P & T Committee response to evolving technologies: preparing for the launch of high-tech, high-cost products. Roundtable discussion.
P & T Committees are entering an exciting era in which the introduction of biotechnology-derived pharmaceuticals is providing life-saving opportunities for conditions for which there was little or no hope for a cure. The P & T Committee at Thomas Jefferson University Hospital has anticipated the challenge that these novel therapeutics present, and has already positioned itself for the pending approval of the first therapeutic human monoclonal antibody. Nebacumab (HA-1A, formerly known as Centoxin; by Centocor) will be used for the treatment of gram-negative sepsis. Although this antiendotoxin has a good side effect profile, its use also carries a high price tag. This will raise several difficult ethical issues once the product is introduced. In this exclusive Hospital Formulary roundtable, members of Thomas Jefferson's P & T Committee and Technology Assessment Subcommittee provide their insights for responsibly managing a high-tech, high-cost product such as nebacumab.
Seltzer
J L
JL
Thomas Jefferson University Hospital, Philadelphia.
Wordell
C J
CJ
Nash
D
D
Johnson
N E
NE
Gottlieb
J E
JE
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001709:Biotechnology / Q000639:trends; D002985:Clinical Protocols; D016527:Drug Costs; D004363:Drug Utilization / Q000592:standards*; D005568:Forms and Records Control; D016905:Gram-Negative Bacterial Infections / Q000188:drug therapy*; D006746:Hospital Bed Capacity, 500 and over; D006785:Hospitals, University / Q000458:organization & administration / Q000592:standards; D006801:Humans; D016134:Organizational Policy; D010606:Pharmacy and Therapeutics Committee; D015143:Philadelphia; D014481:United States; D014486:United States Food and Drug Administration
D000911:Antibodies, Monoclonal