- LOGIN
- MemberShip
- 2025-12-25 21:24:36
- Policy
- How Tenelia latecomers lost chances in preferential sales
- by Lee, Tak-Sun Sep 08, 2020 06:11am
- Although Kyungdong Pharmaceutical first received approval on antidiabetic Tenelia’s incrementally modified drug (IMD), the drug is apparently not eligible for the preferential sales right given to the generic market. Regardless of the preferential right, any Tanelia IMDs that successfully evaded the original’s salt base patent can be launched at the same time. And as the stepped drug pricing system stipulates, the first 20 items approved would also receive premium pricing benefit. According to the industry sources on Sept. 7, the first IMD to have applied for the government approval after evading Tenelia's salt patent and the expiration of the original’s post-marketing surveillance (PMS) period, was not eligible for the preferential sales right to begin with . In order to win the preferential sales right, a drug first has to either request for the first patent trial (or requested within 14 days from the first trial date), or to conclude the patent trial before the first company to request the trial. The second prerequisite condition is to win the patent challenge, and the third is to be a first to apply for the item license. Kyungdong Pharmaceutical’s IMD ‘Teneritine 20 mg tablet,’ approved as of Sept. 4, has met the second and third conditions. But it turns out that the drug has failed to meet the first condition. The original Tenelia has a substance patent, expiring on Oct. 25, 2022, and a salt-base patent, expiring on Feb. 17, 2026. Besides the substance patents the Korean pharmaceutical companies lost at a trial, the follow-on drug companies attempted to challenge the salt-base patent. The first patent challenges were made by Hana Pharm and Intro Biopharma. Hana Pharm first filed a patent trial on Apr. 10, 2015 to nullify Tenelia’s salt-base patent. The two Korean companies are currently developing drugs identical to Tenelia with same active pharmaceutical ingredients and salt base. Meanwhile, pharmaceutical companies with IMDs filed their first patent challenge on Oct. 19, 2018, three years after Hana Pharm’s trial. Kyungdong Pharmaceutical requested for a negative confirmation of patent right scope to evade the original’s patent. In order to acquire the preferential sales right, the IMD companies have to fulfill the prerequisite conditions. The first condition was to complete the legal proceedings before Hana Pharm. The possibility was still open as the Intellectual Property Trial and Appeal Board prioritizes the negative confirmation of patent scope. Unfortunately, however, the final decision on the IMD’s patent evasion was made on the same day as the patent invalidation trial with Hana Pharm and Intro Biopharma. Both trials on patent evasion and invalidation were concluded on Dec. 31 last year. Immediately after trial, the IMD companies applied for both item approval and preferential sales rights, but the Ministry of Food and Drug Safety (MFDS) reportedly denied the application due to the incomplete fulfillment of the prerequisite conditions. If the IMD trial decision was made even a day earlier, Kyungdong Pharmaceutical and other IMD companies would have acquired the preferential sales rights effective from Oct. 26, 2022. Although Hana Pharm and Intro Biopharma have requested the first patent challenge and met the requirements for a successful patent challenge, they failed to apply for the government approval on the day after when Tenelia's PMS ended on Apr. 29. As a result, none of Tenelia's latecomers would have the preferential sales rights. Nevertheless, the first 20 items to be licensed would receive premium pricing, according to the stepped drug price system. The said Korean companies may have failed to win the preferential sales rights through patent challenge, but at least the follow-on drugs would obtain the premium pricing benefit as long as their development speed is fast enough. Meanwhile, Tenelia is a seventh dipeptidyl peptidase 4 (DPP-4) inhibitor released in the South Korean market. Developed by the Japanese-based Mitsubishi Tanabe Pharma, Handok has licensed the sales rights in the Korean market. UBIST reported the drug has made 9.5 billion won from the outpatient prescriptions in the first half of this year.
- Policy
- NA burdened as dispute continues despite Gov-KMA agreement
- by Lee, Jeong-Hwan Sep 08, 2020 06:11am
- As the dispute among medical community is deepening regardless of South Korea’s Ministry of Health and Welfare (MOHW) and Korean Medical Association (KMA) settling on an agreement, the National Assembly is now burdened with a grave responsibility to deliver the agreed terms and to fairly execute the medical reform plan. The Young Doctors’ Emergency Committee representing medical interns, residents and fellows initially intended to protest against the government-medical organization agreement and to continue the collective strike. But they decided to temporarily suspend the strike and return to their jobs on Sept. 6. Nevertheless, the committee stresses the possibility of the young doctors going on a strike again at any time, if need be. The ruling and opposition parties have agreed on establishing a Special Medical Reform Committee under the National Assembly. Now, the both parties are expected to fully implement the agreement, and to calm the public and patient concerned about the agreement impeding the medical reform policy. On Sept. 6, the National Assembly seems to be carefully observing the medical community’s reaction to the agreement signed between the government and the medical organization. Especially, Chair Han Jeongae (Democratic) of Health and Welfare Committee, leading the mediation between the government and the medical professionals, is inevitably trying to read the air in political parties, civic and patient advocacy groups, as well as the medical community. Some of the Democratic Party lawmakers have criticized KMA won the battle against the government, while civic and patient groups are reprimanding the ruling party for waving the white flag to doctors on strike that took patients as hostage. Lawmaker Han said, "I disagree with the criticism that the ruling party raised the white flag. Rather, the party has raised the white flag to the people and patients," and “The lawmakers would continue to discuss the issues regarding the medical reform. And we would do our best to improve policies and regulations to execute measures stated on the government-KMA agreement.” The Young Doctors Emergency Committee, centering the Korean Intern Resident Association (KIRA), has decided to temporarily hold back on the resistance against the agreement and to report back for duty. However, the committee is firmly expressing its intention to take the collective action again as they would closely follow up with the lawmakers’ further support for the agreement. The young doctors are willing to go on the nationwide strike again immediately, if the government and the National Assembly fail to keep their promises with the medical community. The National Assembly is ultimately relieved the doctors halted the strike, but at the same time they now have serious task in their hands. Particularly, the public’s attention would be focused on the Special Medical Reform Committee’s prospective approach as it would consist of both the ruling and opposition parties. The initial implication the Special Committee would face is whether the committee would operate centering the ruling and opposition parties, or include the government and medical representatives. An official from a ruling party lawmaker's office noted, “The ruling party was taken back for a moment as the medical interns, residents and fellows opposed so strongly, when KMA, Democratic Party and the government signed the agreement," but “with the agreement, the government, medical community and the lawmakers can now come together to overcome the COVID-19 epidemic. The discussion on the medical reform can start from the scratch after we overcome the crisis.” The same official elaborated, "What the National Assembly can do right now is to form the Special Medical Reform Committee to sufficiently collect opinions from the medical community and the government." An official from the opposition party lawmaker also stated, "The party believes the lawmakers have done their job. The ruling and opposition parties have agreed on the urgency of halting the medical reform talks and returning the doctors for their duty. And also we are seeing eye-to-eye on arbitrating between the government and the medical community.” The official added, "The National Assembly cannot do anything about the conflict within the medical community escalated since KMA signed the agreement. It is the medical community's job to arbitrate the conflicted community. There is limitation to what lawmakers can do for them."
- Policy
- There is no disadvantage in the long-term Rx due to COVID-19
- by Lee, Hye-Kyung Sep 08, 2020 06:11am
- It has been emphasized once again that there are no disadvantages for appropriate long-term prescriptions within the scope of medically recognized health authorities. It has been clarified that it will not cut down on necessary and appropriate long-term prescriptions so that medical institutions can actively respond to medical gaps due to doctor strikes. The HIRA's Drug Standards Department recently announced a request for cooperation in response to the spread of COVID-19. The amount of work of pharmacists following the preparation of long-term prescriptions for more than 91 days, published in a research report conducted by the pharmacist society In addition to active treatment for the prevention and spread of COVID-19 at each medical institutions, it was made possible for the public to receive health insurance coverage even in the event of an infectious disease crisis. In the request for cooperation, it was stated that there was no disadvantage in the case of long-term prescriptions necessary and appropriate within the scope of medically recognized, excluding drugs for which the number of days of prescription was determined in accordance with the relevant regulations (psychiatric solutions, etc.). Relevant regulations include notification of details on the application standards and methods of medical care benefits, notification of details on application standards and methods of medical treatment benefits for drugs prescribed and administered to cancer patients, and approval from the MFDS. On the other hand, although the health authorities recognize appropriate long-term prescriptions to strengthen coverage, there is no pharmacists' compensation for dispensing fees due to long-term prescriptions, so increasing the work of pharmacists will be inevitable. It has been pointed out that the current pharmacy dispensing fee limits the number of dispensing days to 91 days, so it does not reflect the increase in the pharmacy's workload due to the increasing trend of long-term prescriptions. In addition, with the spread of COVID-19 and face-to-face treatment, long-term prescriptions by medical institutions are rapidly increasing, but there is no discussion on an appropriate compensation system. Looking at the 'Work Volume Relative Value Development Study for the Third Relative Value Reorganization' conducted by the Korean Pharmaceutical Association through the external research service of the HIRA, it is prepared for 91 days or more by properly reflecting the form, scope, and level of the dispensing service. There is a need for a drugstore dispensing fee calculation system such as subdividing the number of days.
- Policy
- SCD's Eylea biosimilar was approved for phase III trials
- by Lee, Tak-Sun Sep 07, 2020 06:12am
- Eylea by BayerSCD Pharm has been approved for a phase III clinical trial of a biosimilar for Eylea (Aflibercept, Bayer), a macular degeneration treatment for the third time in Korea. In June, it was approved for the third phase III clinical trial following Samsung Bioepis and Amgen. It is noted who will succeed in commercialization first in Korea. On the 2nd, the MFDS approved the multinational phase III clinical trial protocol of 'SCD411' applied by SCD Pharm. This clinical trial is a phase III randomized, double-blind, parallel group, multicenter trial that compares efficacy, safety, tolerability, pharmacokinetics, and immunogenicity between SCD411 and Eylea in new vascular age-related macular degeneration test subjects. As a multinational clinical trial, the total number of subjects is 560, and 75 in Korea will be recruited. The test is conducted at Samsung Medical Center, Ajou University Hospital, and Asan Medical Center in Seoul. It is the third phase III clinical approval of Eylea biosimilar this year. On June 11th, Samsung Bioepis, and on June 29th, Amgen's biosimilar was approved by global CRO, Parexel Korea. Eylea, along with Lucentis, is the most used macular degeneration treatment in the world. Macular degeneration is the #1 cause of blindness in the elderly, and there is high demand for medicines. Eylea recorded ₩46.8 billion in sales based on IQVIA last year. SCD Pharm was approved by the US FDA for a phase III clinical trial of Eylea biosimilar in May. The company has announced a plan to release the product in 2023 after applying for approval the next year after going through phase III clinical trials.
- Policy
- The MFDS supports ₩25.6 billion for COVID-19
- by Lee, Tak-Sun Sep 04, 2020 06:53am
- The MFDS has established a budget of ₩25.6 billion next year to support the commercialization of COVID-19 vaccines and K-quarantine products. The MFDS announced on the 2nd that the government budget for 2021 has increased by ₩45.2 billion (8.1%) from ₩559.2 billion this year to a total of ₩604.4 billion. The budget for 2021 includes that ▲ securing food safety for consumers to become healthier ▲ strengthening the management of medicines and medical devices that patients can rest assured ▲ building a preemptive safety foundation for the future. In particular, it announced that it will provide a solid foundation for safety against the post-coronavirus by supporting domestic development, commercialization, and rapid supply of vaccines with high dependence on imports, and to closely manage hygiene and nutrition to small daycare centers that do not have the obligation to hire nutritionists to ensure the safety of children's meals. In detail, a drug design-based quality by design (QbD) model was developed (₩3.2→5.2 billion) for the establishment of a pharmaceutical smart factory, and the 'Advanced Biopharmaceutical Regulatory Science Center' was operated (₩900 million) and a long-term tracking investigation system (₩2.9 billion). In addition, the MFDS explained that it will expand support for the commercialization of innovative medical devices and establish a management system (₩100 million →₩1.2 billion) and technical support for the commercialization of in vitro diagnostic medical devices (₩400 miliion → ₩900 million). In addition, it plans to implement patient-centered safety management of medical products by preparing the basis for evaluation of next-generation medical products (R&D, ₩4.1 billion) using big data produced in medical fields. The MFDS added that it will reinforce national testing equipment and built a BSL3 laboratory (₩700 million→₩4.5 billion) to quickly supply COVID-19 related vaccine and treatment in Korea and will expand support for the operation of Hwasun 'Vaccine Safety Technology Support Center' (2→₩5.8 billion) to improve the domestic vaccine self-sufficiency rate. In addition, to support the development of K-quarantine products, a laboratory dedicated to the quality and performance of in vitro diagnostic medical devices (₩1 billion) was installed, and research on approval/examination evaluation technology for quarantine products such as COVID-19 treatments, vaccines, and masks (R&D, ₩4.4→ 6.9 billion), and it has announced that it will start a business (R&D, ₩3.1 billion) that will lead the biohealth industry. The MFDS announced that when the government budget for 2021 is finalized in December of this year through the parliamentary deliberation process, it will promptly and actively promote next year's major projects, including national tasks, as a vision for 'safe food and medicine, healthy citizens'.
- Policy
- DREC and Cancer Committee to convene more on-paper meetings
- by Lee, Hye-Kyung Sep 03, 2020 06:29am
- The South Korean government is to alleviate on-paper deliberations related regulation for the first threshold of pharmaceutical reimbursement listing—the Drug Reimbursement Evaluation Committee (DREC) and Cancer Deliberation Committee. The Health Insurance Review and Assessment Service (HIRA) preannounced partially revised managerial regulation on the committee that loosens and amends on-paper review regulations. Relevant public opinions would be accepted until Sept. 7. HIRA regularly convenes DREC meeting on every first Thursday of a month, and Cancer Deliberation Committee has scheduled eight meetings for the rest of the year. Amid COVID-19 pandemic, however, DREC and Cancer Committee meetings were postponed or delayed the decision making on drug reimbursement listing due to the regulation limiting on-paper review to two consecutive times. As a result, patients and pharmaceutical companies’ complains have snowballed. Accordingly, HIRA has decided to alleviate the on-paper review regulation stipulated in DREC and Cancer Committee managerial regulations. The current regulation stipulates, ‘a deliberation can be conducted on-paper, in case of urgent or non-critical case, but the on-paper review and deliberation cannot be conducted more than two consecutive times.’ The newly revised regulation would allow on-paper review and deliberation ‘in case the committee chair decides an in-person meeting cannot be convened for urgent or unavoidable reasons, or more than one-third of the registered committees have requested for on-paper deliberation with the attached No. 9 template.’ HIRA official stated, “The on-paper deliberation related regulation would be alleviated to efficiently operate the committees,” and “the revisions were made based on similar regulations in other Expert Evaluation Committees.” When finalized, the latest amendment aims to improve the continuity of tasks such as drug listing or reimbursement expansion, when in-person review is unfeasible due to a threat to public health like COVID-19.
- Policy
- Celltrion's COVID-19 antibody treatment phase I completed
- by Lee, Tak-Sun Sep 03, 2020 06:27am
- The MFDS announced on the 1st that the COVID-19 antibody treatment drug Celltrion is developing has completed phase I clinical administration and is currently under review of phase II/III trial plans. The MFDS announced the progress of the COVID-19 treatment and vaccine clinical trials in the explanatory data. Celltrion's new drug (CT-P59) for neutralizing antibody therapy (CT-P59), has been administered in phase I clinical trials in healthy people, and plans for phase II/III clinical trials are currently under review. Celltrion is recruiting patients with approval for a phase I clinical trial in the UK as well. The 'Plasma Fractionation Treatment' developed by GC Pharma, which was approved for a phase II clinical trial on the 20th of last month, is scheduled to conduct a clinical trial for patients with COVID-19 symptoms within 7 days from September at 6 hospitals including Samsung Medical Center. Specifically, plasma fractionation therapy will be administered to 15 patients per group at low, medium, and high doses in addition to the existing treatment for pneumonia patients identified by imaging diagnosis, patients 70 years of age or older, and patients with underlying diseases over 60 years of age. According to the MFDS, there are currently 22 clinical trials approved in Korea (20 treatments, 2 vaccines). Of these, 5 treatment clinical trials have been completed, and a total of 17 clinical trials currently in progress (15 treatments, 2 vaccines) In addition, 12 clinical trials are being conducted by pharmaceutical companies, and 5 clinical trials are being conducted by researchers. The MFDS announced that it is in the process of prompting national shipment approval with the aim of supplying approximately 30 million seasonal flu vaccines, up 20% from last year, in preparation for the simultaneous outbreak of seasonal flu and COVID-19. Through this, it plans to ship more than for 26 million people before September 22, when the NIP program starts in earnest.
- Policy
- IND for AK-216 (Vildagliptin) by Alvogen Korea was approved
- by Lee, Tak-Sun Sep 03, 2020 06:27am
- Galvus by NovartisAlvogen Korea is launching a phase III clinical trial of Vildagliptin, a diabetes treatment of DPP-4 inhibition. It is entering phase III in 9 months after approval of clinical trial I in November of last year. However, the effectiveness with Metformin, not monotherapy, are verified. While generics for Galvus are aiming for an early release through a patent challenge, it is noteworthy whether they will fall into an ambush On the 31st of last month, the MFDS approved the Phase III Clinical Trial Protocol (IND) for AK-216 (Vildagliptin) by Alvogen Korea. Type of AK-216 is known as a sustained-release tablet taken once a day. Currently, the original drug Novartis' Galvus 50mg requires a total of 100mg twice a day. AK-216 is expected to improve patient convenience by reducing the dosage. This clinical trial demonstrates the efficacy and safety of Vildagliptin SR tablet (AK-216) compared to Vildagliptin (Galvus) when Vildagliptin is administered concurrently to patients with type II diabetes who have insufficient blood sugar control with Metformin alone. It is conducted for comparative evaluation. It is scheduled to be conducted at the Asan medical center in Seoul for 356 patients in Korea. Currently, the material patent of Galvus 50mg is scheduled to expire on March 4, 2022. Ahn-gook and Hanmi succeeded in invalidating 187 days at the Intellectual Property Trial and Appeal Board through a request for invalidation of an extension of the duration, laying the foundation for launching from August 30 next year. However, the decision of the Patent Court, which can be called an appeal trial, is scheduled soon, so the outcome cannot be predicted. In addition, Hanmi has devised a strategy for splitting indications, but it was canceled after the Intellectual Property Trial and Appeal Board dismissed the claim in July. Alvogen's sustained-release tablet is expected to complete phase III clinical trials in line with the expiration of the material patent. Even if Ahn-gook and Hanmi launch generic for Vildagliptin in advance, it is likely that the preoccupation of Alvogen's product will be less affected. Alvogen has been using a strategy to supply developed IMD to other companies through licensing out. Accordingly, it is expected that Vildagliptin SR tablet will receive attention from the various pharmaceutical companies. Galvus recorded an outpatient prescription amount of ₩8.7 billion last year according to UBIST.
- Policy
- 2021 MOHW budget KRW 90.15 tln--KRW 131 bln on COVID-19
- by Kim, Jung-Ju Sep 03, 2020 06:27am
- South Korea’s Ministry of Health and Welfare (MOHW) has finalized next year’s budget plan with 90 trillion won. The state funding for National Health Insurance (NHI) has been raised to 9.5 trillion won. 131.4 billion won was allocated on providing support on R&D seeking COVID-19 treatment and vaccine. Moreover, the state-led new drug R&D program’s budget has increased by 15.1 billion won, and pharmaceutical industry development support was increased by 1.1 billion won to 16.1 billion won. MOHW stated on Sept. 1 that 90.15 trillion won, with 9.2 percent increase compared to this year, has been appropriated for the 2021 budget plan to mainly enhance public health risk response capacity, expand public medicine facility and improve platform for the ‘Inclusive State.’ The government’s projected overall expenditure in 2021, passed by the Cabinet meeting on Sept. 1, would grow by 8.5 percent from this year to 555.8 trillion won. Within the budget plan, MOHW’s projected overall expenditure is to reach 90.15 trillion won, with 9.2 percent increase from this year. The projected figure would take up 16.2 percent of the overall government expenditure. ◆Enhancing public health risk response capacity—R&D on infectious diseases: The government has allocated budget to assist developing COVID-19 treatment and vaccine, and to upgrade equipments for infectious disease control. Total budget of 131.4 billion won, consisting of 62.7 billion won on treatment and 68.7 billion won on vaccine, were finalized. Additionally, 16.5 billion won would be injected for upgrading infectious disease control equipment and testing kit, and developing relevant technology. .The budget was approved for the use of building R&D infrastructure responding against novel infectious diseases like COVID-19 .The government has cleared a budget of 5.2 billion won to continue projecting severity of prognosis and developing treatment through analyzing clinical data from confirmed COVID-19 cases .5.8 billion won was approved to operate antiviral pharmaceutical test lab, while the budget for operating public vaccine development and support center has been expanded from 5 billion won to 13.6 billion won .Also, a budget of 3.3 billion won was given to constructing facility and laboratory infrastructure for the National Infectious Disease Research Institute .◆Preparing for the future health and welfare—fostering K-Bio: MOHW has decided to expand R&D and financial investment on infectious disease, regenerative medicine, data, and new drug .The ministry’s major healthcare R&D budget plan allocated 791.2 billion won for next year, increasing 49.9 percent compared to 527.8 billion won in 2019 .Innovative new drug R&D support would be also provided to nurture Korean-made new drug development .15.1 billion won would be injected to push state-led new drug development, covering candidate medicine discovery to commercialization .Meanwhile, 3.3 billion won would be assigned to state-led new anticancer treatment development .The ministry budgeted 6.8 billion won on training specialists on bioprocessing and AI-basis new drug development and clinical trial .More specifically, 3 billion won on training Korean National Institute for Bioprocessing Research and Training (NIBRT) consultant and instructor, 2.1 billion won on biopharmaceutical specialists, 1 billion won on training and promoting AI-basis new drug development and 700 million won were drawn up for the budget .A separate budget plan for promoting regenerative medicine, backed by the Advanced Bio Act, was set .From basic science research like induced pluripotent stem cell (iPSC) technology for regenerative medicine to developing advanced biopharmaceuticals, rare disease treatment clinical research and relevant R&D would be operated according to the new legislation .Particularly for the regenerative medicine R&D, a budget of 10 billion won on regenerative medicine clinical study, and 6.4 billion won on pan-government regenerative medicine R&D program were set .A big data platform would be built to incorporate public institute data, genome and medical data for the technological innovation in biohealth .And 60.2 billion won would be spent on pan-government medical device R&D program covering from R&D to clinical trial, approval and commercialization .A budget of 5.3 billion won was set for healthcare professionals to conduct clinical evaluation and receive training to use Korean-made medical devices .◆Expanding public medicine: MOHW expanded the state funding for the support on improving medical safety net through NHI coverage enhancement .The publicness of regional medical center would be strengthened as well .The government plans to enhance the infectious disease response capacity of regional medical centers and to expand regional healthcare institutes (from 12 to 15), and provincial healthcare institutes (from 15 to 35) .Also, some of the budget was allocated for the preventive healthcare program, or so-called ‘Korean New Deal.’ As a pilot program, MOHW would expand healthcare centers subject for preventive healthcare program through ICT devices (Bluetooth blood pressure monitor, and blood glucose monitor) currently set as 30 to 80 sites .The healthcare center’s customized healthcare support program via mobile app for high-risk patients with chronic disease would incorporate 160 sites with 20 more sites than this year .Additional human resources for the program would be dispatched as well .◆The Inclusive State—healthcare reimbursement: The government plans to increase the overall NHI reimbursement per beneficiary, currently set at 6.50 trillion won, to 7.23 trillion won with 11.2 percent increase .And by cooperating with NHI, the ministry would continue to enhance healthcare coverage .
- Policy
- HIRA clears all Strensiq pre-approvals from July
- by Lee, Hye-Kyung Sep 02, 2020 06:18am
- Handok’s rare disease treatment Strensiq injection (asfotase alfa) passed the preliminary approval review and processed the first reimbursed administration. Listed for healthcare reimbursement as of June 1, Strensiq is a third drug to be required to receive pre-administration approval for a reimbursed use of the drug. Soliris injection (eculizumab) and Spinraza (nusinersen) are the other drugs required to pass the pre-approval. . Health Insurance Review and Assessment Service (HIRA) Healthcare Review and Assessment Committee has approved of granting reimbursement on two cases that applied in July .Strensiq’s maximum pricings for all doses are set at 806,964 won (12 mg), 1,210,446 won (18 mg), 1,882,916 won (28 mg), 2,689,880 won (40 mg), and 5,379,760 won (80 mg) .Handok has signed the Korean market sales right deal over Strensiq with the U.S.-based company, Alexion on Nov .17, 2016 to strengthen their strategic partnership first made through Soliris .Strensiq is indicated as an enzyme replacement therapy treating bone related symptoms in patients with infantile-onset hypophosphatasia (HPP) .A patient with infantile-onset HPP would receive coverage when qualifying all following conditions—level of alkaline phosphatase (ALP) measures lower than normal range of the certain age and sex group but exceeds normal range of Pyridoxal-5’-phosphate (PLP); bone condition unique to HPP confirmed through radiograph prior to treatment; initial treatment received before the age of 19 .A clinical evaluation (height, weight, reparatory function, motor development stage, ambulatory function and pain) has to be conducted prior to the initial treatment, three and six months into the therapy, and every six months from then on .The pre-approvals were respectively deliberated on male children aged four and six .The four-year-old was diagnosed with HPP eight days after the birth, and started using Strensiq from the first month (June 2016) .The six-year-old was diagnosed with the same disease at 11-month-old and started administering the injection from 21st month (January 2016) .These patients were provided with the coverage on the continuous treatment as their clinical evaluation, blood test and radiological report after the administration improved, and they did not reach the administration suspension standards . Meanwhile, two out of three reimbursed administration applications on spinal muscular atrophy (SMA) treatment Spinraza were approved from last month .The health authority requested additional supplementary data .The 28 administration monitoring reports were all cleared . For this time, Soliris did not have anyone requesting for new administration in a patient with paroxysmal nocturnal hemoglobinuria (PNH), but only three out of six new applications on treating atypical hemolytic uremic syndrome (aHUS) have been cleared .The other three have been denied .
