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.
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。
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。