Aduhelm, the recently approved medicine to treat Alzheimer’s disease, could single-handedly account for 1% of all healthcare spending by next year. The Food and Drug Administration okayed the controversial drug on June 7 to treat Alzheimer’s disease, which affects in the six million patients in the U.S.

According to Axios, Aduhelm is manufactured by Biogen and administered by an intravenous solution at an annual cost of $56,000 per patient. Critics questioned the wisdom of approving this drug not only for its exorbitant cost but also for its limited efficacy, according to an analysis by Altarum, a non-profit research and consulting healthcare organization.

Americans already have the highest cost of healthcare than any other country, says Axios, and this new drug which has not even been shown to halt the progression of Alzheimer’s, let alone cure the disease, will cause a sustained growth in medical spending.

Altarum researchers forecast that Aduhelm will raise total spending on prescription drugs by 8% in the next few years. The cost of prescription drugs also ballooned, by 12% in 2014, when Gilead Sciences put its expensive hepatitis C drugs, Sovaldi and Harvoni, on the market. But the difference is that the hepatitis drugs cure most people after one round of treatment, which would not be the case with the novel Alzheimer’s medication.

Axios points out that the cost analysis does not include additional expenditures on MRIs, PET scans, facility fees and other procedures associated with treatment with the IV drug.

According to The Atlantic, this is the drug “that could break American health care.” Aduhelm’s approval could trigger hundreds of billions in new government spending, without a vote in Congress or any public input on the drug’s effectiveness. Experts say that there is limited evidence it works and can cause serious side effects, proclaiming that could do more harm than good.

Since most of the people with Alzheimer’s disease are eligible for Medicare, even if one-third of the six million Americans suffering from Alzheimer’s disease receive this treatment, it would cost the federal government a whopping $112 billion annually. And because the drug is given by infusion, its delivery is not covered by Medicare Part D, so beneficiaries will have to pay 20% of the costs out of pocket which would amount to at least $11,200 per treatment, according to The Atlantic.

Dr. Sam Gandy, a professor of Alzheimer’s research at the Icahn School of Medicine at Mount Sinai in New York, said he was shocked when the FDA ignored the advice of its neurological drugs advisory panel and approved the Biogen drug.

In an opinion article he wrote for STAT News, the neurologist said approving Aduhelm  was a mistake and added that three members of the FDA advisory committee resigned in protest over the decision to give the drug a much broader use than its original purpose.

He added that approving Aduhelm may block the path for more promising Alzheimer’s drugs, like the inexpensive oral drug galantamine that is being studied extensively in Sweden.

“In a study of thousands of people over many years, these researchers observed that people with Alzheimer’s dementia who took galantamine virtually never declined past moderate-stage dementia. Almost no one taking the drug developed end-stage dementia,” wrote Gandy.

The expert added that past trials of other drugs that, like Aduhelm, reduce the amount of amyloid plaque in the brain, have not shown this mechanism is an effective tool to slow down the progression of disease. Gandy also addressed the question of cost.

“I must ask my patients to be sure to bring their credit cards or check books when they arrive for their appointments, because prepayment out of pocket is the current standard,” for administering Aduhelm, he said.

Gandy concluded that the FDA approval of Aduhelm raises more questions and creates more problems than any new drug approval should.  “This drug is not the ‘new day’ in the fight against Alzheimer’s disease and needs to be approached cautiously, if at all,” he said.