Impact of reference-based pricing for histamine-2 receptor antagonists and restricted access for proton pump inhibitors in British Columbia.

BACKGROUND: Two programs to reduce expenditures for common gastrointestinal drugs were introduced simultaneously by British Columbia (BC) Pharmacare in 1995. Reference-based pricing restricted reimbursement for all histamine-2 receptor antagonists (H2RAs) to the cost of the least expensive H2RA available, generic cimetidine. Special authority restricted reimbursement for proton pump inhibitors (PPIs) to patients who met certain eligibility criteria. We evaluated the effect of reference-based pricing for H2RAs and special authority for PPIs on dispensing and reimbursement for senior citizen beneficiaries of BC Pharmacare. METHODS: Itemized monthly claims data for upper gastrointestinal drugs were obtained from BC Pharmacare for all beneficiaries 65 years of age or older. Periods before and after implementation of reference-based pricing and special authority were compared with respect to defined daily doses dispensed per 100,000 beneficiaries, BC Pharmacare reimbursement per 100,000 beneficiaries, BC Pharmacare reimbursement per defined daily dose and beneficiary contributions per defined daily dose. We used regression models to project forward trends in expenditures observed before implementation of the new policies and hence to estimate accrued cost savings. RESULTS: Before reference-based pricing and special authority, the numbers of defined daily doses that were dispensed and total BC Pharmacare reimbursements for H2RAs appeared to be declining gradually, whereas those for PPIs were rising. With reference-based pricing, the monthly defined daily dose of cimetidine dispensed increased more than 4-fold, to 116,257 per 100,000 beneficiaries, while those of other restricted H2RAs decreased by more than half, to 50,927 per 100,000 beneficiaries. Special authority immediately reduced the dispensed volumes of PPIs by one-fourth, but growth in volume then appeared to resume at its previous rate. The estimated annualized cost savings achieved by reference-based pricing and special authority were $1.8 million to $3.2 million for H2RAs (depending on the estimation method used) and $5.5 million for PPIs. However, beneficiary contributions for H2RAs increased from negligible amounts to approximately 16% of total drug expenditures. INTERPRETATION: Reference-based pricing and special authority appear to have been successful in altering prescribing habits and reducing provincial expenditures for upper gastrointestinal drugs, but they have increased the financial burden on senior citizen beneficiaries.

Therapeutic substitution of cimetidine for nizatidine was not associated with an increase in healthcare utilization.

OBJECTIVE: To examine changes in healthcare utilization resulting from a formulary switch to cimetidine from nizatidine at the Veterans Affairs Pittsburgh Healthcare System. STUDY DESIGN: A retrospective analysis of administrative and clinical data 6 months before and 6 months after the therapeutic substitution. METHODS: The 704 patients who were switched from nizatidine to cimetidine were included in the study. Administrative data included total and primary care clinic visits, emergency room visits, gastrointestinal (GI)-related radiological studies, and GI endoscopic procedures. Discharge summaries were examined, and rates of total and GI-related hospitalizations were calculated. RESULTS: There was no evidence of increased utilization of healthcare resources during the 6 months after the formulary switch. Estimated monthly pharmaceutical savings for the Veterans Affairs Pittsburgh Healthcare System were $7260. CONCLUSIONS: A formulary switch from nizatidine to cimetidine can be accomplished at significant pharmaceutical cost savings, and this retrospective study suggests that this can be done without increasing other aspects of healthcare resource utilization.

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.

Therapeutic-interchange program for oral histamine H2-receptor antagonists.

A therapeutic-interchange (TI) program for oral histamine H2-receptor antagonists at a hospital is described. In 1992 the pharmacy and therapeutics committee at a large teaching hospital accepted cimetidine as the preferred oral H2 antagonist. However, the program to promote cimetidine met with little success. The manufacturer of nizatidine then offered the hospital that drug at a reduced cost relative to all other members of the drug class. The committee recommended including nizatidine on the formulary; implementing a TI program so that when an order for an oral H2 antagonist was written nizatidine would be dispensed; deleting cimetidine and ranitidine tablets from the formulary; and retaining cimetidine and ranitidine oral liquid and i.v. formulations. The program was approved by the medical executive committee and was implemented in August 1994. Extensive efforts to inform the pharmacy, medical, and nursing staffs about the program were undertaken, and the pharmacy established mechanisms for monitoring compliance. Two months into the program, 97% of eligible patients were receiving nizatidine. Actual cost savings in the first four months exceeded $40,000. In July 1997 the same program was applied to famotidine, which had replaced nizatidine as the most cost-effective H2 antagonist. A successful TI program for oral H2 antagonists was achieved by gaining physician support for the program, educating providers, monitoring compliance, and responding to changes in drug costs.

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.

Cimetidine in the treatment of acute intermittent porphyria.

Treatment options for AIP remain limited. Although no single therapy has been proven superior in clinical trials, intravenous hemin appears to be more effective than increased carbohydrate intake, and remains the treatment of choice. At usual dosages the average wholesale price of hemin is $120-475 per day (for a patient weighing 70 kg), compared with $2.50 per day for cimetidine. Cimetidine may offer a more cost-effective and easily administered alternative to hemin therapy. The optimal dosage and duration of treatment with cimetidine have not been established and are likely to be patient-specific. Oral doses of 800 mg/d have been used. In addition to its potential for treatment, cimetidine may also have a role in prophylaxis of acute episodes by maintaining a baseline suppression of ALA synthase activity. Until well-designed, controlled clinical trials demonstrate its efficacy and compare it with other treatment options, cimetidine should be reserved for use only after standard treatment modalities have failed.

Promoting use of a preferred histamine H2-receptor antagonist in managed care organizations.

A program to promote generic cimetidine as the preferred histamine H2-receptor antagonist (HRA) in the managed care organizations (MCOs) served by a pharmacy benefit management company is described. A pharmacy benefit management company conducted a literature review to substantiate the therapeutic equivalence of the HRAs and to set conservative criteria for identifying candidates for conversion to oral cimetidine therapy. During the third quarter of 1994, the prescriber for each patient identified was sent a document listing the patient's current HRA therapy, the date of his or her last prescription refill, and the name and telephone number of the dispensing pharmacy. A letter summarized the literature; outlined the criteria used to identify candidate patients; gave the current indications, dosages, and average wholesale prices of the HRAs; and asked the prescriber to switch the patient to generic cimetidine. HRA use in an MCO that participated in the program was compared with HRA use in a nonparticipating MCO for the second quarter of 1994 (the baseline period), the fourth quarter of 1994, and the first quarter of 1995. The nonparticipating MCO showed no change between baseline and 1995 in the proportion of HRA prescriptions accounted for by brand-name and generic cimetidine combined (14% for each period). The average acquisition cost per HRA prescription remained about $75 for each study quarter. In the participating MCO, the proportion of HRA prescriptions accounted for by brand-name plus generic cimetidine increased from 18% at baseline to 39% in the first quarter of 1995. The average acquisition cost per HRA prescription fell from $71 at baseline to $65 in the first quarter of 1995. A program to shift the use of brand-name HRAs to generic cimetidine in MCOs successfully altered prescribing patterns and reduced expenditures for these agents.

Prophylaxis for stress-related gastrointestinal hemorrhage: a cost effectiveness analysis.

OBJECTIVE: To assess the cost-effectiveness of prophylaxis for stress-related gastrointestinal hemorrhage in patients admitted to the intensive care unit. DESIGN: Decision model of the cost and efficacy of sucralfate and cimetidine, two commonly used drugs for prophylaxis of stress-related hemorrhage. Outcome estimates were based on data from published studies. Cost data were based on cost of medications and costs of treatment protocols at our institutions. MEASUREMENTS AND MAIN RESULTS: The marginal cost-effectiveness of prophylaxis, as compare with no prophylaxis, was calculated separately for sucralfate and cimetidine and expressed as cost per bleeding episode averted. An incremental cost-effectiveness analysis was subsequently employed to compare the two agents. Sensitivity analyses of the effects of the major clinical outcomes on the cost per bleeding episode averted were performed. At the base-case assumptions of 6% risk of developing stress-related hemorrhage and 50% risk-reduction due to prophylaxis, the cost of sucralfate was $1,144 per bleeding episode averted. The cost per bleeding episode averted was highly dependent on the risk of hemorrhage and, to a lesser degree, on the efficacy of sucralfate prophylaxis, ranging from a cost per bleeding episode averted of $103,725 for low-risk patients to cost savings for very high-risk patients. The cost per bleeding episode averted increased significantly if the risk of nosocomial pneumonia was included in the analysis. The effect of pneumonia was greater for populations at low risk of hemorrhage. Assuming equal efficacy, the cost per bleeding episode averted of cimetidine was 6.5-fold greater than the cost per bleeding episode averted of sucralfate. CONCLUSIONS: The cost of prophylaxis in patients at low risk of stress-related hemorrhage is substantial, and may be prohibitive. Further research is needed to identify patient populations that are at high risk of developing stress-related hemorrhage, and to determine whether prophylaxis increases the risk of nosocomial pneumonia.

The effect of an education and feedback intervention on group-model and network-model health maintenance organization physician prescribing behavior.

The authors evaluated the effect of an educational and feedback intervention on H2-blocker prescribing patterns and determined, if such effects differed for network- versus group-model health maintenance organization (HMO) physicians and in academic versus nonacademic settings. Physicians were randomized to receive an educational memorandum alone or combined with feedback regarding their individual prescribing behavior. The memo suggested preferred use of an H2-blocker (cimetidine) that would be less expensive to the HMO. Prescribing was monitored during the 6 months before and after the intervention. The study was undertaken at the primary care practices of a mixed group- and network-model university-affiliated HMO. Thirty group-model (at two academic and four nonacademic sites) and 33 network-model (all in full-time private practice) primary care physicians participated in the study. The analysis utilized weighted and unweighted analysis of covariance of the change in physicians' cimetidine-prescribing rates between the baseline and study periods. A significant response to the intervention was noted among academic and nonacademic group-model HMO physicians, but not among network physicians (adjusted mean absolute prescribing changes of +9.9% and +8.9% versus -2.8%, P = .02). There was no difference in prescribing change based on type of intervention (education versus feedback). The authors conclude that a simple passive educational intervention can be effective at changing group-model HMO physician behavior.

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.

Economic evaluation of health care technologies.

Despite two decades of developments, economic evaluation of medical therapies is still in its infancy. The first decade was mainly a search for a relevant methodology, a period when it was important to establish that new medical technologies carried not only costs but also economic benefits. The costs-of-illness methodology was the most convenient to use and served well to show that new medical technology produced economic benefits. It was obvious, however, that the method had its limitations, particularly in health care systems devoting more and more resources to the elderly, not an economically active part of the population. For other people also, health per se is more important than health as a human capital that improves work capacity. The studies undertaken in the 1970s were mainly based on epidemiological data and undertaken at arms' length from clinical activities in hospitals and in general practice. At the beginning of the 1980s, it became clear that in order to become more relevant, economic evaluations have to be linked much more closely to the clinical evaluation of new technologies. Clinicians and economists have to work together to produce good and relevant studies. The beginning of the 1980s saw such an increase in collaboration between economists and clinicians, and some important studies were undertaken. These studies were mainly concerned with calculating costs for different clinical actions and determining cost-effectiveness using, for example, number of life-years gained. During the last 5 years, interest has been focused on the problems and opportunities of including quality of life and utility estimates in economic evaluations.(ABSTRACT TRUNCATED AT 250 WORDS)

Change in prescribing patterns of intravenous histamine2-receptor antagonists results in significant cost savings without adversely affecting patient care.

OBJECTIVE: The cooperative efforts and educational activities associated with a major histamine2-receptor antagonist (H2RA) formulary change and the clinical and financial results are described. EVALUATION PROCESS: An extensive financial and clinical evaluation was conducted. Sources included primary literature, reference texts, institution-specific financial data, and reports of other hospitals' experiences. INTERVENTIONS: Through cooperative efforts with key members of the medical staff, several interventions were adopted: maintain only one parenteral H2RA on the formulary; develop guidelines for H2RA use and stress ulcer prophylaxis; investigate a target drug-reminder system to promote oral H2RA use. RESULTS: Within a month after implementing the formulary change and educational process, prescribing of parenteral H2RAs changed from 80 percent ranitidine to 99 percent cimetidine. Monitoring of nonformulary ranitidine use revealed only three cases of possible or probable association of adverse central nervous system effects with cimetidine in an eight-month period. Elevations of theophylline, lidocaine, or phenytoin serum concentrations; or prothrombin time above the therapeutic range during warfarin therapy occurred in only 5 of 142 monitored patients who received concomitant therapy with an H2RA. No change in serum theophylline concentrations above the therapeutic range was noted to the hospital before and after the conversion. Savings have been estimated at $250,000 in the first year and $775,000 over four years, mostly from the conversion from intravenous ranitidine to intravenous cimetidine therapy. CONCLUSIONS: Successful intervention can be accomplished by cooperation between the pharmacy and the medical staff to achieve cost savings without sacrificing the quality of care.

Pharmaco-economic considerations in the long-term management of peptic ulcer disease.

Pharmaco-economic consequences of available therapeutic strategies in the management of duodenal ulcer disease are of increasing importance. Terminology and methodology in economic evaluation need to be clarified: direct and indirect costs of duodenal ulcer disease have to be calculated, and results expressed in terms of efficacy, utility or benefits. The economic analysis then compares costs or cost-effectiveness ratios of various strategies. Macro-economic evaluations conducted in France have shown that the overall cost of duodenal ulcer disease was FF 3.5 billion in 1987 in private practice. Several evaluations have shown that indirect costs accounted for more than 50% of the total expense. From a microeconomic point of view, several studies have been conducted with ranitidine and cimetidine. Our own study has shown that one year of treatment with ranitidine 150 mg/day resulted in a decrease in the use of medical resources (clinic visits, endoscopic investigations, duration of hospital stay) and work days lost, when compared with placebo. This resulted in a smaller cost of the ranitidine strategy (FF 2031 per patient for one year for the community, vs. FF 2823 for the placebo strategy). Similar cost-effectiveness ratios for the ranitidine strategy have been shown in the USA. Costs savings have also been demonstrated during long-term treatment with cimetidine for up to 3 years. Studies performed according to Markov's chain model have shown that the costs of continuous and intermittent treatments are identical, the expenses related to investigations and mortality being greater with the latter. More studies are warranted to evaluate the efficiency of the different strategies used in the treatment of duodenal ulcer disease.(ABSTRACT TRUNCATED AT 250 WORDS)

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.

The effects of cimetidine on the cost of ulcer disease in Sweden.

The economic impact of the drug cimetidine on the direct and indirect costs of ulcer disease was studied. Cimetidine appeared on the Swedish market in 1978. Unlike other innovations, whose spread is normally slow during the initial period, cimetidine was introduced very swiftly and its use quickly expanded. It was expected that it would reduce the number of elective ulcer operations, with resulting savings in medical care resources exceeding the cost of the new drug. The use of cimetidine was also expected to reduce the indirect costs related to short- and long-term illness. The aims of the study were: (1) to describe and calculate the economic impact of the introduction of cimetidine; (2) to compare the retrospective calculations with the prospective calculations; and (3) to investigate how routinely collected data could serve as a complement to studies of efficacy, effectiveness, and cost-effectiveness. Retrospective calculation of the economic effects shows that cimetidine has in fact increased the direct costs of medical care. On the other hand, the drop in indirect costs due to reduced long-term absence (disability) from work, and reduced short-term absence from work, exceeded the increase in the cost of medical care. Thus, the total economic cost of peptic ulcer disease was reduced.