Cost-effectiveness of histamine receptor-2 antagonist versus proton pump inhibitor for stress ulcer prophylaxis in critically ill patients*.

OBJECTIVE: To examine the cost-effectiveness of using histamine receptor-2 antagonist or proton pump inhibitor for stress ulcer prophylaxis. DESIGN: Decision analysis model examining costs and effectiveness of using histamine receptor-2 antagonist or proton pump inhibitor for stress ulcer prophylaxis. Costs were expressed in 2012 U.S. dollars from the perspective of the institution and included drug regimens and the following outcomes: clinically significant stress-related mucosal bleed, ventilator-associated pneumonia, and Clostridium difficile infection. Effectiveness was the mortality risk associated with these outcomes and represented by survival. Costs, occurrence rates, and mortality probabilities were extracted from published data. SETTING: A simulation model. PATIENTS: A mixed adult ICU population. INTERVENTIONS: Histamine receptor-2 antagonist or proton pump inhibitor for 9 days of stress ulcer prophylaxis therapy. MAIN MEASUREMENTS AND RESULTS: Output variables were expected costs, expected survival rates, incremental cost, and incremental survival rate. Univariate sensitivity analyses were conducted to determine the drivers of incremental cost and incremental survival. Probabilistic sensitivity analysis was conducted using second-order Monte Carlo simulation. For the base case analysis, the expected cost of providing stress ulcer prophylaxis was $6,707 with histamine receptor-2 antagonist and $7,802 with proton pump inhibitor, resulting in a cost saving of $1,095 with histamine receptor-2 antagonist. The associated mortality probabilities were 3.819% and 3.825%, respectively, resulting in an absolute survival benefit of 0.006% with histamine receptor-2 antagonist. The primary drivers of incremental cost and survival were the assumptions surrounding ventilator-associated pneumonia and bleed. The probabilities that histamine receptor-2 antagonist was less costly and provided favorable survival were 89.4% and 55.7%, respectively. A secondary analysis assuming equal rates of C. difficile infection showed a cost saving of $908 with histamine receptor-2 antagonists, but the survival benefit of 0.0167% favored proton pump inhibitors. CONCLUSIONS: Histamine receptor-2 antagonist therapy appears to reduce costs with survival benefit comparable to proton pump inhibitor therapy for stress ulcer prophylaxis. Ventilator-associated pneumonia and bleed are the variables most affecting these outcomes. The uncertainty in the findings justifies a prospective trial.

Cost-utility of laparoscopic Nissen fundoplication versus proton pump inhibitors for chronic and controlled gastroesophageal reflux disease: a 3-year prospective randomized controlled trial and economic evaluation.

BACKGROUND: Very few randomized controlled trials (RCTs) have compared laparoscopic Nissen fundoplication (LNF) to proton pump inhibitors (PPI) medical management for patients with chronic gastroesophageal reflux disease (GERD). Larger RCTs have been relatively short in duration, and have reported mixed results regarding symptom control and effect on quality of life (QOL). Economic evaluations have reported conflicting results. OBJECTIVES: To determine the incremental cost-utility of LNF versus PPI for treating patients with chronic and controlled GERD over 3 years from the societal perspective. METHODS: Economic evaluation was conducted alongside a RCT that enrolled 104 patients from October 2000 to September 2004. Primary study outcome was GERD symptoms (secondary outcomes included QOL and cost-utility). Resource utilization and QOL data collected at regular follow-up intervals determined incremental cost/QALY gained. Stochastic uncertainty was assessed using bootstrapping and methodologic assumptions were assessed using sensitivity analysis. RESULTS: No statistically significant differences in GERD symptom scores, but LNF did result in fewer heartburn days and improved QOL. Costs were higher for LNF patients by $3205/patient over 3 years but QOL was also higher as measured by either QOL instrument. Based on total costs, incremental cost-utility of LNF was $29,404/QALY gained using the Health Utility Index 3. Cost-utility results were sensitive to the utility instrument used ($29,404/QALY for Health Utility Index 3, $31,117/QALY for the Short Form 6D, and $76,310/QALY for EuroQol 5D) and if current lower prices for PPIs were used in the analysis. CONCLUSIONS: Results varied depending on resource use/costs included in the analysis, the QOL instrument used, and the cost of PPIs; however, LNF was generally found to be a cost-effective treatment for patients with symptomatic controlled GERD requiring long-term management.

Estudio del uso de omeprazol en una farmacia comunitaria de la costa de Girona / Study of the Use of Omeprazole in a Community Pharmacy on the Coast of Girona

Antecedentes: En España se vendieron, durante el año 2007,50 millones de fármacos del grupo de los inhibidores de la bomba de protones (IBP), un 26% más que en el año 2006 según los datos de la empresa IMS Health España. Los IBP son fármacos de consumo elevado y en crecimiento progresivo en el Sistema Nacional de Salud. La elevada prevalencia de la dispepsia, su cronicidad y la potencia farmacológica del omeprazol justificarían, en principio, tan elevado consumo. Sin embargo, su utilización en la prevención gastrointestinal es muchas veces inadecuada, tanto por exceso cuando no están indicados, como por defecto en pacientes que deberían tomarlos. Método: Estudio observacional, descriptivo y transversal, realizado durante un periodo de 52 días (de mayo a junio de 2008). Se incluyó a los pacientes mayores de 18 años, que acudieron a la oficina de farmacia solicitando omeprazol, con o sin receta, y que aceptaron participar en el estudio. Los datos se procesaron mediante el programa SPSS V.15. Se estableció la significación estadística a partir de un valor de p <0,05, mediante las pruebas de la t de Student y la chi al cuadrado de Pearson. Resultados: Se incluyó un total de 82 pacientes, situándose la media de edad (± desviación estándar) en 60,8 ± 14,1 años (rango: 25-87), con diferencias significativas por sexos (p=0,048; intervalo de confianza [IC] del 95%: -12,24 a -0,04). El nivel cultural fue alto. La patología más prevalerte resultó ser la dispepsia funcional en un 36% de las solicitudes, la hernia de hiato en el 20,7% y la úlcera gastroduodenal en el 4,9% de la muestra. La demanda de omeprazol por tratamiento representó el 8% de las solicitudes, por prevención el 26% y por mantenimiento el 57%. Un 28% de la muestra no cumplía con los criterios de uso del omeprazol y un 8,5% se automedicaba. El 70,7% de los usuarios de omeprazol lo utilizaba de forma continua, y la duración media del tratamiento era de 4,65 ± 4,4 años (rango: 1-15). En el momento de la adquisición, el 86,6% de los pacientes no presentaba ningún síntoma, y el 91,5% de la muestra creía que el medicamento controlaba su problema de salud (AU)

Background: throughout the year 2007 in Spain, 50 million medicines of the group of proton pump inhibitors were sold, which according to data from the IMS1 is 26% more than in the year 2006. The consumption of these proton pump inhibitors (PPIs)in the Spanish National Health System is high, and is growing steadily. In principle, the high prevalence of dyspepsia, its chronic nature and the pharmacological potency of Omeprazole justify the above mentioned high consumption. However, in many cases its use for gastrointestinal prevention is inappropriate, due both toan excess in cases in which they are not recommended, as well as a lack in patients who should be taking them. Method: cross-sectional, descriptive, observational study, conducted over a period of 52 days (May-June 2008). The study included patients over the age of 18 years who went to the community pharmacy and requested Omeprazole with or without a prescription, and who agreed to participate in the study. The data was processed using SPSS V.15, establishing statistical significance at p<0.05, using Student's t and Pearson's chi-squaretests. Results: a total of 82 patients were included, with an average age of 60.8 years (SD: 14-1) (range of 25 to 87 years), with significant differences by gender (p= 0.048; CI: -12.24 to -0.04). The cultural level was high. The most prevalent pathology turned out to be Functional Dyspepsia, accounting for 36% of the requests; hiatal hernias accounted for 20.7% and gastroduodenal ulcers for 4.9% of the sample. The requests for Omeprazole as a treatment accounted for 8% of the requests, as preventionfor 26% and as maintenance for 57%. Of the total sample, 28% did not meet the criteria for use of Omeprazole3 and 8.5% was self-medicating. Of the Omeprazole users, 70.7% used it in a continuous manner, with an average treatment duration of 4.65 years (SD: 4.4) (range of 1 to 15 years). In 86.6% of the cases the patients did not show any symptoms at the time of acquisition, and 91.5% of the sample believed that the drug controlled their health problem (AU)

[General practitioners' management of gastroesophageal reflux in France in 2005: a pharmacoeconomic study]. / Etude pharmaco-économique sur la prise en charge du reflux gastro-oesophagien en France en 2005 en médecine générale.

AIMS: Proton pump inhibitors (PPIs) rank third among drug classes in the amount they cost the French health care system annually (more than a billion euros, i.e., 5.7% of community pharmaceutical expenditures, 50% prescribed for gastroesophageal reflux disease (GERD)). METHODS: Data for a representative sample of patients aged 20 years and older, who visited their GP at least once in 2005 for uncomplicated symptomatic GERD came from the Thales database (1200 representative general practitioners (GP) connected to a computerized network) a. RESULTS: In 2005, 122 571 patients (mean age, 56 years, 45% male, 2.6 consultations for GERD) met the inclusion criteria. Extrapolated to the French population, this sample corresponds to 5.7 million people, i.e., 13% of the adult population who visited a GP during the year. PPIs were prescribed as first-line treatment for GERD in 84% of the consultations. Omeprazole, as a proprietary or generic drug, was prescribed most often (79%) and at a full dose (20mg), while other compounds (lansoprazole, pantoprazole, rabeprazole and esomeprazole) were prescribed at half dose in 64% of cases. The extrapolated annual cost of PPIs reimbursed for this indication was 465 million euros (Meuro) at a mean reimbursement level of 73%. Brand-name omeprazole still accounts for 11% of the total cost reimbursed. Complete replacement of brand-name omeprazole by its generic counterpart would reduce costs by 18.35Meuro (-4.3% reimbursed expenditure). The switch from generic full-dose omeprazole to a half dose of other PPIs would allow a further saving of 2.6 (with lansoprazole) to 13.2 Meuro (with pantoprazole). CONCLUSION: A substantial saving in reimbursed pharmaceutical spending in uncomplicated GERD and full compliance with clinical practice recommendations could be achieved by the substitution of less expensive PPIs.

Timely confirmation of gastro-esophageal reflux disease via pH monitoring: estimating budget impact on managed care organizations.

BACKGROUND: Current guidelines recommend the use of pH monitoring to confirm the diagnosis of acid reflux in patients with a normal endoscopy. This analysis evaluated the financial impact of pH monitoring with the wireless pH capsule on a managed care organization (MCO) in the United States. METHODS: A decision model was constructed to project total 1-year costs to manage GERD symptoms with and without the adoption of wireless pH capsules in a hypothetical MCO with 10 000 eligible adult enrollees, of whom 600 presented with GERD-like symptoms. Costs of GERD diagnosis, treatment, and symptom management for those in whom a GERD diagnosis was ruled out by pH monitoring were assessed. The incremental per-member-per-month (PMPM) and per-treated-member-per-month (PTMPM) costs were the primary outcomes. Data sources included literature, expert input, and standardized fee schedules. RESULTS: An increase of 10 percentage points in the use of pH monitoring with wireless pH capsules yielded incremental PMPM and PTMPM costs of $0.029 and $0.481, respectively. The costs of proton pump inhibitor (PPI) therapy to the plan dropped to $236,363 from $238,086, while increases were observed in pH monitoring (from $16 739 to $21 973) and non-GERD therapy costs (from $1392 to $1740). The results were sensitive to the percentage of patients requiring repeat endoscopy before wireless pH monitoring and the cost of PPIs. CONCLUSIONS: Timely and increased use of pH monitoring as recommended in published guidelines leads to less unnecessary use of PPIs with a modest budgetary impact on health plans.

Effectiveness and costs of implementation strategies to reduce acid suppressive drug prescriptions: a systematic review.

BACKGROUND: Evaluation of evidence for the effectiveness of implementation strategies aimed at reducing prescriptions for the use of acid suppressive drugs (ASD). METHODS: A systematic review of intervention studies with a design according to research quality criteria and outcomes related to the effect of reduction of ASD medication retrieved from Medline, Embase and the Cochrane Library. Outcome measures were the strategy of intervention, quality of methodology and results of treatment to differences of ASD prescriptions and costs. RESULTS: The intervention varied from a single passive method to multiple active interactions with GPs. Reports of study quality had shortcomings on subjects of data-analysis. Not all outcomes were calculated but if so rction of prescriptions varied from 8% up to 40% and the cost effectiveness was in some cases negative and in others positive. Few studies demonstrated good effects from the interventions to reduce ASD. CONCLUSION: Poor quality of some studies is limiting the evidence for effective interventions. Also it is difficult to compare cost-effectiveness between studies. However, RCT studies demonstrate that active interventions are required to reduce ASD volume. Larger multi-intervention studies are necessary to evaluate the most successful intervention instruments.

[Validity of proton pump inhibitors' prescriptions in a department of internal medicine]. / Adéquation aux recommandations des prescriptions des inhibiteurs de la pompe à protons dans un service de médecine interne.

INTRODUCTION: Proton pump inhibitors (PPIs) are an efficient therapy, being widely used by physicians. In 2004, cost of PPIs' therapy was as high as 748 millions of euros (for The Caisse primaire d'Assurance Maladie) in France. Although validated indications of PPIs are well known, numerous un-necessary prescriptions of PPIs are common. The aim of this prospective study was to evaluate PPIs' prescriptions of patients in a department of internal medicine. PATIENTS AND METHODS: This is a 12-week assessment of medical charts of patients, receiving PPI therapy in patients in our department of internal medicine. Data were collected by a standardized questionnaire, with regards to: PPIs' nature and regimen, PPIs' indications as well as duration of therapy. RESULTS: The medical charts of 729 consecutive patients, with a mean age of 67 years, were collected. Two hundred (and) twenty-four patients (30.7%) received PPI therapy; 157 of these patients were given PPI before admission in our department. Omeprazole was used in 71% of patients. Duration of PPI therapy was over one year in 45% of cases. Thirty-five per cent of family physicians' PPI prescription were validated and 23.8% of those of physicians working in the department of internal medicine. The main non-conform PPI's indications, by family physicians and internists were as follows: prevention of hemorrhagic risk of anti-platelet agent (21 vs 16.4%), anticoagulant (17.8 vs 16.4%), steroids (8.3 vs 13.4%) or non-steroid anti-inflammatory therapy without risk factor (1.9 vs 9%). Finally, in patients receiving PPI therapy before admission, this therapy was maintained in 76% of cases. CONCLUSION: This prospective study confirms the frequent prescription of PPI therapy in a department of internal medicine (31% of patients). It also underscores the importance of PPIs' use by family physicians and physicians working in a department of internal medicine; this series further highlights the difficulties to interrupt this well tolerated therapy. To date, PPI therapy should be prescribed with a cautious consideration of cost and benefit.

Switch patterns before and after patent expiry of omeprazole: a case study in The Netherlands.

BACKGROUND: An increase of therapeutic substitution after patent expiry might have a negative effect on cost-savings generated with newly introduced generic drugs. To evaluate influences of patent expiry on therapeutic substitution, switch behaviour before and after patent expiry was investigated. AIM: To describe proton pump inhibitor use and investigate substitution patterns from omeprazole before and after patent expiry. METHODS: Data were obtained from the InterAction DataBase. Proportional proton-pump inhibitor use was identified per quarter during the study period 2000-2003. For the second part two cohorts--one before and one after patent expiry--were defined. The number of switchers was quarterly identified during 2-year follow-up period. For statistical analyses the chi-square test and hazard ratio were used. RESULTS: In proportional use, a downward trend for omeprazole was found. After patent expiry, significantly more patients switched to other proton pump inhibitors (P < 0.001). The hazard ratio of 0.62 (95% CI: 0.57-0.69), indicates that for every six patients switching before patent expiry, 10 patients switch after patent expiry. CONCLUSION: After patent expiry more patients switch to another proton pump inhibitor. In light of the total savings achieved with generic omeprazole, the importance of this negative impact on total cost-savings on proton pump inhibitors is unclear.

Physicians' approaches to the use of gastroprotective strategies in low-risk non-steroidal anti-inflammatory drug users.

BACKGROUND: Many doctors unnecessarily prescribe gastroprotective strategies to non-steroidal anti-inflammatory drugs users at low risk of non-steroidal anti-inflammatory drug-related gastrointestinal complications. AIM: To identify factors that predict the overuse of gastroprotective strategies in low-risk non-steroidal anti-inflammatory drug users. METHODS: We distributed a questionnaire to family doctors and general internists consisting of a clinical vignette describing a low-risk hypothetical patient with osteoarthritis who was a candidate for non-steroidal anti-inflammatory drug therapy. Respondents were asked whether they would prescribe this patient a gastroprotective strategy and to estimate the annual risk of that patient developing a gastrointestinal complication with non-steroidal anti-inflammatory drug use. Respondents inappropriately recommending a gastroprotective strategy were compared with respondents who opted not to use gastroprotection. RESULTS: We received 340 responses (response rate of 28.3%), of which 278 supplied analysable data. Thirty-five percent of respondents inappropriately recommended a gastroprotective strategy for the low-risk subject. Inappropriate prescribers were significantly more likely to overestimate the risk of gastrointestinal complications with traditional non-steroidal anti-inflammatory drugs and this was strongly predictive of gastroprotective strategy recommendation in logistic regression. CONCLUSIONS: Many doctors inappropriately recommend gastroprotective strategies in low-risk non-steroidal anti-inflammatory drug users. Improving doctors' awareness of non-steroidal anti-inflammatory drug-associated gastrointestinal risks may lead to a decrease in inappropriate utilization of gastroprotective strategies in low-risk patients.

A 30-month evaluation of the effects on the cost and utilization of proton pump inhibitors from adding omeprazole OTC to drug benefit coverage in a state employee health plan.

OBJECTIVE: On March 1, 2004, the state employee health plan began covering omeprazole OTC (over the counter) at a $5 copayment. Reimbursement to pharmacy providers for omeprazole OTC increased by $10.50 per claim, from $2.50 to a $13 dispensing fee. Initially, neither generic omeprazole prescription (Rx) nor brand omeprazole Rx was covered because omeprazole OTC was available in the same strength as the Rx products at a lower cost, but an omeprazole OTC shortage necessitated coverage of generic omeprazole Rx at a $10 copay. The objective of this study was to evaluate the long-term financial impact of a drug benefit policy change on a mid-size state employee health plan and its beneficiaries associated with the addition to coverage of omeprazole OTC. METHODS: The pharmacy claims database for the employee benefits division (EBD) was used to examine utilization and cost data for beneficiaries who received proton pump inhibitors (PPIs). Pharmacy claims for the 30-month period for dates of service from December 1, 2002, through May 31, 2005, were extracted from the database, yielding a preperiod of 15 months and a postpolicy change period of 15 months. RESULTS: In the 15-month postperiod, the number of PPI claims per member per month (PMPM) decreased by 3.9%, but the days of PPI therapy PMPM increased from 1.71 to 1.82 (6.4%). Price as measured by the allowed charge per day of drug therapy decreased from $4.25 to $2.74 (35.6%) despite an increase of $1.89 (76%) in the average dispensing paid per PPI claim to pharmacies, from $2.49 to $4.38. The average beneficiary copayment decreased by $0.50 (2.0%) per PPI claim, from $25.06 in the preperiod to $24.56 per claim in the postperiod. Therefore, the net heath plan cost for PPIs decreased by $2.20 PMPM (37.6%) during the 15-month postperiod, from $5.84 to $3.64 PMPM, producing savings of $4,207,350, or annualized savings of $3,365,880, in this employee benefit plan of 127,495 members. CONCLUSION: A change in policy to include coverage of omeprazole OTC and an increase in pharmacy reimbursement for omeprazole OTC resulted in 38% net savings to a state employee health plan. The large difference in drug acquisition cost between omeprazole OTC and the other Rx-only PPIs made it possible to implement a program intervention that provided financial benefit to pharmacists, beneficiaries, and the drug plan sponsor despite a 6% increase in PPI utilization.

Comentario. Mayor seguridad para los pacientes y menor coste para la sociedad / Comment. Higher safety for patients and lower costs for society

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