Clinical Strategy: Evidence and Reimbursement
Clinical strategy caught between the demands of reimbursement eligibility
A medical device or in vitro diagnostic may meet all regulatory requirements and yet fail to gain a foothold in everyday clinical practice. The CE marking does not clarify whether the product fits into existing healthcare systems or whether the evidence supporting it justifies its intended positioning. If reimbursement is a key component of the business case, this perspective must already be incorporated into the clinical strategy.
CE marking and reimbursement: two different approaches to evidence
Clinical evaluation under the MDR or performance evaluation under the IVDR (hereinafter: clinical evaluation) demonstrates safety, performance and clinical benefit. The benchmark is a positive benefit-risk ratio in the context of the state of the art; depending on the product, data from the literature may also be used. Proof of superiority over standard care is not generally required – unless the manufacturer claims such an advantage, e.g. as a promotional statement or claim.
For reimbursement, however, depending on the reimbursement route, it may be necessary to demonstrate added benefit over standard care, often on the basis of comparative studies with patient-relevant endpoints such as mortality, morbidity or quality of life. Technical performance parameters or surrogate endpoints are often insufficient for this purpose.
The problem is that evidence sufficient for CE marking may be insufficient for reimbursement. If this evidence is decisive, it should help determine which aspects of benefit are investigated, which claims are pursued and which endpoints are measured.
Choose clinical claims strategically from the outset
Even at the product development stage, it should be clear which clinical statements are to be substantiated and how. The intended purpose, target population, clinical benefit, claims and endpoints must all align. If an advantage over an established treatment is to be demonstrated, the evidence strategy must allow for this comparison. If a crucial endpoint is missing at the end, closing this gap will require considerable effort.
There is a clear boundary here: claims must be covered by the intended purpose and substantiated by the clinical evaluation (Article 7 of the MDR/IVDR; in Germany, the Medicines Advertising Act also applies). The reimbursement outlook influences which statements are strategically relevant – whilst the intended purpose and evidence determine which are permissible.
The key question is: What do we want to say about our product, and what evidence do we need to ensure that these statements are valid both from a regulatory perspective and for our market strategy?
State of the Art: Who or what am I competing against?
If the product is to compete with an established treatment, looking at clinical results alone is not enough. It must also be clarified where it should fit into the care pathway and what costs are associated with it.
Furthermore, whilst the CE marking applies across Europe, reimbursement is regulated at national level. Which assessment and reimbursement pathways are relevant depends, amongst other things, on the respective healthcare system, care sector and product. In Germany, for example, different reimbursement and assessment procedures may apply in the inpatient sector, such as those administered by the Joint Federal Committee.
Do I want to replace or complement an established treatment – and what benefit can I demonstrate, and at what cost? The answer determines the comparison groups, endpoints and the overall evidence strategy.
What is the added value of my product?
‘Innovative’ on its own does not describe clinical benefit.
For medical devices, this may lie, for example, in better patient-relevant outcomes, fewer complications or follow-up interventions. For IVDs, the benefit usually arises indirectly through the diagnostic information provided. High sensitivity or specificity is often not sufficient for reimbursement; the decisive factor is whether the test result improves treatment decisions.
A higher price does not necessarily make the care pathway more expensive – and a clinical benefit is not automatically cost-effective. The question is therefore not just ‘How much does my product cost compared to the alternative?’, but ‘What added value does it offer and how does its use affect the care pathway?’ Health economic data do not replace clinical evidence, but they help to contextualise it.
Does reimbursement even need to be part of my business case?
Not every product needs to displace a standard therapy. A manufacturer may deliberately address a gap in care or initially focus on out-of-pocket payers, selective contracts or selected markets. It is crucial that this positioning is established at an early stage.
It should be clear, however, that without reimbursement, even a clinically superior product often remains confined to niche markets and fails to reach the wider patient population. The initial question is therefore: “What role should my product play in future healthcare provision?”
What does this mean for the clinical strategy?
Evidence generation does not end with CE marking: PMCF or PMPF can, provided the methodology is appropriate, also provide data for subsequent positioning. Furthermore, the EU HTA Regulation provides for joint clinical assessments (JCA) for selected Class IIb and III medical devices, as well as Class D IVDs, under certain conditions; joint scientific consultations help to plan for these requirements at an early stage.
To be clarified at an early stage:
- What is the state of the art and what does the care pathway look like?
- What clinical benefits and claims are covered by the intended purpose?
- Against which treatment should the product be positioned?
- Do the endpoints capture the benefits relevant to reimbursement?
- In which markets and via which reimbursement channels should reimbursement be sought?
- What additional data can PMCF/PMPF provide?
Conclusion
CE marking and reimbursement follow different evidence-based approaches. If reimbursement is essential to the business case, it should help shape the early clinical strategy – from claims, through comparators and endpoints, to PMCF/PMPF. Those who ask these questions too late risk an expensive gap in the evidence.
Does your clinical strategy also support your market access objectives? We review your evidence for medical devices and IVDs to identify gaps between regulatory requirements and reimbursement prospects, and highlight where you can make early adjustments. Please get in touch.
Please note that all information and lists are not intended to be exhaustive, are provided without guarantee and are for information purposes only.
