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TITLE: AN INTRA-ARTICULAR, EXTENDED-RELEASE FORMULATION OF TRIAMCINOLONE ACETONIDE AS A COST-EFFECTIVE THERAPY FOR TREATING OSTEOARTHRITIS OF THE KNEE
AUTHORS:
Scott D. Kelley MD, James R. Johnson PhD, Daniel Thornton MBA
(Flexion Therapeutics, Burlington MA),
Jeffrey R. Skaar PhD, Georgios V. Varsos, PhD, Fred W. Peyerl PhD, MBA
(Boston Strategic Partners, Boston MA)
RESEARCH TOPIC: Cost Studies (CS)
RESEARCH SUBTOPIC: Cost-Effectiveness Analysis (CE)
DISEASE/DISORDER: Arthritis-Osteoarthritis
HEALTH CARE TREATMENT: Drug

ABSTRACT
OBJECTIVES: The present study investigated the cost-effectiveness of a novel, intra-articular, extended-release formulation of triamcinolone acetonide (TA-ER) in comparison to other methods for treating knee osteoarthritis (OA) pain.
METHODS: Clinical outcome data from 324 patients enrolled in three Phase 2 and Phase 3 randomized trials (NCT01487161, NCT02116972, NCT02357459) evaluating an investigational intra-articular corticosteroid formulation (FX006 40 mg) for treatment of knee OA pain were used. In these studies, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A [Pain], -B [Stiffness], -C [Physical Function]) data were assessed at baseline and at 4-week intervals through 12 (one study) or 24 weeks (2 studies) post-treatment. Health Utilities Index Mark 3 (HUI3) scores were calculated from WOMAC values. Cost-effectiveness was assessed using cost per quality-adjusted life years ($/QALY) and the incremental cost-effectiveness ratio (ICER) versus other knee OA treatments, including conventional care with non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, physical therapy, and assistive devices (CC); prescription NSAIDs (diclofenac); and hyaluronic acid treatment regimens with 1-5 intra-articular injections (HAs); based upon 2016 WAC pricing.
RESULTS: TA-ER demonstrated sustained significant improvements from baseline in all WOMAC components through 24 weeks, with concordant improvements in HUI3; peak HUI3 gain from baseline was 0.229 at week 4. Overall, TA-ER treatment produced an average QALY gain from baseline of 0.189 per 6 months, higher than published for CC (0.030), diclofenac (0.078) and HAs (average 0.110). At a hypothetical drug cost of $500, TA-ER yields a $/QALY estimate of $3,201, in comparison to other treatments: diclofenac ($2,708), CC ($10,717), and HAs (average $13,267). TA-ER at this treatment cost provided ICERs of $1,783 versus CC, $3,549 versus diclofenac, and was the dominant strategy versus HA injection regimens.
CONCLUSIONS: Intra-articular TA-ER injection provides sustained positive clinical outcomes, and if priced similarly to HA therapies, will be a cost-effective therapy for treating knee OA pain.

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