The FDA Breakthrough Device Program: Regulatory and Reimbursement Insights and Key Considerations MCRA Presenters John Doucet Ph.D. Tonya Dowd MPH John McDermott MBA info@mcra.com
MCRA Presenters J ohn Doucet, Ph.D. Tonya Dowd, MPH John McDermott, Vice President, MBA Sr. Director, Neurology Reimbursement, Health Regulatory Affairs Sr. Director, Economics & Market Access Reimbursement Strategy Former FDA Policy Lead, Former Global Franchise Breakthrough Device Program Director of Healthcare Former Vice President of Additional prior roles at FDA Economics and Market Access Covance Market Access. include: Acting Director of IDE within Johnson & Johnson’s Former Director of DK Pierce Program, Acting Branch Chief of medical device division Market Access Strategy Neurostimulation Devices Psychiatry Branch Highlights: Highlights: Highlights: • 30+ years of reimbursement, • 30+ years of industry health economics & market experience spanning market • 10+ years of FDA and access experience access, reimbursement, neurology devices experience coverage access programs, • Disease and life sciences • Expertise in neurology devices and health economics and experience: medical devices, covering psychiatric disorders outcomes research (HEOR) molecular dx, biologics, & acute/chronic pain cardiovascular, GI, • Deep experience engaging • Expertise in regulatory ophthalmology, orthopedic, drug and medical device submissions including 510(k), urology industries evaluating a wide IDE, PMA, HDE, 513(g), Q- variety of therapeutic areas Submissions, & De Novo • Expert in upstream product plan including cardiology, urology, development and downstream oncology, rare diseases, and • 13+ years as NIH-funded execution of reimbursement diagnostic imaging neuroscientist at John Hopkins strategies University (5+ million dollars in awarded grants)
Learning Objectives Understand the purpose and benefits of the breakthrough device program and how FDA I reviews designation requests. Understand how breakthrough designation impacts reimbursement, specifically, with II coding, coverage and payment with CMS/Medicare Dialogue with the experts- discussion of FAQs III
Would you ever start training for a marathon 5 days before race day?
The MCRA Model Integrated Development and Commercialization Strategy FDA & European MDR Clinical Evidence Market Access Quality System Healthcare Regulatory Reimbursement is Clinical Evidence Requirements Compliance Execution Multifaceted in Required for All Becoming More Considerations Creates Constituents and Stakeholders Demanding Help Mitigate Risk Technology Value Policies Clinical Evidence Generation with World Class Regulatory and Reimbursement Integration Creates Long Term Value
Sequential Strategy is High-Risk (and common) Reimbursement Regulatory Coding, Coverage, Payment Pivotal Clinical Marketing Pre-Clinical Pilot Clinical Testing Study Authorization Study Strategy A Strategy B Breakthrough Breakthrough Breakthrough Device Device Marketing Device Designation Authorization Reimbursement Statutory Statutory CMS* –Statutory Criteria Criteria Criteria Private Payer Criteria * Centers for Medicare and Medicaid Services
Integrated Strategy is Optimal Reimbursement Regulatory Coding, Coverage, Payment EARLY Do codes, coverage, and Breakthrough Device Eligibility payment pathways Breakthrough Device currently exist for target Marketing Submission population or do we need Breakthrough to create new ones? Device Reimbursement INTEGRATED Optimal Evidence Generation
Breakthrough Program: Origin and Evolution 21 st Century Cures Act December 13, 2016 2015 2016 2017 2018 2020 300+ Breakthrough Designation Requests 100s of Breakthrough Device Interactions
Breakthrough Program Purpose "This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health."* Focus FDA on Breakthrough Devices Promote Collaboration * Breakthrough Devices Program – Guidance for Industry and Food and Drug Administration Staff
FDA Interaction Mechanisms Preclinical Pilot Clinical Pivotal Clinical Marketing Testing Study Study Application 510(k) Standard Interaction Mechanisms: De Novo 513(G) Request for Information Informational Meeting PMA Study Risk Determination Pre-Submission Submission Issue Request Agreement and Determination Meeting PMA Day 100 Meeting Accessory Classification Request Breakthrough Breakthrough Device Interaction Designation Mechanisms Request
Breakthrough Interaction Mechanisms Preclinical Pilot Clinical Pivotal Clinical Marketing Testing Study Study Application 510(k) Breakthrough De Novo Breakthrough Device Interaction Designation PMA Mechanisms Request Data Development Plan (DDP) Sprint Clinical Protocol Agreement Pre-submission Priority Review
Breakthrough Interaction Mechanism: Benefits Standard Device Interaction: Pre-Submission FDA FDA Written Receipt Feedback 0 70 75 Days Can you confirm we're heading in the right direction? FDA Meeting Breakthrough Device Interaction: Sprint or DDP FDA Sponsor FDA Sponsor Written Additional Receipt Summary Feedback Information 0 7 14 21 28 35 40 45 FDA FDA FDA FDA Meeting Meeting Close out Meeting Let's collaborate and identify the right direction together.
Breakthrough Device Criteria Criterion 1: "provide for more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions; AND Criterion 2: (A) that represent breakthrough technologies; (B) for which no approved or cleared alternatives exist; (C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or (D) the availability of which is in the best interest of patients.” Reference: Section 515(b) of Food, Drug and Cosmetic Act
How do you meet Criterion 1? (1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; FDA believes it is appropriate to consider CONGRESS whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current standard of care (SOC) in the U.S. FDA* * For all recommendations, see Breakthrough Devices Program – Guidance for Industry and Food and Drug Administration Staff
How do you meet Criterion 1? Standard Your Device of Care Received marketing authorization for the indication being considered Currently marketed in the U.S. and is a relevant option for patients with the identified disease or condition
How do you meet Criterion 1? (1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; FDA believes it is appropriate to consider CONGRESS whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current standard of care (SOC) in the U.S FDA* * For all recommendations, see Breakthrough Devices Program – Guidance for Industry and Food and Drug Administration Staff
How do you meet Criterion 1? SOC Your Device
How do you meet Criterion 1? (1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions ; ... likelihood of death is high unless the course of the CONGRESS disease is interrupted in a population or subpopulation. ...based on its impact on such factors as survival, day-to-day functioning, and the likelihood that the disease or condition, if left untreated, will progress to a more serious disease or condition. FDA* * For all recommendations, see Breakthrough Devices Program – Guidance for Industry and Food and Drug Administration Staff
Breakthrough Designation = Device + Indications for Use Indication Device Breakthrough for Use Designation
Breakthrough Device – Pivotal Study Design Reimbursement Regulatory Coverage, Coding, Payment Pivotal Clinical Marketing Pre-Clinical Pilot Clinical Testing Study Authorization Study Regulatory Team Clinical Team Reimbursement Team Breakthrough Breakthrough Breakthrough Device Device Marketing Device Designation Authorization Reimbursement Statutory Statutory CMS –Statutory Criteria Criteria Criteria Private Payer Criteria
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