Is ICER's new digital health value assessment framework relevant as technology pivots to OTC?

On Tuesday, the Peterson Health Technology Institute (PHTI) released the ICER-PHTI Assessment Framework for Digital Health Technologies (DHTs), developed in partnership with ICER, to evaluate whether technology solutions improve health and lower costs. PHTI intends to use the framework to conduct value assessments of DHTs, including digital therapeutics, chronic care management apps, remote patient monitoring, and administrative technologies, among others, but provides only minimal information on how assessment topics will be selected.

PHTI will use methods outlined in the framework to examine a product’s clinical safety and effectiveness, real-world user experience, impact on health equity, and economic impact. PHTI will summarize the findings in its assessment by issuing one of the following recommendations:?

• Evidence is sufficient to support adoption
• Potential for performance supports further testing and evidence generation
• Evidence is inadequate to support adoption or further testing at this time

Notably, PHTI’s clinical effectiveness analysis will incorporate ICER’s Evidence Rating Matrix, and PHTI will publish an evidence rating on the safety and effectiveness of assessed DHTs. Additionally, as part of its economic impact assessment, PHTI will publish a threshold price at which the health technology would produce material cost savings compared with the standard of care. This represents a departure from more traditional health technology assessments (HTAs), which measure value based on long-term cost-effectiveness rather than a budget impact analysis.?

To calculate cost savings, PHTI will calculate a threshold price at which the assessed technology will produce 15% cost savings. In cases where the technology treats conditions with very high annual costs under the standard of care, the framework cites that “a 15% cost savings target may not be deemed possible.” In such cases, PHTI will calculate the threshold price based on the treatment producing a 3:1 return on investment. The framework cites “discussions with payers” as the basis for using a 15% cost savings threshold but cites no empirical evidence or academic literature to support this figure.?

The extent to which payers have a willingness to cover digital health technologies remains to be seen. Pear Therapeutics filed for bankruptcy in April 2023, despite having an effective digital therapeutic with transformative potential for patients struggling with opioid use disorder, citing payer reimbursement as a key stumbling block. Akili announced earlier this week that it is pivoting to a non-prescription business model for its digital medicine products, citing impressive adoption and financial statistics since the June 2023 direct-to-consumer release of its attention-deficit/hyperactivity disorder (ADHD) app. If more companies follow Akili’s lead, the new ICER-PHTI framework may already be irrelevant.

On Thursday, the Institute for Clinical and Economic Review (ICER) published its revised Evidence Report assessing the comparative clinical effectiveness and value of atidarsagene autotemcel (arsa-cel) for the treatment of metachromatic leukodystrophy (MLD). ICER concluded there is high certainty of net health benefit, awarding a clinical evidence rating of “A” for the use of arsa-cel in children with presymptomatic late infantile-MLD and presymptomatic early juvenile-MLD compared to usual care. When assessing arsa-cel in children with early symptomatic early juvenile-MLD, ICER issued a clinical evidence rating of “B+,” indicating high certainty that the treatment is better on average than usual care. This evidence rating represents an improvement from ICER’s Draft Evidence Report, which issued an evidence rating of “C++” for this population. ICER calculated the annual health benefit price benchmark (HBPB) for arsa-cel to be between $2.3 million and $3.9 million, noting that the product has not been approved by the Food and Drug Administration (FDA) and that the manufacturer has not yet announced a US price. The report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on September 29, 2023.?

Last week, No Patient Left Behind published a white paper titled, “Getting the Math Right When Measuring the Value of New Medicines,” which found that traditional cost-effectiveness analysis (CEA) methods often omit sources of social value that, when incorporated, move the needle on cost-effectiveness estimates. The authors reviewed ICER assessments for 20 medications, only 8 of which were found to be cost-effective using ICER’s traditional CEA methods. However, after applying generalized cost-effectiveness analysis (GCEA) to account for 2 additional dimensions of value, including diminishing returns to health improvement and dynamic pricing, the authors found that at least 17 of the 20 assessed medications offered good value for money from a societal standpoint. Overall, the authors found that applying GCEA in HTA can lead to more complete and accurate estimates of a treatment’s societal value and facilitate more efficient resource allocation.?

Other value assessment stories that caught our eye:?

• A new study published in the Journal of Managed Care & Specialty Pharmacy titled, “The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States,” explores the barriers and motivations for using value-based care models, including value assessment frameworks, from the perspectives of physicians and quality officers at US cancer centers.?
• A Forbes article authored by Joshua Cohen contributes to the expanding dialogue about the role of CMS as a potential HTA entity. In contrast to a previous article (summarized in the August 25 issue of Health Policy Weekly) that recommended CMS embrace its role and expand its capabilities to conduct HTA, Dr. Cohen asserts that it’s more feasible to have a separate HTA entity whose sole purpose is technology evaluation.?
• In its monthly ICER Analytics email update, ICER revealed that it is introducing a new type of analysis focused on new entrants in classes previously assessed by ICER. These analyses will be available exclusively to ICER Analytics subscribers, which heightens ongoing concerns about the transparency and lack of stakeholder engagement in ICER’s assessments.?

If you need assistance with all things value assessment or ICER-related, please reach out to me.