Impact of RWE on re-assessment of medicines by HTA agencies

The use of real-world evidence (RWE) is important for access and reimbursement decisions for a number of reasons including that it may help to gain a better understanding of the patient population who will receive a medicine; it may also help to better understand the relative effectiveness of medicines by supplementing evidence from conventional randomised controlled trials (RCTs). (for more information, see here)

RWE may be present at the initial assessment of a medicine by a health technology assessment (HTA) agency, or it may be collected after authorisation.

Haute Autorité de Santé (HAS), the national HTA agency in France have assessed the association between the level of reimbursement granted after a medicine was re-assessed by the agency and the alignment of RWE with RCTs. Please note that it was not possible to conclude with absolute certainty that the reimbursement decisions made following the re-assessment of the medicine were directly related to the RWE as other factors may have contributed to the decision (such as new RCT evidence).

For more information about this review, see here.

Managed entry agreements or conditional reimbursement

Real-world evidence may be requested by an HTA agency in the context of a managed entry agreement to better understand areas of uncertainty. Managed entry agreements, also referred to as managed access agreements or conditional reimbursement schemes, are arrangements where a health technology assessment (HTA) agency recommends reimbursement of a technology under certain conditions, such as for data collection or evidence development for the areas of uncertainty (for example, with real-world evidence) and some kind of commercial or risk-sharing agreement (such as a price reduction). This may occur in situations where the decision maker considers the technology to be very promising but there is a high level of uncertainty about the relative effectiveness or other aspects of the medicine. The intention is to re-assess the technology after the evidence is collected or generated.

These types of managed entry schemes are increasingly being considered by HTA agencies, but to different degrees.

Zorginstitut Netherlands (ZIN), the national HTA agency in the Netherlands, have introduced a managed entry agreement or conditional reimbursement scheme (referred to as conditional financing). A review of the scheme can be found here.

IMI ADAPT-SMART have conducted some work on the use of managed entry agreements in the context of adaptive pathways. For more information, see here.