The Potential of Smart Pills and Ingestible Sensors

Medication compliance has always been one of pharmacy’s biggest challenges. With the advancing landscape of digital health technology, however, compliance may no longer be a hard pill to swallow.

Imagine you were able to tell which of your patients took their medications as directed, and which patients forgot. Imagine how your practice would change if you were able to see how medications affected your patients’ blood pressure or heart rate, or if you were able to accurately gauge compliance or dose-response relationships. How would you make a bigger impact on the patients you serve if you had such detailed information?

Proteus Digital Health is developing technology that essentially puts ingestible sensors into pills, and then uses those pills to understand compliance and the effects of medicines our patients are already taking on a daily basis.

I recently interviewed Yoona Kim, PharmD, the company’s head of Clinical Modeling and Analytics and a pharmacist working toward developing technology I believe has the potential to change how patients and providers look at medicines. After speaking with Dr. Kim, I’m truly excited about the technology’s prospects.

What brought you to Proteus?

I’m a pharmacist by training and I got my PhD in health economics. My work experience has led me to Mercer Health & Benefits, Gilead, and Novartis, but 2 and a half years ago, I transitioned to Proteus Digital Health. Proteus foresaw the need to build its health economics evidence base and story, and that’s where I fit in.

Where is Proteus today in terms of development?

Proteus has spent a lot of time developing the technology and gaining FDA approval. We also focused on enhancing the patient experience through user experience studies to ensure ease of use and an engaging platform. Clinical evidence was also a huge priority in the last few years of development.

Now, we’re partnering with customers to deploy the technology in a real-life health care environment and integrate into established clinical workflows and ultimately demonstrate real-world clinical and economic benefit. We’re currently working with several customers in this phase of the process.

Proteus technology is currently compounded into medications through the use of a specialty pharmacy. Does Proteus have a specific specialty pharmacy it uses, or could any specialty pharmacy perform this compounding?

The FDA clearance doesn’t limit or contradict the use of the Proteus technology to a specific population or specific medications. A prescriber may write a prescription for Proteus ingestible sensors to be co-encapsulated with medications to ensure that the sensor is taken with the medications of interest.

With our initial commercial launch, only a small number of pharmacies have access to our ingestible sensors, but it’s our mission to provide digital medicine for everyone, everywhere. Our ultimate goal is to make Proteus technology ubiquitous within all oral medications on the market.

Caregivers and health care providers are obviously interested in digital technology that monitors compliance and medication response, but how has specialty pharmacy reacted to such an offering?

Pharmacists, in general, have been one of our main clinical stakeholders because they’re the ones actually performing adherence counseling and medication management. Because of this, we work very closely with pharmacists within our health-system partners and clinics.

In terms of specialty pharmacy, in particular, there has been a lot of interest, as these pharmacies are still operating with limited information when it comes to medication adherence. Most pharmacies have, at best, used outreach phone calls that aren’t based on any patient-specific data. So, to have that granular data on each patient would really help their targeting and patient outreach efforts.

In late April, the FDA issued a complete response letter to Otsuka for its drug-device combination of Abilify with Proteus' ingestible sensor. What does this mean for Proteus in the near future?

We’re committed to working closely with Otsuka to address the FDA’s questions and will ensure they have all the information they need for a complete and thorough review. The FDA required information related specifically to conditions where the technology is likely to be used and further human factors for investigation. While we’re supporting Otsuka in their application, Proteus continues to deploy our FDA-approved offering.

If Proteus pursues more manufacturer partnerships, how will it attempt to engage providers?

Proteus currently works closely with the care teams within our partner health systems to ensure optimized clinical decision-making among providers. The physician response has been positive. A cluster-randomized trial from our cardiovascular metabolic studies demonstrated significant improvements in blood pressure, and physicians realize this technology has the potential to improve outcomes for their patients.

Will Proteus attempt to engage payers to reimburse for medications equipped with its technology?

We have begun engaging payers with the real-world evidence we’re generating, working with them to pave the reimbursement pathway. Some states have telemedicine and remote monitoring reimbursement codes that we may be able to leverage right now.

What are Proteus’ top 4 disease states in terms of market focus?

Cardiovascular and metabolic diseases, heart failure, and high-value medicines, including specialty medications. For example, we currently have a study going on with the high-cost drugs used to manage hepatitis C.

Which evidence types is Proteus relying on most to communicate the value of its technology to payers?

Real-world studies is a key area for evidence generation. For example, we had a hypertension registry study in the United Kingdom, as well as a study at an actual community pharmacy in the UK. We also recently presented data from a cluster-randomized study, where actual sites of care are split between Proteus sites and usual-care sites.

How will Proteus focus its outreach and communication efforts to payers and providers?

Our clinical evidence is often presented at various medical conferences, and we actively contribute to thought leadership outside of the medical community. For example, Proteus was at the 2016 BIO International Convention. I also recently presented at AMCP for a continuing pharmacy education session on digital health.

Who does Proteus consider to be its main payer going forward?

We’re partnering with health systems and manufacturers. Health systems are undertaking significant risk for the total cost of care for their patients, in light of measureable outcomes under which their reimbursement is based, so they’re interested in partnering with Proteus.

Has Proteus looked into outcomes-based contracting?

Outcomes-based contracting is a long-term aim of ours, but right now, our pricing strategy is based on the value we offer to our customers. We have specific targeting criteria for our initial customers, whose incentives must align with what Proteus is trying to achieve in terms of providing value to patients and health systems. So, while alternative reimbursement models are relevant, what matters to Proteus is the mission of the partner and how well that mission coincides with what Proteus aims to do for its patients.

Why did you choose Barton Health, a small rural hospital, to pilot your technology?

Barton Health had a specific interest in population health management while also dipping their toe into accountable care. So, they were ready for the innovation and first and foremost interested in improving the health of their patients by lowering the burden of cardiovascular disease in their community. In fact, our partnership has evolved through an expanded provider base prescribing Proteus. It’s a partnership that has continued to grow.

How is Proteus positioning itself to have enhanced interoperability with existing electronic medical records (EMRs)?

We have a cloud-based architecture that’s implemented using available standards including the Fast Healthcare Interoperability Resources specification. We’re also working hard to familiarize ourselves with popular EMRs, including EPIC and Cerner, to better understand the current interoperability status and how Proteus can effectively integrate with the EMRs used by our health-system partners.

How does Proteus accommodate patient populations that aren’t tech-savvy?

Years of user experience research has informed our app to be highly engaging and easy to use with very simple language and visualizations. The latest cardiovascular/metabolic study we carried out speaks to this: 56% of patients were low income, 51% had education less than or equal to a high school equivalent, and 24% had some sort of psychiatric comorbidity. It turns out these patients had phenomenal outcomes and actually rated the Proteus system very highly. Patients with traditionally lower rates of technology utilization, including older patients, are highly satisfied with the ease of use of Proteus.

How will Proteus make its data actionable?

Proteus is unique in that it provides health care providers with the root cause of treatment non-response, whether it’s nonadherence or true pharmacologic resistance, so it really allows the provider to optimize her treatment decisions with these medications. In addition, the app allows patients to describe exactly why they aren’t taking a medication, including forgetting to take the medication, side effects, and cost concerns.