Peter Wehrwein

 to restrict Medicare coverage of Aduhelm (aducanumab) to people enrolled in approved clinical trials would likely lead to fewer Alzheimer’s patients taking the drug and reduced Medicare expenditures.

Even so, the cost burden of Aduhelm worries payers. The discussion of the drug's cost has been almost exclusively on the price of the drug itself, which Biogen slashed in half late last year, from $56,000 to $28,200, in a bid to make the drug more palatable to payers. In November 2021, before Biogen announced the price cut, CMS announced a 14.5% increase in 2022 Medicare Part B premiums that was attributed, in part, to the added cost of covering Aduhelm.

., of UCLA argue in a research published in 

 yesterday that Aduhelm will result in spending on PET and MRI scans and other “ancillary” services beyond the cost of the drug itself. In their calculations, the cost of those ancillary services would  comprise 20% of the total estimated Medicare Part B spending associated with Aduhelm.

Prior to the CMS proposal that might restrict coverage to those enrolled in sanctioned clinical trials, Mafi and his colleagues calculated that 1.1 million people might be eligible for Part B coverage of Aduhelm in a “lower bound” estimate that assumes prescribers would stick to the criteria used in clinical trial. Their “upper bound” estimate of eligibility was 5.7 million people.  

Based on those estimates and a projection that just 25% of those eligible would receive Aduhelm, the researchers estimated that Medicare spending on Aduhelm could range from $7 billion per year, $1.4 billion of which would be for ancillary services, up to $37.4 billion, $7.5 billion would be for ancillary services.

Some of the ancillary services included in these calculations are PET scans ($2,300 per year per patient on average, counting  patient coinsurance), routine MRIs ($555), APO E serum testing ($100 per patient), and hospitalization for adverse events ($294). 

One of the important predicates for these calculations is that a large percentage (41% of those on the highest dose) of the patients in the pivotal clinical trials of Aduhelm developed 

 (ARIA) that are characterized by fluid retention and microhemorrhages in the brain. The ARIAs weren’t necessarily serious or symptomatic, but they would likely to mean additional MRI scans and visits with neurologists and, therefore, added expense.

Articles

In a research letter published in JAMA Health Forum, researchers say most of the cost figures for Aduhelm have left out the additional MRI scans and other services that will be required because the drug is associated with the development of amyloid-related imaging abnormalities (ARIAs).

Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm

A final evidence report is scheduled to come out on Aug. 15

When the FDA approved Biogen’s controversial Alzheimer’s drug, Aduhelm (aducanumab), in June 2021, the Institute for Clinical and Economic Review (ICER) joined the chorus of criticism.

 that said that the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms.” Two months later, ICER came out with a pricing report that said the drug should be priced between $2,500 and $8,300 per year, which was far below the initial price of about $56,000 a year. Biogen announced in December that it was halving the price.


This year, ICER has Aduhelm in its sights again although this time the organization is comparing it with two other monoclonal antibodies that target the clumps of beta amyloid in the brain that many experts believe are the main cause of Alzheimer’s.

The two other monoclonal antibodies included in ICER’s review are Eli Lilly’s donanemab and Eisai's lecanemab. The companies submitted applications for FDA approval of both agents late last year, and the regulatory agency is scheduled to make a decision on whether to approve them this year.

 on its website, ICER is accepting public comments on its scoping document for the three-drug review through Jan. 19. A draft evidence report is scheduled to come out May 10 andon August 15.

ICER's analysis is slated to include two as-yet unapproved monoclonal antibody treatments, donanemab and lecanemab, as well as Aduhelm (aducanumab).

ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's  in 2022

FDA Approves Generic of Chantix, Pfizer's Smoking Cessation Drug

This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.

Apotex to Import Generic of Chantix from Canada

This is being done in coordination with the FDA to address the shortage created by the recall of Chantix. 

Express Scripts Releases List of 2022 Formulary Exclusions

Four products on the preferred list this year will be excluded next year.

Nonopioid Pain Therapeutic Achieves More Than 100 Formulary Approvals

Anjeso, a COX-2 inhibito, is a faster-acting injectable formulation of meloxicam. As amnm alternative to opiods, it reduces opioid use after surgery.

Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin.

Apotex's importation of Chantix (varenicline) and Express Scripts' formulary exclusions were among the best read articles this year that didn't concern COVID-19.

Peter Wehrwein

Articles

Researchers: Ancillary Services Would Comprise 20% of Medicare Spending on Aduhelm

ICER To Assess Aduhelm, Other Monoclonal Antibody Treatments for Alzheimer's in 2022

Best Read Articles on News Not Related to COVID-19 in 2021