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Coverage and Shared Risk How are they related?

One of the big problems that payers face when deciding whether or not to pay for a new technology is the uncertainty about its performance in their own context. One option that has been gaining popularity is to propose a type of joint venture arrangement, such as coverage with evidence development (coverage with evidence development), whose main objective is precisely, reduce uncertainty when generating local data.


If you are the creator or provider of a technology, how would you reconcile the payer's need to give their patients the appropriate therapy, with the need to generate local evidence and face the decision of whether or not to cover a technology?


Here are some ideas:

Keep in mind that the more information the payer has, the faster a decision will be made. In this sense, the following 3 questions must be asked:


  1. Does the generation of additional evidence provide information for the decision?
  2. Is it possible to generate relevant and useful evidence after the agreement is finished?
  3. In the event that it is decided to pay for the technology, what would be the cost and impact of reversing the decision?


In general, it can be assumed that, for the creator of the technology, there will be fewer incentives to invest time and resources in generating local evidence, if the technology is already covered.


Therefore, the payer must weigh the utility and the health impact that the generation of new additional evidence. That is to say, the opportunity cost to enter into and implement the agreement. This is where you as the creator of the technology would have the greatest say in the coverage decision.


In this way, in order to provide the payer with useful information for the decision, a risk-sharing arrangement could be designed that involves initial technology coverage. The most common alternatives for entering into agreements are:


  1. Research-only coverage (only with research): Here coverage is conditional on the collection of additional local evidence. In this way, the technology is covered in all patients to whom the technology is directed (this does not imply that covered patients are part of the research) and the decision to continue coverage (paying for the technology) depends on the evidence collected in a group of patients, on whom it is carried out prospective collection of evidence of efficacy and safety.
  2. Research only coverage (only in research): It is the technology coverage only for patients who voluntarily participate in the data collection program.


In this case, the continuation or increase of coverage also depends on the results of the program. Research can be funded by the payer or by the creator of the technology.


Finally, it should be noted that with these agreements, you can negotiate not only the coverage of the technology, but also the price of it.


To delve into the subject you can consult the publication: Walker, S et al. (2012). Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for coverage decisions. Value in Health15(3), 570-579.


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