ADA preview: cardio data in diabetes, drug costs and healthcare reform

Views & Analysis
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The annual American Diabetes Association’s (ADA) Scientific Sessions will give a glimpse of the future direction of diabetes treatment.

Now that ASCO is over, the focus of the medical community shifts west from Chicago to San Diego, which is hosting this year's American Diabetes Association’s (ADA) Scientific Sessions.

Despite the huge surge in scientific progress and R&D investment in oncology, it is diabetes that is the biggest area of drug spending in the US. QuintilesIMS data show that US spending on diabetes prescriptions rose to $51.5 billion in 2016, easily eclipsing cancer drug spending at $45.5 billion.

Spending on diabetes treatments has doubled in just four years, a huge surge in cost reflecting the epidemic of obesity and type 2 diabetes taking its toll on America (as well as pharma price rises).

Diabetes now affects 29 million children and adults in the US, representing 1 in 11 Americans.

There are no signs that this epidemic is levelling off: every 23 seconds someone in the US is diagnosed with type 2 diabetes.

ADA says 86 million Americans have pre-diabetes and are at risk for developing type 2 diabetes, but the vast majority of these are unaware that they have the condition.

While this is, of course, a global problem, the US population is one of the worst affected in the world. However, unlike cancer, this disease doesn't have its own 'moonshot' - type 2 diabetes is wrapped up in complex issues around diet, exercise and social attitudes - a public health puzzle which none of the worst-affected countries has yet cracked.

Despite type 2 diabetes being an ever-growing problem in the US, pharma companies have seen their sales decline in the last few years, as payers have enforced aggressive discounts to contain costs.

Pharma companies in the field are now being forced to recalibrate their business models, investing in trials which prove the cardiovascular benefits of their drugs, alongside new molecular entities. They are also working with digital health tech companies as the market moves towards a disease management model based around patients.

Live from San Diego

This year, pharmaphorum will give on-site coverage of the ADA event in San Diego, with daily updates on all the latest developments and talking points.

Science-wise, the conference agenda is packed, with some major trial data due to be announced.

This year is remarkable for a shift towards cardiovascular outcomes trials across different drug types, brought about by an FDA demand for post-marketing studies. It's clear that the success and failure will increasingly hinge on whether companies can demonstrate that their drug can cut risk of heart attacks, stroke and cardiovascular disease.

Boehringer’s sodium glucose cotransporter-2 (SGLT2) inhibitor Jardiance (empagliflozin) was the first drug to demonstrate cardiovascular benefit in 2015 in its EMPA-REG trial.

Jardiance had dramatically cut the risk of non-fatal heart attacks and strokes and cardiovascular deaths in high-risk type 2 diabetes (T2D) patients, reducing these major adverse cardiac events (MACE) risk by 14%, and cardiovascular death risk by 38%.

This was a momentous event in diabetes, as no drug had ever shown this benefit before; indeed, older diabetes drugs had been shown to make cardiovascular problems more likely.

Such was the impact of  the EMPA-REG trial at the European diabetes congress two years ago, that the audience of clinicians gave the results a standing ovation.

Jardiance now has FDA approval to make these 'cardioprotective' claims, and its rivals are looking to at least match its performance.

Monday will see Janssen make the first presentation on its CANVAS study assessing cardiovascular outcomes of Invokana (canagliflozin), as well as CANVAS-R, which measures renal endpoints.

CANVAS is being watched closely because it could provide an indication as to whether this is a class effect, or limited to Boehringer’s drug.

Novo Nordisk’s Victoza (liraglutide), from the injectable GLP-1 class, has also been shown to reduce cardiovascular death.

However AstraZeneca's GLP-1 drug Bydureon recently failed to reach statistical significance in its own cardiovascular outcomes trial.

Type 1 diabetes

Another Novo Nordisk drug will be the focus of attention on Monday - its next-generation insulin product Tresiba. The DEVOTE trial compares the cardiovascular safety of its long-acting Tresiba (insulin degludec) with Sanofi’s Lantus (insulin glargine) in high-risk patients.

The trial is important to Novo, which is trying to make the case to US payers to use Tresiba instead of Lantus and its cheaper biosimilars.

It's not just the big pharma-funded trials which will be grabbing the headlines, however. The REMOVAL trial is funded by the type-1 diabetes focused charity the JDRF, and will examine if metformin can improve cardiovascular outcomes for type 1 (T1D) patients.

In relation to type 1 diabetes, a key discussion at the congress is entitled The Future Face of Diabetes Care - Beta Cell Replacement vs. Technology.  This will look at whether beta cell replacement or technology such as the artificial pancreas will be the future of treatment.

Click here for a  full list of the key trials highlighted by the ADA committee.

The burgeoning technology that is making the artificial pancreas a possibility is part of a wider digital ecosystem (in T2D and T1D) which is predicted to transform management of the conditions in the coming years. Medical device and digital technology vendors will also be out in force at the meeting.

One such company is Medtronic, one of the giants of medical devices. It will be presenting early data on The Sugar.IQ app, which it has developed with IBM Watson. The app uses cognitive computing to monitor behaviour patterns in patients, looking for any good or bad habits which will influence their blood sugar control. The technology uses continuous glucose monitoring (CGM), insulin delivery and contextual data, and is just one of many looking to offer a complete disease management platform for patients and clinicians.

There is great hope that these new technologies could help to curb the runaway costs of diabetes, by helping to control the disease and prevent complications. Last year QuintilesIMS estimated that the US could save $4 billion a year if older patients followed doctors' orders.

However one major factor behind this non-compliance was the expense of drugs, with patients forced to stop taking medication because of its high cost.

ADA speaks out on health reform, high price of insulin

Like ASCO, where the issue of drug prices came to dominate the agenda, there will be a political dimension to the ADA event.

Late last month the ADA called on the US Senate to reject Donald Trump’s American Health Care Act.

The Congressional Budget Office has warned that Trump’s attempt to take down healthcare arrangements created by his predecessor Barack Obama could mean 23 million Americans lose insurance coverage by 2026.

[caption id="attachment_28695" align="alignnone" width="149"]mick_mulvaney Mick Mulvaney[/caption]

The ADA also hit out at Mick Mulvaney, director of the White House Office of Management and Budget, after he voiced controversial views on healthcare spending.

Mulvaney suggested public funds should not pay for health care for someone who “sits at home, eats poorly and gets diabetes”.

ADA swiftly replied that Mulvaney's comments "perpetuate the stigma that one chooses to have diabetes based on his/her lifestyle."

It added: "We are also deeply troubled by his assertion that access to health care should be rationed or denied to anyone.”

On the issue of drug prices, the ADA has started the “Stand Up For Affordable Insulin” campaign, which notes that the average price of insulin almost tripled between 2002 and 2013.

Just as doctors expressed their anger over drug prices at ASCO, it looks likely that pharma will get a tough time on this at ADA, too.

About the author:

Richard Staines is Senior Reporter at pharmaphorum. He will be reporting live from ADA in San Diego. Follow him on Twitter here.