Evaluation of Medication Therapy Issues, Resolutions, and Adherence Among Persons With HIV in the Pharmacist-Led Patient-Centered HIV Care Model.

OBJECTIVE: To identify medication therapy issues and resolutions and assess their relationship to antiretroviral therapy (ART) adherence among participants of the Patient-Centered HIV Care Model demonstration project. METHODS: Adult persons with HIV (PWH) in the United States were enrolled in the Patient-Centered HIV Care Model from August 2014 to September 2016. Pharmacists conducted regular medication therapy reviews and documented ART and non-ART issues and suggested resolutions. Adherence to ART was calculated using proportion of days covered (PDC), and the mean PDC by the number of ART issues was compared using a generalized linear model with linear trend estimation. RESULTS: The most common ART issue was adherence (57%). Adherence ART issues were resolved by adherence management (48%) or patient education (36%). Participants had a mean of 4.2 ART issues and 6.4 non-ART issues. PDC was 89% for those with 0 ART issues and 73% for those with ≥3 ART issues. Persons with 0 ART issues had an increase in adherence (+8%) in the postperiod, whereas those with ≥3 ART issues had a decrease in adherence (-6%) (P = 0.02) in the postperiod. CONCLUSIONS: Identifying therapy issues could help pharmacists improve care for PWH. Because PWH are an aging population with an increased risk of comorbidities and polypharmacy, pharmacists and providers should collaborate to provide holistic, primary care solutions to address both the number and nature of therapy issues.

Estimated Cost and Savings in a Patient Management Program for Oral Oncology Medications: Impact of a Split-Fill Component.

PURPOSE: A national specialty pharmacy implemented a split-fill option within an oral oncology patient management program to reduce pharmacy costs and medication wastage resulting from early discontinuations. Payers covered dispensed medications at half-quantity intervals for each dispense up to 3 months. Proactive outreach to patients before they had used up the initial dispensed medication quantity helped assess the patient's tolerance to the new medication and adverse effects. This study compared costs for patients with a split-fill option to similar costs for patients without this option taking into account patient discontinuation rates, patient-reported adverse effects rates, estimated pharmacy costs, and potential wastage. METHODS: This retrospective cohort study included patients who were new to therapy on a split-fill medication between September 2015 and August 2017. A 1:1 greedy match algorithm was conducted using propensity variables to match patients from each cohort. Per-month discontinuation rates were determined for both split-fill and non-split-fill groups. The non-split-fill potential wastage was calculated as monthly costs for discontinuations in the following month and weighted by split-fill discontinuation rates. RESULTS: Of the 2,363 program patients who met selection criteria for the 11 medications, 671 patients from each group were matched. Payers with a split-fill program had significant medication savings per covered month ($2,147.60 at 1 month) and at a cumulative 6 months. Modeled wastage indicated that payers without a split-fill program could expect to save $2,646.74 monthly by using this option. Both cohorts had similar rates of adverse effects and time until first reported adverse effect. CONCLUSION: In the first 6 months, the split-fill patient managed program had lower discontinuation rates, significantly reduced pharmacy costs, and reduced potential wastage.

Outcome Evaluation of a Subcutaneous Immunoglobulin Clinical Management Program.

OBJECTIVE: The aim of this study is to compare clinical and cost outcomes of patients undergoing subcutaneous immunoglobulin (SCIG) therapy who were managed by a clinical management program to the matched controls in the United States. METHODS: This was a retrospective cohort study using administrative claims data from the PharMetrics Plus™ (PMTX+) database. The patients from a high-touch SCIG clinical management program were matched to nonprogram patients in PMTX+ database using 1:4 propensity score matching without replacement. All patients were followed for 1 year during the study from September 1, 2011, to June 30, 2014, and both clinical and cost outcomes were compared between the two cohorts using the generalized estimating equation model. FINDINGS: The clinical outcomes were measured by infection- and infusion-related adverse events (AEs). Most of them were not significantly different (P > 0.05) between the intervention group and matched controls. Although the proportion of patients who had a mild less common AE was higher (4.4% vs. 0.0%;P = 0.04), it could be due to increased reporting among the intervention group. The annual adjusted mean total health-care costs of patients in the program (n = 45) were $20,868 lower compared to matched controls (n = 180), representing a 24% lower costs ($66,450 vs. $87,318;P = 0.009). CONCLUSION: This study may demonstrate that clinical management programs for SCIG may be associated with lower health-care costs and comparable infection and severe AE rates. The limitations of this study included a small sample size and a reliance on administrative claim data.

Persistence on HIV preexposure prophylaxis medication over a 2-year period among a national sample of 7148 PrEP users, United States, 2015 to 2017.

INTRODUCTION: Persistence on preexposure prophylaxis for HIV prevention (PrEP) medication has rarely been reported for periods greater than one year, or in real-world settings. This study used pharmacy fill records for PrEP users from a national chain pharmacy to describe persistence on PrEP medication over a two-year period, and to explore correlates with PrEP medication persistence in a real-world setting. METHODS: We analysed de-identified pharmacy fill records of 7148 eligible individuals who initiated PrEP in 2015 at a national chain pharmacy. A standard algorithm was employed to identify TDF-FTC use for PrEP indication. We considered three time periods for persistence, defined as maintaining refills in PrEP care: year 1 (zero to twelve months), year 2 (thirteen to twenty-four months) and initiation to year 2 (zero to twenty-four months). Individuals with 16 or more days of TDF-FTC PrEP dispensed in a 1-month period for at least three-quarters of a given time period (e.g. nine of twelve months or eighteen of twenty-four months) were classified as persistent on PrEP medication for the period. RESULTS: Persistence was 56% in year 1, 63% in year 2 and 41% from initiation to year 2. Individuals aged 18 to 24 had the lowest persistence, with 29% from initiation to year 2. Men had higher persistence than women, with 42% compared to 20% persistent from initiation to year 2. Individuals with commercial insurance and individuals who utilized a community-based specialty pharmacy from the national chain also had higher persistence. Male gender, age >18 to 24 years, average monthly copay of $20 or less, commercial insurance, and utilization of a community-based specialty pharmacy were positively associated in adjusted models with persistence in year 1 and from initiation to year 2; the same correlates, with the exception of utilization of a community-based specialty pharmacy, were associated with higher persistence in year 2. CONCLUSIONS: We found substantial non-persistence on PrEP medication in both year 1 and year 2. Across the entire 2-year period, only two out of every five users persisted on PrEP. Demographic, financial and pharmacy factors were associated with persistence. Further research is needed to explore how social, structural or individual factors may undermine or enhance persistence on PrEP, and to develop interventions to assist persistence on PrEP.

A descriptive study of patients receiving foundational financial assistance through local specialty pharmacies.

OBJECTIVES: To describe the population of patients who received financial assistance from the Good Days Foundation (GDF) as facilitated by Walgreens local specialty pharmacies (LSPs). STUDY DESIGN: This was a retrospective descriptive study. METHODS: This study used a joint foundational and pharmacy claim database between January 1, 2014, and December 31, 2016. RESULTS: Among 1572 eligible patients who received GDF financial assistance as facilitated by Walgreens LSPs, 1524 had disease state information and 14 of these patients receveived financial assistance for 2 disease states (patient count denominator, 1538). The top 3 disease states by patient count were oncology (1403; 91.2%), multiple sclerosis (49; 3.2%), and hepatitis C (39; 2.5%). Of the 777 patients who had complete data and disease state information, 2 received finanical assistance for 2 disease states (denominator, 779); oncology remained the disease with the highest patient count (724; 92.9%). The mean annual financial assistance per patient was highest for hepatitis C ($4156), followed by oncology ($3603) and miscellaneous/rare disease ($1829), which covered 98.8%, 99.3%, and 99.6% of these patients' total co-pay requirements, respectively. In addition to prescription co-pay assistance, 21 patients received travel assistance of $554 per year per patient from GDF. The mean persistence of oncology patients was 170.7 days without a 30-day gap over 1 year of observation time. CONCLUSIONS: The facilitation of treatment by GDF and Walgreens LSPs may be the key to many patients receiving their treatment and maintaining medication persistence. GDF co-pay assistance helped cover most out-of-pocket costs associated with medications and aided with travel expenses for patients, especially in the area of oncology. For many patients, this meant reducing the significant financial barriers to accessing care and facilitating the necessary treatment for their chronic or life-altering disease. Without this assistance, many patients would simply not have been able to meet the expected medication persistence and thus would have received suboptimal treatment.

Outcome evaluation of a pharmacy-based therapy management program for patients with cystic fibrosis.

OBJECTIVE: To compare medication adherence, pulmonary exacerbations, healthcare utilization, and costs for patients with cystic fibrosis (CF) who utilized a pharmacy-based therapy management program to a matched control group. We hypothesized that patient management services would be associated with better medication adherence, and thus require fewer visits to the emergency room or hospitalizations. METHODS: This retrospective, observational cohort study used claims data from the MORE2 claims Registry®. The sample consisted of CF patients, aged 6+, who had ≥1 pharmacy claim for inhaled tobramycin, inhaled aztreonam, ivacaftor, or dornase alfa from 6/2/2014-5/31/2015. Adherence was measured as proportion of days covered (PDC). Propensity score matching and multivariable regression techniques were used to compare outcomes in program participants to matched controls. RESULTS: Of the 236 intervention and 724 control patients meeting selection criteria, 202 were propensity-matched from each cohort. Relative to the control cohort, program patients had 23% higher mean PDC for tobramycin (IRR = 1.23, P = 0.01) and were twice as likely to be adherent to tobramycin (PDC ≥ 80%) than matched controls (OR = 2.14, P = 0.04). Program patients had fewer ER visits (IRR = 0.52, P < 0.01) and slightly lower ER costs (IRR = 0.66, P = 0.06) than the control patients. CONCLUSION: A pharmacy-based therapy management program for CF patients was associated with higher adherence to inhaled tobramycin and lower ER rates. Pharmacies that provide therapy management can support effective CF care management.

Clinical and economic outcomes of a "high-touch" clinical management program for intravenous immunoglobulin therapy.

OBJECTIVE: To compare clinical and economic outcomes of patients who received intravenous immunoglobulin (IVIG) therapies and were managed by a clinical management program vs the outcomes of matched controls using administrative claim data. METHODS: This retrospective cohort study used the PharMetrics Plus™ claim database between September 1, 2011 and June 30, 2014. Patients in the intervention group were from a "high-touch" IVIG clinical management program administered by a home infusion specialty pharmacy. A greedy propensity score matching algorithm was used to identify a control group from non-program patients. Generalized estimating equation models were employed to evaluate differences between cohorts who were followed for 1 year. RESULTS: Clinical outcomes were measured as infections and infusion-related adverse events. The proportion of patients who had serious bacterial infections was significantly lower (4.13% vs 7.75%, P=0.049) in the intervention group (n=242) compared to the control group (n=968). Other clinical outcomes assessed were not different between cohorts (P>0.050). The economic outcomes were measured as healthcare costs. The annual adjusted mean total health care costs of patients in the program were $26,522 lower compared to matched controls, representing a 20% lower cost ($109,476 vs $135,998, P=0.002). A major contribution to this difference ($17,269) was IVIG-related total outpatient cost (intervention vs control groups: $64,080 vs $81,349, P=0.001). CONCLUSION: The patients in this high-touch IVIG clinical management program appeared to have comparable infections or adverse event rates and significantly lower total health costs compared to their matched controls.

Local specialty pharmacy and specialty clinic collaboration assists access to hepatitis C direct-acting antivirals.

OBJECTIVES: To measure prescribed time to therapy (TtT) and sustained virologic response (SVR). Secondary objectives were to assess insurance appeals and copay assistance amount facilitated by a local specialty pharmacy (LSP). METHODS: This descriptive, retrospective study used a joint clinical and pharmacy database of patients who were prescribed direct-acting antivirals (DAAs) at a single-center liver specialty clinic and received LSP services from December 2013 to December 2015. RESULTS: Among 388 patients prescribed DAAs, 364 (94%) patients, who were 18 years of age or older, initiated DAA therapy, and received LSP services, were included in the study. Of these, 211 (58.0%) had cirrhosis, 159 (43.7%) had previous treatment, and 57 (15.7%) had previous liver transplants. Most patients had commercial insurance (n = 249; 68.4%), and 295 (81.0%) required prior authorization. Insurance initially denied coverage to 70 patients (19.2%), for who the LSP drafted appeals for 60 (85.7%). Copay information was available for 154 LSP patients. Although 66 had initial copays of more than $20 per month, the LSP was able to assist most (98.1%; n = 151) with copay reductions to $20 or less. Full financial assistance was received for 20 patients without insurance or any DAA coverage. Among 171 patients with SVR and prescribed TtT information, mean TtT was 12 days (median 4 days), and most received medications within 10 days (n = 122; 71.3%). The overall intention-to-treat SVR rate was 86.8%; the per-protocol (PP) SVR rate was 93.8%. CONCLUSION: Collaboration between providers and an LSP minimized delay in therapy, lowered rates of DAA denial, facilitated patient financial assistance, and helped to optimize clinical outcomes. The PP-SVR rate for this study was similar to rates reported in the literature and higher than expected, considering the inclusion of earlier-generation DAAs and many patients with advanced liver disease.

New all oral therapy for chronic hepatitis C virus (HCV): a novel long-term cost comparison.

BACKGROUND: In the US, the prevalence of hepatitis C virus (HCV) has surpassed the prevalence of human immunodeficiency virus (HIV), with about 3.3 million people chronically infected with the disease. Given the aging of the Baby Boomer generation and the subsequent implementation of age-based screening recommendations, HCV diagnoses are expected to increase. Utilization of anti-viral pharmacotherapy is also expected to increase as more effective and tolerable all-oral therapies for HCV become available in the United States. This research allows payors to assess the disease burden and treatment impact of HCV in their member group. METHODS: A set of three integrated economic models was developed to estimate the disease and cost burden of HCV based on existing literature, wholesale acquisition costs, industry standards, and actuarial judgment. Model 1 estimates the HCV antibody prevalence of HCV in a payer's member group based on population size and the age, sex, and region distribution of the members. Model 2 predicts the number of uncured chronic HCV members who represent the future treatment and medical cost burden for the payer over the next 14 years. Model 3 contrasts the pharmacy, medical, and overall costs for treatment and medical care over 14 years for three therapeutic scenarios: interferon-based standard of care (SOC), all oral therapy, and natural course of disease progression, while accounting for the frequency of HCV genotype within the member population. RESULTS: In a payer population of 100,000 members with an age, sex, and region distribution matching the United States, the seroprevalence of HCV was estimated to be 1.26 %. Combined pharmacy and medical costs for uncured chronic HCV positive members was least expensive for all oral therapy. The per patient with HCV cost savings for all oral therapy compared to SOC were about $3000 per year over 14 years. In a sensitivity analysis, the 12-week all oral therapy for genotype 1 provided overall cost savings vs. a 24-week interferon-based SOC regimen until all oral therapy costs exceeded $99,000. CONCLUSIONS: In most modeled scenarios, the all-oral therapeutic scenario was less costly than SOC, even in sensitivity analyses.

Which modifiable health risks are associated with changes in productivity costs?

The purpose of this retrospective, longitudinal study was to assess longitudinal associations between modifiable health risks and workplace absenteeism and presenteeism and to estimate lost productivity costs. Across the 4-year study period (2007-2010), 17,089 unique employees from a large US computer manufacturer with a highly technical workforce completed at least 1 health risk assessment. Generalized estimating equation models were used to estimate the mean population-level absenteeism and presenteeism for 11 modifiable health risks and adjust for 9 sociodemographic and employment-related factors. Because patient age was highly correlated with several other variables, the analysis was stratified by age (<45 vs. ≥45 years). For all ages, poor emotional health, inadequate exercise, tobacco use, and having a body mass index (BMI) greater than 35 (all P<.05) were consistently associated with both absenteeism and presenteeism. Having a BMI over 35 and poor emotional health were associated with the largest impact in absenteeism (0.46 days) and presenteeism (4.03 days), respectively. Younger and older workers had similar associations between health risks and presenteeism; however, hypertension, blood sugar, inadequate exercise, and alcohol were associated (P⋜.01) with greater absenteeism among older but not younger workers. The results suggest that productivity loss is strongly related to emotional health and obesity-related health risks (eg, BMI, exercise) but differs by age. These findings could help prioritize preventive health programs offered by employers at their worksite health centers. Given the aging of the US workforce, keeping older workers healthy and productive will be crucial to remaining competitive in the global economy. (Population Health Management 2015;18:30-38).

The effect of a collaborative pharmacist-hospital care transition program on the likelihood of 30-day readmission.

PURPOSE: The effect of a collaborative pharmacist-hospital care transition program on the likelihood of 30-day readmission was evaluated. METHODS: This retrospective cohort study was conducted in two acute care hospitals within the same hospital system in the southeastern United States. One hospital initiated a care transition program in January 2011; the other hospital did not have such a program. All patients who were discharged from either hospital to home from January 1, 2010, through December 31, 2011, were included in the study. The two key program components included bedside delivery of postdischarge medications and follow-up telephone calls two to three days after discharge. The likelihood of readmission was assessed using multiple logistic regression. RESULTS: Over the 2-year study period, 19,659 unique patients had 26,781 qualifying index admissions, 2,523 of which resulted in a readmission within 30 days of discharge. After adjusting for various demographic and clinical characteristics, the usual care group (i.e., patients who did not participate in the program) had nearly twice the odds of readmission within 30 days (odds ratio [OR], 1.90; 95% confidence interval [CI], 1.35-2.67), compared with the intervention group (i.e., program participants). For patients age 65 years or older, those in the usual care group had a sixfold increase in the odds of a 30-day readmission (OR, 6.05; 95% CI, 1.92-19.00) relative to those in the intervention group. CONCLUSION: A care transition program was associated with a lower likelihood of readmission and had a greater effect on older patients.

Planning influenza vaccination programs: a cost benefit model.

BACKGROUND: Although annual influenza vaccination could decrease the significant economic and humanistic burden of influenza in the United States, immunization rates are below recommended levels, and concerns remain whether immunization programs can be cost beneficial. The research objective was to compare cost benefit of various immunization strategies from employer, employee, and societal perspectives. METHODS: An actuarial model was developed based on the published literature to estimate the costs and benefits of influenza immunization programs. Useful features of the model included customization by population age and risk-level, potential pandemic risk, and projection year. Various immunization strategies were modelled for an average U.S. population of 15,000 persons vaccinated in pharmacies or doctor's office during the 2011/12 season. The primary outcome measure reported net cost savings per vaccinated (PV) from the perspective of various stakeholders. RESULTS: Given a typical U.S. population, an influenza immunization program will be cost beneficial for employers when more than 37% of individuals receive vaccine in non-traditional settings such as pharmacies. The baseline scenario, where 50% of persons would be vaccinated in non-traditional settings, estimated net savings of $6 PV. Programs that limited to pharmacy setting ($31 PV) or targeted persons with high-risk comorbidities ($83 PV) or seniors ($107 PV) were found to increase cost benefit. Sensitivity analysis confirmed the scenario-based findings. CONCLUSIONS: Both universal and targeted vaccination programs can be cost beneficial. Proper planning with cost models can help employers and policy makers develop strategies to improve the impact of immunization programs.