Physician-Level Data
Since 2006, more than twenty states have considered legislation to ban the commercial use of physician level data. Although three states (New Hampshire, Maine and Vermont) passed such laws with the intent to reduce costs of branded medications, none have done so since 2007. In contrast, opponents of these laws (as well as two federal judges) have proposed that restrictions on commercial use of data would not achieve the stated goals, would compromise patient care and health research, and that alternatives that do not have the potential to harm patients already exist.
MassBio supports the effective and efficient delivery of information to health care providers.
In line with these goals, we present a case study of unintended consequences of data restriction laws. Further, this report illuminates the process of care and dissemination of FDA-approved information supported by such data, and the dangerous ripple effects of selectively reducing access to information as a means to alter drug utilization. DOWNLOAD THE FULL CASE STUDY HERE.
MassBio member, Eisai Inc., which has a research facility in Andover, MA, is a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd, a research based human healthcare company dedicated to developing and marketing specialty drugs that address unmet needs. In January 2009, after approval by the FDA, Eisai launched BANZEL® (rufinamide)-a prescription drug, approved for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in children 4 years and older and adults. LGS is a rare and catastrophic form of epilepsy.
Using physician level data, Eisai-after approval by the FDA-quickly delivered information regarding the clinical use of BANZEL to a specific, targeted physician population, and developed a rigorous, ongoing process for ensuring appropriate use of BANZEL by:
- Identifying the small population of physicians who treat patients with LGS
- Limiting promotion of the drug to child neurologists and epileptologists-neurologists who have completed specialized training in epilepsy and treat only epilepsy-with patients known to have LGS
- Working with physicians to manage risks related to specific concerns
- Providing professional services to enhance patient care
- Monitoring physician experience with BANZEL to quickly and effectively communicate new information to a broader physician community
The data restriction law in New Hampshire resulted in a lack of transparency about which neurologists in the state treat patients with LGS and created uncertainty for Eisai about which neurologists they should contact about BANZEL. Eisai's experience in New Hampshire points to how these laws reduce effectiveness and efficiency in the dissemination of information that impacts patient care and may increase the time it takes to get new drugs to patients-most importantly in this case, potentially delaying access to an effective product for a catastrophic illness.
As states and the federal government move toward healthcare reform, it will be critical for legislators to understand the system of care in order to assess how changes in policy will broadly impact health research and the public welfare.
