How much will aducanumab, the first anti-Alzheimer's drug, cost us?

How much will aducanumab

In the United States, where it has already been approved, the impact on health spending could fluctuate between 30 and 300 billion dollars

Alzheimer's (photo: BSIP / Corbis) Last June 7, with a stroke of a scene that surprised a large part of the scientific community, the FDA (the American drug agency) has approved aducanumab, the first drug for the treatment of Alzheimer's. A drug with a troubled history, with little evidence of efficacy and non-negligible side effects, so controversial that the decision prompted three experts from the committee called by the FDA to comment on the marketing of aducanumab to resign.

And to say that alongside a rather dubious benefit / risk profile, the drug has another, huge, problem. The cost: currently the manufacturing company, Biogen, has set a price of 56 thousand dollars a year per patient, compared to over six million Alzheimer's patients in the United States alone, destined to increase rapidly in the coming years, to away of a population that (as also in Italy) continues inexorably to age. A fair price, according to the company's calculations. A real bomb - many experts denounce - that could be the American health accounts. So let's try to make some calculations to better understand the dimensions of a problem that, with the decision of the European Medicines Agency (EMA) on approval in Europe expected in the coming months, could soon concern us too closely.

Aducanumab: a controversial drug

To begin, a brief review. Aducanumab, trade name Aduhelm, is a monoclonal antibody developed to attack the betamyloid protein, the main constituent of the amyloid plaques present in the brains of many (but not all) patients, and considered one of the most probable causes of cognitive degeneration caused by Alzheimer's. One of the most probable, but certainly not the only one. On closer inspection, in fact, in the past decades several drugs have been developed aimed at targeting amyloid plaques, without any one ever having proved effective in countering the cognitive decline of patients.

Aducanumab would therefore be the first of a new class of drugs, and could represent the first step on the road that will one day lead us to definitively defeat Alzheimer's. The problem is that the data on its effectiveness are extremely controversial. After some encouraging preliminary results, on March 21, 2019 Biogen itself had stopped the two large phase 3 trials launched to verify the actual usefulness of the drug, admitting that the lack of benefits of the drug was so obvious as to make the conclusion of the trials useless. .

How did we get to the approval then? It is easy to say: by analyzing the results again, the company's statisticians would have found that the drug, at high doses, proved to be more effective than placebo in one of the two clinical trials, and in any case useful in a small subset of patients. In the second. An analysis method considered unscrupulous by many independent experts, who accuse the company of having chosen to eliminate negative data and take into account only the positive ones in the new evaluation of the results, but which nevertheless prompted the company to submit the application for approval to Fda and Ema, managing to convince the American agency to approve the marketing, on the condition that a new study is carried out confirming the benefits of the drug, otherwise the approval will be withdrawn.

How much will it cost the Americans?

With the controversy over, it's time to talk about costs. To help us is an analysis carried out by the Kaiser Family Foundation, which tries to calculate the number of patients who could use aducanumab in the United States through Medicare, the (partially) public health insurance program reserved for over 65s, which includes about 80% of American Alzheimer's patients. Not an easy task, because it's all a matter of definitions: the drug has been tested on patients with mild cognitive decline and amyloid plaques in the brain, but has been approved for use by any patient with Alzheimer's. On the basis of which type of patients is taken into consideration, if the entire audience of Alzheimer's patients or only those who fall within the profile described by clinical trials, the possible health expenditure for the drug also changes a lot.

The therefore there are many variables: how insurance companies (and Medicare in particular) will organize themselves for reimbursement, how doctors will decide to prescribe, how long the treatment cycle will be (the company recommends a minimum of 18 months, without specifying, however, whether it is appropriate to continue or not others), and also how many patients will accept to undergo a treatment that is not free from side effects.

Biogen estimates an eligible population of between one and two million patients, based on data relating to the prevalence of mild forms of Alzheimer's in the United States. Not everyone will of course undergo treatment, but if even a quarter of them did, the cost to Medicare (which reimburses 103 percent of the wholesale price of drugs) would be $ 23 billion a year. A record figure, if we think that in 2019 Medicare spent a total of $ 37 billion on drug coverage of the reimbursement group to which aducanumab belongs. And it could be worse: if one million patients received treatment, the cost would soar to $ 57 billion in one year, and over $ 100 billion with two million patients. If the entire population of American Alzheimer's patients had access to treatment, ultimately, the cost would reach over $ 330 billion in a year, about half the record-breaking budget that the US Department of Defense receives.

None of the scenarios just described - the analysis of the Kaiser Family Foundation warn - would be sustainable for the American health system. Not only because it would require an increase in Medicare funding (largely entrusted to American taxes), but also because the direct costs for patients, or "out of pocket", however present, would be around 11 thousand dollars a year. , a good 40% of the average salary of those assisted by the program.

The scenario in Italy

How would things go with us, in the event of Ema's approval of the drug? Patients with Alzheimer's in Italy are about 600 thousand. Using the same proportion of patients with mild cognitive decline that is seen in the United States, we can hypothesize about 50,000 patients eligible for treatment, for a total of nearly three billion dollars annually in expenditure if all patients undergo therapy. . The calculation is rough, and the price will certainly be lower because Italy, with its public national health system, always manages to significantly reduce the cost of reimbursed drugs. Net of the errors, this would still be an absolutely mammoth expense, especially considering that the entire fund for innovative non-oncological drugs currently amounts to 500 million euros per year.


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