Reimbursement DOs And DON’Ts

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No matter how hard you try to manufacture a safe, efficacious, and quality product, it is not going to generate the revenues you anticipated unless it can be properly reimbursed. Here are some quick Dos and Don’ts of the reimbursement process. (Some details have been modified to protect company privacy.)

1. Do – Develop your reimbursement strategy early.
Don’t – Delay developing your reimbursement strategy until just before your product launch.

Real life examples:

Example #1: Company A developed a 4-sensor product that competed with other available 6-sensor products. This product was clinically better and less expensive than its competitors. The company invited Mediclever to check whether they could utilize existing reimbursement mechanisms in France. A short assessment revealed available codes, a positive coverage policy, and payment rates that exceeded the company’s expectations. However, the wording in the identified existing codes specifically indicated 6 sensors! Redesigning the product at that stage was too difficult, and the company was left out of the French market.

Example #2: Company B developed and launched a product in the US market. Unfortunately, the pressure settings employed by their product deviated from the allowable range specified under existing reimbursement mechanisms. The CEO asked Mediclever to provide them with a ‘reimbursable’ specification. The company is currently redesigning their product according to this spec.

Remember: Your reimbursement strategy could affect your product design.

2. Do – Consider reimbursement factors when selecting the most appropriate application to start with.
Don’t – Choose your “killer app” only on the basis of R&D, regulatory criteria, or marketing.

Real life example: Company C developed a platform that could be used for a few applications. The company invited Mediclever to develop and implement its reimbursement strategy, while its pivotal trial, focused on Application I, was underway. Mediclever’s assessment discovered that if the company proceeded with the current Application I, the likelihood for reimbursement was low and might only be granted in five to ten years at a considerable investment. On the other hand, if the company used the same device for Application II, immediately upon receipt of the CE mark, the device would be reimbursed at a lucrative rate. Obviously, the company realized that by continuing with Application I, the company would probably not survive to reach profitability. Consequently, the company abandoned Application I and is currently selling its product, under existing reimbursement mechanisms, for Application II.

Remember: Your reimbursement strategy could affect the first application of your product.

3. Do – Leverage your clinical trial(s) to gather reimbursement related data.
Don’t – Focus only on the regulatory aspects.

Real life example: Company D developed outstanding clinical data for their product and invited Mediclever to help them develop specific reimbursement mechanisms for it. All Payers that Mediclever approached were impressed by the developed clinical ‘evidence’, but wanted the company to also present data regarding a few economic aspects. Since these economic aspects were not observed during the company’s previous clinical trial, the company had to perform a new trial to gather the requested data. Had the company thought about its reimbursement strategy prior to initiating the clinical trials, those economic aspects could have been easily integrated into their previous trials making the investment in a new trial, and the delay in the sale of their product, redundant.

4. Do – Develop your regulatory and reimbursement strategies in parallel.
Don’t – Think that since regulatory clearance comes before obtaining reimbursement that this is a serial process.

Real life example: Company E asked Mediclever to start working on its reimbursement strategy after applying for, and receiving, the regulatory clearance. Unfortunately, the wording that was used in the application substantially decreased the likelihood of reimbursement. Consequently, the company re-applied for the regulatory clearance, this time, with a modified indication for use. Needless to say, this delayed the launch of the product resulting in substantial loss to the company.

Remember: Short regulatory path ≠ optimal reimbursement.

These real-life examples can help you avoid these common mistakes, reduce costs, and reach the market sooner.

To verify the existence of relevant reimbursement mechanisms for your product in the US or any European country, to develop and implement an appropriate reimbursement strategy and for any additional questions, please contact:
Amir Inbar, CEO
Mediclever Ltd.

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Amir Inbar has 13897 articles online and 13 fans

Amir Inbar founded Mediclever (, which provides end-to-end reimbursement consulting services to life-science companies, selling pharmaceuticals and medical technology products in the US and Europe. As an expert reimbursement consultant Amir has consulted for organizations ranging from incubator startups to large, publicly traded companies, assisting them to obtain reimbursement.

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Reimbursement DOs And DON’Ts

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This article was published on 2010/09/25