The Bar Just Got Raised

The Bar Just Got Raised

A few weeks ago Lilly (NYSE:LLY) released preliminary data from their EMPA-REG OUTCOME® study. Back on August 20th the company stated; “Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from EMPA-REG OUTCOME®. This is a long-term clinical trial investigating cardiovascular (CV) outcomes for Jardiance® (empagliflozin) in more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV events. EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of JARDIANCE, when added to standard of care, in CV risk reduction. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke.”

This news was well received given the hypersensitive issue of how diabetes treatments impact cardiovascular events. Yes thanks to our friend that crusading cardiologist Dr. Steven Nissen, cardiovascular events and diabetes dugs have become just as important as glucose control.

Today the company released more detailed data; “Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company’s (NYSE: LLY) Jardiance® (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in patients with type 2 diabetes (T2D) at high risk of CV events. There was a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.”

Shares of Lilly are skyrocketing on the news up nearly 9% so far today.

As exciting as this news is and it is truly exciting it remains to be seen whether this news will change anything in this highly competitive category. It’s important to note concerns have been raised over bone fracture risks and Invokana another SGLT2 from Johnson and Johnson (NYSE:JNJ). Back on September 10th the FDA issued the following warning; “The U.S. Food and Drug Administration (FDA) has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density. Bone mineral density relates to the strength of a person’s bones. To address these safety concerns, we added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.”

This same warning was accompanied by the following statement from the FDA;

“We are continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed.”

As noted in a post on September 11th;

“So on the one hand it may appear that Jardiance has a leg up on other SGLT2’s based on the cardiovascular data, it may also have the same bone fracture issues which are currently plaguing Invokana. The simple fact is until the agency evaluates the risk for other SGLT2’s we just don’t know.

Now here is where things get interesting, let’s assume for a moment that Invokana has the same cardiovascular benefits as Jardiance and Jardiance turns out to have the same bone fracture risks as Invokana. What then? What’s more important the cardiovascular benefits or the bone fracture risks? Considering diabetes can increase the risk of heart disease and strokes, having a drug that can treat the disease and a side effect of the disease would seem to be a big claim to be made. Yet given that the FDA felt it necessary to issue a safety alert for the bone fracture risk this issue cannot be dismissed as unimportant.”

Again as positive as this data we’re just not sure it will matter where it really counts; with payors. Payors who know that JNJ is running cardiovascular studies for Invokana. Payors who just might believe that all SGLT2’s have cardiovascular benefits therefore there is no need to give Jardiance preferential formulary placement over Invokana. As we noted above it’s also quite possible that Jardiance will get the same warning over bone fracture risk. The harsh reality is JNJ won’t sit ideally by and just Lilly waltz all over them. As we noted just yesterday the diabetes drug market has become an all-out battle for share and companies aren’t shy when protect their territory.

For the moment Lilly has set a high bar with this data and basically made JNJ play defense. It is now up to JNJ to at minimum match the data. Still we’re just not sure even if they don’t whether it will matter with payors. And like it or not what payors care about most is keeping costs under control irrespective of cardiovascular benefits. Should JNJ get within a few percentage points of the Lilly that will be good enough for payors.

Lilly has a leg up for now the question is do payors give a damn?