ICER Stands by 85% Lower Price for Aduhelm in Revised Evidence Report

Date: July 1, 2021 | Country: UNITED STATES | Region: NORTH AMERICA | 
Type: Breaking NewsCost EffectivenessPricing & Reimbursement | Keywords: #aducanumab #aduhelm #alzheimers 
#biogen #fda #icer #qaly #threshold

PRICENTRIC BRIEF:

  • In its newly revised Evidence Report, the Institute for Clinical and Economic Review (ICER) maintained a health-benefit price benchmark (HBPB) range lower than $10,000 for Aduhelm (aducanumab), despite the company’s already announced $56,000 price tag. In the updated document, ICER finds that the price range needed to reach standard cost-effectiveness thresholds is $3,000-$8,400, representing an 85%-95% discount from Biogen’s announced list price
  • The group determined that at an annual willingness-to-pay threshold of $100,000, Aduhelm would be cost-effective at a price of $2,950 in terms of quality-adjusted life years (QALY), and in terms of equal value of life years gained, $4,260. ICER also noted that for its $150,000 willingness-to-pay threshold, the therapy’s QALYs gained would support a price of $5,110, and $7,090 for evLYG
  • In the report, ICER also calculated what a fair price would be for a hypothetical chronic maintenance therapy that halted the progression of dementia in people with Alzheimer’s disease. While this hypothetical treatment could be priced between $50,000-$70,000 per year and still meet commonly cited thresholds for long-term cost-effectiveness, according to the group, Aduhelm is not close to being this effective

THE DETAILS

WASHINGTON D.C., United States – In its newly revised Evidence Report, the Institute for Clinical and Economic Review (ICER) maintained a health-benefit price benchmark (HBPB) range lower than $10,000 for Aduhelm (aducanumab), despite the company’s already announced $56,000 price tag.

The Evidence Report assessed the comparative clinical effectiveness and value of aducanumab (Aduhelm) for the treatment of Alzheimers disease, following the U.S. Food and Drug Administration’s (FDA) approval of the drug under its Accelerated Approval pathway at the beginning of June.

In the updated document, ICER finds that the price range needed to reach standard cost-effectiveness thresholds is $3,000-$8,400, representing an 85%-95% discount from Biogen’s announced list price.

The group determined that at an annual willingness-to-pay threshold of $100,000, Aduhelm would be cost-effective at a price of $2,950 in terms of quality-adjusted life years (QALY), and in terms of equal value of life years gained, $4,260. ICER also noted that for its $150,000 willingness-to-pay threshold, the therapy’s QALYs gained would support a price of $5,110, and $7,090 for evLYG.

The draft report was initially open for a four-week public comment period. The updated version reflects changes made based on the breadth of the FDA label, the treatment’s announced price, and comments received from the manufacturer, patient groups, clinicians, and other stakeholders, according to ICER.

Now, key stakeholders — including Biogen, the Alzheimer’s Association, and a former FDA and CMS chief — will discuss the mismatch between the announced price and value-based estimates at a meeting on July 15.

The discussions will also include coverage options for Medicare and private payers, potential research designs for the required confirmatory trial of aducanumab, and the impact of the approval of aducanumab on the future development of treatments for Alzheimer’s disease.

“Individuals and families dread Alzheimer’s disease, and the first therapy that effectively halts or reverses dementia will warrant a very high price in the US health system,” said David Rind, MD, ICER’s Chief Medical Officer.

He added, “Many other drugs have been shown to remove amyloid from the brain yet failed to improve the lives of those with Alzheimer’s disease; none of these other treatments received FDA approval. After months of delving into the data, and working with patient groups, clinical experts, and the manufacturer to gain their perspectives, our judgment remains that the evidence on aducanumab is insufficient to be able to demonstrate that patients get benefits that would outweigh the risks and harms of this treatment.”

In the report, ICER also calculated what a fair price would be for a hypothetical chronic maintenance therapy that halted the progression of dementia in people with Alzheimer’s disease. While this hypothetical treatment could be priced between $50,000-$70,000 per year and still meet commonly cited thresholds for long-term cost-effectiveness, according to the group, Aduhelm is not close to being this effective.

Draft Report

On May 7, ICER published a Draft Evidence Report on the comparative clinical effectiveness and value of Aduhelm for Alzheimer’s Disease, rating the drug’s evidence as being “insufficient” to demonstrate a net health benefit for patients.

Using the combined results from two contradictory Phase 3 randomized trials for a base-case cost-effectiveness analysis, ICER concluded there was a small overall health gain commensurate with value-based prices at traditional cost-effectiveness thresholds.

The group determined that at an annual willingness-to-pay threshold of $100,000, Aduhelm would be cost-effective at a price of $2,560 in terms of quality-adjusted life years (QALY), and in terms of equal value of life years gained, $3,960. ICER also noted that for its $150,000 willingness-to-pay threshold, the therapy’s QALYs gained would support a price of $4,850, and $6,940 for evLYG.

When adjusted in terms of societal perspective, ICER’s annual $100,000 willingness-to-pay threshold was $5,080 when taking evLYG into consideration and $8,290 when considering the $150,000 willingness-to-pay threshold.

EVERSANA Here to Help

In research conducted by Health Strategies Insights by EVERSANA in 2020, payers reported very low interest and feasibility in pursuing value-based agreement for Alzheimer’s disease therapies, so the proposed payment agreements mark a dramatic turn of events for this market.

With Aduhelm’s entry into the Alzheimer’s disease market, how do current brands need to reposition and reaffirm their value proposition to payers and prescribers? Will current and future brands launching into the market be expected to compete aggressively on price or contracting arrangements?

Learn the answers to these questions and many more through Health Strategies by EVERSANA. Reach out to hsiclientservices@eversana.com to discuss further.

EVERSANA™ is the leading independent provider of global services to the life science industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science services for a healthier world. To learn more about EVERSANA, visit eversana.com.

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