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- 2026-04-14 13:28:25
- Company
- Hemlibra reimbursement disapproval raises anxiety
- by Nho, Byung Chul Jun 08, 2021 06:01am
- The head-on clash between the ‘standard to first consider immune tolerance induction (ITI·antibody removal) therapies’ and the ‘due prescription rights of doctors·convenience in administration·saving NHI finances’ have received industry attention. On the 3rd, the Health Insurance Review and Assessment Service (HIRA) held a Pediatric Department Special Review Committee to review medical benefit reimbursement of Hemlibra and disapproved its reimbursement. Therefore the clash between the industry·patient groups and the authorities in normalizing its reimbursement is deemed inevitable. The reimbursement standard for Hemlibra that was implemented in February this year allows reimbursement for pediatric hemophilia patients ▲who failed ITI therapy; ▲who meet the ITI eligibility requirements but have a doctor’s note proving they cannot receive ITI therapy; and ▲whose antibodies reappeared after a successful ITI therapy. On the other hand, for hemophilia patients with antibodies, the reimbursement guidelines recommend to HCPs to first consider using ITI therapy. HIRA’s regulations prioritize the use of ITI therapy in high-antibody patients in years 1-5, patients with frequent bleeding, and patients with intracranial bleeding. The issue arose regarding the reimbursement standard ‘Those who meet the ITI eligibility requirements but have a doctor’s note proving they cannot receive ITI therapy.' The committee requested objective data proving that it was difficult to secure venous blood vessels and that it was impossible to attempt ITI therapy when administering Hemlibra. However, the medical community and patient groups protest saying that “Most patients are under 5 years of age, therefore, providing data on the state of their blood vessels following intravenous injections and objective measurement of their pain is virtually impossible. The specificity of the circumstances and environment isn't being considered.” In other words, their argument is that requesting data based on scientific grounds when there is no objective data to present is in itself nonsense. Two large hospitals, A and B Hospital in Seoul and Daegu, had administered Hemlibra to 4 hemophilia patients under the age of 12 during the last two months according to doctors’ justifiable opinion. The pharmaceutical cost of Hemlibra amounted to 30 million won per patient for the 2 months, and if the hospitals decided to exercise their right of claim rather than suffer the loss, the cost will solely be imposed on the patients. On this, an official from the Korean Society on Thrombosis and Hemostasis said, “Insisting or forcing pediatric hemophilia patients under the age of 12 to receive intravenous ITI therapy is not a desirable means of treating the disease. Also, the HIRA's disapproval of reimbursement for Hemlibra this time is inconsistent with the reimbursement standard that explicitly states that Hemlibra may be administered with a justifiable doctor’s note." Patient groups also strongly expressed their objection, pointing out that “Current standards do not require ITI therapies before existing bypassing therapies. Making the decision to administer Hemlibra does not mean that the doctors did not consider ITI therapies. The committee’s decision to restrict only Hemlibra with such a condition is unacceptable.” Meanwhile, the deliberation results of the Pediatric Department Special Review Committee will be finalized after resolution by the Central Review & Assessment Coordination Committee, and the claims for re-examination and objections to adjust drug costs may be filed within 60 days. Attention is now on whether the voices of the pediatric patients and their parents will be reflected in addition to the efforts made through Cheong Wa Dae’s public petition and Anti-Corruption and the Civil Rights Commission’s adjustment efforts.
- Policy
- PVA is a variable in the negotiation of α-GPC recovery
- by Lee, Hye-Kyung Jun 08, 2021 06:01am
- Re-negotiation on benefit recovery and PVA negotiation related to pharmaceuticals with the brain functional improvement agent "Choline alfoscerate" have emerged as variables. On the 3rd, the MOHW ordered the NHIS to conduct negotiations on 123 items of Choline alfoscerate for 40 days from June 4 to July 13. Choline alfoscerate recovery negotiations, which began on December 14 last year, have been under way four times so far, and 123 items from 58 final companies have not been agreed on. The pharmaceutical industry is questioning the effectiveness of the fourth round of negotiations that will be held again after failing to reach an agreement over the past six months. The NHIS considered the fourth round of negotiations to be the final stage, and says it will ask the MOHW to remove the benefit in the event of a final breakdown. If the NHIS' drug price management department (excluding the generic negotiation department) has been involved in the Choline alfoscerate negotiations due to lack of work and manpower, this time the drug price planning department will be in charge of negotiations. The Pharmaceutical Price System Planning Department is a department led by Lee Young-hee, who was in charge of major negotiations in the past, including high-priced anticancer drugs such as "Keytruda," "Opdivo" and "Spinraza." Based on her experience in negotiating various new drugs, She plans to conclude negotiations on the recovery of Choline alfoscerate. In particular, the inclusion of Choline alfoscerate from a large pharmaceutical company, which is suing the MOHW and the NHIS for suspension of execution, emerged as a variable in the recovery negotiations. Last year, Arlico, Hana, and Kyungbo were lowered as PVA 'Da' type (the amount of drug claims in 2019 increased by more than 60% or increased by more than 10% from 2018 and increased by 5 billion won). The pharmaceutical companies agreed on a contract clause that states that "if permission is revoked as a result of revaluation, the pharmaceutical company must return the full amount of the claim from the date of the MFDS' clinical trial to the NHIS." In the case of PVA negotiations, it is necessary to sign an agreement to return the full amount of the NHIS claim if there are problems with safety and validity such as clinical revaluation as well as drug price reduction. Attention is focusing on what choice pharmaceutical companies with PVA negotiated items will make at a time when the NHIS lowered the recovery rate by up to 50% of health insurance claims in the last third round of negotiations.
- Company
- Pros and cons of the spin-offs and sales of Big Pharmas
- by Eo, Yun-Ho Jun 08, 2021 06:01am
- Mergers, spin-offs, buying, selling... news shows that global Big Pharmas have been busy constantly changing their shape. In particular, the issue that gained the most attention for the past few years was the companies' spin-offs and sales. Although the companies' made the decision under the premise of ‘focusing on one’s strengths,’ such divisions and sales have brought out both positive and negative views. One thing to note is that these changes have been occurring 'serially' among global pharmaceutical companies. ◆Change in the development trend and surging investment cost = Although it is difficult to pinpoint the root cause of the constant change, a trend is evident. Development of new drugs is difficult, even without specifying the 1 in 10,000 probability of success. Also, successful development does not directly translate to actual sales. And this problem continues to intensify. Hidden within the shadow of the often-discussed ‘open innovation' n the global market. exists the rampant new drug famine. Discovering new substances is difficult and the risk keeps increasing, so ‘sharing’ the burden became the solution. With the field of chronic disease ruled out as ‘drugs in need have already been released,’ the industry's focus is now on anticancer drugs and rare diseases. Also, with the increase of cutting-edge new drugs that have dozens of indications for a single substance, Big Pharmas are now faced with a situation where they would need to spend astronomical amounts just on the Phase III trial of its new drugs. As the direct discovery of candidate substances has become increasingly difficult and buying promising new substances (candidate substances) or venture businesses that own such substances, the companies' investment spending has skyrocketed as well. From the Big pharma’s perspective, this means that their already-high proportion of investments have doubled. Not only Takeda, Pfizer, and MSD, which carried out spin-offs and sales of its business units, but companies that prided in their R&D such as Novartis, Sanofi, and Bayer have announced at least 3-5 acquisitions of drug substances or companies every year. The size of mergers and acquisitions by global companies had already exceeded 400 trillion won in 2019. The advent of the 'age of high-priced drugs’ that is emerging as a social issue is not unrelated to this large amount of investments. A Business Development personnel who returned to the Korean subsidiary after working at its global headquarters said, “Big Pharmas are reducing directly conducted projects that start from substance discovery. The companies have turned their direction to buying promising substances to reduce the investment risk. However, the problem that companies face is that the price of venture businesses that own such substances have also been rising rapidly.” ◆Stock price and stockholders… the BU system and spin-offs = The rise in investment cost and corporate spin-offs may seem unrelated at a glance, but this is also not the case. A company's stock price and its stockholders are currently exerting wider influence on the decision-making process of the Big Pharmas than in the past. For example, when a company maintains its size and only increases investment, investors worry that the stock price will fall due to decreased cash flow. The corporate spin-off is one option that such companies could select in these cases. No matter how promising a new drug may be, investment in its substance eventually affects the financial solvency of the company. Spin-offs allow the company to divide its size and profit structure. In other words, the company can subdivide its business by concept to an investment-focused part and a legacy part – and recreate the company. Equity spin-offs do not burden the company as there is no exercise of appraisal rights. Since the company becomes a legally independent company after the spin-off, the spin-off may go public immediately afterward. Prior to such spin-offs, most multinational pharmaceutical companies first proceed with restructurings that have a split-off tendency that may serve as a foothold for improving the financial solvency of the company or for the sale of its businesses. For example, before Pfizer completed its spin-off of Viatris, it had established a 3-Business Unit system and separated its legacy brand ‘Upjohn,’ then spun-off Upjohn and combined it with Mylan N.V. to form Viatris. The recent MSD’s spin-off of Organon and Takeda’s sale of its diabetes and OTC business, Novartis’ decision to independently operate its pharmaceuticals and oncology division, and Abbott’s separation of ts biopharmaceutical division as Abbvie were all made in the same context. An official from one multinational pharmaceutical company said, “The criticism that the pharmaceutical companies are now acting on behalf of its shareholders rather than their patients also stem from this phenomenon. However, with the proportion of venture capital (VC) investors (financial investors) increasing, the companies do not have many options to choose from with regards to their operations."
- Policy
- Pipeltro/Delstrigo will be reimbursed if the amount offered
- by Lee, Hye-Kyung Jun 08, 2021 06:00am
- Pipeltro (Doravirine) and Delstrigo (Doravirine, Lamivudine, Tenofovir), the HIV treatment by MSD, are the two major human immunodeficiency virus. And, were declared "Conditional Coverage" at the first step of the reimbursement if it was accepted below the appraised amount. On the 3rd, the HIRA held the 5th Pharmaceutical Benefits Advisory Committee in 2021, and conducted a review of benefit adequacy for new drugs related to HIV and asthma. Pipeltro, a combination of other anti-retroviral drugs for HIV-1 treatment, and Delstrigo for adult patients were proposed, but MSD's submission to the HIRA was higher than that of the Pharmaceutical Benefits Advisory Committee. Both Pipeltro and Delstrigo have received indications for HIV-1 treatment in adult patients who have no previous experience in antiretroviral treatment. Gilead, GSK, MSD, Janssen, AbbVie, and BMS are competing in the HIV sector in the domestic market, with Gilead and GSK accounting for about 90% of the market. Novartis Korea'sAttectura Inhalation Cap. (150/80μg, 150/160μg, 150/320μg) and Enerzair Breezhaler (150/50/80μg,150/50/160μg) will also be accepted below the evaluation amount. The Board of Review and Assessment assesses the appropriateness of drugs after deliberation by the Pharmaceutical Benefits Advisory Committee in accordance with Article 11-2 of the National Health Insurance Care Benefit Standards. The results of the Pharmaceutical Benefits Advisory Committee assessment are subject to changes in the scope of the drug's detailed benefit and other criteria items, changes in the authorization of the item applied for and revocation of the permit.
- Company
- HPV vaccine market expands 55% midst COVID-19
- by An, Kyung-Jin Jun 07, 2021 06:06am
- The market for the vaccine to prevent cervical cancer has expanded by the greatest amount ever. The increased inoculation rate of the high-priced 'Gardasil 9' has led the total market growth. MSD, which owns two HPV vaccines - 'Gardasil' and 'Gardasil 9' - accounted for 97% of the total market, and boasted its overwhelming influence in the domestic market. According to the industry research institution IQVIA on the 7th, the HPV vaccine market size in Q1 of this year was 22.9 billion won. This was a 55.5% increase from the same quarter of the previous year and the highest-ever quarterly sales record. The COVID-19 outbreak had temporarily slowed down market growth in the first half of last year, but sales turned back upwards in the second half. Since then, the market has been breaking its own record for three consecutive quarters. Compared to the 11.6 billion won in Q1 of 2017, the market size has doubled in 4 years. The high-priced ‘Gardasil 9’ acted as a catalyst in the HPV vaccine’s market growth. In Q1, sales of MSD’s ‘Gardasil 9’ recorded 17.4 billion won, which was a 75.6% YoY increase compared to the 9.9 billion won of the same quarter last year. In the same period, MDS’s other HPV vaccine, ‘Garadsil’ sold 4.8 billion won. Although ‘Garadsil’ also showed a 19.0% YoY increase from the 4.1 billion won in Q1 last year, the market was completely overwhelmed by the surge in sales of ‘Gardasil 9.’ In the same period, GSK’s ‘Cervarix’ sales fell 12.0% in one year to record 0.7 billion won in Q1 this year. Among the three products authorized in the Korean HPV vaccine market, the other two, which are MSD products, account for 97.1% of the domestic HPV vaccine market. In other words, MSD has a monopoly over Korea’s HPV vaccine market. MSD has grasped the lead in Korea’s HPV vaccine market in 2016 with the government selecting ‘Gardasil’ and ‘Cervarix’ as products for Korea’s National Immunization Project, and MSD releasing its follow-up ‘Gardasil 9,’ in the latter half of the same year. After selling 2.5 billion won in the first year of its release, sales of ‘Gardasil 9’ grew rapidly to 15.1 billion won in 2017, and 20.9 billion won in 2018. Since becoming the market leader product in 2019, raising 40.5 billion won in sales, twice the amount compared to the sales of ‘Gardasil,’ it had continued its rise ever since. In Q1 this year, the market share of ‘Gardasil 9’ was 76.0%, which was three times than that of ‘Gardasil.’ ‘Gardasil 9’ is a human papillomavirus virus (HPV) vaccine that was manufactured by adding five HPV serotypes 31, 33, 45, 52, and 58 in addition to the four HPV serotypes 6, 11, 16, 18 already in ‘Garadasil.’ It is being distributed at a high price with the differentiation that it covers the most amount of HPV types among existing HPV vaccines. The cost of inoculation paid by the consumers varies by hospital, but a single shot of 'Gardasil 9' may at most be 100,000 won more expensive than ‘Cervarix.’ Nevertheless, the demand for ‘Gardasil 9’ among adults not subject to NIP increases. News that the vaccine can prevent other HPV-related diseases such as anal cancer, genital warts, premalignant lesion, in addition to cervical cancer had spread through word of mouth, and the ‘couple vaccination’ promotions in obstetrics and gynecology clinics have been increasing the number of male inoculations every year as well. Since last year, the vaccination age for HPV vaccines was expanded to 45 years, and the rate of reinoculations has also increased significantly. One other factor that may have lead to a sales surge in Q1, is the pre-supply orders from hospitals and clinics in preparation for the price hike announced by the pharmaceutical company. MSD Korea has raised the supply price of 'Gardasil 9' and 'Gardasil' by 15% from April this year, citing rising production input costs. MSD Korea has changed its domestic distributor for ‘Gardasil 9' and 'Gardasil' to HK Inno.N this year and has been conducting co-promotion with the company ever since.
- Policy
- Ultomiris can be reimbursed with prior approval
- by Lee, Hye-Kyung Jun 07, 2021 06:06am
- Ultomiris (Ravulizumab), Handok's paroxysmal nocturnal hemoglobinuria (PNH) treatment, will be listed at ₩5,598,942 per bottle starting today (7th). The upper limit price for Soliris (30ml) is ₩5,132,364, so if 3 vials are administered every other week, about ₩400 million won is needed for a year. Ultomiris, on the other hand, can be administered at a maintenance dose every eight weeks from two weeks after the initial dose, which is expected to lower the annual dose per patient compared to Soliris. However, like Soliris, the pre-approval system is introduced, and health authorities check from before to after the administration. The HIRA recently conducted a "Guidance on Establishment and Announcement of Details on Pre-Approval of Ultomiris" and asked the head of the HIRA to apply for approval for use before administration. Medical institutions equipped with personnel, facilities and equipment prescribed by the criteria for madical benefits for hematopoietic stem cell transplantation may apply for prior approval of Ultomiris for patients with paroxysmal nocturnal hemoglobinuria (PNH). The pre-approval review will take place on Thursday the last week of the even month at the Ultomiris Subcommittee, which will be set up within the Medical Review and Assessment Committee. In the event that the Ultomiris subcommittee approves the reimbursed administration, it must be administered within 60 days from the date the medical institution is notified of the results of the deliberation. It must be reapplied if administered after 60 days. Ultomiris was approved by the U.S. Food and Drug Administration (FDA) in December 2018 and the European Medicines Agency (EMA) in July 2018 and obtained an item license on May 21, 2020. Handok applied for insurance registration as of August 31 after the permit, and the HIRA submitted it to the Pharmaceutical Benefits Advisory Committee as of March 4 this year to determine that it would be appropriate to accept it below the weighted average price of alternative drugs. The Pharmaceutical Benefits Advisory Committee considered clinical usefulness to be inferior to Soliris, an alternative drug based on clinical trial results, but found it cost effective if Soliris' weighted average of ₩5,598,942 or less per bottle. As the company accepted it, it has agreed to ₩33 billion through negotiations with the NHIS on expected claims.
- Policy
- SK Bio regains license for 'SKYPneumo'
- by Lee, Tak-Sun Jun 07, 2021 06:06am
- SK Bioscience regained its license for its ‘SKYPneumo,’ the first-ever pneumococcal vaccine developed in Korea. This approval comes in less than a year since the company had withdrawn its license in October last year in the aftermath of losing a patent suit. On the 4th, the Korean Ministry of Food and Drug Safety (MFDS) approved SK Bioscience’s 13-valent pneumococcal vaccine, ‘SKYPneumo prefilled syringe inj..' The vaccine is used for infants six weeks to 6 months old and adults over 50 years of age to prevent pneumococcal disease. It was approved by demonstrating its non-inferiority to the existing vaccines in clinical trials. The MFDS designated the vaccine's re-examination period to June 3rd, 2025. SKYPneumo had been previously approved in July 2016. However, the drug was unable to enter the market after losing a patent suit to Pfizer’s Prevnar 13 which had been dominating the pneumococcal vaccine market. Prevnar 13 is also a vaccine to prevent pneumococcal diseases. SK Bioscience filed a suit claiming the invalidity of the composition and formulation patent of Prevnar 13. However, the Supreme Court rejected the claim in December 2018. Due to this ruling, the company was not allowed to sell SKYPneumo until 2026, when the patent for Prevnar 13 expires. Unable to meet the post-marketing surveillance and other requirements, the company had voluntarily withdrawn its license for SKYPneumo last October. It will be difficult for SK Bioscience to market SKYPnuemo as approved until March 2026, when the patent for Prevnar 13 expires. Therefore, the eyes are on whether SK Bioscience will succeed in avoiding the patent rights with a new strategy and be released in the market. Meanwhile, according to IQVIA, Pfizer’s Prevnar 13 sold 81.3 billion won in sales just last year.
- Policy
- Botulinum Toxin is poorly managed
- by Lee, Jeong-Hwan Jun 07, 2021 06:05am
- Poor management of some domestic botulinum strains has been detected. Illegal circumstances have also been detected, including analysis of strains' sources and characteristics, security management of fungus handlers, illegal acquisition of strains, and suspected cases of false separation reports. Authorities are planning to jointly come up with measures to strengthen safety management of bio pathogens, including botulinum bacteria. On the 3rd, the KDCA announced the results of an all-in-one survey of 24 botulinum-bearing institutions, including Botox producers' acquisition of botulinum strains and illegal transactions. The KDCA conducted a written survey of 24 institutions from December 2 to 11 last year and conducted an on-site survey of 11 institutions from February 3 to March 4 this year. As a result of the investigation, insufficient management was confirmed, including analysis of the source and characteristics of strains, security management of bacteria handlers, illegal acquisition of strains, and suspected cases of false separation reports. Inspection items included permission to possess germs, separation and movement of germs, violations of the Biochemical Weapons Act, detailed copies of experimental notes, interviews with fungal separators, and results of the agency's security system. Botulinum toxins are highly likely to use bioterrorism, which requires strict management, but it has been revealed that there is a lack of human security management system to prevent illegal transactions and exploitation. Suspicions of strains exploitation have been raised through the transfer of some handlers, but problems have also been identified without legal grounds to identify the list of handlers and the status of transfers. There was no regulation on the reasons for disqualification, such as the definition and scope of handlers and criminal experience, so there was even a blind spot for management. In addition, there was no mandatory regulation for record preparation and management, including research notes that record the entire process of research and development, and genetic information on pathogens such as the entire sequence was excluded from the management list. Of the seven institutions that conducted on-site surveys to check whether bacteria were separated, five institutions were not prepared experimental notes by date and experimental process, and two institutions were confirmed to lack experimental notes. It has been confirmed that strains of some institutions reported to be separated in Korea are very similar to those of the United States. Specifically, the problematic strains had a genetic sequence consistency of 99.99% or more with the U.S. strains. While trying to determine the source of botulinum, there were also suspected violations of genetically modified organism and methods for prevention of infectious diseases related to safety management of pathogens. A total of four violations of the law, including two suspected violations of mobile reporting, one violation of genetically modified organism development and approval of experiments, and one suspected false separation report. In consultation with related ministries and the National Assembly, the KDCA plans to revise related laws, including the mandatory submission of strains to test records of bio-terrorism infectious disease pathogens, handler management, and bio-terrorism pathogen data (DB). It will also push for mandatory recording and management, such as preparing research notes and diaries for experiments and production processes related to bacterial handling. The government plans to investigate and analyze overseas cases so that it can check the criminal history and mental history of handlers and introduce the disqualification of handlers in accordance with domestic conditions. The goal is to prevent false reports and illegal transactions by making it mandatory to submit strains if they have bioterrorism pathogens such as botulinum bacteria. It will also quickly respond to bioterrorism by establishing an analysis of the entire sequence of bioterrorism pathogens, genetic diversity analysis, and molecular epidemiological in the event of bioterrorism. In addition, the government will prepare methods and procedures necessary for establishing and implementing security measures for fungal handling agencies to prevent exploitation, outflow, and deviant behavior of strains. "Botulinum, which produce neurotoxins that are fatal to humans, can pose a serious risk to people's health in the event of bioterrorism and accidents," Jeong Eun Kyeong, commissioner of the Korea Disease Control and Prevention Agency (KDCA) said. "We will compensate for the deficiencies in the bioterrorism pathogen management system confirmed by the investigation and strengthen safety management," she said.
- Policy
- Improvements to exempted calculation of psoriasis are urged
- by Kim, Jung-Ju Jun 07, 2021 06:05am
- #iThe registration for exempted calculation of severe psoriasis is just a year away. Patients have pointed out the difficulties and problems of the system. The point is that there are many unequal and unreasonable conditions, so the system should be improved to ensure quality before re-registration. The Korea Organization For Patient Group issued a press release today (3rd) calling for new and re-registration of special cases for severe psoriasis and improvement of the system. Psoriasis has been included in this list since June 2017. However, the government is applying exempted calculation only for "severe injuries" rather than all psoriasis. At the time, the NHIS estimated that out of a total of 1.5 million psoriasis patients, about 22,000 had severe psoriasis. Four years after the application of the special calculation case, only about 4,500 patients have been registered, and patient groups have called for improvement. The Korea Organization For Patient Group pointed out that compared to other immune diseases such as spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, the new registration period and baseline conditions for severe psoriasis are strict, which is equivalent to about 17,500 severe psoriasis patients. They also pointed out, "The fact that the existing treatment, which has been effective in treatment at the time of the five-year re-registration standard for calculation, has been set as a condition for re-registration adds to the difficult situation of psoriasis patients." This organization urged to apply the same special system for exempted calculation of severe psoriasis as ▲spondylarthritis ankylopoietica, Crohn's disease, and rheumatoid arthritis, and,▲it also urged the withdrawal of unreasonable criteria for discontinuing drugs under treatment when re-registration of special cases of calculation after 5 years. The Korea Organization For Patient Group emphasized, "These standard issues have lost equity compared to other diseases, and the pain and difficult situation of patients with severe psoriasis have not been properly identified, so they must be withdrawn."
- Policy
- NA prepares bill to prevent 'price cut lawsuit' gimmicks
- by Lee, Jeong-Hwan Jun 04, 2021 06:06am
- A bill to prevent pharmaceutical companies from filing administrative suits for the purpose of evading or delaying drug price cut dispositions made by the government is expected to be introduced at the National Assembly. The bill will prevent the recurrence of cases similar to the suspended execution of drug price cuts ruling for the brain function enhancer choline alfoscerate, which has been a hot issue since last year’s NA audit. An official from Woni Kim’s office of the NA Health and Welfare Committee explained, “The avoidance of drug price cuts and reimbursement suspensions by companies is an issue that every Health and Welfare Committee member should pay attention to. We are preparing to amend relevant laws.” Woni Kim’s office is not the only place preparing a bill. The bill will aim to recover the reimbursed benefits paid to drugs during the period that the price cuts were avoided using the suspension of execution when the pharmaceutical company that filed the administrative lawsuit in objection to the government’s price cut disposition loses the suit. The key is to impose a penalty and exercise the right to indemnity when a pharmaceutical company deliberately pursues a lawsuit to cancel or delay the government’s justifiable drug price cut disposition. Of course, the bill will also include a provision that compensates for the damage suffered by pharmaceutical companies during the litigation period if the government's unjustifiable drug price cut is proven in court after a pharmaceutical company wins the lawsuit. Also, retroactive application of the bill is also being reviewed in consideration of the fact that many drugs including choline alfoscerate are in litigation to cancel their price cuts. The issue of health insurance finances wasted due to objections to price cut dispositions has been an agenda discussed for many years including at last year’s audit. At the NA audit last year, NA Health and Welfare Committee members Insoon Nam and Jaekeun In of the Democratic Party of Korea had appealed the need to amend the laws, criticizing the cancelation and injunction suit filed by choline alfoscerate makers whose reimbursement reduction and price cuts were set. They pointed out that the administrative suits or suspension of execution filed for the drug price adjustment disposition are being used as a means to preserve or make profit for pharmaceutical companies, or that it is causing unreasonable loss of health insurance finances. In had said that an estimate of 150 billion won of health insurance finances was lost in three years from 2018 to 2020 due to the abuse of drug price reduction cancellation lawsuits by pharmaceutical companies. An official from a member’s office of the NA Health and Welfare Committee said, “Several ruling party members in the committee agree to the validity of such a bill and are coordinating the bill with the Ministry of Health and Welfare. Legislation of this bill requires careful examination in retrospective application, enforcement date, and the supplementary provisions, as the issue on choline alfoscerate is still ongoing.” The official added, “Some have criticized that the drug price reduction cancellation lawsuit and injunctions are being abused as marketing tools by pharmaceutical companies to minimize damage from such price reductions. The Ministry of Health and Welfare and the National Health Insurance Service also agree on the need for the bill, so we expect that a bill will be proposed soon.”
