Pharmaceutical Market Europe • November 2021 • 12
DARWIN'S MEDICINE
Aduhelm has a future – or it doesn’t
Since I spend much of my life researching the evolution of the life sciences industry, I’m often asked for my opinion on current developments in the sector.
And rarely have I been pestered for comment more than regarding Aduhelm (aducanumab), after its approval earlier this year for the treatment of Alzheimer’s disease. ‘Will it succeed?’ is the usual phrasing of the question, which is asked both by those with an interest in that vast disease area and those who see Aduhelm as a bellwether for their own, different markets. There are of course any number of people – analysts, investors and others – speculating on the answer. These are accompanied by those who worry about the regulatory and economic implications and precedents of the FDA’s decision. Among the pharmaceutical market Twitterati, the subject even eclipsed COVID-19 for a while.
But I am a scientist and when I am asked pertinent but simple questions I am immediately reminded of Claude Lévi-Strauss, the French philosopher, and his injunction that ‘the scientist is not a person who gives the right answers, he is one who asks the right questions’. Leaving aside the gender-stereotyping that was typical of his day, this is good advice and if you can bear with me for a couple of paragraphs then I’ll get to the practical, real-world point to which Strauss’s edict leads us.
Despite the certitude of those who opine about Aduhelm’s prospects, nobody really knows whether or not Aduhelm will succeed commercially for Biogen and Eisai. It is a very important and unanswered question not only for those two companies but also for other firms that might seek to emulate them. The question is also being asked by health systems that face the risk of being overwhelmed by the expensive expectations of desperate patients and their families. But simply being an important question doesn’t make it a good question. As Lévi-Strauss was trying to get across, a really good question doesn’t only elicit the required answer, it also helps its formulation by directing the thought processes of the answerer. For example, I learned that it is better not to ask my middle daughter ‘are you revising for your exam?’ and instead to enquire how she plans to fit in revision around her innumerable sporting and social activities. Applying the same Strauss-like thinking to the Aduhelm question takes me away from ‘will it succeed?’ to ‘under what conditions might it succeed or fail?’. Not only would the answer to that question be more useful, but the question wording prompts more careful thought, in exactly the way I tried to do with my teenager.
I’ve seen very little written that tries to answer this longer question. But the ingredients of the answer are in plain sight. Even the most optimistic reading of the data and hopes for future data suggest that Aduhelm is not going to be able to make the wide, strong and unchallengeable claims to efficacy that would guarantee commercial success. The furore over what happened inside the FDA will cast a long shadow over the product’s reputation. Biogen’s ambitious pricing decisions, when cross-multiplied by disease prevalence, also imply that widespread usage is financially impossible.
Even in the US, with all its market exceptionality, payers are coalescing around not providing coverage for the drug. ICER’s final report was exceptionally critical. In the aggregate, these signals suggest that Aduhelm’s future is commercial failure. But set against this are some countervailing positive factors. There seems little doubt that, such is the unmet need, some people will pay almost anything for merely the hope of slower disease development. Phase 4 studies will be aimed at encouraging that hope. The arcane complexities of US healthcare plans offer many little niches that might be exploited. The political power of the elderly and their children makes Alzheimer’s care hard to deny, even on the most rational of grounds. The packaging of Aduhelm as not so much a product but rather a process of diagnosis, monitoring and treatment moves it away from simple price comparisons. And the wealth inequalities of western societies, with many potential patients living in large, realisable assets also point to a large possible self-pay market. Taken together, these positive factors counterbalance the negatives about efficacy and cost.
Given these ambiguous facts, Biogen and Eisai chose to follow the market signals and go to market with Aduhelm. What happens next is essentially an evolutionary question about its fit within the market.
Strauss’s directions lead us, via facts that are already apparent, to two possible futures for Aduhelm. In one, the product runs the gauntlet of rational assessment and value-based pricing decisions. In those circumstances, its future looks dim. But in another future, an Aduhelm-centred disease management process is subjectively valued by wealthy, frightened patients and their families and by governments seeking their votes. The latter already have a track record of ‘following the science’ towards their own expedient ends. For both kinds of payer, the comparator is the distress and cost of caring for Alzheimer’s patients and some at least will chose the hope offered by Aduhelm. Which scenario – rational rejection or subjective hope – will come to pass depends on the deftness with which Biogen and Eisai adapt their business model to fit a future of empowered patients. Once again, Darwin’s explanation of biological complexity also explains that of our own business.
This column is also available as a podcast here or search ‘Darwin’s Medicine’ on your podcast provider.
Professor Brian D Smith works at SDA Bocconi and the University of Hertfordshire. He is a world-recognised authority on the evolution of the life sciences industry and welcomes questions at brian.smith@pragmedic.com