A Payer Perspective on Biomarkers and Targeted Therapies

Transcription

1 A Payer Perspective on Biomarkers and Targeted Therapies IOM Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies January 29, 2015 Louis B. Jacques, MD WASHINGTON DC AUSTIN SAN FRANCISCO Disclaimers My comments are based on my own experiences, in part from prior Federal service at CMS. They represent neither the opinions of any Federal agency, nor those of my current employer or its clients. ADVI has consulting agreements with entities that develop biomarkers or therapies whose use may be informed by biomarker test results. I am covering my own expenses to attend this meeting. 1

2 One Sentence Summary Payers are interested but understandably circumspect. Premises: Science The science (and the evidence) is promising but not yet mature. Cancer is the current clinical space where much of this is developing. Tumor biology (e.g. tumor evolution and multiple pathways) may pose unique challenges. Lessons learned in one clinical space may or may not crosswalk easily to other spaces. Cancer CAD. Finding one target is like finding one road on a map; it may not be the only route or even the preferred route to the destination. Durable patient outcomes may differ from short term outcomes, for better or for worse. 2

3 Premises: Policy The available evidence for decision making will be complicated and incomplete. When is the best time to call the question(s)? Methodologic rigor in clinical studies should align with the harms of being deceived by the wrong answers. When cancer is the context, there is intense political pressure to pay despite evidentiary gaps. Value based health care the use of burdensome poten ally lethal therapies that have essentially no chance of success. Payer enthusiasm depends on Knowing what they are actually paying for Persuasive evidence of benefit in actual clinical practice Adequate infrastructure for technical review and payment determination Medicare MolDX Pilot Unique identification of specific molecular diagnostic tests Technical assessment Test characteristics Actionability Clinical utility (following examples e.g. ACCE, CMS NCDs) Reimbursement determination JE and J11 jurisdictions 3

4 PAMA 2014 Consistent with aspects of the CMS MolDX paradigm Applies only to labs paid under the Clinical Lab Fee Schedule Granular coding for Advanced Diagnostic Tests (ADTs) Payment based on list charge pricing initially (3Q) Final pricing transition based on commercial payer contract pricing calculation CMS may consolidate all ADT local policy and claims processing to 4 or fewer regional contractors (MACs) Expert Advisory Panels Local Coverage Determinations used as policy vehicle for Medicare contractors Broader Questions Personalized medicine v Balkanized medicine. How do we treat everyone the same if everyone wants to be treated uniquely? Balance is a 20% probability of treatment failure accorded the same policy weight as a 20% probability of treatment success? How might molecular testing inform commercial coverage tiers and cost sharing based on likelihood of success or futility? How will the implementation of PAMA and other Federal initiatives modify our current assumptions? Does the news of recent partnerships/acquisitions of test developers by large therapeutic companies signal a fundamental change in this space? 4

5 Louis B. Jacques, MD SVP & Chief Clinical Officer, ADVI ADVI.COM K St, NW Suite 340 WASHINGTON, DC Louis.Jacques@ADVI.COM WASHINGTON DC AUSTIN SAN FRANCISCO 5