The lag from FDA approval to published cost-utility evidence

Abstract

The lag between FDA approval and publication of cost-utility evidence can hamper payers from accounting for value for money in coverage and reimbursement decisions. We examine this gap, and whether it has changed over time. For drugs approved from 2000 to 2010 (n = 274), we searched the Tufts Medical Center Cost-Effectiveness Analysis Registry to identify relevant cost-utility analyses (CUAs). We identified 127 (46%) drugs associated with a CUA, 62 of which had a CUA published in the 3 years following its approval. Compared with drugs approved from 2000 to 2003, a greater proportion of those approved from 2004 to 2006, and from 2007 to 2010, was associated with a CUA published in the 3 years following approval (13 vs 25% [p = 0.06] and 13 vs 32% [p < 0.01], respectively). Study findings indicate that payers now have slightly more rapid access to published CUAs.

Keywords:

• cost–effectiveness
• coverage and reimbursement
• evidence-based medicine
• FDA approvals
• pharmaceuticals

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Today, payers typically must make coverage and reimbursement decisions for many drugs in the absence of published evidence of comparative value.

• The majority of drugs (54%) approved by the FDA from 2000 to 2010 do not have an associated published cost-utility analysis (CUA), and only 23% had a corresponding CUA 3 years following approval.

• The lag from FDA approval to CUA publication has decreased over time, with CUAs more rapidly available for drugs approved in more recent years, indicating that payers now have earlier access to evidence of value.

• Industry-funded CUAs are typically published before unfunded studies or those funded from nonindustry sources.

• If demand for evidence of value grows, it is likely the lag between FDA approval and publication of a CUA will decrease further.