Payers should involve multiple health care stakeholders and consider safety, clinical evidence, economic impact, and other factors when determining coverage for digital therapeutics, according to presenters at AMCP 2022.

“There are some hesitations in regard to effective evaluation strategies of [digital therapeutics],” said Soumya Vishwanath, PharmD, senior manager of formulary strategy, Magellan Rx Management. “However, this space has gained a lot of traction, especially during the COVID-19 pandemic.”

Comparing Digital Therapeutics to Pharmacologic Therapies

Presenters reviewed the advantages and limitations of both digital therapeutics and current pharmacologic options.

Michael C Angelini, MA, PharmD, BCCP, professor, MCPHS University–Boston, cited pharmacologic limitations including efficacy, tolerability, and safety concerns. As many as 66% of clinical trial participants with schizophrenia discontinue treatment, and chronic use of lithium for bipolar disorder can cause renal impairment in up to 20% of patients, Dr Angelini noted.

Pharmacologic treatments are also subject to medication prescribing limitations, such as issues with adherence, stigma associated with medication, cost and access barriers, among others, Dr Angelini said.

“There is a cost to digital therapeutics, but it lowers the pill burden,” Dr Angelini said.

In contrast to pharmacologic treatment, digital therapeutics are not associated with drug interactions or intolerabilities such as allergic reactions, organ damage, or overdoses.

“You can get compulsively hooked on any type of device,” Dr Angelini. “That is a psychological issue, but certainly, you are not going to overdose in the typical sense.”

Digital therapeutics may also improve care access and adherence and could potentially be used in combination with pharmacologic therapy to target symptoms not improving with medication.

However, nonadherence to digital therapeutics can be caused by patients’ forgetfulness and perceived lack of value, as well as cognitive barriers such as a patient not understanding the device, or a clinician showing reluctance to prescribe and use the technology. Digital therapeutics also may not benefit patients with multiple comorbidities or individuals in acute crises such as substance use disorder relapses or manic or psychotic episodes.

“If someone is acutely psychotic, they aren’t using the phone. Digital therapeutics are just not going to be appropriate for that condition,” Dr Angelini said, adding that pills and surgeries also may not be appropriate for some patients, so stakeholders will need to consider the “big picture” when evaluating treatment options.

Coverage Considerations and Recommendations

Few health plans currently cover digital therapeutics, and many payers are still developing methods to evaluate the efficacy and cost-effectiveness of these products, Dr Vishwanath said. Survey findings indicated 40% of payers have a strategy in place specifically geared toward digital therapeutics, while 50% of payers do not have a strategy in place, and 10% of payers do not see the need for a special approach to digital therapeutics.

Dr Vishwanath advised payers to engage multiple stakeholders, including clinicians, pharmacists, end users, and information technology teams, when determining how to implement digital therapeutics into their formularies.

She also advised attendees to consider whether it would be best for payers to approach manufacturers to discuss new digital therapeutics, or vice versa. Several Medicaid programs (Alabama, Louisiana, Maryland, New York, and Texas) are advocating for dossier submissions from companies developing digital therapeutics, Dr Vishwanath noted.

The session included the following considerations to guide coverage decisions:

• Safety: the potential for harm, risks, and side effects
• Clinical evidence: the presence or absence of long-term and comparative efficacy data
• Economic impact: the therapeutic’s ability to fulfill an unmet need in a patient population, improve adherence, or decrease hospitalization
• Applicability: the patient engagement rate and whether the device can be integrated into electronic medical records

Other considerations included health disparities, as well as consequences for patient outcomes if pharmacologic treatment is not working and an alternative digital therapeutic product is not covered.

“Digital therapeutics tend to skew for a younger population and those with middle- to high-income status,” Dr Vishwanath said. “What is the potential for [a] product to reduce these health disparities?”

Digital therapeutics may be covered under the pharmacy benefit if a prescription is required, or the medical benefit if the treatment plan requires durable medical equipment. Payers might also consider a stand-alone benefit.

Potential payment models include value-based contracts between payers and manufacturers, flat fee reimbursement, contracts between the plan and employers or physicians, pilot programs, subscription fees, and bundled payment for facilities, Dr Vishwanath said.

“Perhaps pilot programs are the way to go…if the product is new or you want to incorporate it with a health care provider or the health care system to see what the outcomes of covering a product would be,” Dr Vishwanath said.

Looking Ahead: Devices in the Pipeline

The development of digital therapeutics is expected to grow by 23.1% between 2021 and 2028, Dr Vishwanath said.

There are approximately 137 new products in the pipeline, focused in the areas of neurology and psychiatry (68%), metabolic disorders (10%), gastrointestinal issues (5%), women’s health (5%), oncology (3%), rheumatology (2%), and other (7%).

Twenty-five products are approved or cleared for use and 23 products are commercially available, presenters said. Thirty-three new products are in the discovery phase, 46 products are undergoing proof of concept studies, and 10 products are in pivotal trials. Dr Vishwanath highlighted several products currently being developed by Akili Interactive, Cognoa, Click Therapeutics, and Pear Therapeutics.

Additional research is needed to understand how digital therapeutics measure up to pharmacologic therapy, as well as to other digital therapeutics.

Data is lacking on digital therapeutics’ efficacy for patients with multiple comorbidities and for long-term use, which presents challenges for payers seeking to cover new devices, Dr Vishwanath said. Digital therapeutics were not covered by plans due to lack of follow-up data or concerns over sample size and study design in existing literature, according to survey data.

Digital therapeutics are predicted to expand in areas such as metabolic disorders, mobility, aging, and mental health. As for reimbursement, experts anticipate increased uptake for specific therapeutic areas and disease states, and continued challenges related to data availability. Dr Vishwanath added patients and employers may be willing to shoulder the cost until payers can widely establish a reimbursement pathway.

“This space is really growing,” Dr Vishwanath said.