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- 2025-12-24 12:42:40
- Policy
- CSO expenditure report Act, effective immediately
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The government promulgated the revised Pharmacist Act today (20th), which includes restrictions on co-living and clinical 1+3 of generic and new drugs and mandatory preparation of CSO expenditure reports. In accordance with the revised Pharmaceutical Law, restrictions on 1+3 generic and improvement new drugs and regulations requiring CSOs to be included in the scope of pharmaceutical suppliers and to prepare expenditure reports will be enforced immediately after promulgation. Dailypharm summarized the details and timing of implementation of the revised Pharmacist Act. ◆Limitation of 1+3 on generic and improvement new drugs ◆ The regulation shall be implemented immediately after the announcement to specify data to be submitted when marketing of generic and improvement new drugs. New generics and improvements to obtain marketing permits after today will be subject to restrictions on clinical data. However, the 1+3 regulation was not applied to medicines (IND), which are already undergoing clinical trials. At this time, pharmaceutical companies approved for the clinical trial plan must submit and report to the Minister of Food and Drug Safety within one month from the enforcement date of the revised Pharmaceutical Law, along with evidence that they have decided to jointly develop medicine. In addition, the government decided not to apply 1+3 regulations to the clinical trial data before the enforcement of the revised Pharmaceutical Law. It does not apply regulation retrospectively.(Article 31 (10 through 15) The provisions that prohibit reauthorization and reporting of items less than five years after the date of cancellation of item permits or reports of changes by false or illegal means, and medicines less than three years after the cancellation. (Article 31(16)) ◆Compulsory preparation and submission of CSO expenditure reports ◆ The provisions to include pharmaceutical companies and CSOs entrusted with drug sales promotion tasks to prevent MDs and pharmacists from providing economic benefits such as of January 21 next year. The CSO's regulation requiring preparation and submission of medical and pharmacist expenditure reports and requiring related books and evidence data to be kept for five years will also take effect on January 21st next year. In addition, regulations that allow the Minister of Health and Welfare to conduct a survey on the expenditure reports of pharmaceutical suppliers and announce the results and entrust the work to related institutions or organizations will take effect six months after the promulgation (January 21 next year. The regulation on the disclosure of CSO expenditure reports to the public by an ordinance of the MOHW shall take effect two years after the promulgation, that is, July 21, 2023.(Article 47, Article 47-2, Article 69-4, and Article 95) ◆Designation of Drug Day as National Anniversary =A provision that designates November 18 every year as Drug Day and allows local governments to conduct events, education, and promotional projects or support related group activities shall be implemented immediately. November 18 is expected to be the first day of Drug Day as a national holiday event.(Article 2) ◆Punishment of Rx drug buyers = Regulations that prohibit and punish steroid injections, ephedrine injections, and specialist drugs to consumers who cannot sell drugs such as medicine and pharmacists will also be enforced six months after the date of promulgation. That is, it will take effect on January 21 next year. If the regulation is enforced, consumers who illegally purchase Rx drugs will be fined up to 1 million won, and those who report illegal buyers will be able to pay rewards set by Presidential Decree.(Article 47-4 and 90 and Article 98 (1) 7-3) ◆Expanding the size of the Central Pharmaceutical Review Committee=The provision to increase the number of the Central Pharmaceutical Review Committee, an advisory body of the MOHW and the MFDS, from one to two. ◆Legalization of phase 3 conditional permission system = The provision to upgrade phase 3 conditional quick marketing permission to the Pharmacist Act, which is operated by the notice, shall take effect six months after its promulgation (January 21 next year). It allows the head of the MFDS to quickly approve medicines for serious or rare diseases prescribed by the Act on the Management of Serious or Rare Diseases after a central medical review, and clarified procedures and submissions. Pharmaceutical companies with conditional authorized medicines must check the implementation of the conditions and report them to the head of the MFDS, and the head of the MFDS is allowed to order the implementation of the conditions. If pharmaceutical company that receives conditional permission for facilities and items by fraud or fraudulent means fails to report or fulfills an order to fulfill the conditions, the conditional permission can be revoked. The Pharmaceutical Affairs Act has also raised the provisions related to pharmaceuticals that can be reviewed preferentially for other licensed medicines.(Articles 35 and 35-2 through 6)
- Policy
- Kymriah reimbursement was not discussed at CDRC meeting
- by Lee, Jeong-Hwan Jul 20, 2021 05:47am
- The Korea Leukemia Patients Organization (KLPO) The Korea Leukemia Patients Organization (KLPO) expressed its regrets to the government and Novartis Korea for excluding the first CAR-T treatment Kymriah from the agenda for deliberation at the Review Committee for Cancer Diseases meeting that was held on the 14th. On the 19th, KLPO said, “A disconcerting situation occurred. Kymriah was not even able to enter the first gateway for NHI listing and be put on the agenda for deliberation for the Review Committee for Cancer Diseases meeting. We will fight with the government and Novartis for the reimbursement of Kymriah.” The patient group demanded an explanation from the company and authorities on why Kymriah was not put up as an agenda for deliberation. 4 months had passed since its approval in March but no discussion on its reimbursement has started despite its use of the “approval-benefit appraisal linkage system.” The CAR-T therapy Kymriah is a one-shot personalized gene therapy. 8 out of 10 end-stage acute lymphoblastic leukemia patients and 4 out of 10 end-stage acute lymphoblastic lymphoma patients were found to survive in the long-term with Kymriah. The patient group insisted that the reimbursement discussions need to start as soon as possible as around 200 patients with relapsed or refractory end-stage acute lymphoblastic leukemia or lymphoma die within 3-6 months, KLPO said, “With the issue of reimbursement delays arising due to cost-sharing in ultra-high-priced drugs, we expected the committee to request the company to come up with a reasonable cost-sharing plan. The Ministry of Health and Welfare and Health Insurance Review and Assessment Service needs to explain why Kymriah, a drug in issue for its ultra-high-price rather than its treatment efficacy, was not put on the agenda for deliberation.” “The 6th Review Committee for Cancer Diseases meeting will be held on September 1st. Even if Kymriah is deliberated then, the drug will be listed 2 months later than if it was discussed at the last meeting. The treatment process for life-threatening diseases and the administrative process regarding their financial issues should be considered separately.” “We understand that Kymriah’s NHI listing may become the model for listing ultra-high-priced drugs in Korea and that the government needs to take a careful approach in its reimbursement. However, making excuses that they need the time to review the matter with no preparation in advance for the well-expected ultra-high-priced drug listing issue is negligence on the government’s part.” And as around 30 countries including the U.S. have been using Kymriah, and its treatment is already insured in Japan, KLPO stressed that Kymriah reimbursement should be discussed promptly. Lastly, KLPO added, “In addition to the government, the company also needs to prepare a reasonable cost-sharing plan. We are prepared to fight to our death with the government and Novartis Korea for the prompt benefit listing of Kymriah.”
- Policy
- Pfizer vaccine available in Korea for ages 12 or older
- by Lee, Tak-Sun Jul 20, 2021 05:46am
- Pfizer's COVID-19 vaccine has become available in Korea for people over 12 years of age. The MFDS announced on the 16th that it has approved the change of Comirnaty, which can be used to prevent COVID-19 among people aged 12 and older. The dosage and indications of the vaccine can be diluted once with 0.3ml and inoculated additionally after three weeks, just like the existing 16 years old or older. Pfizer vaccines have also been approved in the United States (May 10, Europe (June 2), Canada (May 5) and Japan (May 31). The MFDS determined that the overall safety was similar to that of those aged 16 or older and was in good condition. In the age of 12–15 years of age, the cases of adverse effects following the inoculation of Comirnaty were similar to those aged 16 and older, with no significant adverse effects. Common adverse effects were injection pain, fatigue, headache, muscle pain, chills, joint pain, and fever, most of the symptoms were mild to moderate and disappeared within days of vaccination. The effectiveness of the 12- to 15-year-olds was sufficient after evaluating the effects of COVID-19 prevention and immune responses. As a result of evaluating the preventive effect of 1,983 people (1,005 vaccine groups and 978 placebo groups) who were not infected with COVID-19 until the 7th after the 2nd vaccination, 0 people in the vaccine group and 16 people in the placebo group showed 100% prevention effect. The virus neutralization test was evaluated on 360 people (12–15 years of age 190, 16–25 years of age 170) who were confirmed not to have been infected with COVID-19 until one month after the second inoculation, and the virus neutralization test met the criteria for ages 16–25 years of age. When comparing immune responses at one month after two inoculations, it met 1.5 times the noninferiority standard. Pfizer vaccines have become available in Korea for people aged 12 and older, but the KDCA has not yet included the age group in the list. Attention is focusing on whether it will be included in the vaccination list after discussions.
- Policy
- Aduhel has been applied for permission in Korea
- by Lee, Tak-Sun Jul 19, 2021 05:56am
- Recently, Aduhel (Aducanumab), a new drug for Alzheimer's disease approved by the U.S. Food and Drug Administration (FDA), has applied for permission in Korea. Aduhel is a new drug for Alzheimer's disease approved by the U.S. FDA in 18 years, the first drug to target the amino acid peptide β-amyloid known to be involved in the disease. The FDA approved after much meandering last month, but controversy still persists. According to industry sources on the 15th, Biogen Korea recently applied for Aduhel's approval from the MFDS. Aduhel was approved by the U.S. Food and Drug Administration on the 7th (local time) on condition that a post-marketing investigation would prove its effectiveness. The FDA determined that Aduhel's therapeutic benefits over risk for Alzheimer's patients. Aduhel did not meet the primary evaluation variables in EMERGE and ENGAGE clinical trial studies. Accordingly, in November last year, the FDA advisory committee decided that there was insufficient evidence to prove its effectiveness. However, Biogen further analyzed the clinical data and applied for approval from the FDA based on validation in the high dose group. Aduhel was approved, but the controversy continues. Three FDA advisors who opposed Aduhel's approval resigned, raising controversy over the appropriateness of the permit. The FDA recently asked the Office of Independent Inspectors (OIG) to investigate Aduhel's approval. Some say that indications may have been reduced as the FDA suggested prescription guidelines and added that patients with mild cognitive impairment or early Alzheimer's should start using Aduhel. The MFDS has been reviewing new drugs approved by the U.S. FDA and European EMA by applying advantage. Therefore, most of them were granted without difficulty. It is expected that Aduhel will not be able to gather consensus during the screening process as controversy continues even after approval. However, it is believed that the demand for new drugs for Alzheimer's disease will be actively reflected in the licensing review. In June last year, Aduhel was approved for clinical 3b in Korea and tested its efficacy on 41 patients.
- Policy
- Once 'out of stock' Bayer Aspirin 100mg to be discontinued
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- Bayer decided to discontinue domestic supply of its antipyretic analgesic, ‘Bayer Aspirin 100mg.’ Despite the company’s explanation that the decision was made due to poor sales, the pharmacys’ eyes are not so kind on the company's decision as they have suffered shortages of stock issues regarding the product. According to the Ministry of Food and Drug Safety on the 15th, Bayer has decided to discontinue the supply of its Bayer Aspirin 100mg tablet on the 31st of this month. Bayer Korea explained, “We made the difficult decision to discontinue import of the product due to a decline in sales. We will discontinue supply with the last import of the product on December 29th last year." However, the company will continue to import and sell the Bayer Aspirin 500mg tablet. The company plans to inform wholesalers and HCPs with an official notice at the time of discontinuation. As the indication, effect, dosage, and regimen of the 100mg and 500mg doses are identical, it seems unlikely that the market withdrawal of the 100mg dose will cause a supply shortage. Bayer Asprin tablets are used to reduce and relieve mild to moderate pain from the common cold and other conditions such as headaches, toothaches, sore throats, menstrual pain, muscle and joint pain, backache, and minor arthritis pain. Patients aged 15 and over may take 500mg~1000mg orally once every 4 hours. As the starting dose is 500mg, it is true that the 100mg tablets are sold less. However, as the dose is increased or reduced according to the patient's age, condition, and symptoms, and a lower dose is required for pediatric patients without an indication, the 100mg tablet does have its use. The Aspirin Protect tab. is also a 100mg product but it has a totally different indication as it is used for the prevention of cardiovascular diseases. Pharmacies have been less trusting of Bayer Aspirin products due to their frequent out-of-stock issues. In particular, in 2017, the company's relocation of its manufacturing plant from Germany from Indonesia had halted sales of the drug for over a year. The company resumed sales in November 2018, but the instability in supply and demand continued with the 100mg product later becoming temporarily out-of-stock. A pharmaceutical industry official said, “The Bayer Aspirin 100mg tablet was out of stock in June, but I didn’t expect the company to stop importing the drug completely. Due to the long-term out-of-stock issue of the 500mg product, I have lingering distrust in the company’s ability to provide a stable supply.” Bayer Aspirin was made by chemist Felix Hoffman in 1897 using acetylsalicylic acid based on a willow bark extract. The product, which has been sold for over 120 years, was released in Korea in 1980. According to IQVIA, the Bayer Aspirin tablet sold around 1.7 billion won in sales in Korea last year.
- Policy
- 2nd AZ·Pfizer·Moderna shot prevents variants by 80%
- by Lee, Hye-Kyung Jul 16, 2021 05:54am
- Study results on the preventive effect of the AstraZeneca, Pfizer, and Moderna vaccine against variants showed that the vaccines had a preventive effect of over 80% after completing the two-dose regimen. The prevention effect was greater against the Alpha variant than the Delta. In preventing symptomatic infections, the vaccines had a similar prevention effect against variants and the original virus. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine and the systemic reaction was at an acceptable level. The National Evidence-based Healthcare Collaborating Agency (NECA, President: Kwang-hyub Han) and the Korean Academy of Medical Sciences (KAMS, President:Ji-Tae Choung) jointly presented the results of the "Rapid review on issues regarding COVID-19 vaccines" study on the 15th. On the preventive effect of the current COVID-19 vaccines against variant strains such as the Alpha, Beta, Gamma, and Delta strains, the vaccines demonstrated a clinically significant effect (prevention of symptomatic infections, hospitalizations, and death). Regarding the preventive effect of the vaccines against variants, the vaccines were slightly less effective against the variants compared to the original virus, but still, the vaccine had a preventive effect of over 80% when subjects completed the two-dose regimen. The vaccines had a stronger preventive effect against the Alpha variant than the Delta. In preventing symptomatic infections, the preventive effect was of the vaccines was at a similar level for variants and the original virus. When completing a single shot of vaccination, the risk of hospitalization and deaths from variant infection was reduced by 78-96%, and after the second shot, by 86-96%. Also, the vaccines' effect on reducing hospitalization and deaths was not largely different against different types of variants, however, the data available as of now were insufficient to discern the severity of the events. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine. Systemic reactions increased after the use of mixed vaccines, but at an acceptable level. On the immunogenicity after receiving mixed vaccinations, the study showed that receiving mixed vaccinations also elicited a neutralizing antibody response against the COVID-19 virus. In general, immune response increased after mixed vaccinations compared to two doses of the AstraZeneca vaccine, and was similar or higher than that measured after two doses of an mRNA vaccine (Pfizer, Moderna). The mixed vaccination had increased systemic response compared to two doses of the same vaccine, but was tolerable and at an acceptable level. However, as only short-term safety studies existed on mixed vaccination, it was difficult to evaluate the adverse events that have a low incidence using studies based on the current scale. The mixed vaccination regimen had increased immune response against the variants compared to two shots of the AstraZeneca vaccine and had an increased or reduced effect compared to two shots of the Pfizer vaccine, depending on the type of variant. But the limitation was that only small-scale studies with limited results existed for review. No direct studies on preventing infections were available and only studies with immunogenicity results existed for review. Mi-young Choi, head of Clinical Evidence Research Team at NECA said, “This study was the first systemic literature review conducted on the use of mixed dose vaccinations and activities against the variant strains. As most of the reviewed literature were studies in progress or unpublished, quantitative and qualitative limitations do exist in our study.” KAMS Policy Director Ho-kee Yum (Chair of the Expert Committee for COVID-19 Response, Korean Medical Association) said, "We can predict and respond to new infectious diseases to a certain extent by studying existing clinical data. I believe the release of reliable study results from a medical society and the government like this will contribute greatly to reducing the public anxiety that has been rising recently and in overcoming the pandemic.”
- Policy
- Patients with SCLS shouldn't get Janssen vaccine
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- The MFDS said Janssen COVID-19 vaccine should not be vaccinated for people with a history of Systemic Capillary Leak Syndrome (SCLS). This is in accordance with the European EMA recommendation and is similar to the action that was taken on the AstraZeneca vaccine on the 14th of last month. The MFDS released the Dear Healthcare Professional Letter on the 12th. EMA's PRAC announced that Systemic Capillary Leak Syndrome should be added as a new side effect of the Janssen vaccine. It reviewed three cases of Systemic Capillary Leak Syndrome in Janssen COVID-19 vaccine recipients, one with a history of Systemic Capillary Leak Syndrome and two with fatalities. Systemic Capillary Leak Syndrome is a rare and serious condition that causes fluid leakage in small blood vessels (moscevascular), mainly resulting in edema in arms and legs, hypoglycemia, blood concentration, and hypoglycemia (critical blood protein). The MFDS said it will add related precautions to the manual by compiling the current status and safety information at home and abroad, stressing that people with a history of Systemic Capillary Leak Syndrome should not be vaccinated against Janssen vaccine.
- Policy
- Generic for Galvusmet was first approved
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- The timing of the sale varies depending on the results of the Supreme Court's lawsuit against the validity of the patent. Hanmi has been approved for the first time in Korea as a generic for Galvusmet, a diabetes complex affiliated with Novartis' DPP-4 inhibitor. Hanmi developed Vildagliptin HCl and licensed both single and multi-drugs including Vilagliptin. Attention is focusing on whether it will preoccupy markets as it has made efforts to commercialize them early. The MFDS approved Hanmi's Metformin HCl-Vildagliptin HCl. Vildaglmet is the first generic for Galvusmet to be licensed in March 2008. It contains the same Vildagliptin HCl as the single Vildagle approved by Hanmi in February this year. The original Galvusmet is a salt-free Vildagliptin. Vildaglmet is the first licensed Galvusmet in Korea, so it is likely to be released first in the market. Material patent of Vildagle can be released earlier than other companies. The material patent expires on 4 March 2022. An-Gook and Hanmi have reduced the term of 187 days on the Intel Property Trial and Appeal Board and 55 days on the Patent Court through a lawsuit against the extension of the patent. It was shortened in the second trial. If the Patent Court cites the Intellectual Property Trial and Appeal Board's verdict, both companies' products can be released within the year and can be released next year according to the Patent Court. However, the Supreme Court may not recognize the claim for invalidation of the extension. If Supreme Court accepts the an extension of patent term, Ahn-Gook and Hanmi, which filed a patent suit, can be the first to put the product on the market before other companies. Hanmi can release both products at the same time because both single and comination drugs are licensed. This is because all patents related to compound drugs have been avoided. Hanmi has experience in co-selling Galvus with Novartis from 2014 to 2016. After the expiration of the copromotion, Hanmi worked on generic development and set up a strategy to preoccupy the market. It sought early release only with permission for efficacy and effects that did not violate patents, but lost a patent lawsuit. Since then, the product has been withdrawn. Outpatient prescription for Galvus and Galvusmet amounts to ₩8.1 billion and ₩36.4 billion, respectively. Hanmi does not have DPP-4 inhibitors. Therefore, early release of Vildagle and Vildaglmet is expected to expand in the diabetes market.
- Policy
- Kymriah's benefit is urgently needed
- by Lee, Jeong-Hwan Jul 15, 2021 07:07pm
- Leukemia patients have urged rapid health insurance registration of the first end-stage leukemia-Lymphoma CAR-T treatment, Kymriah. Korea Leukmia patients organization asked the government to register Kymriah's benefit and pharmaceutical companies to come up with reasonable financial burdens to strengthen access to medicines for leukemia patients. In a statement, the Korea Leukemia patients organization repeatedly called on the government to push for rapid health insurance benefits, including the introduction of Kymriah, at the fifth Cancer Drugs Benefit Appraisal Committee to be held on the 14th. The organization called for a rapid health insurance registration system for new drugs directly linked to life, such as Kymriah. It also added that Novartis Korea should come up with reasonable financial sharing measures to prevent the recurrence of some immuno-cancer drugs, which have delayed health insurance benefits due to controversy over high-dose financial sharing. "Even if Kymriah is passed at the Cancer Drugs Benefit Appraisal Committee on the 14th, the health insurance benefit will not be completed until November this year at the earliest because the NHIS' negotiations and health insurance policy committee procedures are required," said the Korea Leukemia patients organization. It said, "Most patients with recurrent or end-stage acute lymphocytic leukemia or lymphoma die within three to six months. If Kymriah is covered by health insurance in November, many of the 200 patients expected to be treated annually." It said, "It is a pity that patients who cannot afford to pay about 460 million won (non-reimbursed medical expenses disclosed on Samsung Medical Center's website) have to die while waiting for health insurance to be applied." "The government should complete health care benefits within six to seven months, just like Leclaza, the late-stage lung cancer treatment," the organization said. The organization said, "In the case of Kymriah, the scope of 'new drugs directly related to life' should be determined through social discussions, and health insurance should be applied first by the HIRA." The organization also said that "the HIRA's Cancer Drugs Benefit Advisory Committee, the NHIS' Pharmacological Benefit Advice Committee, and the Health Insurance Policy Committee will take the lead." "Glibec, the world's first targeted treatment for chronic myeloid leukemia, was approved by the MFDS on June 20, 40 days after the FDA approved it in May 2001. "In November, five months after the approval, the MOHW announced health insurance benefits. Twenty years later, the Kymriah process should not be delayed than Glivec. "Since August 30, 2017, when Kymria was approved by the U.S. FDA, the issue of high-priced drug prices has been raised."
- Policy
- Benefit plan of Keytruda & Tecentriq will be discussed
- by Moon, sung-ho Jul 13, 2021 11:08pm
- Keytruda (Pembrolizumab) and Tecentriq (Atezolizumab) from global pharmaceutical companies are challenging to expand their benefits as primary drugs for lung cancer. According to the pharmaceutical industry and the medical community on the 10th, the HIRA's Cancer Drugs Benefit Apparel Committee will discuss ways to expand the benefits of the two drugs at its fifth meeting in 2021. In the case of MSD Korea's Keytruda, five benefit expansion proposals were proposed at the fourth Cancer Drugs Benefit Appraisal Committee meeting in May, and two of them were passed. Benefit needs for urinary epithelial cancer secondary therapy and Hodgkin's lymphoma non-responsive secondary and recurrent fourth or higher therapy were acknowledged. Three strongly desired primary care treatments for lung cancer have been put on hold ▲ Primary treatment of progressive non-small cell lung cancer positive to PD-L1 and free from EGFR or ALK mutations (Solo therapy)▲ Primary treatment of metastatic non-flat cell lung cancer without EGFR or ALK mutation (Combination of Pmetrexed and Platinum)▲Transferable squamous non-small cell lung cancer primary treatment (Parclitaxel/Carboplatin combination). The government has put on hold all the expansion of benefits to primary treatments, which require a lot of funding for health insurance, and analysts say it did not recognize the financial sharing plan proposed by MSD. The Cancer Drugs Benefit Appraisal Committee will discuss expanding the benefit of rival drug Roche Korea's Tecentriq at its fifth meeting scheduled to take place on the 14th. According to a senior official at the Cancer Drugs Benefit Appraisal Committee, it was originally planned to be discussed with Tecentriq in this order regardless of Keytruda's introduction to the conference. In a related development, Roche Korea is said to have applied for Tecentriq (Atezolizumab)'s first solo treatment for non-small cell lung cancer shortly after obtaining a certificate of adaptation in April. Not only the pharmaceutical industry but also the medical community are watching this with interest. The ministry also suggested Keytruda be discussed at the Cancer Drugs Benefit Appraisal Committee in July. According to the report, members of the Cancer Drugs Benefit Appraisal Committee believe that Tecentriq's initial treatment financial sharing plan in the past would be the basis for benefit expansion. Health authorities estimate that refunds of initial treatments are equivalent to 25 to 30% of the effect of a reduction in drug prices. It seems impossible to increase benefit unless the pharmaceutical company presents another corresponding sharing plan. "An analysis of Roche's initial financial sharing plan has shown tremendous effect in terms of health insurance finance," said a member of the Cancer Drugs Benefit Appraisal Committee. "Based on clinical trials, the application of three of the nine cycles as a way for pharmaceutical companies to share, actually has a significant cost-cutting effect," he explained. "Moreover, real world data is difficult to produce the efficacy and effectiveness of drugs equivalent to clinical trials. "Like clinical trials, pharmaceutical companies pay for three cycles for drugs that only work for seven weeks, not nine." "The latecomers should come up with corresponding measures, given that the starter accepted the benefit at the expense of considerable damage," he stressed. Another concern is whether combination therapy of Keytruda and Tecentriq will be passed. This is due to Avastin (Bevacizumab), which also affects the patent expiration. The Cancer Drugs Benefit Appraisal Committee is also interested in which of Keytruda's and Tecentriq's primary use of lung cancer can be more effective. "No matter how much Tecentriq lowers its price, Avastin makes it difficult to match Keytruda's combination therapy," said a member of the Cancer Drugs Benefit Apparel Committee. "In the end, we have no choice but to determine which of the two combination therapies can contribute to insurance."
