Jeffrey D. Kent

Budget Impact Modeling for a Single-Tablet Formulation of Ibuprofen and Famotidine for Prevention of Upper Gastrointestinal Ulcers in Patients With Osteoarthritis and/or Rheumatoid Arthritis

BACKGROUNDnSingle-tablet ibuprofen/famotidine is approved by the US Food and Drug Administration for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal (GI) ulcers in patients taking ibuprofen for those indications. Currently, little is known about the cost impact of gastroprotective therapies, and an estimate of the financial consequences of adopting these therapies will be helpful to decision makers.nnnOBJECTIVESnThe goal of this study was to review a model that evaluates the expected financial impact to US health care plans from the introduction of single-tablet ibuprofen/famotidine into the chronic NSAID user population.nnnMETHODSnA budget impact model, considering a typical health plan of 1 million enrollees, was used to compare patients receiving: (1) single-tablet ibuprofen/famotidine; (2) chronic NSAID treatment plus any GI-protective agent; and (3) chronic NSAID treatment without a GI-protective agent.nnnRESULTSnThe expected medication cost for single-tablet ibuprofen/famotidine was

Risk of Upper Gastrointestinal Ulcers in Patients With Osteoarthritis Receiving Single-Tablet Ibuprofen/Famotidine Versus Ibuprofen Alone: Pooled Efficacy and Safety Analyses of Two Randomized, Double-Blind, Comparison Trials

734,192 (

Delays in Initiation of Disease-Modifying Therapy in Rheumatoid Arthritis Patients: Data from a US-Based Registry

81,577 in year 1,

Onset and durability of pain relief in knee osteoarthritis: Pooled results from two placebo trials of naproxen/esomeprazole combination and celecoxib.

244,731 in year 2, and

Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers

407,884 in year 3), corresponding to a total per-member per-month cost of

One-year safety of ibuprofen/famotidine fixed combination versus ibuprofen alone: pooled analyses of two 24-week randomized, double-blind trials and a follow-on extension

0.020 (

One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia

0.007 in year 1,

Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons

0.020 in year 2, and

Nocturnal Asthma: Proof-of-Concept Open-Label Study with Delayed-Release Prednisone

0.034 in year 3). Considering anticipated decreases in the use of other NSAIDs, the use of GI-protective agents, and GI complications, the total expected 3-year drug cost for single-tablet ibuprofen/famotidine was offset by 50%, representing an estimated total budget impact of

Hyperammonemic crises in patients with urea cycle disorders on chronic nitrogen scavenger therapy with either sodium phenylbutyrate or glycerol phenylbutyrate

364,396 or