- LOGIN
- MemberShip
- 2026-05-09 20:39:27
- Policy
- Asan Medical Center to test Kaletra's effect on COVID-19
- by Lee, Tak-Sun Mar 24, 2020 05:19am
- An investigator-sponsored trial (IST) in Korea is in preparation to confirm efficacy of Kaletra and hydroxychloroquine in patients with mild case of COVID-19. On Mar. 20, Korea’s Ministry of Food and Drug Safety (MFDS) has granted an approval on an IST protocol submitted by Seoul Asan Medical Center. The protocol is on open-label, randomized controlled clinical trial among AbbVie’s HIV treatment Kaletra tablet (lopinavir and ritonavir), Elyson Pharm’s malaria treatment Oxiklorin tablet (hydroxychloroquine sulfate) and placebo in patients with mild case of COVID-19 infection. The two drugs are already used in the medical field to treat patients with COVID-19, but the trial is to properly confirm safety and efficacy of those drugs. Central Institutional Review Board (Central IRB) presented COVID-19 treatment guidance on Feb. 13 and recommended using two tablets of Kaletra twice-daily, or 400 mg of hydroxychloroquine as a first-line treatment. However, the medical experts started claiming Kaletra’s efficacy on COVID-19 should be tested as some overseas studies could not confirm the treatment effect. Researchers from Chinese clinical trial centers and University of Oxford, the U.K., have co-conducted a randomized, controlled, open-label trial in 199 confirmed cases of COVID-19 in China, and found 99 patients who received Kaletra and standard of care simultaneously and 100 patients who only received standard of care showed no meaningful difference. Mortality rate for the Kaletra group was at 19.2 percent, whereas the standard-care group was at 25.0 percent. Although there was a gap, statistically speaking the gap was insignificant. Hydroxychloroquine has been controversial recently as the U.S. President Donald Trump has said on Mar. 19 that it received Food and Drug Administration’s (FDA) approval as a COVID-19 treatment, but FDA official soon clarified it was an incorrect information.
- Policy
- DNA vaccine for COVID-19, what are the complications?
- by Lee, Tak-Sun Mar 24, 2020 05:19am
- As the U.S. and China have initiated their clinical trials on COVID-19 vaccines, the public is keen on when Korea would start its vaccine commercialization process. The vaccine currently in the clinical trial phase is a DNA vaccine. The type of vaccine is developed by artificially replicating a part of infectious agent, which makes the development process relatively easier with ensured safety. But because no DNA vaccine has been commercialized for human so far, demonstrating its efficacy would be the crucial key. According to the industry on Mar. 20, the Korean government is in process of discussing with pharmaceutical companies about initiating a COVID-19 vaccine clinical trial. And DNA vaccine is showing the fastest progress at the moment. Among all candidates, a DNA vaccine named ‘GX-19’ seems to be the most likely candidate. Genexine has recently partnered with BINEX, a clinical pharmaceutical CMO, to develop a vaccine. GenNBio, a transplantation specialist company, would be in charge of non-clinical trial in primates to confirm efficacy and safety. The consortium of these companies is aiming to submit the Investigational New Drug (IND) in coming June. The Ministry of Food and Drug Safety (MFDS) plans to expedite the review on the submitted IND. The key is the vaccine’s proven efficacy. MFDS stated sufficient data set is required for an expedited IND review. “Prophylaxis against COVID-19 has to be proven in animal trial or at least in a laboratory setting. Because a vaccine has to be used on human, its efficacy and safety has to be confirmed even before running a full-on clinical trial,” MFDS official said. Apparently, DNA vaccine’s prophylaxis has been confirmed against MERS, another type of coronavirus. However, MFDS explains there has not been data confirming the prophylaxis of the vaccine against COVID-19. Due to the ministry’s requirement, some are skeptical that the clinical trial would start around June or July as planned. The U.S. and China are also accelerating the DNA vaccine development. In the U.S., Moderna Therapeutics’ DNA vaccine, ‘mRNA-1273,’ started its clinical trial from Mar. 16. The U.S.-based company is shooting for commercialization in June 2021. The Chinese state broadcaster CCTV reported Major General Chen Wei’s research team, associated under the Academy of Military Medical Sciences (AMMS), has been approved to conduct a clinical trial on their investigational vaccine. Sources report Major General Chen Wei’s research team has an experience in developing an Ebola vaccine, and both of their Ebola and COVID-19 vaccines are based on DNA. Although the two investigational vaccines’ had their clinical protocols approved through fast-track review with minimized animal testing, the public is raising issues with safety. Sources reported the Korean health authority has not received any inquiry about a clinical trial on Moderna’s or Major General Chen Wei team’s vaccines. The generic style of vaccine development takes longer time than artificially made DNA vaccine, as it has to cultivate a natural form of either virus of cell. However, pharmaceutical companies and health authorities around the world are conservative about conducting clinical trial on DNA vaccine against COVID-19 as not many cases of the vaccine type have been commercialized. Korea’s top vaccine makers like GC Pharma and SK Bioscience have started a research on vaccine commercialization. SK Bioscience is working on developing protein-based subunit vaccine and viral vector vaccine. The Korean company is also in development of ‘vaccine platform’ that could prevent infection from MERS, SARS and COVID-19. GC Pharma has discovered candidate substance from protein found on the surface coronavirus, which the company would be able to mass-produce by using the generic recombinant technology. MFDS official said, “The ministry is having ongoing discussions not only with pharmaceutical companies, but also with ventures developing vaccines. Based on positive data of prophylaxis against COVID-19, the ministry would expedite the review process.”
- Policy
- Price of Roche's Herceptin 150mg (Trastuzumab) falls 8.1%
- by Kim, Jung-Ju Mar 24, 2020 05:18am
- Korea Roche's blockbuster anticancer drug Herceptin 150mg (Trastuzumab) is being added, and the insurance premium will be reduced by more than 8% starting next month. Nelson Pharm's Bedesta cream and Ahn-gook Pharm's Saerogenta cream fell 25.4% each due to governmental adjustment. There are a total of 23 drugs falling due to authority adjustment. AbbVie’s Synagis (Palivizumab) will be voluntarily cut of 1% for each content and item. According to a related industry on the 19th, the MOHW is promoting the revision of the 'pharmaceutical reimbursed list & the upper limit on reimbursements'. Once the revision is confirmed, it will take effect on April 1st. ◆Additional point maintenance and termination = Two items were determined to be maintained on the 1st of next month, and 1 item for items that have been closed. The government maintains additional points until the number of companies are more than 4, if one year has elapsed since the first generic was registered, but the number of companies with the same product is 3 or less. Generics that are listed after one year has elapsed from the first generic registration date are not added. First of all, Myungin Acamprosate 333mg Tablet is increased by 11.1% from ￦135 to ￦150. Whanin Acamprosate Tablet also rises 30.4% from ￦135 to ￦176. On the other hand, Roche's Herceptin 150mg (Trastuzumab) falls 8.1% from ￦394,298 to ￦362,340 after the addition period ends. ◆Authority adjustment and addition termination of authority adjustment items= 23 items of cuts in authority adjustment as of the 1st of next month, and 9 items that had been added were cut by the adjustment and then dropped again at the end of the addition. When the generic is registered, the government directly regulates the upper limit of the first listed product and the product with the same administration route, ingredients, and formulation as the first listed product. In addition, for the first year from the date the first generic was registered, the first listed product is added (or maintained) at 70%, and then the additional point is ended. However, even if one year has elapsed, if the number of companies with the same product is 3 or less, the addition is maintained until 4 or more. First, among the 23 items falling by the authority adjustment, Tronain cream 450g dropped by 12% from ￦22,500 to ￦19,800, and JW shinyak's Panaderm cream fell by 18.5% from ￦24,300 to ￦19,800. Nelson's Bedestar cream 450g fell 25.4% from ￦26,550 to ￦19,800, Bedestar cream 30g from ￦1,770 to ￦1,320, and Ahn-gook's Saerogenta cream from ￦26,550 to ￦19,800. Some products that have been added have dropped due to the adjustment, and some products have been dropped after the addition period has expired. CJ Healthcare’s Almarl 10mg tablet (Arotinolol HCl) from ￦320 to ￦280 from April 1st, Almarl 5mg from ￦207 to ￦182, 12.5% and 12.1%, respectively, will be reduced. As of March 1, next year, the addition will be over and Almarl 10mg will be dropped by ￦214 and Almarl 5mg will be dropped by 23.6% to ￦139 again. As of April 1, Hanmi Urea cream 50g fell from ￦2,495 to ￦2,157, and Hanmi Urea cream 450g from ￦22,472 to ￦19,412, by 13.5% and 13.6% respectively. It is lowered by adjustment, as of March 1, next year, Hanmi Urea cream 50g will be dropped from ￦2,157 to ￦1,650 again, and Hanmi Urea cream 450g will be dropped from ￦19,412 to ￦14,850, by 23.5%. ◆Voluntary price cut = 9 items in which the drug price goes down by the company itself. The government lowers the price by calculating the amount of the application if a manufacturer, consignment manufacturer, seller or importer applies for a lower price at an amount lower than the upper limit of the drug registered in the company's circumstances such as marketing or market share By each item, AbbVie Korea’s Synagis inj fall by 1% by content. For the item, Synagis 50mg will be cut from ￦541,531 to ￦536,116. Synagis 100mg drops from ￦932,996 to ￦923,666 respectively. Hyundai's Uremin 0.1mg (Desmopressin acetate) falls 0.8% from ￦735 to ￦729, and Uremin 0.2mg falls 0.5% from ￦1,136 to ￦1,130. ◆Make up for cost of shortage prevention drugs= 2 items are designated as shortage prevention drugs for cost preservation and 3 items that increase the price. The government has designated drugs that are essential for patient care, but do not have payability, so manufacturers, consignment manufacturers, and importers avoid production or imports and require production or import cost preservation as shortage prevention drugs to conserve costs. Shortage prevention drugs are determined in accordance with the criteria such as: ▲Designation of cost preservation ▲ Adjustment of the upper limit of production cost preservation items ▲ Designation of cost preservation and adjustment of upper limit. First, the production cost preservation items are SK Plasma’s Hepabulin SN (for intravenous hepatitis B human immunoglobulin) and Hepabig inj by Green Cross (for intravenous hepatitis B human immunoglobulin). There are two drugs that raise the upper limit as a production cost preservation item. Celltrion Oxymetholone’s price is raised 20.7% from ￦588 to ￦710 next month. Yuyu ‘s Lincocin 500mg capsule (Lincomycin HCl) will be increased by 13.6% from ￦184 to ￦209. Some drugs are designated as cost-preserving products and have an upper limit. Bukwang's Holoxan 1000mg (Ifosfamide) is raised by 28.5% from ￦12,275 to ￦ 15,779.
- Policy
- Neutropenia is common in children when taking Entecavir
- by Lee, Tak-Sun Mar 23, 2020 06:27am
- Baraclude (Generic: Entecavir)The MFDS has begun to change the license because there have been reports of Neutropenia in pediatric clinical trials of Entecavir, one of hepatitis B treatment. Neutrophils are a type of white blood cells that are granulocytes responsible for the body's immunity. The MFDS announced on the 20th that it is reported that Neutropenia is very common (1 out of 10) in pediatric subjects' clinical trials in Entecavir formulations, and that they are listening to opinions from companies according to the permission change. The safety information came from the European Agency for Medicine (EMA). Based on the information, the Ministry of Food and Drug Safety plans to add to the item of 'extreme adverse reactions-Neutropenia reported very frequently (≥1 / 10)' in pediatric subjects. The pediatric clinical trial indicated in the permit was 195 HBeAg-positive subjects who were treated with this drug for a median duration of 99 weeks. Existing permits included "The adverse drug reactions reported in more than 1% of pediatric subjects included abdominal pain, rash, poor taste, nausea, diarrhea, and vomiting". It is added that "very common (≥1/10) neutrophil reductions have been reported". Entecavir is the most commonly prescribed drug with Tenofovir among hepatitis B treatments. Baraclude by BMS, the original drug for Entecavir, recorded an outpatient prescription amount of ￦71.4 billion last year (Source:UBIST). There are also a number of generic drugs on the market, and 128 items (of 63 companies) are currently licensed. The MFDS instructed related companies to submit the reason and supporting data if there was a review opinion by the related companies by April 6th.
- Policy
- IMD Vildagle to receive reimbursed price of KRW 403
- by Kim, Jung-Ju Mar 23, 2020 06:27am
- Hanmi Pharmaceutical’s dipeptidyl peptidase-4 (DPP-4) inhibiting diabetic treatment Vildagle 50 mg tablet (vildagliptin hydrochloride) would receive health insurance reimbursement from next month. The treatment is an incrementally modified drug (IMD) of Galvus tablet (vildagliptin) that evaded the original’s patent, and it would be listed at a price range of 400 won per tablet. The reimbursed price of Boryung Pharmaceutical’s Pacitol injection (paricalcitol) would be dropped by over 21 percent when its premium pricing period ends in March last year. According to the pharmaceutical industry on Mar. 18, Korea’s Ministry of Health and Welfare (MOHW) is in process of amending the ‘List of Reimbursed Drugs and Maximum Price’ with the said changes. The revision would come in effect from Apr. 1. ◆ Drug listed with maximum price of target product profile (TPP): Hanmi Pharmaceutical’s Vildagle 50 mg tablet would receive reimbursement from next month. Unlike the original Galvus, the IMD has hydrochloride base other than the active ingredient vildagliptin, which was the key to evade the patent. And apparently the IMD has one less indication than the original of ‘using combination therapy when blood sugar level is uncontrollable with sulfonylureas, metformin or thiazolidinediones monotherapy.’ As the drug is on condition to submit evidential data, the ministry is predicted to price the drug at 403 won, or at 90 percent of the TPP. In case the TPP or same-substance drug is not on the list of reimbursed drug, the drugs to submit evidential data but approved as an IMD or as a new formulation would be priced at 90 percent of the TPP. ◆ License-withdrawn items: From next month, total 29 items would be unlisted for reimbursement with their companies voluntarily withdrawing the item license. According to the Pharmaceutical Affairs Act, MOHW is to immediately remove reimbursement on a listed drug which the license is voluntarily returning by its company to Ministry of Food and Drug Safety due to an internal issue. Pharmaceutical companies choose to terminate license on an items as a survival strategy, or for sales or marketability issues. Some of them include Leucokain injection by CJ HealthCare, Montelu V tablet by LG Chem, Solifenocil tablet by Mothers Pharm and Daviroad tablet by GC Pharma. ◆ Pricing reduction after pricing benefit period: The pricing reduction rate for first generics, currently priced with weighted pricing benefit for a year, has been calculated. One of the big names is Boryung Pharmaceutical’s Pacitol injection (paricalcitol). Its price would be adjusted to 53.55 percent of the first-in-class, and it would maintain the price of 15,309 won for one year, until Mar. 31 next year, with the pricing benefit for the Innovative Pharmaceutical Company added. However, the government sustains the pricing benefit until the number of same-substance generic makers is three or less. From Apr. 1 next year, the drug would be priced at 12,056 won with 21.2 percent drop. The pricing benefit on DHP Korea’s Bromonac eye drops (bromfenac sodium hydrate) would also be stripped off from Dec. 31, and its price would be reduced from the beginning of next year. The drug receives weighted pricing of 59.5 percent of the original’s price for a year from the point when the first generic is listed. The pricing benefit would be maintained until the number of same-substance generic makers is three or less. After the pricing benefit period, the eye drop’s price would fall from 1,829 won to 1,646 won by 10 percent. Eight other drugs’ pricing would be lowered by 10 percent when the benefit period expires. These drugs receive pricing benefit of 59.5 percent of the maximum price for a year from the point when the first generic is listed. The benefit would last until the number of same-substance generic makers becomes four or more. The pricing benefit on KMS Pharm’s Elqueenxaban would be dropped from May 31, and the benefits on Union Korea’s Union Rasagiline, Korea Prime Pharm’s Rasat, Korea Pharma’s Pharma Rasagiline, Celltrion’s Cellpaline would be expired from Jan. 31 next year. From then on, their pricing would be reduced by 10 percent.
- Policy
- Revised generic reimbursement regulation to get delayed
- by Lee, Hye-Kyung Mar 23, 2020 06:27am
- Apparently, the postponed action plan on the revised reimbursed generic pricing management, covering all procedures of the listing, would also likely to affect drug pricing negotiation schedule. As the Korea’s Ministry of Health and Welfare (MOHW) is preoccupied with response against COVID-19 outbreak and the main division director’s position still open, the preannouncement of revising ‘Regulation on National Health Insurance Reimbursement Standard’ is getting delayed. The National Health Insurance Service (NHIS), in charge of drug pricing negotiation, has been processing the legislative preannouncement with the government to apply the pricing negotiation terms, previously used on new drug and price-volume linkage system, on generic products as well. A draft of the preannouncement briefly posted on the Ministry of Government Legislation website in February stipulated generic exempted from pricing negotiation for reimbursement listing would be subjected to pricing negotiation track. A pharmaceutical company with generic product has to undertake pre-agreement terms with NHIS on negotiation and agreement compliance when applying for reimbursement to Health Insurance Review and Assessment Service (HIRA). When HIRA completes drug pricing calculation, the applicant company has to negotiate pricing with NHIS for 60 days before the Health Insurance Policy Deliberation Committee (HIPDC) deliberation. The initial plan was to pre-announce the revised regulation and to accept public opinion from February to April, and to start the pricing negation from June. As the negotiation takes at least about 60 days, NHIS had to create a legal foundation before the revised generic pricing system was enforced. However, NHIS’ plan to initiate the generic pricing negotiation by the end of June would be postponed as the legislative preannouncement has not been issued, yet. The NHIS’ key roadmap of the year originally aimed to finish off designing generic negotiation agreement and compliance management task process until coming May with the Generic Negotiation Management Task Force formed under NHIS Health Benefit Strategy Office in January, and also to start drug pricing negotiation and negotiation agreement compliance monitoring in June and July, respectively.
- Policy
- The Review Committee for Cancer Diseases postponed again
- by Kim, Jung-Ju Mar 20, 2020 06:27am
- COVID-19 crisis that spread around the world is prolonged and the face-to-face meeting of the Review and Assessment Committees within HIRA is also changing by choosing the second-best solution. Last month and this month, when the spread of infectious diseases in Korea was at the forefront, once it was postponed or canceled, it was no longer possible to postpone the reimbursement-related discussions. After the health policy deliberlate committee schedule was canceled this month, the affiliated committees were confirmed to have adopted a written or postponed method according to government policies. If the health policy deliberlate committee is the top legislative organization for health insurance, the sub-committees are specialized deliberations by field to introduce the health policy deliberlate committee. These committees, which examine, evaluate and deliberate on pharmaceuticals and medical practices, are under the HIRA, and have specialized discussions in each field. There are a total of seven committees, including the Pharmaceutical Benefits Advisory Committee, which is important for the supply of new drugs, as well as the Review Committee for Cancer Diseases, which is the center of discussions on anticancer drug benefits, the Medical service Expert Evaluation Committee, the Oriental Medical service Expert Evaluation Committee, the Treatment Materials Evaluation Committee, the Human tissue Expert Evaluation Committee, and the Disease Group Evaluation Committee. Among them, the representative drug-related committees that deal with the new drug's reimbursement and the expansion, the discussion of the high-priced drug reimbursement tracks such as RSA, and the general reimbursement standards, are the Pharmaceutical Benefits Advisory Committee and the Review Committee for Cancer Diseases. The Pharmaceutical Benefits Advisory Committee has already decided to conduct a full written review, and it is highly likely that the Review Committee for Cancer Diseases will be discussed in writing accordingly. In particular, the Review Committee for Cancer Diseases was postponed on the 26th of last month, and the government showed a willingness to discuss this month. the HIRA decided to hold a meeting of the Review Committee for Cancer Diseases on the 6th of next month. However, this is also scheduled, and the HIRA is struggling on a case-by-case basis regarding written, face-to-face, and face-to-face substitutions. The remaining five committees are also planning to adopt this month's written or the Review Committee for Cancer Diseases-like approach. The reason why the committee's face-to-face meetings are as important as the health policy deliberlate committee is that detailed deliberations and discussions are carried out in three dimensions for each area of expertise. Depending on the case, a doctor or external person in the clinical field attends to express specific opinions on the necessity of reimbursement and non-reimbursed benefits, and this is important in that it serves as a decisive influence and ground for deliberation. The HIRA, which operates all 7 committees, has already prepared video conferencing systems in Wonju and Seoul Smart Work Center to prepare for this unpredictable situation, and has the same level of face-to-face meetings so that committee members can view or collect opinions. However, even so, in some cases, members of the situation who cannot use video IT equipment must participate, so basically, a written meeting will be adopted and utilized. This is also in accordance with government guidelines. In fact, among the committee members, those who return to their home country after business trips, those whose fever has been confirmed for any reason, and those who belong to hospitals, schools, etc., may be unable to attend meetings due to government policies or organizational schedules. In response, the HIRA said, “Since the meeting cannot be postponed, the methodology will be different according to the trend. Since the distribution of written data is basically provided to all members before the meeting, there is a way to make a decision after internal review with a review opinion in writing. In the case of meetings on sensitive topics, additional meetings may be reviewed for feedback". The HIRA said, “It will be operated in a way to avoid possible face-to-face meetings, but if there are important issues that require face-to-face discussions, it will be selected the next best option such as video conferencing. It will not delay or delay important reimbursement discussions without missing the opinions of the committee members”.
- Policy
- Imfinzi available for reimbursed use from next month
- by Lee, Hye-Kyung Mar 20, 2020 06:25am
- From next month, reimbursed use of Imfinzi (durvalumab) would be available for non-small cell lung cancer (NSCLC) monotherapy. The new reimbursement standard set for Imfinzi would enable administering immunotherapy not only for palliative chemotherapy, but also as consolidation therapy. The reimbursement standard would be also applicable for patients using Opdivo (nivolumab), Keytrua (pembrolizumab) and Tecentriq (atezolizumab). Korea’s Health Insurance Review and Assessment Service (HIRA) has recently posted ‘Revised Notice on Prescription and Administration for Cancer Patients,’ and started accepting public opinion. Without any opposition, the newly changed reimbursed standard would come in effect from Apr. 1. ◆New and revised reimbursement standard for NSCLC immunotherapy: HIRA has decided to follow the study specifying Imfinzi’s applied therapy categorization, staging group and number of concurrent chemoradiation therapy (CCRT), and administration initiation point. And the agency would reflect all terms applied to other existing immunotherapies on Imfinzi as well. For NSCLC consolidation therapy, a doctor with sufficient knowledge and experience in anticancer therapy should administer the immunotherapy at a healthcare institute capable to respond to urgent events such as an unexpected adverse reaction. Also, information regarding the reimbursed use of the immunotherapy has to be submitted to HIRA. HIRA official affirmed, “The reimbursement listing period for Imfinzi would not expire in two years, generally used for immunotherapies, but would expire in a year based on its clinical evidences. When failed to result in effective treatment, another immunotherapy as a palliative therapy cannot be used with reimbursement.” Imfinzi has been approved by Korean health authority for treating patients with locally advanced, unresectable NSCLC that had not progressed after platinum-based chemotherapy and radiation therapy (CRT). The National Comprehensive Cancer Network (NCCN) guideline recommends Imfinzi as a category 1 consolidation immunotherapy for unresectable, Stage III NSCLC patients with no progression after two cycles of platinum-based CCRT. The Pan-Asian ESMO guideline recommends Imfinzi as a consolidation therapy within 42 hours after CRT on patients with unresectable Stage III NSCLC. The new reimbursement standard on Imfinzi would include Opdivo, Keytruda and Tecentriq, used as palliative therapy at second or later-line treatment, in the administration subjects. But, when Imfinzi treatment fails as post-CRT consolidation therapy, reimbursement would not be provided. ◆ New reimbursement standard for Venclexta as chronic lymphocytic leukemia monotherapy as third or later-line treatment: HIRA has decided there is no alternative option for a monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) as third or later-line treatment. During Phase 2 clinical study in adult patients with the indication, Venclexta has achieved overall response rate (ORR) of 65 percent (95% CI: 53-74), median progression-free survival (mPFS) at 24.7 months (95% CI: 19.2-NR) and confirmed that it is a necessary treatment. HIRA official explained, “There is no other option available at third or later-line treatment. As a result, the agency has changed the reimbursement standard reflecting the experts’ opinion to provide treatment opportunity to patients, who cannot use chemo-immunotherapy (rituximab, obinutuzumab) with Venclexta.” ◆Blincyto added as a monotherapy for patients with acute lymphoblastic leukemia: Blincyto has been approved to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive and immature B cell acute lymphoblastic leukemia (ALL). NCCN guideline recommends Blincyto as category 2A treating adult patients with relapsed or refractory Philadelphia chromosome-positive ALL. And for pediatric patients, the guideline recommends the treatment as category 2A to treat relapsed, refractory or multiple relapse after transplanting stem cell. The indication was approved based on a Phase 2 single-group clinical study in adult patient, in which Blincyto achieved complete remission (CR) or complete remission with partial hematologic recovery (CRh) at 36 percent, and median overall survival (mOS) of 7.1 months. Moreover a Phase 2 single-group clinical study in pediatric patient confirmed Blincyto’s clinical efficacy with CR and CRh reaching 32 percent within week two of administration and mOS of 7.5 months. Based on the literature, HIRA has decided to grant reimbursement with 5-percent copayment for remission induction therapy (2 cycles). After reviewing feasibility of providing selective reimbursement on Blincyto, the government body has decided for ALL, stem cell transplantation is a standard of care when the patient reaches CR after remission induction. And the consolidation therapy is only clinically effective in case stem cell transplantation is unlikely after remission induction. Moreover, HIRA judged reimbursement (5-percent copayment) is not adequate for a high-cost use of Blincyto. However, the agency stated three cycles of the consolidation therapy is needed for patients who cannot receive stem cell transplantation due to donor’s issue, and selective reimbursement (30-percent copayment) would be provided for the consolidation therapy on patients who achieved CR or CRh after remission induction therapy and has received pre-approval for stem cell transplantation, as it does not have alternative option at the moment.
- Policy
- New reimbursed price for Imfinzi, Venclaxta and Blincyto
- by Kim, Jung-Ju Mar 20, 2020 06:25am
- From next month, health insurance reimbursement would be granted on AstraZeneca Korea’s locally advanced non-small cell lung cancer (NSCLC) treatment Imfinzi (durvalumab) and AbbVie Korea’s chronic lymphocytic leukemia (CLL) treatment Venclaxta (venetoclax). Two treatments have accepted risk sharing agreement (RSA) terms set down on the negotiation table by Korea’s National Health Insurance Service (NHIS). Amgen’s leukemia treatment Blincyto (blinatumomab) would lower its price by four percent considering the financial impact for increased reimbursed use with expanded indication. According to pharmaceutical industry, Ministry of Health and Welfare (MOHW) is planning to revise the ‘List of Reimbursed Drugs and Maximum Reimbursed Price’ with the said changes. The revision would come in effect from Apr. 1. ◆Imfinzi: The immunotherapy has been approved to treat unresectable, locally advanced NSCLC patients with no progression after platinum-based concurrent chemoradiation therapy (CCRT). The company has submitted an application to Health Insurance Review and Assessment Service (HIRA) for reimbursement listing on Dec. 21, 2018, immediately after receiving an approval from Ministry of Food and Drug Safety (MFDS) in the same month. At a Cancer Deliberation Committee meeting convened in early November last year, HIRA has decided it would be feasible to provide reimbursement on the drug. The committee’s decision was based on clinical study proven clinical efficacy improved than placebo, and also the committee judged its cost-effectiveness would accept ICER value better than the placebo. The refund and expenditure cap type RSA, proposed by the company, was at an acceptable level. The refund type and expenditure cap type of RSA stipulate the applicant company to pay back a set amount of drug reimbursement claim to National Health Insurance Service (NHIS), and to return a certain ratio of the claimed amount exceeding the expected cap. The drug negotiated drug pricing with NHIS from then on to last month As a result, the reimbursed price of the drug would be at 3,350,930 won per 0.5 g and 804,223 won per 0.12 g. ◆Venclaxta: Venetoclax is an orally administered anticancer treatment used to treat CLL as third or later-line treatment, and it is approved as a monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been treated with chemo-immunotherapy and B cell receptor inhibitor, previously. From last May last year, the pharmaceutical company has submitted a reimbursement application to HIRA, immediately after MFDS’ green light, and received a nod from Drug Reimbursement Evaluation Committee (DREC) in last December. DREC official said the treatment has demonstrated clinical efficacy and is eligible for pharmacoeconomic evaluation (PE)-exemption track. The three PE-exemption track qualifications include; an anticancer used for treating life-threatening disease with no alternative option at the same level of treatment; a treatment approved by MFDS based on single-group clinical data without placebo and has difficulty producing evidential data with limited number of patients; a treatment listed for reimbursement in at least three countries out of the seven countries the committee has chosen to refer their adjusted average values. A drug can qualify for the PE-exemption track after qualifying all three conditions. Then after, the company has successfully reached an agreement with NHIS last month on pricing negotiation under the expenditure cap type RSA. The reimbursed price would be at 4,469 won per 10 mg, 22,341 won per 50 mg, and 44,682 won per 100 mg. ◆Blincyto: The anticancer treatment has been approved to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive or negative immature B cell acute lymphoblastic leukemia (ALL). From October 2016, the treatment has been provided with reimbursement in Korea for patients at age over 18. The company has applied for expanded reimbursement to HIRA in February last year, after expanding its indication to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive acute ALL in January last year. At the June meeting convened last year, Cancer Deliberation Committee said selective reimbursement would be granted for remission consolidation therapy to reduce non-reimbursed criteria. The treatment already has essential coverage on its remission induction therapy indication. Its expanded reimbursement was finalized by Drug Reimbursement Evaluation Committee (DREC) in last December. DREC’s decision was based on the treatment’s clinical efficacy and its cost-effectiveness qualification for PE-exemption track for the expanded reimbursement. In this month, the company has finally reached an agreement on negotiated pricing with NHIS. The key was to lower the price by four percent to lessen the financial impact. The negotiated price was decided at 2,346,000 won, reduced from the original price of 2,442,800 won.
- Policy
- Antiepileptic drug Fycompa may face follow-on drugs soon
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- Antiepileptic drug Fycompa Drugs using same substance as Eisai’s Fycompa film coated tablet, used to treat patients with partial-onset seizure, is preparing for a market release. Myung In Pharm and Whan In Pharm recently requested for negative scope confirmation on Fycompa’s crystalline form patent (to be expired on Oct. 14, 2026) to evade infringement. As the prescription volume of Fycompa has been steadily increasing, follow-on drug manufacturers are keeping a close eye on the legal proceeding. According to pharmaceutical sources on Mar. 18, Myung In has requested for a negative scope confirmation on Fycompa’s patent on Feb. 28, followed by Whan In on Mar. 13. Myung In and Whan In, prominent in the Korean central nervous system (CNS) market, are seemingly preparing for the first generic of Fycompa. However, a follow-on drug would have to wait more than three years or so to fully commercialize the drugs as Fycompa still has ongoing post-marketing surveillance (PMS) and substance patent in effect. Fycompa is a non-competitive α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) glutamate receptor antagonist. It has been approved by Ministry of Food and Drug Safety as a new mechanism to treat epilepsy but it is a subject for PMS for six years. During the PMS period, approval application from a latecomer drugs are rejected. Fycompa’s PMS period is to end on July 9 next year. For Myung In and Whan In to receive preferential sales approval for an exclusively launched generic, it would be more advantageous for them to apply for it after July 10 next year. But even after its approval, the follow-on drug would face the barrier of substance patent. The patent is to expire on Oct. 13 2023. Myng In and Whan In have challenged the crystalline form patent, but they have not taken any action on the actual substance patent. The U.S. Food and Drug Administration (FDA) has approved Fycompa in 2017 as a monotherapy for treating partial-onset seizures with or without secondarily generalized seizures in people with epilepsy aged four and older. According to UBIST, the treatment’s outpatient prescription volume, started at around 2 billion won in 2017, has been growing up to 2.7 billion won and 3.4 billion won in 2018 and 2019, respectively. The industry sees that this once-daily treatment has potential to grow further with medication convenience for the patients, which is why the two Korean companies are assertively challenging the original.
