this week ICER has released a number of potential changes to its value system.. Their summary is given in the table below.
Variety of clinical trials
A measure of clinical trial diversity is calculated based on the ratio of people participating in a study compared to the US population of patients with the disease. The categories by which this is measured are race, age, and gender. The tables below describe the calculation. However, it appears that the clinical trial diversity score will not affect the value-based price.
Heterogeneity and subgroups
RCT for ICEMAN The approach aims to answer the following questions to assess the overall credibility of the subgroup’s claim.
- Was the direction of modification of the effect a priori assumed correctly?
- Has the effect modification been supported by prior evidence?
- Does the interaction test suggest that randomness is an unlikely explanation for the obvious
- Did the authors only test a small number of effect modifiers, or did they account for the amount in their modifiers?
- If the effect modifier is a continuous variable, arbitrary cutoff points can be avoided.
In cases where there is no strong evidence of how a treatment can improve performance, ICER will use an approach that links patient utility to performance. ICER writes:
To inform estimates for the indirect approach, ICER will use the published relationship between patient utility scores and patient time use data5 to derive the expected treatment impact on time spent on each action due to the disease and its treatment for the patient. The indirect approach estimates the productive time spent in a given health condition, which, unlike the most typical approach of estimating the lost productive time, makes it possible to record the productive time gained during periods of life extension. Under these circumstances and according to the published literature[Jiao and Basu 2023]ICER will include increased patient productivity and patient consumption costs during life extension periods. Because there is no parallel relationship between patient utility scores and caregiver time use data in the US setting, ICER will assume that caregiver time is proportional to 75% of the patient’s official work time. This estimate is based on the modeled relationship between required care time[Rowen et al. 2016] and wasted patient time[Mukuria et al. 2017] in accordance with assessments of usefulness for patients in the United Kingdom.
Time impact will be evaluated as follows:
ICER will now enable dynamic pricing as follows:
- Net prices will not rise above the inflation rate
- small molecules prices are expected to fall by 75% in year 9 after launch
- Biological treatment prices are expected to fall by 65% 13 years after launch
- These dynamic pricing assumptions will apply to both treatment and comparative intervention.
- This approach, however, would not change the cost-effectiveness of a single cell or gene therapy.
Willingness to pay for QALYs
The ICER HBPB range uses threshold prices from a health system perspective as a starting point, starting with the highest and lowest annual price ranging from $100,000 to $150,000 per QALY and per evLYG. The most common ICER HBPB range includes a treatment price that corresponds to $100,000 per QALY at the bottom and corresponds to $150,000 per evLYG at the top of our range… US dollars. for QALY and for evLYG in our reports.
Single Short Term (SST) Therapy
When considering SST treatments, ICER will use:
- A 50/50 shared savings model in which 50% of the health care system’s lifetime cost reimbursement from a new treatment is “assigned” to the health system rather than fully assigned to the new treatment; And
- A marginal cost recovery model in which the health system cost recovery generated by a new treatment is limited to $150,000 per year, but is otherwise entirely attributable to the new treatment.
ICER notes that health equity considerations will now play a role in the choice of theme.