Paik KCDA Commissioner Jeong Eun Kyeong said that after reviewing the results of the analysis of side effects such as blood clots of the AstraZeneca COVID-19 vaccine of the EMA, follow-up measures such as discontinuation of vaccination in Korea will be decided. On the 17th, Commissioner Jeong responded to inquiries from the People Power Party of the National Assembly's Health and Welfare Committee, Rep. Paik Jong-heon. Rep. Paik Jong-heon explained that 16 people have died after vaccination against AstraZeneca in Korea. Commissioner Jeong Eun Kyeong, "The domestic case will also be reviewed and decided through an expert deliberation committee" Rep. Paik Jong-heon said, "Since there are 16 deaths after vaccination, we have to start causal analysis directly." KCDA Commissioner Jeong Eun Kyeong said that after reviewing the analysis results of side effects such as blood clots from the European Medicines Regulatory Authority (EMA) they will decide on follow-up measures such as discontinuation of vaccination in Korea. On the 17th, Commissioner Jeong responded to inquiries from the People Power Party of the National Assembly's Health and Welfare Committee, and Rep. Paik Jong-heon. Rep. Paik Jong-heon explained that 16 people have died after AstraZeneca vaccination in Korea. He said that Korea should also initiate a safety test for vaccines or drugs that have been discontinued overseas based on the rules on safety of drugs. He requested that the health authorities do not repeatedly say that the deaths after vaccination with AZ vaccination were simply a non-causal result of worsening the underlying disease, and he asked for a direct investigation of causality. He added, "If The EMA announces that there is a problem with the AstraZeneca vaccination, whether Korea will stop vaccination and initiate an investigation, the domestic drug safety standards are suspended by overseas governments, but if the corresponding measures are taken, the pharmaceutical companies will take measures in the domestic market. The pharmaceutical company should report its domestic action plan to the MFDS." He said, "If the EMA investigation reveals that AZ vaccine is associated with side effects, Korea should also immediately evaluate its safety. Rather than rushing to reveal that there is no problem between the vaccine and the side effects of death, people's trust must be strengthened based on accurate information and standards.," Commissioner Jeong Eun Kyeong said that she would review the analysis results of the EMA and the WHO along with domestic cases, and reflect them in the domestic vaccination plan after going through an expert deliberation committee. She said, "We are aware of the domestic regulations that must be reported to the MFDS in the event of an action taken by a foreign government. We will also review domestic cases and make decisions after reviewing the results of the EMA, the WHO and expert deliberation committee."
- Policy
- AZ and Pfizer COVID-19 vaccines to arrive on Mar. 24
- by Kim, Jung-Ju Mar 19, 2021 06:27am
- The detailed arrival schedule for the COVID-19 vaccines to be supplied this month has been finalized. When the vaccines arrive to South Korea, they would be distributed to 22 inoculation centers around the country, where the vaccines would be used to inoculate elderly citizens aged over 75, and elderly care center occupants and workers from Apr. 1. On Mar. 17, the COVID-19 Vaccination Task Force Team, led by the Korea Disease Control and Prevention Agency (KDCA) Director Jeong Eun-kyeong, has announced the vaccines by AstraZeneca and Pfizer to be used from the second quarter would be dispatched soon from Europe. The 500,000 doses of Pfizer vaccines, the South Korean health authority directly negotiated for, would arrive on Mar. 24. The vaccine has already been approved by the Ministry of Food and Drug Safety (MFDS), and it would be used for inoculation immediately after the fast-track lot release inspection. The outstanding 500,000 doses would be supplied in the last week of March. KDCA official said the vaccines are expected to be supplied to the country in April through May, but more specified dates have not been confirmed. Regarding the batch of AstraZeneca vaccines purchased through COVAX, the UNICEF told the 690,000 doses and 1.41 million doses would be dispatched on Mar. 31 and Apr. 22, respectively, from the Netherlands. Considering the customs processing in Europe and shipping take at least two to three days, the first batch would arrive early April and the latter batch would arrive late April. The COVAX-AstraZeneca vaccines are manufactured at SK Bioscience plant in Andong, South Korea, which was listed for an emergency use drug list by the WHO on Feb. 15. To distribute them consistently, the vaccines would be sent to Europe and supplied back to South Korea. The AstraZeneca vaccine has been authorized MFDS as of last Feb. 10, and the batch arriving soon would be used on occupants of nursing facility aged 65 and over, and the facility workers. Director Jeong Eun-kyeong commented, “To initiate the second-quarter inoculation plan promptly and safely, the government would put utmost care in distribution, storing and preparation for the vaccines coming to South Korea.”
- Policy
- Pfizer vaccine is recommended for seniors 65 and older
- by Lee, Jeong-Hwan Mar 19, 2021 06:27am
- It is suggested that the elderly 65 years of age or older with underlying diseases should be vaccinated with Pfizer vaccine, not AstraZeneca vaccine. Due to the risk of blood clots, some foreign countries, including Europe, have stopped vaccinating AstraZeneca vaccine. The question is whether Korea should also recommend Pfizer vaccination to elderly people. On the 17th, Rep. Jeong-sook Seo of People Power Party made such an inquiry to the MOHW and the KCDA at the plenary meeting of the Health and Welfare Committee of the National Assembly. As of the 15th, some EU countries, such as Italy, Germany, and France, have temporarily suspended AstraZeneca vaccination until the announcement of the EMA due to side effects such as blood clots. In Korea, AstraZeneca vaccination began on the 26th of last month, and more than 570,000 people received the vaccination until the 16th. Among them, 71 cases of anaphylaxis were suspected, 8 cases of serious side effects, and 16 cases of death occurred. Based on this, Rep. Jeong-sook Seo argued that Pfizer vaccination should be recommended to citizens aged 65 or older, taking into account the anxiety of the elderly and those with underlying diseases. She said, "I propose to the government authorities, including Minister Kwon Deok-cheol and Commissioner Jeong Eun Kyeong. Plan to vaccinate Pfizer vaccinations for those over 65." She explained that “the public anxiety and the logic of the health authorities coexist, but death cannot be recovered.” Commissioner Jeong Eun Kyeong announced that she would review the necessity through discussions with domestic experts along with EMA’s result of the causal relationship between AZ vaccine and blood clots. She said, “The EMA announcement was scheduled on the 18th, and we are in real-time discussions with domestic vaccine experts. The causal relationship between the side effects of thrombosis and the vaccine was not confirmed. We will review the European announcement and domestic reality to make a decision.”
- Policy
- Sovaldi's criteria for re-examination are relaxed
- by Lee, Tak-Sun Mar 18, 2021 08:26am
- Re-examination criteria of Sovaldi (Sofosbuvir) and Harvoni (Sofosbuvir-Ledipasvir) by Gilead Science Korea are relaxed. This is because the emergence of new drugs and the continuation of COVID-19 epidemic make it difficult to conduct sufficient usability surveys. Since the recently released hepatitis C treatment can be cured, the number of patients is decreasing. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee held last month decided to reduce the number of cases in the post-marketing investigation plan of Sovaldi and Harvoni. Sovaldi and Harvoni received domestic permits in the second half of 2015, and re-examination ends in September and October of this year respectively. New drugs usually need to be investigated for a certain period of time in order to verify side effects after marketing. In the case of Sovaldi and Harvoni, conditions were imposed to conduct investigations of 3,000 patients each for 6 years. If this is violated, the marketing permission is finally canceled along with administrative disposition. The Central Pharmaceutical Affairs Review Committee concluded that it is reasonable to adjust the number of Sovaldi and Harvoni cases from 3000 to 1840 and 798. The reason is that although the number of patients has rapidly decreased due to the emergence of new drugs and the environment of COVID-19. In the minutes of the Central Pharmaceutical Affairs Review Committee meeting, a member said, "This drug is difficult to register for new subjects due to COVID-19 situation and the decrease in prescription itself as the use of other drugs increases and the number of subjects to be treated decreases.” He said, "The number of investigation cases is insufficient to confirm the incidence of abnormal cases according to the results of the investigation after overseas marketing, but it is judged that the plan revision is inevitable." He added, "We recommend that they submit a PSUR to maintain drug surveillance after the end of the post-marketing investigation." Most of the committee members concluded that it is reasonable to adjust the number of cases considering the environment of this drug. In fact, Sovaldi's market share in 2017 was 62% due to the decline in patients, and last year it was only 2%. Last year's outpatient prescription (UBIST) was only ₩900 million. Harvoni's outpatient prescription sales last year was ₩8.6 billion, down half from the initial launch. Sales of Mavyret are also declining. Mavyret's outpatient prescriptions last year were ₩32.6 billion, down 26.6% from the previous year. The Central Pharmaceutical Affairs Review Committee explained that although the use of Sovaldi and Harvoni has declined, it is still essential for the treatment of Hepatocirrhosis genotypes 2 and 3.
- Company
- The outpatient Rx market is shrinking in this winter
- by Chon, Seung-Hyun Mar 18, 2021 06:22am
- With the winter flu season, the outpatient prescription drug market is shrinking. In January and February of this year, the prescription size decreased by 6% from last year. The outpatient prescription drug market has been sluggish since the end of last year. It is analyzed that the prescription drug market has also been affected by a sharp decline due to the prolonged COVID-19. According to the drug research institute UBIST on the 17th, the cumulative outpatient prescription amount in January and February was ₩2,315 billion, a 6.3% decrease from the same period last year. The prescription amount in January was down 7.0% from the previous year, followed by a 5.6% decline in February. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) In last December, the amount of outpatient prescriptions dropped by more than 5% for three consecutive months after falling 6.0% from the previous year to ₩1,235 billion. Last month's prescription amount was the lowest in two years since February 2019. Compared to previous years, sales in the prescription market in January and February are unusual. In last January and February, prescriptions amounted to ₩2.47 trillion, an increase of 3.4% from the same period last year, and the amount of prescriptions in January and February of 2019 increased by 6.3% from the previous year. Despite COVID-19 variable last year, the prescription drug market generally made good progress, but it has been sluggish since winter. Last year, the total outpatient prescription amount was ₩14,855.9 billion, an increase of 0.2% from the previous year. Until November of last year, the cumulative prescription amount was ₩12,385 billion, an increase of 0.8% from the same period last year, but it has declined since December. 지난해 전체 원외 처방금액은 14조8559억원으로 전년보다 0.2% 증가했다. 지난해 11월까지 누적 처방금액은 12조3850억원으로 작년 같은 기간보다 0.8% 늘었지만 12월부터 하락세로 돌아섰다. Monthly outpatient Rx amount increase/decrease from the previous year (Unit: %, Source: UBIST) Since the spread of COVID-19, it is highly likely that the incidence of infectious diseases has greatly decreased due to reinforced personal hygiene management such as hand washing and wearing a mask, leading to a decrease in visits to medical institutions. Since the end of last year, no flu pandemic warning has been issued this winter. According to The KCDA, the number of suspected flu patients per 1,000 outpatients from week 1 to 8 this year is 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, etc., half of the epidemic standard of 5.8. Compared to 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5 outpatients per 1,000 outpatients during the 1st to 10th week of last year., there have been few cases of flu recently. Number of suspected flu patients per 1,000 outpatients (Unit: # of patient, Source: The KCDA) It is also possible that visits to medical institutions have further decreased as the social distancing stage has been elevated due to the rapid increase in the number of COVID-19 confirmed patients since the end of last year. As more than 300 confirmed cases occurred from November 18 last year, the government raised the social distancing from November 24 to level 2 from the previous level 1.5. From then on, only packaging and delivery were allowed from cafes regardless of business hours, and only packaging and delivery were allowed after 9 o'clock from restaurants. As the number of COVID-19 confirmed rapidly increased, the government raised the social distance in the metropolitan area to level 2.5 from December 8 last year. Accordingly, in the metropolitan area, operations such as singing rooms and indoor sports facilities in addition to the existing five types of entertainment facilities such as entertainment bars were additionally suspended. Shops, marts, department stores, movie theaters, PC cafes, and other facilities that are closely related to daily life must also close after 9 p.m. Despite social distancing campaign, the number of COVID-19 confirmed cases surpassed 1,000 and the Seoul Metropolitan Government implemented a super-precipitation measure that banned ``private gatherings with more than 5 people'' from December 23 last year, and the same measures have been applied across the country afterwards. In this month, social distancing in the metropolitan area was eased to level 2, but Strengthened distancing measures are being implemented, such as “private gatherings for more than 5 people” are still banned.
- Company
- Industry to yet again drive for flexible use of ICER
- by Eo, Yun-Ho Mar 18, 2021 06:20am
- The pharmaceutical industry is to push for the versatile use of incremental cost-effectiveness ratio (ICER). Related industry sources reported, a third meeting for the public-private consultative council to improve the drug pricing would be held on Mar. 19. Director Yang Yoon Seok and Deputy Director Choi Kyung-Ho of Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW), representatives from National Health Insurance Service (NHIS), Health Insurance Review and Assessment Service (HIRA), Korean Research-based Pharmaceutical Industry Association (KRPIA), Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and Korea Biomedicine Industry Association (KoBIA) would participate in the meeting. And KRPIA, representing the multinational pharmaceutical companies in South Korea, is to reiterate the needs to flexibly apply ICER, as the organization has been pursuing the change for a long time. While the healthcare coverage enhancement initiative on pharmaceuticals tends to focus on severe and disease and anticancer treatments, the public is demanding for the expansion of ICER range, which decides the reimbursed pricing (upper limit pricing with healthcare coverage) of increasingly expensive new drugs. Particularly, the ICER in South Korea is quoting GDP in 2013, and the industry is pointing out the value does not reflect the latest trend. Even before the Moon Jae-in Care, ICER on new drug treating severe and rare diseases was double the general new drug, or flexibly applied up to GDP 50 million won (2 ICER). And the industry insists more versatile approach is needed. As of 2019, the industry urges the actual value would be over 2 ICER, or 50 million won. An industry insider noted, “We do not mean the ICER used on adjusting the upper limit pricing should be used for all. Literally, using the ICER ‘flexibly’ would make it feasible. The ICER should be lowered for a mild disease treatment, whereas the value for absolutely necessary treatment should be raised.” But the government and the industry would have to see if they can settle on a middle ground. Although the issue of ICER has been addressed at the National Assembly audit, the government has been maintaining conservative stance. In fact, at the National Assembly audit session for NHIS and HIRA last year, HIRA Kim Sun-min answered, “The accessibility problem with the expensive anticancer treatment is regrettable, but it is socially challenging to make the change.” At the time, he said, “Regarding the ICER, we need to predict the effect of the additional cost. Anticancer treatments recently listed would cost about average of 1 billion won for extending one year of life expectancy. Considering patients other diseases, we need further social consensus and discussions.”
