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Reimbursement FAQs
Click on one of the questions below to find your answer.
If you didn't find the information you needed, please write us to: info@mediclever.com
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Download The Reimbursement Checklist here. (PPS 1.6MB)
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How to increase the chances for reimbursement of your Drug / Device in Europe and the US? |
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When should you start dealing with reimbursement issues? |
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Why should you start dealing with reimbursement issues? |
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Register to receive reimbursement related news and articles (free).
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How long does it take to obtain reimbursement? |
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The first thing you should do is check whether your device could fit into an existing reimbursement mechanism. In such a case, reimbursement is almost immediate.
In case there is no existing reimbursement mechanism, obtaining a new coverage decision and a unique code for your drug / device could be a matter of years, depending on the product, its benefits the political and economical environment and many other factors.
However, even in such cases, before all reimbursement mechanisms have been established, there are usually short-term, intermediate reimbursement mechanisms that could provide your drug / device with some sort of reimbursement within months.
To view the above explanation graphically, check out Slide #15 in our Reimbursement Checklist.
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How much does it cost? |
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Naturally, the cost of each reimbursement project may vary according to the product, the country and the relevant reimbursement-related environment.
To receive a business proposal that matches your company's needs, please click here and a Mediclever representative will contact you shortly.
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Where should we start? In which country should we launch our first reimbursement project? |
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As can be seen in the following graph on the left, the market potential in the US turns this market into the first choice for most companies.
In some cases, other factors such as the relatively high entry cost (as can be seen on the following graph on the right) may drive companies to start with a smaller market, typically one of the larger European countries.
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When should we start looking into reimbursement issues? |
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The following diagram is taken from our Reimbursement Checklist.
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Reimbursement Landscape: Should be conducted as early as possible as it could impact product development, relevant applications and the targeted markets.
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Sales Tools: Assuming there are existing reimbursement mechanisms for your drug / device, Sales Tools development should be completed prior to applying for FDA/CE Clearance/Mark.
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Evidence Planning: Assuming there are no existing reimbursement mechanisms for your drug / device, Evidence Planning should be completed prior to initiating clinical studies.
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If we have reimbursement in the USA, will it help us obtain reimbursement in Europe? |
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Formally, no. There is no formal link between reimbursement systems in these countries. However, decision makers become increasingly receptive to reimbursement related data from other countries that may affect their decision making process.
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Is reimbursement in Europe similar for all EU countries? |
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No. As opposed to the general CE mark, each country maintains its different reimbursement mechanisms and reimbursement in one European country does not imply reimbursement in another.
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We have an excellent distributor that we count on. Should we let him/her handle our reimbursement needs? |
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A distributor with reimbursement experience may assist in checking existing reimbursement mechanisms, but should not determine the company's reimbursement strategy or apply for any sort of reimbursement by himself/herself.
For more on this subject, please refer to the article: "Reimbursement Through Distributors", which may be downloaded here.
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