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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.
The pharmaceutical industry has been under scrutiny recently for raising the cost of drugs extraordinary amounts. Turing and Valeant, who hiked the prices of older drugs that lacked generic competition, are perhaps the most notable examples. But a new report from Reuters indicates that while Turing and Valeant may be outliers, they are far from the only US pharmaceutical companies that have considerably raised prices over the past five years.
The Reuters’ report released on April 5, 2016 reviewed the nation’s top 10 most widely used drugs and found that four of the top 10 drug’s prices increased 100% since 2011, while the other six increased 60%. Overall sales of the top 10 drugs went up 44% to $54 billion in 2014 from 2011, Reuters reported, while prescriptions for the medicines fell 22%. Steve Miller, chief medical officer of Express Scripts, told Reuters he thinks the level of drug price increases are “not sustainable.”
Drug price increases
Humira (adalimumab), AbbVie’s blockbuster rheumatoid arthritis drug, surged more than 126%, Reuters found. According to the report, Humira was the most widely used drug in the US in 2014. In November 2015, AbbVie CEO Richard Gonzalez, said the company has 70 patents protecting the drug from biosimilar competitors and doesn’t expect any biosimilars for the drug to reach market until 2022.
Amgen, the maker of ABP 501, the first biosimilar submitted to FDA for Humira, challenged multiple claims on Humira’s ‘157 formulation patent. The US Patent and Trademark Office denied Amgen’s petition to review the patents in January 2016. While this may be a setback for the biosimilar maker, the company said they hope to have their first biosimilar on the market between 2017 and 2019. It is still unclear how the approval of a Humira biosimilar may affect the drugs price.
Also included in the Reuters report is Enbrel (etanercept), marketed by Amgen and Teva in the US, with a price increase of 118%. A spokesperson for Amgen told Reuters, “after most discounts, the average sales price for a dose of Enbrel is at least $200 less than list.” It is important to note, Eli Lilly’s Taltz (ixekzumab), which was recently approved by FDA at the end of March 2016, is expected to be a direct competitor to Enbrel.
Reuters found Johnson & Johnson’s drug Remicade (infliximab) price increased 63%. Caroline Pavis, a spokesperson for the company, told the news organization “average selling price increases were closer to 5.4% per year.” Celltrion and Pfizer’s Inflectra, an infliximab biosimilar, was approved on April 6, 2016 for all of Remicade’s indications except for pediatric ulcerative colitis. Jay Siegel, MD, chief biotechnology officer at Johnson & Johnson, said the company plans to protect its patents for Remicade, which are enforceable until September 2018.
In March 2016, FDA said that it would prioritize approval of generic drugs. By prioritizing generic approval, FDA hopes to increase market competition, and decrease drug prices. It is still to be determined how the approval of biosimilars may affect the prices of biologic drugs like Remicade, Enbrel, and Humira.
Peter Bach, an oncologist at Memorial Sloan Kettering Cancer Center, told Reuters he estimates Enbrel added up to approximately $1 billion in care costs. Amgen spokesperson Kristen Davis told Reuters it would be “impossible to infer revenue growth from list price increases because of other factors, including rebates and discounts.”
Like Davis, several companies said Reuters’ analysis “failed to capture negotiated discounts and rebates.” Drug companies told Reuters they set prices in order to recoup investments in failed drugs, support R&D efforts, and to pay for clinical trials. In the report, Reuters said they shared findings with the eight companies that sold the top 10 drugs. None of the eight companies disputed findings in the report.