Is ICER beginning a new chapter?

On Monday, the Institute for Clinical and Economic Review (ICER) published its updated Value Assessment Framework (VAF), which provides detailed information about the technical methods and assessment process ICER uses to inform its Evidence Reports. The updated VAF will inform ICER’s Evidence Reports launched after October 2023.

ICER also published the public comments it received from 32 stakeholder organizations on its proposed changes and its response to public comments . This is a marked drop from the number of comments ICER received for its 2020 VAF update when the input period was longer and consisted of 2 phases. While there were fewer comments across all stakeholder groups, feedback from patient groups fell the most dramatically, from 21 groups in the prior update to 8 in the current iteration.

Although the updated framework largely resembles ICER’s previous 2020-2023 VAF, ICER made a few notable changes, including minor changes to its comparative effectiveness analyses and long-term cost-effectiveness analyses, along with changes to its assessment process:? Changes to ICER’s comparative effectiveness analyses:

• Health equity adaptations:?Drawing from its health equity white paper , ICER will use methods it developed in-house to assign clinical trial diversity ratings based on relative diversity of race, ethnicity, sex, and age (ie, inclusion of older adults). Additionally, ICER will evaluate the effectiveness of interventions based on the relevant subpopulations—including those that may be defined by the aforementioned categories. ?

Changes to ICER’s cost-effectiveness analyses:

• Inclusion of “non-zero” productivity data when using a modified societal perspective: Clinical trials often do not capture information regarding the broader value of treatments when assessed through the societal perspective. To address this, ICER will now include non-zero inputs to account for the impact of treatments on patient and caregiver productivity when using the modified societal perspective, even when data are not readily available.?
• Additional dimensions of value: Despite recommendations from a broad stakeholder constituency, ICER declined to quantitatively incorporate additional dimensions of value, instead opting to qualitatively consider elements related to unmet need, caregiver burden, and health equity considerations in the rebranded “Benefits Beyond Health” and “Special Ethical Priorities” section of its report. Moving forward, ICER will calculate quality-adjusted life-year (QALY) and equal value of life-year (evLY) shortfall measures and present results during the appraisal committee meeting. ICER also committed to exploring the potential application of the Generalized Risk-Adjusted Cost-Effectiveness (GRACE) framework in future assessments. ?
• Codification of the shared saving scenarios: Initially introduced as exploratory and hypothetical analyses meant to provoke policy discussions on the value of single and short-term therapies (SSTs), ICER’s updated framework codifies the use of its shared savings scenarios to inform its health benefit price benchmark (HBPB) calculations beyond SST treatments. Despite well-documented methodological limitations associated with these analyses, ICER will now consider the use of shared savings scenarios for any treatment (not just SSTs) when (1) a large percentage of the value-based price comes from cost offsets of a comparator, or (2) the comparator therapy price is not known to meet common cost-effectiveness thresholds.
• Dynamic pricing scenarios: Citing stakeholder opposition and methodological limitations, ICER decided against formalizing its proposed dynamic pricing scenarios related to the Inflation Reduction Act’s (IRA’s) Medicare Drug Price Negotiation Program. Instead, ICER committed to working with stakeholders and researchers to assess the feasibility of conducting these analyses in the future.?

Changes to ICER’s assessment process:

• Enhancements to the Patient Engagement Program: ICER will incorporate changes to its Patient Engagement Program, including providing honoraria to patient representatives to help address financial barriers that may hinder participation and convening a Patient Counsel to advise and strengthen ICER’s current Patient Engagement Program.?
• Digital health technology assessments: ICER’s updated VAF states that ICER will use the digital health technology (DHT) assessment framework it developed in partnership with the Peterson Health Technology Institute for assessments of DHTs for reviews starting in 2024. Notably, this framework was not subject to public comment, which poses concerns about the transparency and methodological strength of ICER’s future DHT assessments.?
• Future VAF updates: In a departure from its typical process, ICER’s updated VAF does not include a timeline or describe the process for its next VAF update. However, ICER includes language indicating that it may make interim updates to its framework to incorporate new methods related to dynamic pricing scenarios or adjusting its cost-effectiveness thresholds, implying these updates would take place outside of its typical update process. This raises concerns about transparency and multi-stakeholder involvement, given their absence from the development of the DHT assessment framework.?

On Monday, ICER also published its Draft Evidence Report assessing the comparative effectiveness and value of sotatercept for the treatment of pulmonary arterial hypertension (PAH). ICER issued a B+ evidence rating for sotatercept when added to background therapy, concluding that there is moderate certainty of a small to substantial net health benefit, with a high certainty of at least a small net health benefit. Using a placeholder price of $400,000 per year, ICER’s preliminary cost-effectiveness analyses estimated sotatercept added to background therapy to be $1,805,000 per evLY gained and $2,380,000 per QALY gained, exceeding commonly cited thresholds of cost-effectiveness. However, ICER noted that the actual cost-effectiveness of sotatercept will depend on its price. ICER is accepting stakeholder feedback on these preliminary findings through October 23, 2023.?

ICER also announced this week that Daniel Ollendorf, PhD, MPH, will return to ICER in November 2023 as Chief Scientific Officer (CSO) and Director of Health Technology Assessment (HTA) Methods and Engagement. Dr. Ollendorf previously served as ICER’s CSO from 2007-2018 and is currently the Director of Value Measurement & Global Health Initiatives at the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center, where he focuses on value assessment methods, drug pricing policy, and building international capacity for and interest in HTA. In addition to his new role at ICER, Dr. Ollendorf will maintain a faculty appointment at CEVR and will continue to participate in ongoing research.

Erratum: Last week’s Value Corner erroneously identified Fiona McElwee, rather than Fred McElwee, as a co-author on one of the Innovation and Value Initiative’s Valuing Innovation Project award-winning papers. We regret the error and apologize for the confusion that ran rampant through the value assessment community and the McElwee family!

Understanding ICER’s updated VAF, and the resultant implications for ICER’s future product assessments, is key for manufacturers as they plan their future ICER engagement strategies. We can provide guidance to help organizations understand ICER’s updated methods and the implications for patients, payers, and life sciences companies. Please reach out to me if you need assistance.?