Consumption of medicines used for gastric acid-related disorders in Australia and South Korea: a cross-country comparison.

PURPOSE: The study's aim was to compare the use of proton pump inhibitors (PPIs), histamine 2-receptor antagonists (H2RAs) and mucoprotective medicines (MPs) used for gastric acid-related disorders (GARD) in Australia and South Korea (Korea) from 2004 to 2017. METHODS: Prescription data for PPIs, H2RAs and MPs for Australian outpatients were extracted from the Australian Statistics on Medicines annual reports, with dose-specific and expenditure data obtained from Medicare. Similar data were obtained from Korean National Health Insurance Service claims data. We analysed the volume and expenditure of medicines use annually using the defined daily dose per 1,000 population per day. We calculated which medicines accounted for 90% of use and estimated the proportions of use for low- and high-dose PPIs. RESULTS: While total utilisation for GARD medicines increased over time in both countries, patterns of use differed. Overall, use was somewhat higher in Australia but increased more rapidly in Korea. PPIs were used more extensively in Australia, while more MPs and H2RAs were used in Korea. Expenditure and use of low-dose PPIs is escalating in Korea. CONCLUSION: There were substantial differences in the use of GARD medicines in Australia and Korea over 14 years. Both countries face similar challenges to promote rational medicines use and contain medical care costs. The discrepant prescribing patterns can be attributed to differences in healthcare systems, pharmaceutical policies and demographics. This study provides a baseline to influence more rational use of these medicines. It provides insight into medicines policies for other countries that face similar challenges.

Cost-effectiveness of TLC-sucrose octasulfate versus control dressings in the treatment of diabetic foot ulcers.

OBJECTIVE: Diabetes is one of the most widespread diseases in Germany. Common complications are diabetic foot ulcers (DFU), which are associated with a cost-intensive treatment and serious adverse events, such as infections, amputations. This cost-effectiveness analysis compares two treatment options for patients with DFU: a TLC-NOSF dressing versus a neutral dressing, assessed through a European double-blind randomised controlled trial (RCT), Explorer. METHODS: The evaluation of the clinical outcomes was associated to direct costs (costs for dressings, nursing time, hospitalisation etc.) of both dressings, from the perspective of the statutory health insurance in Germany. Due to the long mean healing time of a DFU, the observation period was extended from 20 to 100 weeks in a Markov model. RESULTS: After 20 weeks, and with complete closure as a primary endpoint, the model revealed direct treatment costs for DFU of €2,864.21 when treated with a TLC-NOSF dressing compared with €2,958.69 with the neutral control dressing (cost-effectiveness: €6,017.25 versus €9,928.49). In the Markov model (100 weeks) the costs for the TLC-NOSF dressing were €5,882.87 compared with €8,449.39 with the neutral dressing (cost-effectiveness: €6,277.58 versus €10,375.56). The robustness of results was underlined by several sensitivity analyses for varying assumptions. The frequency of weekly dressing changes had the most significant influence in terms of parameter uncertainty. CONCLUSION: Overall, the treatment of DFU with a TLC-NOSF dressing is supported from a health economic perspective, because both the treatment costs and the cost-effectiveness were superior compared with the neutral wound dressing.

An economic analysis of inadequate prescription of antiulcer medications for in-hospital patients at a third level institution in Colombia.

INTRODUCTION: The prescription and costs of antiulcer medications for in-hospital use have increased during recent years with reported inadequate use and underused. AIM: To determine the patterns of prescription-indication and also perform an economic analysis of the overcost caused by the non-justified use of antiulcer medications in a third level hospital in Colombia. MATERIALS AND METHODS: Cross-sectional study of prescription-indication of antiulcer medications for patients hospitalized in "Hospital Universitario San Jorge" of Pereira during July of 2012. Adequate or inadequate prescription of the first antiulcer medication prescribed was determined as well as for others prescribed during the hospital stay, supported by clinical practice guidelines from the Zaragoza I sector workgroup, clinical guidelines from the Australian Health Department, and finally the American College of Gastroenterology Criteria for stress ulcer prophylaxis. Daily defined dose per bed/day was used, as well as the cost for 100 beds/day and the cost of each bed/drug. A multivariate analysis was carried out using SPSS 21.0. RESULTS: 778 patients were analyzed, 435 men (55.9 %) and 343 women, mean age 56.6 +/- 20.1 years. The number of patients without justification for the prescription of the first antiulcer medication was 377 (48.5 %), and during the whole in-hospital time it was 336 (43.2 %). Ranitidine was the most used medication, in 438 patients (56.3 %). The cost/month for poorly justified antiulcer medications was € 3,335.6. The annual estimated cost for inadequate prescriptions of antiulcer medications was € 16,770.0 per 100 beds. CONCLUSION: A lower inadequate prescription rate of antiulcer medications was identified compared with other studies; however it was still high and is troubling because of the major costs that these inadequate prescriptions generates for the institution.

[Pharmacoeconomic evaluation of treatment in patients with Helicobacter pylori-associated diseases].

AIM: To estimate the pharmacoeconomic parameters of treatment in patients with Helicobacter pylori-associated diseases when using 6 eradication therapy (ET) regimens. SUBJECTS AND METHODS: The investigation enrolled a total of 231 patients who received anti-Helicobacter pylori therapy according to the intention-to-treat (ITT) principle, including 229 patients who met the protocol requirements, i.e. who completed the prescribed per-protocol (PP) treatment: 106 patients with duodenal bulb ulcer disease, 2 with gastric ulcer, 90 with erosive gastritis, and 31 patients with non-atrophic gastritis. In an outpatient setting, the patients received one of the 6 ET regimens: OAC, RBMA, RBCA, EBCA, sequential OACM therapy, and modified sequential OACMB therapy (O--omeprazole; A--amoxicillin; C--clarithromycin; B--bismuth tripotassium dicitrate, R--rabeprazole; M--metronidazole; E--esomeprazole). Treatment costs were calculated only from direct drug expenditures. The effective cost coefficient (K(eff)) was determined from the cost/ treatment efficiency ratio: K(eff) = cos/eff, where the cost was the average total costs; the eff was efficiency (%). RESULTS: The modified sequential OACMB therapy has proven to be more cost-efficient than the other regimens as it has a lower K(eff), (14). The RBMA regimens can overcome an 80% ET barrier (82.4%); however, in this case the K(eff) is 21.5. the sequential OACM therapy can also overcome an 80% ET barrier (84.8%); the K(eff) being 10.8. Incorporation of the bismuth preparation can achieve a more noticeable therapeutic effect up to 95.4%. The EBCA regimen has turned out to be most expensive with the highest K(eff) of 36.9. The RBCA regimen is most effective with the least K(eff) of 29; the therapeutic effect is 96.7%. CONCLUSION: The clinical cost-efficiency of ET is enhanced by the incorporation of the bismuth preparation for the treatment of patients with H. pylori-associated diseases. The modified sequential OACMB therapy can overcome resistance to clarithromycin and metronidazole with a good cost-efficiency.

Cost-effectiveness analysis: stress ulcer bleeding prophylaxis with proton pump inhibitors, H2 receptor antagonists.

OBJECTIVES: Proton pump inhibitors (PPIs) and H2-receptor antagonists (H2RAs) present varying pharmacological efficacy in preventing stress ulcer bleeding (SUB) in intensive care units. The literature also reports disparate rates of ventilator-assisted pneumonia (VAP) as side effects of these treatments. We compared the cost-effectiveness of these two prophylactic pharmacological options. METHODS: We constructed a decision tree with a 60-day time horizon for patients at high risk for developing SUB, receiving either PPIs or H2RAs. For each treatment strategy, patients could be in one of three states of health: SUB, VAP, or no complication. Contemporary, clinically relevant probabilities were obtained from a broad literature search. Costs were estimated by using a representative US countrywide database. A third-party payer perspective was adopted. Cost-effectiveness and univariate and multivariate sensitivity analyses were performed. RESULTS: Probabilities of SUB and VAP were 1.3% and 10.3% for PPIs versus 6.6% and 10.3% for H2RAs, respectively. Lengths of stay and per diem costs were 24 days and US $2764 for SUB, 42 days and US $3310 for VAP, and 14 days and US $2993 for patients without complications. Average costs per no complication were US $58,700 for PPIs and US $63,920 for H2RAs. The H2RA strategy was dominated by PPIs. Sensitivity analysis showed that these findings were sensitive to VAP rates but PPIs remain cost-effective. The acceptability curve shows the stability of the probabilistic results according to varying willingness-to-pay values. CONCLUSION: PPI prophylaxis is the most efficient prophylactic strategy in patients at high risk of developing SUB when compared with using H2RAs.

Gastroprotective strategies in chronic NSAID users: a cost-effectiveness analysis comparing single-tablet formulations with individual components.

OBJECTIVES: To evaluate the cost-effectiveness of competing gastroprotective strategies, including single-tablet formulations, in the prevention of gastrointestinal (GI) complications in patients with chronic arthritis taking nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: We performed a cost-utility analysis to compare eight gastroprotective strategies including NSAIDs, cyclooxygenase-2 inhibitors, proton pump inhibitors (PPIs), histamine-2 receptor antagonists, misoprostol, and single-tablet formulations. We derived estimates for outcomes and costs from medical literature. The primary outcome was incremental cost per quality-adjusted life-year gained. We performed sensitivity analyses to assess the effect of GI complications, compliance rates, and drug costs. RESULTS: For average-risk patients, NSAID + PPI cotherapy was most cost-effective. The NSAID/PPI single-tablet formulation became cost-effective only when its price decreased from €0.78 to €0.56 per tablet, or when PPI compliance fell below 51% in the NSAID + PPI strategy. All other strategies were more costly and less effective. The model was highly sensitive to the GI complication risk, costs of PPI and NSAID/PPI single-tablet formulation, and compliance to PPI. In patients with a threefold higher risk of GI complications, both NSAID + PPI cotherapy and single-tablet formulation were cost-effective. CONCLUSIONS: NSAID + PPI cotherapy is the most cost-effective strategy in all patients with chronic arthritis irrespective of their risk for GI complications. For patients with increased GI risk, the NSAID/PPI single-tablet formulation is also cost-effective.

Variables associated with stress ulcer prophylaxis misuse: a retrospective analysis.

BACKGROUND: Stress ulcer prophylaxis (SUP) is commonly used in hospitals. Although its indications are better delineated for intensive care unit (ICU) patients, its use in non-ICU settings is somewhat arbitrary and based on judgment. OBJECTIVE: We attempted to assess the extent of SUP overuse in our hospital. We also carefully collected and analyzed several variables to detect associations governing this flawed behavior and its financial burden on the hospital's budget. MATERIALS AND METHODS: We retrospectively analyzed charts of patients admitted to the medical floor of a tertiary referral university hospital over a 1 year period. All adult patients admitted to the medical ward who received at least one dose of SUP were included and reviewed for a multitude of variables in addition to the appropriateness of acid suppression therapy (AST). RESULTS: We included 320 charts and found that 92% of patients admitted during that period were not eligible for SUP. The total inappropriateness of SUP was noted to be 58% (p = 0.015). Increasing age and male gender were found to be significant variables in AST misuse (p = 0.045 and p = 0.010), much like duration of hospital stay (p = 0.008). Comorbidities was also found to be a defining variable for AST overuse (odds ratio [OR] = 3.27). Patients with two or more minor risk factors were also subjected more to SUP inappropriately (OR = 3.53), in addition to patients of certain specialties (Neurology, Infectious Diseases, etc.). Our calculated financial burden was more than $23,000 per year for the medical floor. CONCLUSION: This retrospective study confirmed the growing suspicion that SUP misuse is evident on the medical floors. We also delineated several factors and variables associated with and affecting SUP overuse.

Sequential therapy versus standard triple drug therapy for eradication of Helicobacter pylori in patients with perforated duodenal ulcer following simple closure.

BACKGROUND: Resistance to clarithromycin, a component of standard triple therapy, leads to inconsistent eradication rates of Helicobacter pylori infection. Some studies have shown higher eradication rates for H. pylori using sequential regimen. This study was done to compare the eradication rates for H. pylori infection between the standard triple drug therapy and the sequential therapy. METHODS: Seventy-three patients with perforated duodenal ulcer following simple closure with H. pylori infection were randomized to receive either standard triple drug therapy or the sequential therapy. Standard triple drug therapy comprised of omeprazole, clarithromycin, and amoxicillin for 10 days. Sequential therapy comprised of omeprazole and amoxicillin or the first 5 days followed by omeprazole, clarithromycin, and amoxicillin for the next 5 days. Follow-up endoscopy was done at 2 months to assess the eradication rates, compliance, and side effects with each regimen. RESULTS: Eradication rates for standard triple therapy and sequential regimen were 81.25% and 87.09%, respectively (p = 0.732). The cost of sequential therapy was cheaper and incidence of side effects and compliance were similar in each group. CONCLUSION: Standard triple therapy and sequential therapy have similar efficacy for eradication of H. pylori and sequential therapy is an economical alternative to standard triple therapy.

Proton pump inhibitor dose-related healing rate of artificial ulcers after endoscopic submucosal dissection: a prospective randomized controlled trial.

BACKGROUND/AIMS: Two studies have reported on the superiority of a proton pump inhibitor (PPI) compared with a histamine-2-receptor antagonist for the treatment of artificial ulcers after endoscopic submucosal dissection (ESD), but the optimal dose of PPI remains to be defined. The aim of this study was to evaluate the possibility of reducing the dose of PPI. The authors thus compared 30 mg (standard-dose) and 15 mg (half-dose) lansoprazole in terms of ulcer healing, prevention of bleeding and quality of life. METHODS: 91 patients with gastric mucosal neoplasm were enrolled. All patients who underwent ESD were administered lansoprazole 30 mg daily during the first week, after which they were randomly assigned to either the standard-dose or half-dose group. RESULTS: One patient in each group developed hematemesis. The stage of ulcers, ulcer reduction ratios and scores on the Gastrointestinal Symptom Rating Scale did not differ at 28 and 56 days. The costs of PPI for the half-dose group and standard-dose group were 7,326.5 and 11,698.4 JPY, respectively, i.e. a difference of 471.9 JPY. CONCLUSIONS: A reduced dose of PPI after 1 week of ESD was equivalent in treatment performance to the standard dose and cheaper.

Prophylactic use of omeprazole associated with a reduced risk of peptic ulcer disease among maintenance hemodialysis patients.

BACKGROUND: Patients undergoing maintenance hemodialysis (MHD) have a high prevalence of peptic ulcer disease (PUD). Omeprazole is a proton pump inhibitor with proven efficacy in the prevention and treatment of PUD. However, there is little data on the prophylactic use of omeprazole in reducing the risk of PUD among MHD patients. METHODS: This prospective study included 93 patients undergoing MHD at Zen-Ho Dialysis Center between July 2008 and December 2009. Fifty-three patients were assigned to receive 20 mg of omeprazole daily for 18 months and 40 patients served as control. The Kaplan-Meier method was applied to calculate the cumulative incidence of PUD. RESULTS: The per-protocol population comprised 85 patients (omeprazole group, 49; control group, 36). Both groups had similar baseline characteristics. The need for endoscopy was found to be significantly less (10.2 vs. 44.4%, p = 0.001) in the omeprazole group than in the control group. Dialysis patients in the omeprazole group required fewer blood transfusions and erythropoietin doses than did the control group patients. Kaplan-Meier analysis revealed a higher cumulative ulcer rate in the control group (log-rank test, p = 0.04). However, omeprazole did not reduce the risk of PUD in MHD patients on regular aspirin or warfarin. CONCLUSIONS: We conclude that prophylactic use of omeprazole might be effective to lower the incidence of PUD among MHD patients without regular aspirin or warfarin use. Further large-scale controlled trials should be carried out to confirm our findings.

[Efficacy of bismuth-based quadruple therapy as first-line treatment for Helicobacter pylori infection].

OBJECTIVE: To evaluate the efficacy of bismuth-based quadruple therapy as the first-line treatment for H.pylori infection. METHODS: A total of 136 patients with H.pylori related peptic ulcer or chronic gastritis were randomized into two groups: 67 patients in bismuth-based quadruple group received esomeprazole 20 mg, clarithromycin 0.5 g,amoxicillin 1.0 g,and bismuth potassium citrate 220 mg for 7 d; 69 patients in standard triple group received esomeprazole 20 mg, clarithromycin 0.5 g and amoxicillin 1.0 g for 7 d. Outcome of eradication therapy was assessed by (14)C-UBT. On ITT and PP analysis, calculating the cost-effectiveness ratio (C/E) and the incremental cost-effectiveness ratio (delta C/delta E). RESULT: On ITT and PP analysis, the eradication rates of the quadruple therapy group were 82.09% and 88.71%, and those of the triple therapy group were 66.67% and 73.02% (P<0.05). The cost-effectiveness ratio of two groups was 4.15 and 4.82; The incremental cost-effectiveness ratio of quadruple therapy group was 1.02 as against triple therapy group. CONCLUSION: Compared to the standard triple therapy regimen, the bismuth-containing quadruple therapy regimen has higher eradication rate and cost-effectiveness, which can be recommended as the fist-line treatment for H.pylori infection.

The gain in quality-adjusted life months by switching to esomeprazole in those with continued reflux symptoms in primary care: EncomPASS--a cluster-randomized trial.

OBJECTIVES: Proton pump inhibitors (PPIs) are effective in gastroesophageal reflux disease (GERD), but their cost effectiveness is unknown. This is usually determined by cost/quality-adjusted life year (QALY) gained, but whether PPI therapy improves QALYs has not been assessed in a randomized trial. The PPI acid suppression symptom (PASS) test is a five-item questionnaire that identifies patients with persistent acid-related symptoms. We evaluated whether a PASS test-based management strategy of changing GERD therapy to esomeprazole in those with continued symptoms on another PPI or H(2) receptor antagonist therapy would be cost effective. We expressed the data in terms of cost per quality-adjusted life months (QALM), as this was a 4-week trial. METHODS: This is a multicenter, cluster-randomized, open-label study in primary care physician centers across Canada. Primary care physician centers were randomized to intervention or control arms. Patients on acid-suppressing medication were identified from primary care records and asked to complete the PASS test. PASS test failures at baseline assessment continued current therapy in control practices or switched to esomeprazole 20 or 40 mg daily (the dose was at the clinician's discretion) for 4 weeks in intervention practices. A planned secondary end point was QALM gain, measured using the validated Euroqol (EQ-5D) completed at baseline and 4 weeks. Medication use was also assessed by questionnaire. Canadian unit generic costs were applied to all GERD drugs, except to esomeprazole and lansoprazole, wherein proprietary costs were used (all costs in Canadian $). Data were analyzed using bootstrap sampling. RESULTS: A total of 1,564 patients were recruited from 134 intervention sites and 92 control sites. Data were evaluable for 808 intervention and 445 control patients. The mean (±standard deviation) QALM at 4 weeks in the intervention group was 0.885±0.164 compared with 0.814±0.179 in the control group, resulting in a mean 0.071 (95% CI=0.091-0.051) QALM gain (P<0.0001). Esomeprazole was cost effective for PASS test failures, with a mean cost of $763 (95% CI=456-1,414) per QALM gain. CONCLUSIONS: Esomeprazole was associated with a statistically significant gain in QALMs and was cost effective in primary care patients with persistent acid-related symptoms identified by the PASS test.

Costs and risks in the management of patients with gastric acid hypersecretion.

GOALS: To define both risks and costs of optimal care of patients with gastric acid hypersecretion. BACKGROUND: The management of Zollinger-Ellison syndrome and other gastric acid hypersecretory disorders remains challenging. The optimal strategy for follow-up including gastric acid analysis, laboratory studies, and endoscopy is unknown but important given the potential complications from uncontrolled acid secretion. STUDY: Over the last 18 years, patients with gastric acid hypersecretory disorders have been followed prospectively with gastric acid analysis and endoscopy titrating oral lansoprazole and evaluating for complications. Protocol driven charges were calculated using the most recent information available. RESULTS: After 1 year of treatment optimization, 19 of 67 patients had 43 relapses, (once only in 10 patients). Risk markers for relapse included: (1) antrectomy, 67% relapsed versus 21% in unoperated patients; (2) basal acid output >5 mmol/h (risk=5.17); and (3) poor compliance. On treatment, 79% of 58 intact patients (excluding antrectomy) were lesion-free; 11% had only 1 relapse. Thus 90% were well managed with optimized lansoprazole alone. Protocol driven charges exceeded $25,000 the first year and $7000 annually thereafter. CONCLUSIONS: Relapse is infrequent and generally mild with acid secreting status closely monitored. The ideal strategy to balance costs and testing awaits further study.

Stress ulcer prophylaxis: reducing non-indicated prescribing after hospital discharge.

BACKGROUND: Gastric acid suppressant medications used as stress ulcer prophylaxis (SUP) in the intensive care unit (ICU) are often prescribed inappropriately after discharge. We present tools to reduce the use and cost of non-indicated SUP. OBJECTIVE: To reduce the non-indicated use of SUP after hospital discharge originally started in the ICU, using an education intervention and pharmacist-led medication reconciliation on patient care rounds and at hospital discharge. METHODS: In a retrospective medical record review using a historic control, 356 consecutively admitted patients to the medical/surgical ICU at the University of Wisconsin Hospital were assessed for the appropriate use of SUP at admission to the ICU, at transfer to a general care unit, and at hospital discharge. The education intervention involved teaching both the medical and pharmacist staff about indications for SUP using a memorandum and a pocket guide. Pharmacists also conducted medication reconciliation during daily patient care rounds and at discharge to justify medication use. The outcome of this study is the percentage of patients prescribed non-indicated gastric acid suppressants at hospital discharge. This outcome is compared to a previous study conducted at our hospital. RESULTS: Of 356 eligible patients, 308 (86.5%) received SUP while in the ICU. Thirty-nine (11%) were given continuing SUP after discharge from the hospital, of which 31 (8.7%) had no clear indication. This was a 64.3% reduction from the 24.4% found in the prior study (p < 0.0001). CONCLUSIONS: Educational materials that guide prescribing, pharmacist interaction on patient care rounds, and pharmacist-conducted medication reconciliation significantly reduced the prescribing of non-indicated gastric acid suppressant medications after hospital discharge.

Measuring medicine prices in Peru: validation of key aspects of WHO/HAI survey methodology.

OBJECTIVES: To assess the possibility of bias due to the limited target list and geographic sampling of the World Health Organization (WHO)/Health Action International (HAI) Medicine Prices and Availability survey used in more than 70 rapid sample surveys since 2001. METHODS: A survey was conducted in Peru in 2005 using an expanded sample of medicine outlets, including remote areas. Comprehensive data were gathered on medicines in three therapeutic classes to assess the adequacy of WHO/HAI's target medicines list and the focus on only two product versions. WHO/HAI median retail prices were compared with average wholesale prices from global pharmaceutical sales data supplier IMS Health. RESULTS: No significant differences were found in overall availability or prices of target list medicines by retail location. The comprehensive survey of angiotensin-converting enzyme inhibitor, anti-diabetic, and anti-ulcer products revealed that some treatments not on the target list were costlier for patients and more likely to be unavailable, particularly in remote areas. WHO/HAI retail prices and IMS wholesale prices were strongly correlated for higher priced products, and weakly correlated for lower priced products (which had higher estimated retailer markups). CONCLUSIONS: The WHO/HAI survey approach strikes an appropriate balance between modest research costs and optimal information for policy. Focusing on commonly used medicines yields sufficient and valid results. Surveyors elsewhere should consider the limits of the survey data as well as any local circumstances, such as scarcity, that may call for extra field efforts.

Analysis of the use and cost of stress ulcer prophylaxis for surgical inpatients.

Background Stress ulcer is a superficial and asymptomatic lesion and causes bleeding. As many as 50% of death cases are reported as the result of stress ulcer bleeding. Stress ulcer prophylaxis (SUP) is a drug used to prevent gastrointestinal tract injuries due to stress ulcers. The inappropriate use of SUP drugs can cause adverse drug reactions, and thus SUP drugs are only given to patients in accordance with guidelines in order to avoid the overuse of SUP drugs. The aim of this present study is to analyse the suitability of SUP drug usage based on the criteria from the American Society of Health-System Pharmacists (ASHP) and the drug costs of SUP overuse. Methods An observational descriptive study was conducted from April 24, 2019, to May 17, 2019, in the inpatient surgical ward of Dr. Soetomo General Hospital. Data were obtained from patient medical health records. Results One hundred fifty-two patients used 1404 SUP drugs. Approximately 48% of usage did not suit the ASHP criteria and was considered as medication overuse. The cost of excessive SUP usage during the study period was more than US $65, which is 30.08% of the total drug cost of prescribed stress ulcer drugs. Conclusions The present study suggests that the relatively high excessive drug costs for SUP show a need for monitoring of the application of SUP therapy guidelines.

Gastroprotective drugs in Australia: utilization patterns between 1997 and 2006 in relation to NSAID prescribing.

BACKGROUND: In Australia, the prescribing of proton pump inhibitors (PPIs) and histamine type 2 receptor antagonists (H(2)RAs) for defined gastrointestinal disorders is approved for subsidy by the universal Australian Pharmaceutical Benefits Scheme. These agents also may be used with NSAIDs, but this prescribing is not approved for subsidy. PPI prescribing increased in Australia between 1997 and 2006, and some authorities are concerned that this increase may be due to prescriptions outside the approved indications. OBJECTIVES: The aims of this study were to quantify gastroprotective drug consumption in Australia between 1997 and 2006 and to investigate the relationship over time between this prescribing and NSAID prescribing. METHODS: Data from concession beneficiaries (seniors and welfare recipients) were included. Data on PPIs, H(2)RAs, NSAIDs, and cyclooxygenase (COX)-2 inhibitors dispensed between 1997 and 2006 were gathered from Medicare Australia and are expressed as defined daily doses (DDDs) per 1000 concession beneficiaries per day (CBPDs). Gastroprotective drugs were defined using the World Health Organization Anatomical Therapeutic Chemical classification of 2006. Drug utilization 90% and expenditures in Australian dollars (AUD $, not normalized to an index year) were calculated. RESULTS: H(2)RA prescribing was stable between 1997 and 2001, at approximately 60 DDDs/1000 CBPDs. Dispensation of H(2)RAs began to decrease in 2001 to 20 DDDs/ 1000 CBPDs in 2006. PPI consumption increased consistently, with a sharp change beginning in 2001 (from about 45 to 140 DDDs/1000 CBPDs between 2001 and 2006). The government expenditure for PPIs per concession beneficiary per year also increased from about AUD $26 in 1997 to almost AUD $74 in 2006, whereas the expenditure for H2RAs decreased from about AUD $24 to about AUD $5. Nonselective NSAID prescribing decreased with the introduction of COX-2 inhibitors in 2000. COX-2 inhibitors increased the overall consumption of total NSAIDs in the first 4 years (2000-2003) after their introduction. CONCLUSIONS: The prescribing of H(2)RAs decreased, whereas the prescribing of PPIs increased, between 1997 and 2006 in this population of concession beneficiaries in Australia. During the same period, nonselective NSAID prescribing decreased while COX-2 inhibitor prescribing increased.

Cost analysis of long-term treatment of patients with symptomatic gastroesophageal reflux disease (GERD) with esomeprazole on-demand treatment or esomeprazole continuous treatment: an open, randomized, multicenter study in Switzerland.

OBJECTIVES: To assess the difference in direct medical costs between on-demand (OD) treatment with esomeprazole (E) 20 mg and continuous (C) treatment with E 20 mg q.d. from a clinical practice view in patients with gastroesophageal reflux disease (GERD) symptoms. METHODS: This open, randomized study (ONE: on-demand Nexium evaluation) compared two long-term management options with E 20 mg in endoscopically uninvestigated patients seeking primary care for GERD symptoms who demonstrated complete relief of symptoms after an initial treatment of 4 weeks with E 40 mg. Data on consumed quantities of all cost items were collected in the study, while data on prices during the time of study were collected separately. The analysis was done from a societal perspective. RESULTS: Forty-nine percent (484 of 991) of patients randomized to the OD regimen and 46% (420 of 913) of the patients in the C group had at least one contact with the investigator that would have occurred nonprotocol-driven. The difference of the adjusted mean direct medical costs between the treatment groups was CHF 88.72 (95% confidence interval: CHF 41.34-153.95) in favor of the OD treatment strategy (Wilcoxon rank-sum test: P < 0.0001). Adjusted direct nonmedical costs and productivity loss were similar in both groups. CONCLUSIONS: The adjusted direct medical costs of a 6-month OD treatment with esomeprazole 20 mg in uninvestigated patients with symptoms of GERD were significantly lower compared with a continuous treatment with E 20 mg once a day. The OD therapy represents a cost-saving alternative to the continuous treatment strategy with E.

The Australian rise of esomeprazole-was expenditure on samples a contributor?

BACKGROUND: Administrative data from the Australian Pharmaceutical Benefits Scheme (PBS) showed rapid growth of esomeprazole dispensing when it was launched. Australia has universal prescription medicine coverage (the PBS), which included esomeprazole from August 2002. Free samples of new medicines are commonly provided to doctors. OBJECTIVES: To determine if a relationship exists between marketing expenditure on samples and the dispensing rate for esomeprazole in Australia between June 2002 and September 2006. METHODS: Quarterly sample expenditures at product/brand level for proton pump inhibitors (PPIs) for Australian general practitioners were obtained for July 2002 to September 2006. Corresponding PBS dispensing data were obtained for all PPIs and converted to defined daily dose (DDD)/1000 population/day. Spending on samples was calculated as dollars per dispensed prescription and plotted against time on the Australian market. RESULTS: Total PPI usage increased from 34.2 to 50.8 DDD/1000 population/day over the study period. Expenditure on samples per dispensed prescription was higher when a PPI was new on the market and diminished over 5-6 years to a relatively constant level. The rapid decline in this ratio was demonstrated by a case study following esomeprazole from launch in Australia for almost 5 years clearly demonstrating the initial investment to drive sales. CONCLUSION: A relationship appears to exist between expenditure on esomeprazole samples and its usage in Australia. A high initial investment was followed by a rapid reduction in cost per prescription dispensed, predominantly due to growth in market share. This trend was consistent with other PPIs.

Proton-pump inhibitor utilization associated with the change to nonpreferred formulary status for esomeprazole in the TRICARE formulary.

UNLABELLED: inhibitor (PPI) esomeprazole in the third copayment tier on the TRICARE formulary on July 17, 2005. The change to nonpreferred formulary status for esomeprazole included a $13 copayment increase (from $9.00 to $22.00) for either a 30-day supply purchased from a community pharmacy or a 90-day supply purchased from the mail-order pharmacy and a $0 copayment if obtained from a military pharmacy but with a prior authorization (PA) requirement. The change to nonpreferred formulary status was designed to encourage the use of PPIs other than esomeprazole and to increase the use of the mail-order pharmacy for esomeprazole purchases. OBJECTIVE: To quantify changes in (a) the TRICARE beneficiary utilization of esomeprazole relative to other PPIs and (b) the pharmacy settings used for filling esomeprazole prescriptions following implementation of a copayment increase and nonpreferred formulary status for esomeprazole. METHODS: A census of outpatient pharmacy fill records for prescription acid-reducing medications (PPIs, histamine-2 blockers, misoprostol, and sucralfate) obtained by beneficiaries aged 18 years or older from January 1, 2005, through December 31, 2006, was examined. Interrupted time series regression analyses without a control group were used to compare the utilization of esomeprazole relative to other PPIs, as well as the pharmacy setting used to obtain esomeprazole, in the months before and after the formulary change. The rates of continued esomeprazole use, switching to other prescription PPIs (lansoprazole, omeprazole, pantoprazole, and rabeprazole), switching to non-PPI prescription acid-reducing drugs, and discontinued prescription acid-reducing medication use among existing esomeprazole users (i.e., beneficiaries who obtained esomeprazole as the last PPI fill before the formulary change) were calculated overall and for each pharmacy setting used prior to the formulary change. RESULTS: Over the 24-month study period from January 1, 2005, through December 31, 2006, the total numbers of PPI fills and PPI users increased by 8.5% and 9.0%, respectively, and the number of esomeprazole users decreased by 4.6%. Of esomeprazole users, the percentages of individuals obtaining esomeprazole from military pharmacies and community pharmacies, respectively, decreased from 1.7% to 1.1% and from 89.7% to 81.7%, while the percentage of individuals obtaining esomeprazole from the mail-order pharmacy increased from 8.8% to 17.6%. Time series analysis yielded a positive, statistically significant growth in esomeprazole fills (beta1=0.114; P=0.012) during the 6-month pre-intervention period (January through June 2005) and a significant reduction in August 2005 (beta2=-5.0%; P<0.001), the month immediately following the formulary change. During the 17-month post-intervention period (August 2005 through December 2006), no statistically significant change in trend for esomeprazole fills (beta3=-0.0265; P=0.534) was observed, although a small increase in the raw number of esomeprazole fills was noted. Among the 117,801 existing esomeprazole users, 86,386 (73.3%) continued using esomeprazole, 17,676 (15.0%) switched to other prescription PPIs, 679 (0.6%) used only non- PPI prescription therapy, and 13,060 (11.1%) discontinued all prescription acid-reducing pharmacotherapy after the formulary change. Significantly higher PPI switching and acid-reducing therapy discontinuation rates were observed among men aged 18-44 years and in TRICARE enrollees relative to women, those over 45 years of age, and those who used other health insurance (P<0.001). Individuals who used military pharmacies, where a PA requirement was implemented, were more likely to change pharmacy settings to obtain esomeprazole (43.8%) than were users of community pharmacies (11.9%) or the mail-order pharmacy (22.8%). Mail-order pharmacy users were less likely to discontinue acid-reducing pharmacotherapy (4.9%) than were community (11.9%) or military (12.9%) pharmacy users (P<0.05). CONCLUSIONS: After adjustment for serial correlation, the formulary change was associated with a migration of approximately 5% of all PPI fills and 25% of esomeprazole fills to the preferred PPIs in the first post-intervention month. Over the 17-month post-intervention period, the trend toward increased esomeprazole use was slowed and use of the mail-order pharmacy for esomeprazole fills nearly doubled. Our observed PPI switch rate of 15.0% resembled the rate observed for another insured population that experienced a similar formulary restructuring, but was substantially lower than the rates reported for more sizeable formulary changes. Thus, the present study's copayment differentials for third-tier medications ($19 compared with tier 1 and $13 compared with tier 2 copayments) may be less than the threshold amount required to optimize switching to preferred PPIs.