The time is right for commercializing prescription digital therapeutics

The COVID-19 pandemic put enormous pressure on the healthcare system to fast-track the development and approval of safe and effective treatment options. One positive outcome of this changing market landscape is a faster path to commercialization for digital therapeutics (DTx).

As the DTx pipeline expands, the healthcare market will continue to move beyond traditional medicine. DTx fulfillment methods must prove easy for patients to understand while offering providers visibility into treatment effectiveness and outcomes.

During an October 2022 Academy of Managed Care Pharmacy Nexus session, "Prescription Digital Therapeutics: Formulary Design and Access Trends," a panel of AmerisourceBergen and industry experts provided a detailed overview of trends and market access considerations.

Understanding the current landscape

Prescription digital therapeutics (PDTs) consist of evidence-based, clinically evaluated software that goes through a development and approval process similar to medications and medical devices. Though numerous non-prescription DTx products have seen development, the FDA has approved only nine PDTs to date.¹ The first was reSET, a PDT for treating substance use disorder, developed by Pear Therapeutics.²

The expectation is that the PDT market will expand as developers gain FDA approval for new evidence-based therapeutics for treating and managing diseases and improving health function. Moreover, the FDA has established a Digital Health Center of Excellence to help advance the development of patient-facing digital health technologies.

The FDA has become interested in outcomes that demonstrate the effectiveness of digital therapeutics for meeting the needs of key stakeholders, including developers, payers, providers, and patients. PDT developers must remain cognizant of both market and regulatory factors when assessing commercialization pathways. The prescription status of a product is important, along with long-term efficacy data, and both patient and provider familiarity. Developers also should keep in mind that the FDA's North Star is "responsible and high-quality digital health innovation."

Digital therapeutics companies must overcome a number of challenges on the path to commercialization. In particular, commercialization requires developers willing to invest in the long lead times needed to generate real-world evidence and build trust with providers and patients. In order to gain traction, PDTs must become integrated into healthcare provider workflows — including the ability to bridge offline and online protocols. PDTs also require the development of both new reimbursement models and distribution channels capable of meeting the needs of healthcare providers and patients.

There are six primary pathways for DTx and PDT commercialization:

• Direct-to-consumer
• Value-based contracting
• Device-like reimbursement
• Drug-like reimbursement
• Biopharmaceutical partnerships
• Employee offerings

Evolving coverage trends for PDT products

Payers are already familiar with DTx apps, which include both non-prescription and prescription treatment options. A recent AmerisourceBergen survey found that 88 percent of the participating healthcare decision-makers had reviewed a DTx in the past 18 months.³

As DTx apps evolve, the majority of payers (64 percent) surveyed by AmerisourceBergen said PDT status would improve coverage.³ The survey results also cited diabetes, cardiovascular disease, and asthma/COPD as the most significant therapeutic areas in which PDTs could impact treatment.

Payers will require evidence from randomized clinical trials to support the efficacy of PDTs. While objective clinical effectiveness is the most important consideration for payers, they also want data on proof of long-term benefits, patient adherence, and fulfillment. The vast majority (82 percent) of payers also expect to have access to a PDT dossier.³ Coding is another consideration when it comes to reimbursements. The recent establishment of a Level II Healthcare Common Procedure Coding System (HCPCS) code is a step in the right direction. Code A9291 covers an FDA-cleared, prescription digital behavioral therapy and provides the option for payers to reimburse PDTs as either a pharmacy or a durable medical equipment Medicare benefit. Payers reported that the establishment of A9291 will increase the likelihood of covering PDTs, with most indicating they would classify them as a medical benefit.

Positioning PDTs for market access

Market access for PDTs ultimately requires patient and provider support. Patients need to understand what PDTs are and how they will help them.
Prescribers play a particularly important role in ensuring that a PDT becomes an accepted treatment option. Providers need to know who the appropriate patient is, how to prescribe a PDT, and when to follow up.

Commercial distribution of PDTs is ultimately driven by three key variables: prescribing and ordering, dispensing and adjudication, and support services.

Prescribing and ordering encompasses:

• Evaluating the patient and prescribing the PDT
• Selecting the product within an electronic health record and/or other prescribing mechanisms, such as PDT provider portals
• Communicating data to other providers, patients, caregivers, and payer

Dispensing and adjudication considerations:

• Processing pharmacy and/or medical benefit claims and adjudication
• Dispensing via digital or traditional workflows
• Supporting patients with onboarding

Support services include:

• Copay assistance and nurse case management
• Disease-state education for patients
•  Product education, clinical support, and technical support
• Adherence metrics for patients, providers, and payers

Overcoming distribution and reimbursement barriers requires developers to ensure that providers and patients understand the benefits of a particular digital treatment option. PDT traction will increase as providers and payers integrate digital protocols into healthcare workflows and the prescription fulfillment process. Ready access to patient utilization and outcomes data will support both provider and payer engagement. Reimbursement clarity and streamlined patient access also will improve distribution.

Learning from real-world implementation

The long-term success of PDTs requires healthcare providers to recognize the value of digital therapeutics for treating chronic conditions. Digital developers must become more proactive in offering providers and payers the data they need to validate contract terms, patient outcomes, and return on investment.

One multi-care health system began using a DTx for treating musculoskeletal (MSK) conditions after conducting a clinical assessment of chronic conditions within its insured population. This led to a detailed review of digital MSK therapies that have the potential to reduce the need for surgery and increase the use of physical therapy. The goal was to find the best option for reducing costs and improving outcomes.

The health system found that integrating digital therapy into its electronic records system increased utilization. Claims with ICD-10 diagnoses served to identify MSK spending. HL7 messaging embedded procedures with M and S codes within existing electronic records. The system then referred newly diagnosed MSK patients to virtual DTx for intervention, rather than surgery.

As the use of DTx and PDT grows, healthcare organizations should evaluate them based on their own objectives and the needs of their patient populations. Implementing PDTs requires cross-functional collaboration to define best practices around data generation and engagement with key stakeholders. Such actionable data is essential for developing strategic partnerships and optimizing market access.

References

1. Maas, B. Digital Therapeutics.  RxBenefits.   13 January 2022. Accessed 16 Sept 2022. Available online at: https://www.rxbenefits.com/blogs/digital-therapeutics/

2. Pear obtains FDA clearance of the first prescription digital therapeutic to treat disease. Pear Therapeutics. 14 Sept 2017. Accessed 16 Sept 2022. Available online at: https://peartherapeutics.com/fda-obtains-fda-clearance-first-prescription-digital-therapeutic-treat-disease/

3. Dinger, J, et al. Prescription digital therapeutics (PDT) formulary design and access trends. Presented at AMCP Nexus. National Harbor, Maryland. 12 October 2022.