Objectives: Disease-modifying therapies (DMTs) reduce relapse rates and disability progression for relapsing multiple sclerosis (MS). Although 25% to 30% of all US patients with MS are Medicare beneficiaries, limited information exists on this population. This is the first study using national Medicare data to (1) describe characteristics of patients with MS using DMTs, (2) estimate adherence to DMTs over a 1-year and 3-year follow-up, and (3) examine factors associated with DMT adherence. Methods: This retrospective claims analysis used 2011-2014 100% Medicare files. Monthly adherence to MS DMTs was defined as the proportion of days covered $0.80 with any DMT in each month for 1-year (n = 36 593) and 3-year (n = 17 599) followup samples of MS DMT users. Generalized estimating equation logistic regressions were used to estimate factors associated with adherence to DMTs. Results: Over 90% of patients were eligible for Medicare owing to disability, and about three-quarters qualified for low-income subsidies. A downward trend in DMT adherence was observed over time in both samples. Monthly adherence dropped significantly between December of the prior year to January of the following year (from 76% to 65% in the 1-year followup sample and similar drops seen across all years in the 3-year follow-up sample). Multivariable regressions indicated characteristics such as being low-income, having a disability, and having high patient out-of-pocket DMT costs associated with poor adherence to DMTs. Conclusion: Our study provides important insights into the characteristics and DMT adherence of Medicare patients with MS and highlights the need for interventions and policies mitigating barriers to adherence in this population.

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Background Current understanding of the health care costs of Parkinson's disease (PD) and the incremental burden of advanced disease is incomplete. Objectives The aim of this study was to assess the direct economic burden associated with advanced versus mild/moderate PD in a prevalent national sample of elderly U.S. Medicare beneficiaries with a PD diagnosis. Methods Analyzing 100% fee‐for‐service Medicare claims from 2013, we defined advanced PD with a medication‐based algorithm and calculated all‐cause and PD‐related costs for the overall sample and by disease severity. We measured primary PD‐related costs (based on claims with a primary diagnosis of PD) and any PD‐related costs (based on claims with PD in any diagnostic field). Generalized linear models were used to estimate risk‐adjusted mean cost differences between the advanced and mild/moderate PD groups for the calendar year. Results The final sample (N = 144,703) had mean observed all‐cause, primary PD‐related, and any PD‐related costs of $23,041 (SD, $34,045), $3429 (SD, $7431), and $9924 (SD, $22,140), respectively. Twenty percent of patients were classified as advanced PD. Costs varied substantially; any PD‐related mean costs were $483 for the lowest patient decile (which included 1% of the advanced group) and $48,145 for the highest decile (which included 15% of the advanced group). Incremental risk‐adjusted costs of advanced PD were $5818 (95% confidence interval [CI]: $5411–$6225) for all‐cause costs, $3644 (95% CI: $3484–$3806) for primary PD‐related costs, and $6088 (95% CI: $5779–$6398) for any PD‐related costs. Conclusions Elderly Medicare beneficiaries with PD had substantial variation in PD‐related costs. Advanced PD was associated with a larger economic burden than mild/moderate PD. © 2020 International Parkinson and Movement Disorder Society

Introduction Lack of a gold standard definition for advanced Parkinson's Disease (APD), coupled with absence of disease severity information in diagnostic codes, hinders use of large administrative databases for conducting population health and comparative effectiveness studies. Methods Using pharmacy claims data, we created an algorithm to identify APD: any 30-day average levodopa equivalent dose (LED) >1000 mg/day. Using 2013 100% U.S. Medicare claims, we applied this algorithm and used multivariate logistic regression to examine associations between assigned APD status and claims-based indicators of PD severity (any deep brain stimulation, fall, hallucinations, walker, wheelchair, specialty bed, dementia diagnosis, skilled nursing facility, hospice), adjusting for sociodemographic, clinical, and treatment characteristics. Levodopa >1000 mg/day, levodopa >800 mg/day and LED >800 mg/day were used in sensitivity analysis. Results In our sample ( N = 144,703), 20% were assigned APD status based on the LED >1000 mg/day cut-off. This group had significantly higher odds of having each claims-based indicator, compared with those assigned mild-moderate PD status. Odds ratios were highest for indicators for any DBS (OR: 2.96; 95% CI:2.75–3.19) and specialty bed (OR:2.15, 95% CI: 1.99–2.32) and lowest for fall (OR:1.27; 95% CI:1.20–1.34) and dementia diagnosis (OR:1.21; 95% CI:1.18–1.25). Results based on alternative approaches were similar. Conclusions Medicare patients classified as having APD via a pharmacy claims-based algorithm had higher odds of having claims-based clinical markers of APD, compared with patients categorized as having mild-moderate PD. This proxy strategy could facilitate future claims-based studies and warrants further refinement and validation using medical records or other clinical sources.

. Real-world treatment and outcomes among older adults with chronic lymphocytic leukemia before the novel agents era. Haematologica. 2018; 103:xxx doi:10.3324/haematol.2017.185868 Publisher's Disclaimer. We also examined second-line treatments, defined as re-initiation of at least one or all of the agents in the first-line treatment regimen following a treatment-free interval of > 180 days, or the addition of a new treatment that was not part of the first-line treatment regimen. The second-line treatment start date was defined as the date on which the re-initiated therapy was administered or filled or the date on which the new treatment was added. Time to second-line treatment initiation was defined as the time elapsed between the index (diagnosis) date and the start of the second-line treatment date. E-publishing ahead of print is increasingly important for the rapid dissemination of science. Haematologica is, therefore, E-publishing PDF files of an early version of manuscripts that have completed a regular peer review and have been accepted for publication. E-publishing of this PDF file has been approved by the authors. After having E-published Ahead of Print, manuscripts will then undergo technical and English editing, typesetting, proof correction and be presented for the authors' final approval; the final version of the manuscript will then appear in print on a regular issue of the journal. All legal disclaimers that apply to the journal also pertain to this production process.Survival outcomes included OS (overall survival) and CLL-specific survival from first-line and second-line CLL treatment. We also examined 1-year and 2-year OS rates. However, the older seniors group had a shorter median time to first treatment (4.4 v 6.8 months; P<.001). Rituximab-containing chemoimmunotherapy combinations were the most common treatment approaches overall (utilized in nearly half of patients receiving first-line treatment), yet significant differences were observed in the distribution of treatment approaches between the two age groups (P<.001). For example, a higher proportion of the older seniors group (vs. younger group) received monotherapy with either chlorambucil (21.0% v 9.0%) or rituximab (30.3% v 20.0%).Twelve percent of patients received second-line treatment; again, rates were lower in the older seniors group (10.7% v 14.2%; P=.004). Among patients receiving second-line treatment, the median time from CLL diagnosis to initiation of the secondline treatment was 21.8 months. Similar to the findings for first-line treatment, rituximabcontaining chemoimmunotherapy combinations were the most common second-line treatments (40.8%). 5The median OS from first-line treatment initiation and second-line treatment initiation was 52.4 months and 33.7 months, respectively. Estimated 1-year and 2-year OS rates after first-line treatment initiation were 81.4% and 69.3%, respectively (Table 3). OS rates after second-line treatment initiation were 71.8% at 1 year and 57.5% at 2 years. Patients in the older seniors grou...

Aims To estimate risk factors associated with early hypoglycaemia and its impact on adherence to and persistence with therapy in Medicare Part D beneficiaries with type 2 diabetes who are initiating basal insulin (BI). Materials and methods This retrospective analysis used a 5% sample of Medicare files from 2007–2013, identifying beneficiaries with type 2 diabetes initiating BI from 1 January 2008 to 31 December 2012. Early hypoglycaemia was defined as ≥1 hypoglycaemic event ≤6 months postindex. Outcomes included medication adherence and persistence over 12‐ and 36‐month follow‐up. Multivariable logistic and Cox regression analyses were conducted to examine factors associated with early hypoglycaemia and BI adherence/persistence. Results Of the 14 466 included patients, 1315 (9.1%) experienced hypoglycaemia ≤6 months after initiating BI. Factors associated with early hypoglycaemia were female sex (odds ratio [OR] 1.16 [95% confidence interval [CI] 1.02–1.32]), receipt of a low‐income subsidy under Medicare Part D (OR 1.20 [95% CI 1.01–1.43]), high diabetes complication score index (OR 1.08 [95% CI 1.01–1.15]), and hypoglycaemia during the baseline period (OR 4.24 [95% CI 3.63–4.96]). At 12 months, patients with baseline hypoglycaemia were less likely to be adherent to (OR 0.81 [95% CI 0.70–0.93]) and more likely to discontinue (OR 1.33 [95% CI 1.07–1.66]) their insulin therapy. Results were similar at 36 months. Conclusions Within 6 months of BI initiation, almost 1 in 10 Medicare Part D beneficiaries experienced hypoglycaemia. Early hypoglycaemia was associated with decreased adherence to BI treatment over 12‐ and 36‐month follow‐up.

Background Among the 1.2 million people living with HIV (PLWH) in the U.S., many are covered by Medicare, a federally funded health insurance program for elderly (≥65 years) and disabled (&lt; 65 years) individuals. Medicare has emerged as a major source of HIV care for PLWH. Given limited research in this population, a better understanding of patient characteristics, comorbidities, and comedication use among PLWH in the Medicare program is needed to help optimize clinical care. Methods A retrospective claims analysis of a national cross-sectional sample of fee-for-service (FFS) Medicare beneficiaries with continuous medical and prescription coverage in 2018 was conducted using 100% Medicare administrative claims. The PLWH group included individuals with ≥1 HIV diagnosis code in medical claims and ≥1 pharmacy claim for an anchor antiretroviral (ARV) drug (i.e., NNRTI, PI or InSTI) in 2018. The comparison group included a random sample of Medicare beneficiaries without HIV (PLWoH). Sociodemographic characteristics, comorbidities, and medication use were compared between PLWH and PLWoH. Results The study sample included 86,856 PLWH and 552,645 PLWoH. PLWH were more likely to be younger (mean age: 57.4 vs 71.1 years and &lt; 65 years: 72% vs 18%), male (75% vs 42%), Black (42% vs 10%), eligible for Medicare due to disability (83% vs 27%) and receiving full low-income subsidies (77% vs 31%); all p&lt; 0.001. Prevalence of &gt;3 comorbidities was high in PLWH (70.2%) and only slightly lower than in PLWoH (71.7% p&lt; 0.001). Prevalence of neuropsychiatric conditions, chronic kidney disease, liver disease, COPD, hepatitis B, and hepatitis C were higher in PLWH (Figure 1). The mean hierarchical condition categories risk score was higher in PLWH vs PLWoH (1.81 vs. 1.32; p&lt; 0.001). On average, polypharmacy was higher among PLWH vs PLWoH (annual number of unique medications: 12.6 vs. 9.4 for all drugs and 10.3 vs. 9.4 for non-ARV drugs, both p&lt; 0.001). Figure 1. Percentage of PLWH and PLWoH with multimorbidity and selected comorbid conditions. Abbreviations: COPD=chronic obstructive pulmonary disease; GI=gastrointestinal; PLWH=people living with HIV; PLWoH=people living without HIV All p-values &lt;0.001 except GI Disorders (p=0.14). Conclusion In the Medicare FFS population, multimorbidity and polypharmacy were highly prevalent in PLWH despite their substantially younger age compared to PLWoH. Our findings highlight the need to consider comorbidities and comedications in HIV management including ARV regimens to minimize medication burden and drug interactions, which might improve clinical outcomes. Disclosures Pengxiang Li, PhD, Avalon Health Economics LLC (Consultant)COVIA Health Solutions (Consultant)Healthstatistics, LLC (Consultant) Jianbin Mao, PhD, Merck (Employee)Merck (Shareholder) Girish Prajapati, M.B.B.S., MPH , Merck & Co., Inc. (Employee, Shareholder) Robert Gross, MD, MSCE, Pfizer (Other Financial or Material Support, Serve on DSMB for drug unrelated to HIV) Jalpa A. Doshi, PhD, Acadia (Consultant, Advisor or Review Panel member)Allergan (Advisor or Review Panel member)Biogen (Grant/Research Support)Boehringer Ingelheim (Other Financial or Material Support, Scientific lecture)Catabasis (Consultant)Humana (Grant/Research Support)Janssen, Inc. (Consultant, Grant/Research Support)MeiraGTX (Consultant)Merck (Grant/Research Support, Advisor or Review Panel member)Novartis (Grant/Research Support)Otsuka (Advisor or Review Panel member)Regeneron (Grant/Research Support)SAGE Therapeutics (Consultant)Sanofi (Grant/Research Support)Shire (Advisor or Review Panel member)The Medicines Company (Advisor or Review Panel member)