Therapy Optimization in Multiple Sclerosis: a cohort study of therapy adherence and risk of relapse.

OBJECTIVES: The objective of the Therapy Optimization in MS (TOP MS) Study was to prospectively assess the relationship between MS disease-modifying therapy (DMT) adherence and MS relapse risk over 2 years. METHODS: Potential participants were recruited for TOP MS by specialty pharmacies who dispensed glatiramer acetate and beta interferons for MS nationwide. Signed IRB-approved informed consents were returned to the pharmacies. TOP MS used electronic data capture with monthly patient entries. Adherence, measured by medication possession ratio (MPR), was derived from pharmacy shipment records. Logistic regression examined the association between protocol-defined relapses and DMT MPR (<0.5; >0.5-<0.9; >0.9). RESULTS: TOP MS enrolled 3151 persons with MS, and 2410 completed the full 2 years. Across all therapies, the mean MPR for the 2-year completer cohort of 2049 who maintained the same DMT was 0.9+0.2 (range: 0.1-1.0), with 63.8% reaching a 2-year MPR >0.9. Evaluated by categories of MPR, the proportion of participants remaining relapse-free for 24 months increased with increasing MPR, and the proportion with >1 relapses declined with increasing levels of MPR (p<0.0008). Regression analysis revealed the odds of relapse for a patient in the MPR >0.9 MPR group was 64% that of a patient in the MPR <0.5 category (p=0.02). Use of >1 DMT prior to the current one was an independent predictor of relapse. CONCLUSIONS: The study provides class III evidence that improvement in adherence to DMT for MS is associated with improved clinical outcomes as measured by relapse reduction.

The relationship between alternative medication possession ratio thresholds and outcomes: evidence from the use of glatiramer acetate.

OBJECTIVE: To examine how changes in the medication possession ratio (MPR) affect the probability of multiple sclerosis (MS) relapses and total and MS-related charges among patients treated with glatiramer acetate (GA). METHODS: Data were obtained from i3 InVision™ Data Mart for January 1, 2006 through March 31, 2010. Patients were included if they were diagnosed with MS, initiated therapy with GA, and had continuous insurance coverage from 6 months prior through 24 months after initial use of GA (n=839). Multivariate regressions which controlled for patient characteristics examined the association between achievement of alternative MPR goals and patient relapses and charges. RESULTS: Patients who achieved an MPR of at least 0.7 had significantly lower odds of relapse than those with MPR thresholds below 0.7, with achievement of a threshold of 0.7, 0.8, or 0.9, associated with an odds ratio of relapse of 0.545 (95% CI=0.351-0.824), 0.568 (95% CI=0.371-0.870), and 0.421 (95% CI=0.260-0.679), respectively. Attaining higher MPR thresholds resulted in larger reductions in direct medical charges, excluding GA and other MS-related drugs. MPR of 0.25 was associated with $1699 lower 2-year total direct medical charges (p=0.009) while a threshold of 0.95 was associated with $2136 lower total charges (p<0.001), compared to patients not reaching these respective thresholds. MPR of 0.90 was associated with $986 lower MS-related charges than for those with MPR<0.90 (p=0.050). Results also revealed an association between patient adherence to GA and statistically significant reductions in charges for specific components of care. LIMITATIONS: Results are generalizable only to patients with medical and prescription benefit coverage without regard for functional status. CONCLUSIONS: As adherence improved the odds of relapse decreased and charge offsets generally increased. Results suggest that, despite higher costs associated with increased usage of GA, patient outcomes are improved and there are cost-offsets associated with adherent use of GA.

Effect of immunomodulatory therapy and other factors on employment loss time in multiple sclerosis.

The factors that influence time missed from work among individuals diagnosed with multiple sclerosis were the focus of this study. Records of individuals who were employed and diagnosed with multiple sclerosis between the years 1999 and 2002 (N=284) were examined for details pertaining to their medical claims. Multivariate regressions, controlling for demographic characteristics, type of immunomodulatory medication, and overall severity of illness, were used in the examination of the total number of days missed from work for any reason and those missed due to absenteeism, short-term disability, or worker's compensation. Results indicate that lost work time is affected by severity of illness, and type of immunomodulatory therapy. Comparing individuals treated with the specific immunomodulator glatiramer acetate, interferon beta-1a (intramuscular), or interferon beta-1b, to those who did not receive multiple sclerosis medications of this type; only glatiramer acetate was associated with significantly fewer days missed from work for short term disability (18.24 fewer days, P<0.03), worker's compensation (29.50 fewer days, P<0.04) or any reason (53.70 fewer days, P< 0.003).

Pregnancy complications associated with bacterial vaginosis and their estimated costs.

OBJECTIVE: This study was undertaken to estimate the annual direct costs of complications associated with bacterial vaginosis (BV) in pregnant women in the United States. METHODS: An economic model was developed from evidence in the published literature linking perinatal complications to BV. The estimates of attributable risks were applied to the estimated population of pregnant women in the United States in 1993. The charge data from a database of hospital utilization information were then used to estimate the direct costs of each pregnancy complication and the total direct costs associated with BV. RESULTS: Under the assumptions of our model, the direct costs of preterm labor, preterm delivery, the attendant low birth weight (LBW), and other perinatal complications associated with BV were estimated at nearly $1.0 billion in 1993. Over 40% of the total cost was associated with preterm delivery and intensive care of LBW infants, while another 24.5% of the cost was related to preterm labor. CONCLUSIONS: If the current frequency of BV among pregnant women persists and BV is not detected and treated during pregnancy, the projected annual costs will reach $1.4 billion by the year 2000. Reducing the heavy economic burden associated with BV in pregnant women will require the establishment of effective screening and treatment regimens.