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April 14, 2022

Meeting snapshots - Expert insights from the HealthXL community

Commentary
Philip Connolly
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Over the past month, our HealthXL community members met to discuss topics ranging from evidence gathering for Digital Therapeutics (DTx), to reimbursement  in the US, Software as a Medical Device (SaMD) regulation in the EU among others. 

We have curated some of the key takeaways from these sessions to showcase the top 5 expert insights from these meetings.

#1 On getting reimbursed in the US

When approaching payers to negotiate an access agreement, clinical data and cost-effectiveness are really important, especially the latter. But even when you have the evidence, becoming a trusted advisor for payers in the US is a huge challenge. The 4 key pillars of account management excellence when working with payers for DTx reimbursement are:

1) Customer interest

2) Seek mutual value creation

3) Bring an integrated team approach

4) Ongoing account management

 

Although there is still a long way to go to have clear and easy paths to reimbursement in the US, we are seeing new initiatives that point in the right direction. Recently, there has been a new PDT legislation introduced in the Congress, which has already moved to the finance committee and it is very clear on how it codifies PDT coverage in both Medicare and Medicaid, as well as proposed pricing and payment models. 

#2 On the challenges and best practices for evidence generation for DTx 

Aligning your evidence generation strategy with your commercialization strategy from the early stages is critical to avoid spending more money and time. Knowing who you want to sell to upfront is key to building an efficient and relevant evidence strategy. An approach that some DTx companies take initially is building a less regulated product and collecting real-world evidence. Once they have generated the evidence, they change towards the Software as a Medical Device (SaMD) model, hence a more regulated approach.

#3 On the regulation of Software as a Medical Device (SaMD) in Europe

Given the complexity of the new Medical Device Regulation (EU-MDR) for SaMD in terms of time to market, it can be easier for life sciences companies to start building  solutions that are not classified as medical devices and then build a roadmap towards class I, and then class II, or having only some parts of the solution that are SaMD. 

Artificial intelligence (AI) is still hard to fit in well with medical regulations. There are some changes expected to happen in Europe in the next few years. COCIR recently published a comprehensive paper, “AI in Medical Device Legislation", that focuses on AI-based devices in the scope of the EU MDR. The European Commission also published its proposal for the Artificial Intelligence Regulation (the Draft AI Regulation), which sets out plans for a comprehensive regulatory framework that covers AI systems in general.

#4 On the implementation and adoption of digital health in Oncology 

The combination of a relatively small oncology patient population overall combined with a wide diversity of disease and treatment types results in high levels of customization for small numbers of users or individual drugs. Combining this with distinct geographic differences in treatment paradigms has resulted in a perceived lack of scalability for digital therapeutics in oncology. 

Solutions surfaced in this context were devising ways to efficiently adapt a core solution to different disease types - demonstrating this would be valuable to both pharma partners and investors. Another idea was to take a disease agnostic approach and go directly to patients to get them engaged. Then, in turn, having these people push the tools onto the health care providers. 

#5 On clinical and economic evidence for standalone digital therapeutics (DTx) 

As software solutions, DTx will require ongoing monitoring and updates to fix bugs or improve features. As the industry evolves, there needs to be recognition that DTx products will be iterative - similar to other tech companies in sectors such as entertainment or banking. Non-prescription Standalone DTx, in particular, needs to be heavily consumer-focused and updated regularly to stay relevant. This creates issues as it may require multiple updates and resubmissions with regulators. 

Want to join the conversation? Check out our website for upcoming meetings and events. 

Interested in more expert insights and takeaways? Become a member of our HealthXL Communities for access to polls and summaries from all of our meetings.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

Ready to read more? HealthXL members can access the full peak of the report on the HealthXL Community Hub.

Not yet a member of HealthXL? Download your 11 page snapshot of the report.

Download your 11 page snapshot

Connect with peers and share insights

Don't miss out on the discussion of the latest insights and reports on digital health. Meet with peers and take a deep dive for 75 minutes. Unlike at webinars, you can freely exchange experiences and insights to solve challenges and design the future of DTx.

Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: DTx Reimbursement in the US - PBMs as Coverage Scale Catalysts

10th August @ 10:45AM EDT

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: Value, Cost and Pricing in Regulated Digital Health Solutions

11th August @ 10:45AM EDT

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Sustainable Business Models for DTx

16th August @ 10:45AM EDT

It is one of the key questions that every digital therapeutic (DTx) company must answer - what business model will set them up for success in the long run? Join this meeting to discuss this further and share your experiences with your peers working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Payers Partnerships for DTx

17th August @ 10:45AM EDT

Digital Therapeutics (DTx) vendors face many challenges on their journey to commercialization, such as generating clinical data, health economics evidence and achieving regulatory status. Join this meeting to discuss this topic further and share your experiences with others working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Kevin Darcy
Kevin Darcy
Director, Link Strategy at Veeva Systems
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Kevin Darcy
Kevin Darcy
Director, Link Strategy at Veeva Systems

Are you a HealthXL Member? See the Full Report Here

Non-HealthXL Member? You can purchase the report HERE

HealthXL Digital Health Meetings

Want to join the discussion now?

Join our Digital Health Meetings and take a deep dive for 75 minutes into topics like digital therapeutics, patient support, telehealth, clinical trials, dermatology and many more. These Meetings are not regular webinars: No audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And with a free account on our Community Hub, you stay connected and up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.

Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: DTx Reimbursement in the US - PBMs as Coverage Scale Catalysts

10th August @ 10:45AM EDT

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: Value, Cost and Pricing in Regulated Digital Health Solutions

11th August @ 10:45AM EDT

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight

Executive 1-2-1 with the HealthXL Digital Health Community

15th August @11AM EDT

Do you want to network with other innovators and leaders in digital health? Are you looking to identify potential partners? Join us for the new HealthXL style of virtual speed networking and meet other members working in this space!

Featuring
Aahuti Rai
Aahuti Rai
Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
Chris Wasden
Chris Wasden
Head of Pharma Speciality Solutions & Corporate Strategy, Twill
Featuring
Aahuti Rai
Aahuti Rai
Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
Chris Wasden
Chris Wasden
Head of Pharma Speciality Solutions & Corporate Strategy, Twill
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Sustainable Business Models for DTx

16th August @ 10:45AM EDT

It is one of the key questions that every digital therapeutic (DTx) company must answer - what business model will set them up for success in the long run? Join this meeting to discuss this further and share your experiences with your peers working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC

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