On March 16th the Wall Street Journal’s Health & Wellness section ran an article searching for answers on why sales of the new generation of weight-loss medications are slower than expected. The general conclusion is that the “P’s” in the healthcare value chain – patients, prescribers, and payers, perceive the drugs to have major safety concerns regardless of the FDA’s enforcement of more stringent approval paths.

So why do these safety concerns persist, even with a stricter FDA?

The answer, while clearly multifaceted, can also be simply distilled to one simple fact – the FDA and pharma no longer control the flow and release of drug safety data. The vast reach of the Internet and technical advances in big data analytics has enabled an unprecedented flow of information beyond the censored net of pharmaceutical companies, and an overburdened FDA. As a result, FDA approval is no longer seen as the gold standard of safety.

 

Related Read: An Indecent (Drug Safety) Propsal

 

Knowledge that the FDA is underfunded and understaffed and that pharmaceutical companies are inherently biased in the release of safety data, has caused patients to empower themselves to become their own advocates. They do their own research and push their prescribers and insurers for the best care option. In tandem, Prescribers want and require hard safety evidence, especially as they are being held accountable for curbing readmissions. Combine those factors with the need for Payers, who bear the financial risk for these expensive drugs, demanding to see long-term economic impact studies before they commit to making coverage decisions, and it all results in a system wide change in the healthcare industry’s sales dynamic.

 

Related Read: The Cost of Drug Safety

 

This information seeking trend is worth noting, and it’s one that is enabling the explosive growth of our company. Because while the FDA might deem a drug to have an acceptable risk-benefit profile, the stakeholders who provide access to the drugs are seeking and demanding more independent data, as are the patients who are being prescribed. The need for unbiased, independent, real-world post approval drug safety data has clearly never been greater.

It is no longer acceptable to the public or the managed care industry to blindly accept safety data from the FDA and pharmaceutical companies, who utilize limited clinical trials as their safety measurement.

Instead, they seek out drug safety information that takes into account real-world, current data. It is this real world data and analytics that provides patients and the managed care stakeholders with a renewed sense of understanding, trust and a clear-eyed view of the safety profile of a specific drug. More importantly, it gives them assurances as to not what “may” happen but what is actually happening – an important distinction for patients and providers, as well as payers who are determining long-term budget goals and expectations.

 

Related Read: Monitoring the Safety of Biosimilars by Managed Care Organizations: A Practical Approach

 

An example of this type of safety data provided by AdverseEvents was in January, a short time after its approval, we provided clients with a comparison of Saxenda vs. Qsymia which had been on the market for over a year. Saxenda from Novo Nordisk is a higher dose form of the widely prescribed type 2 diabetes drug Victoza. Saxenda’s label carries a boxed warning for risk of thyroid C-cell tumors and is approved under REMS program cautioning potential risk of medullary thyroid carcinoma and acute pancreatitis. In contrast Qsymia does not carry a boxed warning, and while it does have REMS for increased risk of congenital malformations in infants exposed to the drug, it appears at time of approval to be an overall safer option.

 

Comparison view of AEs on Saxenda’s label vs. the ones on Qsymia’s

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The importance and value of this type of post-marketing is clearly visible when you take note of what AEs have been seen with Qsymia to date. There are currently 2 Active RxSignals for Qysmia and 3 Watchlist RxSignals. (RxSignal indicator looks for serious AEs that are not on a drug’s label, that are showing elevated reporting for a particular side effect.)

 

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The power of this independent data is even more evident when you realize that there is the ability to calculate downstream medical costs for a drug’s side effects via RxCost, a new analytic released as part of AdverseEvents Explorer. Real formulary action can be immediately taken when RxCost reveals that Qsymia costs an additional $1.56 per prescription and that Victoza’s is an additional $3.33 per prescription. (Saxenda data is pending).

 

Qsymia

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Victoza

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The shift in the control of drug safety data is clearly and quickly reshaping the industry. Why are sales for these new weight loss drugs slow to ramp? Simple, FDA and big pharma have yet to understand the paradigm shift that has taken place; the information age has finally arrived in drug safety and independent, real-world data is not only being used, but it is being demanded.

And AdverseEvents is leading the way.

To view the power of independent drug safety data click to download a Drug Safety Comparison of Saxenda vs. Qsymia

 

 

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Jim Davis

Jim Davis

Executive Vice President

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Topics: Drug Safety

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.