Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study

Abstract

BackgroundAdherence to disease-modifying therapies (DMTs) results in the reduction of the number and severity of relapses and delays the progression of multiple sclerosis (MS). Patients with lower adherence rates experience more inpatient visits and higher MS-related medical costs. Fingolimod, the first oral DMT approved by the US Food and Drug Administration, may improve the access and compliance to MS treatment when compared to injectable DMTs.MethodsThis retrospective cohort study used pharmacy claims from Medco Health Solutions, Inc., of patients who initiated DMTs between October 2010 and February 2011. Initiation was defined as no prescription fills for the same DMT in the prior 12 months. Patients without a DMT prescription fill 12 months before the index date were considered naïve users. Compliance was measured via proportion of days covered (PDC) and medication possession ratio (MPR) for 12 months post-index. Discontinuation was defined as a ≥60-day gap of index DMT supply. Cox proportional hazard models compared time to discontinuation between cohorts.ResultsOf 1,891 MS patients (mean age: 45.7; female: 76.4%), 13.1% initiated fingolimod, 10.7% interferon beta-1b, 20.0% intramuscular interferon beta-1a, 18.8% subcutaneous interferon beta-1a, and 37.4% glatiramer acetate. Patients initiating fingolimod had highest average PDC and MPR in both experienced (fingolimod: mean PDC=0.83, 73.7% with PDC≥0.8; mean MPR=0.92, 90.5% with MPR≥0.8) and naïve DMT users (fingolimod: mean PDC=0.80, 66.7% with PDC≥0.8; mean MPR=0.90, 87.4% with MPR≥0.8). The proportion of patients discontinuing index DMT within 12 months was significantly lower for the fingolimod cohort (naïve: 31.3%; experienced: 25.7%). Adjusted results found that patients receiving self-injected DMTs discontinued significantly sooner than fingolimod users. This association was generally stronger in experienced DMT users.ConclusionsFingolimod initiators were more compliant, less likely to discontinue treatment, and discontinued later than patients who initiated self-injected DMT.

Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis

“…Tan et al 19 found that patients who were adherent (measured as an MPR of 0.80) had significantly lower odds of relapse than non-adherent patients (odds ratio ¼ 0.71; 95% CI ¼ 0.59-0.85). These findings suggest that treatment with highly effective and tolerable DMTs that 33 , has compared discontinuation and adherence rates for fingolimod with those for the firstline injectable DMTs. However, that study did not include patients treated with natalizumab.…”

“…A recent claims database analysis demonstrated that patients with MS initiating fingolimod therapy had higher rates of persistence (discussed above) and adherence than patients using GA and IFNs (MPR 80% in treatment-naïve patients; fingolimod, 87.4%; GA, 81.5%; IFNs, 72.8-80.2%; all p50.05) 33 . However, that study did not include patients treated with natalizumab.…”

“…The most common reasons given for IFN discontinuation were side-effects and lack of effectiveness 32 . A US claims database analysis reported discontinuation rates of 43.8% for GA and 44.8-53.9% for IFNs for treatment-naïve patients within 12 months of treatment initiation 33 . A recent retrospective claims database analysis of nearly 7000 patients with MS in the US reported that only 55% and 52-62% of patients were adherent (measured as a medication possession ratio [MPR] 80%) to GA and IFNs, respectively, over 12-36 months 27 .…”

Adesão ao tratamento para esclerose múltipla com terapias de primeira linha: análise longitudinal retrospectiva

“…8,[11][12][13][14]16 A média ponderada do desfecho MPR>0,80 dos três estudos identificados que envolveram ao todo 43.372 pacientes foi de 48,99% para Avonex®, 40,72% para Betaferon® e 43,06% para Rebif®. (11,12,14) Já a média ponderada do MPR em cinco estudos envolvendo cerca de 45 mil pacientes foi de 67,08%, 58,31% e 64,61% para Avonex®, Betaferon® e Rebif®, respectivamente.…”

“…7 Tal decisão foi baseada no Relatório de Recomendação nº 261, de maio de 2016, da Comissão Nacional [8][9][10][11][12][13][14][15][16][17][18][19] Ao identificar a dicotomia dos dois conjuntos de evidências descritos acima (i.e., monitoramento da incorporação versus literatura científica), avaliamos as principais discrepâncias entre os referidos grupos de informações e apontamos as seguintes falhas metodológicas no estudo de monitoramento da incorporação das betainterferonas no SUS, sendo:…”