Digitizing Existing MOA
New Digital MOA
Yes
No
Payer or Employer
Direct-to-Consumer
Are you pursuing FDA clearance?
1
Are you digitizing a validated treatment or developing a new digital mechanism of action?
2
Are you seeking payer/employer reimbursement or going direct-to-consumer?
3
Product
Evidence
Regulatory
Commercial
Duration/Cycles of Use
HCP Workflow Integration
Patient Engagement and Activation
Funding Pathways
Driving Adoption
Channel
Pricing Model
Evolving Solution and Adjacent Evidence
Regulatory Oversight Required
FDA Strategy
Impact of FDA Clearance
Randomized Clinical Trial Design
RWE Requirements
Health Economic Evidence
Submission Type
Payers prefer products with a fixed duration rather than ongoing, open-ended use. Evidence of the ongoing effect of treatment following completion is particularly important to demonstrate. Guidelines for product use in clinical practice are unlikely to deviate from the model tested in trials. If the study assessed a single cycle of therapy, repeat use is unlikely to be supported, at least initially. To justify ongoing or repeat use, manufacturers must provide dynamic features personalized to the individual user, as well as proof of long-term efficacy.
RWE Requirement
A fixed duration of use may be easier to maintain engagement versus expectation for open-ended ongoing use. Behavioral science methods, gamification or rewards can be used to maximize engagement.
Products that more closely follow the existing workflow face lower barriers to adoption (e.g., a solution with high familiarity among HCPs, digitized versions of existing HCP tools and processes). If remote monitoring and engagement with data are required from HCPs, EHR integration can be a crucial requirement. DTx programs create a myriad of new data for HCPs. Many DTx have an assessment or diagnostic component along with their treatment component. Solution-generated data must be surfaced to HCPs in an understandable, actionable way.
Manufacturers must continually iterate the product to ensure patient engagement. Patient self-selection remains a key concern in this space, especially for products where the highest clinical value would often be among patients with limited initial motivation and disease engagement.
For solutions with a novel digital mechanism of action, sham control is often required to appropriately assess the benefit of the active component. Patient inclusion and exclusion criteria must align with the desired target patient population, as payers often point to this as the basis of the appropriate patient segment for coverage. For DTx solutions aiming to replace existing standard of care, the product must demonstrate clinical superiority or clinical noninferiority and incremental cost savings compared to standard of care.
Manufacturers must frequently demonstrate clinical efficacy, cost savings, and patient engagement in real-world settings, in addition to clinical studies. Real-world evidence (RWE) trials and observational studies can be leveraged to further validate a product, especially if the product has evolved since the pivotal trial. Early stage pilots are useful if both parties establish defined KPIs, shared risk, or upfront incentives. Manufacturers can then leverage early demonstration of value to scale with subsequent customers without additional pilots. In addition to clinical and economic evidence, the inherent nature of digital brings new opportunities for validating patient activation and engagement.
Demonstration of user satisfaction (e.g., NPS, app store ratings and user testimonials) is important to differentiate in a crowded direct-to-consumer market. Starting out DTC may allow for a wider user base, including collection of RWE via “opt in” studies with the user population. DTC also allows for demonstration of real-world engagement and retention.
Manufacturers must demonstrate where and how cost savings are generated. For example, savings could come from decreased medication usage, reduced ER visits or hospitalizations, appropriate delay in step-ups, and more. For a new DTx solution, payers will often leverage pilots to assess the economic impact relevant within their population. Successful case studies from employers and payers can serve as one inroad to gain traction with similar organizations.
Consumers are price sensitive, and they often compare DTx with other existing out-of-pocket healthcare costs or consumer tech expenses, such as mobile app subscriptions, wearables, etc. While cost savings evidence is less relevant to the individual consumer, DTx solution must be priced within their acceptable range.
As digital solutions evolve, the actual product being tested may have shifted over multiple studies (e.g., new content, modules, scenarios, algorithms). This can introduce an additional variable and nuance when engaging payers. While manufacturers will need to "lock" the product for a given clinical study, continuous learning and insights will demand continuous product evolution.
For the DTx solution that falls outside of the high-risk, novel category, the pursuit of FDA approval may be more influenced by commercial intent. While FDA approval doesn't confer payer reimbursement, the clinical claims can often be a differentiator. On the other hand, solutions that don't require a provider (for awareness or Rx) are gaining traction via employers without FDA authorization.
Early players in the DTx space received De Novo clearances for truly novel medical devices. As more of these clearances accumulate and increase the number of predicates to point to, there may be more options for a more accelerated 510(k) route to approvals. Manufacturers have leveraged evidence of substantial equivalence to expedite FDA clearance.
For lower-risk DTx solutions, the FDA may exercise enforcement discretion, which allows for more flexibility but also introduces more gray areas. Early and frequent engagement with the FDA is still recommended to ensure interpretation of enforcement discretion is aligned with your internal interpretation.
As health plans typically have a high evidence threshold, contracting with health plans is often a long-term play for manufacturers that have invested in building evidence. Manufacturers may benefit from contracting with small, innovative plans to establish traction before engaging larger, national health plans. Payers are often more receptive to a DTx solution that aims to delay or spare the use of high-cost therapies. For adjunctive DTx solutions that require incremental reimbursement on top of the cost of the existing standard of care, they must demonstrate a clear clinical value proposition and cost savings to justify greater total spend.
Reimbursement does not guarantee enrollment and utilization. Manufacturers must work with the payer or employer on member outreach. If the solution is Rx-only, HCP adoption (both at the institutional level and individual level) is required to drive utilization and pull through revenue. If the DTx solution aims to replace a standard of care, it is critical to obtain HCP buy-in and enable appropriate reimbursement for use, as the DTx solution may displace an existing revenue stream.
Health plans must be engaged with at multiple points over a complex sales cycle. However, employers, managed care companies and others can also provide support and influence.
Pilots, coverage with evidence development or other models to lower entry barriers are still common starting points for establishing payer coverage. Increasingly data-savvy payers expect manufacturers to propose a feasible value-share arrangement for an interventional DTx solution. VBC models can be readily applied to a DTx solution, as its digital nature lends itself well to data collection. For a DTx solution intended to manage versus treat, payers may instead opt for traditional models, such as per member per month (PMPM).
FDA approval does not confer payer reimbursement, as payers are developing their own evidence standards for reimbursement that can differ from regulatory requirements. There is often a trade-off between rigor in clinical evidence and the speed to market. While FDA clearance can further validate and differentiate DTx solutions, it may come at the cost of forgoing the valuable advantage of early, in-market learnings and building an established user base.
If seeking payer reimbursement, manufacturers still need clinical evidence to demonstrate efficacy depending on the evidence standards for mechanism of action and therapy area, as well as the competitive landscape and available substitutions. Payers are frequently willing to accept a more pragmatic design versus strict requirement for a randomized clinical trial. The logic argument linking a primary clinical endpoint to economic savings should be well-accepted within the particular disease area (e.g., weight loss is accepted indicator in diabetes vs needing to show hemoglobin A1c).
The extent of regulatory oversight required is dependent on the level of intervention, novelty, and risk of your DTx solution. New therapies with intent to treat often require the highest level of regulation.
Manufacturers can apply for the breakthrough device designation if the DTx solution is a more effective diagnostic or treatment with no approved or cleared alternatives or if it offers significant advantages over existing approved or cleared alternatives. This allows for opportunity to interact with FDA’s experts through several different program options for timely feedback.
Manufacturers must consider the extent of clinical claims that can be made as a nonregulated DTx solution.
Some manufacturers position their direct-to-consumer products for free or at a reasonable cost to maximize use and collect user data. This allows for product iteration while other funding pathways are explored. Some manufacturers expand upon their consumer offerings to develop parallel regulated versions to expand the opportunity to pursue reimbursement and partnerships.
Manufacturers must invest in continuous solution updates and promotion to stay relevant in this market, which has high competition and short-term payment models. Even for direct-to-consumer solutions, especially those that provide clear clinical utility, providers’ buy-in and recommendations can be key to driving utilization and retention.
Direct-to-consumer solutions are well positioned to leverage digital marketing channels like advocacy groups, social media and patient communities.
Traditionally, consumers have lower willingness to pay for health solutions. However, consumers have demonstrated a higher willingness to pay out-of-pocket in therapeutic areas where self-pay spend is high (e.g., fertility and wellness); for solutions that provide greater value, access or convenience than the standard of care; and for solutions outside existing points of care (e.g., monitoring and condition management).
Manufacturers can take advantage of the early in market learnings. By establishing broad user base and collecting valuable data, manufacturers can also fork the product with a regulated version in the future.
Reset All
Additional evidence may still be required from payers and employers as solution evolves.
Payer
Employer
Innovative employers have more options to actively engage in care for their employees, ranging from direct contracting to onsite clinics. Employers may have a lower bar for evidence, and value a wider set of outcomes than payers. Quite a few successful digital health companies that now enjoy health plan coverage got their start by focusing on employer customers.
Payers are an important channel to employers, and may be happy to take novel solutions to employers as "buy ups" or additional optional coverage. Innovative plans are curating solutions and providing data to employers on the potential impact of digital health solutions. Benefits consultants, employee assistance programs, and digital formularies via PBMs are often gateways to larger employer customers.
Employers are experiencing “pitch fatigue” from hearing from a high volume of digital health solutions. Similar to payers, they are increasingly seeking solutions that offer attractive payment models based on outcomes and performance. Some solutions, leverage a fee-for-service model to shed light on the true costs of the condition before shifting to per member per month (PMPM).
*Please reset and answer all the questions
Digital Therapeutics Navigator
Digitizing existing MoA
New digital MoA
Direct-to-consumer
Are you seeking payer / employer reimbursement or going direct-to-consumer?
Duration / Cycles of Use
Payers prefer products with a fixed duration rather than ongoing open-ended use. Evidence of ongoing effect of treatment is particularly important to demonstrate Guidelines for product use in clinical practice are unlikely to deviate from the model tested in trials. If the study assessed a single cycle of therapy, repeat use is unlikely to be supported at least initially To justify ongoing or repeat use, manufacturers must provide dynamic features personalized to the individual user, as well as proof of long term efficacy
To retain individual users, the product must be dynamic and progressive in terms of content and rewards.
Products that more closely follow the existing workflow face lower barrier to adoption. For example: a solution with high familiarity among HCPs, digitized versions of existing HCP tools and processes, etc. If remote monitoring and insight generation is required from HCPs, EHR integration is required to drive individual HCP adoption DTx programs create a myriad of new data for HCPs. Many DTx have an assessment or diagnostic component along with their treatment component. New data created must be surfaced to HCPs in an understandable, actionable way
For new mechanism of actions (MOAs) such as Akili, sham control is often required to appropriately assess the benefit of the active component. Patient inclusion and exclusion criteria must align with the desired target patient population, as payers often point to this as the basis of the appropriate patient segment For DTx solutions aiming to replace standard of care, the product must demonstrate clinical superiority or clinical noninferiority and incremental cost savings compared to standard of care. must iterate product to design for patient engagement Patient self-selection remains a key concern in this space, especially for products where the highest clinical value would be among patients with low initial motivation, such as mental health
For new mechanism of actions (MOAs) such as Akili, sham control is often required to appropriately assess the benefit of the active component Patient inclusion and exclusion criteria must align with the desired target patient population, as payers often point to this as the basis of the appropriate patient segment For DTx solutions aiming to replace standard of care, the product must demonstrate clinical superiority or clinical noninferiority and incremental cost savings compared to standard of care.
Manufacturers must demonstrate clinical efficacy, cost savings and patient engagement in real-world settings, in addition to clinical studies Real-world evidence (RWE) trials and observational studies can be leveraged to further validate a product, especially if product has evolved since the pivotal trial. Early stage pilots are useful if both parties establish defined KPIs, shared risk or upfront incentives. Manufacturers can then leverage early demonstration of value to scale with subsequent customers without additional pilots In addition to clinical and economic evidence, nature of digital brings new opportunities for validating patient activation and engagement.
Demonstration of user satisfaction, such as NPS score, app store ratings and user testimonials, is important to differentiate in a crowded direct-to-consumer (DTC) market While evidence of engagement is less applicable to consumers, manufacturers must measure and dial in on the metrics of user retention and engagement early on.
Manufacturers must demonstrate where and how cost savings are generated. For example these savings could come from decreased medication usage, reduced ER visits or hospitalizations, appropriate delay in step-ups and more For a new DTx solutions, payers will often leverage pilots to assess the economic impact relevant within their population. Successful case studies from employers and payers can serve as one inroad to gain traction with similar organizations
Consumers are price sensitive, and they often compare DTx with other existing out-of-pocket healthcare costs or consumer tech expenses such as mobile app subscriptions, wearables, etc.
As digital products evolve, the actual product being tested may have shifted over multiple studies. This can introduce an additional variable and nuance when engaging payers While manufacturer will need to "lock" the product for a given clinical study, continuous learning will demand continuous product evolution
For the DTx solution that falls outside of the high-risk, novel category, the pursuit of FDA approval may be a commercial decision While FDA approval does not confer payer reimbursement, the clinical claims can be a differentiator On the other hand, we also see solutions like Sleepio and Omada gaining traction with employers without validation from the FDA
Early players in the DTx space received De Novo clearances for truly novel medical devices. As more of these clearances accumulate and increase the number of predicates to point to, there may be more options for a more accelerated 510(k) route to approvals. Manufacturers have leveraged evidence of substantial equivalence to expedite FDA clearance. Some examples include Dthera and Welldoc BlueStar.
For lower-risk DTx solutions, the FDA may exercise enforcement discretion, which allows for more flexibility but also introduces more gray areas. Early and frequent engagement with the FDA is still recommended to make sure the FDA’s interpretation of enforcement discretion is aligned with your internal interpretation.
As health plans have a higher evidence threshold, contracting with health plans is often a long-term play for manufacturers that have invested in building evidence. Manufacturers may benefit from contracting with small, innovative plans (e.g. Highmark) to establish traction before engaging larger, national health plans. Payers are more receptive to a DTx solution that aims to replace an existing standard of care that is high cost such as a GLP-1 or biologics. For adjunctive DTx solutions that require incremental reimbursement on top of the costs of the existing standard of care, they must demonstrate clear cost savings to payers. For example, they must reduce or delay the use of expensive medications, or reduce emergency department use, hospitalizations and office visit costs.
Reimbursement does not guarantee enrollment. Manufacturers must work with the payer or employer on member outreach If the solution is Rx-only, individual HCP adoption is required to pull through revenue If the DTx solution aims to replace a standard of care, it’s critical to obtain HCP buy-in and provide appropriate reimbursement for use, as the DTx solution may displace existing reimbursement.
Direct sales are often required to engage health plans, due to the complexity of the sales cycle. But employers and managed care companies can provide access to health plans.
Payers prefer pilots and shorter innovation agreements, given the investment required to implement digital solutions. Increasingly data-savvy payers expect manufacturers to propose a feasible value-share arrangement for an interventional DTx solution. VBC models can be readily applied to a DTx solution, as its digital nature lends itself well to data collection. For a DTx solution intended to manage versus treat, payers may instead opt for traditional models, such as per member per month (PMPM), to reduce the resources and infrastructure required.
FDA approval does not confer payer reimbursement, as payers are developing their own evidence standards for reimbursement that can differ from regulatory requirements There is a trade-off between rigor in clinical evidence and the speed to market. While FDA clearance can further validate and differentiate DTx solutions, it comes at the cost of forgoing valuable market advantage due to delayed launch Forking the regulated product with a wellness solution can allow manufacturers to gain in-market learnings and establish a user base
If seeking payer reimbursement, manufacturers still need clinical studies to demonstrate efficacy depending on the evidence standards for mechanism of action (MOA) and therapy area, as well as the competitive landscape Payers are frequently willing to accept more pragmatic design versus strict requirement for a randomized clinical trial The logic argument linking a primary clinical endpoint to economic savings should be well-accepted within the particular disease area, such as weight loss in diabetes.
The extent of regulatory oversight required is dependent on the level of intervention, novelty and risk of your DTx solution. New therapies with intent to treat often require the highest level of regulation
Manufacturers can apply for the Breakthrough Devices Program if the DTx solution is a more effective diagnostic or treatment. This may allow for a faster path with the FDA, including sprint discussions
Manufacturers must consider the extent of clinical claims that can be made as a nonregulated DTx solution
Some manufacturers position their direct-to-consumer (DTC) products for free or at a reasonable cost to maximize use and collect user data User data can then be monetized and sold to third parties (for example: PatientsLikeMe) or used to pursue B2B customers such as Happify or Calm We see some manufacturers like Happify forking their direct-to-consumer (DTC) product with a regulated version to expand the opportunity to pursue reimbursement and partnerships.
Manufacturers must invest in continuous solution updates and promotion to stay relevant in this market, which has high competition and short-term payment models Even for direct-to-consumer (DTC) solutions, especially those that provide a clear clinical utility, providers’ buy-in and recommendations can be key to driving adoption and retention.
Direct-to-consumer (DTC) solutions are well positioned to leverage digital marketing channels like advocacy groups, social media and patient communities
Traditionally, consumers have lower willingness to pay for health solutions However, consumers have demonstrated a higher willingness to pay out-of-pocket in therapeutic areas where self-pay spend is high (for example: fertility and wellness), for solutions that provide greater value than the standard of care (for example: access and convenience solutions like hims or digitized therapy and telehealth solutions like Talkspace and Headspace), and for solutions outside existing points of care (for example: monitoring and condition management)
A DTx solution based on an established mechanism of action (MOA), positioned as adjunctive treatment and in lower-acuity therapeutic areas may not benefit as much from formal validation from the FDA
Additional evidence may still be required from payers and employers as solution evolves
Evolving Solution and Adjacent
PAYERS: As health plans have a higher evidence threshold, contracting with health plans is often a long-term play for manufacturers that have invested in building evidence Manufacturers may benefit from contracting with small, innovative plans (e.g. Highmark) to establish traction before engaging larger, national health plans. Payers are more receptive to a DTx solution that aims to replace an existing standard of care that is high cost such as a GLP-1 or biologics For adjunctive DTx solutions that require incremental reimbursement on top of the costs of the existing standard of care, they must demonstrate clear cost savings to payers. For example, they must reduce or delay the use of expensive medications, or reduce emergency department use, hospitalizations and office visit costs
PAYERS: Direct sales are often required to engage health plans, due to the complexity of the sales cycle. But employers and managed care companies can provide access to health plans EMPLOYERS: Payers are an important channel to employers, and may be happy to take novel solutions to employers as "buy ups" or additional optional coverage Innovative plans are curating solutions and providing data to employers on the potential impact Benefits consultants (for example: Mercer, Willis Towers Watson) and platforms (for example: Solera, Collective Health), employee assistance programs and digital formularies via PBMs are often gateways to larger employer customers
Read more
Go back
Innovative employers have more options to actively engage in care for their employees, ranging from direct contracting to onsite clinics. Employers may have a lower bar for evidence, and value a wider set of outcomes than payers. Quite a few successful digital connected health (DCH) firms that now enjoy health plan coverage got their start focused on employer customers such as Livongo and Omada.
Payers are an important channel to employers, and may be happy to take novel solutions to employers as "buy ups" or additional optional coverage. Innovative plans are curating solutions and providing data to employers on the potential impact. Benefits consultants (for example: Mercer, Willis Towers Watson) and platforms (for example: Solera, Collective Health), employee assistance programs and digital formularies via PBMs are often gateways to larger employer customers.
Employers are experiencing “pitch fatigue” from hearing about a high volume of digital health solutions. Similar to payers, they are increasingly seeking solutions that offer attractive payment models based on outcomes and performance. Some solutions, such as Vivante Health, leverage a fee-for-service model to shed light on the true costs of the condition before shifting to per member per month (PMPM).
Employers
Payers
PAYERS: Payers prefer pilots and shorter innovation agreements, given the investment required to implement digital solutions Increasingly data-savvy payers expect manufacturers to propose a feasible value-share arrangement for an interventional DTx solution. VBC models can be readily applied to a DTx solution, as its digital nature lends itself well to data collection For a DTx solution intended to manage versus treat, payers may instead opt for traditional models, such as per member per month (PMPM), to reduce the resources and infrastructure required.
Payers prefer pilots and shorter innovation agreements, given the investment required to implement digital solutions Increasingly data-savvy payers expect manufacturers to propose a feasible value-share arrangement for an interventional DTx solution. VBC models can be readily applied to a DTx solution, as its digital nature lends itself well to data collection For a DTx solution intended to manage versus treat, payers may instead opt for traditional models, such as per member per month (PMPM), to reduce the resources and infrastructure required.
As health plans have a higher evidence threshold, contracting with health plans is often a long-term play for manufacturers that have invested in building evidence. Manufacturers may benefit from contracting with small, innovative plans (e.g. Highmark) to establish traction before engaging larger, national health plans.
Submit
Back
DTx programs create a myriad of new data for HCPs. Many DTx have an assessment or diagnostic component along with their treatment component. Solution-generated data must be surfaced to HCPs in an understandable, actionable way.
Products that more closely follow the existing workflow face lower barrier to adoption (e.g., a solution with high familiarity among HCPs, digitized versions of existing HCP tools and processes, etc.) If remote monitoring and engagement with data are required from HCPs, EHR integration is required to drive individual HCP adoption and use.
Manufacturers can apply for the breakthrough device designation if the DTx solution is a more effective diagnostic or treatment with no approved or cleared alternatives or if it offers significant advantages over existing approved or cleared alternatives. This allows for opportunity to interact with FDA’s experts through several different program options for timely feedback
p1-1A2A3A
Manufacturers can take advantage of the early in-market learnings. By establishing broad user base and collecting valuable data, manufacturers can also fork the product with a regulated version in the future.
Traditionally, consumers have lower willingness to pay for health solutions. However, consumers have demonstrated a higher willingness to pay out-of-pocket in therapeutic areas where self-pay spend is high (e.g., fertility and wellness), for solutions that provide greater value, access, or convenience than the standard of care, and for solutions outside existing points of care (e.g., monitoring and condition management).
Pilots, coverage with evidence development or other models to lower entry barriers are still common starting points for establishing payer coverage. Increasingly data-savvy payers expect manufacturers to propose a feasible value-share arrangement for an interventional DTx solution. VBC models can be readily applied to a DTx solution, as its digital nature lends itself well to data collection.
For a DTx solution intended to manage versus treat, payers may instead opt for traditional models, such as per member per month (PMPM).
Employers are experiencing “pitch fatigue” from hearing from a high volume of digital health solutions. Similar to payers, they are increasingly seeking solutions that offer attractive payment models based on outcomes and performance. Some solutions leverage a fee-for-service model to shed light on the true costs of the condition before shifting to per member per month (PMPM).
Previous
Direct-to-consumer (DTC) solutions are well positioned to leverage digital marketing channels like advocacy groups, social media, and patient communities.
Manufacturers must invest in continuous solution updates and promotion to stay relevant in this market, which has high competition and short-term payment models. Even for direct-to-consumer (DTC) solutions, especially those that provide clear clinical utility, providers’ buy-in and recommendations can be key to driving utilization and retention.
Some manufacturers position their direct-to-consumer (DTC) products for free or at a reasonable cost to maximize use and collect user data. This allows for product iteration while other funding pathways are explored. Some manufacturers expand upon their consumer offerings to develop parallel regulated versions to expand the opportunity to pursue reimbursement and partnerships.
Payers are often more receptive to a DTx solution that aims to delay or spare the use of high-cost therapies. For adjunctive DTx solutions that require incremental reimbursement on top of the cost of the existing standard of care, they must demonstrate a clear clinical value proposition and cost savings to justify greater total spend.
As health plans typically have a high evidence threshold, contracting with health plans is often a long-term play for manufacturers that have invested in building evidence. Manufacturers may benefit from contracting with small, innovative plans to establish traction before engaging larger, national health plans.
Manufacturers must demonstrate where and how cost savings are generated. For example, savings could come from decreased medication usage, reduced ER visits or hospitalizations, appr While cost savings evidence is less relevant to the individual consumer, DTx solution must be priced within their acceptable range.opriate delay in step-ups, and more. For a new DTx solution, payers will often leverage pilots to assess the economic impact relevant within their population. Successful case studies from employers and payers can serve as one inroad to gain traction with similar organizations.
Demonstration of user satisfaction (e.g., NPS, app store ratings, and user testimonials) is important to differentiate in a crowded direct-to-consumer (DTC) market. Starting out DTC may allow for a wider user base, including collection of RWE via “opt in” studies with the user population. DTC also allows for demonstration of real-world engagement and retention.
Manufacturers must frequently demonstrate clinical efficacy, cost savings, and patient engagement in real-world settings, in addition to clinical studies. Real-world evidence (RWE) trials and observational studies can be leveraged to further validate a product, especially if the product has evolved since the pivotal trial.
Early stage pilots are useful if both parties establish defined KPIs, shared risk, or upfront incentives. Manufacturers can then leverage early demonstration of value to scale with subsequent customers without additional pilots. In addition to clinical and economic evidence, the inherent nature of digital brings new opportunities for validating patient activation and engagement.
If seeking payer reimbursement, manufacturers still need clinical evidence to demonstrate efficacy depending on the evidence standards for mechanism of action (MOA) and therapy area, as well as the competitive landscape and available substitutions. Payers are frequently willing to accept a more pragmatic design versus strict requirement for a randomized clinical trial. The logic argument linking a primary clinical endpoint to economic savings should be well-accepted within the particular disease area (e.g., weight loss is accepted indicator in diabetes vs needing to show hemoglobin A1c).
For solutions with a novel digital mechanism of action (MOA), sham control is often required to appropriately assess the benefit of the active component. Patient inclusion and exclusion criteria must align with the desired target patient population, as payers often point to this as the basis of the appropriate patient segment for coverage. For DTx solutions aiming to replace existing standard of care, the product must demonstrate clinical superiority or clinical noninferiority and incremental cost savings compared to standard of care.
Products that more closely follow the existing workflow face lower barriers to adoption (e.g., a solution with high familiarity among HCPs, digitized versions of existing HCP tools and processes, etc.). If remote monitoring and engagement with data are required from HCPs, EHR integration can be a crucial requirement.
A fixed duration of use may be easier to maintain engagement vs. expectation for open-ended ongoing use. Behavioral science methods, gamification or rewards can be used to maximize engagement.
Consumers are price sensitive, and they often compare DTx with other existing out-of-pocket healthcare costs or consumer tech expenses such as mobile app subscriptions, wearables, etc. While cost savings evidence is less relevant to the individual consumer, DTx solution must be priced within their acceptable range.
p2-1B2B3B
For the DTx solution that falls outside of the high-risk, novel category, the pursuit of FDA approval may be more influenced by commercial intent. While FDA approval does not confer payer reimbursement, the clinical claims can often be a differentiator. On the other hand, solutions that do not require a provider (for awareness or Rx) are gaining traction via employers without FDA authorization.
p3-1A2B3A
p4-1B2A3B
p5-1A2A3B
p6-1B2B3A
p7-1B2A3A
p8-1A2B3B
