Alzheimer’s disease is the most common form of dementia, causing gradual cognitive impairment and memory loss, often beginning with an individual’s short-term memory. There are currently around 900,000 people living with the disease in the UK and an estimated 54 million people globally have some form of dementia.
  
There is no known cure for the disease, but there are medical treatments available for a variety of the symptoms, including memory loss, confusion and other behavioural effects. There are a number of ongoing research projects focusing on the causes and treatment of Alzheimer’s, with a selection of new pharmaceutical products seeking regulatory approval and marketing authorisation.

As a result of the prevalence of the disease and the ever-advancing research, healthcare professionals (HCPs) across the globe use social media to raise awareness of symptoms, offer supporting advice and discuss up-and-coming treatments in the field. CREATION Pinpoint identified almost 70,000 English language posts about Alzheimer’s over the past year posted by 14,000 HCPs worldwide. The most significant driver in the conversation was the controversial US Food and Drug Administration (FDA) approval of Biogen’s Aduhelm (aducanumab), the first novel therapy approved for the disease since 2003. Throughout the year, a number of events spiked the interest and conversation of HCPs as the new product was scrutinised following its FDA approval.

Prior to Aduhelm’s approval, it had had a number of unsuccessful trials, with safety continuing to be a major concern, but Biogen was able to file for regulatory approval with the backing of new analysis and a larger data set. The presentation of this data at #CTAD19 was met with a host of questions as HCPs remained cautiously optimistic of the impact this treatment would have for patients.

Before the approval, sentiment was already divided and it was made more prominent by the views of notable organisations and advocacy groups. While the American Geriatrics Society urged the FDA not to approve the drug, the Alzheimer’s Association promoted aducanumab in a campaign called #moretime.

The week of the accelerated approval of Aduhelm saw a peak of over 5,000 HCP tweets dissecting and deliberating the news. HCPs were unsure of the decision as it was felt that there hadn’t been ‘enough evidence to approve Aduhelm’.

Some HCPs called it a ‘dark day’ as the approval was given despite unsuccesful trials and questions from the FDA’s own scientific advisory panel. When a STAT News article announced the resignation of a panel member, it was shared over 100 times. The evidence appeared multifaceted as HCPs cited the insufficient efficacy data, unreasonably high costs and worrying safety statistics.

A month after Aduhelm’s approval, an article was published in JAMA Internal Medicine from the FDA’s Center for Drug Evaluation and Research (CDER), giving its perspective on the regulatory decision. The piece was introduced to ‘discuss the complexities of the data supporting the aducanumab application and the rationale for the FDA’s decision to grant it accelerated approval’. HCPs responded on Twitter as they considered all the data and surrounding events and conversations.

After months of unfolding controversy, Medicare, the US federal health coverage programme, announced it would be restricting access to Aduhelm to only those patients who were enrolled in clinical trials (and then only randomised approved trials).

Before this announcement, many hospital systems (not to mention individual HCPs) made it clear that they would not be prescribing or administering the drug.
By definition, Medicare only covers products that are ‘reasonable and necessary’, differing from the requirements of an FDA approval when a product must be ‘safe and effective’. Safety concerns increased when a patient’s death was related to a known side effect of Aduhelm, ‘amyloid-related imaging abnormalities’ (ARIA).

‘Medicare only covers products that are ‘reasonable and necessary’, differing from the requirements of an FDA approval when a product must be ‘safe and effective’’

The decision by Medicare to restrict access came after a myriad of conversations about the price tag attached to Aduhelm. Biogen had initially priced the drug at $56,000 for an average dose, but later cut the price by half to around $28,000.

Looking at the conversation from a wider perspective, the pricing issue extended to expose areas of need that could be improved with additional financial investment.

World Alzheimer’s Day saw over 1,000 HCP posts on 21 September, with an increased dialogue about recognising Alzheimer’s symptoms and increasing support for those affected by the disease. Many HCPs used the day to break down the different facets of Alzheimer’s from diagnosis to treatment. Ruminda Gunaratne wrote a tweetorial in which he looked at the question of how to treat Alzheimer’s, making it clear there is no cure, but that cholinesterase inhibitors such as donepezil may have some benefit.
Two other drugs that are in development for Alzheimer’s are donanemab and gantenerumab from Eli Lilly and Roche respectively. Donanemab has earned positive phase 2 results, while gantenerumab has received FDA breakthrough status despite missing its primary endpoint in phase 2/3 trials. HCPs are keeping a close eye on the data as these two new drugs, like Aduhelm, are ‘amyloid clearing’.

Aduhelm’s approval has shown how impactful HCP opinions can be and that a successful approval does not necessarily equate to a successful launch. Despite the desire for an Alzheimer’s cure, HCPs have an obligation to be sure of the safety and efficacy data before prescribing a treatment to their patients. The events were tracked through HCPs’ online conversations, revealing where there were needs and opportunities to support patients in a tangible and effective way. CREATION.co provides HCP insights and tracking services that can keep a finger on the pulse of drug approvals and launches, in order to understand what HCPs think.

Mary Kangley is a Health Insights Consultant at Creation