DTx Value Guide - Digital Therapeutics Alliance

Building Blocks for Scalable Patient Access

Healthcare decision makers (HCDM) play a critical role in providing patients with access to high-quality, clinically validated digital therapeutics. Given the growth of the DTx industry over the last decade and lack of frameworks defining what “good” looks like, many HCDMs have needed to develop their own methods to evaluate DTx products.

DTA’s DTx Value Assessment & Integration Guide provides HCDMs and DTx manufacturers with an initial framework to assess DTx products, their value, and impact in real-world settings. With ongoing engagement from patients, clinicians, payors, and policy makers, this Guide will continue to be updated to ensure ongoing relevance in this quickly evolving ecosystem.

Target Audiences

This Guide is designed to assist healthcare decision makers in assessing and integrating DTx products into clinical use settings. Target audiences for this Guide include:

Advisory Teams

Patient advisory boards, caregivers, and practicing care team members

Authorizing Clinicians

Clinicians qualified to authorize patient use of the product

Clinical Support Teams

Administrative representatives and clinical practice implementation teams

Compliance Teams

Legal, regulatory, privacy, and security teams

End Users

Patients, caregivers, clinicians, and care teams

Payors

Payors, employers, health plan strategy and budgetary approval teams

Policy Makers

Government entities, HTA bodies, and public payors

Product Access Teams

Technical infrastructure, implementation, and support teams

Product Evaluation Teams

P&T committees, formulary developers, and innovation divisions

Dynamic Framework With International Applicability

Healthcare Decision Makers

A consistent set of criteria to rely on when evaluating DTx products
A baseline framework to use when seeking information from DTx manufacturers
A guide that can serve as a starter evaluation process for healthcare systems
A process that can be used in parallel with, or to refine, existing evaluation systems
An initial benchmarking system to compare various DTx products to each other

Clinicians

A framework to assess the legitimacy and impact of DTx products for patient care
A process to determine how to best implement DTx products in practice
A tool to assess DTx appropriateness for individual patient use
A guide to determine how to leverage real-world outcomes in patient care

DTx Manufacturers

A rubric to pre-populate and distribute to appropriate entities (in particular, the DTx Manufacturer version of this Guide, which is currently reserved for DTA member companies)
A framework that provides HCDMs, policy makers, and clinicians with information on product design, impact, and utilization
A more consistent set of expectations to meet across all clinical use environments

This Guide is intended to serve as a conversation starter between HCDMs and DTx manufacturers. It does not provide a definitive decision for HCDMs on whether or not to use a specific product in practice, and does not imply that a product has or has not met all necessary qualifications for clinical use. DTA invites HCDMs to join our efforts in developing the next iterations of this framework.

Integrating DTx Products into Clinical Settings

The following topics covered in this Guide may benefit patients, clinicians, policy makers, and payors from around the world as they increasingly assess and use DTx therapies at scale:

Industry overview – including “Is this product a DTx?” and “Where do digital therapeutics fit into healthcare?” diagrams
Clinical impact & intended use – including product usability and patient centricity considerations
Regulatory & security – including data privacy and governance considerations
Clinical evidence – including product evaluation types and real-world outcomes
Economic assessment – including analysis options and HTA considerations
Implementing digital therapeutics in practice – including clinical team engagement and product integration
DTx product benchmark questions – a high-level snapshot of a DTx product’s stage of development and real-world use
DTx product examples – a list of member company products, based on DTA’s DTx Product Library

Supporting the industry’s continuing evolution

This Guide was developed through a collaborative process, with input from DTA members, as well as clinicians, payors, and others involved in manufacturing, evaluating, supporting, and utilizing DTx products.

As the DTx ecosystem continues to rapidly evolve, this framework will be updated to ensure ongoing relevance with input from all key stakeholders. Please share insights with us on how you are using or implementing this Guide, or if you would like to be part of ongoing efforts.

Share Your Insights

This resource is for educational purposes only and is not intended as legal advice to individual companies. Payors have
differing coverage, coding, and reimbursement policies. Laws, regulations, and payor policies concerning coverage, coding,
and reimbursement are complex and are evolving rapidly. For legal advice, please consult with legal counsel.

Digital Therapeutics Alliance makes no warranty or representation regarding the completeness, accuracy, or timeliness of the
information provided and makes no guarantee of coverage or reimbursement for any digital therapeutic product. Contact the
applicable payor for specific guidance regarding coverage, coding, and reimbursement guidelines.

DTx Value Assessment & Integration

Building Blocks for Scalable Patient Access

Download the Value Assessment & Integration Guide

Target Audiences

Dynamic Framework With International Applicability

Integrating DTx Products into Clinical Settings

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