Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020

Miljković, Miloš D.; Tuia, Jordan; Thibault, Olivier; Haslam, Alyson; Prasad, Vinay

doi:10.1001/jamainternmed.2022.4924

Cited by 17 publications

(8 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Unlike US or Europe, monthly prices in Canada significantly differed for cancer drugs with substantial benefit vs low benefit per MCBS scores. However, consistent with other studies, 1 , 2 there was only a weak correlation between monthly drug prices and PFS or OS gains.…”

Section: Discussionsupporting

confidence: 91%

“…

Cancer drug prices have increased exponentially in the past decade and several studies have demonstrated an increasing disconnect between clinical benefit and prices for cancer drugs approved by the US Food and Drug Administration or the European Medicines Agency. 1,2 This disconnect seemed to exist even in the setting of central price negotiations in Italy. 3 However, to our knowledge this has not been studied for Canada.

…”

mentioning

confidence: 99%

See 1 more Smart Citation

Assessment of Price and Clinical Benefit of Cancer Drugs in Canada, 2011-2020

2023

View full text Add to dashboard Cite

show abstract

Section: Discussionsupporting

confidence: 91%

“…

…”

mentioning

confidence: 99%

Assessment of Price and Clinical Benefit of Cancer Drugs in Canada, 2011-2020

2023

View full text Add to dashboard Cite

show abstract

“…However, evidence has shown the contrary. In a 2022 analysis, the median annual cost of drugs approved based on improvement in overall survival was the lowest of the 3 end points, indicating that factors other than novelty play an important role in drug pricing. It also found that among the drugs approved on the basis of response rate, there was a weak correlation between cost and the magnitude of that gain in response rate, and the same was true in the categories of drugs approved on the basis of gains in progression-free and overall survival …”

Section: Discussionmentioning

confidence: 99%

“…Looking at the prevalence of such innovation in anticancer drugs, a previous study found 332 new drug approvals over 12 years, with 53 (16%) having a novel mechanism of action, 84 (25%) being first approval of a next in class compound, and 195 (59%) being subsequent approvals of the same drug. A similar study also found drug approvals from 2015 to 2020 showing weak correlation between clinical benefit and pricing.…”

Section: Introductionmentioning

confidence: 99%

Cancer Drug Price and Novelty in Mechanism of Action

Miljković,

Tuia,

Olivier

et al. 2023

JAMA Netw Open

Self Cite

View full text Add to dashboard Cite

ImportanceMany economic theories point to regulatory issues and subsidization of research and development costs as the primary factor in the high cancer drug prices in the US. Even so, the association between the median annual cost and novelty of cancer drugs approved in the US remains unclear.ObjectiveTo evaluate the association between the median annual cost and novelty of cancer drugs approved in the US over a 6-year period.Design, Setting, and ParticipantsThis cross-sectional study included all cancer drugs approved by the US Food and Drug Administration (FDA) from January 1, 2015, to December 31, 2020. Drug names, indications, manufacturer, dosage, and measures of activity/efficacy were extracted from the FDA announcement. The search was performed in December 2021. Data were analyzed from January 2022 until April 2022.Main Outcomes and MeasuresAnnual cost of treatment was calculated based on average wholesale price collected from the 2021 Micromedex Red Book database. Mechanism of action was inferred from trial publication or its references.ResultsThere were 224 cancer drug approvals across 119 individual drugs, with a median annual cost of $196 000 (IQR, $170 000-$277 000). Gene and viral therapies were the most expensive (median, $448 000 [IQR, $448 000-$479 000]), followed by small molecule therapy (median, $244 000 [IQR, $203 000-$321 000), and biologics (median, $185 000 [IQR, $148 000-$195 000]). There was no significant difference in cost between first-in-class, next-in-class, and subsequent approvals of an already approved drug.Conclusions and RelevanceFindings of this study indicate that the median annual price of anticancer drugs in the US is not associated with the novelty of their mechanism of action.

show abstract

“…At the same time, a recent report from the United States did not find a link between measures of benefit and the price for drugs that treat cancer. Oncology drugs approved on the basis of overall survival improvement had a lower median price than drugs approved using surrogate end points such as progression-free survival or overall response rate (Miljković et al 2022). This finding about the (non-)relationship between benefits and pricing is especially concerning since (based on my unpublished research) 52 of the 61 new oncology drugs approved in Canada between 2015 and 2020 used surrogate outcomes.…”

Section: Introductionmentioning

confidence: 99%