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- 2026-04-26 18:00:10
- Opinion
- Both to blame of the rising Pharmaceuticals & Korea
- by Eo, Yun-Ho Dec 05, 2019 06:16am
- The pharmaceutical industry is a high value-added industry and Korea is now more interested in new drugs than ever before. As interest has increased, the names of pharmaceutical companies that have reported news such as clinical failures, discontinuations, or controversy about efficacy are very popular on the Internet. It is possible. Samsung and Celltrion's biosimilars are being recognized in the US and Europe, and the government is drawing blueprints for preferential treatment of new drug prices under the development policy of the pharmaceutical industry. But it should be clear. If success is easy, it is not a new drug in the first place. According to the analysis of 9,985 data performed or in progress by the US Food and Drug Administration (FDA) for 10 years from 2006 to 2015, the success rate of the phase I was 63.2%, the phase II was 30.7%, the phase III is 58.1%. If we calculate this and estimate the probability that a new drug will be commercialized, it is only 9.6%. Stopping development and failing clinical trials are strange not to happen. However, there is a herd effect and both to blame. It is also true that many pharmaceutical companies aimed at a bandwagon effect like striking while the iron is hot. The clinical entry and completion data of the developed materials and indiscriminately presented data of the development materials, which are distributed indiscriminately without any explanation of what the drug is, aims only at investor psychology. 'Excellent efficacy compared to OOO drugs', 'It is the first XXX cancer drug', 'Secured cardiovascular safety’. It is attractive but shows no evidence. As a result of how many patients were studied and how long the study was conducted, it is not known how the difference was shown in terms of efficacy and safety compared to the comparison group. There is even a case where a comment from a company official called 'Good Medicine' is all about the medicine. story of domestic drug development is encouraging. It should be duly evaluated. This is no time to care of IR (Investor Relations). Shouldn't the stigma of playing with stocks be free itself from restraints of rebates?
- Opinion
- [Column] Legal disputes over rebate penalty reducing price
- by Lee, Hye-Kyung Dec 05, 2019 06:12am
- This year would be a year to remember as various issues regarding drug pricing broke out, such as ‘lump-sum price reduction on single-use eye drops’, ‘revised generic pricing system’, and ‘litigation against pricing reduction penalty for providing rebate’. Currently the drug pricing system is geared towards paradigm shift, starting with abolished ‘same substance same pricing’ policy. Pharmaceutical companies would be helpless but to seek for other survival tactics in the coming year while the drug pricing ecosystem changes. There are many issues to be talked about regarding drug pricing, but today it would be about a few updates on meaningful court decisions made on pricing reduction as an illegal rebate penalty. However, it would mainly be summarized points of the issues as the lower court made the decisions and the issues are still open for long-running disputes. As I introduced in a column titled ‘Rebate and Kick-back’ published December last year, the Korean Ministry of Health and Welfare (MOHW) imposed maximum reimbursement price reduction on 340 items from 11 pharmaceutical companies accused of providing rebate. Currently, the most of affected pharmaceutical companies have filed administrative litigation against the matter. The pricing reduction penalty has not been imposed for years and related legal dispute has not been talked, either. So the recent legal disputes were raised since various issues occurred with MOHW imposing penalty of the massive scale. Going through each dispute issue, the first issue is about whether to consider nature or property of drug pricing reduction penalty as a sanction or not, according to the Item 12 of Paragraph 4 of Article 13 of Regulation for Criteria for Providing Reimbursed Services in the National Health Insurance, stating “a drug that has been confirmed as having disturbed trade orders by offering money or good for sales promotion, etc”, or also known as former rebate regulation. The distinction of the sanction is crucial, because the ministry’s jurisdiction could change depending on the recognition of the discretionary sanction. In other words, when the court recognizes the penalty as discretionary sanction, the judiciary would then decide the penalty was legitimate respecting the administrative agency’s judgment, if without a significant flaw, but if not then the court could revisit the issue. On the issue, the lower court decided drug pricing reduction penalty imposed based on the former rebate regulation ‘could not be seen as sanction, but rather the maximum reimbursement price adjustment should be judged as discretion of reasonable penalty.’ Therefore, the court meant that it would be considered as a legitimate penalty within the discretionary jurisdiction only when the jurisdiction is considered reasonable. With the said premise, the court ruling made decision on jurisdiction of discretionary authority for each specific disputed issue. First, the court ruled that the Minister of Health and Welfare was not obligated to lay down detailed basis of maximum reimbursement price calculation to affected companies, when imposing the price reduction penalty. The court did not see the legitimate reason as for the minister to consider the company as direct subject, because the regulation defines subjects for notice on reimbursed drug are mutually applied among healthcare institute, National Health Insurance Service (NHIS), policyholder, and dependent. Among drugs provided from Pharmaceutical Company B to Hospital A, should the price be reduced only for drugs prescribed by the rebate-received medical profession? Or should maximum reimbursement prices of all drugs supplied by Company B and prescribed by Hospital A be reduced? The court stated all drugs from Company B could be subject for the maximum price reduction. Rebate provision itself is highly likely to have been provided to promote sales of a specific company’s product, and there was no objective evidence to prove the rebate was provided for a specific product instead. So the court decided the Ministry of Health and Welfare’s penalty was within its jurisdiction of discretionary authority. Then what about a case of Hospital A providing both reimbursed and non-reimbursed drugs. How should the maximum reimbursement price reduction rate be calculated? Should the rebate on non-reimbursed drug be disregarded from the calculation of price reduction rate? The court decided proportionally dividing rebate amount on reimbursed drug, while completely disregarding non-reimbursed drug, was a faulty calculation of maximum reimbursement price reduction rate. The calculation formula for the price reduction rate was wrongful as rebate could have been provided for the non-reimbursed drug, and removing the amount provided to non-reimbursed drug from the calculation would have resulted in excessive reduction rate. Lastly, if the rebate provided to a pharmacist was for the cost of the provider’s prescription drug, would it be possible to reduce the maximum price including the rebate cost? Besides from violating Pharmaceutical Affairs Act, the court saw that the company’s act of providing rebate is difficult to relate back to prescription and sales of the prescription drug. The principle and the norm of dispensing and sales of prescription drug is decided by doctor’s prescription, so the court judged it is unlikely to see the correlation between rebate provided to pharmacist and ‘promotion of dispensing and sales of prescription drug’, except for a special occasion. Therefore, the court stated reduction rate should be calculated without the rebate cost provided to the pharmacist. As for the last decision, the court reviewed standard and process of imposing maximum reimbursement price adjustment penalty more specifically than other previous rebate decisions, which sets judging standard to see if the maximum reimbursement price reduction penalty was reasonable based on the ministry’s discretionary authority. The decisions were made during respective first trials and they are waiting for the appeal. Attention on the issues is heightened to see if the preceding decisions would be sustained in the appeal. In fact, there is a possibility of the change in decision during the appeal, and whichever decision is made at the Supreme Court later, the cases would definitely be the precedents setting a standard of the rebate-induced drug pricing reduction penalty. The heated legal disputes seem inevitable for the healthcare sector, as it is Korea’s new economic growth engine with visible rapid expansion in quality and quantity. Besides, the highly political and technical drug pricing is right in the center of the dispute. Previously mentioned drug pricing paradigm shift seems like it would bring more interesting topics on the table than just the rebate case. Surely the drug pricing policy would attract even more attention in the coming year 2020.
- Opinion
- [Column]GPP can’t be off anymore
- by Jung, Heung-Jun Nov 27, 2019 06:40am
- GPP is a hot potato in the pharmaceutical society. It is unlikely that a executive of the pharmaceutical association with experience in business would completely deny the introduction of GPP. This is because the government and the public have been asking the pharmaceutical association for decades. But the drive is making slow progress. This is because it is difficult for the Korean pharmaceutical society to roll their arms first for a policy that members are not happy with. Former Executive Committee, Chan-hui Cho held a debate to discuss the GPP, but the members' response was cold. The core of GPP is to elevate pharmacy's work level. This ranges from patient services related to medication to systematic and clean management of pharmacies. It is basic not to make unauthorized persons illegal activities, such as dispensing or selling generic drugs. This system aims to induce improvement by certifying excellent pharmacies through evaluation and to raise the level of work of all pharmacies. But members' response to the GPP is not favorable. They recognize the necessity, but they are not very active in accepting, or even view it as another unnecessary regulations. Some used to run a pharmacy at their convenience, but once the GPP is in place, they have to be more careful to meet the criteria and to include being assessed by an outside agency for certification. Nevertheless, the positive side of the GPP certainly exists. First, they can reduce underage pharmacies which do damage to the entire pharmacist society There are many pharmacies that operate in good faith in accordance with desirable pharmacists, but there are some that do not. Because of these pharmacies, the overall status of the pharmacist society falls. The protection of these pharmacies by the Korean pharmaceutical society is nothing less than the surrender of the rights of the whole members. Second, they can increase public confidence in pharmacies and pharmacists. Support of the public is essential for the pharmacist's petition project such as ingredient prescription. It is important to understand that the current situation with low confidence or expectation in pharmacies is the biggest obstacle to the development of pharmacist functions. Members often avoid GPP because of incorrect information or realistic concerns. The idea is that the GPP is tricky to implement a corporate pharmacy or objectionable because it will cost a lot of interior expense. In particular, there seems to be a misunderstanding that hardware elements such as interior and automatic dispenser are important conditions for becoming a pharmacy. Not like that. In order to provide good service, software factors such as pharmacist knowledge and careful care of patients are more important. And the certification system should be made to reflect these software elements well. This can lead to the development of the pharmacist's function, which is the true purpose of the system. In order for the GPP to be settled in a desirable manner, it is correct that the pharmacist society faithfully carries out these concerns and preemptively implements them. Recently, the Anti-Corruption and Civil Rights Commission recommends that the Ministry of Welfare undertake a study on the implementation of the GPP. It is a pity to respond aggressively to the changes of the times and to the demands of the people. We must abandon the current situation where the pharmacist society seems to stand up to the consumer's demands, and change to the stage where the pharmacists renew and gain the trust of the people. Change is always painful. But the power to change on its own is the driving force to open the future. Even now, we expect the pharmacist society to gather wisdom and courage to be on the right track of change.
- Opinion
- [FOCUS]Government sophistication to generic regulations
- by Chon, Seung-Hyun Nov 25, 2019 06:21am
- A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market. At the time, the head of the licensing review department of the Ministry of Food and Drug Safety, who got the news, rejected that "the quality of generic products is meaningless." Generics must pass strict standards from drug substances to finished product manufacturing facilities. In addition, a conformity test should be made in a bioequivalence study demonstrating that the generics are equivalent to the rate and concentration of original drug absorption. "Generic products that have passed all government-set standards and have been approved for sale should be regarded as equal in quality.“ The MFDS is trying to tighten restrictions on generics after last year's issue of Valsartan impurity. The MFDS announced the legislative draft of the “Revision of Partial Rules on the Safety of Pharmaceuticals,” etc. on the 18th. It contains a significant tightening of the licensing requirements for all fair commissioned manufacturing generics. It means that the GMP evaluation data, standards and test method data, which have been exempted from the consigned generic permit screening data, must be submitted. It is noteworthy that MFDS referred to “high quality generics” as the background for strengthening generic regulations. According to the Regulatory Impact Analysis Report of the revised regulations, the MFDS said that they will secure the trust of the people providing 'high quality' medicines and improving the soundness of drug distribution through the quality improvement of generics for each clause that strengthens the regulation of generics. The intention is to supply high-quality generics by strengthening generic regulations. It also means that there is differences in quality between generic products. This is contrary to the conventional view that "quality is equal if it passes the strict licensing process." It seems possible that even with the MFDS, there may be some low quality generics. It is also ambiguous to see how the strengthening of permit standards is related to quality improvement. Submission of GMP assessment data by authorized generic means re-release of data that has already been verified by the MFDS. GMP assessment data need not be submitted when consigning a product that is identical to a previously approved generic. However, one year after the proclamation of amendment, the authorized generics will also be required to produce three manufacturing units (batch) and submit relevant GMP data for approval. The submission of GMP evaluation data by authorized generics disappeared just five years ago. The MFDS implemented ‘the GMP Compliance Certification System’ in 2014, which permits Pharmaceutical production that all factories producing pharmaceuticals requires passing the standards set by the MFDS every three years. At this time, regulations for mandatory production of licensed drugs were relaxed. It was made possible for the establishment within the validity period of the conformity assessment to replace the data on the evaluation of the GMP implementation with the conformity assessment. They have already laid the foundation for strengthening quality management by introducing the ‘Certificate of GMP Compliance of a Manufacturer', and in the situation where the approved facility has determined the suitability of licensed drugs, it is decided that it is redundant regulation to receive the GMP evaluation data of the authorized generics again. The same applies to co-bioequivalence regulations currently underway. On April 15, the MFDS announced a partial revision of the “Regulations on the Authorization, Declaration, and Review of Pharmaceuticals,” which includes tightening regulations on co-bioequivalence regulations. According to the amendment, regulations will be tightened so that up to three authorized generic manufacturers are allowed to one original manufacturer one year after the notification. This means that up to four generics will be granted for each bioequivalence test. After three years, consiged bioequivalence is completely banned. Four years after the notification, only one generic may be approved in one bioequivalence study. As a result, after four years, the same product from the same manufacturing facility must be tested for bioequivalence separately. I don't know what it is related to run separate bioequivalence tests on the same product with ‘high quality generics’. Goal of the MFDS is clear that it tightens regulations of generics. Because of the serious difficulty of generics, the intention is to reduce the number of generics in the market by raising licensing barriers. It is clear that the overflow of generic manufacturing contractors is the cause of generic upheaval. It is also clear that generic upheavals were triggered by changes in government permit regulations. Wouldn't it be better to admit that the government's policies encouraged generic upheaval and try to persuade the reasons for changing the policy stance? Rather, the cause of “quality improvement,” which is not related to the regulations, can lead to confusion in the industrial field. This leads to distrust in government policy. Of course, the government may adjust the regulatory intensity in response to changing market conditions. However, companies need to be able to believe and follow only by providing a clear justification and justification for the new policy. If the government produces a policy without justification and changes the policy stance, in the turn of a hand, credibility falls.
- Opinion
- [Reporter's view] The Korean bio-health industry in Anomie
- by Lee, Jeong-Hwan Nov 20, 2019 11:50pm
- World-class standards of medical technology is Korea's long-standing pride. Advanced bio-new drugs are the future growth fuel that the world pursues, and the Korean pharmaceutical industry is gradually shifting its development focus from generics to new drugs with technology. Expectations and concerns coexist in the public's spotlight toward the medical and biopharmaceutical industries that will affect the future of Korea. It is rare to oppose the achievement of 'high-tech medical and bio-new drugs' that will lower regulatory barriers, speed up the introduction of new technologies, and ultimately directly benefit society and the public. On the other hand, the question of whether to agree to the provision of personal health information necessary for the development of advanced medical and biologic new drugs is not easily nodded in assent. The order to make high-tech medical and new medicine without medical big data is to offer the best dinner without high quality and abundant raw materials. In this respect, The Korean bio-health Industry fell in Anomi. New norms and social values appropriate for advanced medical and biologic drugs and the fourth industrial revolution must be established, but it is the current status of our society that existing traditional norms and values rarely innovate. In other words, the social values, which are essential for the high-level medical care and advanced new drug industrialization, are in a state of confusion and irregularity. Recently, the 4th Industrial Revolutionary Committee urged the government to advance laws and regulations, and to strengthen the capacity for review and licensing. Specifically, the government said that it would reduce social unrest by strengthening public relations about the objective scientific achievements that the biohealth industry would bring along with the revision of the Personal Information Protection Act, medical law, and bioethics law. KIET stated that the Korean bio, IT, and AI industries with excellent technology have fallen into ‘the prisoner's dilemma’, pursuing their own interests among medical world, civil society, and the government. It is a diagnosis that civil society, which has high technology development and government-industrial distrust, is not able to agree on providing sensitive health and medical personal information, and is hindering the development of telemedicine or biomedicine. After all, how to rescue Korea's bio-health industry in an anomalous state is the solution for advanced medical and biomedicine drugs. Citizen anxiety is likely to grow as regulatory innovations take place, and it can create fear that personal information is being used by government or some industries for other purposes. The government should work with expert groups to make concrete plans to break down civil distrust, and quickly resolve the public's lack of cutting-edge bio-information through various public participation external events. Regulatory innovation and industrial development should not be focused on keywords, it made The public, the government, and the industry struggling with each other, and darken the state-of-the-art medical and biopharmaceuticals the future We should be able to explain transparently and specifically how my medical information is used and protected in the development of the biohealth industry and how the individual can finally benefit. Also, it is time to break down chaos and anomie by creating a way for individuals to participate in the biohealth industry.
- Opinion
- [Column] Imposing fine enough to prevent rebate?
- by Kim, Jung-Ju Nov 13, 2019 01:09am
- Korean government’s plan to revise illegal rebate penalty regulation and replace insurance reimbursement suspension with fine on an accused drug product came under fire. However, the government is committed to protect drug access considering patient’s safety and convenience. For the justification of rebate regulation against rebate, the government points its finger on financial factor, other than pure objective of treatment, intervening the process of selecting and purchasing drug products, and negatively affecting on patient’s health, National Health Insurance (NHI) and general medical expense. The objective of rebate regulation is to induce adequate use of drug and transparent trading. The execution of rebate regulation should be able to achieve the objective, and the regulators should maintain fairness when executing it. The existing penalty against rebate is to revoke NHI reimbursement listing and to impose fine depending on the number of committed offenses. The proposed revision of the regulation starts from lowering of upper limit healthcare expense (drug price) to suspension of healthcare reimbursement, as well as imposing of fine, depending on the number of committed offenses. The major differences are utilization of drug price reduction, increase in amount of fine, and excluding revocation of reimbursement listing. It seems appropriate not to remove the responsible drug product from reimbursement listing for the sake of patient’s stable drug access, because it would be far-fetched to correlate illegal practice and quality of the drug. Furthermore, the regulators should contemplate on how effective the revised penalties would be to eradicate the illegal practice, compared to the revocation of reimbursement listing. The purpose of the regulation should not only stress on punitive aspect, but also stress on preventive aspect. Reduction of drug price and increased fine are undeniably punitive. However, the issue is the severity level of the penalty sufficient enough to bring preventive effect. When the level of penalty is bearable, then companies with agenda would rather take the chance of committing offense. Other issues are drug price reduction, reimbursement suspension period and the unclear definition of the ‘period’ when imposing fine. Positively speaking, they could be seen as ‘flexibility’ in administrative measure, but negatively speaking, ‘voluntariness’ of the administrative measures are questionable. It is easy to predict who would exploit and abuse the regulatory standard (interpretation of the term). Also, the term ‘one year-worth of reimbursement cost’ addressed in the regulation summing the amount of fine is ambiguous. Depending on the point of the ‘year’, the accused company’s absolute amount of fine and countermeasure differ vastly. At the moment, dual penalty system is applied on the rebate giver, a pharmaceutical company, and the receiver, a doctor or healthcare institute. But the off-balance between regulations against the giver and the receiver, as addressed by the National Health Insurance Act, are under fire. The regulators are reinforcing financial penalty on rebate-giving product, instead of imposing regulation on the product itself to maintain access to the treatment. On the other hand, regulators suspends license of the rebate-receiving healthcare provider, and also confiscates illegally obtained financial gain. How about some more attention on re-evaluating the fairness between reimbursement revocation on a drug product and suspension of doctor’s license? Or between drug price reduction and reimbursement cost refund, and financial gain confiscated from healthcare providers? Effective execution and fair penalties of rebate regulation should be revisited at this point in time. Moreover, we should not forget to contemplate on revising the regulation to prevent rebate practice in long-term and fundamental fashion, taking the unique qualities of the pharmaceutical industry’s rebate practice and distribution environment into account. Although the ultimate consumer of a drug product is patient, it is undeniable that doctors are in control over the pharmaceutical options. Keeping in mind that a drug is also a commercial product, the regulators would also have to face the reality of marketing without some form of rebate. The point is to bring down healthcare provider’s openness of receiving rebate and the level of rebate provision. Besides the problem within rebate practice, National Health Insurance’ payment system and healthcare provision system should be reformed to achieve fair and good healthcare.
- Opinion
- [Reporter's view] DC the absolute power behind hospital
- by Eo, Yun-Ho Nov 11, 2019 11:08am
- When each hospital’s Drug Committee (DC) is convened, pharmaceutical companies starts a fierce war to land a favorable drug deal. Just like any war in the world, the ‘DC war’ has a winner and a loser. Unfortunately, not always do the winners deserve a win or the losers deserve their defeat. To land a ‘drug code-in’ deal at some general hospitals, ‘inappropriate backdoor dealing’ is more important than outstanding evidences of a drug’s indication and efficacy. Such phenomenon is prevalent when an original’s patent is expired and new generic is released. A hospital’s DC mostly consists of doctors from each department and chief pharmacist. However, sometimes unheard-of drugs get their codes in and push out existing drugs, thanks to hospital foundation’s influence. To this date, a hospital with significantly influential DC brings in representative of a pharmaceutical company and demands for so-called ‘drug code maintenance fee’ on an original drug with expired patent. In fact, the hospital removed well-known original hypertension, hyperlipidemic and antithrombotic items for last two to three years. Their codes were removed, simply because the drug companies refused to pay the ‘maintenance fee’. The illegal rebate paid by drug companies is never handed straight to the foundation. Pharmaceutical industry insiders hint that the money is rerouted and laundered through separate corporations owned by the foundation or distribution companies with a close relationship, and finally gets to the foundation. DC lobbying exists between originals when there is a new generation or type of drug is launched. So for pharmaceutical companies to get a drug code-in deal, they need to coax foundation and doctors. Of course, the effort of Dual Penalty System and Fair Competition Agreement has brought some fairness to the business. Unless solid evidence of a drug is available, growing numbers of hospitals are not guaranteeing DC’s approval, regardless of a good connection between a healthcare provider and a pharmaceutical company. However, hospitals still associate DC with an absolute power. Even though it should be given that hospital’s drug coding depends on fair evaluation.
- Opinion
- [Eyes of a Reporter] Are you a ‘good company?’
- by An, Kyung-Jin Nov 08, 2019 08:45am
- Every year around this time, one book hikes up the best seller ranking at book stores. The book, ‘Trend Korea Series’ by Professor Kim Nando of Seoul National University, summarizes next year’s trend in Korea with a list of keywords. ‘Trend Korea 2020’ had a top ten consumer trend keyword list including ‘fair play’. The book explains how the notion of ‘good company’ has gotten popular among consumers over the years, therefore, ‘fair competitiveness’ would become a more vital factor affecting consumer’s choice. At a recent special lecture session, Professor Kim claimed “Growing up in a society where individuality is prevalent, Millennials wants to change their society with a small effort. Even when buying a product, they put value not only in the product itself, but also in the brand’s good influence towards the society”. With his theory, he further explained the lately popular boycott movement against problematic brand is not just a simple aggression, but an expression of desire to be fair and correct. During the lecture, I suddenly thought of a question. Which pharmaceutical company is actually a ‘good company?’ In Korean society, pharmaceutical companies have a relatively positive public image. The society appreciates how the companies provide needed drugs to patients and contribute in saving lives. How wonderful is it that their income made from drug sales is reinvested toward new drug R&D, and also on corporate social responsibility (CSR) activities. However, some companies have disappointed Koreans and crippled their trust in the industry in recent years. Last year March, a French pharmaceutical company announced it would suspend supplying a contrast agent used for liver cancer treatment due to low pricing in Korea. As a response, the Korean society got infuriated. A British multinational healthcare company has been the infamous company for a while as the one responsible for making humidifier disinfectant with severe health hazard. After developing an anticancer treatment significantly extending patient’s overall survival period, a large-scale pharmaceutical company experienced painful clash and dispute with patient groups as the company insisted on drug pricing at around few million won per month. Global companies are not alone on this topic. Prosecutors are still investigating a Korean bio company accused of manipulating ingredient report on its osteoarthritis gene therapy. An allegation of another Korean company, despite its title of ‘good company’ earned from the society, providing illegal rebate to healthcare provider for prescribing their products turned out to be true and the their executives were sentenced with jail term. Also there are many companies regularly making negative postings at vulnerable time for investors fearing it would affect stock price. In this capitalistic society, reproaching pharmaceutical companies for their profit-making decisions could be too harsh. Supplying needed drug or CSR activities can only be possible, when a company is sustainable. But, shouldn’t the executives of pharmaceutical companies feel more responsible about the society’s higher expectation of business ethics on health related companies? We can only hope that those pharmaceutical companies would repent their wrong choices and stand tall again as a ‘good company’, keeping their initial objective of ‘contributing to public health’ in mind.
- Opinion
- "바비스모PFS 등장, 망막질환 치료 지속성·효율성 전환점"(H/T)
- by Son, Hyung Min
- [데일리팜=손형민 기자] "망막질환 치료는 단순한 시력 개선을 넘어 질환을 얼마나 안정적으로 오래 관리하느냐가 핵심입니다."망막질환 치료가 단기 효과 중심 접근에서 벗어나 장기 관리 전략으로 이동하는 가운데, 프리필드시린지(PFS) 제형 도입이 맞물리며 치료 환경 변화가 본격화되고 있다.특히 이달 1일 급여 출시된 '바비스모(파리시맙)' PFS 제형은 투약 간격 연장과 시술 효율 개선 측면에서 환자 치료 지속성과 진료 환경 변화를 이끌 것으로 기대된다.최순일 누네안과병원 원장최순일 누네안과병원 원장은 최근 데일리팜과 만나 이 같은 변화를 짚으며, 망막질환 치료 패러다임이 장기 관리 중심으로 재편되고 있다고 평가했다.그 변화의 중심에는 이중기전 치료제가 있다. 그간 습성 연령관련 황반변성(nAMD)과 당뇨병성 황반부종(DME) 치료는 VEGF 단일 억제 기전 치료제가 주류를 이뤘다. 여기에 고용량 제제 등장 이전 투약 간격이 최대 2개월 수준에 머물고 안구 내 직접 주사가 반복된다는 점에서 환자 부담이 적지 않았다.이 가운데 바비스모는 혈관내피성장인자(VEGF)-A와 안지오포에틴-2(Ang-2)를 동시에 억제하는 이중특이항체로, 기존 치료와 차별화된 접근을 제시하고 있다. VEGF-A가 혈관 신생을 유도하는 핵심 인자라면, Ang-2는 혈관 불안정성과 누출을 촉진하는 인자로 알려져 있다.최 원장은 "두 경로를 동시에 차단하면 단순히 혈관 생성을 억제하는 수준을 넘어 혈관을 보다 안정적인 상태로 유지하는 데 기여할 수 있다"고 설명했다.이러한 기전적 차이는 임상에서 해부학적 지표 개선으로 이어질 가능성이 크다. 망막액 감소나 황반 두께 정상화 속도 측면에서 보다 빠르고 안정적인 변화를 기대할 수 있으며 이는 투약 간격 연장과 치료 지속성 확보로 연결될 수 있다는 게 전문가들의 평가다. 여러 임상과 리얼월드 데이터에서도 바비스모의 효과가 확인된 바 있다.최 원장은 "시력 개선 효과는 기존 치료제들도 이미 일정 수준에 도달해 있어 체감 차이는 제한적일 수 있다"면서도 "망막이 얼마나 빠르고 안정적으로 건조 상태를 유지하느냐가 장기 예후를 좌우하는 핵심 요소"라고 밝혔다.최 원장은 ▲치료 간격을 조금만 늘려도 재발하는 환자 ▲기존 약제에 대한 반응이 충분하지 않은 환자 ▲망막액이 많거나 변동성이 큰 환자 ▲혈관 불안정성을 시사하는 소견이 반복되는 환자 ▲이전에는 비교적 긴 간격 유지가 가능했지만 점차 약효 지속기간이 짧아지는 환자에서 바비스모가 더 적극적으로 고려될 수 있다고 제시했다. 최 원장은 "안정적인 질환 조절이 필요한 경우 등 이중경로 기전이 필요한 임상적 상황에서 바비스모의 장점을 기대할 수 있다. 또 망막내액, 망막하액이 많거나 변동성이 큰 환자 혹은 염증이나 섬유화와 관련된 우려가 있는 환자에서도 고려될 수 있다"고 분석했다. 이처럼 치료의 중심축이 혈관 억제에서 혈관 안정화로 확장되는 가운데, 실제 진료 환경에서는 또 다른 변화가 동시에 진행되고 있다. 바로 제형 변화다."PFS제형, 시술 표준화·감염관리 측면에서 의미"이달 1일부터 급여 적용된 바비스모 PFS 제형은 편의성 개선을 넘어 진료 과정 자체를 바꾸는 요소로 평가된다.기존 바이알 제형은 약물을 주사기로 뽑고, 바늘을 교체하고, 공기를 제거하는 등 여러 단계를 거쳐야 한다. 반면 PFS는 약물이 미리 충전돼 있어 개봉 후 바로 사용이 가능하다.최 원장은 "안내주사는 눈 안에 직접 약물을 투여하는 시술이기 때문에 작은 오염도 심각한 합병증으로 이어질 수 있다"며 "준비 과정이 줄어든다는 것은 감염 위험을 낮추는 데 있어 매우 중요한 변화"라고 피력했다.최 원장에 따르면 안내염과 같은 합병증은 발생 빈도는 높지 않지만, 발생 시 시력에 치명적인 영향을 줄 수 있어 예방이 무엇보다 중요하다. 이런 점에서 조제 과정 단순화는 단순 편의성을 넘어 안전성 확보 측면에서 의미를 가진다.대규모 시술 환경에서는 이러한 차이가 더욱 크게 작용한다. 실제로 안과에서는 연간 수만 건 단위의 안내주사가 시행되는데, 반복되는 조제 과정에서 발생할 수 있는 변수를 줄이는 것이 중요하기 때문이다.최 원장은 "안내주사는 자주 시행되는 시술이다. 본원에서는 연간 약 2만 건 정도의 안내주사가 시행된다. 시술 건수가 많은 환경일수록 공정 하나가 줄어드는 효과는 단순한 시간이 아니라 시스템 안정성으로 이어진다"고 전했다.이어 "해외 사례를 보면 PFS 제형이 출시된 이후 약 2개월 내에 85% 정도가 PFS로 전환됐다는 보고가있다. 국내 급여 기준이 동일하고 공급에 특별한 제한이 없다면 대부분 PFS 제형으로 전환될 가능성이 높다"고 덧붙였다. PFS 제형은 실제 시술 과정에서도 차이를 만든다. 바비스모 PFS는 얇은 벽 구조(extra thin wall) 니들을 적용해 동일한 압력에서도 더 높은 유속을 확보할 수 있도록 설계됐다. 이에 따라 주입 과정이 보다 부드럽고 신속하게 이뤄질 수 있다.최 원장은 "고령 환자의 경우 시술 중 눈을 고정하는 것 자체가 쉽지 않기 때문에 주입 과정이 빠르고 부드러운 것이 중요하다"며 "이런 요소들이 실제 환자 경험에 영향을 준다"고 언급했다.또 바비스모 PFS는 필터 니들이 함께 제공되는 점도 특징이다. 미세 입자 및 오염물질을 걸러주는 구조로, 시술 정밀성과 안전성을 동시에 높일 수 있다. 해당 니들은 유럽의약품청(EMA)과 미국 식품의약국(FDA) 승인을 받은 전용 필터바늘로 구성돼 있다.최 원장은 "다른 제품들에는 니들이 동봉돼 있지 않은데, 바비스모는 니들이 제품 패키지에 포함되어 있다. 니들 품질이 일정하게 유지된다는 점은 의료진 입장에서 상당히 중요한 요소"라며 "조작감과 안정성 측면에서 일관된 시술 환경을 제공할 수 있다"고 부연했다.이러한 기전적 진화와 제형 개선은 결국 하나의 방향으로 수렴된다. 바로 치료 지속성이다.황반변성과 당뇨병성 황반부종은 수년에서 수십 년에 걸쳐 관리해야 하는 질환이다. 건강보험심사평가원 에 따르면, 국내 황반변성 환자 수는 2020년 약 20만 명에서 2024년 약 56만 명으로 늘어나 지난 5년 사이 150% 이상 증가한 것으로 나타났다. 이 과정에서 치료 간격, 시술 부담, 병원 방문 횟수는 환자의 순응도를 좌우하는 핵심 변수다. 현재 바비스모는 최대 16주까지 투여 간격을 늘린 상황이다. 환자의 장기 치료 부담을 실질적으로 줄일 수 있다는 점에서 큰 의미가 있다는 게 최 원장의 의견이다. 최 원장은 "환자 입장에서는 눈에 직접 주사를 맞는다는 것 자체가 상당한 심리적 부담인데, 이 치료를 오랫동안 반복해야 하기 때문에 병원 방문 횟수와 주사 횟수를 줄일 수 있는지가 중요하다"라며 "한 달마다 치료받는 것과 세 달마다 치료받는 것은 환자 입장에서 완전히 다른 경험이다. 이 차이가 장기 치료 유지 여부를 결정짓는다"고 말했다.이어 "일부 치료제는 효과와 별개로 염증 이슈가 임상적 부담으로 작용하기도 한다. 바비스모는 효과와 함께 안전성 측면에서도 비교적 안심하고 사용할 수 있는 옵션"이라며 "라스트 아이(last eye) 환자처럼 한쪽 시력 보존이 중요한 경우에는 치료 효과뿐 아니라 안전성이 더욱 중요한데, 바비스모는 두 측면에서 모두 신뢰할 수 있는 치료 옵션이 될 수 있다"고 강조했다.
