Humira, Cialis and other drug prices have jumped. Are the increases justified?

• The prices of seven widely used drugs, including arthritis drug Humira and erectile dysfunction medication Cialis, jumped over the past two years, but "had no new important evidence to support their price increases," a new report claims.
• The price hikes for the drugs increased total U.S. drug spending by more than $5.1 billion from 2017 to 2018, according to the analysis.
• Drugmakers dispute the report's findings, with some saying the analysis excluded evidence that supports the medications' benefits.

Drug prices are rising far faster than inflation, causing financial pain for many Americans. Even worse, some of those prices may not be justified by clinical improvements to the drugs themselves, a new report claims. 

A watchdog group says the prices for seven widely used medications — including Humira, Cialis and Lyrica — rose at more than twice the medical consumer price index from the start of 2017 through the end of 2018, yet failed "to support a claim of additional clinical benefit." 

In other words, patients are paying much more money yet may not be getting much more in return, according to the report from the Institute for Clinical and Economic Review, a non-partisan research group. 

Drugmakers dispute the report's findings, saying it excluded important data and failed to assess other issues that can impact drug prices. Nevertheless, the report comes at a sensitive time for drugmakers, with President Donald Trump vowing to take aim at high drug prices.

"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," David Rind, chief medical officer at ICER, said in a statement. "For seven of the nine drugs we reviewed, however, we found that the price increases lacked justification in new evidence."

$5.1 billion in additional spending

The price hikes cost an additional $5.1 billion in spending over the two-year period, according to ICER's analysis. 

The seven drugs that ICER claims have unsupported price hikes are below, with their net price increases in parentheses over the two-year period and the added U.S. spending impact in dollars. The net price increase represents price increases that exclude rebates and other concessions. 

• Humira (15.9%): $1.86 billion
• Rituxan (23.6%): $806 million
• Lyrica (22.2%): $688 million
• Truvada (23.1%): $550 million
  
• Neulasta (13.4%): $489 million
  
• Cialis (32.5%): $403 million
  
• Tecfidera (9.8%): $313 million
  

The analysis found two drugs whose prices had increased yet had "new important positive clinical evidence": Revlimid, a drug for treating multiple myeloma, and Genovya, an HIV medication. However, ICER cautioned that the new evidence didn't necessarily mean the level of price increases were justified, adding that it didn't conduct a full cost-effectiveness assessment on the drugs.

Pfizer, which makes nerve and muscle pain drug Lyrica, said the report "contains certain methodological limitations."

"It does not consider external factors that naturally affect the price of drugs, does not assess the true value the medicine brings to patients over time and does not consider what the appropriate value-based price should be," the company said in a statement to CBS MoneyWatch. 

Pfizer added that pricing is also partially based on the need to fund new research to develop new medications, as well as to "reflect the benefit they bring to patients and society." 

Genentech, the maker of cancer drug Rituxan, said it took issue with the report because it "excludes meaningful, high-quality and peer-reviewed evidence supporting the clinical and economic benefits of Rituxan." It added that its annual average net price increase, when weighted by sales, was approximately 2.5%, which it said is in line with medical inflation. 

Cialis maker Eli Lilly questioned "some of the methodologies and data used in developing this report, and encourage ICER to improve the transparency of its analyses so that others can attempt to reproduce their results," a spokesman said in an email. 

He added that because medicines go off-patent, as in the case of Cialis, drugmakers must price their medications to "reflect both the limited time of patent life when an innovator can receive a fair return for their significant R&D costs, as well as the much longer time a generic is available at a dramatically lower cost."

Truvada manufacturer Gilead said in an email that it "provided real-world evidence and economic evidence which was not considered" in ICER's analysis, adding that it disagreed with the report's assessment that the HIV medication's price increase wasn't supported. 

"Preventive therapies may offer health care systems significant economic savings, which must also be captured in order to have a holistic understanding of a drug's true value," Gilead said.

In:
• Gilead
• Pfizer