A cost-utility analysis of mitoxantrone hydrochloride and interferon beta-1b in the treatment of patients with secondary progressive or progressive relapsing multiple sclerosis.

BACKGROUND: Information on the cost utility of interferon beta-1b and mitoxantrone hydrochloride, 2 disease-modifying agents approved by the US Food and Drug Administration for the treatment of secondary progressive (SP) multiple sclerosis (MS), is limited. OBJECTIVE: The aim of this study was to compare the cost utility of i.v. mitoxantrone hydrochloride administered every 3 months, s.c. interferon beta-1b administered every other day, and routine supportive care from the perspectives of both the insurer and society. METHODS: We used a Markov model with health states based on the Kurtzke Expanded Disability Status Scale (EDSS) scores from both an insurer's and a societal perspective (including direct and total costs, respectively). Theoretical patients entered the model with an EDSS score of 3; their progression was followed for 10 years. Transition probabilities were derived from clinical trial data. Cost and utility inputs were taken from the literature. Sensitivity analyses were conducted on all variables. RESULTS: From the insurer's perspective, the incremental cost-utility ratio of mitoxantrone hydrochloride therapy compared with routine supportive care was 58,272 dollars per quality-adjusted life year (QALY) gained. From a societal perspective, mitoxantrone hydrochloride was more effective and less costly than supportive care. From the perspectives of insurers and society, the cost-utility ratios of interferon beta-1b compared with routine supportive care were 338,738 dollars and 245,700 dollars per QALY gained, respectively. When compared with mitoxantrone hydrochloride, interferon beta-1b had an incremental cost-utility ratio of 741,331 dollars and 658,402 dollars per QALY from the insurer's and society's perspectives, respectively. Cost-utility ratios for mitoxantrone hydrochloride were sensitive to acquisition and administration costs of therapy and to effectiveness at slowing disease progression. Cost-utility ratios for interferon beta-1b were not sensitive to any of the variables included in the model. CONCLUSIONS: Mitoxantrone hydrochloride is likely to be a cost-effective treatment for patients with SPMS or progressive relapsing MS from an insurer' perspective and is cost saving from a societal perspective. Interferon beta-1b is not likely an efficient treatment using conventional comparisons for cost-effectiveness. This analysis has potentially important implications for policy implementation; however, decisions about which agent to use for each patient should consider the treatment's adverse-event profile, the method of administration, and the patient's preferences for these factors.

Moderating effects of coping on the relationship between stress and the development of new brain lesions in multiple sclerosis.

OBJECTIVE: Many patients with multiple sclerosis (MS) report that stress can trigger disease exacerbations. Considerable research has supported a relationship between stress and both clinical exacerbation and the development of new brain lesions. However, these relationships are not always consistent either within patients or across patients, suggesting the presence of moderators. This study examined the hypothesis that coping moderates the subsequent relationship between stress and the development of new brain lesions in MS. METHODS: Thirty-six patients (mean age = 44.4; 22 women, 14 men) with relapsing forms of MS were assessed once every 4 weeks for 28-100 weeks. New brain lesions were identified using monthly Gd+ MRI. Stress was measured within 24 hours before MRI using a modified version of the Social Readjustment Rating Scale that assessed Conflict and Disruption in Routine. Coping was measured at baseline using the Coping with Health Injuries and Problems questionnaire, which produces four scales: distraction, instrumental, palliative, and emotional preoccupation. Data were analyzed using mixed effects logistic regression to account for within-subject correlations. Analyses were lagged such that stress assessments predicted new Gd+ MRI brain lesions 8 weeks later. RESULTS: As reported previously, stress was significantly related to the development of new Gd+ brain lesions 8 weeks later (OR = 1.62, p =.009). Greater use of distraction was found to be a significant moderator of the relationship between stress and new Gd+ lesions (OR = 0.69, p =.037) such that greater use of distraction was associated with a decreased relationship between stress and new Gd+ lesions. Increased instrumental coping was marginally associated with a decreased relationship between stress and new Gd+ lesions (OR = 0.77, p =.081), while increased emotional preoccupation was marginally associated with an increased relationship between stress and new Gd+ lesions (OR = 1.46, p =.088). There was no significant moderating effect for palliative coping (p =.27) and no significant main effects for any coping variables and the subsequent development of new Gd+ brain lesions (p values >.21). CONCLUSIONS: These findings provide modest support for the hypothesis that coping can moderate the relationship between stress and the MS disease activity. Several limitations in this study are discussed. While these findings suggest areas of potentially fruitful research, readers are cautioned that these are preliminary results; inferences regarding the clinical importance of these findings are premature.

Mitoxantrone as a potential therapy for primary progressive multiple sclerosis.

Mitoxantrone (Novantrone) was the first drug approved in western Europe and North America for treatment of secondary progressive multiple sclerosis (SPMS) and progressive relapsing MS (PRMS). Pharmacological properties of mitoxantrone, its role in SPMS, the study rational and design of an ongoing multi-centre, double blind, randomized, placebo-controlled phase 2 trial will be outlined in this article.