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BACKGROUND: There is a need to understand health care resource utilization (HCRU) and costs associated with treatment-experienced people with HIV (PWH) switching treatment regimens. OBJECTIVE: To describe HCRU and cost during lines of antiretroviral therapy (ART) for treatment-experienced PWH switching to or restarting guideline-recommended, integrase strand transfer inhibitor (INSTI)-based multitablet regimens and single-tablet regimens. METHODS: This retrospective claims study used data from Optum Research Database (January 1, 2010, to March 31, 2020) to identify lines of therapy (LOTs) for treatment-experienced adults who switched to or restarted INSTI-based regimens between January 1, 2018, and December 31, 2019. The first LOT during the study period was included in the analysis. We examined all-cause HCRU and costs and HIV-related HCRU and combined costs to the health plan and direct patient costs by site of service and compared between INSTI-based regimens: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (single tablet) vs dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) (single tablet), dolutegravir + emtricitabine/tenofovir alafenamide (DTG+FTC/TAF) (multitablet), and dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+FTC/TDF) (multitablet). Analysis of HCRU by site of service was conducted following inverse probability treatment weighting. Multivariable regression was conducted using a generalized linear model with stepwise covariate selection to estimate HIV-related medical costs and control for remaining differences after inverse probability treatment weighting. RESULTS: 4,251 PWH were identified: B/F/TAF (n = 2,727; 64.2%), DTG/ABC/3TC (n = 898; 21.1%), DTG+FTC/TAF (n = 539; 12.7%), and DTG+FTC/TDF (n = 87; 2.1%). PWH treated with DTG+FTC/TAF had a significantly higher mean of all-cause ambulatory visits than PWH treated with B/F/TAF (1.8 vs 1.6, P < 0.001). A significantly smaller proportion of PWH treated with DTG/ABC/3TC had an all-cause ambulatory visit vs PWH treated with B/F/TAF (90.6% vs 93.9%, P < 0.001). All-cause total costs were not significantly different between regimens. Mean (SD) medical HIV-related costs per month during the LOT were not significantly different between B/F/TAF $699 (3,602), DTG/ABC/3TC $770 (3,469), DTG+FTC/TAF $817 (3,128), and DTG+FTC/TDF $3,570 (17,691). After further controlling for unbalanced measures, HIV-related medical costs during the LOT were higher (20%) but did not reach statistical significance for DTG/ABC/3TC (cost ratio = 1.20, 95% CI = 0.851-1.694; P = 0.299), 49% higher for DTG+FTC/TAF (cost ratio = 1.489, 95% CI = 1.018-2.179; P = 0.040), and almost 11 times greater for DTG+FTC/TDF (cost ratio = 10.759, 95% CI = 2.182-53.048; P = 0.004) compared with B/F/TAF. CONCLUSIONS: HIV-related medical costs during the LOT were lowest for PWH treated with INSTI-based single-tablet regimens. Simplifying treatment regimens may help PWH maintain lower health care costs.
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Fármacos Anti-HIV , Infecções por HIV , Piridonas , Humanos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Estudos Retrospectivos , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Piridonas/economia , Piridonas/uso terapêutico , Fármacos Anti-HIV/economia , Fármacos Anti-HIV/uso terapêutico , Compostos Heterocíclicos com 3 Anéis/economia , Compostos Heterocíclicos com 3 Anéis/uso terapêutico , Tenofovir/uso terapêutico , Tenofovir/economia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Combinação de Medicamentos , Oxazinas/uso terapêutico , Oxazinas/economia , Emtricitabina/uso terapêutico , Emtricitabina/economia , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Compostos Heterocíclicos de 4 ou mais Anéis/economia , Piperazinas/economia , Piperazinas/uso terapêutico , Lamivudina/economia , Lamivudina/uso terapêutico , Inibidores de Integrase de HIV/economia , Inibidores de Integrase de HIV/uso terapêutico , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Substituição de Medicamentos/economia , Amidas , Ciclopropanos , Didesoxiadenosina/análogos & derivadosRESUMO
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.
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Esclerose Múltipla , Humanos , Teorema de Bayes , Metanálise em Rede , RecidivaRESUMO
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.
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Esclerose Múltipla Recidivante-Remitente , Esclerose Múltipla , Estudos Transversais , Crotonatos , Fumarato de Dimetilo/efeitos adversos , Cloridrato de Fingolimode/efeitos adversos , Humanos , Hidroxibutiratos , Imunossupressores/efeitos adversos , Esclerose Múltipla/tratamento farmacológico , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Nitrilas , Pesquisa Qualitativa , Recidiva , ToluidinasRESUMO
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.
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Custos de Cuidados de Saúde , Imunoterapia/economia , Rinite Alérgica/terapia , Adolescente , Adulto , Criança , Estudos de Coortes , Feminino , Recursos em Saúde , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto JovemRESUMO
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.