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1.
J Manag Care Spec Pharm ; 21(1): 23-34, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25562770

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals/adverse effects , Biosimilar Pharmaceuticals/therapeutic use , Data Collection/methods , Drug Approval , Humans , Pharmaceutical Services/organization & administration , United States , United States Food and Drug Administration
2.
J Nurs Manag ; 22(7): 837-47, 2014 Oct.
Article in English | MEDLINE | ID: mdl-23607510

ABSTRACT

AIM: To estimate the relationship between adherence to nurse recommendations about where to seek care and expenditures for health-care services received by callers to a Nurse HealthLine telephone-based triage programme. METHODS: Health-care utilization and claims data from callers to the Nurse HealthLine were included. Adherent callers were those who followed the nurse recommendations, while those who did not were classified as non-adherent. Programme-related savings were estimated using differences in downstream health-care expenditures between adherent and non-adherent callers after using multivariate modelling to adjust for between-group differences. RESULTS: Fifty-five per cent of callers were adherent. Nurses were over three times as likely (41% vs. 13%) to recommend seeking a higher level of care (e.g. emergency room vs. urgent care). Regression analyses showed that the impact of getting members to the appropriate place of care was associated with significant annual savings of $13.8 million (P < 0.05), attributable mostly to Medicare, generating a positive return on investment of $1.59. CONCLUSIONS: This is the first known Nurse HealthLine triage programme exclusively for Medicare beneficiaries with supplemental coverage. IMPLICATIONS FOR NURSING MANAGEMENT: Nurse managers should consider promoting telephone-based triage programmes as complementary to clinical nursing, which has a direct impact on health-care utilization and costs.


Subject(s)
Cost Savings/methods , Nurse-Patient Relations , Patient Compliance/statistics & numerical data , Remote Consultation/economics , Telephone/statistics & numerical data , Triage/methods , Communication , Health Care Costs/statistics & numerical data , Humans , Nursing Evaluation Research , Remote Consultation/methods , Triage/economics , Triage/standards
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