Abstract
BackgroundBiological and targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs) are effective treatments for rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (SpA), but associated with high costs. Therefore, various strategies for safe and cost-effective use of these drugs have been developed, such as tapering and biosimilar use. However, overarching recommendations on how clinicians or hospitals can use these strategies in clinical practice are absent.ObjectivesTo develop evidence-based multidisciplinary recommendations on strategies for cost-effective use of b/tsDMARDs in the treatment of RA, PsA and SpA.MethodsA task force was formed consisting of 13 experts in rheumatology, epidemiology and/or pharmacology from seven European countries. Relevant strategies for cost-effective use were collected and defined using one-to-one interviews with each task force member followed by group discussion. Next, a scoping review in PubMed and Embase was performed to summarize the evidence on each strategy, followed by a Delphi procedure and five online meetings, to form a set of overarching principles and recommendations. Levels of evidence and strengths of recommendations were determined in accordance with the 2018 EULAR additional guidance.[1] If consensus was reached on the formulation of the recommendation in the group meeting, voting on level of agreement was performed by every task force member separately using an online form. Level of agreement varied from 0 (completely disagree) to 10 (completely agree).ResultsTwelve strategies for cost-effective use of b/tsDMARDs were identified and four overarching principles were formulated (Table 1). For 10 strategies, there was enough evidence available to form one or multiple recommendation(s). In total, 20 recommendations were formulated, focussing on: the use of loading doses (2); the use of biosimilars where available (2); combining a csDMARD with a b/tsDMARD to maximise efficacy (3); the use of disease activity guided dose optimisation (4); the use of a drug formulary policy in clinical practice (1); considering using a lower dose where approved (2); improving medication adherence (1); non-medical drug switching within or between drug classes (1); therapeutic drug monitoring and other predictors for selecting or tapering a b/tsDMARD (2); and the use of different routes of administration of the same b/tsDMARD (2). The level of agreement for the recommendations varied between 7.9 (SD 1.2) and 9.8 (0.4).Table 1. Overview of strategies (A) and overarching principles (B) for cost-effective use of b/tsDMARDs in RA, PsA and SpAA.StrategiesAvoid dose loadingBiosimilar/generic drug useCombination therapyDisease activity guided dose optimisationDrug formulary policyDrug wastageInitial lower doseMedication adherenceNonmedical drug switchingOptimizing pharmacokinetic exposureResponse predictionRoute of administrationB.Overarching principlesCost-effectiveness considerations are an important aspect of treatment, and rheumatologists should have a leading role regarding this.Treat-to-target is the cornerstone of b/tsDMARD based treatment in RA, PsA and axSpA.Treatment choices must be based on shared decision making between the patient and the rheumatologist.Reimbursement policies should cover cost-effective use of pharmacological treatments, both on- and off-label, when they are evidence based and supported by (inter)national guidelines.ConclusionThese evidence-based recommendations provide caregivers in rheumatology with a consensus on strategies for cost-effective use of b/tsDMARDs in RA, PsA and SpA. Because high-quality evidence was limited, we were not able to formulate recommendations on all strategies.
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