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Survey Shows Potential, Challenges, and Solutions for Broad PDT Access

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Summary

A recent Pear Therapeutics–Avalere survey of 30 payers and 10 employer self-insured groups identified numerous insights to direct future efforts for broader adoption and coverage of prescription digital therapeutics (PDTs).

PDTs, an emerging class of Food & Drug Administration (FDA)-authorized and prescription-required digital health therapies, have the potential to significantly impact digital health and complement drug treatment regimens. As a follow up to Avalere’s previous insight describing PDTs, this post discusses key findings reported in the Pear Prescription Digital Therapeutics Digest. The Digest provides an in-depth look at the results of a survey jointly conducted by Pear Therapeutics and Avalere. The figures referenced in the insight are available as a downloadable PDF.

Survey Methodology

The survey was distributed to 180 payers and large employer self-insured groups. Of those, 140 potential respondents (78%) had little to no familiarity with PDTs and were removed from the survey (Figure 1). Of the 40 with substantive familiarity with PDTs, 30 were payers and 10 were employer self-insured groups. The payer respondents collectively represented 192 million covered lives. The survey was blinded with the exception of the respondent’s role as a payer or employer self-insured group (Figure 2).

Key Findings

The survey asked the respondents numerous questions related to PDTs, of which some key findings are summarized below.

  • Although reportedly familiar with PDTs, 90% of respondents expect manufacturers to educate payers and providers about the value of PDTs, highlighting a need for evolving education as new PDTs enter the market
  • The most significant drivers of coverage included the evidentiary value of:
    • Randomized controlled trials (RCT)
    • FDA authorization (through de novo and 510(k) pathways)
    • Published real-world evidence as a supplement to RCT
    • Cost offsets
  • 66% of respondents have developed coverage criteria for PDT coverage, the evidentiary threshold resembling that for drugs
  • 69% of respondents did not have concerns about data management and privacy, citing precedence and compliance among other things; the Academy of Managed Care Pharmacy, a leader in formulating industry policy around PDTs, has expressed an “understanding that digital therapeutic innovators collect and process users’ data in a safe, fair, and lawful way” (from PR Newswire)
  • Most respondents stressed the value of PDTs offering clinical safety (65%) and efficacy (95%) to patients
  • Respondents did not think that PDTs would replace existing treatments but would complement an existing treatment (80%) or be co-administered (20%)
  • Respondents identified top value propositions of PDTs (Figure 3); among them were:
    • 24/7 access to care
    • Cost-effectiveness compared to other treatments
    • Providing clinicians with patient-reported outcomes
  • 80% of respondents indicated that PDTs would ultimately be cost effective, while 40% thought that there would be an initially modest increase as they move toward broad coverage
  • 80% of respondents expect pharmacy benefit managers to evaluate and determine PDT coverage
  • Among the means of evaluating PDTs, respondents indicated that:
    • 43% evaluate through pharmacy and therapeutics committees
    • 30% evaluate through a medical benefits committee
    • 12% evaluate through another process or lack a formal process
  • Among coverage or plans to cover (Figure 4), respondents indicated that:
    • 40% currently cover PDTs
    • 50% anticipate coverage within the next 18 months
    • 5% unsure
    • 5% do not anticipate coverage within the next 18 months
  • Respondents showed a lack of consensus when it came to which benefit type would cover PDTs, demonstrating a need for cohesive industry guidance and best practices (Figure 5)
  • Most respondents (60% of payers, 90% of employer self-insured groups) lack a PDT formulary, but as the number of PDTs on the market continues to increase, this may be a viable coverage management strategy
  • A slim majority (53%) of respondents saw value-based contracts (VBC) as the most appropriate mechanism for PDT payment
  • Among the approximate half (48%) of respondents who were interested in direct outcomes-based contracts in a value-based arrangement for PDT payment, key considerations included:
    • Cost savings
    • Patient adherence
    • Reduction in hospitalizations and physician office visit utilization
    • Patient satisfaction
    • Clinical outcomes
    • Reduced patient fall-off
  • Half of respondents indicated that coding and reimbursement education are the greatest need in promoting PDT adoption and coverage
  • Respondents indicated that manufacturers can best alleviate cost impact uncertainties among payers and employer self-insured groups by:
    • Showing cost offsets
    • Engaging in value-based contracting to mitigate risk
    • Clearly identifying the population appropriate for treatment
  • To support providers, manufacturers can:
    • Provide materials for payers to give to their network of providers
    • Engage providers in webinars led by thought leaders
    • Work with provider offices to better understand their needs

As organizations contemplate PDT coverage, the Digest will help them discern these issues and consider its recommendations, including:

  1. Facilitating a coverage process
  2. Understanding the value of FDA authorization as a prerequisite to PDT sale in interstate commerce
  3. Establishing a harmonized evidentiary standard of review and procedure
  4. Defining contracting incentives tied to outcomes (i.e., VBC)
  5. Confirming that the manufacturer can ensure adequate patient data privacy
  6. Establishing and maintaining best practices for PDT management
  7. Supporting providers who will prescribe—and patients who will utilize—these technologies

More information can be found in the Pear Prescription Digital Therapeutics Digest.

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