The Institute for Clinical and Economic Review's price range is far below the $50,000 per year envisioned by some market analysts.
Aducanumab, Biogen’s experimental Alzheimer’s drug, should be priced at between $2,560 to $8,290 a year under standard cost-effectiveness assumptions, according to an announcement today by Institute for Clinical and Economic Review (ICER), the drug pricing think tank in Boston.
That’s far below the price of $50,000 that many analysts are using.
In a scenario favored by Biogen that narrows the analysis to results of the phase 3 trial favorable to aducanumab, ICER says the drug’s cost effectiveness would justify a price between $11,100 and $23,100
The FDA is expected to decide on whether to approve aducanumab next month. After Biogen reversed course and decided to pursue FDA approval for aducanumab, an advisory panel of outside experts cast votes in November 2020 that were tantamount to a vote against approval.
In its main analysis, ICER combined the results of the two critical phase 3 trials of aducanumab, the EMERGE, and ENGAGE trials, to arrive at the $2,560-$8,290 price range if cost-effectiveness criteria were to govern the drug’s price.
Drugmakers set their own prices, but ICER’s assessments have become influential because insurers use them to negotiate price discounts and placement on formularies
Biogen has argued that the ENGAGE trial results should be disregarded and that aducanumab’s effectiveness should be judged by the results from EMERGE trial because, after the trials’ protocols were changed, the EMERGE trial included a greater number of study subjects treated with a higher dose of aducanumab.
The company also says that ENGAGE trial included a greater number of “fast progressors” that offset the positive effects of aducanumab.
Critics and members of the advisory panel have poked holes in the company’s analysis and say it is using a faulty, after-the-fact statistical analysis in hopes of winning an FDA approval.
ICER’s reviewers didn’t entirely eject Biogen’s argument in favor of using only the EMERGE results but it didn’t accept it either. In the end, it rated the evidence for aducanumab’s benefits outweighing its harm as “insufficient.”
“We believe it is possible that ENGAGE and EMERGE found different results because of the explanations put forward by the manufacturer related to rapid progressors and exposure to full-dose therapy; however, other explanations are equally or more likely,” says the executive summary of today’s draft evidence report.
The low-end of price of $2,560 is based on the gain of a quality-adjusted life year being valued at $100,000 and the high-end price of $8,290 is based years of life gained without the quality aspects to which some critics of QALY-based cost-effectiveness object. The higher number also factors in a broader societal perspective to the drug’s benefit.