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Costs of Treating and Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

From the Ottawa Regional Cancer Centre, Cancer Care Ontario, and the University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada.

Address reprint requests to David J. Stewart, MD, FRCPC, Professor of Medicine & Pharmacology, Head of Medical Oncology, Ottawa Regional Cancer Centre-Civic Division, 190 Melrose Ave, Ottawa, Ontario, Canada, K1Y 4K7; Email dstewart{at}cancercare.on.ca

	ABSTRACT

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PURPOSE: To evaluate the effect of ondansetron availability on the costs of managing nausea and vomiting.

METHODS: We retrospectively assessed antiemetic costs (drug costs, nursing time, pharmacy time, physician's time, supplies, and facility "hotel" costs, in 1991 Canadian dollars) for all patients who received moderately or highly emetogenic chemotherapy from 6 months before to 6 months after ondansetron became commercially available in September 1991. We compared the costs for treating patients who received ondansetron versus those who received other antiemetic regimens, the costs for treating patients in the 6 months before versus the 6 months after ondansetron commercial availability, and the costs for treating patients in the first 4 months versus the last 4 months of the study period.

RESULTS: We found no cost differences for patients treated with ondansetron versus other antiemetic regimens. However, there was a significant reduction in emesis management costs for patients treated after versus before the availability of ondansetron: for patients treated in the last third versus first third of the study period, there was a decrease in cost per patient per month of treatment of $374 (95% confidence interval, $243 to $505). These savings were achieved through a reduction in hospital bed days and other costs associated with the prevention and more effective management of nausea and vomiting. At the same time, the number of patients who received emetogenic chemotherapy and their average age increased, presumably because of the better control of gastrointestinal toxicity.

CONCLUSION: Ondansetron availability has been associated with changes in the clinical management of cancer patients receiving chemotherapy and with overall cost savings compared with previously available antiemetic therapy.

	INTRODUCTION

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THE INTRODUCTION OF ONDANSETRON has resulted in a significant improvement in the control of chemotherapy-induced nausea and vomiting^1-3 and in enhanced quality of life for patients undergoing emetogenic chemotherapy.⁴ Although the benefit to patients has been substantial, ondansetron is expensive. It has been suspected that improving the control of nausea and vomiting with ondansetron might reduce personnel and hospitalization costs. Some centers have used smaller ondansetron doses than those recommended by the manufacturer as a means of limiting costs.^5-8 Other centers have introduced methods to limit the use of ondansetron.^9,10 At the Ottawa Regional Cancer Centre (ORCC), the improved control of nausea and vomiting with ondansetron has allowed us to alter our methods of chemotherapy administration, which has resulted in reduced patient hospitalizations and clinic visits. It has also allowed us to offer emetogenic chemotherapy to patients who would not otherwise be candidates for treatment.

To assess the economic impact of ondansetron at the ORCC, we conducted a retrospective study to measure changes in resource utilization for administration of emetogenic chemotherapy and antiemetics associated with the introduction of ondansetron.

	METHODS

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Patient Population
We conducted a retrospective study of the impact of ondansetron availability on the costs of cancer patient treatment at the Ottawa Civic Hospital and the Civic Division of the ORCC. The Ottawa Civic Hospital is an adult care tertiary referral hospital with 600 beds serving a population of 1.2 million. The Civic Division is one of two divisions of the ORCC providing care to adult cancer patients. It employs eight medical oncologists who handle approximately 1,700 new consults each year, approximately 15,000 medical oncology follow-up visits per year, and approximately 10,000 clinic visits annually for intravenous chemotherapy administration. Study participants were all patients who received highly emetogenic chemotherapy (cisplatin 50 to 120 mg/m² on a single day, dacarbazine, nitrogen mustard, or streptozotocin) or moderately emetogenic chemotherapy (cisplatin 20 to 49 mg/m²/d, doxorubicin, or epirubicin 50 mg/m²) in the 6 months before and the 6 months after ondansetron became commercially available in September 1991.

Costing Methodology
Costs (in 1991 Canadian dollars) were calculated for each eligible patient for each month of the 12-month period spanning the introduction of ondansetron, and a cost analysis was performed on a patient-per-month basis. Table 1 lists the clinic and hospital resources utilized for the antiemetic management of patients receiving emetogenic chemotherapy and the formula used to derive costs associated with these resources. Costs included those associated with management of nausea and vomiting and administration of emetogenic chemotherapy. Costs that were not included were actual chemotherapy agent costs, radiology and laboratory costs, and any patient management costs that were not directly related to nausea and vomiting or chemotherapy administration. The drug costs were the acquisition costs of the antiemetics in 1991. For pharmacy supplies, we included the costs of an intravenous initiation bag at each treatment visit and the cost of secondary tubes and bags (one per antiemetic). Personnel costs were calculated by determining the number of relevant tasks performed by personnel (nurse, physician, or pharmacist) for any one patient during 1 month and multiplying that number by the average salary per task for that employee. The nursing, medical, and pharmaceutical tasks were estimated to each require an average of 15 minutes of work time (although they varied in their actual time requirements), and the cost per task reflects the quarter-hourly salary of each employee involved in the task. For outpatients, the clinic nursing tasks were assigned retrospectively, by antiemetic regimen, according to the following formula: five nursing tasks (intravenous initiation, intravenous discontinuation, assessment, teaching, and charting) were allotted for each treatment regimen, and an additional task was added for each individual antiemetic administered. For inpatients, the formula for hospital nursing tasks included three daily charting tasks and one task associated with each of the following: intravenous antiemetic administered, intravenous initiated, intravenous discontinued, and vomiting episode. For outpatient physician workload, the clinical medical tasks were the product of the number of visits in that month multiplied by 3 (baseline assessment, dictation, and prescriptions for visit). For inpatient physician workload, hospital medical tasks were the sum of two baseline tasks per admission and one daily task if the patient experienced nausea and vomiting. For pharmacist workload, the number of pharmacy tasks reflects the number of antiemetics prepared. Clinic and hospital "hotel" costs reflects the cost of management and upkeep of the facility (electricity, heating, air conditioning, maintenance, and administration) for each patient visit to the clinic and each overnight stay at the hospital. These were estimated to be $53 per outpatient visit and $147 for each overnight stay on the inpatient oncology ward. Finally, a total cost estimate per patient per month was calculated by summing the costs assigned to each of the seven categories described above, whether these costs were incurred in the clinic or in the hospital.

Because it was postulated that the use of ondansetron could directly reduce the overall requirement for hospitalization, we performed a separate analysis of the total per diem cost of hospitalization. For this analysis, each day of hospitalization was allocated an average per diem cost of $740 (the amount paid to the hospital's global budget by the Ontario government for each patient day). The total cost per patient per month was the product of the per diem cost times the number of days in hospital.

Data Analysis
We analyzed the data using three different approaches. First, we compared the costs incurred for patients who received ondansetron with the costs for patients who did not. A patient was assigned to the ondansetron group if he or she received ondansetron as a first-line antiemetic therapy during that month. Some patients participating in clinical trials or compassionate release programs received ondansetron before its commercial availability; we included them in the ondansetron group. Although the ondansetron was supplied free of charge for these research patients, costs were calculated as if payment were required.

Second, to reduce the potential bias introduced by the artificial selection of patients for ondansetron therapy, we used two methods to evaluate the cost changes over time in the 12-month study period surrounding the availability of ondansetron: we compared the first 6 months (before ondansetron) to the second 6 months (after ondansetron), irrespective of which antiemetics the patient received. We also divided the study period into thirds, ie, the first 4 months, the 4-month transition period, and the last 4 months, to assess the "learning curve" associated with ondansetron use (Table 2).

SPSS for Windows, release 6.1.2 (SPSS, Inc., Chicago, IL), was used to conduct the statistical analyses. For the demographic comparison of groups, t tests (age and body surface area [BSA]), analysis of variance (age and BSA), and ² analyses (sex, tumor type, cancer stage, and chemotherapy emetogenicity) were used, when appropriate. Simple linear regression analyses (age and BSA), t tests (sex and chemotherapy emetogenicity), and analyses of variance (tumor type and cancer stage) were conducted to assess the effect of variables on cost. The impact on cost of ondansetron use or time period surrounding the availability of ondansetron (before v after or first third v last third of the study period) was analyzed using a multivariate linear regression model. In the analysis of total cost and its individual components (drug, nursing time, supplies, physician, pharmacy, and clinic and hospital hotel costs), all variables were forced into the equation to allow appropriate comparison of the cost coefficient associated with each variable. The analysis of hospital global per diem costs was conducted in a forward-stepping fashion, allowing only variables that reached statistical significance to be entered into the equation. Where confidence intervals are provided, the alpha error was set at 0.05.

	RESULTS

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Demographic Comparison of the Groups
Over the 12-month period that surrounded the commercial availability of ondansetron, the use of ondansetron gradually increased from 6% to 87% for patients receiving moderately or highly emetogenic chemotherapy (Table 2). In the time leading up to the commercial release of ondansetron, there was a gradual increase in the number of patients receiving it through drug studies and compassionate release programs.

Although there was no age difference between the patients receiving ondansetron (51.2 years) and those not receiving ondansetron (51.4 years), there was a statistically significant (P < .01) increase in the average age of patients receiving moderately or highly emetogenic chemotherapy during that year (Table 3). The mean age in the first, second, and last thirds of the study period was 49.3, 50.7, and 53.1 years, respectively. There was also an increase in the total number of patients receiving emetogenic chemotherapy in the middle third (n = 380) and last third (n = 385) of the study period when compared with the first third (n = 238) (P = .00003), again because of the greater acceptability of emetogenic chemotherapy in the postondansetron period. This increase was related to more patients with early-stage disease receiving emetogenic chemotherapy and a rise in the number of patients receiving moderately emetogenic chemotherapy. A bivariate analysis established a significant correlation between stage and emetogenicity of treatment, with more advanced stages receiving the greater proportion of highly emetogenic chemotherapy (P = .0007, ²). A greater proportion of patients receiving ondansetron were female (P < .003) and had breast cancer (P = .0000).

Analysis of Confounding Variables
A univariate analysis demonstrated that, with the exception of body surface area and age, all demographic variables were significant predictors of total cost. Sex, tumor type, cancer stage, and emetogenicity of the regimen were all highly significant (P = .0000). It was believed that cancer stage and tumor type affected cost because of their association with the type and emetogenicity of the chemotherapeutic regimen. In the multivariate analysis, age and BSA were not found to be significant predictors of any component of cost. Therefore, in the multivariate regression analysis conducted to determine the effect of ondansetron use or study time period on the various components of cost, we excluded age, BSA, tumor type, and cancer stage.

Multivariate Analysis
Results of the regression analyses conducted to determine the effect of ondansetron use and availability on cost are listed in Tables 4, 5, and 6. The variables in these equations were chemotherapy regimen emetogenicity, patient sex, and either ondansetron use versus no ondansetron use (Table 4), pre- versus postondansetron commercial availability (Table 5), or last third versus first third of the study period (Table 6). These tables list the regression coefficient of each variable and its associated significance level. The regression coefficient reflects the effect (in Canadian dollars) of that variable on utilization of the resource. The "constant" values in these tables represent costs of other unidentified variables. To obtain an appropriate comparison of the cost coefficients associated with each variable, these variables (emetogenicity, sex, and time variable or ondansetron use) were forced into the regression equation, whether or not they attained statistical significance after correcting for the effect of the other variables. However, because the hospital global per diem cost (Table 7) is a stand-alone cost, ie, not directly related to any other cost studied, the regression analysis for that cost was conducted in a forward-stepping fashion, allowing only its significant predictors to be incorporated into the final regression equation.

The analyses demonstrate that chemotherapy emetogenicity is a significant positive predictor of both total cost and hospital global per diem cost (P = .0000). The effect on total cost of patient management with ondansetron compared with other antiemetics did not achieve statistical significance (P = .13) (Table 4). There was a statistically significant reduction in the costs of nursing, pharmacy, and supplies associated with ondansetron use (P = .0000), but this benefit was offset by the significant cost of acquiring ondansetron (P = .0000). Also, ondansetron's effect on total hospital costs (global per diem cost times number of patient days) did not achieve statistical significance. Later time periods (postondansetron commercial availability and the last third of the study period), however, were significantly associated with a reduction in both total costs and all the individual components of the total cost, with the exception of antiemetic acquisition costs, physician costs, and total clinic hotel costs. The final third of the study period and the postondansetron commercial availability period were associated with significant reductions in nursing time, pharmacy time, supply costs, and hospital hotel costs, each of which contributed a cost reduction of between $22 and $268 (all P = .0000). On the other hand, antiemetic drug costs increased by $43 (P = .0004) and $84 (P = .0000) per patient per month for the postondansetron availability period and the last third of the study period, respectively, reflecting the increased usage of ondansetron. The pre- versus postondansetron availability analysis suggests slightly higher total clinic hotel costs associated with the postondansetron period. The average total cost per patient per month for emesis prevention and control in the first third of the study period and the preondansetron commercial availability period was $1,131 and $1,048, respectively, whereas in the last third of the study period and in the postondansetron commercial availability period, these costs were reduced to $659 and $699, respectively.

When the impact of the time period on hospital global per diem costs was analyzed (Table 7), patients receiving treatment in the postondansetron commercial availability period or in the last third of the study period had a significant cost reduction of more than $1,000 per patient per month (P = .0000). The first third of the study period and the preondansetron commercial availability period had associated hospital per diem costs of $2,216 and $1,880 per patient per month, respectively, whereas the last third of the study period and the postondansetron commercial availability period had hospital per diem costs of $612 and $667 per patient per month, respectively.

Over the 12 months studied, ondansetron use enabled changes in practice that resulted in a dramatic decrease in the number of patients hospitalized for the administration of emetogenic chemotherapy and the management of nausea and vomiting (Table 8): more than 50% of patients who received emetogenic chemotherapy were hospitalized in the first few months compared with approximately 20% toward the end of the study period. The average length of hospital stay for patients who required hospitalization for the management of emetogenic chemotherapy was 6.3 days, and this length of time did not show any change over the study period. In the majority of cases, hospitalization was for chemotherapy administration and emesis prophylaxis, rather than being initiated after chemotherapy for the treatment of poorly controlled nausea and vomiting. Reasons for admitting patients to receive chemotherapy included severe nausea and vomiting during an earlier course of chemotherapy, anticipation that nausea and vomiting would be severe with a chemotherapy regimen, perceived patient frailty, or complexity of the chemotherapy regimen.

Although there was a significant difference over time in total costs and hospital global per diem costs, the choice of antiemetics was not itself a predictor of these costs (Table 4). Furthermore, the average proportion of patients hospitalized (25% to 28%) and the average length of hospital stay (6.3 days) were similar between patients receiving and not receiving ondansetron (Table 8). Hence, cost reduction in the postavailability period was not a direct result of ondansetron use; instead, it was due, at least in part, to other changes in chemotherapy administration practices made possible by the superior antiemetic properties of ondansetron.

Although the number of patients treated with potentially emetogenic chemotherapy increased by 62% from the first third to the last third of the study period (from 238 to 385 patients), the total associated costs (excluding chemotherapy acquisition costs) decreased by 12% (from $269,178 to $235,620).

	DISCUSSION

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION REFERENCES

 
Most previous studies have reported the cost benefit of ondansetron to be at least comparable to that of metoclopramide, despite ondansetron's higher acquisition cost.^11-14 Ondansetron's high acquisition cost is offset by its superiority in emesis control, so that when the cost per successfully treated patient (ie, per patient with complete or near complete control of nausea and vomiting) is determined, ondansetron is equal or superior to other regimens. Furthermore, when all costs related to the predicted management of poorly controlled nausea and vomiting were estimated, ondansetron was significantly more cost-effective than metoclopramide.¹² However, in a retrospective analysis, the decrease in associated costs did not offset the high acquisition cost of ondansetron. The overall cost per successfully treated patient remained more than twice as high in the ondansetron group.¹⁵ In each of these previous studies, patients were randomized to receive either ondansetron or older antiemetic regimens, and no other major changes in practice were introduced in the ondansetron group. When we examined only the antiemetic regimens our patients had received, we also found that drug acquisition costs were higher (by $207 per patient per month) in the ondansetron group than in the group managed with other antiemetics. However, this incremental cost was offset by savings in nursing time, pharmacy personnel, and supplies, resulting in a net increase in cost of only $85 per patient per month (P = .13) in the ondansetron group. The reduction in these associated costs was due to a reduction in the requirement for preparation and administration of antiemetic medications.

In our retrospective review, we noted that significant savings were achieved by changes in clinical practice that were permitted by the superior efficacy of ondansetron. Ondansetron enabled us to administer larger doses of emetogenic chemotherapy in shorter periods of time. As a result, some multiple-day regimens (eg, multiday cisplatin-based regimens) were successfully converted to single-day regimens, and prolonged infusions given on an inpatient basis were converted to relatively short outpatient infusions. Costs fell progressively over the time period of our study as we learned how to take advantage of the superior antiemetic efficacy of ondansetron. During the first month of our study, 66% of patients were hospitalized for administration of emetogenic chemotherapy, whereas 20% or fewer were hospitalized in the last months. The overall cost of emesis treatment and prevention dropped by $270 per patient per month in the last half of the study period compared with the first half and by $374 per patient per month in the last third of the study compared with the first third. The drug acquisition costs were significantly higher in the later study periods, but supply, personnel, and hospital hotel costs were significantly reduced. Because the major savings observed in the later time periods in our study were the result of deliberate changes in patient management, randomized studies of ondansetron versus other antiemetics likely would not have detected these savings.

Although the emesis-related costs per patient dropped in the later part of our study period, the number of patients receiving potentially emetogenic chemotherapy increased, as did the average age of patients receiving emetogenic chemotherapy. It is unknown whether this increase in chemotherapy utilization resulted in a net increase or decrease in total costs to the health care system. However, it is possible, on the basis of a study of non–small-cell lung cancer, that chemotherapy could decrease overall system costs by reducing the requirement for patient hospitalization¹⁶ and prolonging life expectancy.¹⁷

At the same time that potentially emetogenic chemotherapy was becoming acceptable to a wider range of patients, it also became easier to administer. In addition to the shifts from inpatient to outpatient drug administration, and from multiple-day chemotherapy to single-day chemotherapy, efficiency of drug administration improved in the outpatient chemotherapy day care unit. Patients receiving ondansetron generally did not require a benzodiazepine before emetogenic chemotherapy. The reduction in benzodiazepine-induced drowsiness meant that patients were generally able to leave the chemotherapy day care unit more rapidly after completion of chemotherapy administration.

Although the cost of acquiring ondansetron is significantly greater than that of the standard antiemetics, the benefits imparted by its effective symptom control in terms of quality of life make it an attractive choice of therapy. Furthermore, because of improved symptom control, ondansetron has allowed changes in treatment procedures that would otherwise have been much more difficult. These changes have resulted in reduced patient management costs at our center. Even further cost reductions could probably be achieved by optimizing the dose and route of ondansetron administration.^5-8 For example, during the period of our study, it was our usual practice to give at least the prechemotherapy ondansetron intravenously. However, we now administer almost all ondansetron orally, with only occasional patients requiring the increased costs associated with intravenous administration.

In summary, the superior antiemetic properties of ondansetron permitted us to change the administration of emetogenic chemotherapy, yielding substantial cost savings per course of chemotherapy and making emetogenic chemotherapy acceptable to a wider range of patients. This is an example of the most effective therapy also being the most cost beneficial,¹⁸ despite the higher acquisition cost of ondansetron. In an era of cost constraints, it is possible that some of the practices we adopted after ondansetron became available might have been initiated even without ondansetron. However, we believe that most of these changes could not have been made without ondansetron.

	ACKNOWLEDGMENTS

 
Supported in part by a grant from Glaxo-Wellcome Inc

We thank Cynthia Benoit, RN, Diedre Redmond, RN, and Renelle Major, RN, for their careful data collection.

	REFERENCES

TOP ABSTRACT INTRODUCTION METHODS RESULTS DISCUSSION REFERENCES

 
1. Roila F, Tonato M, Del Favero A: Prevention of chemotherapy-induced emesis: The state of the art. Dig Dis 11:343-353, 1993[Medline]

2. Tonato M, Roila F, Del Favero A, et al: Antiemetics in cancer chemotherapy: Historical perspective and current state of the art. Support Care Cancer 2:150-160, 1994[Medline]

3. Butcher ME: Global experience with ondansetron and future potential. Oncology 50:191-197, 1993[Medline]

4. Soukop M, McQuade B, Hunter E, et al: Ondansetron compared with metoclopramide in the control of emesis and quality of life during repeated chemotherapy for breast cancer. Oncology 49:295-304, 1992[Medline]

5. Laplanche A, Gerondeau N: Role of ondansetron in oncology. Bull Cancer 80:568-76, 1993[Medline]

6. Walton SC, Koenig TJ: Effectiveness and economy of low-dose ondansetron. Am J Health Syst Pharm 52:546-547, 1995

7. Nolte J, Lucarelli C, Baltzer L, et al: Development, implementation and assessment of antiemetic guidelines. Proc Am Soc Clin Oncol 14:A1735, 1995 (abstr)

8. Berard CM, Mahoney CD: Cost-reducing treatment algorithms for antineoplastic drug-induced nausea and vomiting. Am J Health Syst Pharm 52:1879-1885, 1995

9. Dranitsaris G, Warr D, Puodziunas A: A randomized trial of the effects of pharmacist intervention on the cost of antiemetic therapy with ondansetron. Support Care Cancer 3:183-189, 1995[Medline]

10. Vermeulen LC Jr, Matsuszewski KA, Ratko TA, et al: Evaluation of ondansetron prescribing in US academic medical centers. Arc Intern Med 154:1733-1740, 1994[Abstract/Free Full Text]

11. Cox F, Hirsch J: Ondansetron: A cost effective advance in anti-emetic therapy. Oncology 50:186-190, 1993[Medline]

12. Buxton MJ, O'Brien BJ: Economic evaluation of ondansetron: Preliminary analysis using clinical data prior to price setting. Br J Cancer 66:64-67, 1992 (suppl 19)

13. Tannenberger S, Lelli G, Martoni A: The antiemetic efficacy and the cost-benefit ratio of ondansetron calculated with a new approach to health technology assessment (real cost-benefit index). J Chemother 4:326-331, 1992[Medline]

14. Cunningham D, Gore M, Davidson N, et al: The real costs of emesis: An economic analysis of ondansetron vs metoclopramide in controlling emesis in patients receiving chemotherapy for cancer. Eur J Cancer 29A:303-306, 1993

15. Ballatori E, Roila F, Berto P, et al: Cost efficacy analysis of two antiemetic treatments: The Italian experience from hospital perspective. Proc Am Soc Clin Oncol 13:A1615, 1994 (abstr)

16. Jaakkimainen L, Goodwin PJ, Pater J, et al: Counting the costs of chemotherapy in a National Cancer Institute of Canada randomized trial in nonsmall-cell lung cancer. J Clin Oncol 8:1301-1309, 1990[Abstract]

17. Rapp E, Pater JL, Willan A, et al: Chemotherapy can prolong survival in patients with advanced non-small-cell lung cancer: Report of a Canadian multicenter randomized trial. J Clin Oncol 6:633-641, 1988[Abstract]

18. Stewart DJ: New and old cancer therapies: Access, cost, and cost effectiveness. Oncol Advisor 2:3-8, 1994

Submitted December 29, 1997; accepted August 20, 1998.

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