Providing Conditional Access to Technology

The terms “coverage with evidence development,” “only in research,” “pragmatic trials,” “policy trials,” “comparative effectiveness research,” “field evaluation,” and “real-time monitoring” have been used in various international contexts to describe the action of a health care administrator or steward to provide access to or funding of (i.e., conditionally approve) a technology only in the context of further evaluation. The term “access with evidence development” (AED) has been more recently proposed as an umbrella term for these evidence development approaches.¹

Collecting further evidence has a strong theoretical basis, in that the value of collecting further evidence can be compared against the value of the opportunity costs from making incorrect decisions under uncertainty.² Similarly, reimbursement decisions could lead to reduced investigation and further data collection in the future, as both market access and third-party payer reimbursement are overcome by the organization who has  commercialized the new technology, leaving fewer incentives to collect further evidence.³ As such, the opportunity losses from adoption must be weighed against the opportunity losses from rejection and more research.

Based on a recently-held summit of leaders in technology management and evidence collection in Banff, Menon et al. have published a consensus statement of key principles for policy-makers and researchers who want to undertake this approach.¹ Among other things, the authors suggest that decision problems require clear articulation and that the governance of these activities “should not be in the hands of any party that would have a vested interest in any decision that might result from the particular AED.”¹

References

1. Menon D, et al. Pharmacoeconomics 2010; 28(2): 109-111.

2. Ades AE, et al. Med Dec Making 2004;24:207–27.

3. Philips et al. The Half-Life of Truth: What Are Appropriate Time Horizons for Research Decisions? Med Decis Making. 2008; 28: 287-299.