Advertising Group Hits Novartis on Kisqali DTC Ad

The National Advertising Division (NAD) of BBB National Programs says Novartis should discontinue making certain claims in a direct-to-consumer (DTC) ad for breast cancer drug Kisqali. The review was precipitated by a complaint about survival benefit claims lodged by Eli Lilly, the maker of competing drug Verzenio.

Lilly took issue with Novartis’ claim that Kisqali it the “Only drug in class with consistently proven survival benefit in HR+/HER2-metastatic breast cancer,” based on data from three Phase 3 trials. NAD determined that the claim was “inherently comparative” and suggested Kisqali is more effective and provides superior survival benefits than other drugs. It also said consumers lack the medical knowledge or experience to understand nuances in clinical trial design or outcomes.

“Further, NAD determined that due to the numerous variations in trial design and other key metrics across clinical trials, the studies submitted are not similar enough to compare the overall survival data or other results,” according to the NAD opinion. “NAD notes that where express or implied comparative performance claims are being made, head-to-head studies of the products at issue constitute the most reliable and persuasive substantiation.”

NAD recommended that Novartis discontinue making the claims in its DTC ads, as well implied claims that:  

• Kisqali provides superior survival benefits as compared to any other available treatment in the CDK4/6 inhibitor class generally and to Verzenio specifically.
• Patients will live longer with Kisqali as compared to any other available treatment in the CDK4/6 inhibitor class generally and to Verzenio specifically.

NAD says it has already received a statement from Novartis that it has agreed to discontinue such claims in its DTC advertising.

Interestingly, the Lilly complaint also targeted the same claim being made in healthcare professional (HCP)-directed ads, which NAD said was acceptable because the audience is much more sophisticated and understand better the advertised results of clinical data than general consumers, especially when provided with appropriate context and detail. “NAD concluded that clinical experience and the context provided in the advertiser’s HCP-directed brochures would both inform the physician’s takeaway of the claim and limit it to the recited facts, and that this audience would interpret the comparative claim here simply as reporting that Kisqali is unique in achieving a statistically significant overall survival benefit across Novartis’ three Phase 3 clinical trials,” the group says.

Asked to comment on the NAD opinion, FDA had this to say: "Generally, the FDA does not comment on third-party findings but evaluates the information as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.  The FDA is committed to protecting public health by helping to ensure that prescription drug promotion is truthful, balanced and accurately communicated.  The FDA takes our responsibilities seriously and will continue to monitor promotion and communications regarding prescription drugs through our surveillance operations.  We encourage consumers to remain vigilant, understand the risks and talk to a healthcare provider about questions related to prescription drugs.  We also encourage anyone who has concerns about potentially false or misleading prescription drug promotion to report this to the agency for further investigation through The Bad Ad Program | FDA."