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CAPITOL PERSPECTIVES Payment (NTAP) program, meant to integrate technology into Medicare sooner. In its 13-year history, only two drugs have received additional reimbursement under that program. The NTAP application process is convoluted and challenging. Even if a manufacturer is successful, the designation is limited to two to three years, and the program provides only partial assistance — still requiring hospitals to eat part of the cost of the new technology. HOW NEW LEGISLATION COULD HELP Therefore, some in Congress are now mulling a legislative solution that would provide Medicare reimbursement at acquisition cost of new antimicrobial products provided in the inpatient setting for unmet medical needs. Enactment of such a provision means the hospital administrator would decide to purchase the novel antimicrobial on its clinical merits only, and financial considerations would be taken off the table. Because so few products would be affected and their prices are modest, the cost to Medicare would be insignificant. But it would make a huge difference to patients who have run out of options. Now some pharmaceutical companies are also considering new methods for leaving the commercialization and marketing of new products to third parties and focusing solely on developing new products and receiving commitments for reimbursement for the R&D; costs. These types of out-of-the-box thinking and market flexibilities are necessary if we are ever going to reestablish a vibrant antimicrobial pipeline. Otherwise the "postantibiotic era" will be permanent and very dangerous. Number of Antibacterial New Drug Application (NDA) Approvals vs. Year Intervals* Number of antibacterial drug NDA approvals 20 15 10 5 0 1980-1984 1985-1989 1990-1994 1995-1999 2000-2004 2005-2009 2010-2012 *Intervals from 1980-2009 are 5-year intervals; 2010-2012 is a 3-year interval. Drugs are limited to systemic agents. Data courtesy of FDA's Center for Drug Evaluation and Research (CDER). John McManus is president and founder of The McManus Group, a consulting firm specializing in strategic policy and political counsel and advocacy for healthcare clients with issues before Congress and the administration. Prior to founding his firm, McManus served Chairman Bill Thomas as the staff director of the Ways and Means Health Subcommittee, where he led the policy development, negotiations, and drafting of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Before working for Chairman Thomas, McManus worked for Eli Lilly & Company as a senior associate and for the Maryland House of Delegates as a research analyst. He earned his Master of Public Policy from Duke University and Bachelor of Arts from Washington and Lee University. He can be reached at jmcmanus@mcmanusgrp.com. 12 LifeScienceLeader.com December 2013