Healthy Men Inc. supports access to important innovative biopharmaceutical products in ways that fully take into account for the impact these products have not only on patients but also on their caregivers, families, and society at large. While every situation requires unique review and commentary, we believe that a balanced and meaningful analysis of the value of any particular medical product, intervention, or service must not only take into account the direct and indirect costs to patients and others, but also the social and humanitarian value they provide. The following are comments HMI provided to the Institute for Clinical and Economic Review (ICER) in support of an advanced Alzheimer’s medication. Our comments point out how looking only at the drug’s economic impact substantially undervalues it benefits in several important dimensions. HMI was joined in these views by over a dozen other organizations with an interest in patient welfare. Click here for the full report.
Dr. Salvatore J. Giorgianni, Jr. PharmD, CMHE
Co-Founder and Vice-President
Chief Alliances and Development Officer
2560 Treasure Cay Ln
Melbourne, FL 32940
January 31. 2023
RE: PUBLIC COMMENT: BETA-AMYLOID ANTIBODIES FOR EARLY ALZHEIMER’S DISEASE
To Whom It May Concern
We are writing to comment on ICER’s proposed assessment of beta-amyloid antibodies for early Alzheimer’s disease.
Healthy Men Inc. (HMI) is a not-for-profit 501(c)3 organization dedicated to advancing the health interests of boys, men and their families and works to support adoption of male-friendly approaches to health care and wellness services.
Men are not only victims of Alzheimer’s Disease (AzD) but also a substantial number of men are caregivers to those who suffer from this condition. HMI would like to provide comment for your consideration from both the perspective of patients and caregivers.
The Current Assessment Algorithms Have A Dangerous And Inappropriate Age Bias
There is no question that AzD is a very complex condition and there is much yet to learn about its pathophysiology and its clinical management. As people around the globe live longer, the potential for developing AzD and length of managing AzD will also increase. The central traditional value assessment used by ICER, and other organizations, is the quality-adjusted life year (QALY). There have been numerous reviews, analyses and expert comments over the years that have pointed out technical, philosophical and sometimes ethical, criticisms of the QALY; these are well known to ICER and are beyond the scope of our comments. In the case of AzD, HMI, as well as others patient advocacy and clinical practice believe because AzD is primally a condition afflicting older persons with QALY’s heavy reliance on economic metrics structured for individuals much earlier in life the tool is not fully applicable as currently structured and applied. In an ethical and sociologic context, applying the current formulas imposes a significant and stigmatizing age-bias on the assessment process that is most inappropriate. HMI believes that approaches other than the traditional QULY must be applied to any evaluation of the value of a treatment for this devastating disease. HIM is not aware of any such algorithms for assessing the value of treatments for conditions that are seen in older persons. We, and other experts, believe that until such an adjusted and tailored assessment tool is accepted any analysis of value, such as the one proposed by ICER, is meaningless and worse is tainted by ageism.
The Analytic Approach Does Not Adequately Include Caregiver and Family Economic Factors
Current analytic approaches used by ICER do not take into account quality and cost metrics for caregivers. This is of fundamental importance to assessing the value of a therapeutic entity or approach. The analysis of AzD is an example of a complex condition that has substantial persona and financial impacts on the afflicted individual as well as the caregivers. It should be particularly noted that caregivers are people, caregiving is stressful both mentally and physically, thus consideration of the potential impact of adverse mental and physical health problems because of ineffective patient treatment modalities must be accounted for. Leaving these assessments out of the equation simply provides not only a incomplete picture of value but also misleads payors who cover healthcare costs not only the patient but, as is most frequently the case, their family member caregivers. ICER’s assessments for AzD are an unfortunate excellent example of this methodologic deficiency.
Great Care Is Needed To Make Every Effort To Properly Characterize Value Of These Treatments Or Important Incremental Private Sector Investment In This Area Of R&D Will Be Curtailed Or Halted.
It is essential that research into these areas continue and that both public and private entities have sufficient societal support for their work and financial support for their work. It is obvious that unless private business who have the brunt of the financial exposure in discovery, research, development, and commercialization of marketable medications have confidence in their ability to price products they bring to market in a way that fully accounts for the investment, uncertainty and risks of work in this complex and uncertain area they will simply pull-back. This cannot be allowed. HIM urges all organizations who conduct cost-effectiveness analysis, formulary management and clinical care guidelines to appreciate the level of risk, not only in the development cycles of products for AzD but also the risks associated with market entry of these products and an important component of their utility analysis. To not consider industry and academic institution incentives to work in this area is completely self-defeating to the advancement of basic and applied research as well as access to a steady-stream of improved treatments.
We appreciate the opportunity to provide our comments. Please feel free to contact HMI if you would like to discuss.
Respectfully,
Salvatore J. Giorgianni, Jr., PharmD, CMHE
Vice-President and Co-Founder,
Healthy Men Inc.
Chair-Emeritus and Co-Founder,
American Public Health Association Men’s Health Caucus.
