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- 2026-03-18 22:46:44
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- Forxiga by AstraZeneca appeals against Dong-A ST
- by Kim, Jin-Gu Sep 02, 2020 06:18am
- ForxigaAstraZeneca, which failed in the first round of the patent dispute over the SGLT-2 inhibitor-based diabetes treatment, Forxiga (Dapagliflozin), launched a counterattack against Dong-A ST. It disagrees with the trial decision of the Patent Tribunal, who sided with the generic company, and filed a lawsuit to the Patent Court of Korea to cancel the trial. As AstraZeneca led the patent dispute to the second trial, the 'Pro-drug' method of patent avoidance strategy brought up by Dong-A ST was also put to the test. In the pharmaceutical industry, The pharmaceutical industry is paying attention to the patent court's ruling on whether a new patent strategy that came out long ago can continue. According to the pharmaceutical industry on the 31st, AstraZeneca filed a lawsuit against Dong-A ST to cancel the trial decision in the Patent Court of Korea on the 28th. The intention is that the trial decision made by the Intecllectial Property Trial and Appeal Board is unfair. On June 23, the Board sided with Dong-A ST in a trial to confirm the passive scope of rights filed by Forxiga on a material patent. This decision received great attention from the pharmaceutical industry. This is because many pharmaceutical companies have challenged Forxiga’s material patent, but only Dong-A ST has succeeded in avoiding it. It is explained that there was a technology called 'pro drug' behind Dong-A ST's ability to overcome the patent. Chemical structure of DapagliflozinProdrugs are a different strategy, seemingly like salt-modifying drugs. It is a kind of incrementally modified drugs. It is a way to improve a little differently from the original by changing the substituent of the substance. However, the difference between the salt and the substituent is large. The chemical structure of the substance itself does not change. The chemical structure of the prodrug is partially changed. There is also a big difference in technology. it can be changed by simple ionic bonding. In the case of prodrugs, the substituents must be changed in a more tricky way, called a covalent bond. The likelihood of success is also lower. The salt change strategy adopted by many generic companies in the past has become impossible due to the so-called 'Solifenacin ruling' in January of last year. The Intecllectial Property Trial and Appeal Board (1st trial) regarded the prodrug as a new one different from the original ingredient. On the other hand, AstraZeneca believes that the product being developed by Dong-A ST exhibits the same pharmacokinetics in the body as Dapagliflozin, and is converted into Dapagliflozin to exert an effect, so it is believed to be infringing Forxiga's material patent. Accordingly, AstraZeneca said that it will reaffirm the scope of the rights of material patents and protect Forxiga's intellectual property rights. Sang-pyo Kim, CEO of AstraZeneca Korea said, "Material patent for Dapagliflozin is the result of research and development with a lot of effort and cost, and such excellent patent technology is respected until the expiration date." Forxiga has two material patents. One expires on April 7, 2023, and the other expires on January 8, 2024. Among them, the patent invalidation lawsuit that expires in 2024 won the first trial by generics, and the second trial is currently underway. Dong-A ST is the only one that has avoided both patents. Dong-A ST is expected to be released in the second half of next year as soon as it has undergone clinical and approval. If it goes as planned, it means that it will be possible to release the generic nine months ahead of other companies.
- Company
- Indication of Alunbrig expanded as ALK-positive lung cancer
- by Sep 02, 2020 06:18am
- The indication has been expanded as the first line treatment of Takeda Pharmaceutical Korea's lung cancer treatment, Alunbrig. Takeda Pharmaceutical Korea (CEO Moon Hee-seok) announced on the 28th that The MFDS approved Alunbriq (Brigatinib), an anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer drug, to expand its indication as a first-line treatment for ALK-positive advanced or metastatic non-small cell lung cancer on the 27th. Alunbrig has been used in the treatment of ALK-positive advanced or metastatic non-small cell lung cancer, which has been treated with Crizotinib in April of last year under insurance coverage. With the expansion of this indication, Alunbrig can also be used in patients with ALK-positive non-small cell lung cancer who have not been treated with existing primary ALK inhibitors. The approval was based on a second interim analysis of the ALTA-1L clinical trial in 275 patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who had not previously been treated with ALK inhibitors. Patients enrolled in the ALTA-1L clinical trial were randomly assigned to the Alunbrig group and the Crizotinib group according to the brain metastasis and past chemotherapy at baseline. The primary endpoint is the progression-free survival (PFS) evaluated by the Blinded Independent Review Committee (BIRC), and the secondary endpoint is the objective response rate (ORR) evaluated by the BIRC, the intracranial objective response rate (intracranial ORR), intracranial PFS and overall survival (OS). As a result of the second interim analysis conducted based on the progress up to June in 2019, it was confirmed that patients receiving Alunbrig improved the risk of disease progression or death by about 51% compared to the crizotinib group. (HR, 0.49; 95% CI, 0.35-0.68; log-rank P
- Company
- Now, a transition of power in the contraceptive market
- by Sep 01, 2020 06:13am
- The domestic over-the-counter (OTC) pre-contraceptive market, which was almost monopolized by imported finished products, is showing mixed trend. Sales of top-tier products such as Myvlar have been sold out for a long period of time, resulting in a sharp decrease in sales, and recently released products are fiercely competing, causing changes. According to IQVIA, a drug market research institute, the size of the major OTC pre-contraceptive drug market in the first half of this year was ₩7.9 billion, down 29% from ₩11.1 billion in the same period last year. Data: IQVIA The market contracted as sales of top-tier products fell sharply. In particular, Dong-A imports Myvlar from Bayer, but it has been discontinued as the problem of changing overseas production plants prolonged. Eventually, there was little sales in the first half of this year. Myvlar, which ranked second in the market, is not expected to recover easily as the out-of-stocks prolong. Dong-A's Melian also suffered a temporary out-of-stock phenomenon, but was able to maintain sales because the supply was fast. Melian's sales in the first half of the year were ₩800 million, up 4.5% from the previous year.. Again this year, Mercilon by Alvogen Korea became first place in OTC contraceptives. The gap with the second place also widened in the absence of Myvlar. However, Mercilon's sales declined slightly compared to last year. Mercilon's sales for the first half of this year were ₩3.9 billion, a 27.8% decrease from the same period last year (₩5.4 billion). Alvogen Korea, which jointly sold Mercilon with Yuhan until the first half of last year, signed a co-promotion contract with Chong Kun Dang from the second half of the contract. Along with Mercilon and Myvlar, Alesse sales by Ildong also declined 19% from 1.1 billion in the first half of last year to ₩900 million. Alesse is an item introduced by Pfizer Pharmaceuticals. OTC products The recent disruption in the supply of imported finished products and the launch of various domestically manufactured items is also leading the market change. First of all, Senseday, developed by Yuhan and introduced last year, is evaluated to have settled relatively, although sales have slowed slightly compared to last year. Senseday recorded ₩600 million in sales in the first half of this year. Ildong also introduced its own product. These are two types of Daon and Baraon released in May. They are estimated to have generated sales of ₩300 million and ₩100 million respectively in the first half of this year. Pharmaceutical companies that have launched their own products, such as Yuhan and Ildong, are competing to promote their brands to consumers. Yuhan expanded its product lineup by releasing a condom named Senseday, and Ildong launched an advertisement with a striking blue package and singer Son Dam-bi as a model. Alvogen Korea is trying to recover sales by attracting positive responses from pharmacists through the 'Mercipharm' campaign that supports contraceptive medication consultation with its partner Chong Kun Dang. With domestic companies introducing follow-up products one after another, attention is paid to the changes in the OTC contraceptive market, which was announced as a gap in sales of top-tier products was created.
- Company
- “Cosidering PPI when prescribing NOAC in high-risk patient"
- by Eo, Yun-Ho Sep 01, 2020 06:13am
- Professor Kim Min-su Already, it has been ten years since new oral anticoagulant (NOAC) has launched in the South Korean market. Experts are actively discussing the practical use of NOAC as relevant prescription records have been accumulated. Regarding the off-label prescription of the drug, the interest has heightened recently on optimizing the dose and bleeding control in Asian population. An example would be simultaneously using proton pump inhibitors (PPIs) with NOAC or dual antiplatelets therapy (DAPT) to manage gastrointestinal bleeding. Clinical evidences are collected to support the East Asian Paradox theory that claims antiplatelets therapy in East Asians and Westerners demonstrate different outcomes in efficacy and safety. Professor Kim Min-su of Cardiology Department at Chungnam National University Sejong Hospital spoke to Daily Pharm that, “In a clinical scene where there a patient has gastrointestinal bleeding while using NOAC, the therapy is maintained with PPI-like gastric mucous membrane protector, if the case is not critical.” As for DAPT, PPI prescription is recommended by American College of Chest Physicians (CHEST) guideline for antiplatelet therapy in patients with atrial fibrillation (AF). The guideline recommends minimizing the risk of gastrointestinal bleeding in patients with AT, who uses aspirin and oral anticoagulant together, by administering 75 mg to 100 mg of PPI. Professor Kim stressed, “DAPT has reportedly increased the risk of gastrointestinal bleeding and led to death. As long-term DAPT is prevalently used in high-risk patients having myocardial infarction, the use of PPI to manage gastrointestinal bleeding should be taken in account.” He added, “We need to be careful on the interaction between antiplatelets and PPI. It dpends, but a drug-drug interaction definitely exists. Also the risk of bleeding could vary for NOAC based on the range of doses like once-daily or twice-daily.” So how about the private clinics prescribing NOAC, when the concern on bleeding still exists? Actually, experts claim the clinics prescribing the drug is not problematic. In fact, the Korean Heart Rhythm Society apparently provides training sessions on NOAC in six different regions with carefully selected speakers. The organization is also expanding programs to raise awareness of the disease. Professor Kim stated, “Even tertiary hospitals, most of the time, provide no other treatment than NOAC prescription for the first-time treated patient with chronic AF. A primary healthcare institute can sufficiently prevent and manage stroke after giving essential exams.” The professor added, “There shouldn’t be any issue for a primary healthcare provider to prescribe NOAC. In the age of warfarin, the prescription of anticoagulants was difficult with lack of international normalized ratio (INR) monitoring equipment and prescription management. But, the time has changed now. The issue is irrelevant with using PPI and NOAC. Personally, promoting prescription of anticoagulants in private clinics would enhance the management of AF in South Korea.”
- Company
- GC-Novartis report COVID-19 cases, all other test negative
- by Kim, Jin-Gu Sep 01, 2020 06:12am
- Although confirmed cases of COVID-19 were reported from GC Pharma and Novartis Korea, sources confirmed others in the companies were not further infected. According to pharmaceutical industry sources on Aug. 28, all workers, who had a close contact with the confirmed cases in the same department or in the vicinity at GC Pharma and Novartis Korea, were tested negative. On Aug. 24, GC Pharma reported its one employee from the R&D center at the Yongin Headquarters has been tested positive for COVID-19. While working from home since Aug. 21, the employee showed symptoms like coughing, sore throat and fever and was tested positive on Aug. 24. GC Pharma closed the headquarters and R&D center on the next day and informed all employees to stay at home. Immediately the buildings were disinfected. Although the patient was confirmed when working from home, all the colleagues working at the same department were tested as well. The company reported every one of them has been tested negative. Regardless, the Korean company plans to maintain the work-from-home system for a while. Novartis underwent the same ordeal as it reported a confirmed case a day prior to GC Pharma. On Aug. 23, Novartis’ Sandoz Korea division had one confirmed case, and each from Novartis and Sandoz, who came in contact with the first case, were tested positive. However, the company reported no other confirmed cases were found in the company. Novartis and Sandoz are housed on 48th and 49th floor in IFC Seoul Building. The patient was reportedly working from the 48th floor, and all other employees on the same floor were tested negative. Regardless of having a close contact or not, all employees were ordered to work from home. Tentatively, the change in workplace is to last until next week. But depending on the situation, the employees may work from home longer, the company official says. A sales person from Boehringer Ingelheim Korea, assigned to respiratory department at general hospitals, has been tested positive on Aug. 25. The company immediately sent home all employees, who had a close contact with the patient, and they are to work from home indefinitely. The multinational company plans to take fruiter actions and test more people who came in contact to follow up with the patient’s epidemiological investigation.
- Company
- New HIV drug Biktarvy sales of ₩20 billion in one year
- by Kim, Jin-Gu Aug 31, 2020 05:58am
- It is confirmed that Gilead Science's new HIV treatment, Biktarvy, made close to ₩20 billion in a year after it entered the market in earnest. According to the analysis, Gilead is maintaining the leadership in the HIV treatment market due to the rapid growth of Biktarvy. ◆Biktarvy, sales of ₩14.4 billion in the first half of this year, Cumulative ₩19.4 billion Biktarvy According to IQVIA, a drug market research institute on the 31st, the sales of Biktarvy in the first half of the year are estimated at ₩14.4 billion. Biktarvy is a combination HIV treatment which consists of Bictegravir, Emtricitabine, and Tenofovir alafenamide. After receiving approval from the MFDS in January of last year, it entered the market in earnest while receiving reimbursement in July of the same year. Yuhan is in charge of marketing in the domestic market. For the first half year from July to December, Biktarvy's sales amounted to ₩5 billion. Adding ₩14.4 billion in sales until the first half of this year is ₩19.4 billion. In less than a year of launch, it has produced close to ₩20 billion in sales. Quarterly sales of Biktarvy by Gilead Sciences and major HIV treatments (unit: ₩billion, data: IQVIA) Compared to existing treatments, the efficacy and safety are improved, and the rate of onset of resistance is low. Bictegravir is an active ingredient that is evaluated as a strong second-generation integrative enzyme inhibitor and has high resistance. Tenofovir alafenamide is also a second-generation Tenofovir, changing its base to significantly lower its toxic effects on kidneys and bones, the company explains. It can be taken with/without food, and the size of the pill is smaller than that of existing treatments. ◆Gilead maintains market leadership amid rapid growth in Biktarvy With Biktarvy's rapid growth, Gilead remains a leader in the HIV treatment market. In the domestic market, Gilead, GSK, MSD, Janssen, AbbVie, and BMS are competing for HIV treatment. Among them, Gilead and GSK are known to occupy about 90% of the market. In the case of Gilead, the total sales of five treatments (Genvoya, Descovy, Truvada, Stribild) including Biktarvy in the first half of this year were ₩27.7 billion, up 19% from ₩22.3 billion in the first half of last year. The sales of other treatments, excluding Biktarvy, declined, but Biktarvy offset this. It is explained that the prescriptions for Genvoya are being replaced by Biktarvy. GSK's Triumeq posted sales of ₩15.4 billion. It increased by 16% compared to ₩13.3 billion in the first half of last year. GSK's another HIV treatment Tivicay increased 14% from ₩2.2 billion to ₩2.5 billion over the same period, and Kivexa decreased 23% from ₩1.7 billion to ₩1.3 billion. GSK plans to pursue Gilead with a new HIV treatment, Dovato. After being approved in Korea in March this year, Dovato entered the market in earnest after being listed as a health insurance benefit in June. Dovato is a single tablet that is a mixture of two ingredients: Dolutegravir and Lamivudine. Semiannual sales of major HIV treatments (unit: ₩100 million, data:IQVIA) In addition, MSD's Isentress recorded sales of ₩2.8 billion in the first half of this year, Prezcobix by Janssen of ₩1.3 billion, AbbVie's Kaletra of ₩1.3 billion, and BMS' Evotaz of ₩500 million. In the case of AbbVie’s Kaletra, it was mentioned as one of the potential treatments at the beginning of the COVID-19 incident in the first half of this year.
- Company
- Sanofi Pasteur Korea welcomes new GM Pascal Robin
- by Eo, Yun-Ho Aug 31, 2020 05:57am
- General Manager Pascal Robin The newly appointed general manager at Sanofi Pasteur Korea, Pascal Robin has started his work in the office from Aug. 25. According to the company, General Manager Pascal Robin has been successfully serving various executive-level positions for over two decades in pharmaceutical industry distribution management, strategy, management and marketing. After joining Sanofi Pasteur in 2002, he has been diversifying his expertise in all vaccination market as he comprehensively covered all areas from production to sales in domestic and global markets, and in emerging and advanced countries. Prior to his appointment in Sanofi Pasteur Korea, Robin led the vaccine sector of the company in Romania and Moldva and also took the job as a general manager at Sanofi Romania managing three areas regarding OTC, specialty care and consumer healthcare. General Manager Pascal Robin stated, “I am exhilarated to take over the general manager position in Korea, where the company has been contributing immensely to protect people in South Korea from the risk of various infectious diseases prevalent in the country by providing diverse vaccine portfolio covering infants to elderly for over 30 years.” He added, “Besides a number of new vaccine portfolio against infectious disease, the company is in process of seeking two investigational vaccines to tackle COVID-19, capable of mass-production. Amid exceptional pandemic we are currently experiencing, the company would do its best to fulfill the responsibility and role of a global vaccine company leading the vaccine market.”
- Company
- Kadcyla passed deliberation for cancer maintenance therapy
- by Eo, Yun-Ho Aug 31, 2020 05:57am
- According to related industries, the Antibody-drug conjugate (ADC) Kadcyla (Trastuzumab emtansine) passed the cancer disease review committee of the HIRA (26th). The exact criteria for applying for an increase in benefits is 'post-operative adjuvant therapy for HER2-positive early breast cancer patients with invasive residual lesions after receiving preoperative adjuvant therapy based on Taxane and Herceptin (Trastuzumab). Kadcyla, which was registered as a refund type of the Risk Sharing Agreement (RSA) in August 2017, is now available to prescribe benefits for HER2-positive, unresectable, locally advanced or metastatic breast cancer patients who have failed treatment with Herceptin and Taxane-based anticancer drugs. Roche aimed to increase benefits shortly after obtaining indications for early breast cancer in August last year, but failed. After passing through the cancer disease review committee, Kadcyla is approaching the expansion of the coverage of early breast cancer maintenance therapy in about a year of expanding indications. Meanwhile, in the KATHERINE study, Kadcyla reduced the risk of recurrence by 50% compared to Herceptin monotherapy, the current standard treatment, in patients in the high-risk recurrence group who were found to have residual cancer despite preoperative chemotherapy and surgery. The fact that the increase in the benefits of breast cancer treatment drugs has been focused mainly on the 'metastatic breast cancer' category is also a point of interest in the review of the cancer disease review committee. Treatment for breast cancer has a different purpose depending on the stage. If prolonging survival is the goal of metastatic breast cancer in terms of treatment strategy, the treatment goal of early breast cancer is cure. Currently, Herceptin (Trastuzumab) is the only targeted treatment that has been applied as a benefit in adjuvant therapy after surgery for early breast cancer. Sohn Joo-hyuk, a professor of oncology at Severance Hospital, said, "The supply environment for breast cancer drugs is much improved than before. However, if the opinions of specialists are reflected in the gray area, it will help to build a better environment. There is a need to apply more flexible benefits to the use of drugs."
- Company
- Venclexta passed the cancer disease review committee
- by Eo, Yun-Ho Aug 31, 2020 05:57am
- Anti-cancer drug Venclexta is in a hurry to expand the coverage to second-line leukemia therapy According to related industries, AbbVie's Venclexta (Venetoclax) was held yesterday (on the 26th) as a second-line combination therapy for relapsed, refractory chronic lymphocytic leukemia (CLL) that received previous treatments including at least one chemotherapy. It passed the cancer disease review committee of the HIRA. Venclexta was approved by the MFDS in May 2019 as a monotherapy for patients with chronic lymphocytic leukemia who are relapsed or refractory to chemoimmunotherapy and B-cell receptor pathway inhibitors. It was listed on the reimbursement list since last April. This drug started the registration process immediately after adding the indication for the combination therapy of Mabthera (Rituximab), which was proposed to the committee this time in March. It shows the presence of Venclexta in the CLL area. Venclexta's efficacy in second-line therapy was demonstrated in the Phase III study MURANO. As a result of the analysis of the primary evaluation index, the progression free survival (PFS) of the combined Venclexta and Mabthera group was significantly improved. The risk of disease progression or death was reduced by 83%, and the overall survival rate was higher than that of the standard treatment group, Bendamustine and Mabthera. In addition, in MURANO's Post-Treatment Follow-up Study, 130 patients in the Venclexta and Mabthera combination group who completed the treatment for two years without progression of the disease were progressed at 18 and 24 months after dosing. The estimated survival rates were 75.5% and 68.0%, respectively. Eom Ki Seong, director of the Chronic Leukemia Center at the Catholic University of Korea, Seoul ST. Mary’s Hospital said, "Chronic lymphocytic leukemia is a disease that is highly likely to refractory to first-line treatment or recur after treatment, so more effective and diverse treatment options are essential for these patients."
- Company
- Cancer Committee leaves Keytruda confused, now what?
- by Eo, Yun-Ho Aug 28, 2020 06:19am
- An immunotherapy Keytruda (pembrolizumab) indicated as a first-line treatment on lung cancer is still lost in a thick fog with its attempt to expand healthcare coverage. And it has been three years already. Health Insurance Review and Assessment Service’s (HIRA) Cancer Deliberation Committee was gathered on Aug. 26 to deliberate granting healthcare reimbursement on breast cancer treatment Kadcyla, leukemia treatment Venclexta (venetoclax), and Keytruda. The conversations on Kadcyla and Venclexta were relatively simpler, and the committee eventually passed those products. On the contrary, the talk on Keytruda started off with a financial plan the Cancer Deliberation Subcommittee worked on for three meetings to provide the health insurance benefit while lessening the financial burden on National Health Insurance. But, still to the next day of meeting on Aug. 27, the pharmaceutical industry was conflicted over the committee’s unclear conclusion either ‘passing’ or ‘rejecting’ the reimbursement decision. Even the press coverage delivered completely contrasting news. ◆First question—was the financial plan not good enough? Then what actually went down with the committee? Still, there is no clear answer. But according to Daily Pharm’s investigation, the Cancer Deliberation Committee’s decision on Keytruda was close to ‘differing’ it, yet again. A member of the committee who was present at the meeting commented, “We were not satisfied with the revised financial plan brought to the table. Some even said it was worse than the initial version [MSD submitted to the government body in May, prior to the June Cancer Committee meeting]. The company should have put more effort on it.” This is the part, where some were convinced the committee has ‘rejected’ expanding the coverage on Keytruda. Nevertheless, from a commonsensical perspective, the assumption is unconvincing. The subcommittee that first deliberated the financial plan included members not only from the government or financial experts, but also from the Cancer Deliberation Committee. Actually, the pharmaceutical company itself was excluded from the conversation. In other words, the financial plan the subcommittee members, including the Cancer Committee representatives, worked on for three times was technically worsening the financial strain. And if the committee member at the meeting was present at the subcommittee meetings, it means the member was not convinced with the financial plan they worked on. It could be that the Cancer Committee member was skeptical with the way the subcommittee was amending the plan. And regardless of the subcommittee’s settlement, the Cancer Committee could have been largely unconvinced about the plan. In such case, then the decision should have been clear that it was ‘rejected.’ ◆Second question—sending the unsatisfying financial plan back to the company? But they say the conclusion was not a rejection. If it was then the talks on expanding Keytruda’s coverage should have ended, technically. But after the Cancer Committee meeting, HIRA informed that the financial plan would be sent back to MSD. An insider from HIRA said, “The meeting’s conclusion has not been clearly decided, yet. The discussion details would be compiled and sent to MSD as an offer.” In case of rejecting the decision, the government agency could have simply announced so. But HIRA’s action means the coverage could be expanded depending on MSD’s decision to accept the offered financial plan. The Cancer Committee and HIRA’s stories do not coincide. The government has yet to follow with a clear explanation. Putting all clues together, the following can be deducted; The expanded coverage on Keytruda has been heavily demanded by patient support groups. As no clear answer was provided for a long time, the patient group’s fury was directed towards both the government and the company. In such tight spot, the Cancer Committee and the government would have felt pressured to ‘reject’ the decision. Moreover, the last Cancer Committee’s deliberation on Keytruda was an exceptional case; to revise the financial plan, the committee convened the subcommittee and discussed specifically about financial issues without much of a concern on ‘clinical efficacy.’ Even if MSD accepts the revised plan, Keytruda would have to go through the Cancer Committee again, and not skip ahead to Drug Reimbursement Evaluation Committee (DREC). The latest decision could have meant the Cancer Committee was “skeptical about the subcommittee’s revision,” and yet they are “willing to discuss the plan again, after the pharmaceutical company accepts the offered plan.” In other words, the committee passed on the ticking bomb to MSD. As for the company, all eyes are now on the company while they are burdened to make a decision to accept the revised financial plan. A market access expert from a multinational pharmaceutical company pointed out, “Seeing the updates on Keytruda listing talks, it is unlike other anticancer treatment listing process with so many unprecedented happening. The entire procedure is veiled and far from being transparent. The government needs to put down a clearer guideline for the coverage expansion procedure.”
