A FINANCIAL IMPACT ASSESSMENT OF INTRODUCING LUMIRACOXIB ONTO THE FORMULARY OF THE UK NATIONAL HEALTH SERVICE FOR THE MANAGEMENT OF PATIENTS WITH OSTEOARTHRITIS

Background: Selective cyclooxygenase-2 (COX-2) inhibitors reduce the incidence of serious gastrointestinal (GI) adverse events (AEs) associated with traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Avoiding these GI events may be associated with savings that can offset the higher drug acquisition costs of COX-2s.Objectives: To assess the 5-year financial impact of introducing lumiracoxib for the treatment of patients with osteoarthritis (OA) not using low-dose aspirin for cardioprotection in a hypothetical population of 1 million adults >50 years of age covered by the UK's National Health Service (NHS).Methods: A Markov model was developed to simulate the costs of hospitalizations, outpatient visits and medications for the management of OA and NSAID-associated AEs including dyspepsia, symptomatic ulcers, complicated GI events, myocardial infarction, severe skin, renal and hepatic events for lumiracoxib, celecoxib, diclofenac, ibuprofen, naproxen, and respective traditional NSAID (tNSAID) plus proton pump inhibitor (PPI) combinations. Relief of arthritic pain was assumed equal across all comparators. The budget impact was evaluated by comparing the costs between a baseline scenario without and a future scenario with lumiracoxib. Drug market shares of baseline and future scenarios were based on a survey of physicians and on IMS data: lumiracoxib (0% to 14.65%), celecoxib (22.83% to 18.00%), diclofenac (25.33% to 24.28%), ibuprofen (22.19% to 20.89%), naproxen (4.86% to 4.51%), diclofenac+PPI (12.17% to 8.53%), ibuprofen+PPI (11.74% to 8.31%), and naproxen+PPI (0.87% to 0.83%) over 5 years. The prevalence of OA was assumed to be 15%. The age and gender distributions of OA patients were taken from the TARGET [1,2] trial. Event risks were obtained for patients treated with lumiracoxib in the TARGET trial and for other treatments using adjusted relative risks based on AE rates observed in the CLASS [3] trial (lumiracoxib and celecoxib studied at higher than approved dose). Lumiracoxib was priced 10 pence less than celecoxib (£0.72) based on British National Formulary. Costs of managing AEs were derived from the medical literature.Results: In a population of 1 million over the age of 50, 150 000 patients with OA are estimated. If all OA patients have a history of a prior GI event, the incremental cost for drugs, hospitalization, and outpatient care are -£2239750, -£2176100, and £224171, respectively, resulting in an overall saving of £4191679 per 1 million lives. If no OA patients have a history of a prior GI event, the saving was reduced to £2636861 per 1 million lives. Spending for 150000 OA patients (per 1 million lives) Costs: Drug (£) Hospital (£) Outpatient (£) Total (£) With prior GI event Baseline Tx pattern 138 394 443 19 772 392 18 986 116 177 152 951 Future Tx pattern 136 154 693 17 596 292 19 210 287 172 961 272 Savings 2 239 750 2 176 100 -224 171 4 191 679 Without prior GI event Baseline Tx pattern 131 947 113 7 704 552 16 626 084 156 277 749 Future Tx pattern 129 827 137 7 047 821 16 765 930 153 640 888 Savings 2 119 976 656 731 -139 846 2 636 861 Lumiracoxib treatment (Tx) pattern: baseline=0%; future=14.65%. Conclusion: Substantial savings over 5 years are projected after inclusion of lumiracoxib onto the NHS formulary.References: 1. Schnitzer et al. Lancet 2004;364:665-674.2. Farkouh et al. Lancet 2004;364:675-684.3. Silverstein et al. JAMA 2000;284:1247-1255.Citation: Ann Rheum Dis, volume 66, supplement II, year 2007, page 258Session: Health service and outcome research