“At launch, we will have a comprehensive health equity offering,” declared a Biogen executive in an internal presentation detailing the marketing plan for Alzheimer’s drug Aduhelm.
Biogen’s health equity program for Aduhelm would address “Early Detection, Diagnosis, and Affordability,” according to the presentation, dated April 2021. The company intended to supplement it with promotional materials targeted at Black and Latino patients and their healthcare providers. It also planned to shell out millions for media advertising focusing on patients of color and on multilingual patient outreach.
There was just one problem: Neither the marketing playbook nor a plan to craft a public narrative that the company promoted health equity and access was supported by Aduhelm’s clinical trials. In its initial Phase 3 studies for the drug, just 3.0% of participants were Hispanic and 0.6% were Black, while 0.03% were American Indian or Alaska Native.
The confidential marketing scheme, released along with an 18-month congressional investigation into the controversial approval of Aduhelm, doesn’t just highlight the problem of racial disparities in clinical trials. Many clinical trials do not include certain minority groups in spite of the high disease incidence and mortality in their population.
With the Food and Drug Administration granting accelerated approval to Leqembi (lecanemab), a similar amyloid-removal drug from Biogen and Eisai, the congressional report represents a cautionary tale. The prevalence of patients should drive clinical trials, or a company’s FDA-approved label will be limited. The label should drive commercial focus.
“Unfortunately, communities of color are usually brought into the consideration set at the tail end of the process,” said Andrea Richardson, EVP, global head of diversity, equity and inclusion at Zeno Group. “There is a bit of organizational behavior change that we need to see moving forward that includes communities of color in the consideration set at the very beginning and not as an afterthought.”
Marketing was just one aspect of the Aduhelm rollout that opened it to criticism. Concerns included the drug’s efficacy, safety, affordability and list price.
Aduhelm received accelerated approval from the FDA on June 7, 2021. Less than 12 months later, the firm pulled the plug on the launch. The move was made after Medicare severely restricted reimbursement and Biogen saw paltry sales levels that paled in comparison to blockbuster forecasts.
The unsealed documents show how Biogen planned to target communities of color. The plan called for the company to craft a public narrative that it promoted health equity and access. Additionally, it suggested working behind the scenes to enlist and build support for Aduhelm among Alzheimer’s disease advocacy organizations that serve people of color.
As part of its strategy, Biogen would design promotional materials targeted at Black and Latino patients and their healthcare providers. Among other initiatives, it planned to buy advertising slots on Telemundo and BET. The company indicated it could spend upwards of $3 million on media advertising focusing on patients of color alone and approximately $1 million on multilingual patient outreach and funding for patient transportation.
Those proposed plans, however, were not adequately supported by Aduhelm’s clinical trials, which were far from inclusive. Only 0.6% of participants (19 individuals) identified as Black, 3% as Hispanic, 0.03% (1 person) as American Indian or Alaska Native, and 0.03% as Native Hawaiian or Pacific Islander, according to published data about the studies.
“Older Black adults are estimated to have up to double the rate of Alzheimer’s disease incidence than older White people,” the researchers noted. “Despite this, Biogen reported that only six Black people were randomized to the treatment dose approved by the FDA.”
Only after the Centers for Medicare and Medicaid Services’ proposed national coverage decision, which required that patients in CMS-approved trials be representative of the national population diagnosed with Alzheimer’s disease, did Biogen promise to increase diversity in its Phase 4 confirmatory trial, lawmakers pointed out.
The Aduhelm revelations have important ramifications for how manufacturers of future treatments should conduct their clinical research and their marketing to AD physicians, patients, payers and other stakeholders. At the very least, not having sufficient data on people of color can result in a lack of trust.
But there are encouraging signs. One is the greater awareness that this is a moral and scientific problem.
April’s FDA draft guidance around diversity, equity and inclusion in clinical trials emphasizes the connection between disease prevalence and trial participation. Getting participation in a trial to equal prevalence of people in the disease state is one way to ensure that clinical discoveries have universal impact.
And while Aduhelm’s clinical trials were woefully devoid of non-white participants, the trial for Leqembi was a different story. It was obvious, researchers said, that this trial made efforts to enhance global enrollment of a diverse group of participants.
In the Leqembi trial, 20% of subjects were non-white. In the U.S., 6.1% and 28.1% of 3,638 screened participants, and 4.5% and 22.5% of randomly assigned participants, were Black and Hispanic, respectively, according to data published in the New England Journal of Medicine.
Such efforts need to scale in order for the problem of racial disparities in clinical trials to improve, Richardson stressed.
“All communities that will be impacted by this or future therapies need to be included in the process end to end, from trials through drug development, for these patients to feel an authentic level of trust once a product enters the market,” she said.