In the United States, where it has already been approved, the impact on healthcare spending could fluctuate between 30 and 300 billion dollars
On 7 June, with a twist that surprised a large part of the scientific community, theFda (the American drug agency) approved theaportanumab, the first drug for the treatment of Alzheimer’s. A medicine with a troubled history, with little evidence of efficacy and non-negligible side effects, so controversial that the decision pushed three experts of the committee called by Fda to comment on the marketing ofaportanumab a resign.
And to say that alongside a rather dubious benefit / risk profile, the drug has another, enormous, problem. The cost: currently the manufacturing company, Biogen, has set a price of 56mila dollari per year per patient, compared to over six millions of sick of Alzheimer only in the United States, destined moreover to increase rapidly in the coming years, due to 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 the accounts of the health care americana. 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 (Mom) on the approval in Europe expected in the coming months, could soon concern us too closely.
Aducanumab: a controversial drug
To begin, a brief review. Aducanumab, commercial name Aduhelm, it’s a antibody monoclonal developed to attack the protein betamiloide, main constituent of plaques amyloidi present in the brains of many patients (but not all), and considered one of the most probable causes of cognitive degeneration caused byAlzheimer. One of the most probable, but certainly not the only one. On closer inspection, in fact, several drugs have been developed over the past few decades to target plaques amyloidi, with no one ever proven effective in countering the cognitive decline of patients.
Aducanumab it would therefore be the first of a new class of drugs, and could represent the first step on the road that one day will lead us to definitively defeat theAlzheimer. The problem is that the data on its effectiveness are extremely controversial. After some encouraging preliminary results, on 21 March 2019 the same Biogen he had stopped the two greats trial of step 3 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: analyzing the results again, the company’s statisticians would have found that the drug, ad other doses, Yes is proved more effective than placebo in one of the two trial clinical, and in any case useful in a small subgroup of patients also in the second. A method of analysis considered unscrupulous by many independent experts, who accuse the company of having chosen to remove i data negative and take only those into account positive in the new evaluation of the results, but which nevertheless prompted the company to submit the application for approval to the FDA and EMA, managing to convince the American agency to approve the marketing, provided that a new study is carried out that confirms the benefits of the drug, under penalty of withdrawal of approval.
How much will it cost the Americans?
With the controversy out of the way, it’s time to talk about costs. To help us is an analysis carried out by Kaiser Family Foundation, which tries to calculate the audience of patients they could use aportanumab in the United States through Medicare, the (partially) public health insurance program reserved for over 65, in which about the80% 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 decline cognitive dear e plaques amyloidi in the brain, but has been approved for use by any Alzheimer’s patient. On the basis of which type of patients is taken into consideration, whether the entire audience of Alzheimer’s patients or only those who fall within the profile described by the clinical trials, the possible health expenditure for the drug also changes a lot.
The variables are therefore many: how the insurance companies (and in particular Medicare) for the reimbursement, as they decide to to prescribe doctors, 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 without effects collateral.
Biogen estimates an eligible population of between one and two million patients, based on data on the prevalence of mild forms of Alzheimer in the United States. Not all of them will obviously undergo the therapy, but even if only a quarter of them did, the cost to it Medicare (which reimburses 103 percent of the wholesale price of the drugs) would be equal to 23 billions dollars a year. A record figure, if we think that in 2019 Medicare spent a total of 37 billion dollars for drug coverage of the reimbursement group to which it belongs aportanumab. And it could be worse: if a million patients received the treatment, the expense would skyrocket 57 billion of dollars in a year, and would exceed i 100 billion dollars with two million of patients. If the entire population of American Alzheimer’s patients had access to treatment, eventually, the expense would go beyond that 330 billion dollars a year, about half the record budget that the US Department of Defense receives.
None of the scenarios described above – the Kaiser Family Foundation analyzes warn – would be sustainable for the American health system. Not just because it would require a increased Medicare funding (largely entrusted to American taxes), but also because the direct costs for patients, or “out of pocket“, However present, would be around the 11mila dollars year, a good one 40% of the average salary of the beneficiaries of the program.
The scenario in Italy
How would things go with us, in the event of a drug approval by Mom? Patients with Alzheimer in Italy they are about 600mila. Using the same proportion of patients with mild cognitive decline that is seen in the United States, we can speculate about 50mil patients eligible for treatment, a total of nearly three billion dollars annual expenditure in the event that 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, it would still be an absolutely mammoth expense, especially considering that the whole fund for innovative non-cancer drugs is currently equal to 500 million euros nodded.