You can find Part 1 of this mini-series, an overview of diagnostic Performance-Based Risk Sharing Agreements in the US, in the News section of the Centivis website.
Summary
An increasing number of performance-based agreements (PBRSAs) for diagnostics/devices have been created in Europe over the last 5 years.
PBRSAs, also known as managed entry arrangements or patient access schemes, are arrangements between a payer and a manufacturer, where the level or continuation of reimbursement is linked to the real-world performance of a product, such as health or economic outcomes, in a defined patient population over a specified period of time. Coverage with evidence development (CED) is a type of PBRSA, where coverage is subject to generating additional evidence from a pre-defined study.
A recent study, completed under the aegis of EU Horizon 2020 COMED project, articulates the characteristics and challenges of the European CED landscape.
The authors examined all phases of device CED programs in Europe, including addressing the desirability of a CED scheme, its design, implementation as well as evaluation – along with the challenges stakeholders experienced to date.
The study identified 78 schemes. In the 24 schemes where decisions were publicly available, coverage was confirmed (or conditional coverage prolonged due to data quality issues) in 91% of cases.
What we learned from the study
25 stakeholders from national/regional health authorities, national insurance bodies, hospitals, and universities, provided insights on existing CEDs, as well as their perceptions on 13 pre-identified challenges.
During 2015-2020, seven European countries had running CEDs for devices, with a total of 78 schemes. Five countries only had pharmaceutical CEDs in place, while 11 had no CEDs at all (Figure 1).
Figure 1. Seven countries had device CEDs in place, with a total of 78 CED schemes during 2015-2020. Source
Overview of the 78 CED schemes
The autors have compiled a database of the 78 schemes, which is available in Supplement 4 of the study.
Eight diagnostic CEDs are included:
Four non-IVD: three imaging and one implanted sensor projects,
Four IVD: two projects for continuous/flash glucose monitoring were included, one in Ireland and one in Switzerland, as well as and two multigen cancer assays in Switzerland.
Of the 78 identified schemes, 24 had publicly available coverage decisions. Coverage was confirmed (or conditional coverage prolonged due to data quality issues) in 22 cases.
How CEDs can be initiated
The study identified three main pathways for CED initiation in Europe (Figure 2):
HTA assessment identifies uncertainties in clinical and/or cost-effectiveness, but criteria for CED schemes is met. An HTA assessment would be carried following a request for:
Registration in positive reimbursement list,
Additional remuneration,
Evaluation of a product in use.
Active screening by Health Authority or HTA units.
CED application by the manufacturer/provider, and where the application is considered eligible by the Health Authority.
Figure 2. Diagnostic CEDs in Europe have three main ways of being initiated. Source
Challenges
While there were no clear patterns in the decision makers’ perceptions about challenges, many of the bottlenecks were common to all technologies in all geographical areas.
The lack of established HTA capacity in some countries is hindering CEDs, as HTAs would ideally help identify the uncertainties that a successful CED could solve.
CEDs are not costless activities. The financing of CED programs in Europe fall on either the manufacturer/care provider or becomes a shared cost between the manufacturer and the national/regional payer.
Some of the challenges stakeholders are facing, can be found in Figure 3 below. For a full list of challenges, please refer to Table 5 in the study.
Figure 3. Some of the challenges with diagnostic CED programs in Europe. Source
Considerations for CED schemes
Feasibility of collecting data: A manufacturer should be aware of routinely collected data or registries it could tap to answer the research question, as this may affect study design. The feasibility and burden of data collection should be discussed amongst all stakeholders at the start of the scheme. Data points should also be routinely checked to ensure they are meaningful for answering the question.
Fast followers: Manufacturers might invest time and effort into a CED scheme but fast follower competitors entering the market could also benefit from it.
Experience matters: Though a CED with its study design and data collection burdens seem like a daunting undertaking, Payers in countries with CEDs rated the associated challenges lower than those whose jurisdiction had no CEDs in place yet.
For the full study, please see here
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