By Deena Beasley
(Reuters) — Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry's embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
The median annual list price for a new drug was $300,000 in 2023, according to the Reuters analysis of 47 medicines, up from $222,000 a year earlier. In 2021, the median annual price was $180,000 for the 30 drugs first marketed through mid-July, according to a study published in JAMA.
More than half of the new products approved by the Food and Drug Administration in 2023 and 2022 were for orphan diseases, meaning they affect fewer than 200,000 Americans, and some are not expected to become big sellers. The orphan rate is slightly higher than the 49% seen in the previous five years.
A high price is justified for a drug with a lot of value to patients, but «prices are just going up and up without any clear rationale as to why,» said Dan Ollendorf, chief scientific officer at the Institute for Clinical and Economic Review (ICER), an influential group that evaluates the value and prices of medicines.
He said many rare disease and cancer drugs are not being priced relative to their benefit, but the lack of alternatives gives manufacturers negotiating leverage.
Reuters analyzed 55 novel drugs approved by the FDA last year, up from 37 in 2022. The agency's biologic division approved 17 new products, including four gene therapies.
The analysis excludes vaccines and drugs used intermittently such as Pfizer (NYSE:PFE)'s COVID-19 antiviral Paxlovid. It also excludes drugs that have not yet launched commercially.
Of the 47 medications included in the analysis, the highest
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