Speakers:
Samuel Falsetti
Randall Kaye, MD
The past decade has produced a flood of research into digital therapeutics, resulting in the commercialization of prescription digital therapeutics (PDTs) which are expected to disrupt current healthcare markets. The reach of digital therapeutics in terms of use is increasing, as is their potential to reduce healthcare costs and impact public health. This will inevitably force a paradigm shift amongst providers, regulators, and payers to reassess approaches to make sure PDTs are included in treatment strategies across multiple therapy areas. The technologies required for digital therapeutics are evolving, as are the regulatory pathways to approval, but reimbursement still requires real world evidence (RWE) to demonstrate value. Cross-functional teams bringing these therapeutics to market include medical affairs professionals, who are learning how to address the particular requirements for establishing medical value for PDTs, along with planning and executing medical communications. This session will address the complexities of commercializing prescription digital therapeutics (PDTs), discuss how medical value is established for PDTs, and discuss how medical affairs professionals are addressing these challenges in developing and executing medical communications for PDTs.
Learning objectives:
Samuel Falsetti
Randall Kaye, MD
The past decade has produced a flood of research into digital therapeutics, resulting in the commercialization of prescription digital therapeutics (PDTs) which are expected to disrupt current healthcare markets. The reach of digital therapeutics in terms of use is increasing, as is their potential to reduce healthcare costs and impact public health. This will inevitably force a paradigm shift amongst providers, regulators, and payers to reassess approaches to make sure PDTs are included in treatment strategies across multiple therapy areas. The technologies required for digital therapeutics are evolving, as are the regulatory pathways to approval, but reimbursement still requires real world evidence (RWE) to demonstrate value. Cross-functional teams bringing these therapeutics to market include medical affairs professionals, who are learning how to address the particular requirements for establishing medical value for PDTs, along with planning and executing medical communications. This session will address the complexities of commercializing prescription digital therapeutics (PDTs), discuss how medical value is established for PDTs, and discuss how medical affairs professionals are addressing these challenges in developing and executing medical communications for PDTs.
Learning objectives:
- Know how to differentiate prescription digital therapeutics (PDTs) from pharmaceuticals
- Understand the complexities of pivotal trial programs and regulatory approval for PDTs
- Understand how medical value is established for PDTs
- Recognize the key challenges addressed by medical affairs professionals in developing and executing medical communications for PDTs
You can access this item by buying entire section
Buy entire section: