Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

BACKGROUND: The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? OBJECTIVE: To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. METHODS: Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. RESULTS: The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). CONCLUSIONS: The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.

Assessment of pharmacists' opinions toward the behind-the-counter category of medications.

OBJECTIVES: To determine pharmacists' opinions toward implementation of a behind-the-counter (BTC) category of medications and assess pharmacists' level of agreement with dispensing certain medications in this category. METHODS: 473 licensed pharmacists from Ohio were randomly selected for inclusion in the study, 248 of whom completed the survey (52.4% response rate). A self-administered, mailed questionnaire was used to collect data on pharmacists' opinions toward a BTC category, including usefulness to patients, reimbursement issues, impact on patient care, and access issues. The researchers also assessed the degree to which pharmacists felt educationally prepared regarding a BTC category and the potential need for further training and/or education. The questionnaire also included 25 prescription drugs identified from pharmacist focus groups to evaluate appropriateness for inclusion in a BTC category. RESULTS: Pharmacists moderately agreed (5.78 ± 1.33 [mean ± SD]) that introducing a BTC category of medication would advance the profession's goals of providing more pharmacist-directed patient care. Pharmacists also moderately agreed (6.09 ± 1.71) that patient counseling should be mandatory before providing any medications in a BTC category. At their current practice site, pharmacists moderately agreed (5.65 ± 1.62) that they would participate in providing BTC medications; however, they felt the largest issue pertaining to a BTC category of medications was the added amount of time that would be spent with patients (5.34 ± 1.53). On the other hand, pharmacists moderately agreed (5.82 ± 1.26) that they would take the time to counsel patients on BTC medications. Prescription prenatal vitamins (1 mg folic acid), triamcinolone cream, silver sulfadiazine cream, mometasone nasal inhalation, fluconazole 150 mg, epinephrine injection, promethazine, and mebendazole were considered the most appropriate for a BTC category of medications. CONCLUSION: Ultimately, pharmacists moderately agreed that a BTC category is a change in the pharmacy profession that they were willing to embrace.