Background The introduction of biologics in Rheumatoid Arthritis (RA) had a dramatic impact on pharmaceutical budgets. Policy-makers initially struggled to make informed resource allocation decisions on use of biologics due to a poor evidence base. With emerging biologics for Systemic Lupus Erythematosus (SLE), we examine the state of the evidence and consider whether lessons from RA have been learnt.
Objectives To conduct a structured review of the literature to determine the evidence base for supporting policy-making regarding biologics for SLE.
Methods The review comprised of three parts. First, a scoping phase was conducted which reviewed documents from European and North American reimbursement authorities regarding policies towards biologics in RA. In particular, we sought historical documents where evidence gaps were highlighted in the early decision making. Second, we reviewed current documents to identify sources for informing these evidence gaps. Third, we comprehensively searched and reviewed the SLE literature to (i) identify information possible source of evidence, and (ii) critically appraise this evidence.
Results Our scoping phase highlighted 7 evidence gaps mentioned by policy makers pertaining to decisions regarding decisions in RA. In general, we found that evidence for SLE was lacking. In particular, the lack of a suitable surrogate outcome for costs and values will hamper the development of decision models.
Conclusions After reviewing the current evidence base, we believe that policy-makers are ill equipped to be making informed decisions regarding allocation of resources for biologics for SLE. With many biologics beginning to emerge, there exists a small window of opportunity to generate evidence to address this important topic.
Disclosure of Interest None Declared