- by Eo, Yun-Ho Apr 8, 2020 06:24am
The talks on anticancer treatment coverage enhancement has been postponed yet again.
Pharmaceutical industry sources reported the Korean health authority has canceled the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee’s meeting, initially scheduled today on Apr. 8. The government agency plans to push the meeting back two weeks later.
After postponing the Cancer Deliberation Committee meeting from Feb. 26, the schedule has been called off again. Affected pharmaceutical companies are expressing their concerns, now that Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW has been reportedly dispatched to Central Disaster and Safety Countermeasure Headquarters on COVID-19.
The delayed meeting schedule has added more items on the committee’s agenda, and some items were inevitably put off to May agenda depending on their priority level.
Originally, major items like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) were supposed to be deliberated in February.
And in April, the Cancer Committee was supposed to review BMS’ multiple myeloma treatment Revlimid (lenalidomide) and MSD’s immunotherapy Keytruda (pembrolizumab).
A multinational pharmaceutical company official said, “Despite the national emergency, cancer patients are still waiting for their treatment to get listed. Delaying the meeting twice would cause a significant damage. The government should be more considerate of those patients when handling pharmaceutical reimbursement listing and expansion.”
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC).
PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication as a second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application.
Moreover, Revlimid was targeting reimbursement expansion on its maintenance treatment indication as a monotherapy, and Keytruda’s reimbursement expansion application included an indication as a first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also included two new indications&8212;first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel.
- COVID-19 may cause another outbreak with immunization gap
- by Lee, in-bok Apr 8, 2020 06:21am
- The National Immunization Program (NIP) for both children and adult is stepping into an alarming state as a gap in the program is widening while the COVID-19 curve has not been flattened, yet.
The fear of healthcare-associated infection is surging amid the COVID-19 outbreak and many people are avoiding hospital visits as a precaution. But immunization experts are voicing concerns of a secondary impact as COVID-19 bringing down the children’s immunization rate drastically.
Fear of COVID-19 outbreak hindering state-run vaccination program
According to medical industry on Apr. 3 the COVID-19 outbreak has caused a sharp drop in the vaccination rate in Korea compared to last year.
The outbreak-stricken people around the country have started avoiding healthcare institutes as their fear of infection has outweighed the benefits of receiving vaccination.
Including university hospitals, most of hospitals and clinics are basically paralyzed with most of people cancelling the vaccination appointment.
A pediatrics and adolescents doctor at a clinic in Bundang commented, “To tell the truth, the pediatrics are open but without any actual patients visiting and not even for vaccination. Some parents and their children visit hospitals wearing with all kinds of preventive equipment, but we had no one visiting for vaccination in last month.”
“Although the hospital is sending out text messages regarding vaccination schedule to registered contacts, but none of them has showed up on their scheduled dates. Even when outpatients who need follow-up visitation are avoiding university hospitals, who would think of visiting clinics for vaccination?” the director added.
University hospitals continue to provide medical service for patients with severe conditions, but generally all vaccination schedules have fallen through.
A university hospital director in Seoul explained, “As the virus is still spreading across the country, the hospital is strictly controlling incoming visitors with a fever check at entrance and separate doors to pediatrics. We do not allow walk-ins but require an appointment-basis visits and a visitor’s guardian is restricted to only one.”
“All doctors, nurses and even reception staffs are wearing level D PPE at the hospital. Although the hospital is far better prepared than during the past MERS outbreak, fear of infection has taken over the visitors and most of appointments including vaccination are canceled at the moment,” the hospital director said.
Vaccination experts worried over adult vaccination gap firing up a secondary outbreak
The medical experts carefully express their concern over the gap in essential immunization of hepatitis B, BCG, DTap, varicella and MMR.
These diseases could cause cross infection between an adult to a child and vice versa, which could entail another nationwide outbreak.
When the seroprevalence rate of hepatitis in adults in 30s and 40s has fallen under 20 percent, continuous delay in vaccination on all adults and children could start a detrimental outbreak. As the adults with low seroprevalence rate are highly likely to have become parents by now, a whole household with children could be vulnerable to the infection.
An infectious disease expert at a doctor’s association in South Gyeongsang province pointed out, “The seroprevalence rate in Korean adults over the age of 20 is at around 10 percent, because most of them had not received boosting injection. So delayed vaccination in their children could put their whole family in danger.”
Concerns on measles and whooping cough are also high. Many of adults have not had boosting injection for measles vaccines. Whooping cough was close to eradication in Korea, but the immunization rate has been constantly falling due to the lack of public awareness and prevalence rate in Korea climbing up every year.
According to Korea Centers for Disease Control and Prevention (KOEDC), nine cases of whooping cough were reported in 2008 but the number has surpassed 800 in 2018 and 1,000 in 2019.
Since the outbreak in 2018, measles is a high-risk as the nationwide immunization rate has dropped.
An executive director at the Korean Society of Pediatric Infectious Diseases pointed out, “As pertussis is spreading through adults these days, delaying or cancelling vaccination could put many people at a huge risk. Korea is definitely not safe from pertussis.”
The executive director stressed, “At least measles and DTaP vaccination included in the NIP should be done. As polyvalent vaccines with DTaP are available now, public awareness of the vaccines should be raised better”
Accordingly, medical experts argue the government should recognize the state’s widening gap in vaccinations and plan out response actions.
The infectious disease expert from the doctor’s association warned, “The biggest obstacle in the immunization program amid the COVID-19 outbreak is the growing fear of healthcare-associated infection and public health centers unable to provide services. If the current situation is to continue for a long time, the nationwide immunization rate would dip alarmingly, and other infectious disease could start spreading.”
The expert added, “The government should raise awareness of the poor immunization state and related risk to prevent other outbreaks. Families with children, who have missed the vaccination schedule, should look into catch-up immunization schedule immediately.”
- Boots, withdraws from the pharmacy market in 3 years
- by Kim JiEun Apr 8, 2020 06:21am
- 'Boots', which opened ambitiously in Korea, claiming to be a premium health & beauty store, eventually withdrew their business after failing to overcome the continuing sluggish profitability.
According to the industry on the 6th, the company recently decided to withdraw its entire business and closed the recently opened stores.
In 2017, E-Mart received a lot of attention in the H&B market as it landed in Korea by exclusively contracting with Walgreen Boots Alliance, the UK's No.1 H & B store company.
In addition to opening and operating 33 stores only in the year of landing in Korea, it was also differentiated from existing H & B stores based on “Premium”.
However, it was reported that e-mart decided to withdraw its business after failing to overcome the continued deficit and deteriorating profitability. It is also analyzed that the boots that failed to dominate the competition with other H & B stores in Korea are factors that failed.
E-Mart closed 18 boots stores in the first half of last year, and it was confirmed that the six remaining stores were closed in turn following the closing of Starfield COEX and Sinchon stores earlier this year.
With the withdrawal of the boots business, the pharmacies operated by each store were forced to close.
It is known that there are about 6 pharmacies in Boots, 4 of which are now closed, and the other 2 are in business and are in negotiations with the head office.
Boots Star Pharmacy in Starfield Hanam branch also closed on the 5th.
At the time of opening the store, it contracted for a 5-year lease, but the business was withdrawn after 3 years of opening, so the branch could not fill the contract period and stopped operating the pharmacy.
Yong-han Choi, Rph, said the branch had planned to withdraw from business since February, and that road shops were almost closed. Stores and pharmacies were closed on the 5th, when the discount event to remove inventories ended.
Pharmacist Choi said it was unfortunate that the branch was the first pharmacy and could not finish the five-year contract period, and in fact it was closed by a compromise. He added that he plans to rent another store in Starfield Hanam, where he opened the pharmacy independently, and it is just like starting a new one.
- GV1001 developed as a demetia drug, approved for COVID-19
- by Lee, Tak-Sun Apr 8, 2020 06:21am
- The Ministry of Food and Drug Safety approved a new drug candidate 'GV1001' by GemVax, which is being developed as a treatment for dementia, for the purpose of treating COVID-19 patients.
The request for approval for the use of treatment was made by Kyungpook National University Chilgok Hospital.
The MFDS approved the use of GV1001 (Tertomotide HCl), applied by Kyungpook National University Chilgok Hospital on the 3rd, for COVID-19 confirmed patients. Kyungpook National University Chilgok Hospital applied for two cases, and two patients received GV1001.
GemVax, which is developing GV1001, said that GV1001 has applied for a patent related to COVID-19.
GV1001 is a peptide derived from hTERT (Human Telomerase reverse transcriptase). The enzyme telomerase maintains the length of telomere located at the ends of chromosomes, and the treatment has anti-inflammation, anti-oxidation cellular protective effects, as well as anti-cancer effect. GemVax is currently conducting clinical trials to develop Alzheimer's treatments.
GemVax explained that GV1001 proved through preclinical studies to prevent cytokine storms by regulating various inflammatory mediators such as cytokines against severe inflammation caused by COVID-19 infection.
The approval for the use of treatment is a system that enables the use of clinical trial drugs for treatment purposes in order to provide treatment opportunities to patients with life-threatening diseases without other means of treatment.
In other words, it is different from commercialization clinical trials for product approval for large-scale patients, or sponsor-investigator trials conducted by researchers to prove effectiveness or safety. Approval of use for treatment purposes requested by the hospital is permitted for individual patients, and at the time of application by the company, two or more persons are permitted. Therefore, there is not enough data to demonstrate the effectiveness or safety of the therapeutic use.
- Will Rovelito by Handok & Sanofi succeed?
- by Lee, Tak-Sun Apr 7, 2020 06:44am
- Handok & Sanofi-aventis Korea are jointly developing a combination of Irbesartan & Amlodipine, which is antihypertensive drug and are expecting synergy effect between the two companies.
Previously, Sanofi-aventis Korea co-developed Rovelito (Irbesartan-Atorvastatin calcium trihydrate), a new combination drug for hypertension/ hyperlipidemia with Hanmi Pharm. Because it was successful in the market through joint promotions, interest is also gathered in this joint development with Handok.
In a business report reported to the DART of the Financial Supervisory Service on the 30th of last month, Handok signed a license agreement with Sanofi-aventis Korea for the domestic development, manufacture and licensing of antihypertensive combination drug on October 18 last year. The contract ends on October 17, 2029.
The antihypertensive combination drug made by both companies is Aprovasc & CoAprovel. Prior to this, the substance of the combination was revealed through clinical approval from the MFDS on March 4th.
It is a combination drug of ARB-based Irbesartan and CCB-based Amlodipine besylate by Sanofi, and a phase II clinical trial will be conducted to confirm efficacy and safety from a total of 440 people this month to March 2021.
To date, several ARB-CCB combinations are available, but Irbesartan-Amlodipine combinations are not available. Therefore, it is expected that there will be a prescription merit due to product rarity.
In addition, synergies can be doubled if joint marketing is continued between the two companies. Sanofi-aventis Korea has already demonstrated its power through joint marketing of Rovelito with Hanmi Pharm.
Rovelito was also a combination drug developed jointly between the two companies. In 2012, the two companies agreed to jointly develop a new drug that combines Irbesartan and Atorvastatin, and acquired an item license in November 2013 under the name 'Rovelito'.
Last year's outpatient prescription amount (Source: UBIST) for Rovelito was &8361;20.1 billion, and Rovelito pushed out Yuhan's Duo Well (&8361;18.1 billion/Telmisartan-Rosuvastatin) and Daewoong Pharmaceutical Olostar (&8361;12 billion /Olmesartan medoxomil/Rosuvastatin) and holds the No. 1 position in the ARB-statin market.
In the industry, Rovelito is said to be desirable as a combination of foreign pharmaceutical companies and domestic pharmaceutical companies. Therefore, it is paying attention to whether joint development of Sanofi and Handok will succeed.
However, in the case of Rovelito, it was the first product among ARB-statin preparations, so the competition was not severe. The combination of ARB and Amlodipine (including 3 drugs) is not expected to be an easy challenge to the Sanofi-Handok, as there are more than 1,000 licensed products and market competition is fierce.
- President Moon posted a memorial message on SNS
- by Kang, Shin-Kook Apr 7, 2020 06:40am
- On the 4th, President Moon Jae-in expressed his condolences to Ms. A, a medical doctor working in Gyeongsan, Gyeongbuk, infected with COVID-19.
President Moon said through social networking services (SNS), "It was very sad that our infected medical staff was sacrificed for the first time while treating a COVID-19 infected patient."
Mr. A, who ran a private clinicl, died while undergoing treatment after being diagnosed with COVID-19, showing symptoms of pneumonia after treating a COVID-19 confirmed patient in February.
President Moon said he wishes the tranquil rest of the deceased, who was always strict to himself and kind to the patient, and said that the people will be of the same mind and give deep comfort to his family.
In addition, President Moon welcomed the spring of April, saying that he would not be able to tell the sadness of the MD’s family who could not keep his self-isolated state even at the moment of leaving, but he sincerely pay tribute to the medical staff who don't take care of their bodies to overcome the unfinished COVID-19 disease.
President Moon emphasized that aside from his clinic work, the enthusiasm to run for medical care is helping the community overcome COVID-19. and The medical staff is enough to win everyone's respect. "
On the other hand, the KMA also held a time of silence for 1 minute at noon on the 4th to commemorate the deceased MD A.