Nov 30, 2022

Hemgenix Pricing Reflects Escalating Big Pharma Trend of Setting Higher and More Out-of-Control Launch Prices on New Products

Washington, D.C. – The Campaign for Sustainable Rx Pricing (CSRxP) released a statement today in response to pharmaceutical companies CSL Behring and uniQure setting a $3.5 million price tag on their hemophilia drug Hemgenix, which was recently approved by the U.S. Food and Drug Administration (FDA) as a treatment for adults with Hemophilia B. The pricing of the drug makes it the most expensive drug in the world and is more than $600,000 higher than what the Institute for Clinical and Economic Review (ICER) estimated for the upper limits of a fair price.

“CSRxP welcomes breakthroughs for serious conditions like hemophilia but new treatments must be priced fairly to be accessible to patients and sustainable for the U.S. health care system,” said CSRxP executive director Lauren Aronson. “The $3.5 million price tag for Hemgenix is just the latest example in an escalating Big Pharma trend of setting out-of-control launch prices on new products that policymakers must address.”

The pricing of Hemgenix follows a trend of Big Pharma companies setting increasingly out-of-control launch prices on new products.

Big Pharma’s Increasingly Out-of-Control Launch Prices

In August, a Reuters analysis found Big Pharma’s launch prices on new medications are on pace for record highs in 2022 – with the median annual price of the new treatment costing $257,000.

In June, an academic study published in The Journal of the American Medical Association (JAMA) from researchers affiliated with Harvard University and Brigham and Women’s Hospital found Big Pharma companies hiked launch prices by 20 percent every year for 14 years — and that nearly half of all brand name prescription drugs now cost more than $150,000 per year when they are brought to market.

Recent Examples of Big Pharma’s Egregious Launch Prices

In November, Provention Bio set a $193,900 price tag for a course of treatment with the brand name prescription drug Tzield, which was approved by the U.S. Food and Drug Administration (FDA) as a treatment for Type 1 diabetes. Even Wall Street analysts expressed shock and concern at the pricing of the brand name drug.

  • Gregory Renza, an analyst at RBC Capital Markets, said “This (price) is much higher than perhaps what the Street was expecting.”
  • David Hoang, an analyst at SMBC Nikko Securities, said “Investors will have some level of concern that this pricing could lead to insurance hurdles.”

In October 2022, brand name drug maker Amylyx set a list price of $158,000 annually on the company’s new and unproven treatment for amyotrophic lateral sclerosis (ALS), Relyvrio, following FDA approval. The FDA’s approval came even though the drug has only completed Phase II trials, while most FDA-approved drugs typically require Phase III trials. Amylyx’s $158,000 price tag for Relyvrio was between five and 17 times what experts estimated would be a fair price for the treatment that lacks clear evidence on its clinical value for patients.

Learn more about market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.