Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance.

BACKGROUND: There is a need for postmarketing evidence generation for novel biologics and biosimilars. OBJECTIVE: To assess the feasibility, strengths, and limitations of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN) to examine the utilization and comparative safety of immune-modulating agents among patients with autoimmune diseases. METHODS: We conducted a retrospective cohort study among patients enrolled in health insurance plans participating in the BBCIC DRN between January 1, 2006, and September 30, 2015. Eligible patients were adult (≥18 years) new users of a disease-modifying nonbiologic and/or biologic agent with a prior diagnosis of rheumatoid arthritis (RA), other inflammatory conditions (psoriasis, psoriatic arthritis, ankylosing spondylitis), or inflammatory bowel disease (IBD). Follow-up started at treatment initiation and ended at the earliest of outcome occurrence (serious infection); treatment discontinuation; or switching, death, disenrollment, or end of study period. The study leveraged the FDA Sentinel System infrastructure for data management and analysis; descriptive statistics of patient characteristics and unadjusted incidence rates of study outcomes during follow-up were calculated. RESULTS: Eligible patient drug episodes included 111,611 with RA (75% female), 61,050 with other inflammatory conditions (51% female), and 30,628 with IBD (52% female). Across all 3 cohorts, approximately half of the patient drug episodes initiated a biologic (50% in RA; 60% in psoriasis, psoriatic arthritis, ankylosing spondylitis; and 55% in IBD). The crude incidence rate of serious infection was 9.8 (9.5-10.0) cases per 100 person-years in RA, 7.1 (6.8-7.5) in other inflammatory conditions, and 14.2 (13.6-14.8) in IBD patients. CONCLUSIONS: This study successfully identified large numbers of new users of biologics and produced results that were consistent with those from earlier published studies. The BBCIC DRN is a potential resource for surveillance of biologics. DISCLOSURES: This study was funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC). HealthCore conducted this study in collaboration with Harvard Pilgrim Health Care. Zhang and Sridhar were employed by HealthCore at the time of this study. Haynes is employed by HealthCore funded by PCORI, the NIH, and the FDA. Barr and Eichelberger were employed by AMCP at the time of this study. Lockhart is employed by the BBCIC. Holmes and Clewell are employed by AbbVie. Accrott is an employee of and shareholder in Amgen. Marshall and Brown are employed by Harvard Pilgrim Health Care. Barr is a shareholder in Roche/Genentech. Curtis has received research grants from and consults with the following: Amgen, AbbVie, BMS, CORRONA, Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, and UCB. Brown has received research grants from GSK and Pfizer and consulting fees from Bayer, Roche, and Jazz Pharmaceuticals, along with funding from the Reagan-Udall Foundation for the FDA to conduct studies for medical product manufacturers, including Eli Lilly, Novartis, Abbvie, and Merck. Brown is also funded by PCORI, the NIH, and the FDA. McMahill-Walraven subcontracts with Harvard Pilgrim Health Care Institute for public health and safety surveillance distributed data network activtities and with the FDA, GSK, and Pfizer. She also reports fees from Reagan Udall Foundation for the FDA and the Patient Centered Outcomes Research Institute.

Capture of biologic and biosimilar dispensings in a consortium of U.S.-based claims databases: Utilization of national drug codes and Healthcare Common Procedure Coding System modifiers in medical claims.

PURPOSE: To assess the capture of biologics (originator and biosimilar) in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN), with a focus on medical claim National Drug Code (NDC), a new data field, and Healthcare Common Procedure Coding System (HCPCS) modifier. METHODS: We conducted a repeated cross-sectional study among patients with medical and pharmacy benefits enrolled in insurance plans participating in the BBCIC DRN between 1 January 2013 and 30 September 2017. We calculated the proportion of medical claims with ≥1 NDC and identified select biologics using four different approaches: (a) specific HCPCS alone, (b) specific HCPCS and NDC, (c) non-specific HCPCS with NDC, and (d) HCPCS with modifiers (applicable to biosimilars). Numbers of dispensings were calculated for each biologic by approach and select patient and claim characteristics. RESULTS: More than 1.5 million eligible participants contributed approximately 4 million person-years of data, including 1.2 billion medical claims. The proportion of medical claims with ≥1 NDC increased from 1.2% in 2013 to 3.0% in 2017. Medical claim NDCs identified 39% and 28% of vedolizumab dispensed in 2014 and 2015 and 30% of Epogen/Procrit dispensed overall. Out of 26,381 filgrastim biosimilar dispensings identified, 51% had a HCPCS modifier and 12% had a medical claim NDC for Zarxio. HCPCS modifiers and medical claim NDCs were present for 38% and 3% of all infliximab biosimilars dispensed (total n = 1,244). CONCLUSIONS: Medical claim NDC and HCPCS modifier improves identification of select biologics without product-specific HCPCS code, thereby facilitating product-specific biologic research.