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.

BACKGROUND: Single-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. OBJECTIVES: The 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. METHODS: A 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. RESULTS: The expected medication cost for single-tablet ibuprofen/famotidine was $734,192 ($81,577 in year 1, $244,731 in year 2, and $407,884 in year 3), corresponding to a total per-member per-month cost of $0.020 ($0.007 in year 1, $0.020 in year 2, and $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 $364,396 or $0.010 per member per month. Sensitivity analyses of cost and market share variables and clinical and drug characteristics identified the most influential variables to be the cost of the drug and persistence to the ibuprofen/famotidine formulation, respectively. CONCLUSIONS: The expected decrease in treatment costs for less serious GI-related complications illustrates the benefits of single-tablet ibuprofen/famotidine as a gastroprotective therapy in patients receiving chronic NSAID treatment, with a modest financial impact on total health care costs.

A prospective randomized trial of either famotidine or omeprazole for the prevention of bleeding after endoscopic mucosal resection and the healing of endoscopic mucosal resection-induced ulceration.

BACKGROUND: It has been reported that inhibitors of gastric acid secretion prevent bleeding after endoscopic mucosal resection for mucosal gastric neoplasm. However, uncertain whether an histamine2-receptor antagonist or proton-pump inhibitor is more effective. AIM: To evaluate prospectively the effectiveness of famotidine or omeprazole for ulcer management after endoscopic mucosal resection. METHODS: From July 2003 to October 2004, 57 patients were randomly assigned to famotidine or omeprazole for the management of endoscopic mucosal resection. Both drugs were given intravenously for the first 2 days, thereafter by mouth. The bleeding rates after endoscopic mucosal resection, the effects on the healing of endoscopic mucosal resection-induced ulceration, and cost-benefits were compared. RESULTS: Twenty-eight patients received famotidine and 29 received omeprazole. No significant difference was observed between the two groups in patient characteristics. The bleeding rates after endoscopic mucosal resection were not significantly different (18% vs. 14%) between the groups. Similarly, no differences were seen in the size of the endoscopic mucosal resection-induced ulceration at 1, 30 and 60 days after resection between groups. The total costs of anti-secretory agents demonstrated a significant cost-benefit to those treated with famotidine (10,420 yen vs. 17,782 yen). CONCLUSIONS: Famotidine is suggested as a better alternative to omeprazole for the management of endoscopic mucosal resection, as it showed a clear cost-benefit, and the healing results after endoscopic mucosal resection were similar for the two treatment strategies.

[Evaluation of the efficacy and the cost-effectiveness of maintenance treatment of gastroesophageal reflux disease: proton pump inhibitor versus histamine-2-receptor antagonist].

GERD is a common condition and acid-suppressing agents are the mainstay of treatment. A cost-effectiveness analysis comparing a PPI, lansoprazole (LPZ) and a H2RA, famotidine (FAM) for the maintenance treatment of reflux esophagitis in Japan was performed using a Markov chain approach. The time period studied was 6 months and payer perspective was chosen. Transition probabilities were estimated from meta-analyses. Expected days without esophagitis (healthy days) were 166 for LPZ 30 mg/day, 161 for LPZ 15 mg/day and 143 for FAM 40 mg/day. Direct costs were 55,624 yen for LPZ 30 mg/day, 42,078 yen for LPZ 15 mg/day and 67,969 yen for FAM 40 mg/day. Cost-effectiveness ratio (direct costs/healthy days) was 335 yen for LPZ 30 mg/day, 262 yen for LPZ 15 mg/day and 477 yen for FAM 40 mg/day. Lansoprazole was superior to famotidine with regard to both efficacy and cost-effectiveness and therefore is the preferred therapeutic agent for the maintenance treatment of GERD.

A simple institutional educational intervention to decrease use of selected expensive medications.

OBJECTIVE: To determine whether a simple educational intervention can influence use of prescription medications at an institution. DESIGN: Cost-effectiveness analysis of prescribing behavior before and after an educational intervention. SETTING: A large, urban, free-standing academic rehabilitation hospital. PARTICIPANTS: Physicians, residents, and physician extenders. INTERVENTIONS: The hospital's pharmacy department provided simple written educational material about cost differences of various prescription medications to attending and resident physicians, nurse leaders, and case managers. Telephoned reminders were given when targeted medications were prescribed. MAIN OUTCOME MEASURES: Total prescription medication use was recorded monthly for 12 months before and after the intervention. Pharmaceuticals monitored were subcutaneously administered anticoagulants, histamine type 2 (H2) blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs). RESULTS: A 32% decrease in use of the more costly anticoagulant and a 20% increase in use of the less costly anticoagulant (p <.0001), representing an estimated annual savings of nearly $66,000. Use of more costly H2 antagonist decreased 50% and use of less costly H2 antagonist increased 128% (p <.0001). With written intervention only, use of more costly NSAIDs declined 28%, whereas use of less costly NSAIDs increased 58% (p <.0020). CONCLUSION: Providing physicians with simple pharmaceutical cost information and telephone reminders decreased the use of targeted more costly medications.

[Intravenous treatment with quamatel in reflux-esophagus and erosive gastritis]. / Intravenozno lechenie s quamatel pri reflux-ezofagit i eroziven gastrit.

Organism's good tolerance toward Ranitidin and Famotidin makes possible an application of doses higher than the ones put into everyday practice. This is a very favorable circumstance considering the fact that according to some authors the decreasing of acidity in oesophagus apparently depends on the applied dose of the medicine. Thus the treatment with famotidin 2 x 40 mg allows an additional decreasing of acidity in lower oesophagus. We investigate the effect of intravenous application of famotidin (quamatel) in dose 2 x 20 mg and 2 x 40 mg as monotherapy in cases of reflux-oesophagitis and erosive gastritis as well as organism's tolerance toward it. There are 23 patients studied--17 men and 6 women, between 18 and 70 years old. The diagnoses are: reflux-oesophagitis--23, chronic erosive gastritis and reflux-oesophagitis--8. The patients are selected according to clinical criteria--scalding and/or pain in the oesophagus accompanied with acidity in the mouth cavity. The diagnoses are put gastoscopically. The results of the intravenous applying of quamatel are accounted in reference to the clinical complaints (scalding and/or pain in the oesophagus, acidity in mouth cavity) as well as to the endoscopic and histologic changes in the oesophagus and stomach mucosa. In patients with chronic erosive oesophagitis the efficiency of treatment was confirmed with complete epithelization of the erosions in 22 of 23. The short-period use of large doses 2 x 40 mg quickly improves the clinic symptoms and decreases the period of epithelization twice. The clinic experience shows that the intravenous form of quamatel remains the most effective in cases of short-term and intensive therapy of erosive gastritis with accomplicated hard and emergency clinical cases when the aim is to be avoided the peroral application of anti-ulcer means. An important advantage of the intravenous treatment with quamatel is its low price.

Antiulcer drug prescribing in hospital successfully influenced by "immediate concurrent feedback".

OBJECTIVE: To determine whether immediate concurrent feedback (ICF) focused on inpatient omeprazole prescribing achieved more rational and cost-effective antiulcer drug prescribing and usage. METHODS: In a 1400-bed teaching hospital, an audit (by specially trained personnel) was conducted to monitor inpatient prescribing of omeprazole (1) in preference to H2-antagonists and other drugs according to agreed criteria (Helicobacter pylori eradication, severe reflux esophagitis, rapid ulcer healing deemed urgent because of severe symptoms or complications, high-dose steroid therapy of > or =30 mg/day prednisolone) and (2) appropriateness of intravenous dosing (oral route not feasible or contraindicated). After baseline monitoring for 1 month, followed by relevant antiulcer drug therapy education, ICF was instituted for 1 year. This entailed explanatory memoranda requesting a change in prescribing issued to the respective medical teams of patients whose omeprazole prescription did not "conform." The main outcomes of the study were omeprazole prescription numbers per month and the proportion conforming, defined daily doses of antiulcer drugs used and corresponding expenditures, and pertinent antiulcer drug utilization data from 9 other local hospitals. RESULTS: Baseline omeprazole prescribing conformed in 32 of 173 (18%) of the patients compared with 451 of 546 (83%) during institution of ICF (P < 0001; chi2 test). Correspondingly, average overall omeprazole and ranitidine usage (inpatient and outpatient) and expenditure decreased (44% and 45%, respectively); collectively, use of less expensive alternatives increased about 61%. Estimated savings averaged about HK$150,000 ($20,000) per month. No comparable changes in usage were noted in 9 other local hospitals. CONCLUSION: Regarding hospital antiulcer drugs, this ICF strategy was associated with more rational prescribing and usage, and an important saving of resources.

Using multiple pharmacoeconomic methods to conduct a cost-effectiveness analysis of histamine H2-receptor antagonists.

A formulary decision at a health care institution was studied by using two pharmacoeconomic methods. A pharmacoeconomic study was undertaken to assess the impact of a 1995 formulary decision to designate cimetidine as the primary histamine H2-receptor antagonist (H2RA) and to restrict the use of famotidine. Consecutive patients receiving either i.v. cimetidine or famotidine for stress ulcer prophylaxis were reviewed during a two-month period in 1997, and information on demographics, dosage and duration of H2RA therapy, admission date, laboratory test values, and adverse drug reactions was collected. Data for 62 patients (43 cimetidine recipients and 19 famotidine recipients) were evaluated. Therapy was categorized as successful or failed, and the data were then evaluated by decision analysis to evaluate the cost-effectiveness of the agents and by multiattribute utility theory (MAUT) to incorporate a humanistic evaluation of the treatments, namely, the number of doses administered and the number of times dosages were changed. The decision tree revealed that the average cost of receiving cimetidine was $82.01 and the average cost of famotidine therapy was $92.45. The MAUT analysis showed that cimetidine was the preferred agent as long as cost was valued at greater than 60% of the decision-making process and efficacy remained equal between the two agents. Two pharmacoeconomic methods lent support to a formulary decision at a health care institution.

Switching the histamine H2 receptor antagonist famotidine to nonprescription status in Canada. An economic evaluation.

The aim of this study was to compare the direct medical costs associated with the treatment of patients with heartburn/nonulcer dyspepsia under 2 scenarios: (i) no nonprescription histamine H2 receptor antagonist (H2RA) is available (the 'status quo scenario'); and (ii) the H2RA famotidine (at a daily dosage of 10mg) is available over-the-counter (OTC) at retail pharmacies (the 'OTC scenario'). We employed a decision analysis model over a 16-week period that considered direct medical costs from 2 alternative perspectives: (i) society, including the cost of self-medication borne by patients; and (ii) a provincial third-party payer for healthcare. Data concerning direct medical costs associated with consumer self-medication and physician prescription of medication (including pharmacist dispensing fees), tests and procedures, and consultations with general practitioners and specialists were drawn from a clinician panel, published unit costs, and special surveys of institutional databases. All costs are reported in 1993 Canadian dollars ($Can; $Can1 = $US0.72, October 1995). From a societal perspective, the expected cost per patient over a 16-week period is not substantially different between the status quo and the OTC scenarios ($Can98 and $Can96, respectively). From a provincial third-party payer perspective, the expected costs per patient for the same scenarios are $Can95 and $Can89, a saving of $Can6 per patient. These results are sensitive to the proportion of patients who initially choose to see their physician rather than self-medicate, and the percentage of patients achieving successful treatment of symptoms. Changes in the rate or the cost of nonprescription medication, tests/procedures and physician visits do not affect the relative cost rankings. The total number of physician visits remained constant in both scenarios. From the societal cost perspective, the availability of famotidine in nonprescription form yields total costs that are similar to the status quo. However, from the perspective of the provincial payer, the expected costs per patient are likely to be slightly lower than the status quo if famotidine is available in unrestricted OTC scenario use. To generate significant savings to provincial payers, the number of people choosing immediate physician contact would have to be reduced, although not substantially, in the OTC scenario.

Safety and cost of rapid i.v. injection of famotidine in critically ill patients.

The safety and cost of famotidine in intensive care patients given the drug by rapid i.v. injection or slow i.v. infusion were studied. All patients admitted to the medical-coronary care and surgical intensive care units (ICUs) at a university teaching hospital over a two-month period who had orders for at least one dose of famotidine injection for any indication were randomly assigned to receive the drug by rapid i.v. injection or slow i.v. infusion via volumetric chamber. Data on patient demographics, drug administration time, adverse effects, cardiovascular variables, and costs (including drug acquisition, supply, and nursing personnel costs) were collected prospectively. Fifty-three patients received famotidine by i.v. injection (a total of 1041 doses) and 52 by i.v. infusion (1006 doses). The mean +/- S.D. duration of famotidine administration was 44 +/- 12 seconds in the i.v.-injection group and 19 +/- 5 minutes in the i.v.-infusion group. Adverse effects possibly related to famotidine occurred in three injection-group patients and two infusion-group patients. No significant difference between the groups in cardiovascular variables (mean arterial pressure, heart rate, and respiratory rate) was noted. Cost savings for the injection group relative to the infusion group totaled $2886 for the two-month study period. Half of the savings came from reduced supply costs and half from reduced personnel costs. The annualized savings to the institution would be about $17,300. Rapid i.v. injection of famotidine appeared to be as safe in ICU patients as giving the drug by slow i.v. infusion and was less costly.

A pharmacoeconomic analysis of IV H2-receptor antagonist use in 40 hospitals.

The objectives of this study were to determine (1) the expenditures of hospitals for IV histamine2-receptor antagonists (H2-RA), and (2) the cost savings that might be realized if only a single IV H2-RA was purchased for use. Forty hospitals provided data about purchase prices for each IV H2-RA dosage form purchased (cimetidine, ranitidine, and famotidine), the number of each dosage form used during the 12-month study period, purchase price and extent of usage for supplies, labor costs for preparing and administering IV H2-RAs, and IV H2-RA dosage schedules. The study showed that most hospitals were spending more money for IV H2-RAs than necessary given the pricing structures of the three products available to them at the time of this study. Also, that significant cost savings could be realized if a single H2-RA was used exclusively.

Strategy for developing a safe and cost-effective H2-receptor antagonist program.

The pharmacy staff of a community tertiary-care hospital evaluated efficacy and safety before addressing cost considerations in the transition to a capitation program with cimetidine as the preferred H2-receptor antagonist. Safety concerns were resolved by permitting the use of an alternative drug certain patients considered to be at high risk. Despite initial resistance to mandatory participation in the program, the physician and nursing staffs have grown supportive, and the annual cost savings, which include the costs of labor and supplies as well as acquisition, have been substantial.

Criteria-based DUE aids in selection of preferred agent.

The combination of a criteria-based drug utilization evaluation and a comprehensive drug literature review can be effectively used to reach therapeutically sound, cost-efficient formulary decisions. This report describes the approach to evaluating the available H2-receptor antagonists used by the Pharmacy & Therapeutics Committee of Memorial Medical Center, a 550-bed, community-based teaching hospital affiliated with the Southern Illinois University School of Medicine in Springfield.