Exact Sciences’ experience with the FDA and CMS parallel review program

Abstract

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.

Keywords:

• Cologuard^®
• colorectal cancer screening
• FDA-CMS parallel review
• in vitro diagnostic
• multitarget stool DNA
• premarket authorization
• reimbursement
• stool DNA-based colorectal cancer screening test
• stool DNA testing

Acknowledgements

The authors wish to acknowledge D Hochberg and O Kolman of Health Advances, who provided Figure 3 and its supporting data (used with permission).

Financial & competing interests disclosure

The authors are employees of Exact Sciences. Assistance with the writing and development of the manuscript was provided by B Dreitlein, R Fowler and L Wychowski of Envision Pharma Group, and was funded by Exact Sciences Corporation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Colorectal cancer is highly preventable if detected early, yet screening rates remain suboptimal, despite the availability of multiple screening methods.

• Cologuard^® is a technologically advanced, non-invasive, multitarget stool DNA screening test for adults of either sex, 50 years or older, who are at typical average risk for colorectal cancer.

• The US FDA reviews the clinical safety and efficacy attributes of innovative class III in vitro diagnostics under a stringent premarket approval (PMA) process, which was a required intermediary step for Cologuard.

• Traditionally, Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations involve a lengthy evaluation process to determine whether an FDA-approved product meets the reasonable and necessary threshold for national coverage under the Medicare benefit.

• In October 2011, the FDA and CMS launched a parallel review pilot program to partially coordinate the regulatory approval and coverage reimbursement procedures for selected products that meet specific criteria, with the aim of reducing delays in access to important new medical device technologies.

• The parallel review pathway offers a more harmonized and collaborative approach toward evidence generation, thereby ensuring that the independent requirements of both the FDA and CMS agencies are met.

• Cologuard became the first product to successfully navigate the FDA-CMS parallel review process. On 11 August 2014, Cologuard received simultaneous approval by the FDA and preliminary National Coverage Determination by CMS thus facilitating access for Medicare beneficiaries soon after launch.

• The parallel review process shortened the expected interval from FDA approval to CMS coverage for Cologuard.

Notes