Harnessing the Biologics and Biosimilars Collective Intelligence Consortium to Evaluate Patterns of Care.

INTRODUCTION: As clinical trials test efficacy rather than effectiveness of medications, real-world effectiveness data often vary from clinical trial data. Given the recent market entry of multiple biologics and biosimilars, a dedicated assessment of these diverse agents is needed to build the evidence base regarding efficacy and safety of innovator biologics and biosimilars. PROGRAM DESCRIPTION: The Academy of Managed Care Pharmacy's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was convened to address the lack of real-world, postmarket outcome evidence generation for innovator biologics and corresponding biosimilars. The BBCIC is a multistakeholder scientific research consortium whose participants prioritize topics and collaboratively conduct research studies. The BBCIC conducts a wide range of analyses, including population characterization, epidemiologic studies, and active observational studies, and develops best practices for conducting large-scale studies to provide real-world evidence. OBSERVATIONS: Over the past 3 years, we undertook multiple descriptive analyses with the goal of characterizing data availability and demonstrating the feasibility and efficacy of using the BBCIC distributed research network (DRN), which includes commercial claims data from 2008-2018 covering approximately 100 million lives, with approximately 20 million active members in 2017 from 2 major U.S. health plans and 3 regional integrated delivery networks. We analyzed 4 medication classes of particular interest to biologics and biosimilars development: insulins, granulocyte colony-stimulating factors, erythropoietic-stimulating agents, and anti-inflammatories. We were able to identify exposures and user characteristics in all 4 categories. Herein we describe the successes and challenges of conducting some of our analyses, specifically among insulin users with type 1 diabetes mellitus. IMPLICATIONS: Our results demonstrate the BBCIC DRN's ability to identify and characterize exposures, cohorts, and outcomes that can contribute to more sophisticated comparative surveillance of biosimilars and innovator biologics in the future. Additional linkages to laboratory data and a wider range of insurance carriers will further strengthen the BBCIC DRN. DISCLOSURES: This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC; Eichelberger was employed by the BBCIC at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. This work was presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.

Descriptive Analysis of Long- and Intermediate-Acting Insulin and Key Safety Outcomes in Adults with Type 2 Diabetes Mellitus.

BACKGROUND: As new biosimilar and follow-on insulins enter the market, more data are needed on safety, effectiveness, and patterns of use for these products to inform prescriber and patient decision-making regarding treatment. Additionally, data are needed regarding real-world patterns of use to inform future studies comparing the safety and effectiveness of bio-similars to already approved agents for diabetes treatment. OBJECTIVE: To analyze the medication use patterns, adverse events, and availability of glycated hemoglobin (A1c) values for adult patients with type 2 diabetes mellitus (T2DM) who use long-acting insulin (LAI) or neutral protamine Hagedorn (NPH), an intermediate-acting insulin. METHODS: We used the Biologics and Biosimilars Collective Intelligence Consortium's (BBCIC) distributed research network (DRN) for this descriptive analysis. The analysis time frame was January 1, 2011, to September 30, 2015, and included patients continuously insured for at least 183 days before the first date of a filled prescription for LAI or NPH insulin alone or with rapid- or short-acting insulin or sulfonylureas, whether newly starting insulin or switching to a different product. Insulin exposure episodes were the unit of analysis, and patients were classified in cohorts according to treatment. We followed patients until end of health plan enrollment or the end of the study period. We used occurrence of a study outcome, switch to another medication regimen, discontinuation of the current medication, or study end date to mark the end of an insulin episode. We describe demographics and availability of A1c values for analysis. Study outcomes included severe hypoglycemic events and major adverse cardiac events (MACE). RESULTS: We identified 103,951 patients with T2DM from a database of 39.1 million patients with commercial or Medicare Advantage pharmacy and medical benefits, who contributed 279,533 unique insulin exposure episodes. Most episodes (89%) included patients using LAI, and 52% of patients contributed data to 2 or more exposure cohorts. Insulin episodes lasted an average of 3.5 months, and patients had an average follow-up of 8.6 months. The unadjusted rate of severe hypoglycemic events requiring medical attention was 96.9 per 10,000 patient-years at risk (10kPYR). The unadjusted incident MACE rate was 676.9 events per 10kPYR. 38,330 T2DM patients in the BBCIC DRN had a baseline A1c available, and of those, less than 50% had a follow-up A1c result. CONCLUSIONS: Among patients with T2DM, our observed insulin patterns of use and rates of severe hypoglycemic outcomes and MACE are consistent with other studies. We noted a paucity of A1c results available, which implies that additional data sources may be needed to augment the BBCIC DRN. DISCLOSURES: This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC and the Academy of Managed Care Pharmacy (AMCP). Eichelberger was employed by the BBCIC and AMCP at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. This work was previously presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.

Therapeutic options for lowering LDL-C in type 2 diabetes: a nurse practitioner's perspective.

PURPOSE: The majority of patients with type 2 diabetes mellitus (T2DM) have multiple risk factors for cardiovascular disease (CVD). Low-density lipoprotein cholesterol (LDL-C) is a key therapeutic target to reduce CVD risk. This article reviews therapeutic strategies that nurse practitioners (NPs) may use in the management of patients with T2DM requiring lipid management. DATA SOURCES: The evidence used in developing this review included evidence-based reviews, clinical trials, guidelines, and consensus statements. Relevant publications were identified through a search of the literature using PubMed and other search engines. CONCLUSIONS: Lowering LDL-C levels may reduce CVD risk, but achieving goals can be challenging. Lifestyle modifications (including diet, exercise, and smoking cessation) are key components of lipid management and reduction of CVD risk. Statins can be effective to reduce lipids. However, patients may not achieve lipid goals with monotherapy or may experience intolerable adverse effects. Alternative statins or statins along with other lipid-lowering agents remain good options. IMPLICATIONS FOR PRACTICE: Achieving LDL-C goals requires a comprehensive treatment plan that incorporates lifestyle and pharmacologic interventions. Patient commitment in setting goals and self-management is essential. NPs can play an important role in educating patients as well as prescribing appropriate treatments.

A pharmacist-based screening program of octogenarians starting new medications.

OBJECTIVE: To measure the impact of clinical pharmacists in primary care practices who closely monitor patients older than 80 years after initiation of new medications. METHODS: The study was an uncontrolled pilot trial performed at a group-model health maintenance organization in the Pacific Northwest between August and December 1999. Forty-eight patients who were older than 80 years and were prescribed at least one new medication in their primary care clinic were called at home 3 to 6 days after starting a new medication and asked questions focusing on compliance and potential adverse drug events. RESULTS: More than 20% of patients (10 of 48) had a clinically important change made as a result of the pharmacist telephone monitoring; 42% of patients (20 of 48) either experienced an undesired medication effect (14 of 48) or an inadequate effect (6 of 48). Pharmacists spent an average 11.3 minutes at an estimated cost of $6.40 per patient. CONCLUSION: A simple, inexpensive pharmacist-based program to screen for medication problems after initiation of new medicines may improve the care to a population older than 80 years.