Could the Lack of an Efficient and Affordable Diagnostic Pathway Limit Market Access for New Alzheimer’s Treatments?

The promise in the coming years of a novel therapeutic to slow the progression of the debilitating effects of Alzheimer’s disease (AD) is exciting and represents a monumental step forward in treating patients with AD.  The lack of an efficient and affordable diagnostic pathway to identify patients early in the disease presents a significant obstacle to realizing these benefits, however, and it suggests an imminent need for continued research in this area.

M ore than 5 million people in the United States and more than 15 million people worldwide have diagnoses of Alzheimer’s disease (AD). In the United States alone, it is estimated that health care expenses and lost wages attributable to AD total $80–100 billion annually. Because AD mostly affects adults over 65 years of age, AD is becoming a major health care resource issue as life expectancy increases.

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 Many pharmaceutical companies are spending hundreds of millions of dollars on phase 3 trials in an attempt to bring novel AD treatments to market in the next 3–5 years. Rather than providing only mild symptomatic relief, these therapies may finally be capable of slowing the progression of this debilitating disease. Although the prospect of new therapeutics in AD is reason for celebration, market access challenges could dramatically reduce the potential benefits from these new advances.

Drugs in the current pipeline are believed to be only effective for patients in the prodromal to mild/moderate stages of the disease. Because AD is a progressive neurological disease, often characterized in its early stages by symptoms associated with traditional signs of aging (forgetfulness, memory loss, etc), separating those with AD from those with normal symptoms of aging, those experiencing adverse responses to medication, or those with other types of dementia, requires significant testing.

As of now, there are no simple blood tests or assessments that can properly diagnose patients in the early stages of AD—the only patients likely to respond to treatment. Such diagnostics are being developed by numerous companies; however, none of them appear to be far enough along in the pipeline that they are likely to come to market within the next several years.

Genomic tests are currently not helpful in diagnosis, either. While the Apo-E4 test indicates a genetic predisposition to AD, it provides no detail on the status or progression of the disease. Furthermore, patients who do not test positive for the gene can still develop AD.

Positron emission tomography (PET) imaging offers clear evidence of AD and regional plaque burdens; however, it is an expensive technology to use, and the current number of PET machines installed is completely inadequate to screen all patients over 65 years of age. Furthermore, because PET scanning is not reimbursed for the purpose of diagnosing AD, providers currently have no reason to invest in the additional capacity that would be required to address the potential influx of patients. With the average brain PET scan reimbursement from Medicare being ~$1,350 in 2016, the cost of simply screening the population over 65 years of age (~35 million) annually would exceed $47 billion. To put this figure into context, the total annual spending on mammography testing in the United States is roughly $8 billion annually.

Given the demographics of the patient population, the costs for diagnostic testing are going to fall almost exclusively on Medicare, whether via private plans or via government-contracted entities. Considering the staggering cost burden that this would place on the Medicare system, it is not surprising that there are no current plans to reimburse providers for these diagnostic costs.

Although efficient and affordable tests may not be perfected in time for the launch of novel therapeutics, tests that are at least sensitive (ie, can rule out AD), if not specific (ie, can rule in AD), would, at minimum, reduce the number of patients that need to undergo more expensive testing to determine whether they are early in disease progression.

With the current pressure on health care spending, an efficient and affordable diagnostic pathway will be required to ensure the identification of those patients who will respond to novel therapeutics. Although a reliable diagnostic process will not solve the next problem of how to pay for these expensive, yet valuable, therapeutics, it will at least help to identify the subset of patients who need and will respond to treatment.