Due to Taiwan’s rapidly aging population and evolving disease types, it is vital for the public’s health and wellbeing to accelerate medical innovations and shorten the time to market for new and improved devices. The Committee would like to thank the Taiwan Food and Drug Administration (TFDA) for offering manufacturers expedited measures for document preparation during the period of COVID-19. Member companies have also been developing and launching innovative devices to protect the health of the people of Taiwan. While post-market monitoring has become more stringent under the new Medical Device Act, we look forward to close communication and cooperation with the regulators to help make continued progress towards streamlining the pre-market approval process.
The Committee also appreciates the willingness of the Ministry of Health and Welfare (MOHW) and its National Health Insurance Administration (NHIA) to listen to stakeholders’ feedback and modify policy directions accordingly. We urge the government to show flexibility in the treatment of different kinds of medical devices, in particular to maintain room for advanced technology so that the Taiwanese people can continue to enjoy the benefits of research and development. Our Committee members will keep on providing high-quality products to meet patient needs and enable Taiwan physicians stay at the forefront of the international medical community.
Suggestion 1: Accept MDSAP audit reports as qualified substitutes for EIRs in QSD simplified regulatory pathway submissions.
Submission of an Establishment Investigation Report (EIR) issued by the U.S. FDA is a requirement under Taiwan’s simplified Quality System Documentation (QSD) regulatory pathway for auditing manufacturing sites located in the U.S. In 2016, the U.S. FDA issued a letter recognizing the Medical Device Single Audit Program (MDSAP) audit report as equivalent to an EIR for this purpose. The Committee urges TFDA to similarly accept MDSAP audit reports as an equivalent substitute for an EIR, enabling American manufacturers to have access to the same simplified regulatory pathway to QSD as European and Japanese manufacturers.
Suggestion 2: Maintain the simplified pre-clinical test substitution pathway while seeking pre-market technical dossier exchange agreements with other countries.
Passage of the Medical Devices Act has brought changes in regulatory procedures. Although the government has announced a simplified pathway allowing holders of certificates of market approval from countries that have signed a Memorandum of Understanding with Taiwan on Pre-market Review Technical Collaboration to be exempt from pre-clinical test reports by the TFDA’s Medical Device and Cosmetics Division, to date no country has signed such an MOU with Taiwan. Once such agreements are in place, Taiwan will be able to engage in the exchange of pre-market technical dossiers with the relevant countries.
In the meantime, it should be recognized that the European Medical Device Regulation (MDR), which took effect in May 2021, is even more stringent than the previous Medical Device Directive (MDD) and ensures more rigorous evaluation of safety and efficacy. For its part, U.S. FDA approval has always been highly regarded internationally. When a product has been approved by both the U.S. and European regulatory review bodies, that should provide convincing verification of its safety and functionality. As a result, the time and human resources needed for review in Taiwan could be greatly reduced. The Committee therefore recommends providing industry with a reasonable grace period by maintaining the current simplified pathway until Taiwan has been able to sign MOUs with other countries.
Suggestion 3: Regulate medical device manufacturers according to the identity of the design holder (the legal manufacturer).
In line with the growing trend of supply chain globalization, quality management systems nowadays cover multiple design and manufacturing facilities for simultaneous auditing, as opposed to independent auditing of a single manufacturing facility. The Committee suggests that TFDA’s Quality, Monitoring, and Management Division establish an auditing program that reviews manufacturers based on who is the design holder, also known as the legal manufacturer.
Consideration could be given to including multiple manufacturing sites under a single market-approval license for a device. The resulting supply chain flexibility and agility would help ensure a stable supply of medical devices and smooth customs clearance to the ultimate benefit of Taiwan’s healthcare providers. The Committee suggests that TFDA’s Medical Device and Cosmetic Division establish a license management program to manage all physical facilities under a given legal manufacturer. Establishment of this management scheme would bring Taiwan’s regulatory environment more in line with that of the international community, including the U.S. FDA.
Suggestion 4: Expedite patient access to new technologies through more efficient NHI review processes.
4.1 Assign a temporary procedure code during the review of a new NHI procedure.
Some new procedure applications go through a Health Technology Assessment (HTA). In those cases, NHIA will announce a temporary self-pay code for the new procedure during the NHIA reviewing period. But most new procedure applications do not undergo an HTA. In those cases, during the review period the medical device company needs to arrange for each individual hospital to submit a new patient-self-pay procedure application at the county or city health bureau level. Because the process is so time-consuming and involves voluminous paperwork, it poses a barrier for new procedures to enter the Taiwan market.
To protect patients’ right to have access to new-technology medical treatments, we suggest that NHIA assign a temporary procedure code for all new-procedure applications while they are under NHIA review, regardless of whether there is an HTA. The healthcare providers could charge patients a full self-payment fee for early access.
4.2 Shorten the time to market for new-function medical devices by loosening the criteria for accepting applications.
Given the ever-changing nature of medical devices, there have been situations where procedure codes corresponding to new-function medical devices cannot be found. At the same time, the review process for applying for new procedure codes is quite lengthy because of the time needed to collect the required information, hold discussions, and reach the final decision. It is important for patients to be able to receive early access to new-function medical devices to aid in their treatment, as well as for health providers to accumulate local clinical experience. We suggest that NHIA broaden the current practice of assigning temporary codes. They should be made available not only for devices that already have corresponding procedure codes, but also for those that provide other data, such as ICD-10-PCS codes (an international system of medical classification used for procedural coding) or data from smaller-scale clinical trials. The aim is to encourage manufacturers to continuously introduce new medical technologies and new medical devices into Taiwan and increase patient accessibility to new-function medical devices.
Suggestion 5: Improve the pricing mechanism for new-function medical devices.
5.1 Revise the formula for calculating reimbursement pricing for functional improvement devices.
For medical devices with improved functionality in the new-function category, reimbursement prices are calculated using a formula based on the existing reimbursement price, with another 15% added on for each of seven factors deemed to have been achieved. We recommend that NHIA increase the add-on percentage to 25% for each criterion that is met. We also propose adding four more factors: (1) easier and smoother clinical operation; (2) more advantageous infection control; (3) more practical clinical results from hospitals; and (4) use of smart healthcare to benefit treatment.
In current practice, NHIA will usually accept just one or two criteria, which means the price of a proposed new device will only have a 15-30% markup on the existing reference product. In our experience, that level is generally insufficient to reflect product value and cost. A higher mark-up per factor, plus acceptance of the proposed four additional criteria, would more effectively reflect the value of advanced technology and encourage industry to continuously bring innovative medical devices to Taiwan.
5.2 Use Real-World Evidence methods to evaluate new-function medical devices.
NHIA’s current practice for classifying and pricing new-function medical devices is to use published clinical papers as reference, evaluating the strength of the evidence based on the grade of recommendation given to the device. Under the current pricing mechanism, only journal papers giving a high grade of recommendation can be recognized as solid evidence to obtain a high price for an innovative new medical device. But these kinds of journal papers are not easy to get published, especially for innovative products.
For drug pricing, using clinical papers as a main reference in determining pricing is reasonable. There are many ways to design and conduct a randomized clinical study. The outcomes can be demonstrated through efficacy or safety data. But for medical devices, it is not easy to conduct a clinical study that separates patients into two distinct groups, such as one group that receives a traditional stent and the other a drug-eluting stent by random assignment. Therefore, level 1 – a grade of “A” evidence – is difficult to obtain.
Moreover, a new generation of the device with functional improvements may be introduced every few years. Clinical studies frequently cannot keep up with that rapid pace of development. A system known as Real-World Evidence (RWE) is used in medical device regulatory decisions to assess safety and efficiency. It relies on collecting comprehensive practical data from multiple sources, including clinical trials and healthcare studies conducted by certified laboratories and institutes. We recommend that NHIA utilize RWE to support coverage and pricing decisions when evaluating new-function medical devices. The U.S. Food and Drug Administration already utilizes RWE to support its regulatory decision-making for medical devices, as does its Australian counterpart. RWE can encompass all kinds of evidence in addition to published journal papers, including manufacturers’ clinical papers to prove the safety and efficacy of the new product, as evidence to consider in determining whether to approve the license.
因醫療器材具多樣態的產業特性,隨著人口高齡化及疾病形態的改變,加速創新產品及縮短產品上市時間,是提升人民健康福祉的必要途徑。台灣美國商會醫療器材委員會首先感謝食品藥物管理署,於 COVID-19 疫情期間給予廠商文件準備之權宜緩衝措施,會員公司也持續致力研發和引進創新產品,共同守護台灣人民的健康。在醫療器材新法架構下的上市後監控亦趨嚴謹,相信透過與政府密切的溝通與合作,期望政府持續精簡查驗登記審查流程,以促進新產品及新技術的引進。
有關健保相關議題,醫材委員會感謝衛福部與健保署傾聽相關團體的回應,重新思考健保政策實施方向。委員會敦請主管機關在規劃政策法規時,能夠針對不同類別的醫材品項保留彈性,提供可預測的給付流程,達到雙方合意一致的核價,尤其是先進的科技產品,使得台灣民眾得以與世界同步從新科技研發成果獲益。會員公司將持續引進高品質的產品,不但提供病患所需,也支持台灣的醫療專業人員保持在國際醫療界的領先地位。
我們的建議如下:
建議一:接受醫療器材單一稽核計畫(Medical Device Single Audit Program, MDSAP)稽核報告可替代醫療器材優良製造規範簡化模式之美國食品藥物管理署所出具之查廠報告(EIR)
美國 FDA 所出具之查廠報告(以下簡稱 EIR)係「醫療器材優良製造規範美國廠簡化模式」必要文件之一,而 FDA 於2016 年發表書面聲明認同醫療器材單一稽核計畫(Medical Device Single Audit Program, MDSAP)之稽查報告與 EIR具有相同效力。建請貴署接受醫療器材單一稽核計畫之稽查報告(MDSAP audit report)可視為 EIR 之替代報告,以使得美國製造廠,能與日本與歐洲其他國家製造廠維持同等簡化審查流程。
建議二:有關查驗登記減免臨床前測試報告方案,建議先保留美歐簡化方案,並加強進行與各國簽訂上市前審查技術合作協議,給予業界足夠的執行緩衝時間
《醫療器材管理法》的通過帶來法規的改變。有關醫粧組公告之查驗登記減免臨床前測試報告方案,其中得以與我國訂有醫療器材上市前審查技術合作協議國家官方所出具之核准上市證明取代,然至今尚未有簽訂之國家。而《歐盟醫療器材法規法規》(MDR)新法規於 2021 年 5 月正式實施後,其法規要求更趨嚴謹,對產品的安全性及有效性相較過去《醫療器材指令》(MDD)更加嚴格把關。若該產品同時經美國與歐盟審查,可顯示其安全及功效性已經過兩方主管機關之確認,國內可藉此減少審查之人力與時間成本。故建請醫粧組提出明確之技術合作簽訂方案,述明其方案對雙方的實益。在尚未完成簽訂前,維持目前方案即維持檢附美國官方及歐盟會員國、英國及瑞士之官方或權責機關出具之核准上市證明文件,替代「臨床前測試及原廠品質管制」資料(簡稱歐美簡化方案)。
建議三:建立醫療器材製造業者以設計並以其名義上市(即法定製造廠Legal manufacturer)之管理模式
3-1 因應全球化的供應鏈趨勢,當今的品質管理系統可涵蓋設計及多個製造廠一同審查,而非以單一廠或委託廠來管理,建請監管組建立法定製造廠之管理審查機制。
3-2 製造業者以設計並以其名義上市之產品許可證管理考量整體面向可包含多個製造廠,確保供貨來源穩定,達到產品供應應變的靈活度,包含後續通關相關事宜等,以提升醫療機構服務量能。建請醫粧組提出以法定製造廠下管理許可證模式,此行可與國際法規調和(如現行美國以法定製造廠為主的醫材管理模式),並將國內醫療產業推向國際,達到雙贏局面。
建議四:透過更有效率的健保審查流程,以加速病患對新醫療科技的可近性
4-1 於審核新增診療項目時,先給予虛擬醫令代碼
現行健保署僅針對少數新增診療項目辦理醫療科技評估(HTA),例如支付點數較高、對於健保財務影響甚鉅及療效未明等項目。且僅有辦理醫療科技評估(HTA)之項目,於評估期間, HTA 自費虛擬醫令代碼才得以被健保署公告並同意保險醫事服務機構向民眾提供自費服務。惟多數診療項目新增案並不會辦理醫療科技評估(HTA),於健保署審查期間,若該項目要以自費方式向民眾提供醫療服務,則需透過醫療器材廠商與各保險醫事服務機構合作,向直轄市、縣(市)主管機關進行自費項目新增報備並取得核准。向健保署申請新診療項目納入健保給付及向直轄市、縣(市)主管機關報備自費項目核准之作業需耗費人力、資源及時間完成複雜的申請文件,且健保署及直轄市、縣(市)主管機關審查時間冗長,易阻礙新醫療科技進入台灣醫療市場及其發展。
為保障病患權益取得最新的療程,故針對醫院或醫學會申請之新診療項目‚建請貴署比照「保險醫事服務機構收取自費特材費用之原規範」,對於貴署審核中之新增診療項目,無論其中未完成之新診療項目是否會進行醫療科技評估(HTA),於完成審核程序之前,該等診療項目應給予虛擬醫令代碼‚並同意保險醫事服務機構可向保險對象收取全額自費。
4-2 放寬受理新功能醫材申請案之條件以提高新功能醫材可近性
醫療器材發展日新月異,近年來已出現新功能醫材無法找到對應診療項目之情形。而國內申請新增診療項目之審查時程較長,為提升民眾使用新功能醫材可近性,累積本土臨床使用經驗與發展臨床證據不受新增診療項目審查流程牽制,建議健保署對於申請新功能類別之醫材,若申請者可提供對應的 ICD-10-PCS 碼,目前雖尚無對應之診療項目,亦應先將申請之醫材列入尚未納入給付品項表,以鼓勵廠商持續引進新醫療科技並提升民眾使用新功能醫材可近性。
建議五:對於全民健保新功能類別的特殊材料,建立更完善之核價機制
5-1 調整新功能類別特材的核價加算百分比及增加相關考慮因素
依現行藥物給付項目及支付標準中,針對功能改善特材,若為依照既有類似功能類別特材支付點數核價者,得比較已收載之既有類似功能類別特殊材料支付點數,依相關因素加算核價。
惟醫療科技日新月異,數位化及智慧醫療技術產品為醫療環境持續帶來進步,然現行計算方式已無法完全反映產品價值,例如:降低併發症發生率、減少住院天數、縮短手術時間、提升臨床使用便利性、具有專利或取得美國 FDA 或歐盟認證等。委員會建議健保署增修藥物給付項目及支付標準,除應調整各項加算比例,從現行百分之十五提高至百分之二十五,並在現有的七項新功能類別核價相關考慮因素外,再增加四項因素:(1)對病人或醫療從業人員更具操作便利性、(2)有利於感染控制、(3)有來自醫院更具臨床實用性的證據、(4)具智慧醫療技術有利於臨床治療方式。
依現行核價方式,申請的特材大約只能得到百分之十五至百分之三十的加算,實無法反映產品的價值與成本。期能透過提高每項因素的加算百分比,並納入更多加算因素,以切實反映新醫療科技之臨床價值,持續精進醫療及照護品質。
5-2 採認真實世界數據及證據(Real-World Data and Evidence, RWD & RWE),增加新功能類別特殊材料分類認定之彈性
目前健保對新功能類別特殊材料的分類判斷,係以臨床試驗文獻比較證據為主要依據,並依臨床實證等級做為後續給付核定重要參考。然因醫療器材產品特性使其與治療過程高度關聯,尤其特材的使用常需搭配醫師操作,臨床研究上,因病患的狀況不同,也不若藥品的臨床試驗得以採用各種設計方式以展現療效或安全性的改善。考量特材利用傳統實證醫學的研究設計及實際執行的難度,實不易取得高證據等級之文獻。
另外,新功能類別特材,產品常常於數年內即能研發新的改良,臨床試驗進行的頻率不一定能跟上進步的速度。因此,真實世界數據及證據(Real-World Data and Evidence; RWD & RWE)已獲先進國家採用於評估醫材的安全性及有效性,做為審核產品上市之參考。委員會建議健保署於新功能類別特殊材料的分類判斷及後續給付核價,除臨床實證等級文獻外,亦應採認真實世界數據及證據,包括:來自調查/登記資料庫、認證機構/醫療院所/實驗室的資料或測試報告等。藉由採認多樣化的證據,以完善特殊材料的功能分類及核價機制,幫助新的醫療科技與器材能更容易進入台灣,提供更好的醫療環境。
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