K. Managed Entry and HTA
When HTA is used to inform reimbursement decisions about a new technology (or new application of an existing technology), it may encounter promising, yet non-definitive evidence regarding effectiveness, safety, economic impacts, or other attributes that are important to payers as well as other stakeholders. In these instances, rather than delaying any coverage until stronger evidence is available, payers may seek an arrangement for managed entry of the technology. These arrangements offer several forms of potential societal benefit. They can enable access for certain types of patients for whom existing evidence suggests net health benefit, provide some financial compensation for generating better evidence sooner than in the absence of reimbursement, enable refinement of clinical technique and services delivery, and build expertise and experience among physicians and other providers.
Some government and private sector payers have provided certain forms of coverage for selected “investigational” or “experimental” technologies since the 1990s in order to compile evidence for making more informed coverage policies (Beebe 1997; Brenner 2002; McGivney 1992; Medical Technology Leadership Forum 1999; Sheingold 1998; Wood 2001). More recently, such forms of “conditional coverage” have been subsumed under the broader term, “managed entry.”
Intentionally or otherwise, payers have long been providing reimbursement for investigational technologies, including prior to the 1990s in some instances. In the US, such instances have included reimbursement for many off-label uses of drugs approved for other indications, drugs with “treatment investigational new drug” (IND) designations by the FDA, certain devices being evaluated under investigational device exemptions (IDE) designations by the FDA, certain medical and surgical procedures being provided in qualifying clinical trials, and certain technologies whose coverage has been legislatively mandated (Steinberg, Tunis 1995).
Managed entry refers to a range of innovative payment approaches that provide patient access under certain conditions. Three main purposes are to manage: uncertainty about safety, effectiveness, or cost effectiveness; budget impact; and technology utilization for optimizing performance (Klemp 2011). In one general framework of managed entry (Carlson 2010), two main types that are based, at least in part, on health outcomes are conditional coverage and performance-linked reimbursement. Conditional coverage includes coverage with evidence development (CED) and conditional treatment continuation.
CED, a broad category of managed entry, refers to limited coverage for a new technology in parallel with specified data collection to provide stronger evidence about the effectiveness, safety, or other impacts of the technology of interest to payers. This enables some patient access to the technology while reducing uncertainty through real-world experience and generating evidence to inform revised coverage policies as well as clinical practice decisions (Trueman 2010). CED includes coverage “only in research” (i.e., coverage for a technology only when used in members of the payer’s patient population who are participating in clinical trials of the technology) and coverage “only with research” (i.e., coverage for a technology only when also being used contemporaneously in a sample of the payer’s patient population participating in clinical trials of the technology). Two types of performance-linked reimbursement are outcomes guarantee, where payment (or rebates) depend on achievement of predetermined health outcomes targets, and pattern or process of care, such as demonstrated impact on clinical decisions or patient adherence to prescribed regimens (Carlson 2010).
Certainly, various forms of managed entry can help to optimize use of a technology. CED and other forms of managed entry have had various levels of success to date, and face certain practical challenges (Berger 2001; Cooper 2001; Hutton 2007; Miller 2008). These arrangements can be difficult to negotiate and manage, and further evaluation is needed to assess their ability to achieve their purposes (Klemp 2011).