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Background: Cost-effectiveness analyses (CEAs) have been performed for oral non-disease-altering osteoarthritis (OA) treatments for well over a decade. During that period the methods for performing these analyses have evolved as pharmacoeconomic methods have advanced, new treatments have been introduced, and the knowledge of associated adverse events (AEs) has improved., Objective: The objective of this systematic review was to trace the development of CEAs for oral non-disease-altering treatments in OA., Methods: A systematic search for CEAs of OA oral treatments was performed of the English-language medical literature using the following databases: PubMed, EMBASE, MEDLINE In-Process, EconLit, and Cochrane. Key requirements for inclusion were that the population described patients with OA or arthritis and that the analysis reported at least one incremental cost-effectiveness ratio. Each identified publication was assessed for inclusion. Thirteen characteristics and all AEs appearing in each included CEA were extracted and organized. Reference lists from these CEAs were also searched. A chronology of key CEAs in the field was compiled, noting the characteristics that advanced the state of the art in modeling oral OA treatments., Results: Thirty publications of 28 CEAs were identified and evaluated. Developments in CEAs included an expanded set of comparators that broadened from non-steroidal anti-inflammatory drugs (NSAIDs) only to NSAIDs plus gastroprotective agents, cyclooxygenase-2 inhibitors, and opioids. In turn, AEs expanded from gastrointestinal (GI) events to also include cardiovascular (CV) and neurological events. Efficacy, which initially was presumed to be equivalent for all treatments, evolved to treatment-specific efficacies. Decision-tree analyses were generally replaced by Markov models or, occasionally, stochastic or discrete event simulation. Finally, outcomes have progressed from GI-centric measures to also include quality-adjusted life-years., Conclusion: Methods used by CEAs of oral non-disease-altering OA treatments have evolved in response to changing treatments with different safety profiles and efficacies as well as technical advances in the application of decision science to health care.

Background: Duloxetine has recently been approved in the USA for chronic musculoskeletal pain, including osteoarthritis and chronic low back pain. The cost effectiveness of duloxetine in osteoarthritis has not previously been assessed. Duloxetine is targeted as post first-line (after acetaminophen) treatment of moderate to severe pain., Objective: The objective of this study was to estimate the cost effectiveness of duloxetine in the treatment of osteoarthritis from a US private payer perspective compared with other post first-line oral treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), and both strong and weak opioids., Methods: A cost-utility analysis was performed using a discrete-state, time-dependent semi-Markov model based on the National Institute for Health and Clinical Excellence (NICE) model documented in its 2008 osteoarthritis guidelines. The model was extended for opioids by adding titration, discontinuation and additional adverse events (AEs). A life-long time horizon was adopted to capture the full consequences of NSAID-induced AEs. Fourteen health states comprised the structure of the model: treatment without persistent AE, six during-AE states, six post-AE states and death. Treatment-specific utilities were calculated using the transfer-to-utility method and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores from a meta-analysis of osteoarthritis clinical trials of 12 weeks and longer. Costs for 2011 were estimated using Red Book, The Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project database, the literature and, sparingly, expert opinion. One-way and probabilistic sensitivity analyses were undertaken, as well as subgroup analyses of patients over 65 years old and a population at greater risk of NSAID-related AEs., Results: In the base case the model estimated naproxen to be the lowest total-cost treatment, tapentadol the highest cost, and duloxetine the most effective after considering AEs. Duloxetine accumulated 0.027 discounted quality-adjusted life-years (QALYs) more than naproxen and 0.013 more than oxycodone. Celecoxib was dominated by naproxen, tramadol was subject to extended dominance, and strong opioids were dominated by duloxetine. The model estimated an incremental cost-effectiveness ratio (ICER) of US$47,678 per QALY for duloxetine versus naproxen. One-way sensitivity analysis identified the probabilities of NSAID-related cardiovascular AEs as the inputs to which the ICER was most sensitive when duloxetine was compared with an NSAID. When compared with a strong opioid, duloxetine dominated the opioid under nearly all sensitivity analysis scenarios. When compared with tramadol, the ICER was most sensitive to the costs of duloxetine and tramadol. In subgroup analysis, the cost per QALY for duloxetine versus naproxen fell to US$24,125 for patients over 65 years and to US$18,472 for a population at high risk of cardiovascular and gastrointestinal AEs., Conclusion: The model estimated that duloxetine was potentially cost effective in the base-case population and more cost effective for subgroups over 65 years or at high risk of NSAID-related AEs. In sensitivity analysis, duloxetine dominated all strong opioids in nearly all scenarios.