Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study

<p>Abstract</p> <p>Background</p> <p>The goal of this research was to compare the demographics, clinical characteristics and treatment patterns for newly diagnosed multiple sclerosis (MS) patients in a commercial managed care population who received disease-modifying drug (DMD) therapy versus those not receiving DMD therapy.</p> <p>Methods</p> <p>A retrospective cohort study using US administrative healthcare claims identified individuals newly diagnosed with MS (no prior MS diagnosis 12 months prior using ICD-9-CM 340) and ≥ 18 years old during 2001-2007 to characterize them based on demographics, clinical characteristics, and pharmacologic therapy for one year prior to and a minimum of one year post-index. The index date was the first MS diagnosis occurring in the study period. Follow-up of subjects was done by ICD-9-CM code identification and not by actual chart review. Multivariate analyses were conducted to adjust for confounding variables.</p> <p>Results</p> <p>Patients were followed for an average of 35.7 ± 17.5 months after their index diagnosis. Forty-three percent (n = 4,462) of incident patients received treatment with at least one of the DMDs during the post-index period. Treated patients were primarily in the younger age categories of 18-44 years of age, with DMD therapy initiated an average of 5.3 ± 9.1 months after the index diagnosis. Once treatment was initiated, 27.7% discontinued DMD therapy after an average of 17.6 ± 14.6 months, and 16.5% had treatment gaps in excess of 60 days.</p> <p>Conclusions</p> <p>Nearly 60% of newly-diagnosed MS patients in this commercial managed care population remained untreated while over a quarter of treated patients stopped therapy and one-sixth experienced treatment gaps despite the risk of disease progression or a return of pre-treatment disease activity.</p

Parents' reported preference scores for childhood atopic dermatitis disease states

BACKGROUND: We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic dermatitis would assign different preferences to the health state scenarios compared with parents who did not have a child with atopic dermatitis. METHODS: Subjects were parents of children aged 3 months to 18 years. The sample was derived from the General Panel, Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris Interactive. Participants rated health scenarios for atopic dermatitis, asthma, and eyeglasses on a visual analog scale, imagining a child was experiencing the described state. RESULTS: A total of 3539 parents completed the survey. Twenty-nine percent had a child with a history of atopic dermatitis. Mean preference scores for atopic dermatitis were as follows: mild, 91 (95% confidence interval [CI], 90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4); moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61 (95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1); asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI, 86.3 to 87.4). CONCLUSIONS: Parents perceive that atopic dermatitis has a negative effect on quality of life that increases with disease severity. Estimates of parents' preferences can provide physicians with insight into the value that parents place on their children's treatment and can be used to evaluate new medical therapies for atopic dermatitis

Comparison of Benefit-Risk Assessment Methods for Prospective Monitoring of Newly Marketed Drugs: A Simulation Study

AbstractObjectivesTo compare benefit-risk assessment (BRA) methods for determining whether and when sufficient evidence exists to indicate that one drug is favorable over another in prospective monitoring.MethodsWe simulated prospective monitoring of a new drug (A) versus an alternative drug (B) with respect to two beneficial and three harmful outcomes. We generated data for 1000 iterations of six scenarios and applied four BRA metrics: number needed to treat and number needed to harm (NNT|NNH), incremental net benefit (INB) with maximum acceptable risk, INB with relative-value–adjusted life-years, and INB with quality-adjusted life-years. We determined the proportion of iterations in which the 99% confidence interval for each metric included and excluded the null and we calculated mean time to alerting.ResultsWith no true difference in any outcome between drugs A and B, the proportion of iterations including the null was lowest for INB with relative-value–adjusted life-years (64%) and highest for INB with quality-adjusted life-years (76%). When drug A was more effective and the drugs were equally safe, all metrics indicated net favorability of A in more than 70% of the iterations. When drug A was safer than drug B, NNT|NNH had the highest proportion of iterations indicating net favorability of drug A (65%). Mean time to alerting was similar among methods across the six scenarios.ConclusionsBRA metrics can be useful for identifying net favorability when applied to prospective monitoring of a new drug versus an alternative drug. INB-based approaches similarly outperform unweighted NNT|NNH approaches. Time to alerting was similar across approaches

Methods for evaluation of medication adherence and persistence using automated databases

PURPOSE: Our aim was to perform a systematic review of the methods currently being used to assess adherence and persistence in pharmacoepidemiological and pharmacoeconomic studies using automated databases. METHODS: A MEDLINE search of English language literature was performed to identify studies published between January 1, 1980 and March 31, 2004 that evaluated adherence, compliance, persistence, switching, or discontinuations of medications using automated dispensing data (pharmacy records). Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to specified criteria. RESULTS: A total of 136 articles met the criteria for evaluation. The types of measures of adherence and persistence commonly reported include the medication possession ratio and related measures of medication availability (77 studies), discontinuation/continuation (58 studies), switching (34 studies), medication gaps (13 studies), refill compliance (7 studies), and retentiveness/turbulence (4 studies). Specific issues considered include the assessment of exposed time to drug therapy and specification of the follow-up period. CONCLUSIONS: The terminology, definitions, and methods to determine adherence and persistence differ greatly in the published literature. The appropriateness and choice of the specific measure employed should be determined by the overall goals of the study, as well as the relative advantages and limitations of the measures

Consequences of poor compliance with bisphosphonates

BACKGROUND: Prior research on the ability of bisphosphonates to prevent fractures and related health care utilization has been based on high levels of compliance achievable in clinical trial settings. This study was undertaken to assess rates of osteoporotic fractures and health care utilization as a function of bisphosphonate compliance in usual clinical practice. METHODS: This retrospective cohort study used 2000-2004 pharmacy and medical claims data from 45 large U.S. employers. Our sample included persons diagnosed with osteoporosis, aged 40 years or older, and who initiated use of either alendronate or risedronate. Main outcome measures were medication compliance, rates of osteoporotic fracture, and costs for inpatient care, outpatient services, and prescription drugs. RESULTS: We identified 17,988 new users of bisphosphonate therapy. After 1 to 3 years of follow-up, only 30.6% to 42.9% of patients could achieve high compliance (80%-100%), 17.4%-23.0% moderate compliance (79%-40%), and 33.8%-52.0% had low compliance (0%-39%). Multivariate models of fracture risk showed benefits (p\u3c10) with compliance levels of at least 60%, after which no risk benefit could be detected. Multivariate models of health care costs showed statistically significant (p\u3c.05) total costs savings of $859 to$366 per year with high to moderate compliance levels. However, individuals achieving less than 40% compliance had no detectable decrease in inpatient or outpatient costs to offset the increase in drug costs. CONCLUSIONS: Reductions in fracture risk and overall health costs can be detected in individuals achieving as little as 60% to 40% compliance with bisphosphonates. However, as many as 34% of patients in the first year of therapy and 52% by the third year will not reach even the minimal compliance levels required to receive benefits

Medical care costs of Paget\u27s disease of bone in a privately insured population

INTRODUCTION: Medical care costs are difficult to calculate in diseases such as Paget\u27s disease because they have low detection rates and a wide range of clinical manifestations that commonly occur in aging patient populations. MATERIALS AND METHODS: Using 2001-2002 MarketScan Research databases, this study linked medical claims, prescription records, and encounter data on 2.8 million active and retired employees to create a longitudinal panel with 24 months of observation. Patients with Paget\u27s disease were identified by ICD-9 code 731.0. Matched controls (MC) were identified through an exact match procedure using gender, age, and predicted Medicare costs estimated with a risk adjuster. Diagnostic and expenditure records were extracted for the sample and prevalence rates calculated for 20 conditions with well-documented associations to Paget\u27s disease. Comorbidities and health care costs of Paget\u27s disease patients were compared to those of the MCs, and the differences tested using Chi-square and t tests. RESULTS: Our study identified 244 matched pairs. The average age was 72.7 years; 50.8% were female. Significantly higher comorbidities (P \u3c 0.05) were detected in Paget\u27s disease patients relative to MCs for: pathological fractures (4.9% vs. 0.4%), heart murmurs (3.3% vs. 0.4%), low back pain (19.7% vs. 8.6%), spinal stenosis (16.4% vs. 9.8%), and hearing loss (13.5% vs. 5.7%), respectively. Biannual per patient outpatient costs were significantly higher in Paget\u27s disease patients (Paget\u27s disease $9301 vs. MC$6339, P \u3c 0.05), especially for services associated with physician visits and diagnostic tests. Prescription costs for antiresportive agents and analgesics were also higher (Paget\u27s disease $1115 vs. MC$507, P \u3c 0.05). Inpatient costs (Paget\u27s disease $16,144 vs. MC$21,480) were comparable. CONCLUSION: This study is the first to describe the excessive costs of Paget\u27s disease, based on known patterns of disease expression, evaluation, and treatment

The effect of health related quality of life on reported use of health care resources in patients with osteoarthritis and rheumatoid arthritis: a longitudinal analysis.

OBJECTIVE: In today's cost conscious environment, health services researchers are consistently trying to find ways to predict future health care resource utilization (HCRU) and its associated costs. We evaluated the impact of health related quality of life (HRQL) on future HCRU in patients with arthritis. METHODS: A total of 642 patients with rheumatoid arthritis (RA) and 395 patients with osteoarthritis (OA) completed at least 2 and as many as 6 consecutive surveys at 6 mo intervals. Information collected included demographics, HRQL questionnaires [Medical Outcome Study Short Form 36 (SF-36), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), and the Stanford Health Assessment Questionnaire (HAQ)], and HCRU over the previous 6 months. Longitudinal data analysis was perfomed to assess the effect of HRQL on future HCRU. RESULTS: Statistically significant associations between HCRU and HRQL variables were noted. Higher rates of HCRU were found in those in the worst quarter compared with those in the best quarter of HRQL. With the HAQ, OA and RA patients in the worst quarter reported a 199% (p < 0.05) and 48% (p < 0.05) increase in rheumatologist visits, respectively. With the WOMAC Function, increases were as high as 196% (p < 0.05) in rheumatologist visits for patients with OA. Patients with RA with a high level of HRQL as measured by the SF-36 (physical component score) reported a decrease of 31% (p < 0.01) in general practitioner visits and a decrease of 52% (p < 0.01) in hospitalization (mental component score). CONCLUSION: These findings suggest that HRQL may be used to predict future health care consumption. Such an approach may lead to a more efficient allocation of resources by providing useful information to health care providers and health care decision makers

Three-tiered-copayment drug coverage and use of nonsteroidal anti-inflammatory drugs

BACKGROUND: Previous studies of 3-tier formularies are rare, although the evidence suggests that their cost-sharing structure reduces overall drug spending. However, it is unclear how incentive-based formularies affect the selection of medications with safety advantages, or restrict the access that high-risk populations have to recommended therapies in the higher tiers. This study was designed to determine whether 3-tier formularies influence the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in a population of patients with arthritis. METHODS: This retrospective study used the 2000 MarketScan Research Database, which contains person-level claims data for employer-sponsored health plans. The sample for this study consisted of 20 868 individuals treated for osteoarthritis or rheumatoid arthritis and using NSAIDs while enrolled in tiered drug plans (n = 32). The likelihood of any use of cyclo-oxygenase (COX-2)-selective inhibitors was determined as a function of tiered drug plan coverage, adjusting for other person-level and plan-level covariates. RESULTS: Use of COX-2-selective inhibitors decreased (63.0% vs 53.6% vs 41.6%, respectively) and use of generic NSAIDs increased (37.7% vs 40.7% vs 55.7%, respectively) as formularies incorporated 1, 2, and 3 tiers. Enrollees in 3-tier plans with arthritis and serious gastrointestinal comorbidities (odds ratio, 0.51; 95% confidence interval, 0.40-0.66) were significantly less likely to use COX-2-selective inhibitors compared with patients in 1-tier plans. CONCLUSIONS: Three-tier formularies appear to reduce the use of COX-2-selective inhibitors among all patients with arthritis, even those at risk of experiencing gastrointestinal complications from using nonselective NSAIDs. These findings are among the first to suggest that tiered-copayment drug plans may be influencing the selection of medications beyond generic and branded products

Bone density consequences of initiation and compliance with therapy for osteoporosis

OBJECTIVE: There are many effective osteoporosis (OP) medications with a variety of dosing intervals and delivery options, but even when diagnosed, OP is often undertreated. We sought to determine the bone density consequences of the decision to initiate and comply with therapy for OP. METHODS: We identified 243 women who received a dual x-ray absorptiometry (DXA) evaluation and fulfilled the World Health Organization criteria for OP. One year later, the patients were asked to return for a followup DXA. Administrative electronic health records were used to identify prescription drug use. RESULTS: A total of 142 women (58%) initiated pharmacologic therapy for OP during the year after the initial DXA; 144 returned for a followup DXA after 1 year. For those women with \u3e/=66% of days receiving therapy, the mean annual change in spine bone mineral density (BMD) was 4.5% compared with 2.0% for those with \u3c66% of days receiving therapy and 0.8% for those not receiving OP therapy (P \u3c 0.001). For those women with \u3e/=66% of days receiving therapy, the mean change in hip BMD was 2.3% compared with 0.3% for those with \u3c66% of days receiving therapy and -0.8% for those not receiving OP therapy (P \u3c 0.001). CONCLUSION: We found significant bone density consequences of the decision to initiate and comply with therapy in the first year after diagnosis of OP. Improvement in both initiation rates of treatment as well as compliance are needed in order to reduce the frequency of osteoporotic fractures