Weekly View

September 30, 2022

Good morning, everyone.

Yesterday, the FDA approved Relyvrio, Amylyx Pharma’s therapy for amyotrophic lateral sclerosis (ALS). According to ICER’s analysis, the therapy would only achieve traditional thresholds of cost-effectiveness if priced between $9,100 to $30,700 per year.

We also recommended that manufacturers should seek to set prices of new medications that will foster affordability and access for all patients by aligning prices with the patient-centered therapeutic value of their treatments, and not based on the price of existing ALS medications. This is especially important for ALS since new drugs are anticipated to be used in combination with other very expensive drugs, creating the highest risk for financial toxicity due to health care costs.

Let’s see what else happened this week...

ICER in the News

ALS drug wins FDA approval despite questionable data

The Associated Press

FDA approves controversial new drug designed to slow the progress of ALS

NBC News

Cambridge biotech wins approval for much-debated ALS drug

The Boston Globe

Medicare Price ‘Negotiation’ Process Could Enable National Value Framework – CMS’ Blum

Pink Sheet

The Medicare drug price negotiation program established by the Inflation Reduction Act could help move the US toward a framework for determining drug value and how much to pay for it, according to Centers for Medicare and Medicaid Services principal deputy administrator and chief operating officer Jonathan Blum.

ICER’s President Steve Pearson, MD, MSc was also quoted from a recent interview with Pink Sheet:

“Creation of the rules around how CMS will set prices will be challenging because the biopharma industry is poised for court challenges to block progress, [said] Institute for Clinical and Economic Review president Steve Pearson... ‘You could assume that might mean they will write their regulations in as algorithmic an approach as possible so it can’t look like they are factoring in things kind of helter-skelter’ and draw accusations of being arbitrary and capricious, he suggested.


‘On the other hand, everybody wants some nuance here, even in the things that are in the statute, like ‘unmet need,’ Pearson continued. ‘No one knows the dollar numbers you would put on’ how a drug fills an unmet need ‘but that would push you toward a higher price. So if we want nuance, then the tradeoff might, in some people’s minds, create a higher risk for lawsuits to find some success.’”

Pharmaceutical News


Medicare lays out the bureaucracy it will need to negotiate drug prices


New documents obtained by STAT outline how Medicare is planning to build out a sizable new bureaucratic infrastructure to handle its new power to negotiate drug prices and penalize drugmakers for price hikes. In materials sent to lawmakers earlier this month, CMS proposes establishing a Medicare Drug Rebate and Negotiations Group with six divisions:

  • Division of Rebate Agreements & Drug Price Negotiations
  • Division of Policy
  • Division of Data Assessment and Analytics
  • Division of Manufacturer Data and Inflation Rebate Operations
  • Division of Manufacturer Compliance and Oversight
  • Division of Contract Support

The proposal includes hiring 95 full-time employees, according to the organizational chart CMS provided. The roles include analysts, contracting officers, pharmacists, data managers, and economists.

Millions of Americans will save on Medicare fees next year

The Associated Press

For the first time in a decade, Americans will pay less next year on monthly premiums for Medicare’s Part B plan, which covers routine doctors’ visits and other outpatient care. The 2023 decrease in monthly Medicare premiums comes after millions of beneficiaries endured a tough year of high inflation and a dramatic increase to premiums this year. Most people on Medicare will pay $164.90 a month for Part B coverage starting next year, a savings of $5.20.

The decrease helps to offset last year’s $21.60 spike, which was driven in large part by a new Alzheimer’s drug, Aduhelm, administered intravenously in doctors’ offices and introduced to the market last year with a $56,000 price tag. Medicare set strict limitations on the drug’s use earlier this year and the drugmaker Biogen has since cut the medication’s cost in half.

Health insurers are painting a misleading picture of Medicare Advantage savings, experts say


The health insurance industry is continuing its campaign to convince the public that Medicare Advantage saves taxpayers money, but experts say federal data still concludes the exact opposite — and that the program as currently designed is a drain on Medicare’s trust fund.

Multimillion-dollar gene therapies offer hope and huge cost concerns


The era of multimillion-dollar gene therapies has arrived, providing a ray of hope to patients with debilitating diseases — but also presenting huge affordability challenges. Though the expected number of patients who'll likely receive the treatments is relatively low, it's unclear how small employers, state Medicaid programs, and the rest of the health system will absorb such large costs all at once.

Importantly, ICER developed a set of methodology adaptations that we apply when assessing potential cures and other treatments that qualify as high-impact “single or short-term therapies,” or SSTs. 

Employer Benefit Seen From New Medicare Drug Price Law


Employers could reap some of the benefits of the drug pricing provisions in the Inflation Reduction Act, despite fears costs might be shifted to the private market, analysts say. Despite calls by employer groups to allow commercial plans, such as those sponsored by employers, to benefit from the law’s provisions, Congress ended up shelving those provisions in order to get the bill through the Senate.

Employers may benefit anyway because lower prices to Medicare could mean lower prices in the commercial market. In addition, drug manufacturers will have some incentive to keep increases in the commercial market lower to avoid paying rebates to Medicare.

Experimental Alzheimer's drug shows benefits in phase 3 trial, company says

NBC News

The Japanese drugmaker Eisai said Tuesday its experimental drug for Alzheimer’s disease, lecanemab, helped slow cognitive decline in patients in the early stages of the illness. The company said that in a phase 3 clinical trial, the drug slowed cognitive decline by 27% after 18 months. The results were announced in a news release and have not yet been peer-reviewed.

ICER is currently reviewing lecanemab as a part of our Alzheimer's disease assessment. Our Draft Evidence Report will be published on December 22nd. 

 White House pitches drug pricing reforms as a way to extend cancer patients’ lives


The White House is pitching an added benefit to Democrats’ recent drug pricing reform package: lower cancer death rates. A new analysis by the Council of Economic Advisers focused on the new law capping Medicare patients’ out-of-pocket costs for pharmacy drugs at $2,000 per year, starting in 2025. Over 449,000 current Medicare enrollees with a prior cancer diagnosis would save an average of nearly $1,600 per year on prescription drugs because of the out-of-pocket cap. Right now, there’s no limit on patients’ out-of-pocket costs. 

The White House is framing the law as a boon to President Biden’s Cancer Moonshot, which aims to reduce the death rate from cancer by at least 50% over the next 25 years.


Join ICER!

Want to work for a fast-paced, mission-driven organization? Look no further! ICER is looking to expand our team, which includes a diverse set of clinicians, researchers, and policy experts.

Research and Health Economics

Program and Operations

Key Upcoming Dates
  • 10/11: Menopause Draft Evidence Report

  • 10/17: Multiple Sclerosis Draft Evidence Report

  • 10/20: Obesity Management Final Evidence Report

  • 10/20: Final Report -- Unsupported Price Increases Occurring in 2020 in California

When you make a gift to ICER, you help keep ICER independent.  
LinkedIn Share This Email