Healthcare resource use and costs of multiple sclerosis patients in Germany before and during fampridine treatment

This study shows the differences in MS-related healthcare resource use and costs of patients in Germany initiating and continuing treatment with fampridine for at least 12 months compared to the 12 months prior to treatment initiation.

Patients starting fampridine treatment were, on average, 50 years old, which demonstrates that the disease had already progressed, as the average age for disease onset is 30 [12]. The mean age at the start of fampridine therapy, however, is slightly lower in Germany than in the United States (US), where the mean age is 55 years [13].

Before commencing fampridine treatment, many patients used medications such as muscle relaxants and antidepressants, which is similar to other findings [13]. The percentage of non-DMT users was slightly higher with 46% in this German population compared to 38% of MS patients in the US, as noted by M Jara, MF Sidovar and HR Henney [13] in 2014. Almost every patient had at least 1 outpatient visit, 24% were hospitalized due to MS in the treatment period, and 81% utilized physical therapy in addition to fampridine treatment. This study reveals that the combination of fampridine treatment and physical therapy is common in Germany, supporting the fact that fampridine is used complementary to rather than in place of physical therapy [14, 15] whereas physical therapy was deemed the appropriate comparator in the fampridine German Arzneimittelmarkt-Neuordnungsgesetz AMNOG) (ie, evaluation of new pharmaceuticals in Germany) value dossier. However, as the requested comparison did not include sufficient data, no additional benefit was stated [14]. The significant reductions in corticosteroid use and inpatient stays after initiating fampridine might be due to improvement of mobility problems. Improvement could also be due to the increase in physical therapy. Furthermore, the increasing use of physical therapy might also suggest that patients became more active to deal with mobility issues after experiencing the benefit from fampridine. It is also possible that individuals motivated to initiate and adhere to fampridine treatment might also be subsequently motivated to attend physical therapy sessions. In addition to physical therapy, other outpatient care played an important role in treating MS (approximately 19 visits per year per patient), as GPs were contacted at least twice and neurologists at least once per quarter. M Jara, MF Sidovar and HR Henney [13] reported that 79.1% of the first fampridine prescriptions were prescribed by neurologists in the US, which is higher than the estimated 45% of MS patients visiting a neurologist for their MS in our study.

The total MS-related healthcare costs were significantly higher in the fampridine treatment period compared to the period before fampridine treatment, mainly due to the increased pharmacotherapy costs. Pharmacotherapy accounted for 82% of post-index MS-related costs, followed by the inpatient sector, with 8%. A high percentage of prescription costs relative to overall MS-related costs (65%) was also found by JD Prescott, S Factor, M Pill and GW Levi [16] in 2004. However, in contrast to the increasing pharmacotherapy costs, the MS-related inpatient costs declined during fampridine treatment compared to the pre-treatment period (€1,333 vs €1,565, P < 0.001). This means that while the main cost driver (pharmacotherapy) increased, the second highest cost component (inpatient costs) declined simultaneously.

The different patient subgroup analyses revealed findings that were consistent with the overall analysis. Prescription costs were the highest in all subgroups, followed by inpatient costs, except within the continuous DMT and ≥50-year-old subgroups, where physical therapy costs were higher than the inpatient costs. However, slight differences were observed, for example in the 3 subgroups measuring DMT treatment concerning characteristics such as age, comorbidity burden, and MS-related inpatient stays. The no DMT subgroup mostly had significant changes from pre- to post-fampridine initiation, including MS-related hospitalizations, corticosteroid use, and MS-related sick leave days. It was assumed that these patients were not relapsing-remitting MS patients; therefore, they had limited options for DMT treatment and may benefit the most from fampridine. Another explanation might be that without DMT treatment these patients were more willing to adhere to fampridine treatment and subsequently also physical therapy.

Several limitations of this study should be mentioned. First, there were no comparisons to fampridine discontinuers or non-users, and further research is warranted in these areas as the results cannot be generalized to those patient groups. Second, no information on clinical outcomes, such as Expanded Disability Status Scale scores, is available in claims data, so the severity of the disability could not be evaluated. Third, no adjustments, such as for the use of physical therapy, outpatient visits, or disease progression, were made and therefore the impact of these aspects on the outcomes could not be estimated. Fourth, claims data are not collected for research but instead for accounting purposes and therefore include only sectors that are reimbursed by the statutory health insurance. Therefore, indirect costs such as societal costs of MS-attributable informal care could not be assessed. Additionally, compliance with medication regimens could only be approximated based on prescription fills, as the actual intake is not observable in this data source. Last, the number of outpatient visits could only be approximated and may be underestimated, as flat charges for outpatient visits on a quarterly basis exist in Germany.