Handling related publications reporting real-world evidence in network meta-analysis: a case study in multiple sclerosis.

Aim: The presence of two or more publications that report on overlapping patient cohorts poses a challenge for quantitatively synthesizing real-world evidence (RWE) studies. Thus, we evaluated eight approaches for handling such related publications in network meta-analyses (NMA) of RWE studies. Methods: Bayesian NMAs were conducted to estimate the annualized relapse rate (ARR) of disease-modifying therapies in multiple sclerosis. The NMA explored the impact of hierarchically selecting one pivotal study from related publications versus including all of them while adjusting for correlations. Results: When selecting one pivotal study from related publications, the ARR ratios were mostly similar regardless of the pivotal study selected. When including all related publications, there were shifts in the point estimates and the statistical significance. Conclusion: An a priori hierarchy should guide the selection among related publications in NMAs of RWE. Sensitivity analyses modifying the hierarchy should be considered for networks with few or small studies.

The Patient and Clinician Assessment of Gastrointestinal (GI) Related Adverse Events Associated with Oral Disease-Modifying Therapies in Multiple Sclerosis: A Qualitative Study.

INTRODUCTION: Current guidelines for relapsing-remitting multiple sclerosis (RRMS) call for treatment with disease-modifying therapies (DMTs) early in the disease to prevent relapses and accumulation of neurologic impairment and disability. However, patients taking certain oral DMTs may experience gastrointestinal (GI)-related adverse events (AEs), particularly at dose titration. We conducted qualitative research with healthcare professionals (HCPs) and patients in Canada to contextualize their experiences with three oral DMTs: dimethyl fumarate (Tecfidera®), fingolimod (Gilenya®), and teriflunomide (Aubagio®). The objectives of this study were to (1) gather qualitative data to better understand the patient and HCP experience of GI AEs in oral MS DMT treatment in Canada and (2) determine to what extent two patient-reported outcome (PRO) instruments used in recent oral DMT trials capture what is important to patients regarding GI AEs in oral MS DMT treatment (content validity) and to provide qualitative data to help interpret PRO scores. METHODS: This was a qualitative, non-interventional, descriptive, cross-sectional study comprising HCP and patient interviews conducted in English and French, using a 1:1 semi-structured interview approach. RESULTS: Patients reported 16 unique GI AE concepts related to oral DMTs. The most commonly reported symptoms were diarrhea, indigestion, and nausea. While patients acknowledged the negative impact associated with GI-related AEs, most characterized the treatment experience as positive, focusing on preference for oral administration, perceived efficacy of DMTs in terms of lack of MS relapses, slowed progression of their disease, and improvement in MS symptoms. Results supported the content validity (relevance, comprehension, and comprehensiveness) of the two PROs assessed. HCP feedback reinforced patient perspectives on both GI concepts and the two PRO instruments. CONCLUSION: Outcomes of these research activities include experiential data on the symptom and impact experience of oral DMTs in MS from both patients and HCPs that contribute to the process of determining therapeutic value.

Healthcare costs for allergic rhinitis patients on allergy immunotherapy: a retrospective observational study.

OBJECTIVE: Subcutaneous immunotherapy (SCIT) for allergic rhinitis (AR) has been shown to control symptoms for up to several years following treatment discontinuation, but the effect of SCIT on healthcare costs for commercially insured patients is unknown. The objective of this study was to compare healthcare costs and resource utilization for patients with AR who received SCIT compared with those who discontinued SCIT shortly after initiation. METHODS: This retrospective cohort study evaluated medical and pharmacy claims from the Optum Research Database from January 2009 through February 2014 for adults and pediatric patients with >7 (continuers) vs. ≤7 (discontinuers) injection visits for SCIT within 60 days of initiation. RESULTS: After 1:1 propensity score matching, each cohort included 6710 patients. Continuers were less likely than discontinuers to use oral corticosteroids (27.7% vs. 29.6%, p = .018), or to have ≥1 respiratory-related emergency room visit (5.4% vs. 6.5%, p = .008) and ≥1 inpatient stay (1.1% vs. 1.7%; p = .002). Continuers were more likely than discontinuers to have ≥1 AR-related office (98.8% vs. 94.6%, p < .001) or outpatient visit (2.4% vs. 1.7%, p = .002). Continuers had greater mean total AR-related costs than discontinuers ($1918 vs. $646, p < .001). Unadjusted mean total respiratory-related costs were lower for continuers than discontinuers, although the difference was not statistically significant ($1589 vs. $1785, p = .077); when adjusted with a generalized linear model, these costs were significantly lower among continuers (p < .001). CONCLUSIONS: Continued SCIT use is associated with decreased emergency room visits and inpatient stays, decreased oral corticosteroid use, and lower respiratory-related costs, compared with early discontinuation.

Health care resource use and associated costs among patients with seasonal versus perennial allergic rhinitis.

BACKGROUND: Health care resource use (HRU) and costs among patients with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) have not been widely studied. OBJECTIVE: To develop an algorithm to classify patients with SAR and patients with PAR, and to evaluate treatment patterns, HRU, and costs among these patients. METHODS: Patients with allergic rhinitis (AR) were identified retrospectively by using electronic medical records and administrative claims data, with an index date as the earlier of the date of AR diagnosis or allergy medication use. Patients with AR were followed-up from 12 months before the index date through 12 months after the index date (follow-up) and were classified as SAR or PAR based on medication patterns during follow-up. AR-related HRU, allergy immunotherapy administration, and costs per patient per year during follow-up were compared between patients with SAR and those with PAR, with analyses stratified by asthma diagnosis before the index date and by physician specialty (primary care physician versus specialist). RESULTS: Approximately 23% of patients with AR were classified as having PAR and 77% as having SAR. During follow-up, the patients with PAR had more allergy medication prescriptions versus the patients with SAR (8.0 versus 2.4 prescriptions), higher prescription medication costs ($1551 versus $313), higher allergy immunotherapy cost ($180 versus. $118), and higher total AR-related costs ($1944 versus $643); all with p < 0.001. Patients with asthma had higher costs than those without asthma. Patients seen by a specialist has higher costs than those treated by a primary care physician. CONCLUSION: Patients with PAR experienced more AR-related prescription drug use and higher health care costs than patients with SAR, with prescription drug costs being the main cost driver. Treatments that reduce the need for ongoing prescription medication use have the potential to be cost saving.