Always criticizing US innovation, the time spent in the approval process for high-risk medical devices is often used to support this argument than the European approval process.1, the Food and Drug Administration (FDA) should lower its standard for approval of medical devices, Because a slow approval process delays Americans from acquiring innovation and lifesaving technologies. However, reviewing the data suggests using the appropriate endpoint instead of the same amount of time or less patients it needs to get innovative, high-risk medical devices in the US because it is in the four largest European markets (Germany, France, Italy and the United Kingdom) 2 - This is mainly because the patient is generally repaid until the decision is made, which often takes place in Europe and the United States.
The United States and Europe are fair in this regard, and must consider three standard equipment innovations, equivalent to the start and end points, and the level at which patients receive reimbursement definitions. First, we focus on innovative, high-risk devices because such devices in the United States require the most powerful evidence of clinical benefit and the relevant approval process, the subject of relative effectiveness debate in different countries. In addition, previous studies have shown that low-risk devices achieve similar amounts of time to market access in the US and Europe.
Second, more accurate market access requires a measurement of the total time elapsed between the submission of an application and market access. Compared to previous studies, the date of application submission and market access chronology, but from the date of submission, varies from country to country.
Third, patient visits should be equated with the availability of reimbursement, rather than approval with the device, as a wide range of patients enter a new device until reimbursement by a country or third party payer does not occur. Previously comparing the duration of the measurement process used by US and European systems, but the duration of the measurement process, but not innovative, high-risk equipment has reached the market, most patients can benefit from it, after obtaining regulatory approval, immediately, although they may Visiting the patient can afford to take out from the pocket. Instead, there is a second level of review, through public or private insurance companies to decide whether and at what price, they will pay for the equipment. In general, public systems take longer to make payment decisions than private insurers, and significantly more Europeans have public insurance than Americans. Two-thirds of the US population is covered by private health insurance, only one-fifth, and received public funds for reimbursement, mainly managed by the Center for Medicare and Medicaid Services (CMS).
For the public and private systems in the United States, patients accessing the device began to submit applications to the FDA. The FDA's review is based on pre-market approval (PMA) process innovations, high-risk equipment, safety and effectiveness (clinical benefit), and commentary on time information is public. In fiscal 2011, the FDA approved the application of 40 PMA. The average review time was 13.1 months, due to FDA review time of 8.4 months, and 4.7 months, the agency's sponsor to address the inadequacies in the application ("sponsor").3 CMS waiting Time to provide reimbursement for the majority of the equipment when they receive FDA approval. However, the number of devices per year is limited and the CMS has responded to external requests for verification or has limited evidence of clinical benefit or conflicting devices covering the country. This process has averaged 8.6 months in the past five financial years.4, although it is difficult to get a private insurance company how to make coverage decisions, and rumor information from private insurance companies indicates that the data is decided in a few weeks after a few weeks. The FDA approves the quantity and quality of evidence based on clinical benefit.
In contrast, in Europe, most of the 27 member states of the European Union (EU) have publicly funded health care systems that include about four-fifths of the population of the four largest equipment markets. All EU countries require equipment to first obtain a European General (CE certification) mark, which refers to the recognition symbol for the product, indicating the entire EU market. The CE mark is carried out in the process of making a profit-for-profit, third-party certification body ", which has been approved by a Member State to assess the safety and performance of the equipment, but has no effectiveness evaluation (which requires more clinical data). Although public The data is limited and the rumor information from the notified body indicates that the process takes one to three months, excluding the sponsor's time.
Most patients in Europe do not have innovative, high-risk equipment, and the CE sign is received as soon as the access device is accessed. Each country must first reimburse, a process, although the CE mark can be significantly less than the decision to make changes between countries.5 based on the need for FDA-approved clinical data, European reimbursement standards are often similar or higher than the FDA Approval of the device. European countries may need additional data equipment for safety and effectiveness, as well as cost effectiveness.
In France, a centralized body makes the decision to reimburse the safety and effectiveness of a single piece of equipment. In Italy, the decision to reimburse the regional, UK and German equipment types or procedures for a broader assessment, rather than a single device. Often, innovative equipment is not included in the existing diagnostic-related group (DRG) requirements for a longer health technology assessment process, assessing safety, clinical benefits, and cost-benefit reviews. The timely reimbursement of information provided by the government varies from country to country. The estimated time average is 71.3 months, in the German range of 36.0 48.0 months, in France, in the Italian range of 16.4 to 26.3 months, and is expected to be 18 months in the UK.
Using this information, we decided to bring innovative, high-risk devices in US patients to spend less time or similar than the top four European markets. The process of the American public (CMS) requires about half of the Italian and British, in France, as long as it is in Germany, less than a third. The difference in market access is even greater when it comes to private insurance companies (including the majority of the US population), which often reimburse FDA-approved decisions within the next few months.
To further illustrate this point, we compared the time to five innovations in France, Italy for the approval of high-risk medical devices, and the US States.These case studies show that the average time for market access for these devices is 26.3 months for France, 30.8 months in Italy, in the United States and 15.3 months.
These numbers may not fully capture why the device market reaches faster in one country than in another and does not reflect all the innovative, high-risk equipment experience. However, unless the level of risk of the same standard is used, the starting point and end point of the process, the critical endpoint of market access, and the exact comparison cannot be made.
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