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Biomedical subjects

B E Hillner

Publications and source records attributed to B E Hillner.

At least 19 recordsLinked to original sources
PubMed2000

Pamidronate in prevention of bone complications in metastatic breast cancer: a cost-effectiveness analysis.

PURPOSE: Pamidronate is effective in reducing bony complications in patients with metastatic breast cancer who have known osteolytic lesions. However, pamidronate does not increase survival and is associated with additional financial costs and inconvenience. We conducted a post-hoc evaluation of the cost-effectiveness of pamidronate using the results of two randomized trials that evaluated pamidronate 90 mg administered intravenously every month versus placebo. PATIENTS AND METHODS: The trials differed only in the initial systemic therapy administered (hormonal or chemotherapy). Total skeletal related events (SREs), including surgery for pathologic fracture, radiation for fracture or pain control, conservatively treated pathologic fracture, spinal cord compression, or hypercalcemia, were taken directly from the trials. Using a societal perspective, direct health care costs were assigned to each SRE. Each group's monthly survival was equal and was projected to decline using observed median survivals. The cost of pamidronate reflected the average wholesale price of the drug plus infusion. The value or disutility of an adverse event per month was evaluated using a zero value (events avoided) or an assigned one (range, 0.2 to 0.8). RESULTS: The cost of pamidronate therapy exceeded the cost savings from prevented adverse events. The difference between the treated and placebo groups was larger with hormonal systemic therapy than with chemotherapy (additional $7,685 compared with $3,968 per woman). The projected net cost per SRE avoided was $3,940 with chemotherapy and $9,390 with hormonal therapy. The cost-effectiveness ratios were $108,200 with chemotherapy and $305, 300 with hormonal therapy per quality-adjusted year. CONCLUSION: Although pamidronate is effective in preventing a feared, common adverse outcome in metastatic breast cancer, its use is associated with high incremental costs per adverse event avoided. The analysis is most sensitive to the costs of pamidronate and pathologic fractures that were asymptomatic or treated conservatively.

Antineoplastic Agents↗
PubMed2000

Hospital and physician volume or specialization and outcomes in cancer treatment: importance in quality of cancer care.

PURPOSE: To conduct a comprehensive review of the health services literature to search for evidence that hospital or physician volume or specialty affects the outcome of cancer care. METHODS: We reviewed the 1988 to 1999 MEDLINE literature that considered the hypothesis that higher volume or specialization equals better outcome in processes or outcomes of cancer treatments. RESULTS: An extensive, consistent literature that supported a volume-outcome relationship was found for cancers treated with technologically complex surgical procedures, eg, most intra-abdominal and lung cancers. These studies predominantly measured in-hospital or 30-day mortality and used the hospital as the unit of analysis. For cancer primarily treated with low-risk surgery, there were fewer studies. An association with hospital and surgeon volume in colon cancer varied with the volume threshold. For breast cancer, British studies found that physician specialty and volume were associated with improved long-term outcomes, and the single American report showed an association between hospital volume of initial surgery and better 5-year survival. Studies of nonsurgical cancers, principally lymphomas and testicular cancer, were few but consistently showed better long-term outcomes associated with larger hospital volume or specialty focus. Studies in recurrent or metastatic cancer were absent. Across studies, the absolute benefit from care at high-volume centers exceeds the benefit from break-through treatments. CONCLUSION: Although these reports are all retrospective, rely on registries with dated data, rarely have predefined hypotheses, and may have publication and self-interest biases, most support a positive volume-outcome relationship in initial cancer treatment. Given the public fear of cancer, its well-defined first identification, and the tumor-node-metastasis taxonomy, actual cancer care should and can be prospectively measured, assessed, and benchmarked. The literature suggests that, for all forms of cancer, efforts to concentrate its initial care would be appropriate.

Clinical Competence↗
PubMed2000

Tamoxifen should be cost-effective in reducing breast cancer risk in high-risk women.

PURPOSE: To estimate the cost-effectiveness of tamoxifen in the prevention of breast cancer. PATIENTS AND METHODS: Clinical trial results of National Surgical Adjuvant Breast Program P-1 compared tamoxifen versus placebo in the prevention of breast cancer, and direct medical care costs were estimated from the Agency for Health Care Policy and Research and local sources. The base estimate of effectiveness included all women on the trial. RESULTS: For every 100 women treated for 5 years, 1.665 expected cancers would not be detected. If breast cancer death is fully prevented by this strategy, then the cost-effectiveness of tamoxifen compared with no intervention is $8,479 per additional year of life gained. If lifetime prevention of the risk of death from breast cancer exceeded 17%, then the cost-effectiveness ratio would be less than $50,000 per year of life gained (a common benchmark). CONCLUSIONS: Tamoxifen for breast cancer prevention should be cost-effective under nearly all circumstances. Its use will require additional resources because it is not cost saving, but it fits within accepted guidelines.

Adult↗
PubMed2000

Cost-effectiveness of adding an electron-beam boost to tangential radiation therapy in patients with negative margins after conservative surgery for early-stage breast cancer.

PURPOSE: Electron-beam boosts (EBB) are routinely added after conservative surgery and tangential radiation therapy (TRT) for early-stage breast cancer. We performed an incremental cost-utility analysis to evaluate their cost-effectiveness. METHODS: A Markov model examined the impact of adding an EBB to TRT from a societal perspective. Outcomes were measured in quality-adjusted life years (QALYs). On the basis of the Lyon trial, the EBB was assumed to reduce local recurrences by approximately 2% at 10 years but to have no impact on survival. Patients' utilities were used to adjust for quality of life. Given the small absolute benefit of the EBB, baseline utilities were assumed to be the same with or without it, an assumption evaluated by Monte Carlo simulation. Direct medical, time, and travel costs were considered. RESULTS: Adding the EBB led to an additional cost of $2,008, an increase of 0.0065 QALYs and, therefore, an incremental cost-effectiveness ratio of over $300,000/QALY. In a sensitivity analysis, the ratio was moderately sensitive to the efficacy and cost of the EBB and highly sensitive to patients' utilities for treatment without it. Even if patients do value a small risk reduction, the mean cost-effectiveness ratio estimated by the Monte Carlo simulation remains high, at $70,859/QALY (95% confidence interval, $53,141 to $105,182/QALY). CONCLUSION: On the basis of currently available data, the cost-effectiveness ratio for the EBB is well above the commonly cited threshold for cost-effective care ($50,000/QALY). The EBB becomes cost-effective only if patients place an unexpectedly high value on the small absolute reduction in local recurrences achievable with it.

Adult↗
PubMed2000

American Society of Clinical Oncology guideline on the role of bisphosphonates in breast cancer. American Society of Clinical Oncology Bisphosphonates Expert Panel.

PURPOSE: To determine clinical practice guidelines for the use of bisphosphonates in the prevention and treatment of bone metastases in breast cancer and their role relative to other therapies for this condition. METHODS: An expert multidisciplinary panel reviewed pertinent information from the published literature and meeting abstracts through May 1999. Additional data collected as part of randomized trials and submitted to the United States Food and Drug Administration were also reviewed, and investigators were contacted for more recent information. Values for levels of evidence and grade of recommendation were assigned by expert reviewers and approved by the panel. Expert consensus was used if there were insufficient published data. The panel addressed which patients to treat and when in their course of disease, specific drug delivery issues, duration of therapy, management of bony metastases with other therapies, and the public policy implications. The guideline underwent external review by selected physicians, members of the American Society of Clinical Oncology (ASCO) Health Services Research Committee, and the ASCO Board of Directors. RESULTS: Bisphosphonates have not had an impact on the most reliable cancer end point: overall survival. The benefits have been reductions in skeletal complications, ie, pathologic fractures, surgery for fracture or impending fracture, radiation, spinal cord compression, and hypercalcemia. Intravenous (IV) pamidronate 90 mg delivered over 1 to 2 hours every 3 to 4 weeks is recommended in patients with metastatic breast cancer who have imaging evidence of lytic destruction of bone and who are concurrently receiving systemic therapy with hormonal therapy or chemotherapy. For women with only an abnormal bone scan but without bony destruction by imaging studies or localized pain, there is insufficient evidence to suggest starting bisphosphonates. Starting bisphosphonates in patients without evidence of bony metastasis, even in the presence of other extraskeletal metastases, is not recommended. Studies of bisphosphonates in the adjuvant setting have yielded inconsistent results. Starting bisphosphonates in patients at any stage of their nonosseous disease, outside of clinical trials, despite a high risk for future bone metastasis, is currently not recommended. Oral bisphosphonates are one of several options which can be used for preservation of bone density in premenopausal patients with treatment-induced menopause. The panel suggests that, once initiated, IV bisphosphonates be continued until evidence of substantial decline in a patient's general performance status. The panel stresses that clinical judgment must guide what is a substantial decline. There is no evidence addressing the consequences of stopping bisphosphonates after one or more adverse skeletal events. Symptoms in the spine, pelvis, or femur require careful evaluation for spinal cord compression and pathologic fracture before bisphosphonate use and if symptoms recur, persist, or worsen during therapy. The panel recommends that current standards of care for cancer pain, analgesics and local radiation therapy, not be displaced by bisphosphonates. IV pamidronate is recommended in women with pain caused by osteolytic metastasis to relieve pain when used concurrently with systemic chemotherapy and/or hormonal therapy, since it was associated with a modest pain control benefit in controlled trials. CONCLUSION: Bisphosphonates provide a meaningful supportive but not life-prolonging benefit to many patients with bone metastases from cancer. Further research is warranted to identify clinical predictors of when to start and stop therapy, to integrate their use with other treatments for bone metastases, to identify their role in the adjuvant setting in preventing bone metastases, and to better determine their cost-benefit consequences.

Bone Neoplasms↗
PubMed2000

Post hoc economic analysis of temozolomide versus dacarbazine in the treatment of advanced metastatic melanoma.

PURPOSE: To determine the potential economic implications resulting from oral temozolomide (TEM) compared with intravenous (IV) dacarbazine (DTIC) for metastatic melanoma. PATIENTS AND METHODS: We performed a cost-effectiveness (CE) analysis using hazard ratios (HRs) from the phase III (Schering I95-018) trial comparing TEM 200 mg/m(2)/d orally for 5 days every 28 days with DTIC 250 mg/m(2)/d IV for 5 days every 21 days. Sensitivity analyses assessed a range of TEM's efficacy and costs, direct nonmedical costs, and the DTIC schedule. RESULTS: The trial found an overall survival trend favoring TEM; median survival times of patients treated with DTIC and TEM were 6.4 and 7.7 months, respectively (HR = 1.18; 95% confidence interval [CI], 0.92 to 1.52; intention to treat, P =.20). The mean increase in survival of TEM over DTIC was 1.1 months. The projected average costs per patient were greater with TEM than DTIC ($6,902 v $3,697, respectively). The incremental CE ratio using TEM was $36,990 per life-year or $101 per day of life gained. The CE ratio's 95% CI ranged from -$65,180 (DTIC is more effective) to $18, 670 per year of life gained. The CE ratios decreased 50% if direct nonmedical costs were included and increased 50% if DTIC's efficacy was unchanged if given as a single daily dosage. Sixty percent of simulations found TEM with a CE threshold of less than $50,000 per life-year gained. CONCLUSION: Although the base-case efficacy of TEM compared with DTIC was not statistically significant, its associated incremental CE would be comparable with many interventions. TEM for metastatic melanoma illustrates the tension confronting providers choosing between similar agents that markedly differ in convenience and costs.

Administration, Oral↗
PubMed1999

Is the use of radiation therapy after mastectomy cost-effective?

With the publication of two randomized trials showing an improvement in overall survival after the use of postmastectomy radiation therapy, interest in the use of radiation therapy in this setting has been rekindled. These results are in contrast to those reported in the most recent meta-analysis of the Early Breast Cancer Trialists' Collaborative Group, in which a statistically significant survival benefit was not detected. Although evidence of a survival benefit was sufficient in the past for an intervention to gain acceptance, payers are increasingly interested in knowing whether its use is also cost-effective. This article briefly reviews the methods used in performing cost-effectiveness analyses, summarizes the results of one published and a second preliminary cost-effectiveness analysis of postmastectomy radiation therapy, and highlights several areas for future research.

Breast Neoplasms↗
PubMed1999

Predictors of Medicare costs in elderly beneficiaries with breast, colorectal, lung, or prostate cancer.

BACKGROUND: Determining the apportionment of costs of cancer care and identifying factors that predict costs are important for planning ethical resource allocation for cancer care, especially in markets where managed care has grown. DESIGN: This study linked tumor registry data with Medicare administrative claims to determine the costs of care for breast, colorectal, lung and prostate cancers during the initial year subsequent to diagnosis, and to develop models to identify factors predicting costs. SUBJECTS: Patients with a diagnosis of breast (n = 1,952), colorectal (n = 2,563), lung (n = 3,331) or prostate cancer (n = 3,179) diagnosed from 1985 through 1988. RESULTS: The average costs during the initial treatment period were $12,141 (s.d. = $10,434) for breast cancer, $24,910 (s.d. = $14,870) for colorectal cancer, $21,351 (s.d. = $14,813) for lung cancer, and $14,361 (s.d. = $11,216) for prostate cancer. Using least squares regression analysis, factors significantly associated with cost included comorbidity, hospital length of stay, type of therapy, and ZIP level income for all four cancer sites. Access to health care resources was variably associated with costs of care. Total R2 ranged from 38% (prostate) to 49% (breast). The prediction error for the regression models ranged from < 1% to 4%, by cancer site. CONCLUSIONS: Linking administrative claims with state tumor registry data can accurately predict costs of cancer care during the first year subsequent to diagnosis for cancer patients. Regression models using both data sources may be useful to health plans and providers and in determining appropriate prospective reimbursement for cancer, particularly with increasing HMO penetration and decreased ability to capture complete and accurate utilization and cost data on this population.

Aged↗
PubMed1999

A sociodemographic and economic comparison of breast reconstruction, mastectomy, and conservative surgery.

BACKGROUND: There are a variety of surgical choices for women with early-stage breast cancer, including breast-conserving surgery, mastectomy, or mastectomy plus reconstructive surgery. This report examines some of the factors that affect these choices and the costs of the various treatment options. METHODS: Data from the Virginia Cancer Registry were linked to insurance claims from the Trigon Blue Cross and Blue Shield Company for women with local and regional staged breast cancer from 1989 to 1991 in Virginia. Multivariate analyses and cost studies were performed. RESULTS: There were 592 women who underwent breast-conserving surgery (BCS, 26%), mastectomy (58%), or mastectomy plus reconstruction (16%). Increasing age reduced the use of reconstruction. The choice of reconstruction was not affected by tumor size, nodal status, or race. Sixty percent of women had immediate breast reconstruction at the time of mastectomy; the majority had the implant procedure. The cost of BCS ($21,582) was higher than that of mastectomy ($16,122, P < .01). The costs for BCS and mastectomy were significantly lower than for mastectomy plus reconstruction ($31,047, P < .05). The 2-year cost for immediate reconstruction was $8200 less than for delayed procedures and was similar to the cost of BCS. CONCLUSIONS: Age was the driving force in reconstruction decisions. Clinical factors such as tumor size and nodal status were more important for the choice between BCS and mastectomy. There are significant cost differences between the various procedures. For a similar cosmetic outcome, BCS is less expensive than breast reconstruction. When reconstruction is required, a simultaneous procedure is less expensive.

Blue Cross Blue Shield Insurance Plans↗
PubMed1998

A comparison of patterns of care of nonsmall cell lung carcinoma patients in a younger and Medigap commercially insured cohort.

BACKGROUND: The objective of this study was to examine and compare lifetime treatment patterns and hospitalization of incident nonsmall cell lung carcinoma (NSCLC) between pre-Medicare eligible (age < 65 years) and supplemental Medigap (age > or = 65 years) enrollees in a commercially insured cohort using insurance claims. METHODS: Claims from Virginia Blue Cross and Blue Shield beneficiaries with NSCLC submitted between 1989-1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, disease stage, and type of tumor. Initial treatment categories were stratified using Physicians' Current Procedural Terminology codes. RESULTS: There were 1706 incident NSCLC patients; 349 were age < or = 64 years ("younger") and 1212 were age > or = 65 years ("elderly"). Having commercial insurance was not associated with any survival advantage compared with national averages at 2 years. In comparison with elderly patients, younger patients more often were treated with surgery for local disease (80.2% vs. 54.8%) and surgery alone or in combination with radiation for regional disease (51.9% vs. 32.0%). Radiation was used more often in elderly patients compared with younger patients with local disease (30.5% vs. 14.0%) but less often in patients with distant disease (76.2% vs. 54.9%). Compared with elderly patients, younger patients presenting with distant disease received more chemotherapy (18.8% vs. 5.1%; P <0.001); late palliative use of chemotherapy or radiation occurred in only 4-8% of younger patients. Compared with elderly patients, younger patients with regional or distant disease spent more days in the hospital (compared with national averages at 2 years: regional disease, 30.0 vs. 23.9 days; distant disease, 33.0 vs. 21.4 days; P <0.0001). CONCLUSIONS: The results of this study show that more comprehensive health insurance is not associated with better outcomes in patients with NSCLC. Age specific trends for greater use of surgery, radiation, and total hospitalization in younger patients is consistent with other reports. Commercial health care claims supplemented by clinical staging from cancer registries can address long term practice patterns in patients with cancer.

Aged↗
PubMed1998

Cost-effectiveness assessment of interferon alfa-2b as adjuvant therapy of high-risk resected cutaneous melanoma.

The use of interferon alfa-2b (IFN-alpha 2b) as adjuvant therapy of high-risk resected cutaneous melanoma was recently found to significantly improve relapse-free and overall survival in the Eastern Cooperative Oncology Group trial 1684 (E1684). However, treatment toxicities and costs may limit its widespread use. A cost-effectiveness and cost-utility analysis of this therapy was conducted using a hypothetical cohort of patients as if they had entered E1684. Survival and recurrence rates were calculated at 7 and 35 years for typical 50-year-old melanoma patients based on the clinical results of E1684 and natural history databases. Costs included all treatment-related costs (i.e. drug acquisition and administration, monitoring and treatment-related toxicity) and the costs of treating recurrences. Estimated utility values were assigned based on data from other oncology trials. The model predicted that IFN-alpha 2b provided an extra 0.52 years of life compared with observation at 7 years; however, at 35 years, the survival benefit of IFN-alpha 2b increased almost 4-fold to nearly 2 years. At 7 years, the cost per year of life gained was U.S. $32,600 and the cost per quality-adjusted life-year (QALY) gained was U.S. $43,200. At 35 years, these costs decreased to U.S. $13,700 and $15,200, respectively. These costs are comparable with those of other well-established medical interventions. Although these results require confirmation in a prospective study, it appears that the use of high-dose IFN-alpha 2b for patients with high-risk melanoma is cost-effective.

Antineoplastic Agents↗
PubMed1998

Review of cost-effectiveness assessments of chemotherapy in adjuvant and advanced breast cancer.

Economic assessments of treatment alternatives in breast cancer have been predominantly ones addressing the role and type of adjuvant therapy. These assessments have shown that the effectiveness of the intervention drives the cost-effectiveness results. Other key factors were the relative risk of recurrence, the time frame considered and only minimally the costs of the intervention. Assessments in advanced breast cancer are few in parallel with the limited number of phase III trials. Future assessments should address neoadjuvant therapy, high-dose adjuvant therapy and agents that alter disease associated complications agents such as biphosphonates.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

Cost-effectiveness of routine radiation therapy following conservative surgery for early-stage breast cancer.

PURPOSE: To examine the cost-effectiveness of radiation therapy following conservative surgery for early-stage breast cancer. METHODS: Using a Markov model, a cost-utility analysis was performed to compare a strategy of radiation therapy versus no radiation therapy in a hypothetical cohort of 60-year-old women following conservative surgery. Local recurrence, distant recurrence, and survival rates used in the model were derived from randomized trial data. Utilities for the nonmetastatic health states were collected from actual patients. Direct medical costs were estimated using data from a single institution. Transportation and time costs were also estimated. Years of life, quality-adjusted life-years (QALYs), costs, and incremental cost/QALY over a 10-year time horizon were calculated by the model for each strategy. RESULTS: The addition of radiation therapy results in a cost increase of $9,800 per patient, no change in life expectancy, and an increase of 0.35 QALYs per patient, which leads to an incremental cost-effectiveness ratio of $28,000/QALY, which is well below $50,000/QALY, a commonly cited threshold for cost-effective care. Sensitivity analysis shows the ratio to be heavily influenced by the cost of radiation therapy and the quality-of-life benefit that results from decreased risk of local recurrence. CONCLUSION: Radiation therapy following conservative surgery is cost-effective compared with other accepted medical interventions. This study illustrates the importance of considering an intervention's effect on quality of life, as well as survival in defining cost-effectiveness.

Breast Neoplasms↗
PubMed1998

Costs of care associated with non-small-cell lung cancer in a commercially insured cohort.

PURPOSE: To examine the cost of incident cases of non-small-cell lung cancer (NSCLC) in a commercially insured cohort. METHODS: Claims from Virginia Blue Cross and Blue Shield (BCBS) beneficiaries with lung cancer from 1989 to 1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, stage, and type of cancer at diagnosis. Costs for all medical care included insurance payment, copayments, and deductibles for 2 years after diagnosis or until death. RESULTS: Three hundred forty-nine incident NSCLC patients were evaluated. The mean 2-year cost for each patient after diagnosis or until death was $47,941 (95% confidence interval, $43,758 to $52,124). Total average costs and hospital days were significantly lower for local disease ($37,514, 21.2 days), but were similar for regional ($52,797, 30.0 days) and distant ($49,382, 33.0 days) disease. Hospital days accounted for 48% and hospital-based claims for 70% of costs. Initial treatments, which included radiation, unadjusted for stage, had the lowest survival rates and the highest costs, and were associated with the most hospital days. Initial stage, race, gender, and age were not predictors of total 2-year costs. The independent predictors of total 2-year costs were type of treatment: any radiation therapy, any surgery, or any chemotherapy (all, P < .001). Inpatient hospital days was only a modest predictor of costs after adjusting for type of treatment. Patients who survived less than 1 year spent 30.5 days in hospital and had an average cost of $47,280. CONCLUSION: The direct health care costs of younger NSCLC patients care are substantial. These results should serve as a benchmark for future comparisons as the United States market shifts to managed care.

Blue Cross Blue Shield Insurance Plans↗
PubMed1998

Overview of economic analysis of Le Chevalier Vinorelbine Study.

The costs and relative cost-effectiveness of different treatments for common illnesses are an increasing concern. New treatments for advanced non-small-cell lung cancer are having an impact. However, these treatments vary markedly in their direct financial costs, toxicity, and quality-of-life profiles. Direct comparisons between most combination regimens are not yet completed. Vinorelbine (Navelbine) is the first new agent approved in the United States for the treatment of metastatic non-small-cell lung cancer in more than a decade. We previously reported results of a post-hoc economic analysis that compared the anticipated cost-effectiveness of three regimens used to treat non-small-cell lung cancer (vinorelbine alone versus vinorelbine plus cisplatin [Platinol] versus vindesine plus cisplatin, the assumed standard treatment in Europe). Results showed that vinorelbine plus cisplatin was the most effective regimen. Using vinorelbine alone as a baseline, vinorelbine plus cisplatin added 56 days of life at an additional cost of $2,700, resulting in a cost-effectiveness ratio of $17,700 per year of life gained. Similarly, vindesine plus cisplatin added 19 days of life at a cost of $1,150, or $22,100 per year of life gained. Compared to vindesine plus cisplatin, vinorelbine plus cisplatin added 37 days of life at a cost of $1,570, or $15,500 per year of life gained. We conclude that the incremental cost-effectiveness of the vinorelbine plus cisplatin regimen was less than most commonly accepted medical interventions. If vinorelbine is preferred because of its favorable toxicity profile, the additional effectiveness of cisplatin added substantial efficacy at an acceptable cost.

Antineoplastic Agents, Phytogenic↗