A Review of Empirical Analyses of Disinvestment Initiatives.

BACKGROUND: Disinvesting in low-value health care services provides opportunities for investment in higher value care and thus an increase in health care efficiency. OBJECTIVES: To identify international experience with disinvestment initiatives and to review empirical analyses of disinvestment initiatives. METHODS: We performed a literature search using the PubMed database to identify international experience with disinvestment initiatives. We also reviewed empirical analyses of disinvestment initiatives. RESULTS: We identified 26 unique disinvestment initiatives implemented across 11 countries. Nineteen addressed multiple intervention types, six addressed only drugs, and one addressed only devices. We reviewed 18 empirical analyses of disinvestment initiatives: 7 reported that the initiative was successful, 8 reported that the initiative was unsuccessful, and 3 reported that findings were mixed; that is, the study considered multiple services and reported a decrease in the use of some but not others. Thirty-seven low-value services were evaluated across the 18 empirical analyses, for 14 (38%) of which the disinvestment initiative led to a decline in use. Six of the seven studies that reported the disinvestment initiative to be successful included an attempt to promote the disinvestment initiative among participating clinicians. CONCLUSIONS: The success of disinvestment initiatives has been mixed, with fewer than half the identified empirical studies reporting that use of the low-value service was reduced. Our findings suggest that promotion of the disinvestment initiative among clinicians is a key component to the success of the disinvestment initiative.

Estimating Population Health Benefits Associated with Specialty and Traditional Drugs in the Year Following Product Approval.

OBJECTIVE: Compared to traditional drugs, specialty drugs tend to be indicated for lower prevalence diseases. Our objective was to compare the potential population health benefits associated with specialty and traditional drugs in the year following product approval. METHODS: First, we created a dataset of estimates of incremental quality-adjusted life-year (QALY) gains and incremental life-year (LY) gains for US FDA-approved drugs (1999-2011) compared to standard of care at the time of approval identified from a literature search. Second, we categorized each drug as specialty or traditional. Third, for each drug we identified estimates of US disease prevalence for each pertinent indication. Fourth, in order to conservatively estimate the potential population health gains associated with each new drug in the year following its approval we multiplied the health gain estimate by 10% of the identified prevalence. Fifth, we used Mann-Whitney U tests to compare the population health gains for specialty and traditional drugs. RESULTS: We identified QALY gain estimates for 101 drugs, including 56 specialty drugs, and LY gain estimates for 50 drugs, including 34 specialty drugs. The median estimated population QALY gain in the year following approval for specialty drugs was 4200 (IQR = 27,000) and for traditional drugs was 694 (IQR = 24,400) (p = 0.245). The median estimated population LY gain in the year following approval for specialty drugs was 7250 (IQR = 39,200) and for traditional drugs was 2500 (IQR = 58,200) (p = 0.752). CONCLUSIONS: Despite often being indicated for diseases of lower prevalence, we found a trend towards specialty drugs offering larger potential population health gains than traditional drugs, particularly when measured in terms of QALYs.

The lifetime medical cost burden of overweight and obesity: implications for obesity prevention.

This study quantifies age-specific and lifetime costs for overweight (BMI: 25-29.9), obese I (BMI: 30-34.9), and obese II/III (BMI: >35) adults separately by race/gender strata. We use these results to demonstrate why private sector firms are likely to underinvest in obesity prevention efforts. Not only does the existence of Medicare reduce the economic burden that obesity imposes on private payers, but, from the perspective of a 20-year-old obese adult, the short-term costs of obesity are small. This suggests that legislation that subsidizes wellness programs and/or mandates coverage for obesity treatments might make all firms better off. Ironically, Medicare has a greater incentive to prevent obesity because when an obese 65 year old enters the program, his/her costs are immediate and higher than costs for normal weight individuals.

Dosage, titration, and gaps in treatment with extended release niacin in clinical practice.

OBJECTIVE: To examine the dosage, titration patterns, and gaps in treatment of newly-initiated ER niacin in clinical practice. RESEARCH DESIGN AND METHODS: Historical cohort study using the Ingenix Lab/Rx database. Patients were at least 20 years old, received an initial, index ER niacin prescription between January 1, 2001 and June 30, 2003, and had no ER niacin use in the preceding 12 months. Follow-up data were collected for at least 6 months after the index date. MAIN OUTCOME MEASURES: Average daily dosage (ADD) and titration patterns of ER niacin therapy at defined time points after the index prescription, and the incidence and timing of continuous gaps of >/=30 days in ER niacin therapy. RESULTS: A total of 14 386 patients initiating ER niacin were followed for a mean of 6.5 months after the index prescription. The ADD of the initial ER niacin prescription was 750 mg. Forty percent of patients experienced a >/=30-day gap in therapy immediately after the first prescription. Almost 80% had at least one >/=30-day gap in therapy during the post-index period, and the ADD of the last prescription prior to discontinuation was /=1000 mg and only 7.6% reached the dose of 2000 mg. CONCLUSIONS: A considerable proportion of new ER niacin users failed to reach recommended daily maintenance dosages in clinical practice. The main limitations of the study include its reliance on administrative data, inability to capture over-the-counter niacin use, and evaluation of reasons for suboptimal titration. Future research should determine the extent to which gaps in ER niacin therapy and failure to titrate to optimal dosages are due to poor tolerability, physician practice, or other factors.

Contemporary analysis of secondary failure of successful sulfonylurea therapy.

OBJECTIVE: To revise older estimates of secondary failure that may no longer describe the contemporary pattern of sulfonylurea (SU) monotherapy and to identify predictors of such failure. METHODS: We identified 4,091 patients who achieved hemoglobin A1c (A1C) <8% within 1 year after initiation of SU therapy as their first-ever antihyperglycemic drug after January 1, 1996. The study subjects underwent follow-up until they added or switched antihyperglycemic medication, had A1C > or =8%, or terminated health plan membership or until December 31, 2004. We defined secondary failure by using two separate but overlapping approaches: (1) the addition of or switch to another antihyperglycemic drug after 6 months of SU therapy or (2) the first A1C measurement > or =8.0%. RESULTS: The level of A1C achieved within 1 year after initiation of SU treatment was the most powerful predictor of secondary SU failure. About 50% of patients whose best A1C was 7.0% to 7.9% added or switched antihyperglycemic drugs within 40 months, whereas it took nearly 60 months for those in the 6.0% to 6.9% A1C category and 74 months in the A1C <6.0% category to reach a 50% failure rate. Similarly, more than half of those patients whose best A1C was 7.0% to 7.9% had an A1C value > or =8% within 24 months, whereas it took nearly 60 months for study subjects in the 6.0% to 6.9% A1C category and 86 months for those in the <6.0% category to have SU failure. Younger age and weight gain were also predictive of failure. CONCLUSION: Secondary failure of SU therapy is inversely associated with the level of A1C achieved within the first year of SU monotherapy. Clinicians should quickly consider therapeutic adjustments to lower the A1C level rapidly if initial success is not achieved.

Discontinuation of lipid modifying drugs among commercially insured United States patients in recent clinical practice.

Although several lipid-modifying drug (LMD) treatments and strategies are available to successfully manage patients at risk for cardiovascular events, the benefits of drug treatment can be realized only if these therapies are continued on a long-term basis. Previous observational studies examining rates of discontinuation with LMDs are not generalizable to current clinical practice in the United States. In this study, the discontinuation of newly initiated LMD classes in recent clinical practice was compared in a geographically diverse, commercially insured United States population. Administrative claims from the Ingenix Lab/Rx Database were used to identify patients aged >or=20 years who were newly prescribed statins, extended-release niacin, fibrates, bile acid sequestrants, or ezetimibe from January 1, 2001, to June 30, 2003. An LMD class was considered discontinued if a patient did not receive a prescription from the same LMD class within 180 days of the most recent prescription expiration date. The median time to discontinuation was 8.2 months in the bile acid sequestrant group, followed by 12 months in the extended-release niacin group, 17.4 months in the fibrate group, and 27.5 months in the statin group. By the end of 1 year, the adjusted cumulative incidence of discontinuation was 68.3% in bile acid sequestrant users, 55.4% in extended-release niacin users, 39.9% in fibrate users, 33.0% in ezetimibe users, and 28.9% in statin users (p <0.001 for all LMD classes vs statins). In conclusion, despite the changes in lipid treatment paradigms and the importance of long-term lipid therapy, this study found high discontinuation rates of LMD classes in recent United States clinical practice.

Propoxyphene use and risk for hip fractures in older adults.

BACKGROUND: Published guidelines have identified propoxyphene as an inappropriate medication for use in aged patients. It is no more effective than acetaminophen, yet has been associated with the same adverse effects (AEs) associated with other opioid drugs. In particular, its central nervous system-related AEs, dizziness and sedation, may increase the risk for fracture resulting from falls in older adults. Nonetheless, US studies have reported widespread use of propoxyphene in the elderly US population. OBJECTIVE: The aim of this study was to examine the risk for fracture associated with propoxyphene use in older adults. METHODS: This prospective cohort study used a large administrative claims data set from adults aged > or =65 years. A time-varying (lagged) covariate defined each person as a propoxyphene user or nonuser based on propoxyphene exposure in the 14 days before each fracture event in the cohort. Another time-varying measure stratified propoxyphene users based on their mean daily dose of propoxyphene (high dose = >260 mg; low dose = < or =260 mg of propoxyphene hydrochloride or equivalent napsylate salt). Time-dependent Cox regression models were used to estimate the association between propoxyphene exposure and occurrence of hip fracture (using International Classification of Diseases, Ninth Revision, Clinical Modification code 820.xx). RESULTS: A total of 362,503 patients were included in the analysis. During a mean follow-up of 464 days, approximately 10% (37,569) of the sample had > or =1 propoxyphene prescription filled and approximately l% (5065) sustained a hip fracture. Propoxyphene users had a 2-fold higher risk for hip fracture (hazard ratio [HR] [95% CI], 2.05 [1.87-2.25]) compared with nonusers of analgesics. Multivariate analysis found a dose-response relationship between propoxyphene and hip fracture risk (low dose, HR [95% CI], 1.45 [1.26-1.67]; high dose, HR [95% CI], 2.05 [1.85-2.29]). Other opioid analgesics were associated with an increased risk for hip fractures. CONCLUSIONS: The results of this cohort database study suggest that propoxyphene use among adults aged > or =65 years is associated with increased risk for hip fracture and suggest a need for interventions to reduce propoxyphene use in older adults. Clinicians should be aware of the risk for hip fracture with other opioids as well and weigh them against potential benefits when prescribing for older adults.

Trends in lipid management among patients with diabetes.

OBJECTIVE: To examine trends in lipid management (cholesterol testing, treatment, and goal attainment) among patients with diabetes and to analyze the factors associated with initiation of lipid-lowering therapy. METHODS: We conducted a longitudinal, retrospective study of patients with diabetes identified during a 24-month baseline period (January 1, 1995, to December 31, 1996) and for whom follow-up was continued for 5 years (1997 to 2001). Generalized estimating equations were used to test for time trend effects in lipid management. We modeled the days from baseline to the first lipid-lowering prescription fill date with a multivariate Cox proportional hazards regression model. RESULTS: Rates of lipid testing, treatment, and goal attainment significantly improved (P<0.001) during the 5-year study period: from 37% to 67% for lipid testing; from 19% to 41% for treatment with a lipid-lowering agent; from 22% to 37% for achievement of low-density lipoprotein cholesterol (LDL-C) levels < 100 mg/dL; and from 54% to 75% for achievement of LDL-C levels < 130 mg/dL. The relative likelihood (hazard rate) of treatment with lipid-lowering agents was greater for patients with LDL-C levels > or = 100 mg/dL relative to patients with LDL-C concentrations < 100 mg/dL. Treatment with lipid-lowering agents of patients with a cardiovascular event during follow-up was approximately 3 times more likely relative to those without such an event. CONCLUSION: We found that rates of lipid testing, treatment, and goal attainment improved significantly between 1997 and 2001. Nevertheless, ample room for improvement of these rates continues to exist. Particular attention may be warranted to ensure that patients with diabetes receive lipid-lowering agents not only after a cardiovascular event but also before such an event occurs.

Employer-paid nonmedical costs for patients with diabetes and end-stage renal disease.

INTRODUCTION: Disease conditions such as end-stage renal disease (ESRD), which have severe consequences of disability and mortality, can generate substantial costs for large employers providing life insurance and disability insurance benefits. This study is the first to examine such disease-related nonmedical costs for employers and models the following employer-paid costs for ESRD in patients with diabetes: 1) life insurance benefits, 2) disability benefits, and 3) cost of replacing a worker. METHODS: We simulated a hypothetical cohort of 10,000 individuals with the age and sex distribution of a typical employee population in the United States. Data sources for the model parameters included the United States Renal Data System and proprietary life insurance and disability insurance claims databases. In addition, we used published information to identify the structures of typical employee benefits programs and annual salary information and to estimate the cost of replacing lost workers. RESULTS: The study estimated that employers may incur life insurance costs of 55,055 dollars per ESRD-related death, disability insurance costs of 31,671 dollars per ESRD-related disability, and worker replacement costs of 27,869 dollars per ESRD-related lost worker. Overall, the total monthly cost per employee with ESRD and diabetes was 5439 dollars. CONCLUSION: Our study finds that, other than the large direct medical costs documented in literature, ESRD onset also results in substantial nonmedical costs for employers. As employers continue to debate changes in the structure of future health plan benefits to reduce health care costs, they should consider potential indirect cost savings of providing affordable access to medical care that prevents or delays disability and mortality in their workers.

Treatment escalation and rise in HbA1c following successful initial metformin therapy.

OBJECTIVE: To describe secondary failure of initial metformin therapy in patients who achieved initial HbA(1c) (A1C) <8% and to identify predictors of failure. RESEARCH DESIGN AND METHODS: We identified 1,288 patients who achieved A1C <8% within 1 year of initiating metformin as their first-ever antihyperglycemic drug. Subjects were followed until they added/switched antihyperglycemics, they terminated health plan membership, or 31 December 2004. We defined secondary failure using two separate but overlapping approaches: 1) addition/switch to another antihyperglycemic drug or 2) first A1C measurement >8.0% after at least 6 months on metformin. RESULTS: The best A1C achieved within 1 year of metformin initiation was the most powerful predictor of avoiding secondary failure. Approximately 50% of subjects whose best A1C was 7-7.9% added/switched antihyperglycemic drugs within 36 months, whereas it took >60 months for those in the 6-6.9% A1C category to reach a 50% failure rate. Those who achieved an A1C <6% did not reach a 50% rate of adding/switching drugs until 84 months. For the alternative secondary failure outcome, about half of those whose best A1C was 7.0-7.9% reached an A1C >8% within 24 months. Only approximately 25% of subjects in the 6-6.9% category failed by 48 months, and >80% of subjects in the <6% category remained below 8% through 60 months. CONCLUSIONS: Whether defined by adding/switching to another drug or by reaching an A1C of 8%, secondary failure is inversely associated with the reduction of A1C achieved within the 1st year of metformin monotherapy.

Propoxyphene use by community-dwelling and institutionalized elderly Medicare beneficiaries.

OBJECTIVES: To provide the first comparable national prevalence estimates on use of propoxyphene, a potentially inappropriate drug, by elderly Medicare beneficiaries living in the community and institutions and to determine whether institutionalized beneficiaries are at a greater risk for receiving propoxyphene than community-dwelling beneficiaries. DESIGN: Cross-sectional study. SETTING: U.S. representative sample of elderly using Medicare database. PARTICIPANTS: Nationally representative sample of community-dwelling (n = 9,851, weighted n = 32.5 million) and institutionalized (n = 1,099, weighted n = 2.3 million) Medicare beneficiaries aged 65 and older. MEASUREMENTS: National estimates on prevalence of propoxyphene use and the odds of receiving propoxyphene were the two main outcome measures. RESULTS: Annual prevalence of propoxyphene use in 1998 was 6.8% by all community-dwelling elderly beneficiaries and 15.5% by institutionalized elderly beneficiaries. Beneficiaries in long-term care facilities had almost 40% higher odds of receiving propoxyphene (odds ratio = 1.38, 95% confidence interval = 1.1-1.8) than beneficiaries in the community even after controlling for other factors in a logistic regression. Other risk factors include female, rural residence, poor health, and history of osteoporosis or hip fracture. Beneficiaries residing in regions in the midwest and south were more than twice as likely to receive propoxyphene as those in the mid-Atlantic area. CONCLUSION: These results show that propoxyphene use by U.S. community-dwelling seniors is high but is much higher in the institutionalized population. These findings suggest that prescribing for older adults with pain could be improved, especially for vulnerable long-term care residents.