QOL Assessment in Rheumatoid Arthritis 843 mended parameters Study horizon Duration of therapy Continous Extrapolation beyond trial duration efrom observational studies,trials and other sources Modelling beyond therapy Specify any additional benefit or ham after therapy is stopped Use relative effects from cor Clinical outcomes measures HR-C rseevent reports with patients as the un of analysis) H zard of health states (egQALYs) es for health policy decisions Resource utiization servational data ment of RA,there has been an increase in these of biological DMARDs in RA.In a study conducted types of analyses in recent years. in methotrexate-resistant patients,the costs fo achieving an ACR20 when other agents were added the E L methotrexate ranged from $US1500 to explored an RA-specific standardized frame ues). (reference ase)for use in economic evaluations.7 QALY In a series of six were cal Recommendations for key evaluations in economic ated with bi studies include duration of therapy,extrapolation IS95 205 beyond trial duration,modelling of results after ther- POALY apy is discontinu ed,synthesis of comparisons where dMost ICERswe <$US50000 T OALY head-to-head tri do he threshold that is hist ically cited as ing outcome QALY mortalit od value for additional spending ICERs of states (e.g SUS100 000 per QALY gained have also been used tion of thera and ulati on risk stratification. to justify additional drug spending. Specific rec mended clinical outco es for this framework are ioint counts.visual analogue scale est evaluation of pain.physical measure of function by in studies of etane ept a Studies s ciated with the QALY ed.Both Doar ay he otable for cluded that biological DMARDs are the benefits obtained with these ag ents.Doan et interventions than non-biological agents.but their al.7 reviewed several economic analyses of the use value in patients with inadequate response to other 2008 Ads Data Information BV.All rights resorvod oconomics 2008:26 (10) QOL Assessment in Rheumatoid Arthritis 843 Table III. Reference case: a recommended standard framework for economic evaluations in rheumatoid arthritis (RA). Reproduced from Welsing et al.[78] with permission of Expert Reviews Ltd Methodological element Recommended parameters Study horizon Trial-based analysis: minimum 1 year Model-based analysis: minimum 5–10 years Duration of therapy Continuous Extrapolation beyond trial duration Report clinical data alone Extrapolate using evidence from observational studies, trials and other sources Include sensitivity analysis Minimize use of expert opinion Modelling beyond therapy Specify any additional benefit or harm after therapy is stopped Synthesis of comparisons where Use relative effects from controlled trials head-to-head trials do not exist Clinical outcomes measures Joint count, pain by visual analogue scale, physical measure of function (e.g. HAQ) Measure of inflammation (CRP/ESR) HR-QOL Toxicity (adverse event reports with patients as the unit of analysis) Mortality Hazard rates for mortality from observational studies Valuation of health states (e.g. QALYs) Patients’ values for clinical choices General populations’ values for health policy decisions Resource utilization Include all associated direct medical and nonmedical costs Report indirect costs (productivity losses) separately Discontinuation of therapy Report discontinuation rates from trials, adjusted using observational data Therapeutic sequence Include modelling of the most commonly used therapeutic sequence with sensitivity analysis to aid in consideration of alternate strategies Population risk stratification Include clear definition of underlying population, including low- and high-risk groups CRP = C-reactive protein; ESR = erythrocyte sedimentation rate; HAQ = Health Assessment Questionnaire; HR-QOL = health-related quality of life. ment of RA, there has been an increase in these of biological DMARDs in RA. In a study conducted types of analyses in recent years. in methotrexate-resistant patients, the costs for achieving an ACR20 when other agents were added To enhance economic outcomes research in RA, to methotrexate ranged from $US1500 to the Economics Working Group of OMERACT has $US10 900 (year 2000 values).[80] In a series of six explored an RA-specific standardized framework (reference case) for use in economic evaluations.[77] studies in which QALYs were calculated from Recommendations for key evaluations in economic health utility measures, ICERs associated with bio￾logical DMARDs in methotrexate-resistant patients studies include duration of therapy, extrapolation beyond trial duration, modelling of results after ther- ranged from $US3500 to $US85 395 per QALY gained. Most ICERs were <$US50 000 per QALY, apy is discontinued, synthesis of comparisons where head-to-head trials do not exist, clinical outcome the threshold that is historically cited as indicating a good value for additional spending.[79] measures, mortality, valuation of health states (e.g. ICERs of QALYs), resource utilization, rates for discontinua- $US100 000 per QALY gained have also been used to justify additional drug spending.[79,81] tion of therapy, and population risk stratification.[77] Specific recommended clinical outcomes for this In a similar review of anti-TNFα therapies, framework are joint counts, visual analogue scale Wong[82] estimated $US28 924–32 320 per QALY evaluation of pain, physical measure of function by gained in studies of etanercept and infliximab when HAQ, measures of inflammation, HR-QOL and tox- only direct costs were used. If indirect costs were icity (table III).[78] included, the estimates fell below $US10 000 per QALY gained. Both Doan et al.[79] and Wong[82] Studies suggest that the cost associated with the use of biological DMARDs may be acceptable for concluded that biological DMARDs are more costly the benefits obtained with these agents. Doan et interventions than non-biological agents, but their al. value in patients with inadequate response to other [79] reviewed several economic analyses of the use © 2008 Adis Data Information BV. All rights reserved. Pharmacoeconomics 2008; 26 (10)