Cost of treatment in patients with metastatic soft tissue sarcoma who respond favourably to chemotherpy. The SArcoma treatment and Burden of Illness in North America and Europe (SABINE) study.

Treatment of metastatic soft tissue sarcoma (mSTS) commonly includes multiple lines of chemotherapy, until a decline in performance status precludes further treatment. The primary objective of this study was to describe the lifetime healthcare resource utilisation and cost among mSTS patients with favourable response to chemotherapy. SABINE was a multi-centre (n = 25), multi-country (n = 9) retrospective chart review study of mSTS patients with favourable response to chemotherapy following 4 cycles. Healthcare resource utilisation was collected from first line until death or end of follow-up. Costs were analysed by health states (defined by treatment line, chemotherapy use and disease progression) and estimated by multiplying the mean weekly cost per health state by the expected number of weeks spent in each health state. Expected per-patient lifetime medical cost was €65 616 (95% CI: €51 454-€85 003); comprised of IV chemotherapy (31.7%), inpatient care (24.8%), concomitant medication (11.0%), oral chemotherapy (8.9%), outpatient visits (8.8%), radiotherapy (6.3%), hospice (4.0%), imaging (3.7%) and laboratory (0.7%). Weekly costs were 280-330% higher during chemotherapy treatment periods than off-chemotherapy, especially after disease progression. Per-patient costs were highest in the USA and lowest in the Netherlands and UK. The economic burden of mSTS is considerable and the amount of resources devoted to its treatment varies across countries.

Incremental cost-effectiveness analysis comparing rofecoxib with nonselective NSAIDs in osteoarthritis: Ontario Ministry of Health perspective.

BACKGROUND: Clinical trials have shown rofecoxib, a selective inhibitor of cyclo-oxygenase-2, to be associated with fewer gastrointestinal complications than non-selective nonsteroidal anti-inflammatory drugs (NSAIDs). OBJECTIVE: To evaluate the potential clinical and economic consequences of rofecoxib prescription in Ontario, Canada, for patients with osteoarthritis (OA) aged >65 years who did not respond to paracetamol (acetaminophen) therapy. DESIGN: Decision analytic modelling study. METHODS: A model was constructed to compare rofecoxib and nonselective NSAIDs with respect to their gastrointestinal complications in patients with OA. The model had a 1-year horizon and considered direct medical costs from the perspective of the Ontario Ministry of Health. Event rates were estimated from a pooled analysis of 8 phase IIb/Ill clinical trials. The number of perforations, ulcers and bleeds (PUBs) with each strategy was used as the primary measure of effectiveness. RESULTS: In the base-case scenario, the expected total cost per patient-day on nonselective NSAIDs was 1.60 Canadian dollars (Can dollars) versus 1.67 Can dollars on rofecoxib (1999 values). Rofecoxib was associated with 0.0109 fewer PUBs per patient per year. The incremental cost to avoid 1 additional PUB by substituting rofecoxib for nonselective NSAIDs was 2247 Can dollars. The rofecoxib strategy became dominant if a gastroprotective agent was prescribed to more than 27.5% of the patients receiving nonselective NSAIDs. CONCLUSION: For patients with OA aged >65 years in whom paracetamol therapy has failed, rofecoxib may represent a cost-effective alternative to nonselective NSAIDs. Increased costs for drug acquisition are offset, in part. by avoidance of gastrointestinal complications and reduced use of gastroprotective agents. Rofecoxib may offer increased benefit among patients at a higher risk of serious gastrointestinal events.

An economic overview of prostate carcinoma.

BACKGROUND: In the United States in 2000, 180,400 new cases of prostate carcinoma were expected to occur, with 31,900 men expected to die from this illness. In addition, prostate carcinoma is the cause of over half a million disability-adjusted life-years. This study summarizes the current body of published literature about the economics of prostate carcinoma. METHODS: The authors used a MEDLINE-based literature review for relevant articles from 1990 to the present. RESULTS: The authors' search returned 216 articles, 56 of which met the criteria of interest. Prostate carcinoma is costly to treat, currently averaging above $20,000 per case. Cost of care is directly related to stage of disease and comorbidity. Substantial geographic variation exists, even within small locales, with regard to care patterns and cost. In-hospital mortality, length of stay, and cost are inversely related to case volume. Care rendered in health maintenance organizations is generally less technologically intensive than in the fee-for-service sector. Out of the 18 cost studies examined, 13 were cost-minimization analyses and five assessed cost-effectiveness. From a cost perspective, laparoscopic pelvic node dissection was favored over an open pelvic procedure; 3D conformal radiation therapy was favored over 2D; and radiation therapy was favored over radical prostatectomy. Cost-effectiveness analyses favored the use of metastron, mitroxantone plus prednisone over prednisone alone, flutamine with either medical or surgical castration, and orchiectomy as the androgen suppression therapy. CONCLUSIONS: The literature on the economics of prostate carcinoma is relatively meager. Most cost studies were done on small samples, had short follow-up periods, used charges rather than cost data, and did not include adequate representation of all stages of disease. Additional research is needed.

Economic evaluation of a 2-dose hepatitis B vaccination regimen for adolescents.

OBJECTIVE: To investigate the economic implications of a 2-dose hepatitis B virus vaccination regimen compared with the current 3-dose vaccination regimen for adolescents in 3 settings: public schools, public health clinics, and private sector settings in the United States. METHODS: To measure resource utilization and costs associated with the administration of the 3-dose regimen and to assess vaccination compliance rates with this regimen, primary data were collected with the use of questionnaires tailored for each setting. Conservative modeling assumptions were used to derive 2-dose compliance rates from 3-dose compliance data. The results were incorporated into a decision analytic model, which was used to examine short-term and lifetime scenarios for an adolescent cohort receiving the 2-dose versus the 3-dose regimen. In the short-term analysis, the vaccination program costs were compared for the 2 regimens. In the lifetime analysis, the model also incorporated long-term disease costs for those individuals who contract hepatitis B. RESULTS: Predicted increases in compliance with a 2-dose vaccination regimen contributed to a higher probability of seroprotection in each setting. In the lifetime analysis, this positive impact of improved compliance resulted in a lower infection rate and greater cost-effectiveness for the 2-dose regimen in all settings, including private sector settings, where it cost an average of only $964 per year of life gained, and in public schools, costing an average of $1246 per year of life gained. In public health clinics, the 2-dose regimen had both lower expected lifetime costs and better clinical outcomes than the 3-dose regimen. In the short-term analysis, costs were higher for the 2-dose regimen, reflecting higher total vaccine acquisition costs without the long-term offset of cost savings from reduced infection. Sensitivity analyses identified cost per dose of vaccine and the probability of completing the regimens as the most sensitive model variables. CONCLUSIONS: Improved compliance with a 2-dose regimen would contribute to a higher probability of adolescents' achieving seroprotection. When the long-term consequences of hepatitis B virus infection are included, the 2-dose regimen would be cost-effective compared with the 3-dose regimen in all settings and cost saving in public health clinic settings.

Economic evaluation of rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs for the treatment of osteoarthritis.

BACKGROUND: Results of phase III clinical trials of rofecoxib, a selective inhibitor of cyclooxygenase 2, have shown that osteoarthritis patients treated with rofecoxib had significantly fewer clinically significant gastrointestinal (GI) adverse events than those who received nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). OBJECTIVE: This paper explores the potential economic implications of the use of rofecoxib versus nonselective NSAIDs for the treatment of osteoarthritis via a decision analytic model based on rofecoxib clinical data and the published literature. METHODS: Base-case 1-year analyses were done with data on GI adverse events, specifically perforations, ulcers, and bleeds (PUBs), obtained from a prespecified pooled analysis of the rofecoxib clinical trials. Analyses were also performed using pooled results of two 12-week endoscopic surveillance trials, with adjustments for silent ulcers of 40% and 85%. RESULTS: Under base-case conditions, the expected cost savings in GI problems and comedications averted with rofecoxib versus NSAIDs was 0.81 dollars per day, representing an 85% offset of the difference in drug price. For rofecoxib versus NSAIDs, the expected cost per PUB avoided with rofecoxib was 4738 dollars, and expected cost per year of life saved was 18,614 dollars. In analyses based on endoscopic data, therapy with rofecoxib was less expensive than therapy with NSAIDs, regardless of silent ulcer adjustment. Results were most sensitive to prophylactic GI comedication rates, and were robust over a range of model assumptions and costs. CONCLUSIONS: In this analysis based on differences in clinically significant GI events for osteoarthritis patients, cost differences between rofecoxib and NSAIDs were markedly offset by expected cost savings in GI problems and comedications averted with rofecoxib. Costs per year of life saved with rofecoxib versus NSAIDs were well within accepted benchmarks for cost-effectiveness. When endoscopic data alone were considered, rofecoxib was cost saving across all assumptions about silent ulcer rates.

Gastrointestinal-related healthcare resource usage associated with a fixed combination of diclofenac and misoprostol versus other NSAIDs.

OBJECTIVE: To compare gastrointestinal (GI) healthcare resource use (HCRU) and associated costs in patients taking a fixed combination of diclofenac and misoprostol versus other nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: We analysed a sample (49,033 patients) of the Government of Quebec Health Insurance Agency database. Patients were included in the study if they did not have GI events during the year preceding the date of their first NSAID prescription dispensing (the index date). Patients were followed up for 2 years. A 3-stage model was used to determine the factors that influenced the direct medical costs of GI HCRU: (i) a logistic regression model (model 1) to estimate the risk of GI HCRU; (ii) a linear regression model (model 2) to estimate the direct costs of GI HCRU for those who had such events; (iii) multiplying the estimated risks from model 1 by the estimated costs from model 2 gave the estimated direct costs of GI HCRU for all patients. STUDY PERSPECTIVE: Provincial government of Quebec, Canada. RESULTS: 1,533 patients were prescribed diclofenac/misoprostol at the index date and 10,540 another NSAID. Comorbidity markers were not significantly different between the 2 groups. Of the diclofenac/misoprostol patients, 23 (1.5%) were hospitalised for GI problems compared with 194 (1.8%) of the NSAID group; 403 (26.3%) of diclofenac/misoprostol patients used gastroprotective agents compared with 2,849 (27.0%) of the NSAID patients; 118 (7.7%) of diclofenac/misoprostol patients had GI diagnostic tests compared with 682 (6.5%) of the NSAID patients. The average direct medical cost of GI HCRU was 310.52 Canadian dollars ($Can)/patient (1997 values) in the diclofenac/misoprostol group compared with $Can231.19/patient (1997 values) in the NSAID group. When adjusted for baseline factors, the ratio of the total direct medical cost of GI HCRU in the diclofenac/misoprostol group to that of the NSAID group was 1.15 (95% confidence interval: 0.89, 1.48). CONCLUSIONS: Our data showed no significant differences in GI HCRU among patients taking diclofenac/misoprostol compared with those taking NSAIDs.

The effect of additional shots on the vaccine administration process: results of a time-motion study in 2 settings.

CONTEXT: The introduction of combination vaccines to the pediatric regimen offers the possibility of reducing the number of injections required to reach full vaccination status. Fewer injections benefit the patient/child and the parent/caregiver, and the healthcare provider may benefit from savings in personnel time associated with vaccine administration. To date, however, these savings have not been quantified. OBJECTIVE: To study the vaccine administration process in a managed care environment. STUDY DESIGN: We studied 2 settings in which vaccinations were administered: (1) a devoted injection room and (2) the examination room as part of the well-child examination. For each setting, we documented the vaccine administration process, identified vaccine-related activities, and quantified the time savings in each activity by reductions in the number of shots. PATIENTS AND METHODS: For vaccine recipients younger than 2 years, time-motion data on vaccine-related activities in 2 managed care settings were collected by a professional industrial engineering consultant. Activity time data by the number of shots administered were analyzed using linear regression adjusting for patient age. RESULTS: We observed 276 vaccination visits (137 in an examination room, and 139 in an injection room). Total nurse time associated with vaccine administration decreased by 2.4 and 1.7 minutes per shot eliminated in the examination room setting (P = .006) and in the injection room setting (P < .001), respectively. Significant time savings were realized for activities associated with vaccine preparation, vaccine injection, and administrative duties. In addition, infant crying time decreased by 1.0 and 0.4 minutes per shot eliminated in the examination room and injection room settings, respectively (P < or = .001 for both). CONCLUSIONS: Significant reductions in vaccine administration time could be achieved by eliminating injections during a well-child regimen.

Cost effectiveness of anterior cruciate ligament reconstruction in young adults.

The cost effectiveness of ligament reconstruction for acute anterior cruciate ligament tears in young adults was compared with the cost effectiveness of nonoperative management. A decision tree was constructed to predict the expected functional outcomes for operative and nonoperative treatment. Outcome probabilities were derived from the surgical and natural history literature. Cost data were based on averaged figures from the senior author's institution. Utility values were determined from a questionnaire administered to 285 local university students. Cost effectiveness was calculated in terms of dollars spent per additional quality adjusted life year provided by the surgical reconstruction for the initial 7 years after an injury. The operative strategy provided 5.10 quality adjusted life years versus 3.49 years for nonoperative treatment, yielding a marginal effectiveness of 1.61 quality adjusted life years. The estimated total costs of the operative and nonoperative strategies were $11,768 and $2333, respectively, for a marginal cost of $9435. The resulting marginal cost effectiveness ratio was $5857 per quality adjusted life year. These data suggest that, when based on functional outcomes, anterior cruciate ligament reconstruction is a cost effective method of treatment for acute tears in young adults. The cost effectiveness ratio predicted compares favorably with those of other health care interventions that aim to improve quality of life.

Economic analysis of finasteride: a model-based approach using data from the Proscar Long-Term Efficacy and Safety Study.

Benign prostatic hyperplasia (BPH) is one of the most common medical conditions in older men in the United States. BPH is often associated with a reduction in quality of life and may progress to acute urinary retention (AUR), the inability to pass any urine. Recently, a 4-year placebo-controlled clinical trial known as the Proscar Long-Term Efficacy and Safety Study (PLESS) demonstrated that finasteride use reduces the risk of developing AUR by 57% and the need for BPH-related surgery by 55%. The economic implications of these findings were investigated using a model-based decision-analytic approach to compare finasteride with both watchful waiting and alpha-blocker therapy. The modeling used the longest-term published controlled data concerning alpha-blockers, which were for the alpha-blocker terazosin. The base case considered a 64-year-old man (the mean age of a PLESS patient) with prostatic enlargement on digital rectal examination and moderate-to-severe symptoms of BPH. The model suggested savings in surgical and AUR costs with finasteride versus watchful waiting, with an estimated 25% of total finasteride costs recouped in savings on surgical events avoided in the first year. Over 2 years, the expected cost per patient starting finasteride therapy was $2304, whereas the expected cost per patient starting terazosin was $2334. Analyses also explored the variation in economic results by baseline levels of prostate-specific antigen (PSA), a proxy for prostate volume. For patients with PSA levels > or =1.4 ng/mL, expected 2-year costs with finasteride and terazosin were $2342 and $2479, respectively. For patients with PSA levels > or =3.3 ng/mL, expected 2-year costs with finasteride were $373 less than with terazosin ($2347 vs $2720). Results were robust over a range of model assumptions and cost estimates. The analyses illustrate that all medical interventions, including watchful waiting, have associated costs. Finasteride shows cost offsets compared with watchful waiting and cost savings compared with terazosin over 2 years. Finasteride appears to be more economical in men with higher PSA levels.

Continuous-risk utility assessment in medical decision making.

The authors argue that for risky medical treatment decisions, conventional utility assessment techniques are inadequate due to their emphasis on unrealistic risk magnitudes and sure consequences, leading to assessment questions that are unfamiliar to most patients, have little educational value, and do not reliably extend to the application at hand. As an alternative, medical utility assessments should be performed in a continuous-risk domain with risk levels matching those of the actual decision problem. In support of this position, the authors describe an empirical study that compares the responses of subjects under a conventional assessment protocol with those of subjects under a continuous-risk utility assessment protocol. Preliminary results show that conventional assessment protocols result in significantly lower estimates of the degrees of risk aversion compared with a more realistic continuous-risk protocol.