Pharmacy Benefit Research Articles

How pharmacy can start to solve the inequity puzzle

How pharmacy can start to solve the inequity puzzle

ASHP Foundation's forecast report feels more relevant than ever this year

ASHP Foundation's forecast report feels more relevant than ever this year

Association Between Cost-Saving Prescription Policy Changes and Adherence to Chronic Disease Medications: an Observational Study.

Pharmacy benefit design is one tool for improving access and adherence to medications for the management of chronic disease. We assessed the effects of pharmacy benefit design programs, including a change in pharmacy benefit manager (PBM), institution of a prescription out-of-pocket maximum, and a mandated switch to 90 days' medication supply, on adherence to chronic disease medications over time. We used a difference-in-differences design to assess changes in adherence to chronic disease medications after the transition to new prescription policies. We utilized claims data from adults aged 18-64, on ≥ 1 medication for chronic disease, whose insurer instituted the prescription policies (intervention group) and a propensity score-matched comparison group from the same region. The outcome of interest was adherence to chronic disease medications measured by proportion of days covered (PDC) using pharmacy claims. There were 13,798 individuals in each group after propensity score matching. Compared to the matched control group, adherence in the intervention group decreased in the first quarter of 2015 and then increased back to pre-intervention trends. Specifically, the change in adherence compared to the last quarter of 2014 in the intervention group versus controls was - 3.6 percentage points (pp) in 2015 Q1 (p < 0.001), 0.65 pp in Q2 (p = 0.024), 1.1 pp in Q3 (p < 0.001), and 1.4 pp in Q4 (p < 0.001). In this cohort of commercially insured adults on medications for chronic disease, a change in PBM accompanied by a prescription out-of-pocket maximum and change to 90 days' supply was associated with short-term disruptions in adherence followed by return to pre-intervention trends. A small improvement in adherence over the year of follow-up may not be clinically significant. These findings have important implications for employers, insurers, or health systems wishing to utilize pharmacy benefit design to improve management of chronic disease.

Reduced medical spending associated with integrated pharmacy benefits.

Although pharmacy benefit carve-outs are promoted as a cost-containment tool, their impact on medical spending is not well understood. We compare the health care spending of Blue Cross and Blue Shield of Louisiana (BCBSLA) members covered by an integrated ("carved-in") pharmacy benefit with that of members covered under a pharmacy benefit carve-out. Matched, longitudinal cohort study. We identified members with coverage through an employer contracting for administrative services only (ie, self-insured) and determined whether they received a pharmacy benefit through BCBSLA. We matched members with and without integrated benefits using a baseline year and compared their medical spending trajectories in 3 subsequent years. These comparisons were repeated in the subset of patients with chronic comorbidities. Among patients with chronic illnesses, relative growth in per-member per-month (PMPM) medical spending was significantly lower in the integrated benefit group by the second and third follow-up years. Neither the level nor the growth of PMPM medical spending significantly differed in the full population sample, although point estimates suggest that the integrated benefit members may be on a lower cost growth trajectory over time. Members with chronic illnesses receiving an integrated pharmacy benefit experienced slower medical cost growth compared with members covered by a pharmacy carve-out. Group leaders and brokers should consider the additional cost savings achieved by integrated pharmacy benefits when comparing the total costs of carve-in vs carve-out prescription drug programs.

Alopecia Areata Treatment Patterns, Healthcare Resource Utilization, and Comorbidities in the US Population Using Insurance Claims.

IntroductionAlopecia areata (AA) is an autoimmune disorder causing sudden, non-scarring hair loss. There are currently no drugs approved for AA treatment. This study assessed prevalence of comorbidities, treatments, and healthcare costs and resource utilization among patients with AA in the USA.MethodsPatients diagnosed with AA between January 2011 and December 2018 were identified in IBM MarketScan® Research Databases. Eligible patients had no other hair loss-related disorders and were continuously enrolled with medical and pharmacy benefits at least 12 months before and after AA diagnosis. Descriptive statistics were used to summarize comorbid conditions, treatments related to AA or other autoimmune/inflammatory conditions, and all-cause and AA-specific healthcare costs and resource utilization identified from claims data.ResultsA total of 68,121 patients with AA were identified. Mean (SD) age was 40.3 (17.8) years and 61.0% were female. The most common comorbidities included hyperlipidemia (22.4%), hypertension (21.8%), thyroid disorders (13.1%), contact dermatitis or eczema (10.8%), depression (9.5%), and anxiety (8.4%). Comorbid autoimmune diseases included atopic dermatitis (2.8%), psoriasis (2.1%), chronic urticaria (1.5%), and rheumatoid arthritis (1.1%). During the 12-month follow-up period, 37,995 patients (55.8%) were prescribed treatment for their AA or other comorbid autoimmune/inflammatory disease; 44.9% of treated patients were prescribed therapy within 7 days of AA diagnosis. Of patients receiving treatment, 80.3% received topical steroids and 30.0% received oral steroids. Mean (SD) total healthcare costs were $11,241.21 ($43,839.69) for all-causes and $419.12 ($1534.99) for AA. AA-related expenses were driven by outpatient and prescription costs.ConclusionPatients with AA have a high comorbidity burden and lack of treatment. Current AA treatments, including systemic therapies other than oral steroids, were not frequently utilized in this study population. Healthcare costs incurred by patients with AA went beyond AA-related expenses. Longitudinal data are needed to better understand treatment trajectories and the disease burden in patients with AA.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01845-0.

DIR reform, supply chain security, and more

DIR reform, supply chain security, and more

Changes in Type 2 Diabetes Medication Utilization and Costs in the United States, 2014-2019.

The objective of this study was to describe national changes in utilization and associated costs of antidiabetic medications in the United States from 2014 to 2019, across different drug classes and insurance plans. This retrospective, cross-sectional study examined administrative claims from a large national pharmacy benefits manager from January 1, 2014, to December 31, 2019. Patients aged 18 years and above enrolled in commercial, Medicare, or Medicaid health plans who filled ≥1 prescription claim for an antidiabetic medication(s) during the 6-year period were included. Utilization was examined as the total number of 30-day adjusted prescription fills per user per month (PUPM). Gross costs were calculated as the sum of plan costs (net of rebates) and member out-of-pocket costs. Differences in mean utilization and costs PUPM between 2014 and 2019 for each medication class were calculated. The final analytic sample increased from 745,290 patients in 2014 to 1,596,006 in 2019. Antidiabetic medication utilization increased by 8.8% from 2014 to 2019, driven by increases in sodium-glucose cotransporter 2 inhibitor (48.7%; P<0.001), glucagon-like peptide 1 receptor agonist (11.8%; P<0.001), insulin (8.1%; P<0.001), and metformin (2.9%; P<0.05) utilization. Average costs PUPM rose 47.5% (P<0.001), from $126.52 in 2014 to $186.58 in 2019. Sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and combination drugs contributed significantly to these increased costs, with 6-year cost differences of 57.3%, 46.9%, and 47.2%, respectively (all P<0.001). Our study demonstrates a shift in antidiabetic medication class utilization from 2014 to 2019, where associated costs net of rebates significantly increased to a disproportionately greater extent than the significant increase in utilization PUPM.

Budget Impact Analysis of Switching Chemotherapy Patients Using Granulocyte Colony-Stimulating Factors (G-CSFs) from Pegfilgrastim to Short-Acting G-CSFs in the United States

Introduction: Neutropenia is a common complication in patients receiving myelosuppressive chemotherapy for nonmyeloid malignancies. Severe and febrile neutropenia (FN) are associated with prolonged hospitalization, serious infections and broad-spectrum antibiotic use, decreased quality of life, and increased medical costs and mortality. G-CSFs are often administered to reduce incidence, severity, and duration of FN in chemotherapy patients. While pegfilgrastim is dosed once per chemotherapy cycle (14-day efficacy), data suggest the average duration of short-acting G-CSF use is considerably shorter than 14 days. This analysis estimated the budget impact of increasing utilization of short-acting G-CSFs (filgrastim [Neupogen®], tbo-filgrastim [Granix®, a filgrastim follow-on biologic], and filgrastim-sndz [Zarxio®, a filgrastim biosimilar]) while decreasing utilization of long-acting pegfilgrastim (Neulasta®) products for patients with nonmyeloid malignancies treated with myelosuppressive chemotherapy from a US payer perspective.Methods: An interactive budget impact model was developed to estimate changes in drug and administration costs associated with a projected 10% reduction in pegfilgrastim market share (an estimated 7.6% of the total G-CSF market) and an equal increase split evenly across short-acting product lines (approximately 1/3 allocated to 300-mcg products and 2/3 allocated to 480-mg products within product lines) for patients with nonmyeloid malignancies treated with myelosuppressive chemotherapy within a 1-million-member health plan. Patient self-administration at home was assumed for 40% of patients receiving short-acting G-CSFs and 10% of patients receiving long-acting agents, with the remaining administered by health care provider (HCP) in an office or other outpatient setting. Patients receiving short-acting G-CSFs were assumed to require 10 doses per chemotherapy cycle, with long-acting agents given once per cycle. Self-administered products were purchased via the patient's pharmacy benefit at an assumed Tier 3 formulary status with a patient copay of $57 per prescription. HCP-administered products were assumed to be primarily (85%) purchased through the patient's medical benefit and provided on site, while a small proportion of patients (15%) were assumed to purchase G-CSFs through their pharmacy benefit to be HCP administered; in both cases, administration costs for injections were included, and with pharmacy benefit adjudication, a patient drug cost-share was applied ($57 per prescription). Base-case data were derived from publicly available resources. The budget impact was calculated using a 1-year time horizon, along with the difference in effective per-member per-year (PMPY) cost between current and proposed scenarios; univariate sensitivity analyses were conducted.Results: The effective annual per-patient plan drug costs ranged from $12,288 to $30,772 for short-acting G-CSFs and from $27,013 to $33,698 for pegfilgrastim (depending on dose and adjudication channel per product). The estimated total effective annual plan cost prior to the utilization shift was $425,518,352 (PMPY = $425.53) and was $419,985,093 (PMPY = $419.99) following the shift. The home administration budget increased by $5,793,056, while the HCP administration budget decreased by $11,326,314, for an overall annual cost savings of $5,533,259 (PMPY = $5.54). Per-patient savings for tbo-filgrastim and filgrastim-sndz ranged from 16.1% to 54.5%, depending on dose and adjudication channel. The model was most sensitive to changes in pegfilgrastim acquisition cost and the patient's medical benefit cost-share.Conclusions: Budget impact analyses examine the financial impact associated with the introduction of new treatments or shifting existing treatment patterns to help decision makers determine how best to allocate resources. Without considering additional impacts of health plan contracted rates and manufacturer rebates, the annual plan per-patient drug cost for tbo-filgrastim and filgrastim-sndz formulations were substantially less expensive than pegfilgrastim for an average treatment cycle. This analysis estimated an annual US health plan cost savings of over $5.5 million or more than $5.50 PMPY following an overall 7.6% utilization shift from long-acting to short-acting G-CSFs. DisclosuresJames:Teva Pharmaceuticals: Consultancy. Trautman:Teva Pharmaceuticals: Consultancy. Szabo:Teva Pharmaceuticals: Employment. Tang:Teva Pharmaceuticals: Employment.

Opioid Utilization Patterns in United States Patients with Sickle Cell Disease

Opioid Utilization Patterns in United States Patients with Sickle Cell Disease

Access to Care for Medicaid and Commercially-Insured United States Patients with Sickle Cell Disease

Access to Care for Medicaid and Commercially-Insured United States Patients with Sickle Cell Disease

Evaluation of Treatment Patterns Among Patients with Newly Diagnosed, Persistent, and Chronic Immune Thrombocytopenia (ITP) Treated with Eltrombopag in Real World Setting in the US

BACKGROUND: The thrombopoietin receptor agonist (TPO-RA) eltrombopag was approved for the treatment of chronic immune thrombocytopenia (cITP), >12 months after initial ITP diagnosis. The registration trials however included patients with ITP duration >6 months. Moreover, with increasing familiarity and confidence with the use of TPO-RAs in ITP, the use of these agents in real world has not been restricted to cITP.OBJECTIVE: The objective of this study was to describe treatment characteristics of eltrombopag use among adult patients diagnosed with ITP initiating treatment ≤6, 7-12, and >12 months after their initial ITP diagnosis in the real-word setting.METHODS: A retrospective cohort study was conducted using MarketScan® - Commercial and Medicare Supplemental Database, and PharmetricsPlusTM Adjudicated Claims Database. Adult patients (≥18 years) with ≥2 non-diagnostic outpatient claims separated by ≥30 days or ≥1 inpatient claim carrying a diagnosis code for ITP during Jul 1, 2010 - Jun 30, 2014 were eligible for inclusion. The index date was the date of the first ITP diagnosis. Patients were excluded if they had continuous enrollment in medical and pharmacy benefits for <24 months prior and <18 months following the index date, or had a medical claim for secondary thrombocytopenia during the pre-index period. Timing of eltrombopag initiation was calculated from the index date to the date of first eltrombopag claim. Patients were categorized into 1 of 3 cohorts, those initiating treatment ≤6, 7-12, or >12 months after index date. Treatment outcomes were assessed among a subset of patients regardless of follow-up period post the index ITP diagnosis but who had ≥6 months of continuous enrollment in medical and pharmacy benefits after initiating treatment with eltrombopag; treatment duration, medication possession ratio (MPR), time to treatment discontinuation and time to treatment restart were compared among patients initiating treatment ≤6, and 7-12 after ITP diagnosis to those initiating treatment >12 months after their index ITP diagnosis. MPR was calculated as the sum of the days' supply for all fills divided by the number of days between the first and last fill plus days' supply of the last fill. Outcomes compared between cohorts using t-tests and chi-square tests. RESULTS: A total of 7,068 patients - 3,264 patients in MarketScan and 3,804 in PharMetrics - were eligible for inclusion in the study; 117 (3.6%) and 139 (3.7%), respectively, received eltrombopag. More than half of patients in both MarketScan and PharMetrics initiated treatment ≤12 months after their index diagnosis (see Table 1). The average treatment durations were similar among patients initiating treatment ≤6 months (120.8±57.1; P =0.456) and 7-12 (110.5±59.5; P =0.991) months after index diagnosis compared to those initiating treatment >12 months after index diagnosis (110.3±64.7). The MPR was 0.9 in all 3 cohorts; 84.0%, 73.7% and 78.3% patients initiating treatment ≤6 months, 7-12 months and > 12months after index diagnosis, respectively were considered to be adherent based upon an MPR≥0.8. The proportion of patients who discontinued treatment were not statistically significant between cohorts (≤6 months: 53.3% [ P =0.816]; 7-12 months: 57.9% [ P =1.000]; >12 months 56.5%). Time to treatment discontinuation was statistically longer among patients initiating treatment ≤6 months compared to those initiating treatment >12 months after index diagnosis (63.7±37.3 days vs 39.5±26.4 days; P =0.035); however the difference between patients initiating treatment 7-12 and >12 months after index diagnosis (50.3±30.5 days vs 39.5±26.4 days; P =0.365) was not significant. Twelve percent (P =0.307), 26.3% (P =1.000) and 21.7% of patients initiating treatment ≤6 months, 7-12 and >12 months after index diagnosis restarted eltrombopag. The average time to treatment restart was approximately 50 days across all 3 cohorts. CONCLUSION: Although eltrombopag is currently approved for patients with chronic ITP, results of this study indicate that in real world setting physicians have been using it in patients with newly diagnosed and persistent ITP, with overall treatment patterns being very similar to those in patients with cITP. These data, supported by other real world studies underscore the clinical utility of eltrombopag in early-stage ITP and warrant further exploration in more robust prospective studies. [Display omitted] DisclosuresStafkey-Mailey:Xcenda: Employment. Roy:Novartis: Employment, Equity Ownership. Lokhandwala:Xcenda: Employment. Yuan:Xcenda: Employment. Landsman-Blumberg:Xcenda: Employment. Siddiqui:Novartis: Employment, Equity Ownership. Ghaznawi:Novartis: Employment, Equity Ownership.

A pharmacist-managed virtual consult service for patients with rheumatologic conditions requiring specialty or infused medications

To describe a pharmacist-managed virtual consult service practice model for rheumatology patients and evaluate its initial impact on compliance with institutional critical care guidelines for biologic response modifiers (BRMs). Pharmacologic care of patients with rheumatologic conditions often revolves around the use of BRMs. While these drugs are generally well tolerated, nearly all of them carry risks for serious adverse events. The severity of these possible problems necessitates a thorough initial and ongoing clinical workup. Based on results of a needs assessment, a virtual consult service was introduced at the University of Illinois Hospital and Health Sciences System (UI Health) in August 2018 to integrate clinical, specialty pharmacy, and therapeutic infusion services for proactive medication and safety management of patients with rheumatologic conditions requiring treatment with BRMs. The consult service was managed by an embedded clinical pharmacist and a postgraduate year 1 specialty pharmacy resident, who evaluated each request for therapy appropriateness prior to submission for insurance approval. Forty-one percent of the pharmacy benefit consult orders required a pharmacist intervention prior to referral to the specialty pharmacy. All consults (100%) adhered to the safety management guidelines for BRMs after review by the pharmacist. The pharmacist-managed virtual consult service is a novel practice model in specialty pharmacy that permits pharmacists to manage multiple patients simultaneously, virtually, and with optimal impact on medication selection and management at or before the point of prescribing.

Real-World Patterns of Care for Patients with Follicular Lymphoma Treated with Lenalidomide and Rituximab (R2) in the US Medicare Population

Introduction: Follicular lymphoma (FL) is the most common indolent lymphoma and the second most common subtype of non-Hodgkin lymphoma (NHL). While rituximab-based immunochemotherapy remains a standard in front-line and relapsed FL settings, novel therapies hold the potential for chemotherapy-free treatment and may offer particular clinical benefit in the subgroup of patients with early relapse following immunochemotherapy. Rituximab with lenalidomide (R2) represents one such chemotherapy-free regimen currently in late-stage clinical trials for indolent lymphoma. While we await final reports from these ongoing trials, little is known about the current use of R2 in the routine care of patients with FL.M ethods: Our population-based cohort study utilized 100% Medicare claims data from January 2009 through December 2014. We selected a population of patients with FL (ICD-9: 202.0x) with at least one claim for rituximab during the identification period (January 1, 2010 through October 31, 2014). We then identified the subgroup of patients who received R2 by requiring claims for at least two consecutive cycles of lenalidomide and rituximab. The first prescription date for lenalidomide was defined as the index date. Patients were required to have continuous medical and pharmacy benefits for ≥ 12 months pre-index date (the baseline period), and ≥ 2 months post-index date (the follow-up period). Treatment discontinuation was defined as a gap in therapy of > 60 days. Patients initiating R2 within 90 days of a prior treatment were considered refractory to previous therapy. Patient demographics, clinical characteristics, and previous treatment regimens were recorded throughout the pre-index period. Patients receiving R2 were followed until the end of data availability.Results: Of 18,199 patients with FL receiving rituximab-based therapy during our study period, 226 (1.2%) were identified as receiving R2. The median age at the time of receiving R2 was 75 years (interquartile range [IQR] = 9 years); patients were mostly male (56.2%) and white (89.8%). Comorbid conditions at the initiation of R2 therapy were common, with a mean Charlson comorbidity index score of 5.1. Medical claims related to anemia (65.5%), chronic obstructive pulmonary disease (36.7%), and kidney dysfunction (30.5%) were the most prevalent comorbid conditions. The median time from the first identifiable FL claim until R2 initiation was 589 days (IQR = 895 days). Almost all patients (n = 224) showed evidence of previous FL-related treatment, with 39% showing evidence of at least two prior lines of treatment during the study period before initiating R2 therapy. A significant proportion of patients were refractory to their previous therapy (57.5%), and of those patients 35.3% were receiving R-chemotherapy, 26.2% were receiving rituximab monotherapy, and the remaining 38.5% were receiving other chemotherapy agent or regimens. The most frequent treatment regimens received in the pre-R2 period were rituximab monotherapy (42.5%), rituximab + bendamustine (38.9%), R-CHOP (rituximab + cyclophosphamide, doxorubicin, vincristine, and prednisone [24.4%]), and rituximab + cyclophosphamide (20.4%). Additionally, 26.1% of patients had prior radiotherapy use. The median treatment gap between previous FL therapy and R2 was 124 days (IQR = 293 days). The median duration of R2 therapy was 100 days (IQR = 99 days).Conclusions: In our large US population-based study of older patients with FL receiving therapy between 2009 and 2014, R2 therapy was used infrequently compared with rituximab monotherapy and standard immunochemotherapy. R2 was nearly exclusively administered in the relapsed setting, with almost half of patients receiving R2 immediately being refractory to other rituximab-based treatments. With claims through the end of 2014, our study does not account for the impact of other recently approved novel FL therapies. Overall, R2 therapy has historically been limited to the relapsed/refractory FL setting and future observational studies will be important to assess whether upcoming R2 trial results impact FL treatment and outcomes in the real-world setting. DisclosuresHuntington:Pharmacyclics: Honoraria; Janssen: Consultancy; Celgene: Consultancy, Other: Travel. Keshishian:Celgene: Other: Employee of STATinMED Research, which is a paid consultant to Celgene Corporation. Xie:Celgene: Other: Employee of STATinMED Research, which is a paid consultant for Celgene Corporation. Baser:Celgene: Other: Employee of STATinMED Research, which is a paid consultant for Celgene Corporation. McGuire:Celgene: Employment, Equity Ownership.

Quality of Care in United States Children with Sickle Cell Anemia

Quality of Care in United States Children with Sickle Cell Anemia

Risk of Myelodysplasia and Acute Myeloid Leukemia in Patients with Chronic Lymphocytic Leukemia Treated with Fludarabine and Bendamustine

Background: Patients with Chronic Lymphocytic Leukemia (CLL) receive a variety of treatments that have the potential to induce myeloid malignancies. One such treatment, fludarabine, has been associated with a five-year risk of therapy-related myeloid neoplasia (t-MN) of 4.8% (Smith et. al 2011). This finding was supported by others showing a rate of t-MN of approximately 2.8% to 11% associated with fludarabine (Short et. al 2015). It is not known where new therapies, such as bendamustine, have a similar rate of t-MN compared to fludarabine. Using the Veterans Administration Central Cancer Registry (VACCR), we sought to identify the association between CLL-directed therapy and t-MN.Methods: We used the VACCR to identify patients diagnosed with CLL between September 1999 and October 2015. Pharmacy Benefits Management records were used identify patients who received bendamustine or fludarabine as initial treatment of CLL. ICD-9 codes for myeloid leukemia, monocytic leukemia, and other unspecified leukemia (205-208.8) as well as myelodysplastic syndrome (238.72-238.76) were used to identify cases of t-MN. Medical records of all cases were reviewed for diagnosis of t-MN through review of clinical notes, laboratory data, and subsequent treatment. Comparisons between groups were performed with independent samples t-test. Comorbidity was assessed using the Charlson (Romano) index score. Cox proportional hazards regression modeling was used to assess associations between treatment and development of t-MN while controlling for age and comorbidity index. The study was approved the Saint Louis VA Medical Center institutional review board.Results: A cohort of 7155 patients with CLL were available for analysis of which 1084 received fludarabine and 460 received bendamustine as initial therapy. Mean age at initial therapy was higher with bendamustine (68.9 years vs. 64.9, p<0.001) and there was a longer mean duration of time between CLL diagnosis and treatment in patients who received bendamustine (44.9 months vs. 26.9, p<0.001). Comorbidities were higher in patients receiving bendamustine compared to fludarabine, (2.1 vs. 1.6, p<0.001). Patients who were followed a median of 42.8 months after fludarabine and 23.6 months after bendamustine (p<0.001). Median year of diagnosis of CLL was 2005 compared to 2008 for bendamustine with median age of diagnosis of 62 for fludarabine versus 64 for bendamustine. Of 148 patients identified by ICD9 codes, 31 had confirmed t-MN. There were 26 (2.4%) cases of t-MN in the fludarabine group compared to 5 (1.1%) in the bendamustine group (Pearson chi-square p=0.093). In adjusted analysis, there was no significant difference between development of t-MN associated with bendamustine versus fludarabine (adjusted Hazard Ratio aHR 0.75; 95% Confidence Interval: 0.27-2.05).Conclusion: In this retrospective analysis of treatment for CLL, bendamustine was not associated with reduced rates of t-MN compared to fludarabine. This study is limited by a shorter follow-up period for patients treated upfront with bendamustine, longer follow-up is needed. DisclosuresSanfilippo:Bristol Meyers Squibb: Speakers Bureau. Carson:Seattle Genetics: Honoraria.

Risk of Herpes Zoster in Patients with Chronic Lymphocytic Leukemia Treated with Fludarabine or Bendamustine

Background: Patients with Chronic Lymphocytic Leukemia (CLL) are susceptible to infections due to impaired humoral immunity, both as a complication of the disease and treatments received. Herpes zoster (HZ) is painful, vesicular rash due to the reactivation of latent varicella zoster virus that is more common in patients with compromised immunity. Fludarabine is a purine analog that has long been incorporated in chemotherapy regimens for CLL and has been known to cause lymphocyte depletion and increased risk of viral infection and reactivation. Bendamustine is a newer therapy that has been increasingly used for the treatment of CLL. The aim of this study is to explore the rates of herpes zoster infection in patients treated with bendamustine compared to fludarabine using the Veterans Administration Central Cancer Registry (VACCR).Methods: We used the VACCR to identify patients diagnosed with CLL between September 1999 and October 2015. Pharmacy Benefits Management (PBM) records were used identify patients who received bendamustine or fludarabine as initial treatment of CLL. ICD-9 codes for HZ infection (053) were used to identify potential cases. PBM records were collected for prescriptions of acyclovir or valacyclovir at a dose of 1500mg/day or higher within 30 days of ICD9 code and treatment was verified as appropriate for HZ. Comparisons between groups were performed with independent samples t-test or chi-square as appropriate. Comorbidity was assessed with Charlson (Romano) index and outcomes by the Kaplan-Meier method. Cox proportional hazards regression modeling was used to assess associations between treatment while controlling for age at treatment and comorbidity index. The study was approved the Saint Louis VA Medical Center institutional review board.Results: A cohort of 7155 patients were identified and fludarabine was given as initial therapy in 1084 patients and bendamustine in 460 patients. Comorbidities were higher in patients receiving bendamustine compared to fludarabine, (2.11 vs. 1.63, p<0.001) and median age at treatment of patients receiving bendamustine was higher than fludarabine (68.1 years vs. 64.4, p<0.001). Median follow up was 42.8 and 23.6 months for the fludarabine and bendamustine groups, respectively (p<0.001). In univariate analyses, bendamustine was associated with reduced rate of HZ (Hazard Ratio (HR) 0.61, 95% CI: 0.40-0.94, p=0.026). When adjusting for age and comorbidity, bendamustine was continued to be associated with reduced rates of HZ (adjusted HR (aHR) 0.60, 95% CI:0.39-0.93, p=0.022). Five patients (20%) in the bendamustine group and 43 patients (32%) in the fludarabine group had prescriptions for acyclovir or valacyclovir in the year prior to HZ diagnosis (p=0.243).Conclusions: In this retrospective analysis of CLL treatments, bendamustine was associated with lower rates of herpes zoster compared to fludarabine, even in older patients with more comorbidities. [Display omitted] DisclosuresSanfilippo:Bristol Meyers Squibb: Speakers Bureau. Carson:Seattle Genetics: Honoraria.

Clinical Features of Patients With Progressive Supranuclear Palsy in an US Insurance Claims Database.

Background: Progressive supranuclear palsy is a rare neurodegenerative movement disorder and little is known about its epidemiology.Objective: Estimate age-adjusted prevalence of progressive supranuclear palsy and describe antecedent diagnoses and progressive supranuclear palsy patient features in the 5 years before first diagnostic code.Methods: In a nested case-control study in the IBM MarketScan Commercial and Medicare Supplemental Databases, a large set of US insurance databases containing medical service and prescription drug claims from employer-based commercial and Medicare supplemental health insurance plans, progressive supranuclear palsy cases (identified via International Statistical Classification of Diseases 9th/10th revision codes) and controls were included if enrollment was ≥1 month in the study period (October 1, 2015–October 31, 2017). Two controls with no diagnosis codes for PSP were matched to cases on birth year, sex, enrollment time in the database, and pharmacy benefit eligibility. Controls were assigned a randomly selected index date from their eligibility period. Prevalence of progressive supranuclear palsy was estimated in 2016 among patients with ≥1 month of continuous enrollment in that year. Prevalence ratios for comorbidities (claim/diagnosis codes) were examined in the ≤ 5 years before index date (first progressive supranuclear palsy claim date).Results: Age-adjusted progressive supranuclear palsy prevalence was 2.95/100,000 in 2016. The most common diagnosis codes in cases vs. controls in the 5 years pre-index were gait abnormalities (79.3 vs. 21.8%), pain in joint (54.9 vs. 36.0%), Parkinson's disease (54.6 vs. 1.0%), fatigue (49.8 vs. 21.6%), and cerebrovascular disease (45.6 vs. 16.4%).Conclusions: In this large database analysis, based on preliminary analyses, the prevalence of diagnosed progressive supranuclear palsy was 2.95/100,000, which is lower than many prior studies. Typical symptoms suggestive of progressive supranuclear palsy were present before index date, indicating a potential delay in time to diagnosis. The identification of diagnostic codes for clinical features of progressive supranuclear palsy that occurred before index date may be used to develop predictive models to identify potential progressive supranuclear palsy patients earlier in their disease course.

Development and validation of a systematic process for expansion of clinical pharmacy activities for comprehensive medication management in primary care within the Department of Veterans Affairs

AbstractMedication misadventures can be considered either misuse, underuse, or overuse of medication therapy. With over 80% of Americans taking at least one medication per week and an increased percentage of hospital readmissions associated with a medication‐related problem, a strategy must be integrated that can ensure medications are optimized. Comprehensive medication management (CMM) is a patient‐centered process for ensuring medication optimization and improving patient health outcomes that is delivered by a clinical pharmacist working in collaboration with the patient and other health care providers. The Department of Veterans Affairs (VA) is the largest integrated health care system in the United States and has strong clinical pharmacy practice in primary care. In an effort to increase the practice of the clinical pharmacy specialist delivering CMM, we outline a national implementation program conducted by the VA Pharmacy Benefits Management Services Clinical Pharmacy Practice Office to evaluate individual facility quality care needs, matched clinical pharmacist training needs, and the overall impact achieved with clinical pharmacist expansion of CMM.

Who Will Be Responsible for the Dialysis Bill? A Case Report and Narrative Review of Insulin Affordability 100 Years After the Discovery of Insulin.

A 46-year-old woman was type 1 diabetes diagnosed at the age of 9 who had previously been on an insulin pump. Other co-morbidities included CKD IV, HTN, and hypothyroidism. She presented with hyperglycemia of 400 mg/dl and fluid retention. Her GFR had decreased to 13. Her physical exam was notable for respiratory distress and anasarca. She failed to respond to aggressive IV diuresis and urgent hemodialysis was initiated. The patient had been lost to outpatient follow-up for a year. She had been co-managed by an endocrinologist and a primary care physician but had stopped going to her endocrinologist over a year ago due to inability to afford the co-pays. She subsequently lost her insurance and had to pay out of pocket for her insulin; at this point, she decided to stop seeing her PCP and began to ration her insulin. Due to social stigma, she did not mention her financial issues to her healthcare providers. After identifying these challenges, we decided to start her on a more affordable regimen of NPH insulin. Through social work assistance, we were able to obtain a charity hemodialysis chair and discharge her home. She applied to Medicaid. Healthcare expenditure with regard to diabetes rose to $327 billion from $245 billion in 2012. The price of insulin has continued to increase even after the drug's patent has expired due to the combination of FDA requirements, a monopoly in the insulin market, and the lack of federal price controls and Pharmacy Benefits Managers. The high out of pocket costs for insulin has led to many instances of insulin rationing among both uninsured and insured. This led to death in some cases as well as poorly controlled diabetes with increased complications and mortality as in our case. We present a case report and narrative review on insulin affordability.

PMH22 The Use of Naloxone in Opioid Overdose and Overdose at-Risk Populations: A Retrospective Medical Claims Analysis

Opioid overdose (OOD) is a serious public health crisis in the US. Naloxone, an opioid antagonist, reverses opioid overdoses. Data on prevalence, demographics, and healthcare utilization of OOD and OOD at-risk individuals remain largely unreported. Naloxone prescriptions for these groups are examined. This retrospective analysis used anonymized Optum health claims data, included over 180 million covered lives from Commercial, Managed Medicare and Medicaid plans. Eligible patients were ≥ 18 years old with medical and pharmacy benefits and minimum 30 days continuous enrollment from January 2016 - December 2019. ICD-10 codes for opioid poisoning were used to identify the OOD population (OODP). The OOD at-risk population (ARP) was classified utilizing one or more CDC risk factor criteria, identified through use of both ICD-10 codes and NDC drug codes. NDC drug codes were used to identify individuals prescribed naloxone in both cohorts. Of 7.87 million individuals included, prevalence of OODP declined by 9% from 2016-2019. In the same period, prevalence of ARP declined by 16%. In 2019, the largest group of OODP was aged 30-49 years (35%), male (53%), Caucasian (75%), and Medicaid beneficiaries (60%). In contrast, ARP were mostly aged ≥50 years (65%), female (61%), Caucasian (73%), and Medicare beneficiaries (70%). Only 20% of OODP and 5% of ARP received naloxone in 2019. Cost per opioid overdose episode was $3,200 for individuals on naloxone and $10,400 for those not. This large retrospective analysis suggests that despite CDC guidelines and prevalence of opioid overdose and at-risk patients, naloxone remains under-dispensed, which may result in a high healthcare utilization burden. Preliminary data suggests that previously unrecognized populations appear to be at-risk and require further evaluation. Analysis of healthcare costs associated with at-risk populations and the impact of naloxone administration on disease state management and OOD-associated morbidity and mortality is ongoing.