What's Next for the FDA-CMS Parallel Review Pilot?

Transcription

1 What's Next for the FDA-CMS Parallel Review Pilot? Yarmela Pavlovic, Partner Hogan Lovells US LLP San Francisco November 4, 2015

2 Parallel Review Pilot Program Joint program by the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) Designed to decrease the time between FDA approval of new medical technology and a national coverage determination (NCD) by CMS First announced in 2010, implemented in 2011 To date one product (Exact Sciences Cologuard) has successfully completed the Parallel Review process. Program does not change existing separate review standards for FDA device approval and CMS coverage determination 2

3 Pilot Program Criteria Program designed to accommodate innovative technologies meeting the following criteria: Technology is the subject of a formal Pre-Submission interaction (under FDA s Pre-Submission Program), or an approved IDE application; Technology would require Premarket Approval (PMA) or a de novo petition; and Technology falls within the scope of a Part A or Part B Medicare benefit category and is not already subject of a national coverage decision (NCD). 3

4 Pilot Program Experience One product has completed program Cologuard (Exact Sciences) Noninvasive colon cancer screening Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. Subject of an approximately 10,000 patient pivotal study FDA and CMS review approximately 1 year from submission of clinical study results (including panel meeting) Approved by FDA August 11, 2014 Draft NCD announced by CMS the same day Final NCD issued October 9,

5 Parallel Review Program Next Steps Pilot set to run late 2015 FDA and CMS extended their memorandum of understanding in June 2015 Allows them to share data indefinitely New proposals reportedly coming in December 2015 FDA still accepting applications for program 5

6 Payer Communication Task Force (PCTF) Charged with identifying ways to shorten the time from FDA approval to coverage by Payers Includes both public and private payers Working to facilitate involvement of payers in early clinical trial discussions between the Agency and companies Potentially presents opportunities for companies that would not have qualified for Parallel Review program Company may invite Payer stakeholders, whether public or private, to attend the company s pre-submission meetings with FDA FDA and CMS reportedly committed to provide some form of feedback to all manufacturers who make the request Facilitated via FDA s pre-submission program Goal is to allow for collaborative input to help companies design clinical trials that meet a variety of business objectives, including regulatory, coverage and payment decisions 6

7 Considerations Companies considering involvement in the Parallel Review program may consider the following: Parallel Review appropriate for companies that plan to seek an NCD immediately Many technologies do not require an NCD from CMS because they can be covered by regional contractors without action by CMS or are used in patient populations not covered by Medicare Where funding is limited and FDA approval may be achievable based on more limited data, a company may decide not to seek Payer input at an early stage Parallel Review process does not affect coding and reimbursement If technology can be covered by a regional contractor without CMS involvement, coding and reimbursement are typically more pressing Process happens entirely outside the scope of the Parallel Review process. Payer input could be obtained separately, though FDA would not hear the feedback 7

8 Hogan Lovells has offices in: Alicante Amsterdam Baltimore Beijing Brussels Budapest* Caracas Colorado Springs Denver Dubai Dusseldorf Frankfurt Hamburg Hanoi Ho Chi Minh City Hong Kong Houston Jeddah* Johannesburg London Los Angeles Luxembourg Madrid Mexico City Miami Milan Minneapolis Monterrey Moscow Munich New York Northern Virginia Paris Perth Philadelphia Rio de Janeiro Riyadh* Rome San Francisco São Paulo Shanghai Silicon Valley Singapore Sydney Tokyo Ulaanbaatar Warsaw Washington DC Zagreb* "Hogan Lovells" or the "firm" is an international legal practice that includes Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses. The word "partner" is used to describe a partner or member of Hogan Lovells International LLP, Hogan Lovells US LLP or any of their affiliated entities or any employee or consultant with equivalent standing. Certain individuals, who are designated as partners, but who are not members of Hogan Lovells International LLP, do not hold qualifications equivalent to members. For more information about Hogan Lovells, the partners and their qualifications, see. Where case studies are included, results achieved do not guarantee similar outcomes for other clients. Attorney Advertising. Hogan Lovells All rights reserved. *Associated offices