On Tuesday, the Peterson Center on Healthcare
announced a new effort to develop evidence-based assessments that evaluate the clinical benefits and economic impact of digital health tools (DHTs). Launched with a commitment of $50 million, the new
Peterson Health Technology Institute (PHTI) will collaborate with the Institute for Clinical and Economic Review (ICER) to establish a DHT-tailored value assessment framework to guide PHTI’s evaluations of emerging digital health innovations. PHTI asserts that “despite significant investment, most digital health tools lack sufficient evidence to support their claims about clinical benefits.”
Demonstrating value is necessary, but not sufficient, for a DHT’s success. ICER previously ventured into digital health value assessment in 2020 with an
evaluation of the comparative clinical effectiveness and value of 3 DHTs for the treatment of opioid use disorder. Although ICER found Pear Therapeutics’ DHT reSET-O to be cost-effective, the company faced
reimbursement challenges and ultimately declared bankruptcy in April 2023. Pear’s President and CEO Corey McCann summed up the challenges facing DHT in a LinkedIn
post:
“We’ve shown that our products can improve clinical outcomes. We’ve shown that our products can save payors money. Most importantly, we’ve shown that our products can truly help patients and their clinicians. But that isn’t enough. Payors have the ability to deny payment for therapies that are clinically necessary, effective, and cost-saving.”
PHTI’s digital health framework will add to existing efforts. In a recent
Value in Health study, researchers elicited stakeholder feedback to inform the development of a comprehensive framework for assessing the value of DHTs for managing chronic conditions. The authors identified stakeholder consensus on the relative importance of 33 indicators across 6 value domains: health inequalities, data rights and governance, technical and security, economic characteristics, clinical characteristics, and user preferences. However, several areas without consensus were also identified. The authors concluded there is a need for a coordinated health technology assessment and regulatory policy response to develop an approach for assessing DHTs.
On Monday, an ICER-authored
study published in
PharmacoEconomics championed the equal value life-year (evLY) as an alternative or complementary measure to the quality-adjusted life-year (QALY), highlighting its “special relevance” to contemporary US policymaking where the QALY is often challenged or prohibited, such as in the Medicare Drug Price Negotiation Program (MDPNP) under the
IRA.
The evLY is more commonly known as the equal value of life-years gained (
evLYG), the ICER-developed measure created to address
concerns that QALY-based analyses have the potential to be
discriminatory. ICER states that a cost-effectiveness threshold of $84,000 per evLYG gained would be needed to maintain alignment with a threshold of $100,000 per QALY gained.
The authors assert that the conceptual analysis of the evLY and its use in multiple ICER evidence reports “suggest it can play a useful role to inform decision-making” and state that the measure “has not been rejected by disability community advocates and policymakers.” However, concerns about the evLY have been raised by patient advocates such as the
ALS Association and the
Alliance for Aging Research; it remains to be seen whether evLYs make the cut for allowable MDPNP inputs.
If you need assistance with all things value assessment or ICER-related, please contact
Kimberly Westrich.
