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Digital Therapeutics Alliance Digital Therapeutics: Pharmacy Care Innovation and Implications for Policy Megan Coder, executive director, Digital Therapeutics Alliance Susan Cantrell, chief executive officer, Academy of Managed Care Pharmacy Laura Topor, president, Granada Health and former NCPDP® Trustee Megan Coder, PharmD, MBA Executive Director Digital Therapeutics Alliance Copyright © 2021 DTA What is a digital therapeutic? Digital therapeutics (DTx) deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioral, mental, and physical diseases and disorders. Whether DTx products are used independently, in tandem with remote or in-person clinician-delivered therapy, or paired with medications, devices, and other therapies, DTA stands behind rigorous patient-centered core principles, ethical standards, and product development best practices to ensure product integrity, user-centered designs, patient privacy, and validated clinical outcomes. Copyright © 2021 DTA Digital Therapeutic Core Principles Copyright © 2021 DTA What diseases do DTx products target? Blood disorders • ICU delirium Respiratory system disorders • Coagulation disorders, including hemophilia • Opioid use disorder (OUD) • Asthma • Pain (acute, chronic) • Chronic obstructive pulmonary disease (COPD) Neoplasms • Panic disorder, panic attacks • Cancer, side effect management Digestive system disorders • Post-traumatic stress disorder (PTSD) • Cancer, drug therapy optimization • Irritable bowel syndrome (IBS) • Schizophrenia (positive symptoms) Endocrine, nutritional, and metabolic diseases • Stress-related chronic diseases Skin and subcutaneous tissue disorders • Diabetes, type 1 • Substance use disorder (SUD) • Skin disorders • Diabetes, type 2 Nervous system disorders Musculoskeletal system and connective tissue • Metabolic syndrome • Epilepsy disorders • Obesity • Insomnia, sleep disorders • Movement disorders • Pre-diabetes • Lupus • Orthopedic conditions Mental, behavioral, and cognitive disorders • Migraine • Osteoarthritis • Alcohol use disorder • Multiple sclerosis (MS) Pregnancy and childbirth • Attention-deficit/ hyperactivity disorder (ADHD) • Parkinson’s disease (PD) • Post-partum depression • Anxiety Circulatory system disorders • Autism spectrum disorder Injury, poisoning, and certain other consequences • Hypertension • Depression of external causes • Stroke • Eating disorders • Traumatic brain injury (TBI) *As of March 2020 Copyright © 2021 DTA DTx Product Categories Digital therapeutics generally align with one of these categories based on the product’s primary purpose: Digital Therapeutic to: Digital Therapeutic to: Digital Therapeutic to: TREAT A DISEASE MANAGE A DISEASE IMPROVE A HEALTH FUNCTION* Level of medical claims Medium to high-risk claims Medium to high-risk claims Low to medium-risk claims Must use clinical endpoints to Must use clinical endpoints to Must use clinical endpoints to Clinical endpoints support product claims support product claims support product claims Clinical trials and ongoing Clinical trials and ongoing Clinical trials and ongoing evidence Clinical evidence evidence generation required evidence generation required generation required Third-party validation of efficacy Third-party validation of efficacy Degree of regulatory oversight Regulatory oversight and safety claims by regulatory and safety claims by regulatory or depends on local regulatory body or equivalent national body equivalent national body frameworks Prescription required OR Patient access Prescription required Non-prescription product Non-prescription product *Incudes digital therapeutics that prevent a disease Copyright © 2021 DTA Copyright © 2021 DTA FDA’s Emergency Use Authorization “In the context of the COVID-19 public health emergency, the use of digital health technologies, including software as a medical device or other digital therapeutics solutions, may improve mental health and well-being of patients with psychiatric conditions during periods of shelter-in-place, isolation, and quarantine. In addition, the use of such technologies has the potential to facilitate “social distancing” by reducing patient contact with, and proximity to, health care providers, and can ease the burden on hospitals, other health care facilities, and health care professionals that are experiencing increased demand due to the COVID-19 public health emergency.” -U.S. Food and Drug Administration (source) Copyright © 2021 DTA Medicare Benefit Categories https://www.healthaffairs.org/do/10.1377/hblog20201021.783035/full/ Copyright © 2021 DTA DTA Paper: Rural & Underserved Communities Download at https://dtxalliance.org/wp-content/uploads/2021/01/DTA_Rural-Health_r13_110220.pdf Copyright © 2021 DTA DTx Value Assessment & Integration Guide Draft Table of Contents:* *Content subject to change prior to launch How do we differentiate between different digital health • Real-world data (RWD) types generated by DTx Clinical Practice Considerations products? products • DTx product benefits for patients and caregivers Digital Therapeutic Landscape • Developing targeted real-world evidence (RWE) • DTx product benefits for clinicians and health systems • Digital health ecosystem product overview • Assessing and applying real-world evidence (RWE) • Product authorization and distribution • Digital therapeutic definition and core principles • Health Economic and Outcomes Research (HEOR) • Clinician team engagement • DTx product types • Access to product outcomes • DTx industry code of ethics How do we evaluate the economic impact of digital therapeutics? How to we assess DTx product compliance with applicable How do we identify high quality digital therapeutics? Economic Assessment regulations? DTx Product Assessment: Safety, Efficacy, Intended Use • How DTx products address payor needs Compliance Assessment: Regulatory, Data, and IP • DTx product assessment and evaluation • Factors that affect DTx therapy economic impact Considerations • Clinical & economic evidence expectations • DTx economic impact evaluation framework* • Regulatory oversight • DTx product evaluation types • DTx economic impact evaluation considerations • Region-specific regulatory pathway considerations • Assessing clinical trial evidence • Product security best practices • DTx product technical considerations How do we deliver digital therapeutics to patients? • Product data integrity, quality, and governance • Product appropriateness and usability Implementing Digital Therapeutics • Intellectual property considerations • • DTx products on the market DTx implementation and engagement* • Appropriateness of implementation studies DTx Product Case Studies What types of data do digital therapeutics generate? • Ensuring quality data sets DTx Product Clinical Evaluation: Product Ongoing Conclusion and look at the horizon Effectiveness & Economic Impact How do we implement and optimize DTx products in • Interpreting real-world data (RWD) clinical practice? Copyright © 2021 DTA Susan A. Cantrell, RPh, CAE​ Chief Executive Officer AMCP Mission To improve patient health by ensuring access to high-quality, cost-effective medications and other therapies. Digital Therapeutics (DTx) What are they and where do they fit into pharmacy and medical benefits? Forum Objectives • Describe digital therapeutics (DTx) and how managed care organizations evaluate their value. • Identify where digital therapeutics fit in within a coverage benefit. • Outline evidentiary standards needed for coverage of digital therapeutics. • Outline how payers/managed care organizations may leverage digital therapeutics for value-based care and patient engagement. Characteristics of DTx • Software that delivers a clinical mechanism-of-action, either alone or in combination with other standard-of-care treatments, to improve outcomes • As with other treatments (e.g., small molecule drugs, biologics, devices), stakeholders expect • Appropriate clinical evidence of safety and efficacy • Good manufacturing practices Solutions Along the Patient Journey Focus areas to improve care along the patient journey Outpatient Inpatient Prescription medication Home health New modalities • Moving PCP visits to • Reduction of re- • Reducing price • Reducing unit cost of • Increase in revenue from virtual modalities admissions dispersion home care through virtual visits • Reducing price • Reducing price virtualization and tele- • Percent of value created dispersion dispersion health captured by digital • Care avoidance from • Reducing expensive ER solutions (assumed personal health/self- visits 10%) diagnostic tools Opportunity for digital therapeutics • Self-service • Financial transparency • Clinical transparency into • Quantified self wellness • Virtual access • Remote patient through better tracking of use and adherence • Treatment adherence tools engagement outcomes • Health monitoring and coaching • Remote care • Social connectivity • Wearables Evidence Requirements • Varies based on medical claim or function • Should align with standards for clinical evidence • Evidence of safety and efficacy based on • Standardized endpoints for the disease area • Appropriate patient population • Clinical trials conducted using good clinical practices • Clinical evidence must be evaluated by appropriate health authorities and receive market authorization with a regulatory label • Ongoing data to support modifications/improvements to product follow GMPs Payer Evaluations • Value determination • Patient
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