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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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Reimbursement Questions:
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Reimbursement Answers:
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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 device is a matter of years. Such projects could range between 3 years to much more, depending on the product, its benefits the political and economical environment and many other factors.
However, even in such cases, until a reimbursement project is fully completed, there are usually short-term, intermediate reimbursement mechanisms that could provide your device with some sort of reimbursement within months.
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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 Israeli 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 Israeli 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 gray shaded area below depicts a typical path of a medical device start-up from initial idea to commercialization. The blue area on the right depicts the appropriate reimbursement related activities in accordance with each of the stages on the left. |
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In this stage, we search whether the anticipated device could benefit from any existing reimbursement mechanisms, allowing immediate reimbursement after regulatory approvals. If there are such existing mechanisms, we indicate their value and the steps required to utilize them.
In case no existing reimbursement mechanisms were found, we outline a recommended reimbursement strategy, to be followed once the company reaches the commercialization stage.
The deliverable is a reimbursement report that could be integrated in the company's business plan.
In some cases, reimbursement related findings could even influence the planned features and functionality of the product. |
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Receiving inputs from a reimbursement consultant prior to initiating your clinical trials, and adding a few reimbursement-related inquiries to the protocol, may eliminate the need in conducting additional trials especially for the reimbursement.
Furthermore, regulatory submissions, especially in the US, may impact your reimbursement path later on and therefore, should be reviewed in advance by a reimbursement consultant. |
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In this stage, we implement the strategy we defined in stage 1.
Whenever possible, we utilize existing mechanisms. In all other cases, we launch a reimbursement project in which we outline processes and criteria for obtaining coverage, including the development of new or modified codes and the establishment of favorable coverage guidelines for such codes.
Whenever possible, we also explore possibilities of utilizing short-term, intermediate reimbursement mechanisms. |
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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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Reimbursement related decisions may substantially impact the company's success in the long-term, and are therefore strategic in nature. Hence, it is advised to maintain all reimbursement-related decision making at the company's headquarters.
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.
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