Medicare savings from conservative management of low back pain.

OBJECTIVES: Low back pain (LBP) is a common and expensive clinical problem, resulting in tens of billions of dollars of direct medical expenditures in the United States each year. Although expensive imaging tests are commonly used, they do not improve outcomes when used in the initial management of idiopathic LBP. We estimated 1-year medical costs associated with early imaging of Medicare beneficiaries with idiopathic LBP. STUDY DESIGN: We used a 5% random sample of Medicare fee-for-service enrollees between 2006 and 2010 to determine 12-month costs following a diagnosis of idiopathic LBP. We analyzed costs of care and patient outcomes according to whether or not the patients had been referred for early imaging following their initial diagnosis. METHODS: We employed an instrumental variables analysis using risk-adjusted physician-level propensity to order imaging for patients without LBP as an instrument for imaging use among patients with LBP. We selected this approach to adjust for confounding by indication when estimating the relative costs of early imaging of LBP compared with conservative management. RESULTS: Early imaging is strongly associated with increased costs of care in the first year following LBP diagnosis. Patients receiving an early magnetic resonance imaging scan accrued $2500 more in Medicare expenditures than conservatively managed patients, and patients who received computed tomography accrued $19,900 more. CONCLUSIONS: Medicare beneficiaries with low-risk LBP frequently receive early imaging studies. Early imaging was associated with greater long-term costs than a conservative diagnostic strategy; Medicare expenditures could be reduced by $362 million annually by managing newly diagnosed LBP in accordance with clinical guidelines.

Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL.

BACKGROUND: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data. METHODS AND RESULTS: We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation. CONCLUSIONS: Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

Health and economic benefits of early vaccination and nonpharmaceutical interventions for a human influenza A (H7N9) pandemic: a modeling study.

BACKGROUND: Vaccination for the 2009 pandemic did not occur until late in the outbreak, which limited its benefits. Influenza A (H7N9) is causing increasing morbidity and mortality in China, and researchers have modified the A (H5N1) virus to transmit via aerosol, which again heightens concerns about pandemic influenza preparedness. OBJECTIVE: To determine how quickly vaccination should be completed to reduce infections, deaths, and health care costs in a pandemic with characteristics similar to influenza A (H7N9) and A (H5N1). DESIGN: Dynamic transmission model to estimate health and economic consequences of a severe influenza pandemic in a large metropolitan city. DATA SOURCES: Literature and expert opinion. TARGET POPULATION: Residents of a U.S. metropolitan city with characteristics similar to New York City. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: Vaccination of 30% of the population at 4 or 6 months. OUTCOME MEASURES: Infections and deaths averted and cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: In 12 months, 48 254 persons would die. Vaccinating at 9 months would avert 2365 of these deaths. Vaccinating at 6 months would save 5775 additional lives and $51 million at a city level. Accelerating delivery to 4 months would save an additional 5633 lives and $50 million. RESULTS OF SENSITIVITY ANALYSIS: If vaccination were delayed for 9 months, reducing contacts by 8% through nonpharmaceutical interventions would yield a similar reduction in infections and deaths as vaccination at 4 months. LIMITATION: The model is not designed to evaluate programs targeting specific populations, such as children or persons with comorbid conditions. CONCLUSION: Vaccination in an influenza A (H7N9) pandemic would need to be completed much faster than in 2009 to substantially reduce morbidity, mortality, and health care costs. Maximizing non-pharmaceutical interventions can substantially mitigate the pandemic until a matched vaccine becomes available. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, National Institutes of Health, and Department of Veterans Affairs.

Cost-effectiveness of genotype-guided and dual antiplatelet therapies in acute coronary syndrome.

BACKGROUND: The choice of antiplatelet therapy after acute coronary syndrome (ACS) is complicated: Ticagrelor and prasugrel are novel alternatives to clopidogrel, patients with some genotypes may not respond to clopidogrel, and low-cost generic formulations of clopidogrel are available. OBJECTIVE: To determine the most cost-effective strategy for dual antiplatelet therapy after percutaneous coronary intervention for ACS. DESIGN: Decision-analytic model. DATA SOURCES: Published literature, Medicare claims, and life tables. TARGET POPULATION: Patients having percutaneous coronary intervention for ACS. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: Five strategies were examined: generic clopidogrel, prasugrel, ticagrelor, and genotyping for polymorphisms of CYP2C19 with carriers of loss-of-function alleles receiving either ticagrelor (genotyping with ticagrelor) or prasugrel (genotyping with prasugrel) and noncarriers receiving clopidogrel. OUTCOME MEASURES: Direct medical costs, quality-adjusted life years(QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS OF BASE-CASE ANALYSIS: The clopidogrel strategy produced$179 301 in costs and 9.428 QALYs. Genotyping with prasugrel was superior to prasugrel alone, with an ICER of $35 800 per QALY relative to clopidogrel. Genotyping with ticagrelor was more effective than genotyping with prasugrel ($30 200 per QALY relative to clopidogrel). Ticagrelor was the most effective strategy($52 600 per QALY relative to genotyping with ticagrelor). RESULTS OF SENSITIVITY ANALYSIS: Stronger associations between genotype and thrombotic outcomes rendered ticagrelor substantially less cost-effective ($104 800 per QALY). Genotyping with prasugrel was the preferred therapy among patients who could not tolerate ticagrelor. LIMITATION: No randomized trials have directly compared genotyping strategies or prasugrel with ticagrelor. CONCLUSION: Genotype-guided personalization may improve the cost-effectiveness of prasugrel and ticagrelor after percutaneous coronary intervention for ACS, but ticagrelor for all patients may bean economically reasonable alternative in some settings.

Transcatheter aortic valve replacement in nonsurgical candidates with severe, symptomatic aortic stenosis: a cost-effectiveness analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) seems to improve the survival and quality of life of patients with aortic stenosis ineligible for surgical aortic valve replacement. METHODS AND RESULTS: We used a decision analytic Markov model to estimate lifetime costs and benefits in a hypothetical cohort of patients with severe, symptomatic aortic stenosis who were ineligible for surgical aortic valve replacement. The model compared transfemoral TAVR with medical management and was calibrated to the Placement of Aortic Transcatheter Valves (PARTNER) trial. TAVR increased life expectancy from 2.08 to 2.93 years and quality-adjusted life expectancy from 1.19 to 1.93 years. TAVR also reduced subsequent hospitalizations by 1.40 but increased complications, particularly stroke (from 1% to 11% lifetime risk), and also increased lifetime costs from $83,600 to $169,100. The incremental cost-effectiveness of TAVR was $116,500 per quality-adjusted life-year gained ($99,900 per life-year gained). Results were robust to reasonable changes in individual variables but were sensitive to the level of annual healthcare costs caused by noncardiac diseases and to the projected life expectancy of medically treated patients. CONCLUSIONS: TAVR seems to be an effective but somewhat expensive alternative to medical management among patients with symptomatic aortic stenosis ineligible for surgery. TAVR is more cost-effective for patients with a lower burden of noncardiac disease.

Three large-scale changes to the Medicare program could curb its costs but also reduce enrollment.

With Medicare spending projected to increase to 24 percent of all federal spending and to equal 6 percent of the gross domestic product by 2037, policy makers are again considering ways to curb the program's spending growth. We used a microsimulation approach to estimate three scenarios: imposing a means-tested premium for Part A hospital insurance, introducing a premium support credit to purchase health insurance, and increasing the eligibility age to sixty-seven. We found that the scenarios would lead to reductions in cumulative Medicare spending in 2012-36 of 2.4-24.0 percent. However, the scenarios also would increase out-of-pocket spending for enrollees and, in some cases, cause millions of seniors not to enroll in the program and to be left without coverage. To achieve substantial cost savings without causing substantial lack of coverage among seniors, policy makers should consider benefit changes in combination with other options, such as some of those now being contemplated by the Obama administration and Congress.

Cost-effectiveness of statins for primary cardiovascular prevention in chronic kidney disease.

OBJECTIVES: The authors sought to evaluate the cost-effectiveness of statins for primary prevention of myocardial infarction (MI) and stroke in patients with chronic kidney disease (CKD). BACKGROUND: Patients with CKD have an elevated risk of MI and stroke. Although HMG Co-A reductase inhibitors ("statins") may prevent cardiovascular events in patients with non­dialysis-requiring CKD, adverse drug effects and competing risks could materially influence net effects and clinical decision-making. METHODS: We developed a decision-analytic model of CKD and cardiovascular disease (CVD) to determine the cost-effectiveness of low-cost generic statins for primary CVD prevention in men and women with hypertension and mild-to-moderate CKD. Outcomes included MI and stroke rates, discounted quality-adjusted life years (QALYs) and lifetime costs (2010 USD), and incremental cost-effectiveness ratios. RESULTS: For 65-year-old men with moderate hypertension and mild-to-moderate CKD, statins reduced the combined rate of MI and stroke, yielded 0.10 QALYs, and increased costs by $1,800 ($18,000 per QALY gained). For patients with lower baseline cardiovascular risks, health and economic benefits were smaller; for 65-year-old women, statins yielded 0.06 QALYs and increased costs by $1,900 ($33,400 per QALY gained). Results were sensitive to rates of rhabdomyolysis and drug costs. Statins are less cost-effective when obtained at average retail prices, particularly in patients at lower CVD risk. CONCLUSIONS: Although statins reduce absolute CVD risk in patients with CKD, the increased risk of rhabdomyolysis, and competing risks associated with progressive CKD, partly offset these gains. Low-cost generic statins appear cost-effective for primary prevention of CVD in patients with mild-to-moderate CKD and hypertension.

An economic analysis of conservative management versus active treatment for men with localized prostate cancer.

Comparative effectiveness research suggests that conservative management (CM) strategies are no less effective than active initial treatment for many men with localized prostate cancer. We estimate longer-term costs of initial management strategies and potential US health expenditure savings by increased use of conservative management for men with localized prostate cancer. Five-year total health expenditures attributed to initial management strategies for localized prostate cancer were calculated using commercial claims data from 1998 to 2006, and savings were estimated from a US population health-care expenditure model. Our analysis finds that patients receiving combinations of active treatments have the highest additional costs over conservative management at $63 500, followed by $48 550 for intensity-modulated radiation therapy, $37 500 for primary androgen deprivation therapy, and $28 600 for brachytherapy. Radical prostatectomy ($15 200) and external beam radiation therapy ($18 900) were associated with the lowest costs. The population model estimated that US health expenditures could be lowered by 1) use of initial CM over all active treatment ($2.9-3.25 billion annual savings), 2) shifting patients receiving intensity-modulated radiation therapy to CM ($680-930 million), 3) foregoing primary androgen deprivation therapy($555 million), 4) reducing the use of adjuvant androgen deprivation in addition to local therapies ($630 million), and 5) using single treatments rather than combination local treatment ($620-655 million). In conclusion, we find that all active treatments are associated with higher longer-term costs than CM. Substantial savings, representing up to 30% of total costs, could be realized by adopting CM strategies, including active surveillance, for initial management of men with localized prostate cancer.

Cost-effectiveness of early colectomy with ileal pouch-anal anastamosis versus standard medical therapy in severe ulcerative colitis.

BACKGROUND: Inflammatory bowel diseases are costly chronic gastrointestinal diseases. We aimed to determine whether immediate colectomy with ileal pouch-anal anastamosis (IPAA) after diagnosis of severe ulcerative colitis (UC) was cost-effective compared to the standard medical therapy. METHODS: We created a Markov model simulating 2 cohorts of 21-year-old patients with severe UC, following them until 100 years of age or death, comparing early colectomy with IPAA strategy to the standard medical therapy strategy. Deterministic and probabilistic analyses were performed. RESULTS: Standard medical care accrued a discounted lifetime cost of $236,370 per patient. In contrast, early colectomy with IPAA accrued a discounted lifetime cost of $147,763 per patient. Lifetime quality-adjusted life-years gained (QALY-gained) for standard medical therapy was 20.78, while QALY-gained for early colectomy with IPAA was 20.72. The resulting incremental cost-effectiveness ratio (Δcosts/ΔQALY) was approximately $1.5 million per QALY-gained. Results were robust to one-way sensitivity analyses for all variables in the model. Quality-of-life after colectomy with IPAA was the most sensitive variable impacting cost-effectiveness. A low utility value of less than 0.7 after colectomy with IPAA was necessary for the colectomy with IPAA strategy to be cost-ineffective. CONCLUSIONS: Under the appropriate clinical settings, early colectomy with IPAA after diagnosis of severe UC reduces health care expenditures and provides comparable quality of life compared to exhaustive standard medical therapy.

How the Patient-Centered Outcomes Research Institute can best influence real-world health care decision making.

The Affordable Care Act of 2010 created the Patient-Centered Outcomes Research Institute to promote and fund comparative effectiveness research and to ensure that the product of this research improves real-world health care decisions. Notwithstanding limitations imposed by Congress on the institute's ability to influence federal payers' coverage and payment policies, the organization now has considerable potential to help standardize and coordinate comparative effectiveness research in the United States. Still, many questions remain about how this important new entity will function--and a central challenge will be to produce comparative effectiveness assessments that can be readily disseminated to, and used by, a wide range of health care stakeholders, especially providers and patients. I recommend that the institute adopt a comparative effectiveness assessment format that compares interventions on the basis of their clinical risks and benefits, economic considerations, and the insights they might offer into medical care. I also offer an example of how this proposed assessment and rating approach might work in the presentation of findings that weigh cardiac bypass versus angioplasty as alternatives for the treatment of coronary disease in which multiple coronary arteries require intervention.

Knowing loved ones' end-of-life health care wishes: attachment security predicts caregivers' accuracy.

OBJECTIVE: At times, caregivers make life-and-death decisions for loved ones. Yet very little is known about the factors that make caregivers more or less accurate as surrogate decision makers for their loved ones. Previous research suggests that in low stress situations, individuals with high attachment-related anxiety are attentive to their relationship partners' wishes and concerns, but get overwhelmed by stressful situations. Individuals with high attachment-related avoidance are likely to avoid intimacy and stressful situations altogether. We hypothesized that both of these insecure attachment patterns limit surrogates' ability to process distressing information and should therefore be associated with lower accuracy in the stressful task of predicting their loved ones' end-of-life health care wishes. METHOD: Older patients visiting a medical clinic stated their preferences toward end-of-life health care in different health contexts, and surrogate decision makers independently predicted those preferences. For comparison purposes, surrogates also predicted patients' perceptions of everyday living conditions so that surrogates' accuracy of their loved ones' perceptions in nonstressful situations could be assessed. RESULTS: Surrogates high on either type of insecure attachment dimension were less accurate in predicting their loved ones' end-of-life health care wishes. It is interesting to note that even though surrogates' attachment-related anxiety was associated with lower accuracy of end-of-life health care wishes of their loved ones, it was associated with higher accuracy in the nonstressful task of predicting their loved ones' everyday living conditions. CONCLUSIONS: Attachment orientation plays an important role in accuracy about loved ones' end-of-life health care wishes. Interventions may target emotion regulation strategies associated with insecure attachment orientations.

Cost-effectiveness analysis of nephron sparing options for the management of small renal masses.

PURPOSE: A recent increase in the detection of contrast enhancing renal masses 4 cm or smaller suspicious for malignancy has led to the widespread use of nephron sparing options. Limited data exist to help clinicians decide which of these competing nephron sparing therapies is most appropriate. We performed a cost-effectiveness analysis to evaluate the relative clinical and economic merits of commonly available nephron sparing strategies for small renal masses. MATERIALS AND METHODS: We developed a decision analytic Markov model estimating the costs and health outcomes of treating a healthy 65-year-old patient with an asymptomatic unilateral small renal mass using competing nephron sparing options of immediate intervention (ie open and laparoscopic partial nephrectomy as well as laparoscopic and percutaneous ablation), active surveillance with possible delayed intervention and nonsurgical management with observation. Benefits were measured in quality adjusted life-years. We used a societal perspective, lifetime horizon and willingness to pay threshold of $50,000 per quality adjusted life-year gained. Model results were assessed with sensitivity analyses. RESULTS: In the base case scenario the least costly option was observation and the optimal option was immediate laparoscopic partial nephrectomy, which had an incremental cost-effectiveness ratio of $36,645 per quality adjusted life-year gained compared to surveillance with possible delayed percutaneous ablation. Results were sensitive to age at diagnosis, health status and tumor size. CONCLUSIONS: Immediate laparoscopic partial nephrectomy is the preferred nephron sparing option for healthy patients younger than 74 years old with a small renal mass. Surveillance with possible delayed percutaneous ablation is a cost-effective alternative for patients with advanced age or significant comorbidities. Observation maximizes quality adjusted life-years in patients who are poor surgical candidates or with limited life expectancy (less than 3 years).