BIG PHARMA WATCH: BIG PHARMA SET RECORD FOR OUT-OF-CONTROL LAUNCH PRICES IN 2022 AS MEDIAN PRICE OF NEW TREATMENTS SURGED PAST $220,000

Brand Name Drug Companies Setting Egregious Prices on New Products Not Justified by Clinical Value for Patients

In case you missed it, Reuters released a new analysis that found the median annual price among drugs approved by the U.S. Food and Drug Administration (FDA) in 2022 exceeded $200,000. In the second half of 2022, the median price of the 17 novel drugs approved by the FDA was $193,900, bringing the median annual price among all drugs approved in the year to $222,003.

In August, a Reuters analysis found that Big Pharma was on track for record-breaking launch prices after 13 novel drugs used to treat chronic conditions entered the market in the first half of the year with a record-setting median annual price of $257,000 – significantly higher than the $180,000 mark set over the same period in 2021.

An academic study published in The Journal of the American Medical Association (JAMA) in June 2022, by researchers affiliated with Harvard University and Brigham and Women’s Hospital, found that for 14 years, “from 2008 to 2021, launch prices for new drugs increased by 20 percent per year.”

Examples of Egregious 2022 Launch Prices

In November, pharmaceutical companies CSL Behring and uniQure set 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.

Also in November, Provention Bio set a $193,900 price tag for a course of treatment on the brand name prescription drug Tzield, which was approved by the FDA as a treatment for Type 1 diabetes. According to Reuters, Tzield will launch at a price of $13,850 per vial, with a total of 14 vials needed for a full course of treatment, for a total cost of $193,900. Wall Street analysts expressed shock and concern at the pricing of the brand name drug — which far exceeded expectations.

• 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.” Hoang expected a price in the $70,000-$80,000 range. Pink Sheet reported analysts expected a final price between $100,000 and $115,000.

In October, 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.

Read the full analysis from Reuters, “U.S. new drug price exceeds $200,000 median in 2022,” HERE.

Read more on Big Pharma’s egregious pricing practices in 2022 HERE.

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