ICER Proposes Changes to Its Values ​​Framework – Healthcare Economist

this week ICER publishes some potential changes to its value framework. A summary of these is listed in the table below.

clinical trial diversity

The clinical trial diversity measure is calculated based on the ratio of the number of people in the trial to the number of patients with the disease in the United States. The categories to measure this are race, age and gender. The table below describes the calculations. However, clinical trial diversity measures do not appear to affect value-based prices.

Heterogeneity and subpopulations

this RCT Iceman The methodology aims to answer the following questions to assess the overall credibility of subgroup claims.

1. Is the direction of effect modification correctly assumed a priori?
2. Does prior evidence support effect modification?
3. Does an interaction test indicate chance as an unlikely explanation for an apparent phenomenon
   Effect modification?
4. Did the authors only test a small number of effect modifiers or consider their number
   Statistical Analysis?
5. Whether arbitrary cut points are avoided if the effect modifier is a continuous variable

productivity impact

In the absence of strong evidence of how treatments improve productivity, ICER will use an approach that links patient utility to productivity. ICER wrote:

To inform indirect method estimates, ICER will use the relationship between published patient utility scores and patient time-use data to derive treatment expectations for time spent in each activity as a result of the disease and its management of the patient Influence. Indirect methods value productive time spent in a given health state, in contrast to most typical approaches to assess lost productive time, creating an opportunity to capture productive time gained during life extension.In these cases, and consistent with the published literature[Jiao and Basu 2023], ICER will include patient productivity time gained during life extension and patient consumption costs. Since there is no parallel relationship between patient utility scores and nursing staff time-use data in the US setting, ICER will assume that nursing staff time is proportional to 75% of the patient’s official labor time.This estimate is based on the modeled relationship between the hours of care required[Rowen et al. 2016] impatient time[Mukuria et al. 2017] According to patient utility scores in the UK setting.

The timing impact will be assessed as follows:

dynamic pricing

ICER will now employ dynamic pricing as follows:

• The net price will not be higher than the inflation rate
• Small molecule Suppose the price falls 75% in a year 9 after launch
• biological treatment Suppose the price falls 65% 13 years after launch
• Both treatment and comparison interventions will be subject to this dynamic pricing assumption
• However, this approach does not allow for changes in cost-effective discovery of one-off cell or gene therapies

Willingness to pay per QALY

ICER wrote:

The starting point for ICER’s HBPB range uses threshold-based prices from a healthcare system perspective, ranging from $100,000 per QALY and per evLYG to a maximum and minimum annualized price of $150,000. The most common ICER HBPB ranges include meeting treatment prices at the low end of $100,000 per QALY and the high end of $150,000 per evLYG… ICER will continue to offer threshold-based prices from $50,000 to $200,000 per QALY and evLYG in our report.

Single Short-Term (SST) Therapy

When reviewing SST therapies, ICER will use:

• A 50/50 shared savings model in which 50% of the lifetime health system cost offset for new treatments is “allocated” to the health system rather than all allocated to new treatments; and
• A cost reimbursement cap model in which health system cost reimbursement from new treatments is capped at $150,000 per year, otherwise all allocated to the new treatments.

topic

ICER noted that health equity considerations will now play a role in their topic selection.