Pear Prescription Digital Therapeutics (PDT) Digest – Medical Alley Association

Pear Prescription Digital Therapeutics (PDT) Digest

Pear Therapeutics Launches Pear Prescription Digital Therapeutics Digest, Provides Roadmap for Payer Coverage Considerations

  • Pear Therapeutics is the leader in developing and commercializing prescription digital therapeutics (PDTs) to treat serious disease, with three FDA-authorized PDTs
  • Inaugural edition of the Digest explores employer and payer stakeholder knowledge of PDTs as well as current considerations and perceptions that compromise the coverage landscape

Pear Therapeutics, in collaboration with Avalere Health, conducted a survey of payers and employers to develop and publish the first annual Pear Prescription Digital Therapeutics Digest (Pear PDT Digest), outlining current challenges and opportunities with PDTs, identifying barriers to coverage, and proposing solutions and recommendations to inform coverage decisions, and ultimately improving patient access.

This project supports efforts from key industry leaders such as the Academy of Managed Care Pharmacy (AMCP) and the Digital Therapeutics Alliance (DTx Alliance) to define the coverage landscape and provide guidance to payers. AMCP has recently identified the following as key considerations3 to improve support for appropriate and evidence-based coverage decisions for digital therapeutics, including the:

  • Vital role that Pharmacy and Therapeutics Committees, or equivalent bodies, have in the evaluation of digital therapeutic products;
  • Expectation that clinical evidence of a digital therapeutic product will be reviewed in comparison to standards of care;
  • Importance of approval or market authorization by a regulatory body to payers;
  • Expectation that digital therapeutic innovators generate and publish evidence that demonstrates that their product improves quality of care;
  • Necessity that coverage decisions for digital therapeutics are based on scientific data that demonstrate that a product is appropriate and safe. As with traditional drug therapies and biologics, evidence of cost-effectiveness—to the extent that it is available—is also important to support payers’ coverage decisions;
  • Understanding that digital therapeutic innovators collect, store, and process users’ data in a safe, fair, and lawful way; and
  • Need for communicating impactful product updates to payers, healthcare decisionmakers, and patients.

The Pear PDT Digest incorporates findings from a survey of 40 major US payers and employers on their perspectives of the PDT market landscape. All respondents reported a high level of familiarity with PDTs as a requirement for participating in the survey. Variation in stakeholder responses regarding coverage and reimbursement pathways for PDTs confirms fundamental misconceptions about PDTs among key players in this space.

The survey results address the following key questions, as they relate to market access for PDTs, including:

  • What are the evidentiary requirements for review?
  • What is the value proposition for PDTs?
  • How are payers covering or thinking about covering PDTs?
  • What is the consensus approach to contracting?
  • What are the critical items from an operational perspective?
  • To what extent will this category evolve over the next 12 months?

This Digest is the first in a series of publications in which we will provide key insights, as they relate to PDTs, and track payers’ level of familiarity with—and management of—PDTs. The goal of this Digest series is to provide a road map for payers and employer groups to use as a starting point as they review, cover, and manage PDTs.

About Pear Therapeutics

Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of opioid use disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst® for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.

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