The results of this study suggest that patients with transformed migraine have a lower health-related quality of life than patients with migraine. These findings indicate that the headache chronicity associated with transformed migraine has a significant influence on quality of life. The results highlight the importance of effective management of headaches to avoid the progression of migraine to the more disabling transformed migraine.

In this study, DMD adherence was associated with a significantly lower rate of severe relapse and lower total costs over 2 years. Causality cannot be inferred because adherence and outcomes were measured over the same period. The study was subject to limitations associated with use of claims data and the absence of clinical measures.

BackgroundThe purpose of this study was to compare two methods of adherence calculation using administrative data for patients with multiple sclerosis (MS) who are prescribed disease-modifying drugs.MethodsPharmacy-billed disease-modifying drug prescription claims were selected from the 2007–2008 LifeLink™ Health Plan Claims Database. The index date was the first disease-modifying drug prescription claim. Two cohorts were created: all patients with a disease-modifying drug claim in 2007 and a subset with continuous eligibility for 12 months post-index. Adherence was calculated across all disease-modifying drugs for 12 months post-index. Medication possession ratios (MPRs) with variable (start to end of therapy) and fixed (365 days) duration denominators were calculated. Variable MPR was calculated by summing days supply from the first to the last prescription (inclusive) divided by time between the last prescription date plus days supply and the first prescription date. Variable MPR was evaluated for all patients and the continuously eligible cohort. Fixed MPR used the same numerator but divided by 365 days of follow-up and evaluated only for the continuously eligible cohort.ResultsThere were 3405 patients with MS and a disease-modifying drug claim in 2007 and 2145 in the continuously eligible cohort. Means for variable MPR ranged from 87.5% ± 16.6% for the continuously eligible cohort to 90.5% ± 16.0% for the 2007 cohort. The comparable value for fixed MPR was 78.0% ± 28.2% for the continuously eligible cohort. Fixed MPR gave a consistently lower rate of adherence than variable MPR at an 80% adherence threshold.ConclusionDifferent adherence measures can yield different outcomes, especially when using different eligibility criteria. These results demonstrate the importance of full disclosure of methods used for calculations and specification of the study population.

and IFN β-1a IM injection had the least favorable cost-effectiveness ratio ($141,721 per relapse avoided). Sensitivity analyses showed that these results were robust to changes in key input parameters, such as the number of relapses and disease progression steps in untreated patients, the RRR in clinical relapse and progression rates, the rate of persistence, the average cost of relapse, and the average cost of a disease progression step.CONCLUSION: This evaluation suggests that IFN β-1a SC injection, IFN β-1b SC injection, and glatiramer acetate represent the most cost-effective DMDs for the treatment of RRMS, where cost-effectiveness is defined as cost per relapse avoided, assuming that (a) the RRR in relapses and disease progression steps calculated from multiple DMD placebo-controlled clinical trials reflect real differences among DMDs over 2 years; and (b) resource unit costs derived from published sources reflect economic consequences of relapses and disease progression. Although several forms of MS exist, the most common course is known as relapsing-remitting MS (RRMS), which affects about 85% of MS patients. This form of MS is characterized by relapses of neurologic symptoms followed by periods of recovery. Progression of disease can lead to increasingly severe disability. Since the introduction of immunomodulatory biologic agents, such as interferon betas and glatiramer acetate, treatment has helped to change the course of the disease. Under budgetary constraints, health services payers are challenged to differentiate the economic value of these agents for formulary selection and/or placement.

Studies have not previously reported the indirect cost burden of multiple sclerosis (MS) from an employer perspective. To compare annual indirect costs between privately insured US employees with MS and matched employee controls. A retrospective analysis of a privately insured claims database containing disability data from 17 US companies was conducted. Employees with >/=1 MS diagnosis (ICD-9-CM: 340.x) after 1 January 2002, aged 18-64 years, were selected. Employees with MS were matched by age and sex to employee controls without MS. All were required to have continuous health coverage 3 months before MS diagnosis (baseline) and 12 months after (study period). Main outcomes measures included study period annual indirect (disability and medically related absenteeism) costs. For completeness, we also included measures of direct (medical and drug) costs. Chi-squared tests were used to compare baseline co-morbidities and differences in indirect resource use (disability and medically related absenteeism) between employees with MS and controls. Wilcoxon rank-sum tests were used for univariate comparisons of disability and medically related absenteeism days and associated annual indirect and direct costs between employees with MS and controls. Generalized linear models, controlling for differences in baseline characteristics, were used to estimate risk-adjusted annual costs for employees with MS and controls. Employees with MS (n = 989) averaged 44 years of age, and 66% were female. Compared with employee controls, employees with MS had significantly higher rates of mental health disorders, other neurological disorders and physical disorders measured by the Charlson Co-morbidity Index. Employees with MS were more likely to have short-term or long-term disability than employee controls (21.4% vs 5.2%, respectively; p< 0.0001), resulting in a higher mean number of disability days per year (29.8 vs 4.5; p < 0.0001). Employees with MS also had a higher rate of medically related absenteeism and associated absenteeism days than employee controls. On average, annual costs (year 2006 values) for disability were significantly higher for employees with MS ($US3868) than employee controls ($US414; p < 0.0001). Annual medically related absenteeism costs were also higher for employees with MS than for controls ($US1901 vs $US1003, respectively; p < 0.0001). On average, total annual indirect costs for employees with MS were $US5769 compared with $US1417 for controls (p < 0.0001). MS is a chronic and debilitating disease that poses a substantial employer burden in terms of medically related absenteeism and disability costs. Indirect costs of employees with MS were >4 times those of employee controls.

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The EVIDENCE trial concluded that administering high-dose/high-frequency subcutaneous (SC) interferon-beta-1a (IFNb1a) was more effective in preventing relapses among patients with relapsing multiple sclerosis (MS) than low-dose weekly intramuscular (IM) IFNb1a after 64 weeks. This analysis utilized discrete-event simulation (DES) to model the potential longer-term clinical and economic implications of this trial. A DES predicting the course of relapsing MS and incorporating the effect of IFNb1a therapy was developed. The model began by randomly reading in actual patient data from the trial to create 1000 patients. Each simulated patient was replicated - one was assigned to receive SC IFNb1a three times a week and the other to receive IM IFNb1a once a week. During the simulation, patients may (i) experience relapses, with associated short- and long-term impacts on costs and disability; (ii) develop new T2 lesions detected by a magnetic resonance imaging scan; (iii) discontinue treatment because of adverse events or lack of response; (iv) advance to secondary progressive MS; or (v) die. Model inputs were mainly obtained from the EVIDENCE trial, but were taken from published literature if they could not be obtained from the trial. Direct medical costs ($US, year 2006 values) to the US payers were primarily obtained by updating a published cost analysis. Costs and benefits were discounted at 3% per annum. Extensive sensitivity analyses were conducted to test the robustness of the model results. Based on 100 replications of 1000 patient pairs over 4 years, SC IFNb1a was predicted to enable more patients to avoid relapse (216 vs 147). Total mean costs per patient (discounted) were $US79 890 with SC IFNb1a versus $US74 485 with IM administration, a net increase of $US5405 per patient. However, SC IFNb1a was estimated to prevent 0.50 relapses and save 23 relapse-free days per patient, yielding incremental cost-effectiveness ratios of $US10 755 per relapse prevented and $US232 per relapse-free day gained. Sensitivity analyses revealed that the result was most sensitive to the treatment efficacy, model time horizon and cost of IFNb1a treatment. Based on the results observed in the EVIDENCE trial, the model predicted that SC IFNb1a would yield greater health benefits over 4 years than IM IFNb1a, at a cost that would seem to be a reasonable trade-off.

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