The economic burden of head and neck cancer: a systematic literature review.

BACKGROUND: This systematic literature review aimed to evaluate and summarize the existing evidence on resource use and costs associated with the diagnosis and treatment of head and neck cancer (HNC) in adult patients, to better understand the currently available data. The costs associated with HNC are complex, as the disease involves multiple sites, and treatment may require a multidisciplinary medical team and different treatment modalities. METHODS: Databases (MEDLINE and Embase) were searched to identify studies published in English between October 2003 and October 2013 analyzing the economics of HNC in adult patients. Additional relevant publications were identified through manual searches of abstracts from recent conference proceedings. RESULTS: Of 606 studies initially identified, 77 met the inclusion criteria and were evaluated in the assessment. Most included studies were conducted in the USA. The vast majority of studies assessed direct costs of HNC, such as those associated with diagnosis and screening, radiotherapy, chemotherapy, surgery, side effects of treatment, and follow-up care. The costs of treatment far exceeded those for other aspects of care. There was considerable heterogeneity in the reporting of economic outcomes in the included studies; truly comparable cost data were sparse in the literature. Based on these limited data, in the US costs associated with systemic therapy were greater than costs for surgery or radiotherapy. However, this trend was not seen in Europe, where surgery incurred a higher cost than radiotherapy with or without chemotherapy. CONCLUSIONS: Most studies investigating the direct healthcare costs of HNC have utilized US databases of claims to public and private payers. Data from these studies suggested that costs generally are higher for HNC patients with recurrent and/or metastatic disease, for patients undergoing surgery, and for those patients insured by private payers. Further work is needed, particularly in Europe and other regions outside the USA; prospective studies assessing the cost associated with HNC would allow for more systematic comparison of costs, and would provide valuable economic information to payers, providers, and patients.

A systematic review assessing the economic impact of sildenafil citrate (Viagra) in the treatment of erectile dysfunction.

INTRODUCTION: Sildenafil was the first oral phosphodiesterase type 5 (PDE5) inhibitor introduced as primary therapy for erectile dysfunction (ED). In the 7 years following its market launch, sildenafil was prescribed by more than 750,000 physicians to more than 23 million men worldwide. To date, few studies have evaluated the economic impact of sildenafil in treating ED. AIM: To evaluate the cost-effectiveness and impact of sildenafil on health care costs for patients with ED in multiple countries. MAIN OUTCOMES MEASURES: Economic outcomes including cost, cost-effectiveness, cost of illness, cost consequence, resource use, productivity, work loss, and willingness to pay (WTP) were investigated. METHODS: Using keywords related to economic outcomes and sildenafil, we systematically searched literature published between July 2001 and July 2011 using MEDLINE and EMBASE. Included articles pertained to costs, WTP, and economic evaluations. RESULTS: In the last 10 years, 12 studies assessed economic outcomes associated with sildenafil for ED. Most studies were conducted in the United States and the United Kingdom, with one study identified in Canada and one from Mexico. Six studies evaluated cost of illness, cost consequence, or cost of care, and four studies evaluated WTP or drug pricing by country in the United States and the United Kingdom. In the United States and the United Kingdom, costs to health care systems have increased with demand for treatment. Cost analyses suggested that sildenafil would lower direct costs compared with other PDE5 inhibitors. U.S. and U.K. studies found that patients exhibited WTP for sildenafil. The two cost-effectiveness models we identified examined ED sub-groups, those with spinal cord injury and those with diabetes or hypertension. These models indicated favorable cost-effectiveness profiles for sildenafil compared with other active-treatment options in both Mexico and Canada. CONCLUSIONS: The relative value of sildenafil vs. surgically implanted prosthetic devices and other PDE5 inhibitors, is underscored by patients' WTP, and cost-effectiveness in ED patients with comorbidities.

Economic outcomes for celecoxib: a systematic review of pharmacoeconomic studies.

Osteoarthritis and rheumatoid arthritis are conditions that are associated with significant clinical burden, and impact on patients' functional status and quality of life. Medical costs related to treating these common and disabling conditions place an economic strain on healthcare systems. This systematic review was conducted to investigate the impact of celecoxib on healthcare costs for patients with rheumatoid arthritis and osteoarthritis. In total, 24 studies examined economic outcomes associated with celecoxib in patients with these conditions. Six of these studies evaluated economic outcomes in developing regions, including Mexico, Asia and Turkey. Across all geographies, most studies were cost-effectiveness analyses comparing celecoxib with nonselective NSAIDs alone or in combination with gastroprotective agents. Overall, based on local standards, economic models indicated favorable cost-effectiveness profiles for celecoxib compared with nonselective NSAIDs and other active-treatment options. Cost analyses indicated that the use of celecoxib resulted in lower direct medical costs.

Burden of disease and unmet needs in tuberous sclerosis complex with neurological manifestations: systematic review.

OBJECTIVES: Tuberous sclerosis complex (TSC) is a progressive genetic disorder characterized by pervasive benign tumor growth. We sought to assess the current understanding of burden of TSC-related neurological manifestations. METHODS: We systematically searched MEDLINE- and EMBASE-indexed, English-language literature (5/2000-5/2010) and non-indexed materials. RESULTS: In total, 119 articles were included, 115 on epidemiology and treatment. Recent prevalence estimates from Ireland and Taiwan report TSC in 1:14,000-25,000 individuals, below older estimates of 1:10,000. While neurological manifestations are common, treatment is largely unaddressed by guidelines and focuses on symptoms, with resection standard for subependymal giant cell astrocytomas (SEGAs) and common practice for refractory epilepsy. Antiepileptic drugs and mammalian target of rapamycin inhibitors safely, effectively minimize the need for surgery for severe epilepsy and SEGAs. CONCLUSION: Morbidity and treatment burden of prevalent neurological manifestations is significant, suggesting substantial economic and humanistic burden; however, these areas are poorly studied, indicating total disease burden is unknown. Future research should assess quality of life, caregiver burden, and costs.

The economic burden of metastatic breast cancer: a systematic review of literature from developed countries.

OBJECTIVE: Breast cancer, the most common malignant cancer among women in Western countries, has poor prognosis following metastasis. New therapies potentially extend survival, but their value is questioned when benefits are incremental and expensive. The objective of our study was to understand the economic impact of metastatic breast cancer (MBC) and its treatment, and to evaluate the designs of these studies. METHODS: We systematically reviewed the MEDLINE-indexed, English-language literature, identifying 31 articles on the economic evaluation of MBC in 10 developed countries, including studies of per-patient costs, gross national costs, and cost-effectiveness models. We also included health technology assessments (HTAs) from government and regulatory agencies. RESULTS: Total per-patient costs of MBC are only available for Sweden ($17,301-$48,169 annually, depending on patient age (2005 USD)). Most economic analyses of per-patient direct costs originate from the US; across all countries, data indicate that this burden is substantial. Gross national costs of MBC are available only for the UK (cost of incident MBC cases is estimated to be $22 million annually (2002 GBP)). Many cost-effectiveness analyses suggest that a number of new and established treatments are cost-effective compared to standard care in various countries, but many offer small increments in survival. The cost-effectiveness of trastuzumab, capecitabine, and nab-paclitaxel has been evaluated in many recent studies. CONCLUSION: Most economic evaluations of MBC have utilized secondary rather than primary data, and have used scenarios and assumptions which may be inaccurate or outdated. The quality of evidence disseminated to decision-makers could be improved by adherence to best practices in cost-effectiveness analyses.

Financial impact of a novel pre-eclampsia diagnostic test versus standard practice: a decision-analytic modeling analysis from a UK healthcare payer perspective.

OBJECTIVE: Pre-eclampsia (PE), a leading cause of maternal and perinatal morbidity and mortality, is only detected after symptomatic onset. Early diagnosis may be possible with a new serum test, with resulting clinical and economic benefits versus standard practice. The authors evaluated the financial impact to the UK National Health Service (NHS). METHODS: A decision-analytic model was developed in which a cohort of 1,000 pregnant women receiving UK obstetric care was simulated. The economic impact of improved sensitivity and specificity of the novel PE test [Roche Diagnostics, Rotkreuz, Switzerland] over current diagnostic practice was modeled. While there is no specific approved diagnostic test to detect PE, physicians are using a combination of tests including blood pressure, proteinuria, Doppler, serum uric acid, etc. The novel PE test constitutes two novel biomarkers Placenta Growth Factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) which can be quantitatively analyzed using an automated system widely available in hospitals or laboratories (Elecsys/Cobas, Roche Diagnostics) and measures the levels of PlGF and sFlt-1 growth factors in pregnant women. The analysis assumed administration of the £31.13 test (the equivalent of 52 Swiss Francs [CHF]) after 20 weeks of gestation as an addition to current practice. True-positive and false-negative patients were assumed to develop mild or severe PE, eclampsia, or death. A hybrid research approach was adopted; when available, data for model inputs were obtained from published literature and public databases. Interviews with obstetricians, laboratory managers, and healthcare payers were used to validate model inputs and fill utilization-related data gaps. RESULTS: The model estimates that the costs associated with managing a typical pregnancy are £1,781 per patient when the new test is used versus £2,726 with standard practice. This represents savings of £945 per pregnant woman, if the test is used as a supplementary diagnostic tool. The savings are attributed to the new test's improved performance and its ability to better classify the pregnant patients. CONCLUSIONS: The novel test has the potential to provide substantial cost savings for NHS. Even when the novel test's cost is added to the current cost of care, the benefits exceed the additional cost, driven by the test's ability to reduce the rates of false-positive and false-negative diagnoses compared to current standard of care. Potential study limitations include the use of a pooled average of the individual sensitivities and specificities of currently used tests since no data were available on combination testing, the reliance on clinical trial data versus actual practice, and the use of clinical expert opinion when published data were unavailable.

Adoption and use of health information technology in physician practice organisations: systematic review.

BACKGROUND: Health information technology (HIT) has the potential to improve clinical outcomes, increase health provider productivity and reduce healthcare costs. Over half of all patient care is delivered in physician practice organisations, yet adoption and utilisation of HIT in these groups lags behind inpatient facilities. OBJECTIVE: To better understand current utilisation rates along with benefits and barriers to HIT adoption in physician practice organisations. METHODS: Published literature on the adoption and use of HIT in physician practice organisations within the USA between 12 January 2004 and 12 January 2009 and indexed in MEDLINE and EMBASE was included in the systematic review. Grey literature was also searched. Studies related to the adoption and use of HIT in hospitals and community health centres were excluded. RESULTS: A total of 119 articles were eligible for inclusion in the review. Adoption rates across physician groups remain low, with between 9% and 29% of practices having implemented electronic medical records. HIT improves clinical outcomes, increases the use of vaccinations and improves medication adherence. Furthermore, HIT adoption leads to cost savings for physician groups, improves staff productivity and enriches patient-provider interactions. The largest barrier to HIT adoption in physician groups is the high initial and ongoing costs of electronic systems. Lack of sufficient training, a disorganised or non-receptive practice culture and technological problems such as inadequate connectivity appear to impede effective HIT use. CONCLUSIONS: HIT has the potential to positively impact on physician practice organisations, although significant and diverse barriers block adoption. Research into these obstacles should be coupled with efforts to understand barriers to effective implementation after HIT adoption.

A review of the current evidence for maintenance therapy in ovarian cancer.

OBJECTIVES: Ovarian cancer (OC) typically is diagnosed at advanced stages, in which the primary goal of therapy is to prolong progression-free survival (PFS) and overall survival (OS). In recent years, maintenance therapy has been tested for this purpose in advanced OC (AOC). Literature on maintenance therapy in AOC was systematically reviewed to assess current knowledge regarding the impact of this therapeutic approach. METHODS: A MEDLINE search was performed 2/2009 for articles published 1/2001-1/2009 pertaining to OC maintenance therapy guidelines, patterns, and outcomes. A second search used keywords specific to maintenance and included primary studies published in the last 10 years. Of 406 sources identified, 36 primary studies and 16 review articles were included in this systematic review. A third search used the keyword "consolidation" to find maintenance articles not identified through other searches; of 48 additional sources, 13 primary studies and 6 reviews were included. A fourth search of non-MEDLINE-indexed sources yielded 14 additional relevant publications from the same time period. RESULTS: Among practice guidelines identified, only the National Comprehensive Cancer Network (NCCN) 2008 guidelines provide recommendations regarding maintenance therapy, assigning it a category 2B recommendation. No studies were identified that reported current treatment patterns or economic outcomes in maintenance therapy; quality of life data were reported in one study. A variety of agents have been tested for maintenance, with paclitaxel the most commonly evaluated. The Southwest Oncology Group-Gynecologic Oncology Group 178 trial has found that 12 cycles of paclitaxel extend PFS (by 7 months) compared to 3 months paclitaxel, but could not adequately evaluate OS. CONCLUSIONS: Maintenance therapy may improve clinical outcomes in AOC, but additional research is needed to demonstrate an OS advantage. Future studies should investigate the long-term clinical benefit of maintenance treatment and its impact on resource utilization and health-related quality of life.

Economic burden of follicular non-Hodgkin's lymphoma.

Follicular non-Hodgkin's lymphoma (FNHL), a slow-growing cancer of the immune system, constitutes about 15-30% of all incident non-Hodgkin's lymphoma in developed countries. Its incidence is rising worldwide. Patients can live many years, but FNHL is considered incurable. We systematically reviewed the English-language MEDLINE-indexed and non-indexed economic literature published in the past 10 years on FNHL, identifying 23 primary economic studies. The economic burden of FNHL is significant, but available data are generally limited to retrospective considerations of hospital-based direct treatment costs, with little information available regarding societal cost of illness. Most direct cost information originates from the US, with one estimate of $US36 000 for the per-patient incremental cost of FNHL care during the first year following diagnosis. The most studied treatment is rituximab, which may offer similar overall costs to fludarabine considering higher resource use with fludarabine complications. Nearly all cost-effectiveness models identified by this review evaluated rituximab for relapsed/refractory FNHL responding to chemotherapy induction. Rituximab is supported as a cost-effective addition to standard chemotherapy by two models in the UK and one in the US, as maintenance therapy instead of stem-cell transplant by one UK model, and as maintenance therapy instead of observation alone by one model each in France, Spain and Canada. The UK National Institute for Health and Clinical Excellence updated guidance on rituximab in February 2008, concluding that it is cost effective when added to induction chemotherapy, and when used as maintenance therapy. No studies of per-patient or national indirect costs of illness were identified, with the only study of indirect costs a Canadian survey documenting lost work productivity. Across all study types identified by our review, the most common focus was on the direct costs of rituximab. As new treatments for FNHL come to market, more real-life cost data are imperative to calculate their relative cost effectiveness.

Impact of comorbid depression or anxiety on patterns of treatment and economic outcomes among patients with diabetic peripheral neuropathic pain.

OBJECTIVE: The objective of this retrospective analysis was to assess the correlation of comorbid depression and/or anxiety to patterns of treatment, healthcare utilization, and associated costs among diabetic peripheral neuropathic pain (DPNP) patients, employing a large US administrative claims database. RESEARCH DESIGN AND METHODS: Patients under age 65 with commercial insurance and patients aged 65 and older with employer-sponsored Medicare supplemental insurance were selected for the study if they had at least one diagnosis of DPNP in 2005. The first observed DPNP claim was considered the 'index date.' All individuals had a 12-month pre-index and 12-month follow-up period. For both populations, two subgroups were constructed for individuals with depression and/or anxiety (DPNP-DA cohort) or without these disorders (DPNP-only cohort). Patients' demographic characteristics, clinical characteristics, and medication use were compared over the pre-index period. Healthcare expenditures and resource utilization were measured for the post-index period. Two-part models were used to examine the impact of comorbid depression and/or anxiety on healthcare utilization and costs, controlling for demographic and clinical characteristics. RESULTS: The study identified 11,854 DPNP-only and 1512 DPNP-DA patients in the Medicare supplemental cohort, and 11,685 and 2728 in the commercially insured cohort. Compared to DPNP-only patients over the follow-up period, a significantly higher percentage of DPNP-DA patients were dispensed pain and DPNP-related medication. All components of healthcare utilization, except home healthcare visits and physician office visits, were more likely to be provided to DPNP-DA patients versus the DPNP-only cohort (all p < 0.01). Controlling for differences in demographic and clinical characteristics, DPNP-DA patients had significantly higher total costs than those of DPNP-only patients for Medicare ($9134, p < 0.01) and commercially insured patients ($11,085, p < 0.01). LIMITATIONS: Due to the use of a retrospective administrative claims database, limitations of this study include the potential for selection bias between study cohorts, mis-identification of DPNP and/or depression, and inability to assess indirect costs as well as use and cost of over-the-counter medications. CONCLUSIONS: These findings indicate that the healthcare costs were significantly higher for DPNP patients comorbid with depression and/or anxiety relative to those without such disorders.

Impact of a hypertension management/health promotion program on commercial driver's license employees of a self-insured utility company.

OBJECTIVE: Federal regulations governing transportation safety disqualify commercial drivers with persistent uncontrolled hypertension. We sought to determine whether a hypertension management and health promotion program designed for commercial drivers improved blood pressure (BP) outcomes among drivers employed by a self-insured utility company. METHODS: This retrospective study examined the employment-related medical examinations of 501 randomly selected commercial drivers for measurements of BP, height, and weight taken before and after the intervention. RESULTS: After the program, significantly fewer employees had uncontrolled hypertension according to the Department of Transportation hypertension guidelines (17.2% vs 26.1%, P < 0.01). This improvement was consistent across subgroups defined by diabetes, obesity, and use of antihypertensive medication. CONCLUSIONS: An education program improved control of BP among commercial drivers, improving their health and safety, and reducing the number at high risk of medical disqualification.

Warfarin exposure and the risk of thromboembolic and major bleeding events among medicaid patients with atrial fibrillation.

BACKGROUND: Outcomes of anticoagulation have been assessed in commercially insured populations, but similar data do not exist for Medicaid populations. OBJECTIVE: To assess the association between warfarin exposure and rates of thromboembolic and bleeding events among patients with nonvalvular atrial fibrillation (NVAF) enrolled in California Medicaid. METHODS: Using a retrospective cohort design based on administrative claims data, we selected Medicaid enrollees aged 50 years and older based on their first claim with a diagnosis of AF between January 1, 1998, and March 31, 2002. Patients were excluded if they had selected contraindications to warfarin, claims for valve replacement procedures, or evidence that AF resulted from transient or reversible causes. Pharmacy claims and prothrombin time tests were used to define subsequent periods of warfarin use (exposure) and nonuse (nonexposure) by all patients. The relative rates of hospitalization for thromboembolic and bleeding events associated with periods of warfarin exposure versus nonexposure were estimated. RESULTS: The 4355 study patients had a mean age of 74 years, and 65% were female. Fifty-nine percent filled any prescriptions for warfarin following AF diagnosis. Across all patients, warfarin exposure occurred during 37% of days after diagnosis. Thromboembolic events were 27% less frequent during periods of warfarin exposure relative to periods of non-exposure (p < 0.01). Major bleeding events were not significantly more common during periods of warfarin exposure (p = 0.55). CONCLUSIONS: In this Medicaid population with NVAF, warfarin use was low and was associated with a relatively modest reduction in thromboembolic events, with no increase in major bleeding risk.

Assessment of the economic burden of COPD in the U.S.: a review and synthesis of the literature.

The costs of chronic obstructive pulmonary disease (COPD) pose a major economic burden to the United States. Studies evaluating COPD costs have generated widely variable estimates; we summarized and critically compared recent estimates of the annual national and per-patient costs of COPD in the U.S. Thirteen articles reporting comprehensive estimates of the direct costs of COPD (costs related to the provision of medical goods and services) were identified from searches of relevant primary literature published since 1995. Few papers reported indirect costs of COPD (lost work and productivity). The National Heart, Lung, and Blood Institute (NHLBI) provides the single current estimate of the total (direct plus indirect) annual cost of COPD to the U.S., $38.8 billion in 2005 dollars. More than half of this cost ($21.8 billion) was direct, aligning with the $20-26 billion range reported by two other recent analyses of large national datasets. For per-patient direct costs (in $US 2005), studies using recent data yield attributable cost estimates (costs deemed to be related to COPD) in the range of $2,700-$5,900 annually, and excess cost estimates (total costs incurred by COPD patients minus total costs incurred by non-COPD patients) in the range of $6,100-$6,600 annually. Studies of both national and per-patient costs that use data approximately 8-10 years old or older have produced estimates that tend to deviate from these ranges. Cost-of-illness studies using recent data underscore the substantial current cost burden of COPD in the U.S.

Trends in the treatment of acute myeloid leukaemia in the elderly.

INTRODUCTION: Acute myeloid leukaemia (AML) is the most common type of leukaemia among adults in the US. However, data on longitudinal treatment patterns and outcomes associated with AML and its relapse are sparse, particularly among the elderly. This study documents changes in treatment patterns and outcomes among elderly AML patients over the past decade. METHODS: Using the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database, we retrospectively evaluated trends in mortality, treatment patterns, healthcare resource utilisation and Medicare payments associated with AML and its relapse among Medicare beneficiaries > or =65 years of age who were initially diagnosed with AML in a SEER registry between 1991 and 1999. Chemotherapy was ascertained from examination of inpatient and outpatient bills. AML relapse and retreatment were identified using a validated algorithm. Costs of care were based on total Medicare payments. RESULTS: A total of 3439 elderly patients with AML were identified. Median survival across all study patients was 2.4 months (mean +/- SD 5.6 +/- 6.8 months), with medians of 3.9, 2.2 and 1.4 months for patients 65-74 years of age, 75-84 years of age and > or =85 years of age, respectively. Fewer than 7% of patients were alive at 2 years, and there was very little variation during the decade of our analysis. Costs and overall healthcare utilisation patterns also changed very little, with the exception of those relating to hospice use and chemotherapy. Hospice use more than doubled during the decade (from 12% to 29% among patients diagnosed in 1991 and 1999, respectively; p < 0.0001), mostly among the oldest patients. Administration of chemotherapy also increased from 29% of patients diagnosed in 1991 to 38% of patients diagnosed in 1999 (p = 0.014), with the increase being seen mostly among younger patients and those treated in teaching hospitals. Average total costs (+/- SD) were US$51,888 +/- $54,825 and declined by age as a result of lower survival. A total of 192 patients (16% of treated patients) relapsed and received retreatment with chemotherapy. These patients survived a median 18 months, with a median duration of remission of 8 months, and average total costs three times higher than the overall sample. CONCLUSIONS: The high early mortality and costs associated with AML have not changed significantly over the past decade. However, treatment patterns appear to be changing, with increasing use of chemotherapy and hospice care. The ongoing introduction of new treatments for AML in the elderly is likely to further impact treatment patterns, and may change the economic burden of the disease. Our findings can be used as a baseline against which the benefits of new therapies can be compared.

Direct costs of COPD in the U.S.: an analysis of Medical Expenditure Panel Survey (MEPS) data.

Chronic obstructive pulmonary disease (COPD) is a costly cause of morbidity and mortality in the U.S. The objective of this study was to use contemporary national data-specifically, those from the 2000 Medical Expenditure Panel Survey (MEPS)-to estimate direct costs of COPD in the U.S. from an all-payer perspective. Due to constraints of MEPS data, indirect costs were excluded from our analyses, as were costs of long-term oxygen therapy and costs from nursing homes and long-term care facilities. Two methods of cost estimation were employed. First, we estimated resources used and expenditures incurred by individuals with COPD that were directly attributable to the disease (attributable cost approach). Second, we compared overall medical expenditures of patients with COPD to those of the non-COPD population; the resulting difference represented excess costs of COPD. Approximately 1.7% (n = 144) of the nearly 8,300 persons in the analysis data set aged > or = 45 years used medical resources and incurred expenditures related to treatment of COPD. Mean attributable costs per patient were estimated at dollar 2,507, with more than one-half of these costs (dollar 1,365) associated with hospitalization. Mean excess costs of COPD, after adjustment for sociodemographic factors and smoking status, were substantially higher, at dollar 4,932 per patient. Results of our study indicate that COPD-associated healthcare utilization and expenditures are considerable, and that annual per-patient costs of COPD are comparable to those of other chronic diseases of the middle-aged and elderly.