Managed Care Pharmacy Research Articles

ES04.03 Overcoming Resistance by Improving Treatment Compliance

ES04.03 Overcoming Resistance by Improving Treatment Compliance

Budget Impact Analysis of Eliglustat for the Treatment of Gaucher Disease Type 1 in the United States.

Gaucher disease type 1 (GD1) is a rare, genetic, lysosomal storage disease with no cure. Current treatment options include intravenous (IV) enzyme replacement therapy ([ERT]; imiglucerase, velaglucerase alfa, or taliglucerase alfa) or oral substrate reduction therapy ([SRT]; eliglustat or miglustat). The cost to U.S. payers of an IV-administered drug can vary depending on the site of care (i.e., home, outpatient clinic, or hospital setting). Treatment with oral eliglustat may present an opportunity for cost savings. To evaluate the budget impact from a U.S. payer perspective associated with transitioning patients receiving ERTs to the oral SRT eliglustat for the treatment of adults with GD1. A budget impact model estimated the change in pharmaceutical and administration costs resulting from increasing the market share of eliglustat from 12% (current) to 44% (new). The market share for eliglustat was drawn equally from existing shares of imiglucerase (40%) and velaglucerase alfa (40%) and assumed to be static over the analysis period. ERT costs were adjusted to account for site of care-based markup and the proportion of patients receiving infusions in each site of care (home, infusion center, or hospital outpatient). Annual ERT costs were calculated assuming a biweekly dose of 47.4 U per kg, a 72-kg patient weight, and 24 infusions per year. The effect of key variables was tested in the sensitivity analyses. All costs are expressed in 2017 U.S. dollars. In a new plan with 5 million members and 25 GD1 treated patients, increased use of eliglustat resulted in an annual savings of $1,526,710 and a total savings of $4,580,130 (13.6%) over 3 years. The corresponding annual per member per month savings was $0.025. This is further illustrated in the sensitivity and scenario analyses where the use of eliglustat was cost saving in all cases. Shifting more patients receiving ERT in the hospital outpatient setting to eliglustat resulted in increased savings. Based on these analyses, increased use of eliglustat resulted in meaningful cost savings to a payer's overall budget. Cost savings are highest among patients switching from ERT administered in a hospital outpatient setting. The results suggest that cost savings are also likely achievable from initiating patients on oral eliglustat instead of infusion-based therapy from the outset of treatment. This study was sponsored by Sanofi Genzyme. Evidera received funding from Sanofi Genzyme to conduct this study and prepare the manuscript. The sponsor collaborated on the study design, analysis, interpretation of results, and writing of the manuscript. Nalysnyk is an employee of and shareholder in Sanofi Genzyme. Ward, Cele, and Uyei are employees of Evidera, which provides consulting and other research services to biopharmaceutical companies. Sugarman was also an Evidera employee when the study was being conducted and the manuscript written. This study was presented as a poster at the Academy of Managed Care Pharmacy Nexus 2016, October 3-6, 2016; National City, MD, and at the International Society for Pharmacoeconomics and Outcomes Research, 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.

Effect of Lumacaftor/Ivacaftor on Pulmonary Exacerbation Rates in Members with Cystic Fibrosis in a Medicaid Population.

Lumacaftor/ivacaftor (LUM/IVA) is indicated for patients with cystic fibrosis (CF) homozygous for the F508del mutation in the CFTR gene. In clinical trials, LUM/IVA decreased pulmonary exacerbation rates. To our knowledge, there is no published data evaluating real-world outcomes for Medicaid patients receiving LUM/IVA. To compare CF pulmonary exacerbation rates before and after initiation of LUM/IVA in 1 state's Medicaid program. This pre-post claims analysis screened fee-for-service and managed Medicaid members who had ≥ 1 pharmacy claim for LUM/IVA between July 2, 2015, and September 30, 2016. Members were included if they were aged ≥ 6 years with a CF diagnosis and homozygous for the F508del mutation, consistent with the indication at study initiation. Exclusion criteria included Medicaid as a secondary payer or any break in coverage during the study. The index date was defined as the first claim for LUM/IVA. Demographics and outcomes were derived from pharmacy and medical claims. Outcomes included overall rate of pulmonary exacerbations (reported as the total events for the study population 6 months before and after the index date and average annualized rate). Pulmonary exacerbation was defined as any combination of medical claims for an emergency room (ER) visit or inpatient hospitalization with a CF pulmonary exacerbation or respiratory infection (ICD-9/10-CM codes) or pharmacy claims for an oral or intravenous antibiotic (excluding macrolides). A gap of > 7 days was considered a new pulmonary exacerbation. Paired t-test was used to test significance. 21 patients met inclusion criteria with an average age at treatment initiation of 20.1 years. Average proportion of days covered (SD) was 0.62 (0.29). The number of pulmonary exacerbations increased from 45 to 48 during the 6 months before and after the index date, respectively, and the annualized rate increased from 4.37 to 4.66 (P = 0.69). While the number of pulmonary exacerbations associated with antibiotics alone increased (23 to 33; P = 0.08), those associated with at least 1 ER visit or inpatient hospitalization decreased (22 to 15; P = 0.08). This analysis did not find a decrease in pulmonary exacerbation rate for Medicaid members receiving LUM/IVA; however, adherence was low. Further study of similar populations is needed to better understand the long-term effect of treatment. No outside funding supported this study. The authors have nothing to disclose. A poster of this project was presented at the Academy of Managed Care Pharmacy Managed Care & Specialty Pharmacy Annual Meeting 2018 in Boston, MA, on April 23-26, 2018.

The Effect of a Pediatric Rare Disease on Subscriber Retention Rates for Commercial Health Insurers in the United States.

The advent of personalized medicine creates opportunities for regenerative therapies to deliver extended clinical benefit from a single administration. Policymakers and health insurers in the United States are evaluating coverage and payment arrangements for these therapies. One challenge involved in these evaluations is the perception that subscribers change insurers relatively often. However, the effect of pediatric rare diseases on retention rates for commercial health insurers has not been well studied. To develop estimates for subscriber retention by a commercial insurer for up to 10 years. Three population cohorts were examined: (1) all subscribers, (2) subscribers with any dependent aged 16 years or younger, and (3) subscribers with any dependent aged 16 years or younger diagnosed with a chronic rare disease that typically results in a debilitating state or high mortality, usually associated with high health care costs regardless of whether a treatment is available. The analysis was conducted for a sample of fully insured and self-insured group business within the commercial health insurance market for these study cohorts. The MarketScan Commercial Claims and Encounters research database covering the time period from January 1, 2007, through December 31, 2016, was used as the basis for the analysis. Subscribers were included in the family-based cohorts beginning with the first observed month with a dependent aged 16 years or younger and were retained in the analysis until the subscriber or insurer withdrew from the dataset (whichever came first). Subscribers were included in the family-based rare disease cohorts if their qualifying dependent was reported with at least 2 occurrences for any of the rare diseases studied. A Kaplan-Meier estimator was used to produce retention rates for all populations for up to 120 months. An adjustment for interval censoring was applied to the family-based cohorts. A log rank test with chi-square statistic was used to determine statistical significance. The analysis found that the subscriber retention rate within the self-insured groups was higher than within the fully insured groups (P < 0.0001). In addition, the probability of retaining subscribers with a dependent aged 16 years or younger compared with all subscribers was significantly greater (P < 0.0001). The analysis also found the probability of retaining subscribers with a qualifying dependent with a rare disease compared with subscribers with any dependent aged 16 years or younger was significantly greater (P < 0.0001). This study demonstrated that families with a child with a rare disease remained with their commercial health insurer longer than families who did not have a child with a rare disease. The analysis will be a useful resource when evaluating alternative payment arrangements and cost/benefit analyses of regenerative therapies that offer an extended duration of clinical benefit. This study was sponsored by AveXis, which provided input into the study design, decided to submit the study results for publication, and performed an editorial review of the manuscript. Kuester, Jackson, and Runyan received consulting fees from AveXis during the conduct of this study. Pezalla and Nussbaum received consulting fees from Milliman during the conduct of this study. Nussbaum reports consulting fees from Sarepta Therapeutics and Ultragenyx Pharmaceutical outside of this study and serves on the Commercial Advisory Board of Gilead Sciences. A variation on this topic was presented at the Academy of Managed Care Pharmacy Nexus 2018; October 22-25, 2018; Orlando, FL.

What Patients Know About Services to Help Manage Chronic Diseases and Medications: Findings from Focus Groups on Medication Therapy Management.

Managing and treating patients with multiple chronic conditions presents challenges on many levels. Pharmacist-delivered medication therapy management (MTM) services, mandated as part of the Medicare Part D drug benefit, are designed to help patients manage their chronic conditions and medications. To identify factors that influence patient understanding and use of MTM services and potential strategies to educate individuals about MTM. Participants who had at least 2 chronic conditions, were taking 2 or more prescription medications, and were aged 18 years or older were recruited from community-based settings to participate in focus groups. The focus groups aimed to identify participants' perceptions and use of MTM services, barriers and facilitators to utilization, and medication problems. Participants were asked to complete a 14-item health care questionnaire and view a brief, 3-minute video introducing the topic of MTM before the group discussion. The health care questionnaire data were analyzed in Microsoft Excel. The focus group responses were transcribed and entered into the computer program ATLAS.ti for thematic analysis. Two independent reviewers qualitatively coded the discussion question responses; a third reviewer investigated discrepancies and facilitated consensus among the reviewers. Participants (N = 27) were mostly female (70.4%), college educated (62.9%), and had Medicare insurance (81.5%). Seven themes were identified: (1) new proposed names for MTM, (2) mechanisms to gain interest in and to promote the value of MTM, (3) familiarity with MTM, (4) pharmacists' training and expertise in MTM, (5) experience with MTM, (6) reasons for nonparticipation in MTM, and (7) preferred method to learn about MTM. Participants did not understand the term "medication therapy management" and felt the interpretation of "therapy"' differed between health care professionals and the public. Some participants used MTM services to learn about appropriate use of their medications, while others were unsure about their eligibility, associated costs, and how to access the services. Participants had limited pharmaceutical knowledge but felt pharmacist-provided MTM services were helpful. Participants were unfamiliar with pharmacists' skills and training. Participants' experiences with MTM services ranged from disregarding the invitation to participate to having pharmacists identify drug-drug interactions. Reasons for nonparticipation in MTM services included being unaware of their eligibility, failing to read excessive information from insurance companies, and being uncertain of the identity of the telephone caller. Preferred methods for learning more about MTM services included the Internet, e-mail, information availability at physician's office, and television advertisements. These results suggest that the lay public remains largely unaware of MTM services and that the term "MTM" is not well understood. Clearly, tailored public health campaigns and patient engagement strategies are needed to promote MTM in chronic disease management, pharmacists as respected providers, and the importance of the prescriber-MTM pharmacist collaborative relationship in managing medications for patients with multiple chronic conditions. Grant funding from SinfoniaRx to Taylor, Axon, Campbell, Fair, and Warholak was used to help conduct this project. Boesen is employed by SinfoniaRx. The other authors have nothing to disclose. This original research was presented as a poster at the Academy of Managed Care Pharmacy 27th Annual Meeting and Expo; April 7-10, 2015; San Diego, CA.

Integrating Innovative Telehealth Solutions into an Interprofessional Team-Delivered Chronic Care Management Pilot Program.

Pharmacist-delivered medication therapy management (MTM) services can improve patient outcomes, yet little is known about outpatient, interprofessional telepharmacy programs. To evaluate an outpatient, interprofessional telehealth chronic care management (CCM) pilot program. This 6-month program integrated family medicine providers, a university-based medication management telepharmacist, and an interprofessional care coordinator using telehealth solutions for CCM and pharmacy education services. A physician referred patients at risk for medicine-related problems to the telepharmacist. Eligible patients had 3 or more chronic conditions or took at least 5 medications, were aged 18 years and older, and had at least 1 appointment with their primary care provider during the program. The care coordinator met patients in person to facilitate these virtual clinic processes. The telepharmacist conducted a comprehensive medication review (CMR) via video-conferencing technology, providing CCM based on primary diagnosis, current medications and allergies, laboratory results, and previous chart notes. The consultation was documented in the electronic health record (EHR) for provider review and modification in real time. 69 patients received telepharmacy consultations and on-site registered nurse support during the program. Most patients were female (56.5%), aged 51-70 years (60.1%), Caucasian (72.4%), and non-Hispanic/Latino (71.0%). Patients had 1-9 chronic conditions, such as hypertension (82.6%), diabetes (56.5%), hyperlipidemia (31.9%), depression (30.4%), and osteoporosis (29.0%). Most patients (94.2%) took at least 5 chronic disease medications, such as statins (11.2%), nonsteroidal anti-inflammatory drugs (8.4%), selective serotonin reuptake inhibitors (6.5%), beta blockers (6.5%), and calcium channel blockers (5.6%). The telepharmacist completed 200 interventions for safety (49.0%), vaccines (24.5%), care gaps per national consensus guidelines (13.5%), adherence (10.0%), and cost savings (3.0%). Patients' providers accepted one third (n = 75, 37.5%) of the telepharmacist recommendations (e.g., monitoring and medication changes). This telehealth program constituted an added service for patients while simultaneously filling a gap in on-site pharmacist counseling services. Integrating the telepharmacist and registered nurse was crucial to clinical service provision. The results are encouraging; however, more research must examine the effectiveness of telehealth services in reaching underserved populations, improving patient care, and decreasing health care costs. External funding from SinfonîaRx was used to help conduct this project. Boesen is employed by SinfonîaRx. At the time this project was conducted, Martin was employed at the University of Arizona Medication Management Center but is now employed by SinfonîaRx. The other authors have no disclosures to report. This original research was presented as a poster at the Academy of Managed Care Pharmacy Nexus 2015; October 26-29, 2015; in Orlando, FL.

Treatment Patterns Among Patients with Psoriatic Arthritis Treated with a Biologic in the United States: Descriptive Analyses from an Administrative Claims Database.

In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use. To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor. Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database. Biologic therapies comprised those that were approved by the FDA for the treatment of PsA at the time of the study initiation (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, or ustekinumab). Outcomes included adherence, persistence, and discontinuation of the index biologic; initiation of adjunctive medications (nonbiologics, including those commonly used for pain and/or inflammation); and dose escalation of the index biologic during the 12-month follow-up period. Of the 1,235 patients included, 52.5% were female, and mean (SD) age was 50.3 (12.1) years. The mean (SD) duration of persistence with a newly initiated index biologic (etanercept [48.1%], adalimumab [24.0%], infliximab [10.4%], golimumab [8.3%], ustekinumab [7.2%], or certolizumab pegol [2.0%]) was 246 (128) days; 44.5% of patients persisted with the index biologic for ≥ 12 months. During the 12-month follow-up period, 22.9% of patients switched to a different biologic, 26.8% discontinued without switching or restarting, and 5.8% discontinued and restarted the index biologic. Of the 1,010 patients who persisted with the index biologic for > 90 days, 45.6% received ≥ 1 adjunctive medication during the period from 90 days after the index date to the end of persistence or 12 months. The most commonly initiated adjunctive medications were corticosteroids (22.0%), opioids (17.1%), and nonsteroidal anti-inflammatory drugs (12.9%). Overall, 9.6% of patients had a dose escalation of the index biologic in the immediate 12-month post-index period. This real-world study of treatment patterns for PsA, which used a large U.S. claims database, demonstrated that the majority of patients with PsA discontinued their index biologic (TNFi or anti-IL-12/23 inhibitor) before 12 months. Nearly half of patients initiated an adjunctive medication, many of which were pain and conventional anti-inflammatory medications. This study was sponsored by Novartis Pharmaceuticals. Optum was commissioned by Novartis to conduct this study, but employment was not contingent on results of the study. Walsh is a paid consultant for Novartis. Adejoro was an employee of Optum at the time of the study and writing of the manuscript. Chastek is an employee of Optum. Palmer and Hur are employees of Novartis. Results of this study were presented as an abstract and poster at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX; and the EULAR 2017 Annual European Congress of Rheumatology; June 14-17, 2017; Madrid, Spain.

AMCP Partnership Forum: Managing Care in the Wave of Precision Medicine.

Precision medicine, the customization of health care to an individual's genetic profile while accounting for biomarkers and lifestyle, has increasingly been adopted by health care stakeholders to guide the development of treatment options, improve treatment decision making, provide more patient-centered care, and better inform coverage and reimbursement decisions. Despite these benefits, key challenges prevent its broader use and adoption. On December 7-8, 2017, the Academy of Managed Care Pharmacy convened a group of stakeholders to discuss these challenges and provide recommendations to facilitate broader adoption and use of precision medicine across health care settings. These stakeholders represented the pharmaceutical industry, clinicians, patient advocacy, private payers, device manufacturers, health analytics, information technology, academia, and government agencies. Throughout the 2-day forum, participants discussed evidence requirements for precision medicine, including consistent ways to measure the utility and validity of precision medicine tests and therapies, limitations of traditional clinical trial designs, and limitations of value assessment framework methods. They also highlighted the challenges with evidence collection and data silos in precision medicine. Interoperability within and across health systems is hindering clinical advancements. Current medical coding systems also cannot account for the heterogeneity of many diseases, preventing health systems from having a complete understanding of their patient population to inform resource allocation. Challenges faced by payers, such as evidence limitations, to inform coverage and reimbursement decisions in precision medicine, as well as legal and regulatory barriers that inhibit more widespread data sharing, were also identified. While a broad range of perspectives was shared throughout the forum, participants reached consensus across 2 overarching areas. First, there is a greater need for common definitions, thresholds, and standards to guide evidence generation in precision medicine. Second, current information silos are preventing the sharing of valuable data. Collaboration among stakeholders is needed to support better information sharing, awareness, and education of precision medicine for patients. The recommendations brought forward by this diverse group of experts provide a set of solutions to spur widespread use and application of precision medicine. Taken together, successful adoption and use of precision medicine will require input and collaboration from all sectors of health care, especially patients. DISCLOSURES This AMCP Partnership Forum and the development of the proceedings document were supported by Amgen, Foundation Medicine, Genentech, Gilead, MedImpact, National Pharmaceutical Council, Precision for Value, Sanofi, Takeda, and Xcenda.

Understanding the Relationship between Primary Care Provider (PCP) Encounter Cadence, Medication Adherence, and Diabetes Control

Introduction: Regular PCP encounters are associated with wellbeing; there is limited evidence to support the ideal PCP encounter cadence to optimize patient outcomes. The aim of this study was to measure the association between PCP encounter cadence and medication adherence and diabetes control, among those newly diagnosed with T2DM. Methods: A cohort of 7,106 persons enrolled in a Medicare Advantage health plan and newly diagnosed with T2DM between 7/1/12-6/30/13, was identified and followed for 36 months. Two methods measured PCP encounter cadence: total PCP encounters (frequency) and quarters with PCP encounter (regularity). Proportion of days covered (PDC) assessed noninsulin diabetes medication (NIDM) adherence (PDC ≥80.0%). Diabetes control was defined as A1c ≤ 8.0%. Logistic regression was used to measure the relationship between PCP encounter cadence and outcomes (NIDM adherence, diabetes control). Covariates included patient demographics, Charlson Comorbidity Index score, chronic conditions, healthcare utilization, insulin use, and prior NIDM adherence and diabetes control. Results: Overall, 5,212 and 326 people met inclusion criteria for the NIDM adherence and diabetes control analyses, respectively. Adjusted models indicated that each additional PCP encounter was associated with a 12.3% increase in the likelihood of NIDM adherence (95% CI 1.10, 1.15), and each additional quarter with a PCP encounter was associated with a 27.4% increase in the likelihood of NIDM adherence (95% CI 1.22, 1.33). PCP encounters (OR 1.06; 95% CI 1.00, 1.12) and quarters with a PCP encounter (OR 1.13; 95% CI 0.98, 1.30) were directionally associated with diabetes control. Conclusion: Our findings suggest that frequency and regularity of PCP encounters were associated with medication adherence. This study contributes to the data needed to establish evidence-based guidelines for PCP encounter cadence, for those newly diagnosed with T2DM. Disclosure S.E. Wixson: None. J. Dobbins: Employee; Self; Humana Inc. T.A. Cordier: Employee; Self; Humana Inc.. Stock/Shareholder; Self; Humana Inc.. G. Haugh: None. A. Renda: None. L.E. Happe: Employee; Self; Humana. Other Relationship; Self; Journal of Managed Care Pharmacy. A. Turchin: Research Support; Self; Sanofi-Aventis. Advisory Panel; Self; Merck Sharp &amp; Dohme Corp., Monarch Medical Technologies. Stock/Shareholder; Self; Brio Systems. Research Support; Self; Eli Lilly and Company.

AMCP Partnership Forum: Managing Care in the Wave of Precision Medicine.

Precision medicine, the customization of health care to an individual's genetic profile while accounting for biomarkers and lifestyle, has increasingly been adopted by health care stakeholders to guide the development of treatment options, improve treatment decision making, provide more patient-centered care, and better inform coverage and reimbursement decisions. Despite these benefits, key challenges prevent its broader use and adoption. On December 7-8, 2017, the Academy of Managed Care Pharmacy convened a group of stakeholders to discuss these challenges and provide recommendations to facilitate broader adoption and use of precision medicine across health care settings. These stakeholders represented the pharmaceutical industry, clinicians, patient advocacy, private payers, device manufacturers, health analytics, information technology, academia, and government agencies. Throughout the 2-day forum, participants discussed evidence requirements for precision medicine, including consistent ways to measure the utility and validity of precision medicine tests and therapies, limitations of traditional clinical trial designs, and limitations of value assessment framework methods. They also highlighted the challenges with evidence collection and data silos in precision medicine. Interoperability within and across health systems is hindering clinical advancements. Current medical coding systems also cannot account for the heterogeneity of many diseases, preventing health systems from having a complete understanding of their patient population to inform resource allocation. Challenges faced by payers, such as evidence limitations, to inform coverage and reimbursement decisions in precision medicine, as well as legal and regulatory barriers that inhibit more widespread data sharing, were also identified. While a broad range of perspectives was shared throughout the forum, participants reached consensus across 2 overarching areas. First, there is a greater need for common definitions, thresholds, and standards to guide evidence generation in precision medicine. Second, current information silos are preventing the sharing of valuable data. Collaboration among stakeholders is needed to support better information sharing, awareness, and education of precision medicine for patients. The recommendations brought forward by this diverse group of experts provide a set of solutions to spur widespread use and application of precision medicine. Taken together, successful adoption and use of precision medicine will require input and collaboration from all sectors of health care, especially patients. DISCLOSURES This AMCP Partnership Forum and the development of the proceedings document were supported by Amgen, Foundation Medicine, Genentech, Gilead, MedImpact, National Pharmaceutical Council, Precision for Value, Sanofi, Takeda, and Xcenda.

Development of a Pharmacoeconomic Model to Demonstrate the Effect of Clinical Pharmacist Involvement in Diabetes Management.

A data collection tool was developed and nationally deployed to clinical pharmacists (CPs) working in advanced practice provider roles within the Department of Veterans Affairs to document interventions and associated clinical outcomes. Intervention and short-term clinical outcome data derived from the tool were used to populate a validated clinical outcomes modeling program to predict long-term clinical and economic effects. To predict the long-term effect of CP-provided pharmacotherapy management on outcomes and costs for patients with type 2 diabetes. Baseline patient demographics and biomarkers were extracted for type 2 diabetic patients having > 1 encounter with a CP using the tool between January 5, 2013, and November 20, 2014. Treatment biomarker values were extracted 12 months after the patient's initial visit with the CP. The number of visits with the CP was extracted from the electronic medical record, and duration of visit time was quantified by Current Procedural Terminology codes. Simulation modeling was performed on 3 patient cohorts-those with a baseline hemoglobin A1c of 8% to < 9%, 9% to < 10%, and ≥ 10%-to estimate long-term cost and clinical outcomes using modeling based on pivotal trial data (the Archimedes Model). A sensitivity analysis was conducted to assess the extent to which our results were dependent on assumptions related to program effectiveness and costs. A total of 7,310 patients were included in the analysis. Analysis of costs and events on 2-, 3-, 5-, and 10-year time horizons demonstrated significant reductions in major adverse cardiovascular events (MACEs), myocardial infarctions (MIs), episodes of acute heart failure, foot ulcers, and foot amputations in comparison with a control group receiving usual guideline-directed medical care. In the cohort with a baseline A1c of ≥ 10%, the absolute risk reduction was 1.82% for MACE, 1.73% for MI, 2.43% for acute heart failure, 5.38% for foot ulcers, and 2.03% for foot amputations. The incremental cost-effectiveness ratios for cost per quality-adjusted life-year during the 2-, 3-, 5-, and 10-year time horizons were cost-effective for the cohorts of patients with a baseline A1c of 9% to < 10% and ≥ 10%. CPs acting as advanced practice providers reduced A1c from baseline for veterans with type 2 diabetes compared with modeled usual care. Archimedes modeling of the A1c reductions projects a decreased incidence of diabetes complications and overall health care spending when compared with modeled usual care. There was no outside funding source or sponsor for this project. None of the authors report any conflicts of interest. The views expressed in this article are those of the authors and do not necessarily reflect the views or policies of the U.S. Department of Veterans Affairs. Preliminary data from this project were previously presented in abstract form at the Academy of Managed Care Pharmacy 27th Annual Meeting and Expo; April 8-10, 2015; in San Diego, California.

PHP10 - Combatting Rising Obesity in AMCP Dossiers? The New AMCP Dossier Format – Version 4.0

In 2000, the Academy of Managed Care Pharmacy (AMCP) released a Format for Formulary Submissions. This format provided a framework for manufacturers to submit evidence required by healthcare decision makers in their consideration of products for formulary placement. In April 2016, a new format iteration (version 4.0) was released; one key change was the ability to submit separate product dossiers for each indication. This research investigates the frequency of drugs being approved by the Food and Drug Administration (FDA) with multiple indications to which this new recommendation would apply. FDA New Drug Application and Biologic License Application Efficacy Supplement and New Molecular Entity (NME) approvals were analyzed (01/01/2016-11/31/2017) and the number of previous FDA-approved indications for each drug approved was extracted. Statistical tests were completed using SAS® version 9.4. 240 FDA approvals were identified (first-half [H1] 2016: 53, second-half [H2] 2016: 45, H1 2017: 66, H2 2017: 76). Overall, 60% (144/240) were NMEs with had prior approval in another indication, with the number of NMEs with prior approvals increasing over time (H1 2016: 72%, H2 2016: 58%, H1 2017: 62%, H2 2017: 51%, p=0.02 [Cochrane-Armitage trend test]). Of the 96 non-NMEs, the average number of prior FDA approvals was 2.2, becoming significantly greater over time (H1 2016: 1.0, H2 2016: 2.0, H1 2017: 2.2, H2 2017: 2.5, P<0.0001 [Poisson regression]). Nine therapies had at least 5 indications or more (H1 2016: 1.9%, H2 2016: 2.2%, H1 2017: 3.0%, H2 2017: 6.6%). FDA approvals are increasingly associated with a greater frequency and number of prior approvals. Utilization of the option within the new AMCP dossier format to submit separate AMCP dossiers for each indication can enable more concise and compelling value propositions to be communicated in line with each individual FDA approval and best support formulary decision-making.

Meeting Abstracts - AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018.

The AMCP Managed Care & Specialty Pharmacy Annual Meeting 2018 in Boston, Massachusetts, is expected to attract more than 3,800 managed care pharmacists and other health care professionals who manage and evaluate drug therapies, develop and manage networks, and work with medical managers and information specialists to improve the care of all individuals enrolled in managed care programs. The AMCP Abstracts program provides a forum through which authors can share their insights and outcomes of advanced managed care practice. Abstracts are presented as posters on Wednesday, April 25, from 12:30 pm to 2:30 pm. Posters will also be displayed on Tuesday, April 24, from 5:45 pm to 7:30 pm, and on Thursday, April 26, from 9:30 am to 11:00 am. Podium presentations for the Platinum award-winning abstracts are Thursday, April 26, from 8:00 am to 9:15 am. Professional abstracts that have been reviewed are published in the Journal of Managed Care & Specialty Pharmacy's Meeting Abstracts supplement.

Michigan Pharmacists Transforming Care and Quality: Developing a Statewide Collaborative of Physician Organizations and Pharmacists to Improve Quality of Care and Reduce Costs.

Inappropriate drug use, increasing complexity of drug regimens, continued pressure to control costs, and focus on shared accountability for clinical measures drive the need to leverage the medication expertise of pharmacists in direct patient care. A statewide strategy based on the collaboration of pharmacists and physicians regarding patient care was developed to improve disease state management and medication-related outcomes. Blue Cross Blue Shield of Michigan (BCBSM) partnered with Michigan Medicine to develop and implement a statewide provider-payer program called Michigan Pharmacists Transforming Care and Quality (MPTCQ), which integrates pharmacists within physician practices throughout the state of Michigan. As the MPTCQ Coordinating Center, Michigan Medicine established an infrastructure integrating clinical pharmacists into direct patient care within patient-centered medical home (PCMH) practices and provides direction and guidance for quality and process improvement across physician organizations (POs) and their affiliated physician practices. The primary goal of MPTCQ is to improve patient care and outcomes related to Medicare star ratings and HEDIS measures through integration of clinical pharmacists into direct patient care. The short-term goal is to adopt and modify Michigan Medicine's integrated pharmacist practice model at participating POs, with the long-term goal of developing a sustainable model of pharmacist integration at each PO to improve patient care and outcomes. Initially, pharmacists are delivering disease management (diabetes, hypertension, and hyperlipidemia) and comprehensive medication review services with future plans to expand clinical services. In 2015, 10 POs participated in year 1 of the program. In collaboration with the MPTCQ Coordinating Center, each PO identified 1 "pharmacist transformation champion" (PTC). The PTC implemented the integrated pharmacist model at 2 or 3 practice sites with at least 2 practicing physicians per site. MPTCQ is a unique collaboration between a large academic institution, physician organizations, a payer, and a statewide coordinating center to improve patient care and address medication-related challenges by integrating pharmacists into a PCMH network. Pharmacists can actively provide their medication expertise to physicians and patients and optimize quality measure performance. This project was funded by Blue Cross Blue Shield of Michigan. Choe and Spahlinger are employees of Michigan Medicine. Tungol Lin, Kobernik, Cohen, Qureshi, Leyden, and Darland are employees of Blue Cross Blue Shield of Michigan. At the time of manuscript preparation, Share and Wesolowicz were employees of Blue Cross Blue Shield of Michigan. Study concept and design were primarily contributed by Choe, along with the other authors. Choe, Tungol Lin, and Kobernik collected data, and data interpretation was performed by Choe, Tungol Lin, Cohen, and Wesolowicz. The manuscript was written primarily by Choe, along with Tungol Lin and assisted by Kobernik, Cohen, Leyden, and Qureshi. The manuscript was revised by Leyden, Spahlinger, Share, and Darland. Material from this manuscript was previously presented as an education session at the 2016 AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 19-22, 2016; San Francisco, California.

Disparities in Initial Oral Antidiabetic Medication Adherence Among Veterans with Incident Diabetes.

Medication nonadherence is a prevalent public health issue, particularly among patients with diabetes mellitus (DM), and negatively affects health outcomes. Because of the prevalence of DM among U.S. veterans, it is crucial to understand how well these patients adhere to oral antidiabetic (OAD) medication and whether certain subgroups are more likely to be nonadherent. To assess initial OAD medication use among veterans with uncomplicated DM and determine factors associated with adherence in the first 2 years of treatment. This was a retrospective cohort study using data from the Veterans Affairs (VA) Corporate Data Warehouse from 2002 through 2014. The first diagnosis for uncomplicated DM was determined, and then medication use was assessed following OAD initiation. OAD use was assessed by proportion of days covered (PDC) for the first 2 years of therapy using outpatient VA pharmacy records. Adherence was determined both continuously and categorically, with a PDC of ≥ 80% used to indicate adherence. Logistic regression was used to determine if certain patient characteristics were associated with being adherent to OADs. A total of 148,544 veterans with uncomplicated DM were assessed, most of whom were white, aged ≥ 55 years, and initiated OAD therapy on metformin. A large portion resided in the southern part of the United States. In the first year, PDC averaged 79.2% (SD = 25.9), and 63.2% were adherent to OAD therapy; however, these numbers declined in the second year, when the average PDC was 71.3% (SD = 35.8), and only 59.1% were adherent. Over the course of both years, PDC averaged 75.3% (SD = 28.4), and 50.9% were adherent. The odds of being adherent were higher among older adults and significantly lower among veterans self-identifying as either African American (OR = 0.61; 95% CI = 0.59-0.63), Native American (OR = 0.67; 95% CI = 0.61-0.75), or Hawaiian/Pacific Islander (OR = 0.84; 95% CI = 0.76-0.92) when compared with whites. Veterans who were either divorced/separated (OR = 0.86; 95% CI = 0.83-0.88) or never married (OR = 0.89; 95% CI = 0.86-0.93) also had lower odds of being initially adherent to OAD therapy compared with those who reported being married. Being nonadherent in year 1 was highly predictive of remaining nonadherent in year 2 (OR = 12.8; 95% CI = 12.23-12.94), with only 22.2% nonadherent in the first year (8.2% overall) becoming adherent in the second year of therapy. Across both years, all minorities were less likely to be adherent (compared with whites), and average adherence differed among all geographic regions of the country. Within the first year of OAD therapy, medication adherence was suboptimal among veterans with DM, and second-year results indicate that adherence is likely to decline over time. Future studies should consider deeper regional and subgroup analysis to determine what contributes to variation in medication use in communities across the country. This study was supported by a KL2 Career Development Grant from the University of Tennessee Health Science Center's Institute for Research, Innovation, Synergy and Health Equity and by resources from the U.S. Department of Veterans Affairs. Hung and Kovesdy are employees of the Department of Veterans Affairs. Opinions expressed are those of the study authors and do not necessarily reflect the views of the Department of Veterans Affairs. None of the authors declared significant relevant financial conflicts of interest. Results of this study were presented as a poster at the Academy of Managed Care Pharmacy Nexus Conference on October 3-6, 2016, in National Harbor, Maryland.

Treatment Patterns Among Patients with Psoriatic Arthritis Treated with a Biologic in the United States: Descriptive Analyses from an Administrative Claims Database.

In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use. To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor. Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database. Biologic therapies comprised those that were approved by the FDA for the treatment of PsA at the time of the study initiation (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, or ustekinumab). Outcomes included adherence, persistence, and discontinuation of the index biologic; initiation of adjunctive medications (nonbiologics, including those commonly used for pain and/or inflammation); and dose escalation of the index biologic during the 12-month follow-up period. Of the 1,235 patients included, 52.5% were female, and mean (SD) age was 50.3 (12.1) years. The mean (SD) duration of persistence with a newly initiated index biologic (etanercept [48.1%], adalimumab [24.0%], infliximab [10.4%], golimumab [8.3%], ustekinumab [7.2%], or certolizumab pegol [2.0%]) was 246 (128) days; 44.5% of patients persisted with the index biologic for ≥ 12 months. During the 12-month follow-up period, 22.9% of patients switched to a different biologic, 26.8% discontinued without switching or restarting, and 5.8% discontinued and restarted the index biologic. Of the 1,010 patients who persisted with the index biologic for > 90 days, 45.6% received ≥ 1 adjunctive medication during the period from 90 days after the index date to the end of persistence or 12 months. The most commonly initiated adjunctive medications were corticosteroids (22.0%), opioids (17.1%), and nonsteroidal anti-inflammatory drugs (12.9%). Overall, 9.6% of patients had a dose escalation of the index biologic in the immediate 12-month post-index period. This real-world study of treatment patterns for PsA, which used a large U.S. claims database, demonstrated that the majority of patients with PsA discontinued their index biologic (TNFi or anti-IL-12/23 inhibitor) before 12 months. Nearly half of patients initiated an adjunctive medication, many of which were pain and conventional anti-inflammatory medications. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals. Optum was commissioned by Novartis to conduct this study, but employment was not contingent on results of the study. Walsh is a paid consultant for Novartis. Adejoro was an employee of Optum at the time of the study and writing of the manuscript. Chastek is an employee of Optum. Palmer and Hur are employees of Novartis. Study concept and design were contributed by Walsh, Chastek, Adejoro, Palmer, and Hur. Adejoro, Chastek, Walsh, Palmer, and Hur collected the data. Data interpretation was performed by Walsh, Palmer, Adejoro, Chastek, and Hur. The manuscript was written and revised by Walsh and Hur, along with the other authors. Results of this study were presented as an abstract and poster at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, Texas; and the EULAR 2017 Annual European Congress of Rheumatology; June 14-17, 2017; Madrid, Spain.

Increasing uptake of comparative effectiveness and patient-centered outcomes research among stakeholders: insights from conference discussion.

The goal of comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) is to improve health outcomes by providing stakeholders with evidence directly relevant to decision making. In January 2017, the Pharmaceutical Research and Manufacturers Association Foundation, alongside the Academy for Managed Care Pharmacy, organized a conference aimed at engaging experts and opinion leaders representing clinicians, patients and payers to identify and discuss barriers and strategies to enhancing uptake and use of CER/PCOR. This report summarizes the conference discussion in the following sections: preconference survey; summary of barriers and strategies to the uptake of CER/PCOR identified by conference attendees; and future perspectives on the field.

Health Care Costs and Thromboembolic Events in Hydroxyurea-Treated Patients with Polycythemia Vera.

Patients with polycythemia vera (PV) are at increased risk of thromboembolic events (TEs), which are key contributors to reduced overall survival compared with the age- and sex-matched general population. In addition to aspirin and phlebotomy to maintain hematocrit level < 45%, many patients receive cytoreduction with hydroxyurea (HU), which is associated with improved survival and may reduce the risk of cardiovascular events and TEs. However, 1 in 4 patients become resistant to or intolerant of HU. In the general population, prophylaxis and treatment following arterial and venous thromboses are associated with increased health care resource utilization and costs. To describe the health care resource utilization and costs associated with TEs in patients with PV treated with HU in the United States. This retrospective cross-sectional analysis of the Truven Health Analytics MarketScan Research Databases included adult patients with a PV diagnosis who were newly treated with HU and continuously enrolled in medical and pharmacy benefit plans for ≥ 12 months pre- and post-index. HU treatment administration, persistence, adherence, and related adverse events, as well as TEs, were reported during the 12-month follow-up period. HU treatment patterns were further analyzed in a subgroup analysis comparing patients with and without a ≥ 45-day gap in HU treatment. Health care resource utilization and costs were analyzed in a subgroup analysis comparing patients who had TEs in the 12-month follow-up period with those who did not. Tests for statistically significant differences across the comparison groups were conducted, including chi-square tests for categorical variables and t-tests for continuous variables. The records of 1,322 patients with PV were included in this study. Mean age was 66.0 years; 51.3% were men; and 14.0% had a history of TEs. During the first year of HU treatment, 764 (57.8%) patients had a treatment gap of ≥ 45 days; however, treatment adherence was similar between those with and those without a gap (85.2% vs. 90.7%, respectively). TEs occurred in 216 (16.3%) patients within 12 months of HU initiation. Health care resource utilization was higher for patients with TEs versus those without, including the proportion of patients requiring inpatient services (50.9% vs. 18.4%; P < 0.001) and emergency room visits (48.1% vs. 26.3%; P < 0.001) and the mean number of inpatient admissions (1.7 vs. 1.3; P = 0.004); office visits (18.9 vs. 14.1; P < 0.001); and prescriptions (45.8 vs. 36.2; P<0.001). In addition, total mean health care costs ($45,040 vs. $16,438; P < 0.001); inpatient costs ($18,952 vs. $4,794; P < 0.001); outpatient costs ($20,844 vs. $8,046; P < 0.001); and outpatient pharmacy costs ($5,244 vs. $3,598; P = 0.002) were higher among patients with TEs than those without. Patients with PV receiving treatment with HU remain at risk for TEs. The occurrence of TEs during the 12-month follow-up in this patient population was associated with higher health care resource utilization and costs. This study was funded by Incyte Corporation. Parasuraman and Paranagama are employees and stockholders of Incyte Corporation. Shi and Bonafede are employees of Truven Health Analytics, which was awarded a research contract to conduct this study with and on behalf of Incyte Corporation. Study concept and design were contributed by all of the authors, who also interpreted the data and wrote and revised the manuscript. Bonafede and Shi collected the data. This study was presented as an abstract at the Academy of Managed Care Pharmacy NEXUS Annual Meeting on October 26-29, 2015, in Orlando, Florida.

The Current Status of Outcomes-Based Contracting for Manufacturers and Payers: An AMCP Membership Survey.

As the United States health care system shifts from traditional volume-based payments to value-based payments, outcomes-based contracts (OBCs) are gaining popularity among payers and manufacturers as a mechanism for the shift toward value. Under this model, stakeholders hope to align drug payment and value to real-world performance metrics (e.g., biomarkers and health care resource utilization). To understand the experiences, perceptions, and needs of payers and manufacturers related to OBCs. The Academy of Managed Care Pharmacy (AMCP) and Xcenda conducted an online survey with AMCP payer and manufacturer members. Participants were asked a series of questions regarding their use of OBCs, barriers to implementation, and elements required in establishing successful OBCs. The importance and urgency of specific impediments to successful OBC implementation were also assessed. The survey was fielded May 12, 2017, to June 7, 2017, yielding 65 responses (35 payers/30 manufacturers). While a minority of payers/manufacturers had at least 1 OBC in place (20%/33%), a majority had interest in future OBC use (71%/63%). Among those with at least 1 OBC in place, 86%/80% of payers/manufacturers had renewed at least 1 OBC in the past 5 years. All payers and 60% of manufacturers with OBCs included compliance measures. Improvement in clinical outcomes was also common (71%/70%) (e.g., reaching set laboratory values goals), and 71%/60% included avoidance of unnecessary medical resource use (e.g., hospitalization and emergency department visit). The barrier most frequently identified by payers in implementing OBCs was evidence that OBCs reduced pharmacy spending (60%), while manufacturers identified the inability to obtain accurate data/outcome measures (73%) as a major limiting factor. Payers/manufacturers endorsed the use of easily measurable outcomes (91%/100%) as most important in establishing successful OBCs. Manufacturers, and to a lesser extent payers, indicated that regulations and legal issues need to be addressed to make progress in OBC implementation (e.g., safe harbor for preapproval health care economic information [77%/46%] and exemption of OBCs for best-price requirements [83%/51%]). The only exception was the clarification of regulations for discussing information outside of an FDA-approved label, in which both manufacturers and payers indicated a very strong need (100%) to be addressed. Surveyed AMCP members are interested in OBCs and recognize their alignment to societal health goals and health care affordability, although actual use of these contracts has been somewhat limited to date. Results from this survey indicate that there is potential for OBC use to increase as barriers and limitations are addressed. This research was sponsored by the Academy of Managed Care Pharmacy and Xcenda. Duhig, Kaufman, and Hughes are employed by Xcenda. Saha is employed by the Academy of Managed Care Pharmacy. Smith has nothing disclose. Study concept and design were contributed by Duhig, Kaufman, Saha, and Hughes. Kaufman and Hughes collected the data, and data interpretation was performed by all the authors. The manuscript was written by Saha, Smith, and Duhig, along with Kaufman and Hughes.

Paying for Cures: How Can We Afford It? Managed Care Pharmacy Stakeholder Perceptions of Policy Options to Address Affordability of Prescription Drugs.

High-priced medications with curative potential, such as the newer hepatitis C therapies, have contributed to the recent growth in pharmaceutical expenditure. Despite the obvious benefits, health care decision makers are just beginning to grapple with questions of how to value and pay for curative therapies that may feature large upfront cost, followed by health benefits that are reaped over a patient's lifespan. Alternative policy options have been proposed to promote high value and financially sustainable use of these therapies. It is unclear which policy options would be most acceptable to health care payer and biomedical manufacturer stakeholders. To (a) briefly review pharmaceutical policy options to address health system affordability and (b) assess the acceptability of alternative policy options to health care payers and biomedical manufacturers before and after an Academy of Managed Care Pharmacy (AMCP) continuing pharmacy education (CPE) session. We searched MEDLINE and Cochran databases for pharmaceutical policy options addressing affordability. With input from a focus group of managed care professionals, we developed CPE session content and an 8-question survey focusing on the most promising policy options. We fielded the survey before and after the CPE session, which occurred as part of the 2016 AMCP Annual Meeting. We first conducted a chi-squared goodness-of-fit test to assess response distributions. Next, we tested how responses differed before and after by using an ordered logit and a multinomial logit to model Likert scale and unordered responses, respectively. Although risk-sharing payments over time remained the most favorable choice before (37%) and after (35%) the CPE session, this choice was closely followed by HealthCoin after the session, which increased in favorability from 4% to 33% of responses (P = 0.001). About half of the respondents (54%) indicated that legislative change is the most significant barrier to the implementation of any policy. As high-cost curative drugs reach the market, managed care stakeholders need information from a balanced education source regarding alternative policies to address affordability. We found that after the AMCP CPE session, risk-sharing payments over time and HealthCoin were the most favorable options. No funding was provided for this research. Carlson reports consulting fees from Genentech, Pfizer, and Seattle Genetics. The other authors have nothing to disclose. Study concept and design were contributed by Yeung, Garrison, and Carlson. Yeung collected the data, which were interpreted by Yeung and Basu. The manuscript was written by Yeung, Suh, and Bansal and revised by Yeung. A portion of this research was presented at the Academy of Managed Care & Specialty Pharmacy Annual Meeting as a continuing education session entitled "Paying for Cures: How Can We Afford It?" on April 20, 2016, in San Francisco, California.