scholarly journals The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study (Preprint)

2018 ◽  
Author(s):  
Kristina F Simacek ◽  
John J Ko ◽  
Debbie Moreton ◽  
Stefan Varga ◽  
Kristen Johnson ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Mixed Methods ◽  
Financial Burden ◽  
The United States ◽  
Insurance Companies ◽  
Access Barriers ◽  
Web Based ◽  
Disease Modifying ◽  
The Impact

BACKGROUND In the United States, people with relapsing-remitting multiple sclerosis (RRMS) can face difficulty accessing disease-modifying therapies (DMTs) because of insurance, pharmacy, or provider policies. These barriers have been associated with poor adherence and negative health outcomes. OBJECTIVE The goals of this study were to describe the overall occurrence of difficulties and delays associated with gaining access to DMTs among people with RRMS, to assess DMT adherence during periods of reduced access, and to contextualize the patients’ journey from receipt of a prescription for DMT to obtaining and taking their medication when faced with access barriers. METHODS We recruited US-based adults self-reporting RRMS from a Web-based health data-sharing social network, PatientsLikeMe. Individuals were invited to complete a Web-based survey if they reported a diagnosis of RRMS and were prescribed a DMT for MS. Follow-up phone interviews were conducted with 10 respondents who reported experiencing an MS-related relapse during the time they had experienced challenges accessing DMTs. RESULTS Among 507 survey completers, nearly half were either currently experiencing an issue related to DMT assess or had difficulty accessing a DMT in the past (233/507, 46.0%). The most frequently reported reasons for access difficulty were authorization requirements by insurance companies (past issues: 78/182, 42.9%; current issues: 9/42, 21%) and high out-of-pocket costs (past issues: 54/182, 29.7%; current issues: 13/42, 31%). About half (20/39, 51%) of participants with current access issues and over a third (68/165, 41.2%) of those with past issues went without their medication until they could access their prescribed DMT. Relapses were reported during periods of reduced DMT access for almost half (56/118, 47.5%) of those with past issues and nearly half (22/45, 49%) of those with current issues. Resolving access issues involved multiple stakeholder agents often coordinated in a patient-led effort. Among those who had resolved issues, about half (57/119, 47.9%) reported that doctors or office staff were involved, under half (48/119, 40.3%) were involved themselves, and about a third (39/119, 32.8%) reported the drug manufacturer was involved in resolving the issue. Follow-up interviews revealed that the financial burden associated with obtaining a prescribed DMT led to nonadherence. Additionally, participants felt that DMT treatment delays and stress associated with obtaining the DMT triggered relapses or worsened their MS. CONCLUSIONS This study expands current research by using a patient-centered, mixed-methods approach to describe barriers to MS treatment, the process to resolve barriers, and the perceived impact of treatment barriers on outcomes. Issues related to DMT access occur frequently, with individuals often serving as their own agents when navigating access difficulties to obtain their medication(s). Support for resolution of DMT access is needed to prevent undue stress and nonadherence.

scholarly journals The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study

10.2196/11168 ◽  
2018 ◽  
Vol 20 (10) ◽  
pp. e11168 ◽  
Author(s):  
Kristina F Simacek ◽  
John J Ko ◽  
Debbie Moreton ◽  
Stefan Varga ◽  
Kristen Johnson ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Mixed Methods ◽  
Mixed Methods Study ◽  
Access Barriers ◽  
Disease Modifying Therapy ◽  
Disease Modifying ◽  
The Impact

scholarly journals Health economics of disease-modifying therapy for multiple sclerosis in the United States

2021 ◽  
Vol 14 ◽  
pp. 175628642098703
Author(s):  
Daniel M. Hartung
Keyword(s):  
United States ◽  
Multiple Sclerosis ◽  
Financial Burden ◽  
Economic Value ◽  
The United States ◽  
Insurance Companies ◽  
Disease Modifying Therapy ◽  
Price Increases ◽  
Significant Disability ◽  
Disease Modifying

Multiple sclerosis (MS) is chronic neuroinflammatory condition associated with significant disability. The economic burden of MS is substantial, and high and rising disease-modifying therapy (DMT) prices are the single largest drivers of healthcare expenditures. Over much of the last decade, price increases for most DMTs have surpassed 10% annually. Currently, many MS DMTs exceed US$90,000 a year and their economic value is widely debated. In addition to creating a financial burden for the healthcare system, high DMT costs negatively impact patients through unaffordable out-of-pocket costs and excessive restrictions by insurance companies. The objective of this narrative review is to summarize economic issues related to MS DMTs, including trends in pricing, relative value, and effects on patient care in the United States.

scholarly journals COVID-19 is associated with multiple sclerosis exacerbations that are prevented by disease modifying therapies

2021 ◽  
Author(s):  
Afagh Garjani ◽  
Rodden M Middleton ◽  
Rachael Hunter ◽  
Katherine A Tuite-Dalton ◽  
Alasdair Coles ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Cohort Study ◽  
Expanded Disability Status Scale ◽  
Community Based ◽  
Web Based ◽  
The United Kingdom ◽  
Disease Modifying Therapies ◽  
Disability Status ◽  
Disease Modifying ◽  
The Impact

ABSTRACTBackgroundInfections can trigger exacerbations of multiple sclerosis (MS). The effects of the coronavirus disease 2019 (COVID-19) on MS are not known. The aim of this study was to understand the impact of COVID-19 on new and pre-existing symptoms of MS.MethodsThe COVID-19 and MS study is an ongoing community-based, prospective cohort study conducted as part of the United Kingdom MS Register. People with MS and COVID-19 were invited by email to complete a questionnaire about their MS symptoms during the infection. An MS exacerbation was defined as developing new MS symptoms and/or worsening of pre-existing MS symptoms.ResultsFifty-seven percent (230/404) of participants had an MS exacerbation during their infection; 82 developed new MS symptoms, 207 experienced worsened pre-existing MS symptoms, and 59 reported both. Disease modifying therapies (DMTs) reduced the likelihood of developing new MS symptoms during the infection (OR 0.556, 95%CI 0.316-0.978). Participants with a higher pre-COVID-19 webEDSS (web-based Expanded Disability Status Scale) score (OR 1.251, 95%CI 1.060-1.478) and longer MS duration (OR 1.042, 95%CI 1.009-1.076) were more likely to experience worsening of their pre-existing MS symptoms during the infection.ConclusionCOVID-19 infection was associated with exacerbation of MS. DMTs reduced the chance of developing new MS symptoms during the infection.

scholarly journals Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies

2021 ◽  
Author(s):  
Maria Pia Sormani ◽  
Irene Schiavetti ◽  
Matilde Inglese ◽  
Luca Carmisciano ◽  
Alice Laroni ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Immune Response ◽  
Cumulative Incidence ◽  
Vaccine Dose ◽  
Ministry Of Health ◽  
Disease Modifying Therapies ◽  
Disease Modifying ◽  
Antibody Levels ◽  
The Impact

Background. Patients with Multiple Sclerosis (pwMS) treated with anti-CD20 or fingolimod showed a reduced humoral response to mRNA-based SARS-CoV-2 vaccines, while the degree of such responses is unimpaired and similar in pwMS treated with other disease modifying therapies (DMTs), or untreated. However, the nature of the SARS-CoV-2 vaccine-induced immune response is based also on cellular immunity and there is emerging evidence that anti-SARS-CoV-2 specific CD4 and CD8 T cell responses can be detected after vaccination also in patients with low antibody levels. In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection and to identify correlates of reduced protection in frail vaccinated pwMS on different DMTs. Methods. We designed a long term clinical follow-up of the CovaXiMS (Covid-19 vaccine in Multiple Sclerosis) , a prospective multicenter cohort study enrolling pwMS scheduled for SARS-CoV-2 vaccination with mRNA vaccines and tested for SARS-CoV-2 antibodies before and after the second vaccine dose. These patients were followed with periodic phone calls up to a mean time of 6 months, and all the SARS-CoV-2 breakthrough infections were registered. The impact of DMTs on cumulative incidence of breakthrough Covid-19 cases was presented by Kaplan-Meier curves. A multivariable logistic model was run to assess factors associated to a higher risk of breakthrough infections. Findings. 1705 pwMS (81.6% BNT162b2 and 18.4% mRNA-1273) had a full vaccination cycle (2 vaccine doses, 21/28 days apart). Of them, 1509 (88.5%) had blood assessment 4 weeks after the second vaccine dose. During follow-up, 23 breakthrough Covid-19 infections (cumulative incidence: 1.5%, SE=0.3%) were detected after a mean of 108 days after the second dose (range, 18-230). Of them, 9 were on ocrelizumab, one on rituximab, 4 on fingolimod, 6 on dimethyl-fumarate, one on teriflunomide, and 2 were untreated. Just two cases (a woman on ocrelizumab and a man on teriflunomide) required hospitalization. The probability to be infected was associated only with SARS-CoV-2 antibody levels measured after 4 weeks from the second vaccine dose (HR=0.63, p=0.007); an antibody level of 660 U/mL was calculated as the cut-off for higher risk of infection. Interpretation. Our data show that the risk of breakthrough SARS-CoV-2 infections is mainly associated with reduced levels of the virus-specific humoral immune response. Funding. FISM [2021/Special-Multi/001]; the Italian Ministry of Health grant Progetto Z844A 5x1000. Italian Ministry of Health: Ricerca Corrente to IRCCS Ospedale Policlinico San Martino.

scholarly journals Therapeutic Value of Single Nucleotide Polymorphisms on the Efficacy of New Therapies in Patients with Multiple Sclerosis

2021 ◽  
Vol 11 (5) ◽  
pp. 335
Author(s):  
María José Zarzuelo Romero ◽  
Cristina Pérez Ramírez ◽  
María Isabel Carrasco Campos ◽  
Almudena Sánchez Martín ◽  
Miguel Ángel Calleja Hernández ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Mechanism Of Action ◽  
Dimethyl Fumarate ◽  
Response To Treatment ◽  
Nucleotide Polymorphisms ◽  
New Therapies ◽  
Therapeutic Value ◽  
The Impact

The introduction of new therapies for the treatment of multiple sclerosis (MS) is a very recent phenomenon and little is known of their mechanism of action. Moreover, the response is subject to interindividual variability and may be affected by genetic factors, such as polymorphisms in the genes implicated in the pathologic environment, pharmacodynamics, and metabolism of the disease or in the mechanism of action of the medications, influencing the effectiveness of these therapies. This review evaluates the impact of pharmacogenetics on the response to treatment with new therapies in patients diagnosed with MS. The results suggest that polymorphisms detected in the GSTP1, ITGA4, NQO1, AKT1, and GP6 genes, for treatment with natalizumab, ZMIZ1, for fingolimod and dimethyl fumarate, ADA, for cladribine, and NOX3, for dimethyl fumarate, may be used in the future as predictive markers of treatment response to new therapies in MS patients. However, there are few existing studies and their samples are small, making it difficult to generalize the role of these genes in treatment with new therapies. Studies with larger sample sizes and longer follow-up are therefore needed to confirm the results of these studies.

scholarly journals Use of newer disease-modifying therapies in pediatric multiple sclerosis in the US

Neurology ◽  
2018 ◽  
Vol 91 (19) ◽  
pp. e1778-e1787 ◽  
Author(s):  
Kristen M. Krysko ◽  
Jennifer Graves ◽  
Mary Rensel ◽  
Bianca Weinstock-Guttman ◽  
Gregory Aaen ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Side Effect ◽  
Pediatric Patients ◽  
Dimethyl Fumarate ◽  
Short Term ◽  
Pediatric Multiple Sclerosis ◽  
Disease Modifying Therapies ◽  
The Us ◽  
Disease Modifying

ObjectiveTo characterize the use and safety of newer disease-modifying therapies (DMTs) in children with multiple sclerosis (MS) and clinically isolated syndrome (CIS) treated under 18 years of age.MethodsThis is a cohort study including children with MS or CIS followed at 12 outpatient practices participating in the US Network of Pediatric MS Centers. DMT use, including duration, dose, and side effects, was analyzed. Newer DMTs were defined as agents receiving Food and Drug Administration approval or with increased use in adult MS after 2005.ResultsAs of July 2017, 1,019 pediatric patients with MS (n = 748) or CIS (n = 271) were enrolled (65% female, mean onset 13.0 ± 3.9 years, mean follow-up 3.5 ± 3.1 years, median 1.6 visits per year). Of these, 78% (n = 587) with MS and 11% (n = 31) with CIS received DMT before 18 years of age. This consisted of at least one newer DMT in 42%, including dimethyl fumarate (n = 102), natalizumab (n = 101), rituximab (n = 57), fingolimod (n = 37), daclizumab (n = 5), and teriflunomide (n = 3). Among 17%, the initial DMT prescribed was a newer agent (36 dimethyl fumarate, 30 natalizumab, 22 rituximab, 14 fingolimod, 2 teriflunomide). Over the last 10 years, the use of newer agents has increased, particularly in those ≥12 years and to lesser extent in those <12 years. The short-term side effect profiles of newer DMTs did not differ from those reported in adults.ConclusionNewer DMTs are often used in pediatric MS, and have similar short-term safety, tolerability, and side effect profiles as in adults. These findings may help inform pediatric MS management.

scholarly journals Economic burden of bronchiectasis in Germany

2018 ◽  
Vol 53 (2) ◽  
pp. 1802033 ◽  
Author(s):  
Roland Diel ◽  
James D. Chalmers ◽  
Klaus F. Rabe ◽  
Albert Nienhaus ◽  
Robert Loddenkemper ◽  
...  
Keyword(s):  
Matched Control ◽  
Financial Burden ◽  
Chronic Obstructive Lung Disease ◽  
Insurance Companies ◽  
Chronic Obstructive ◽  
Health Insurance Companies ◽  
Comorbidity Index ◽  
German Statutory Health Insurance ◽  
Direct Expenditure

Estimates of healthcare costs for incident bronchiectasis patients are currently not available for any European country.Out of a sample of 4 859 013 persons covered by German statutory health insurance companies, 231 new bronchiectasis patients were identified in 2012. They were matched with 685 control patients by age, sex and Charlson Comorbidity Index, and followed for 3 years.The total direct expenditure during that period per insured bronchiectasis patient was EUR18 634.57 (95% CI EUR15 891.02–23 871.12), nearly one-third higher (ratio of mean 1.31, 95% CI 1.02–1.68) than for a matched control (p<0.001). Hospitalisation costs contributed to 35% of the total and were >50% higher in the bronchiectasis group (ratio of mean 1.56, 95% CI 1.20–3.01; p<0.001); on average, bronchiectasis patients spent 4.9 (95% CI 2.27–7.43) more days in hospital (p<0.001). Antibiotics expenditures per bronchiectasis outpatient (EUR413.81) were nearly 5 times higher than those for a matched control (ratio of mean 4.85, 95% CI 2.72–8.64). Each bronchiectasis patient had on average 40.5 (95% CI 17.1–43.5) sick-leave days and induced work-loss costs of EUR4230.49 (95% CI EUR2849.58–5611.20). The mortality rate for bronchiectasis and matched non-bronchiectasis patients after 3 years of follow-up was 26.4% and 10.5%, respectively (p<0.001). Mortality in the bronchiectasis group was higher among those who also had chronic obstructive lung disease than in patients with bronchiectasis alone (35.9% and 14.6%, respectively; p<0.001).Although bronchiectasis is considered underdiagnosed, the mortality and associated financial burden in Germany are substantial.

Differences in Career Satisfaction, Work–life Balance, and Stress by Gender in a National Survey of Pharmacy Faculty

2018 ◽  
Vol 33 (4) ◽  
pp. 415-419 ◽  
Author(s):  
Eric J. Ip ◽  
Tristan A. Lindfelt ◽  
Annie L. Tran ◽  
Amanda P. Do ◽  
Mitchell J. Barnett
Keyword(s):  
Career Satisfaction ◽  
Pharmacy Practice ◽  
The United States ◽  
Work Life ◽  
School Level ◽  
Work Life Balance ◽  
Academic Rank ◽  
Life Balance ◽  
Web Based ◽  
The Impact

Introduction The percentage of women pharmacy students and pharmacy faculty has greatly increased over the last 40 years. However, it is not known whether gender differences exist in terms of career satisfaction, work–life balance, and stress in the pharmacy academia workplace. Methods Results from a national web-based survey administered to American Association of Colleges of Pharmacy (AACP) members were utilized. Bivariate analyses were conducted to compare differences among faculty according to gender (men vs women). A series of multivariate models controlling for demographic and other faculty and school-level factors were created to explore the impact of gender on satisfaction with current position, satisfaction with work–life balance, and perceived stress. Results Among the 802 survey respondents, 457 (57.0%) women were more likely to be younger, hold a lower academic rank, and be in a pharmacy practice department, relative to 345 (43.0%) men. In adjusted results, men pharmacy faculty were more likely to report being extremely satisfied with their current job, more likely to report being extremely satisfied with their work–life balance, and score lower on a standardized stress measure relative to women. Conclusion While primarily descriptive, the results suggest women pharmacy faculty in the United States are less satisfied with their current academic position, less satisfied with their current work–life balance, and have higher stress levels compared to men even after controlling for age, academic rank, and department (along with other factors). Further research is needed to explore and address causes of the observed gender-related differences among pharmacy faculty.

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