CLINICAL AND ECONOMIC IMPACT OF A SPECIALTY CARE MANAGEMENT PROGRAM AMONG PATIENTS WITH MULTIPLE SCLEROSIS: A COHORT STUDY

BACKGROUND - THE STUDY QUESTION?

Background

Multiple sclerosis (MS) is not curable, and most patients require continuing disease-modifying therapy for many years. First-line options such as interferon ß and glatiramer acetate reduce the relapse rate, but require frequent self-injections. Long-term treatment adherence is often poor. Care management programs have been shown to improve treatment adherence in a variety of other chronic disease states, but have not been extensively examined in patients with MS.

Why this study?

This study examined the clinical and economic impact of a specialty care management program for patients with MS. The intervention includes mailing MS medications and disease-specific patient information, regular assessment calls by nursing staff, and medication refill reminder calls.

GENERAL STUDY OVERVIEW

Title/citation

Tan H, Yu J, Tabby D, et al. Clinical and economic impact of a specialty care management program among patients with multiple sclerosis: a cohort study. Mult Scler. 2010;16:956-963.

Funding

WellPoint Inc., Indianapolis, Indiana, USA

Trial design

Retrospective administrative claims data for a cohort of patients with MS who were prescribed MS medications. The dataset included integrated medical and pharmacy claims data from 13 geographically dispersed US health plans. Participants were evaluated for 12 months after entry into the program; nonparticipants were evaluated for 12 months using randomly generated start dates. Nonparticipants included patients who chose to obtain their medications from other sources, who lived in geographic areas that were not included in the intervention, or who were enrolled in other care management programs.

Enrollment

3993 patients with MS were identified; 3125 (78.3%) participated in the program and 868 (21.7%) did not.

METHODS

Inclusion criteria

  • >18 years of age
  • At least 2 medical claims with International Classification of Diseases codes for MS
  • At least 1 MS medication, including interferon ß-1a (both intramuscular and subcutaneous), interferon ß-1b, glatiramer acetate (GA), mitoxantrone, or natalizumab.

Exclusion criteria

Not specified

Randomization

None

End points

  • Medication adherence, assessed using the medication possession ratio (MPR)
  • Medication persistence; discontinuation was defined as the failure to obtain MS medication within 60 days of the depletion of the previous supply
  • MS-related hospitalization during 12 months before and 12 months after index date
  • MS-related costs during 12 months before and 12 months after index date

 

Statistical Analyses

  • Statistical differences were compared between the participant and nonparticipant groups.
  • Continuous variables were assessed using the Wilcoxon rank-sum test.
  • Categorical variables were assessed using the Chi-square test.
  • Multivariate analyses were used to adjust for demographic and clinical characteristics, including age, sex, type of health plan, comorbid conditions, length of treatment history, baseline healthcare utilization, and other factors.

RESULTS

Baseline characteristics

  • The average age was approximately 46 years; 75% were female.
  • Baseline medications included interferon ß-1a intramuscular (37.3%), glatiramer acetate (31.4%), interferon ß-1a subcutaneous (16.6%), interferon ß-1b (13.5%), natalizumab (0.8%), and mitoxantrone (0.5%).
  • Participants and nonparticipants were similar in terms of demographic characteristics and baseline commodities
  • Participants were less likely to be covered by health maintenance organization (26.8% vs 16.9%), and had a longer treatment history since beginning MS treatment (16.8 years vs 14.6 years; P <.001).

End points

  • Over 12 months, the mean MPR was better for the participant group (0.86) than the nonparticipant group (0.64; P <.001). In addition, the MPR improved from baseline among participants (mean improvement, 0.08) and decreased among nonparticipants (mean decrease, 0.03; P <.001).
  • Persistence was also better for patients in the intervention group. The mean time from initiation to discontinuation of therapy was 306.1 days for the intervention group and 246.9 days for the nonintervention group (P <.001). Persistence increased by a mean of 29.2 days during the study in the intervention group and decreased by a mean of 9.2 days in the nonparticipants (P <.001). After controlling for baseline factors, persistence was greater by an average of 50.6 days in the intervention group.
  • The incidence of MS-related hospitalizations decreased from 9.6% during 12 months before the program to 7.1% during the program for the participants. Hospitalization increased from 10.1% to 12% in nonparticipants. The hospitalization rate at 12 months was significantly lower for the participants (7.1% vs 12%; P <.001).
  • MS-related expenditures, excluding pharmacy costs, decreased by a mean of $264 among participants but increased by $1536 among nonparticipants (P <.001).
  • Pharmacy costs increased by an average of $4735 in the participant group versus $2551 in the nonparticipant group (P <.001).
  • Total costs increased by a mean of $4471 per patient among participants and by $4087 per patient among nonparticipants (P <.001; Figure).





MANAGED CARE IMPLICATIONS/DISCUSSION
  • In this study, an MS specialty care management program significantly improved several aspects of MS care in a large, commercially insured patient population.
  • Patients who participated in the intervention exhibited significantly better medication adherence and persistence over 12 months than nonparticipants.
  • Compared with the 12 months before the program, the intervention also reduced the incidence of MS-related hospitalization. This outcome may reflect the prevention of severe MS exacerbations
  • MS-related treatment costs, excluding pharmacy costs, were lower for participants in the intervention program.
  • Lower healthcare costs were offset by higher pharmacy costs for patients who participated in the intervention, which resulted from improved treatment adherence and persistence. Overall treatment costs were higher for the participants than the nonparticipants by an average of $384 per patient after 12 months.
  • The investigators noted that the program should still be considered beneficial even if it did not reduce total treatment costs during the 1-year study period, as it may result in better long-term health outcomes for the participants.
  • The authors noted that disease management programs often take many years to produce beneficial effects among participants. In this study, improvements were noted after only 1 year, which is especially encouraging considering the long-term, chronic nature of MS.
  • This study did not randomize patients to intervention or control groups, but compared those who participated with those who declined to participate. The study also did not examine patient-reported outcomes or patient preferences for or attitudes about the intervention, nor did it evaluate health-related quality of life.
  • The investigators also did not evaluate the degree of patient participation during the study. Some patients may have participated only partially or intermittently. This would tend to decrease the effectiveness of the intervention, but was not specifically evaluated.
  • Finally, although the demographic and disease characteristics of participants and nonparticipants were similar, it is possible that the 2 groups differed in ways that were not measured.
  • Once the decision to authorize treatment with an MS therapy is made, attention should be paid to the most proven methods to assure medication adherence.

 

 

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