The cost of oncology drug costs can fluctuate substantially after initial launch, but with few exceptions, the price tag tends to steadily increase over time regardless of market circumstances, according to new findings
At a follow-up period of 12 years (mean, 8 years), the mean cumulative cost increase of all 24 patented, injectable anticancer drugs included in the study was 36.5% (95% confidence interval [CI], 24.7% – 48.3%).
Annual changes in cost did not appear to be affected by new supplemental US Food and Drug Administration (FDA) approvals, new off-label indications, and/or new competitors.
The study was published online October 10 in the Journal of Clinical Oncology.
Increasing drug prices have been a cause of great concern among patients, providers, and payers, note the authors, led by Daniel A. Goldstein, MD, Davidoff Cancer Center, Rabin Medical Center, Petach Tikvah, Israel.
Financial toxicity has become a well-established “side effect” of cancer care, with many patients experiencing varying levels of distress related to the cost of their care. A recent analysis found that over a third of patients with cancer who have health insurance are facing out-of-pocket costs that are higher than they anticipated. Not surprisingly, those experiencing the highest economic burden were the most distressed.
The authors note that studies have demonstrated that severe financial hardship leads to increased mortality, as hundreds of thousands of patients with cancer are reported to be delaying care, cutting their pills in half, or skipping drug treatment entirely.
Costs Continue to Jump
In addition, payers are also experiencing a growing economic burden and facing resource allocation challenges while dealing with budget constraints, say the authors.
Dr Goldstein and his colleagues sought to systematically measure the cost trajectories of 24 oncologic agents approved between 1996 and 2012, and also to see how the market structure influences changes in cost.
They used the average sales prices published by the Centers for Medicare & Medicaid Services in order to account for discounts and rebates. They adjusted costs to both general and health-related inflation rates.
In looking at annual general and health-related inflation rates, the mean cumulative cost increases were 19.1% (95% CI, 11.0% – 27.2%) and 8.4% (95% CI, 1.4% – 15.4%). But even though the mean annual general inflation rate was 1.09% and the health-related inflation rate was 1.15%, the mean annual change in the monthly cost of the drugs was 3.73%.
Looking at the individual drugs, the following agents incurred high changes in cost from the time of their initial launch to 12 years: Arsenic trioxide (Trisenox, Teva), approved in 2000 for the treatment of acute promyelocytic leukemia, experienced a 95.5% cost increase; nelarabine, approved in 2005 for the treatment of T-cell acute lymphoblastic leukemia, an 83.2% increase; rituximab (Rituxan, Genentech), approved in 1997 for non-Hodgkin’s lymphoma, an 85.2% increase; and trastuzumab (Herceptin, Genentech), approved for metastatic human epidermal growth factor receptor 2–positive breast cancer in 1998, a 78.4% increase.
The only drug that actually decreased in price following its launch in 2012 was Ziv-aflibercept (Zaltrap, Sanofi), which was approved for metastatic colorectal cancer. Its price declined by 12.8% from baseline in 3 years, but the decrease came about only after Memorial Sloan-Kettering Cancer Center announced that it would not use the drug. Writing in a New York Times an op-ed piece, three oncologists said that the drug was “phenomenally expensive” and “no better” than bevacizumab (Avastin, Genentech) in this setting.
Although both drugs improve the median survival of patients with metastatic colon cancer by 1.4 months compared with standard chemotherapy, bevacizumab costs about $5000 per month, which is less than half the official cost of aflibercept.
New Regulations Needed
Dr Goldstein and his coauthors note that the price increases observed in their study could not be explained by changes in any of the market structure variables examined. New supplemental approvals, adding in off-label indications, and the emergence of new competitors into the marketplace had seemingly no influence on the rates of price change.
They point out that while Medicare is not legally permitted to negotiate prices in the United States, that is not the case in other countries, where prices are controlled and negotiated. For example, a recent study showed that drug prices are higher in the United States than in United Kingdom, both at launch and after launch (J Oncol Pract. 2017;13:e538-e542).
“To maintain a sustainable health care system, it is essential to take into account that in addition to rising launch prices of new anticancer drugs, costs often change substantially after launch,” they conclude, cautioning that prices may continue to rise regardless of market volume or competitors who enter the marketplace.
“Individual price hikes have been the main focus of the public debate over drug prices,” the authors write. “Our study reveals that gradual price increases over the years might result in substantial cumulative increases. One potential solution toward managing this problem is to introduce new regulations into the marketplace.”
Dr Goldstein reports relationships with TailorMed and AstraZeneca; coauthor Salomon M. Stemmer reports relationships with Novartis, TEVA Pharmaceuticals Industries (institutional), Eli Lilly (institutional), Novartis (institutional), MSD Oncology (institutional), Roche (institutional), Bristol-Myers Squibb (institutional), AstraZeneca (institutional), and Genomic Health.
J Clin Oncol. Published online October 10, 2017. Abstract
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