- Granulocyte colony stimulating factors (G-CSF). BBCIC’s first CER Research Team convened in Q1 2019 to focus on G-CSF. Outcomes of interest in this ongoing study are incidence of hospitalizations for febrile neutropenia in breast, lung, and hematologic cancer patients. Some chemotherapy agents create potentially life-threatening infections in part because they reduce white cells. CSFs help reduce the likelihood of these infections by shortening the time white cells are low. All filgrastim and pegfilgrastim products available in the United States are included in this study.
Descriptive Analysis Studies
- Oncology data fitness and descriptive analysis. To prepare to conduct CER in oncology, the consortium will evaluate the current data capabilities of the BBCIC DRN and identify additional data sources to enrich BBCIC capabilities in measures relevant to oncology outcome, including cancer stage and effectiveness measures that may not be readily available in standard administrative claims data sets. This work will establish the BBCIC DRN to conduct future product- or disease-specific CER.
Descriptive Analysis Studies with Expected Manuscripts in 2019
- Biologic anti-inflammatory (AI) therapies and incidence of hospitalizations for serious infections among patients with autoimmune diseases (e.g., rheumatoid arthritis, psoriasis, or inflammatory bowel disease such as Crohn’s disease) being treated with AI. Several biologics are approved to treat all or some of these conditions, three of which have FDA- approved biosimilars (i.e., Remicade/Inflectra, Enbrel/ Erelzi, and Humira/Amjevita). (NCT 02922192)
- Long-acting insulins and control of blood sugar and the incidence of hypoglycemia and major cardiac events in patients with Type 1 and Type 2 diabetes. (NCT 02922179)
- Colony stimulating factors (CSFs) and incidence of hospitalizations for febrile neutropenia in breast and lung cancer patients. Some chemotherapy agents create potentially life-threatening infections in part because they reduce white cells. CSFs help reduce the likelihood of these infections by shortening the time white cells are low. (NCT 02922192)
- Erythropoietin Stimulating Agents (ESAs) and chronicity of hemodialysis (HD) and important covariates and confounders for HD populations among selected BBCIC data partners. BBCIC assessed whether we have a sufficiently similar population of HD patients to that described by the United States Renal Data System (USRDS).
- Long- and intermediate-acting insulins. There is sufficient exposure in the BBCIC DRN to insulin glargine and the available follow-on biologic to begin a CER study expected to convene in 2020. Outcomes of interest are the incidence of hyperglycemia, incidence of hypoglycemia, control of blood sugar, and major cardiac events in patients with Type 1 and Type 2 diabetes. A Patient Reported Outcome (PRO) element will also be included in this study to capture the patient experience through a mobile phone app.
Descriptive Analysis Studies
- Switching patterns descriptive analysis. Building on the consortium’s Switching Methods Workgroup recommendations, BBCIC will test study designs and methods for handling switching as a confounder or covariate in the BBCIC DRN. Switching between biosimilars and reference biologics, or between different classes medication, is a challenge in CER studies as it introduces potential bias and complicates the study design. BBCIC will use anti-Inflammatory agents as a test case.
Data and Standards Workgroups
- CER Statistical Approach Workgroup. To reduce rework by each CER team on statistical design, the BBCIC convened a workgroup to develop recommendations on a standard methodologic approach to conducting BBCIC CER studies. The workgroup discussed design and analytic options (e.g., propensity score methods, discontinuity or instrumental variables, difference-in-difference) and identified options for supplemental analyses to address the potential alternate explanations for observed effects.
- ICD9 to ICD10 Mapping Workgroup. To prepare to conduct CER, BBCIC convened a workgroup to convert all ICD9 criteria from current Descriptive Analysis Protocols to ICD10. This is a complex process that requires significant work beyond simple backward/forward mapping including developing the best criteria for actual phenotyping.
- Improving Capture of NDC on Physician Office Claims Workgroup. For optimal product identification of biologics and biosimilars, NDCs are recommended for all physician office claims. BBCIC convened a research workgroup to conduct a descriptive analysis of occurrence of NDCs and J-codes in the Procedure Table of the common data model (CDM). The workgroup also explored NDCs captured in data partner claims data warehouses.
- Switching Pattern Workgroup. As we wait for sufficient infliximab biosimilar exposures to conduct CER, BBCIC convened a workgroup to conduct an initial descriptive analysis on innovator switching patterns. The Switching Patterns Workgroup’s purpose was to improve the conduct of biosimilar switching studies by establishing recommendations for best practices for the conduct of innovator and biosimilar switching studies and for treating switching/sequencing as a covariate/confounder in CER studies. The workgroup’s recommendations used anti-inflammatory agents as a case study but will include considerations for switching studies in other biologic classes.