Paying for new drugs for new bugs: Regulation is only one side of the coin

Cynthia Goldsmith, Centers for Disease Control and Prevention

This image is a transmission electron micrograph (TEM) of the West Nile virus.

Article Highlights

  • The New Technology Add-on Payment program could provide the foundation for Medicare policies that reward innovation

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  • CMS should revisit the regulations governing NTAP

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  • The experience of Dificid frames a path for how CMS could encourage innovation through the NTAP program

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FDA and Congress are making great strides in improving the regulatory pathway and intellectual property protection for anti-infectives. But without changes in the reimbursement process, the package of incentives may not be enough to spur innovation in the class.

Deadly infections with bacteria that resist even the strongest antibiotics are on the rise in hospitals in the United States, and there is only a “limited window of opportunity” to halt their spread, health officials at the Centers for Disease Control & Prevention warned this spring. In this case, the bacteria in question were bugs normally found in the gut. 

According to the CDC, they have acquired a lethal trait: they are unscathed by antibiotics, including carbapenems, a group of drugs that are generally considered a last resort. When these resistant germs invade parts of the body where they do not belong, like the bloodstream, lungs or urinary tract, the illness may be untreatable. It was one of these bugs – a drug-resistant form of the feared bacteria Klebsiella that triggered a notorious outbreak in 2011 at a hospital at the National Institutes of Health that killed six people and made another 11 seriously ill.

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About the Author

 

Scott
Gottlieb
  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

    Click here to read Scott’s Medical Innovation blog.


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