While the Alliance does not endorse or take positions on specific drug products, the Alliance continues to express our concern regarding ICER's methodology that systemically undervalues the lives of older individuals, persons with a disability, and those in communities of color.
In the letter, the Alliance encouraged ICER to revise their value assessment methodology in order to more accurately capture the value of therapeutics to patients, caregivers, and communities that may benefit from treatments for Alzheimer's disease.
The Alliance also proposed principles for an alternative and equitable value assessment for Alzheimer's disease treatments.
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To Whom It May Concern,
On behalf of the
Do Not Ignore the Value of Alzheimer's Innovation
The development of effective therapies to prevent, delay, and better manage AD and related dementias is one of the most pressing and complex public health challenges facing our nation. Alzheimer's disease is the only top-ten cause of death in
The human cost of not finding a cure for Alzheimer's disease is astronomical. An AD drug development program's total cost is estimated at
ICER's Made-Up "Modified Societal Perspective" Does Not Cut It
To evaluate the effectiveness of established value assessment approaches in terms of a disease's true impact on family caregivers, communities, and social service needs, the report authors analyzed publicly available financial and public health data specific to AD. The authors explain that total costs for AD care exist disproportionately beyond medical costs, with an extensive burden on families and residential long-term care. In fact, the status quo of AD care consists of systems of care that depend on low-paid workers or family caregivers, create multi-generational family burdens, and exacerbate existing racial disparities. Available public health data show Alzheimer's has immeasurable and intangible effects on both the patient and caregiver, including unintended job loss, reduction in income, behavioral and psychiatric consequences, and much more.
However, ICER's method of disease burden analysis incorporates direct medical costs into its model and relegates the costs of health effects to family caregivers or work loss for family members related to care needs for loved ones with AD to its subjective "modified societal perspective" as a "co-base-case analysis." ICER states that the rationale for this additional analysis is due to "the large impact of AD on caregivers," which makes it seem as though it would better account for the caregiver perspective. Instead, the modified societal perspective that ICER invented penalizes the caregiver for the productivity and economic impacts of keeping a loved one at home, as captured in report summary and comment:
"In addition, keeping a patient in earlier AD states longer, which delays the transition to long-term care, can increase productivity losses for the caregiver...This highlights the complexities of capturing caregiver perspectives in the modified societal perspective in that caregivers may prefer to keep loved ones at home, rather than in a long-term care facility, although doing so may increase the negative financial impact on the caregiver."
This statement illustrates the tension inherent in the assumptions underlying ICER's value assessment framework, even under the modified societal perspective proposal, illustrating its inherent weakness and inability to truly account for the family caregiver perspective. From a patient, family caregiver, and societal perspective, there is significant value to prolonging independence and identity that is not reflected in medical costs or solely captured in caregiving burden. Slowing the progression of AD means prolonging independence and identity, both lowering caregiver burden in earlier stages of the disease and providing immense intrinsic value to patients and their families that outweighs opportunity costs lost elsewhere. If this value is not reflected in the value assessment, that is a shortcoming of the model in accurately capturing and incorporating value, not of patients and caregivers in valuing non-monetary outcomes. If value assessment fails to accurately capture value to those who benefit from the therapeutic, then the exercise is incomplete.
ICER's Use of QALYs to Value Alzheimer's Disease Presents a Moral Quandary
The use of cost-effectiveness assessment to judge therapeutic value from a payer's perspective, and technical issues using quality-adjusted life years (QALYs) renders the approach problematic. The QALY has significant limitations when dealing with complex diseases such as AD, as they do not recognize value driven by public health improvement, transformation, or even societal value. These issues are not unique to AD, although the characteristics of AD and the ecology of care around people with AD highlight these issues.
Use of QALY-based cost-effectiveness analysis is a significant issue for people with Alzheimer's disease since the majority of those with dementia are the oldest old--of the estimated 6 million people with Alzheimer's disease who are age 65 and older, 80 percent are 75 years or older, and more than a third are 85 years or older./1 Also, people aged 65 years and older with Alzheimer's disease are likely to have a comorbid condition such as coronary artery disease (38 percent), diabetes (37 percent), chronic kidney disease (29 percent), congestive heart failure (28 percent), and chronic pulmonary disease (25 percent). When applied to healthcare decision-making by insurance companies, this can mean that treatments for these more vulnerable people are deemed "too expensive" and therefore "not cost-effective" to cover.
Objections about reliance upon QALY-based methodologies also extend to race. For example, Black Americans have an average life expectancy lower than whites. As such, treatments for conditions that disproportionately affect Black individuals may be assessed as lower value. Furthermore, Black and Latino communities experience Alzheimer's disease at higher rates than the general population. Data from the CHAP study shows that 18.6 percent of Black Americans and 14 percent of Hispanic Americans age 65 and older have Alzheimer's disease compared to 10 percent of White Americans./2 ICER should not use measures that are unable to incorporate equity considerations, which may inadvertently promote structural discrimination.
ICER Pooled Clinical Trial Data with No Adjustments for Exposure
ICER's evaluation of the cost-effectiveness of aducanumab in the draft evidence report inappropriately pooled the data of the ENGAGE and EMERGE trials without adjusting for the number of people titrated to a higher dose for the different time periods. Fewer trial participants had the opportunity in ENGAGE to receive high-dose treatment than the patients in EMERGE. By not adjusting, ICER's approach provides an inaccurate picture of the value of the treatment. In its
Next Steps Along a Better Path
To accurately assess the value of Alzheimer's disease treatments, Milliman's report outlines an alternative, equitable value assessment framework for use in AD that accounts for the ecosystem that surrounds people with AD, including the impact treatments may have on ameliorating social ills such as racial disparities. The principles include that such a framework should:
* Utilize metrics that, when appropriate, apply the same standards regardless of age or socioeconomics,
* Capture the health-related value of AD treatments not only for patients but also for their family caregivers, and
* Appropriately account for changes in non-health outcomes and issues of community value related to AD patients and their caregivers.
The Alliance will be working in the coming months with leading experts in health economics to further expand upon an alternative value framework for Alzheimer's therapies. The question of whether ICER will modernize and take steps along a better path is in their hands.
If you have questions, please contact me at [email protected]. Thank you for considering our comment.
1/ Rajan KB, Weuve J, Barnes LL, McAninch EA, Wilson RS, Evans DA. Population estimate of people with clinical AD and mild cognitive impairment in