口袋女优

Launch prices of cancer drugs over the last decade were substantially higher in the U.S. than in similar, high-income European countries, and the gap only increased in the years after approval, according to an economic analysis.

From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S., as compared to $8,305 in Germany, $6,955 in Switzerland, and $7,355 in England, reported Kerstin N. Vokinger, MD, JD, PhD, of the University of Zurich, and colleagues.

And, as described in , prices were not necessarily associated with clinical benefits in any of the surveyed countries.

"The findings of this study suggest that although the U.S. would need to take the most substantial steps to address the high costs of cancer drugs, Europe could also reexamine their pricing regulations to ensure better alignment with the clinical value," the group wrote.

"The two key takeaways from this study are that drug prices are rising faster in the U.S. than in Europe, and that regardless of geography, drug prices do not reflect clinical benefit," Syed Yousuf Zafar, MD, of the Margolis Center for Health Policy at Duke University in Durham, North Carolina, told 口袋女优.

"This second point must not be lost," said Zafar, who was not involved in the study. "In light of the recent uproar around the Alzheimer's drug aducanumab [Aduhelm], we must not forget that anti-cancer drugs are approved with price tags 10 times higher, yet with only incremental additional benefit."

Vokinger's team identified 65 new drugs approved by the FDA between Jan. 1, 2009, and Dec. 31, 2019, with initial indications for adult solid tumor and hematologic cancers. They included for analysis cancer drugs approved by the European Medicines Agency (EMA) and Swissmedic by Dec. 31, 2019 for the same indications as in the U.S.

Researchers extracted launch prices and annual price changes for those drugs in the U.S., England, Germany, and Switzerland. To assess the clinical benefit of these cancer drugs, they applied two value frameworks at product launch, and at the end of the study period, to the pivotal clinical trials supporting regulatory approval:

• European Society for Medical Oncology's Magnitude of Clinical Benefit Scale () v1.1
• American Society of Clinical Oncology's (ASCO)-Value Framework v2.0 ()

Lowest monthly treatment costs at launch were higher in all three European countries by the end versus the start of the study period (2018-2019 vs 2009-2010, respectively), and substantially so in the U.S.:

• Germany: $5,888 vs $4,289
• Switzerland: $6,593 vs $5,784
• England: $6,867 vs $3,939
• U.S.: $14,580 vs $5,790

During the study, 74% of the cancer drugs had unit price increases in the U.S. that were greater than inflation. On the other hand, none of the 60 drugs in Germany, only one of 62 in England, and just seven of 56 drugs in Switzerland had median unit price increases greater than inflation.

In all, the median unadjusted post-launch unit price change in the U.S. was 4.9% annually and 2.7% annually after adjusting for inflation. However, England, Germany, and Switzerland all saw prices decreases after adjusting for inflation.

"There were no associations between launch prices and clinical benefit using the ASCO-VF or the ESMO-MCBS scores or between post-launch price changes and clinical benefit," Vokinger and colleagues reported.

Vokinger's group suggested that if policymakers are going to address the high cost of cancer drugs, they must consider both launch prices and the cumulative effect of price changes after approval.

"An important step would be to allow CMS to negotiate drug prices," Zafar said. "Our inability to negotiate drug prices at the federal level presents a significant difference between health policy in the U.S. versus Europe. Price negotiation is not a panacea, but it must serve as a critical first step."

The Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3), which the House of Representatives is currently wrestling with, contains a number of far-reaching drug pricing reforms, including a provision giving the HHS secretary authority to negotiate some prescription drug prices for both Medicare and the private market.

In the meantime, Zafar pointed out that while oncologists have no control over how drugs are priced, "we have control over how drugs are prescribed."

"We must treat patients based on the best evidence," he said. "When more than one equally effective drug exists within a particular class, we must prescribe the less expensive drug. Use of evidence-based clinical pathways have been shown to reduce cost while maintaining effectiveness."

Comment