SUMMARY: Sometimes there are just no words to express my outrage. Here is the executive summary of the Government’s report on AbbVie. I’m disgusted, sad, and angry. Mostly I’m angry because this reflects badly on all the good people within our industry who are trying to do great work and help people. Here is the executive summary from the report.
Humira, a drug used to treat rheumatoid arthritis and other autoimmune diseases, is the highest grossing drug in the world. In 2020 alone, AbbVie collected $16 billion in U.S. net revenue for Humira. Today, AbbVie charges approximately $77,000 for a year’s supply of Humira—470% more than when the drug was launched in 2003.
The Committee’s investigation uncovered the following key findings:
- Uninhibited Price Increases: Since launching Humira in 2003, AbbVie (and its predecessor company Abbott Laboratories) have raised the drug’s price 27 times, including by nearly 30% in one 10-month period. A 40-milligram syringe of Humira is now priced at $2,984, or $77,586 annually—a 470% increase from the drug’s launch. AbbVie has also raised the price of Imbruvica by 82% since launching the drug in 2013. Today, Imbruvica is priced at $181,529 per year for a patient taking three pills per day, compared to $99,776 per year at launch.
- Price Increases Not Justified by Rebates: Internal data show that AbbVie’s list price increases for Humira and Imbruvica far outpaced any discounts and rebates paid to pharmacy benefit managers and other members of the supply chain. Humira’s net price—which subtracts discounts and rebates—increased by 110% between 2009 and 2018, from $16,663 per year to $35,041 per year. For a patient taking 3 tablets daily, the annual net price of Imbruvica increased from $72,587 in 2013 to $115,533 in 2017 (the last year for which AbbVie provided the Committee data).
- Record Corporate Revenue Driven by Price Increases: Since 2003, AbbVie has collected over $107 billion in U.S. net revenue from Humira. AbbVie’s yearly U.S. net revenue from Humira more than tripled from $5.3 billion in 2013—the year it separated from Abbott—to $16.1 billion in 2020. Due in large part to AbbVie’s price increases, Humira is the highest-grossing drug in the United States. U.S. net revenue for Imbruvica has increased from $492 million in 2014 to $4.3 billion in 2020. AbbVie’s U.S. net revenue for both drugs has increased every year since the drugs entered the market.
- Hundreds of Millions in Executive Compensation and Bonuses: Since separating from Abbott in 2013, AbbVie has paid its highest-ranking executives over $480 million in compensation. AbbVie’s CEO Richard Gonzalez alone was paid nearly $170 million over that period. AbbVie’s internal documents show that from 2015 to 2018, senior executive bonuses were tied directly to Humira’s net revenue, allowing them to profit from AbbVie’s price increases. The first year this net revenue incentive was added to the calculation coincided with the highest period of price increases in Humira’s history— over 30% in a 10-month period.
- Lack of Medicare Negotiation Costing Taxpayers Billions: U.S. law prohibits Medicare from negotiating directly with drug companies to lower prices. According to AbbVie’s internal data, the company collected nearly $10 billion in Humira net revenue from Medicare Part D between 2010 and 2018. If Medicare had received the same discounts during that period as the Department of Defense—which is permitted to negotiate directly for lower prices—taxpayers would have saved $7.4 billion. Similarly, if Medicare had received the same discounts during that period as the Department of Veterans Affairs, taxpayers would have saved $7 billion. AbbVie also collected $4.7 billion in Imbruvica net revenue from Medicare Part D between 2014 and 2018. If Medicare had received the same discounts as the Department of Defense and Department of Veterans Affairs, taxpayers would have saved $1.6 billion.
- Exploitation of the U.S. Patent System to Extend Humira and Imbruvica Monopolies: Internal company documents show that AbbVie views the U.S. patent system as far more protective of its pricing monopoly than patent systems in the rest of the world. AbbVie has obtained or applied for over 250 patents on Humira to block competition from lower-priced biosimilars. The last of these patents is set to expire in 2037. Approximately 90% of AbbVie’s patent applications were filed after Humira was already approved and brought to market, suggesting that they were intended to block competition and protect revenue rather than necessary to incentivize the company’s development of the drug. AbbVie’s CEO has publicly acknowledged the company’s strategy of overwhelming competitors by filing hundreds of patents on Humira, regardless of whether they are valid under U.S. law.
- Abuse of the Orphan Drug Act: AbbVie protected its Humira monopoly by abusing the Orphan Drug Act (ODA), a law that incentivizes the development of drugs that treat rare diseases and conditions. Contrary to the stated purpose of the ODA, AbbVie sought orphan drug protections for Humira even though it was a blockbuster drug with billions of dollars in sales each year. Today, AbbVie holds eight orphan designations and approvals for Humira. AbbVie also secured longer market exclusivity periods under the ODA by seeking separate, staggered market approvals and exclusivity periods for different age groups of patients affected by the same rare disease.
- Shadow Pricing with Amgen: AbbVie’s largest competitor for Humira is Enbrel, Amgen’s blockbuster biologic treatment for rheumatoid arthritis and other conditions. Instead of pricing Humira and Enbrel below one another to gain market share—as expected in a competitive market—AbbVie and Amgen engaged in a practice known as “shadow pricing,” consistently following the other company’s price increases. As a result, both companies repeatedly raised the price of Humira and Enbrel by nearly identical amounts. The graph below shows AbbVie’s and Amgen’s pricing for Humira and Enbrel from 2003 to 2021.
- Profit-Driven Research Expenditures: In response to the Committee’s request, AbbVie identified a total of $5.19 billion in “Humira Research & Development” expenditures between 2009 and 2018—approximately 4.2% of the company’s Humira worldwide net revenue over that period.