Aims: To evaluate the cost-effectiveness of percutaneous patent foramen ovale (PFO) closure, from a US payer perspective. Lower rates of recurrent ischemic stroke have been documented following percutaneous PFO closure in properly selected patients. Stroke in patients aged <60 years is particularly interesting because this population is typically at peak economic productivity and vulnerable to prolonged disability. Materials and methods: A Markov model comprising six health states (Stable after index stroke, Transient ischemic attack, Post-Transient Ischemic Attack, Clinical ischemic stroke, Post-clinical ischemic stroke, and Death) was constructed to evaluate the cost-effectiveness of PFO closure in combination with medical management versus medical management alone. The base-case model employed a 5-year time-horizon, with transition probabilities, clinical inputs, costs, and utility values ascertained from published and national costing sources. Incremental cost-effectiveness ratio (ICER) was evaluated per US guidelines, utilizing a discount rate of 3.0%.

Colorectal cancer (CRC) is the third most commonly diagnosed cancer and the second leading cause of cancer death among men and women combined in the USA. Although the benefits of early CRC detection are widely recognized, screening rates are suboptimal. Cologuard is a multitarget stool DNA screening test that offers a unique non-invasive option for CRC screening. Cologuard was the first product to be reviewed under a pilot parallel review program jointly conducted by the US FDA and the Centers for Medicare & Medicaid Services (CMS). This parallel review process shortened the overall review for Cologuard and resulted in a preliminary National Coverage Determination that coincided with FDA approval.

A simple search of the US FDA and the Centers for Medicare and Medicaid Services (CMS) websites demonstrates that the science of personalized medicine is far more advanced than current coverage and reimbursement policies. When one searches the websites of the FDA and CMS for pharmagenomics, personalized medicine and genetic testing, over 1800 hits come up on the US FDA website, and 52 hits come up on the CMS website. Although this is no surprise to those involved in the field of personalized medicine, it does illustrate the uphill battle that we face in educating policy makers on the need to appropriately cover and reimburse molecular diagnostics for use in a personalized medicine paradigm. A fully integrated personalized medicine paradigm will be driven by the ability to eliminate the reimbursement and coverage barriers that impact a patient's ability to access technological innovations in molecular diagnostic testing. For the purpose of this discussion, molecular diagnostic tests will be defined as a clinical diagnostic test performed on DNA, RNA or protein.