A new consortium to measure the safety and effectiveness of Biologics and Biosimilars
The Academy of Managed Care Pharmacy (AMCP) just announced the launch of the Biologics and Biosimilars Collective Intelligence Consortium (http://BBCIC.org). The BBCIC was established to monitor the safety and effectiveness of Biologic & Biosimilar medications using real world healthcare data covering more that 100 million lives in the United States.
Parnassus Consulting was engaged to help build this new consortium based on prior experience building other data consortiums including the Observational Medical Outcomes Partnership and the FDA Sentinel Network. Parnassus Consulting’s role over the past 2 years has been to complete a feasibility study and business plan, recruit participants, raise funding, develop the consortium charter and launch consortium operations.
Here is more information about the consortium:
The BBCIC is an important new consortium that represents a paradigm shift in how healthcare stakeholders work together to monitor the effectiveness and safety of medications. The BBCIC is founded on the premise that ALL healthcare stakeholders should be engaged in the process of medical research and the communication of scientific findings. The BBCIC also fills a current gap in the post-approval surveillance of biosimilar medications. Biosimilars are a new class of medications now coming to the US market and require a proactive systematic approach to monitoring effectiveness and safety.
Background:
Biosimilars are somewhat analogous to generic drugs in that they are a lower cost version of a novel branded medication. Biologic medications like Neupogen, Humira, Enbrel and others have biosimilars coming to market. However, unlike generic medications which are based in chemistry that can produce identical versions of a branded medication; biosimilars are developed using biological processes and cell lines which can never be exactly duplicated. Therefore the FDA regulations for generic medications are not applicable. The Affordable Care Act required that the FDA create a regulatory approval pathway for biosimilars which have already been available in Europe for a decade. This new approval pathway is a significant market making event that literally opens the door for hundreds of new medications. However, what has been lacking until now is a proactive approach to monitoring the safety and effectiveness of these medications. Because these medications are not identical copies, hence the name biosimilars, physicians and consumers want to be assured that they medications are just as effective and safe as the current novel biologic alternatives.
Monitoring the effectiveness and safety of any medications after they are approved by regulatory authorities is a complex process. Deciding what research questions to ask; what research methods and data to use; how to interpret the results; and ultimately how to improve the practice of medicine is so complex that a new research finding can take as much as 17 years to broadly impact the practice of medicine. But what if the principal stakeholders go through this process together? What if managed care organizations, pharmaceutical companies, pharmacy benefit managers, physician advocacy organizations, consumer advocacy organizations, etc. all work together through a common process where they can all contribute to a healthy debate.
Current research is a fragmented activity shaped by traditional market and regulatory forces. Pharmaceutical companies individually fund their own studies. Academic investigators apply for grants from PCORI, the NIH and private foundations to conduct research. Managed care organizations do their own analysis to determine formulary and reimbursement policy. But each stakeholder is doing the research from their own perspective and is often criticized by the other stakeholders as conducting analysis that is biased, incomplete or not addressing real world needs. The premise of the BBCIC is that we can improve the credibility and adoption of medical evidence if all stakeholders work through the process together. This approach has never been applied at such a broad scale.
We are building off of substantial work completed over the past 8 years to establish a national data infrastructure that currently covers over 100 million lives. Harvard-Pilgrim Health Care Institute and Harvard Medical School’s Department of Population Medicine led efforts to create the Sentinel Network which is a national network of healthcare organizations that make their healthcare data available for research. The approach is known as a distributed research network because the participating healthcare organizations keep all of their data intact behind their firewalls, but organize it into a common data structure so that a standard approach to research can be efficiently used. This approach enables very large populations to be monitored in a faster more systematic way while enable healthcare organizations to retain control of how the data is being used and protecting patient privacy. It also keeps the data close to the organization that produced the data and therefore knows their data best. Each participating managed care organization or healthcare provider knows their business and clinical practices that result in important differences in the data across the participants.
The Parnassus Consulting team that worked on this program included Dan Foltz, Tom Scarnecchia, Lily Samin and Daniel Scarnecchia. Both Tom Scarnecchia and Daniel Scarnecchia
are from a partner company called Digital Aurora.
More information on this consortium can be seen at http://bbcic.org.