Mordin M, Hogue S, Barrows S, van Amerongen D. Safe and effective versus reasonable and necessary: is the deck stacked against medical devices? Poster presented at the 2013 ISPOR 18th Annual International Meeting; April 30, 2013. [abstract] Value Health. 2013 May; 16(3):246.

OBJECTIVES: US Food and Drug Administration (FDA) approval does not necessarily equate with coverage by the Centers for Medicare and Medicaid Services (CMS) or private payers for a device or a drug. The FDA is charged with determining the safety and efficacy of medical products. In contrast, payers are primarily concerned with whether medical products are reasonable and necessary. As health care costs continue to rise, manufacturers face increasing pressures to justify product prices and provide rationale to payers to support favorable funding decisions. Our objective was to review coverage decisions for devices and reasons for noncoverage to determine whether payers are expecting more pharmaceutical-like evidence.

METHODS: We reviewed Washington State Health Technology Assessment (HTA) decisions for therapeutics from 2007 through 2012. Reasons for noncoverage were classified as lack of clinical efficacy or other.

RESULTS: We identified 22 therapeutic HTA reviews, of which 11 included some level of noncoverage determination for the product or procedure. The reason for noncoverage was stated as a perceived lack of clinical efficacy evidence. For example, a 2008 decision against implantable infusion pumps for the treatment of chronic noncancer pain was based partly on the fact that “[t]he only kind of evidence about whether implantable infusion pumps are effective for patients with chronic noncancer pain comes from uncontrolled case series.” Such statements demonstrate the disparity between FDA approval of devices and payer expectations for efficacy evidence to support coverage decisions. Payer evidence requirements for medical devices continue to move closer to those historically associated with pharmaceuticals.

CONCLUSIONS: No roadmap exists for determination of reasonable and necessary levels of evidence for device-coverage decisions. FDA and payer evidence requirements are not aligned. Moving forward, evidence-generation efforts for devices will, in most cases, have to exceed FDA requirements in order for payer evidence needs to be met.