Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review.

It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared with pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports. Three approaches were taken. First, a review of the most recent HTA methods guidelines from 14 selected HTA agencies and 5 HTA networks was undertaken. Next, HTA reports from these agencies were reviewed for inclusion of MD-specific characteristics for 16 selected MDs. Finally, a narrative literature review on this topic was conducted. A total of 13 of the included HTA organizations, and some HTA networks (2/5), have published either general or MD-specific method guidelines, whilst several addressed MD-specific characteristics. NICE included all four MD characteristics in their guidelines, but this did not equate to their inclusion in published HTA evaluations. European Network HTA (EUnetHTA) described the inclusion of LC (within patient safety) and OI within their guidance. The results highlight a lack of consistency. For the narrative review, 10/149 articles identified were reviewed. Most provided recommendations on challenges faced by HTAs, proposed steps to address uncertainties around MD characteristics and reported a lack of methodological guidance for evaluating MDs. A lack of inclusion of MD characteristics in HTA is a complex interplay of several important factors. For these characteristics to become a formal part of HTA of MDs in the future, clear guidance and frameworks are required to enable manufacturers to develop appropriate evidence, and HTA practitioners to assess their impact more broadly.

The Economic Consequences of Cardiac Surgery Associated Acute Renal Dysfunction After Heart Surgery.

The Society of Thoracic Surgeons definition of acute renal failure requires a 3-fold rise in creatinine, creatinine > 4 mg/dL (with at least 0.5mg/dL rise from preoperative value), or new hemodialysis requirement. This definition does not capture the incidence, clinical impact, and economic burden of lesser degrees of acute renal dysfunction. A retrospective cohort study using discharge data from 650 hospitals was extracted from the Premier administrative database (2010-2014) for index cardiac cases (isolated coronary artery bypass grafting, isolated valve, and coronary artery bypass grafting-valve). We documented acute renal dysfunction through International Classification of Diseases (ICD) 9-CM codes and hospital charges, excluding those patients with pre-existing renal dysfunction. The incidence, length of stay , and total hospital costs associated with renal dysfunction for each of the index procedures were captured. The results reported are unadjusted for demographic and clinical factors. A total of 200,471 procedures were available for analysis in the database. The mean age was 66 years, 68.2% were male and 74% were white. Based on ICD 9-CM codes and hospital charges for these cases, 27,216 (13.6%) patients had some level of renal dysfunction. In addition to increase in length of stay, patients who developed renal dysfunction had an associated 57-85% increase in total cost of hospitalization. The incidence of renal dysfunction in this study is higher than reported previously. The Society of Thoracic Surgeons definition of renal failure captures only severe disease and may miss lesser degrees of dysfunction, which nonetheless have an impact on patient outcome and costs.

Intrinsic properties of medical devices: considerations for economic evaluation.

Introduction: In recent decades, medical devices (MDs) have increasingly become an integral part of patient care. However, when it comes to designing and appraising economic models, researchers typically follow pharmaceutical templates (e.g. CHEERS) to assess their economic viability. This study evaluates the generalizability of four device-specific criteria, as recommended by the recent MedtechHTA project, of learning curve, incremental innovation, dynamic pricing, and organizational impact with a broader group of MDs including diagnostics and implantables. The purpose was to determine the applicability of these criteria to a broader range of MDs.Areas Covered: We determined the extent to which these criteria could be applied to each device type and attempted to identify common themes. We performed a literature search using PubMed and Google of a range of devices to understand the clinical significance, operation, and economic viability.Expert Opinion: Our findings suggest that the four characteristics are not applicable to all device types. Prior evaluation of a device's intrinsic properties (such as longevity and device location) and its FDA risk classification could help to indicate the applicability of the criteria. Documenting this process when assessing the additional four criteria on the CHEERS checklist would improve the transparency of future economic evaluations.

The effect of prophylaxis on pediatric HIV costs.

The objective of this study was to determine and compare the cost to treat HIV(+) and HIV(-) pediatric patients both before and after HIV prophylaxis became the standard of care. Retrospective chart review of a pediatric HIV/AIDS specialty clinic's medical charts was conducted for clinical and healthcare utilization data on 125 children diagnosed from 1986 to 2007. Mean HIV-related costs were compared using bootstrapped t-tests for children born in the pre-prophylaxis (1979-1993) and prophylaxis eras (1994-2007). Patients were also stratified into two categories based on death during the follow-up period. Lastly, national cost-savings were estimated using mean costs, national number of at-risk births, and national perinatal HIV transmission rates in each era. For HIV(+) children, mean annual per patient treatment cost was $15,067 (95% CI: $10,169-$19,965) in the pre-prophylaxis era (n = 40) and $14,959 (95% CI: $9140-$20,779) in the prophylaxis era (n = 14); difference not statistically significant (p > 0.05). For HIV(-) children, mean annual per patient treatment cost was $204 (95% CI: $219-$627) for the pre-prophylaxis era (n = 2) and $427 (95% CI: $277-$579) for the prophylaxis era (n = 69); difference statistically significant (p < 0.05). A projected cost-savings of $16-23 million annually in the USA was observed due to the adoption of prophylaxis treatment guidelines in pediatric HIV care. The prophylaxis era of pediatric HIV treatment has been successful in decreasing perinatal HIV transmission and mortality, as reflected by clinical trials and national cost-savings data, and emphasizes the value of the rapid adoption of evidence-based practice guidelines.

Fee comparisons of treatments for nonmelanoma skin cancer in a private practice academic setting.

OBJECTIVE: To compare fees for biopsy, treatment procedure, repair, and 2-month follow-up for nonmelanoma skin cancer (NMSC) treatments: electrodesiccation and curettage (ED&C), excision, and Mohs micrographic surgery (MMS). METHODS: A cost comparison of 936 primary NMSCs diagnosed in 1999/2000 at a University affiliated dermatology practice. Clinical data was from medical record review. 2007 Medicare Fee Schedule costs determined fees for surgical care. Pearson chi-square tests, t-tests and analysis of variance compared fee differences. Linear regression determined independent effects of tumor and treatment characteristics on fees. RESULTS: Mean fees/lesion were $463 for ED&C, $1,222 for excision, and $2,085 for MMS (p < .001). For all treatments, primary procedure costs were highest (38%, 45%, and 41%). Total repair fees were higher with MMS ($735) vs excisions ($197). Fees were higher for head and neck tumors (p < .001), H-zone tumors (p < .001), and tumors smaller than 10 mm in diameter (p = .04). Regression models predicted that the treatment fees would be $2,109 for MMS and $1,252 for excision (p < .001). Tumor size greater than 10 mm in diameter (added $128), tumors on the head and neck (added $966), and MMS (added $857 vs excision) were independently related to higher fees (p < .001). CONCLUSION: Even after adjusting for risk factors, MMS has higher fees than excision for primary NMSC. Repairs accounted for the majority of this difference. These fee comparisons provide a basis for comparative effectiveness studies of treatments for this common cancer.

Lifetime medical expenditures among hypertensive men and women in the United States.

OBJECTIVE: Our objective was to estimate lifetime medical expenditures that can be attributed to hypertension, by gender, in the United States, given important gender differences in both survival and medical expenditures. METHODS: We estimated lifetime medical expenditures among hypertensive and nonhypertensive men and women aged 20 and older. Expenditures were estimated from the 2001 to 2004 Medical Expenditure Panel Survey and life expectancies were estimated from the 1986 to 2002 National Health Interview Survey Linked Mortality Files. Assuming that medical technology, the cost of health care services, the incidence of disease, and survival were fixed, the cross-sectional age-specific expenditures and the survival profiles were used to estimate the lifetime expenditures from ages 20 to older than 85. PRINCIPAL FINDINGS: The estimated lifetime expenditure for an average life table individual at age 20 was $188,300 for hypertensive men and $254,910 for hypertensive women; however, a greater share of lifetime expenditures can be attributed to hypertension among men ($88,033) than among women ($40,960). CONCLUSION: Although hypertensive women had greater lifetime expenditures than hypertensive men, hypertension was associated with a greater increase in lifetime expenditures for men than for women. Gender differences in both survival and health care utilization have important implications for gender differences in lifetime medical expenditures.

Socioeconomic status, health care use, and outcomes: persistence of disparities over time.

PURPOSE: To determine the persistence of disparities in health care use and outcomes in socioeconomically diverse populations of epilepsy patients. METHODS: We followed patients for a year at one clinic in Houston and two in New York City that serve predominantly low-income, minority, Medicaid-insured, or uninsured patients, and a fourth clinic in Houston that serves a more balanced racial/ethnic and higher socioeconomic status (SES) population. We interviewed the patients several times regarding health care use, seizures, side effects, and outcomes, and examined differences between the patients at the three low-SES clinics and the patients at the high-SES clinic. KEY FINDINGS: After controlling for patients' age, gender, race/ethnicity, marital status, seizures, and side effects we found that low SES patients had consistently higher use of the hospital emergency room and more visits to a general practitioner. Hospitalizations were also consistently higher but the differences were not significant in most periods. Neurologist visits were relatively similar. Patients at the low SES sites also had a greater likelihood of having uncontrolled seizures, drug-related side effects, to be stigmatized, and have a lower overall quality of life throughout the study period. SIGNIFICANCE: These findings suggest the persistence of SES-related disparities in health care use and outcomes among patients with epilepsy who are receiving regular care.

Pediatric HIV costs across three treatment eras from 1986 to 2007.

OBJECTIVE: Life has changed dramatically for infants exposed perinatally to HIV to HIV primarily because of a successful translational research program that has also affected treatment costs. We compared treatment costs among HIV+ patients in an HIV/AIDS specialty clinic across 3 treatment eras: monotherapy (pre-1990), combination therapy (1990-1996), and highly active antiretroviral therapy (HAART) (1997-2007). We also estimated cumulative health care costs among pediatric HIV/AIDS patients born in each era. PATIENTS AND METHODS: Data on health care use were collected from medical records of 126 infants born to HIV+ mothers during a 21-year period (1986-2007) (728 person-years). The Drug Topics Red Book 1999 was used for drug costs, the Current Procedural Terminology Medicare Fee Schedule codes for outpatient costs, and the Healthcare Cost and Utilization Project Kids' Inpatient Database for inpatient costs. Generalized estimating equations and bootstrapped ordinary least-squares models were used to determine 2007 costs, cumulative costs, and cost savings. RESULTS: Lifetime cost savings with HAART were $6.7 to $23.3 million, depending on incidence. Average total costs per HIV+ person per month were $1306 ($318 for drugs, $896 for total medical) in the monotherapy era, $2289 ($891 for drugs, $1180 for total medical) in the combination-therapy era, and $1814 ($1241 for drugs, $320 for total medical) in the HAART era. Total costs during the HAART era were 25.2% lower than costs during the combination-therapy era, because the 34% higher HAART drug costs were compensated for by total medical costs (inpatient+outpatient) that were 57% lower, which was a significant change (P<.001). The cumulative costs for treatment of an HIV+ patient were highest during the monotherapy era ($196,860) and lowest during the HAART era ($181,436). CONCLUSIONS: Our results show that the cost burden for the treatment of HIV+ pediatric patients has decreased over time. This historical examination of treatment-era costs demonstrates the value of technologic advances in treatment.

Gender disparities in medical expenditures attributable to hypertension in the United States.

OBJECTIVE: We sought to examine and attempt to explain gender disparities in hypertension-attributable expenditure among noninstitutionalized individuals in the United States. METHODS: Using the 2001-2004 Medical Expenditure Panel Survey and the Aday and Andersen health care use model, we estimated hypertension-attributable health care expenditures for inpatient stay, outpatient visits, prescription drugs, office visits, and emergency room (ER) visits among men and women by applying the method of recycled prediction. Hypertensive individuals were identified using International Classification of Diseases, 9th edition, codes or self-report of a diagnosis of hypertension. RESULTS: The adjusted mean hypertension-attributable expenditure per individual was significantly higher for women than for men for prescription drugs, inpatient stays, office visits, outpatient visits and ER visits expenditures. However, as age increased, the gender difference in adjusted mean expenditures became smaller and eventually reversed. This reversal occurred at different ages for different expenditures. For prescription drugs, office visits and outpatient expenditures, the reversal in expenditures occurred around age 50 to 59. The maximum difference was observed in outpatient expenditures, where women's average expenditure was $102 more than men's below age 45 but $103 less than men's above age 75. These differences remained significant even after controlling for predisposing, enabling, and need predictors of health care use. CONCLUSION: Our findings imply that there are gender disparities in hypertension-related expenditures, but that this disparity depends on age. These findings support recent findings on gender disparities in heart diseases and raise the question of physicians' bias in their diagnostic or prognostic approaches to hypertension in men and women.

Concordance of survey and billing data in a study of outpatient healthcare cost and utilization among epilepsy patients.

We assessed the concordance between healthcare utilization and cost measured with patient survey and billing data among 226 epilepsy patients in a large multi-specialty group practice. Does survey information on utilization combined with prices, provide a cost of care that is approximately equal to the cost of care derived from billing data, utilizing the same price structure? Do measures of cost from survey and billing data yield the same correlates of cost among epilepsy patients? If so, survey data may be utilized to estimate correlates and cost of epilepsy care in cases where complete billing information is not available. For five of eight outpatient services, the concordance coefficients exceeded the practical cut-off value for clinical studies, suggesting substantial agreement between the billing and survey data. Cost was higher when computed from billing data, but the overall concordance (.75) between the cost estimates is relatively high, and comparable to findings in studies on other types of patients. The average 6-month outpatient cost difference was $11 between the two sources of cost estimates. Correlates of cost were similar, whether cost was measured with survey or billing data. The results suggest that correlates of cost and cost estimates derived from survey data may yield similar findings to cost estimates from billing data for policy related studies of epilepsy patients.

Sociodemographic disparities in epilepsy care: Results from the Houston/New York City health care use and outcomes study.

PURPOSE: The purpose of this study was to identify sociodemographic disparities in health care use among epilepsy patients receiving care at different sites and the extent to which the disparities persisted after adjusting for patient characteristics and site of care. METHODS: Three months of health care use data were obtained from baseline interviews of approximately 560 patients at four sites. One-half of the patients were from a Houston site and two NYC sites that serve predominantly low-income, minority, publicly insured, or uninsured patients. The other half were at the remaining site in Houston that serves a more balanced racial/ethnic and higher sociodemographic population. Differences in general and specialist visits, hospital emergency room (ER) care, and hospitalizations were associated with race/ethnicity, income, and coverage. Logistic regression was used to assess the extent to which the differences persisted when adjusting for individual patient characteristics and site of care. RESULTS: Compared to whites, blacks and Hispanics had higher rates of generalist visits [odds ratio (OR) = 5.3 and 4.9, p < 0.05), ER care (OR = 3.1 and 2.9, p < 0.05) and hospitalizations (OR = 5.4 and 6.2, p < 0.05), and lower rates of specialist visits (OR = 0.3 and 0.4, p < 0.05). A similar pattern was found related to patient income and coverage. The magnitude and significance of the disparities persisted when adjusting for individual characteristics but decreased substantially or were eliminated when site of care was added to the model. DISCUSSION: There are sociodemographic disparities in health care for people with epilepsy that are largely explained by differences in where patients receive care.

Cost to achieve an undetectable viral load using recommended antiretroviral regimens.

PURPOSE: The April 2005 Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents recommended 9 regimens to be combined with 2 nucleoside reverse transcriptase inhibitors (NRTIs). These regimens are effective in lowering viral load but are expensive. This study aimed to determine the cost for each regimen to achieve an undetectable viral load. METHOD: 52 clinical trials were reviewed. The outcome measure was cost per undetectable patient, C/PU, where C = cost of a drug, and PU = percent of patients with undetectable viral loads. RESULTS: For 30 weeks, cost per undetectable (<400 copies/mL) ranged from 4,416 dollars (efavirenz) to 23,110 dollars (nelfinavir); for 42 weeks, the range was 5,729 dollars (efavirenz) to 24,071 dollars (indinavir/ritonavir); for 60 weeks, it ranged from 9,535 dollars (efavirenz) to 26,829 dollars (fosamprenavir); and for 84 weeks, it ranged from 12,203 dollars (efavirenz) to 22,960 dollars (nelfinavir). For <50 copies/mL, at 30 weeks the range was from 7,140 dollars (efavirenz) to 17,548 dollars (atazanavir); for 42 weeks, it ranged from 9,849 dollars (lopinavir/ritonavir) to 13,181 dollars (nelfinavir); for 60 weeks, it ranged from 8,702 dollars (nevirapine) to 36,034 dollars (atazanavir); and for 84 weeks, it ranged from 15,660 dollars (efavirenz) to 29,177 dollars (indinavir/ritonavir). CONCLUSION: Efavirenz's low price and high effectiveness make it the least expensive means of achieving an undetectable viral load.