The surge of digital therapeutic (DTx) solutions on the market, fueled by increased demand for telehealth services amid the COVID-19 pandemic, has U.S. payers and pharmacy benefit managers scrambling to figure out if and how to cover these products that don’t always fit neatly into the pharmacy or medical benefit. Clarivate access and reimbursement expert Chris Lewis reviews key highlights from discussions at the 2021 annual conference of the Academy of Managed Care Pharmacy (AMCP).
DTx describes evidence-based therapeutic interventions driven by software programs to prevent, manage or treat a specific disease or disorder. Well-known examples include WellDoc’s BlueStar for diabetes management and products from Pear Therapeutics that deliver cognitive behavioral therapy for substance and opioid addiction (reSET and reSET-O) and insomnia (Somryst), respectively.
Payers and providers are wading through 300,000 digital health solutions1 on the market and creating their own approaches to covering these products in their insurance plans, said Snezana Mahon, PharmD, vice president and general manager of Care Solutions Evernorth, the health services division of Cigna that includes the pharmacy benefit manger Express Scripts. Mahon and Samir Mistry, PharmD, vice president of pharmacy at PreferredOne, a Minnesota-based commercial health plan, described their approaches to coverage of digital therapeutics at the AMCP conference.
“The future of pharmacy is to lean in and step forward and understand that this is new, this is different, there is no guidebook, there is no blueprint, none of us has ever done this before”.”
A Clarivate Access & Reimbursement study on insomnia drugs revealed that 9 in 10 surveyed pharmacy and medical directors said their managed care organizations (MCOs) either already had a policy in place for covering DTx or expected to have one by June 2021.
Source: Clarivate Access & Reimbursement, June 2020
Payers assess clinical and economic aspects of DTx
Some products, such as those from WellDoc and Pear Therapeutics, are FDA-approved for prescription, but many products have not taken this pathway and have not been studied in rigorous randomized controlled clinical trials. For those without clinical trial data, payers will likely use peer-reviewed studies, white papers and any other available research, Mahon said. Both PreferredOne and Evernorth consult multiple stakeholders—clinicians, pharmacists, consultants, brokers, IT teams and end users—to evaluate products and gauge market receptivity.
The economic assessment weighs product cost against its benefits, asking:
- What is the product’s place in therapy, and does it solve an unmet need or close a gap in care?
- Will the product improve adherence, thus reducing hospital use and polypharmacy?
- Will the product reduce the total cost of care for a patient?
One key consideration is whether physicians and their patients will actually use the DTx:
- Is the device or platform easily understood, easy to use, and able to effectively deliver a patient’s health metrics to the physician?
- Can the data be integrated into the physician’s EMR workflow?
- Does the company have a go-to-market and communication strategy to target end users?
Evaluating coverage via the pharmacy vs. the medical benefit
In the absence of an industry playbook, many plans are left to their own devices to assign DTx to a benefit. Plan sponsors that use the Express Scripts PBM have access to a customizable digital formulary for pharmacy benefit coverage. Mahon noted that some clients want to create a new digital insurance benefit. However, the consensus seems to be that most DTx will be covered under the pharmacy benefit or medical benefit (or both).
The decision is often influenced by the product sourcing, Mistry said. PreferredOne tends to use the medical benefit for products categorized as DME and those sourced directly from the manufacturer, as well as products used during an office visit and those that require specialist or case manager intervention. Additionally, plans whose PBMs limit their contracting on the pharmacy side may choose to cover DTx under medical.
Pharmacy benefit coverage tends to be a better fit for a prescription-based DTx. Going through the pharmacy benefit also facilitates easier application of member cost-sharing and provides multiple touchpoints for member engagement, including at the pharmacy, Mahon said.
Contracting and data capture considerations are key
Some plans will contract with DTx companies as they do with pharmaceutical manufacturers, both for rebate agreements and risk-based contracts. Mistry said PreferredOne has been working on value-based contracts with some vendors tied to meeting certain performance benchmarks. For instance, high rates of discontinuation of therapy or a failure to reduce the total cost of care might trigger a refund to the plan.
Value-based contracting requires integrating many data elements, including medical and pharmacy claims data and patient-reported outcomes. In fact, data capture and sharing across the healthcare ecosystem are critical to the success of DTx, as well as resolving HIPPA-related patient privacy issues and ensuring data security. Incorporating this data is one of the biggest challenges the industry is working to overcome.
Insights from this blog post come from Clarivate analysis of presentations and discussions at the Academy of Managed Care Pharmacy (AMCP) conference in April 2021, as well as Clarivate Access & Reimbursement physician and payer research.
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References:1. Research2Guidance, HealthXL