Many Drugs Could Come Equipped with Ingestible Sensors

Proteus Digital Health recently announced a new pipeline of research using their bioingestible sensors. Now, if you are not familiar with Proteus Digital Health, you may at least have heard of one of their recent products that got FDA approval. Otsuka had teamed up with Proteus several years back and will be releasing their Abilify MYCITE to the market this year. I had written about this product, but the breakdown is that patients on the Abilify MYCITE can be monitored for their adherence.

Proteus platform is rather straightforward. A patient applies a patch to their upper left abdomen (above the stomach essentially) that detects when a medication with a sensor embedded or attached to it dissolves. This data can then be transmitted, such as to the patient's smartphone to keep a personal record, but also uploaded to a platform clinicians can access to track adherence for their patients.

Now, Proteus has detailed that they have a pipeline of more than 30 drugs across the spectrum of mental health, cardiology, metabolic conditions, infectious diseases, and oncology in the works. This is staggering to say the least. Many critics were quick to say that the use of sensors in the mental health population was subject to many issues, namely the diseases themselves (i.e., schizophrenia). But that doesn't detract from the platform's use across all therapeutic areas.

In a statement, Andrew Thompson, CEO of Proteus said, “Our extensive clinical trial, and commercial experience with digital medicines with thousands of patients has been overwhelmingly positive. The products are well accepted by consumers, secure, private, fully HIPAA compliant, and extraordinarily safe. More importantly, we have shown consistently that patients who choose to use DigiMeds take them about 90% of the time, compared to medication possession of 50% with regular drugs. Physicians coach patients, and properly titrate medicines at 3 times the rate when they have accurate data on drug use, and activities of daily life that our solutions provide. This is more important than ever: on March 26, 2018 the Annals of Pharmacotherapy published a study estimating that inappropriate drug use costs the United States $524.4 billion a year, about 16% of total United States healthcare spending. Wider use of digital medicines will help many patients and will help save a lot of money.”

The critical thing here is the cost. Often, it is cited that the adherence market is around $300 billion, based on a study published almost a decade ago. With an aging population, and more drugs entering the specialty market, the cost has skyrocketed. Whoever can address adherence stands to make a significant amount of money. Now, Proteus platform is excellent at tracking the oral medication market, and since a majority of medications are oral, its a large piece of the $500 billion problems.

But which meds should have a sensor in them? Obviously not all at this point, it's too pricey. Why take a $4 generic drug and ratchet it up to >$50 for instance? Odds are payers won't want that. But, if your drug costs you >$10,000 for a therapeutic course, adding a couple hundred to make sure your patients are adherent is most likely worth the price. And that is why areas like ID, and oncology are highly attractive, since many of their drugs are falling into the specialty marketplace.

IProteus is currently in the process of recruiting for studies, and many are ID. These include therapies for ART, ARV, PReP, and Hep C. Many of those are costly drugs, and pharma sees a market. They not only can use Proteus system to monitor adherence during their clinical trials, which the FDA seems to be aiming for in the future, but also have a product to release that payers would want to cover as well.

It's quite the exciting time we live in. We have never really been able to track adherence to this degree in clinical practice. In a way, we have thrown open Pandoras Box. In the past, we could say that we had encouraged adherence, but never honestly knew if a patient did or did not take them. Thus, we were protected from any failure in therapy, and it was placed on the patient. But now... what do we do if we see a patient isn't taking their medication? It is now on us, and I do feel it will open new pathways to the pharmacy profession to have duties with monitoring, and guiding adherence interventions. This will likely occur with specialty pharmacists, and insurance companies, but could trickle down as the market utilization of ingestible sensors increases in the future.

I am a big believer that we need to start educating pharmacists, and clinicians on this technology, and how to integrate it into the workflow. It's one thing to track adherence, it's another thing to act on that data, and make it meaningful.

Reference

Proteus Digital Health® Announces Digital Medicines Pipeline Development and Expansion into Oncology. Proteus Digital Health. April 25, 2018. https://www.proteus.com/press-releases/proteus-digital-health-announces-digital-medicines-pipeline-development-and-expansion-into-oncology/