Aims: To better understand the impact of the clinical course of multiple sclerosis (MS) and disability on employment, absenteeism, and related factors.Materials and methods: This study included respondents to the North American Research Committee on Multiple Sclerosis Registry spring 2015 update survey who were US or Canadian residents, aged 18–65 years and reported having relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), or primary progressive MS (PPMS). The RRMS and SPMS participants were combined to form the relapsing-onset MS (RMS) group and compared with the PPMS group regarding employment status, absenteeism, and disability. Multivariable logistic regression was used to examine the relationship between employment-related outcomes and factors that may affect these relationships.Results: Of the 8004 survey respondents, 5887 (73.6%) were 18–65 years of age. The PPMS group (n = 344) had a higher proportion of males and older mean age at the time of the survey and at time of diagnosis than the RMS group (n = 4829). Female sex, age, age at diagnosis, cognitive and hand function impairment, fatigue, higher disability levels, ≥3 comorbidities, and a diagnosis of PPMS were associated with not working. After adjustment for disability, the employed PPMS sub-group reported similar levels of absenteeism to the employed RMS sub-group.Limitations: Limitations of the study include self-report of information and the possibility that participants may not fully represent the working-age MS population.Conclusions: In MS, employment status and absenteeism are negatively affected by disability, cognitive impairment, and fatigue. These findings underscore the need for therapies that prevent disability progression and other symptoms that negatively affect productivity in persons with MS to enable them to persist in the workforce.
The aim of this study was to describe the treatment journey of patients with multiple sclerosis (MS).This study was conducted in 2 phases. The first consisted of a claims-based analysis of data from patients diagnosed with MS between October 1, 2010, and May 31, 2014. Study patients were aged ≥18 years, had ≥12 months of continuous eligibility before and after the earliest MS diagnosis (index date), ≥1 disease-modifying therapy (DMT) claim postindex, and no claims with a code for DMT or MS during the 12-month preindex period. The second phase consisted of medical record reviews in a subset of patients in the claims study who had ≥1 neurologist visit within 90 days of the index MS diagnosis.A total of 1639 patients were selected for claims-based analysis, and medical record analysis was conducted in a subset of 327 of those patients. The mean age in both samples was 42 years; females constituted about 70% of each group. Medical records showed that within a year of the first neurologist visit, 97.6% patients had a confirmed MS diagnosis; however, in 58.0%, MS type was not specified. MS symptoms were documented in less than half of all patients at the index neurologist visit. Early management consisted of magnetic resonance imaging (98.5% of patients), and the management of flares (annualized relapse rate, 0.3 [0.6] per patient). Use of spinal tap (21.7%), Expanded Disability Status Scale score (4.6%), and timed 25-foot walk score (8.6%) to evaluate disease progression was infrequent. The percentages of patients discontinuing the first DMT over time were high (43.1% among patients with 12-24 months of postindex follow-up, to 65.7% among patients with >36 months of postindex follow-up). Neurologists noted that about 10% of patients had difficulty adhering to an MS medication regimen, and documented several reasons for discontinuation, including adverse drug events and lack of desired effectiveness.In clinical practice, early MS treatment in DMT users is focused on symptom management, irrespective of MS type. Patients may benefit from initiating optimal treatment earlier. First-line therapy was often a transient option.
Medical professionals are often challenged by lack of patient compliance with pharmaceutical treatments. Research has shown that patients with diabetes have one of the lowest medication adherence rates at 65% to 85%. Some causes have been identified in the literature, but the influence of type of medication is unknown. This study assessed the impact of a broad range of factors on medication adherence and persistence among adult patients with type 2 diabetes mellitus.Patients were selected from the Truven Health MarketScan Research Databases of healthcare administrative claims (2009 through 2012), assigned to mutually exclusive cohorts based on initiation of saxagliptin (a dipeptidyl peptidase-4 [DPP-4] inhibitor), or a glucagon-like peptide 1 (GLP-1) receptor agonist (daily or twice daily formulation), sulfonylurea (SU), or thiazolidinedione (TZD), and screened for continuous enrollment 1 year before and after drug initiation. Adherence and persistence were measured using proportion of days covered and time to discontinuation, respectively. Multivariate models were used to examine the impact of study drug and demographic and clinical factors.Overall, 45.1% of patients were adherent with their study drug over the 1 year follow-up period. Adherence was higher among patients who were male, older, or residing in non-Southern states. Adherence was better with mail-order use and lower levels of cost sharing. Patients taking a GLP-1 (OR = 0.40, 95% CI = 0.37, 0.42), SU (OR = 0.49, 95% CI = 0.46, 0.52), or TZD (OR = 0.54, 95% CI = 0.51, 0.57) were less likely to be adherent compared with those taking saxagliptin. Results were mixed regarding the impact of comorbidities and polypharmacy on medication adherence. Influencing factors may be the type of comorbidity, overall health level, number of drugs, and complexity of the drug regimen.Adherence was measured using data for prescriptions dispensed and it is not known whether patients actually took the medications, hence adherence may be overestimated. Whether patients who discontinued the study drugs switched to other diabetes medications or discontinued treatment completely was not measured.Identified risk factors can guide medical professionals in their attempts to increase the likelihood of patient adherence to drug treatment regimens.
Disease-modifying therapy (DMT) for multiple sclerosis (MS) can reduce relapses and delay progression; however, poor adherence and persistence with DMT can result in sub-optimal outcomes. The associations between DMT adherence and persistence and inpatient admissions and emergency room (ER) visits were investigated.Patients with MS who initiated a DMT in a US administrative claims database were followed for 1 year. Persistence to initiated DMT was measured as the time from DMT initiation to discontinuation (a gap of >60 days without drug 'on hand') or end of 1-year follow-up. Adherence to initiated DMT was measured during the persistent period and was operationalized as the medication possession ratio (MPR). Patients with an MPR <0.80 were considered non-adherent. Claims during the 1-year follow-up period were evaluated for the presence of an all-cause inpatient admission or an ER visit. Adjusted odds ratios (AORs) for inpatient admission or ER visit comparing persistent vs non-persistent and adherent vs non-adherent patients were estimated using logistic regression models adjusted for patient characteristics.The final sample included 16,218 patients. During the 1-year follow-up period, 35.3% of patients discontinued their initiated DMT and 13.9% were not adherent while on therapy. During that same period, 10.0% of patients had an inpatient admission and 24.9% had an ER visit. The likelihoods of inpatient admission and ER visit were significantly decreased in persistent patients (AOR [95% CI] = 0.50 [0.45, 0.56] and 0.65 [0.60, 0.69], respectively) and in adherent patients (AOR [95% CI] = 0.83 [0.71, 0.97] and 0.86 [0.77, 0.95], respectively).Persistence and adherence with initiated DMT are associated with decreased likelihoods of inpatient admission or ER visit, which may translate to improved clinical outcomes.
The growing number of treatments for relapsing multiple sclerosis (MS) provides opportunities to consider patient preferences in treatment decisions.We designed a Web-based, discrete-choice experiment survey to analyze treatment preferences in patients with relapsing-remitting MS (RRMS). The survey presented hypothetical MS treatments defined by six attributes: risk of MS progression, time between relapses, risk of serious infection, treatment-related flu-like symptoms and gastrointestinal symptoms, and route and frequency of administration. Preference weights estimated with random-parameters logit were used to calculate importance scores and preference shares among three pairs of subsamples.Patients with a self-reported physician diagnosis of RRMS (N = 301) completed the survey: 56% rated their disability level as normal or mild; 43% currently used a self-injectable treatment. Respondents with normal or mild disability levels placed greater weight on avoiding injections with flu-like symptoms and risk of progression, whereas patients with worse disability placed greater weight on reducing risk of progression and risk of serious infection. Patients taking injectables placed the most weight on risk of progression and risk of serious infection, whereas respondents not taking injectables placed the most weight on route and frequency of administration. Differences in preferences between subgroups were significant (P < .05). The presence of common adverse events associated with daily pills and injectables altered predicted preferences for route of administration.Preferences of patients with RRMS varied depending on current treatment and disability level, especially regarding mode of administration. Considering patient preferences for treatment features may lead to higher treatment satisfaction and adherence.
Disease-modifying therapies (DMTs) impact the natural history of relapsing forms of multiple sclerosis (RRMS) by reducing annual relapse rates and slowing disability progression. The effect of DMTs on indirect costs has not been consistently explored in cost-effectiveness studies thus far. The value to patients of an emerging DMT, ocrelizumab, was quantified in comparison to subcutaneous interferon beta-1a (IFNβSC) for the prevalent RRMS population with mild-to-moderate disability in the US, based on two Phase 3 trials, OPERA I and OPERA II, of ocrelizumab vs IFNβSC in RRMS.A Markov model was developed to compare disability progression as measured by Expanded Disability Status Scale (EDSS) and relapse outcomes over a 30-year horizon for ocrelizumab vs IFNβSC. Direct, indirect, and informal costs (2016 US dollars) and utilities for EDSS health states were obtained from the literature. Hazard ratios for disability progression and relapse rates were estimated from clinical trials. Value was assessed by calculating the net monetary benefit (NMB), defined as the monetary value of discounted quality-adjusted life years (QALYs) minus total costs, where the value of a QALY was $150,000. One-way sensitivity analyses were conducted.Ocrelizumab was associated with an incremental gain of 0.84 QALYs and cost savings of $287,713 relative to IFNβSC, resulting in an incremental NMB (INMB) of $413,611 per person over 30 years. The INMB increased by $151,763 for those initiating ocrelizumab at EDSS level 1 vs level 4. Influential parameters were QALY value, treatment costs, and disability progression; however, all sensitivity analyses indicated that the INMB for ocrelizumab relative to IFNβSC was ≥$300,000 per person.Ocrelizumab provides greater value to RRMS patients compared with IFNβSC. Initiating ocrelizumab at lower EDSS levels leads to a greater cumulative value due to slower disability progression, which extends years with higher quality-of-life.
Objective: To estimate and compare treatment preferences among patients with relapsing-remitting multiple sclerosis (RRMS). Background: There is a need to understand the trade-offs patients make in treatment decision-making as more therapies become available for the treatment of RRMS. Methods: US patients who reported receiving a physician diagnosis of RRMS completed a web-based, discrete choice experiment survey that presented 10 choices between pairs of hypothetical MS treatments. The treatment attributes were informed by the literature and clinician input and tested in patient interviews. Attributes included: chance of MS progression; years between relapses; risk of serious infection; route of delivery and frequency of administration; and chance of flu-like and gastrointestinal symptoms. The treatment profiles in the questions were created using an experimental design. Results: A total of 301 patients completed the survey: 81[percnt] were female; mean age was 54 years; 56[percnt] rated their disability level as "normal" or "mild"; 79[percnt] reported receiving treatment; and 42[percnt] used an injectable MS treatment. Overall, respondents with normal or mild disability had significantly different preferences than respondents with moderate or worse disability (p<0.05). Patients with worse disability placed the greatest weight on reducing the chance of MS progression and risk of serious infection. Patients with normal or mild disability placed the greatest weight on avoiding injections with flu-like symptoms, followed by the chance of progression. Overall, patients receiving an injectable treatment had significantly different preferences than those who did not (p<0.05). Injectable users placed the most weight on the chance of progression and risk of serious infection and preferred intravenous therapy administered twice a year versus every month. Conclusions: The preferences of RRMS patients varied depending on their current treatment and disability level. Considering patient preferences for efficacy, side effects and dosing may lead to higher treatment satisfaction and adherence. Supported by Genentech, Inc.
Aim: To conduct a cost-effectiveness analysis to compare ocrelizumab vs subcutaneous (SC) interferon beta-1a for the treatment of relapsing multiple sclerosis (RMS).Methods: A Markov cohort model with a 20-year horizon was developed to compare ocrelizumab with SC interferon beta-1a from a US payer perspective. A cohort of patients with relapsing-remitting MS (RRMS) and Expanded Disability Status Scale (EDSS) scores of 0–6, who initiated treatment with ocrelizumab or SC interferon beta-1a, were entered into the model. The model considered 21 health states: EDSS 0–9 in RRMS, EDSS 0–9 in secondary-progressive multiple sclerosis (SPMS), and death. Patients with RRMS could transition across EDSS scores, progress to SPMS, experience relapses, or die. Transition probabilities within RRMS while patients received ocrelizumab or SC interferon beta-1a were based on data from the two SC interferon beta-1a-controlled Phase III OPERA I and OPERA II trials of ocrelizumab in RMS. Transitions within RRMS when off-treatment, RRMS-to-SPMS transitions, transitions within SPMS, and transitions to death were based on the literature. Utilities of health states, disutilities of relapses, costs of therapies, and medical costs associated with health states, relapse, and adverse events were from the literature and publicly available data sources. The model estimated per-patient total costs, incremental cost per life year (LY) gained, and incremental cost per quality-adjusted LY (QALY) gained. Deterministic sensitivity analyses (DSA) and probabilistic sensitivity analysis (PSA) were conducted to evaluate the robustness of the model results.Results: Ocrelizumab was associated with a cost savings of $63,822 and longer LYs (Δ = 0.046) and QALYs (Δ = 0.556) over a 20-year time horizon. The results of the model were robust in the DSA and PSA.Limitations: The model did not consider subsequent treatments and their impact on disease progression.Conclusions: The results suggest that ocrelizumab is more cost-effective than SC interferon beta-1a for the treatment of RMS.
Treatment decisions in multiple sclerosis (MS) are affected by many factors and are made by the patient, doctor, or both. With new disease-modifying therapies (DMTs) emerging, the complexity surrounding treatment decisions is increasing, further emphasizing the importance of understanding decision-making preferences.North American Research Committee on Multiple Sclerosis (NARCOMS) Registry participants completed the Fall 2014 Update survey, which included the Control Preferences Scale (CPS). The CPS consists of five images showing different patient/doctor roles in treatment decision making. The images were collapsed to three categories: patient-centered, shared, and physician-centered decision-making preferences. Associations between decision-making preferences and demographic and clinical factors were evaluated using multivariable logistic regression.Of 7009 participants, 79.3% were women and 93.5% were white (mean [SD] age, 57.6 [10.3] years); 56.7% reported a history of relapses. Patient-centered decision making was most commonly preferred by participants (47.9%), followed by shared decision making (SDM; 42.8%). SDM preference was higher for women and those taking DMTs and increased with age and disease duration (all P < .05). Patient-centered decisions were most common for respondents not taking a DMT at the time of the survey and were preferred by those who had no DMT history compared with those who had previously taken a DMT (P < .0001). There was no difference in SDM preference by current MS disease course after adjusting for other disease-related factors.Responders reported most commonly considering their doctor's opinion before making a treatment decision and making decisions jointly with their doctor. DMT use, gender, and age were associated with decision-making preference.
