AbbVie’s blockbuster arthritis drug Humira® (adalimumab) took the number one spot on a list of seven drugs collectively responsible for a $5.1 billion jump in U.S. medical spending, despite the fact that no new research or evidence over the past three years has supported these increased prices, according to a new report.
The net change in the price of Humira increased by 15.9%, which equated to a $1.857 billion increase in spending. Humira’s 2018 sales revenue also largely outpaced that of other drugs at $13.685 billion—a 19.1% eight quarter wholesale acquisition cost (WAC) change. 2018 sales revenue for the second drug on the list, Revlimid®, was $6.469 billion.
The “Unsupported Price Increase Report” was published by the Institute for Clinical and Economic Review (ICER) on Oct. 8.
“The norm in the United States has been for most pharmaceutical manufacturers to increase prices year after year—even accounting for the discounts they give insurers, and even for drugs that already sit at the top of the chart of spending for drugs in the US,” said David Rind, MD, chief medical officer of ICER, in a press release. “The goal of ICER’s new [Unsupported Price Increase] report is to provide the public and policymakers an explicit and independent approach to determine whether price increases could potentially be supported by new clinical evidence. If new evidence emerges that shows a treatment may be more beneficial than what was previously understood, perhaps that new evidence could warrant some level of price increase. For seven of the nine drugs we reviewed, however, we found that the price increases lacked justification in new evidence.”
Humira: Price Hikes Not Supported by Clinical Evidence
Humira garnered Food and Drug Administration (FDA) approval in 2002 and is indicated for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis, juvenile idiopathic arthritis, adult and pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, adult and adolescent hidradenitis suppurativa, and adult and pediatric noninfectious uveitis. According to ICER’s report, the treatment indications that constitute more than 10% of the drug’s use are RA, PsA, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
For the ICER report, all data spanning Jan. 1, 2016, and Dec. 31, 2018, on the safety and clinical effectiveness of Humira were taken into consideration. This included 204 references (160 conference presentations and 44 published manuscripts) provided by the manufacturer; ICER did not conduct an additional search for evidence.
“However, none [of the submitted references] met our inclusion criteria of new information on benefits and/or harms within the indications that account for greater than 10% of use,” according to the report. The reasons why the studies were not eligible for inclusion were, according to ICER (some studies met more than one criteria but were grouped into one category):
- Study design does not meet our criteria for assessing efficacy (e.g., single arm study) (n = 76)
- Intervention/comparison outside our scope (TNF inhibitors vs. non-TNF inhibitors) (n = 62)
- Previously known information about adalimumab (e.g., efficacy of adalimumab vs. placebo in plaque psoriasis) (n = 28)
- Outcomes not relevant to our scope (e.g., cost-effectiveness analysis) (n = 25)
- Adalimumab in all comparison arms (n = 6)
- Abstract – limited information on study design (n = 5)
- Indication accounts for less than 10% of use (e.g., nail psoriasis) (n = 2)
The third drug on the list of those who contributed to the significant increase in medical spending was Lyrica® (pregabalin), which treats pain caused by fibromyalgia.