First 'Digital Drug' Faces a Second Litmus Test: Improving Adherence

Otsuka’s Abilify got its second wind last week when US regulators cleared the off-patent pill for use with an ingestible sensor and digital ingestion-tracking system made by Proteus Digital Health.

But whether Otsuka can save its otherwise commodity drug from generic oblivion may depend on how well it can demonstrate to health plans and organized providers over the next 12 months that the first so-called digital drug improves adherence.

While it’s approved to track ingestion of the drug, the system’s ability to improve patient compliance has not been shown. The company says it’s now testing that potential in the real world, through alliances with a limited number of health plans and hospitals.

The approval came two years post-registration, after an FDA rejection last year, then a resubmission this past May, and finally a favorable nod from the agency several months later. It didn’t take long, though, for questions about the first-of-its-kind drug/tech combo, dubbed Abilify MyCite, to surface, namely the ethics of applying a digital technology to a psychiatric drug.

The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

An ingestible sensor embedded in the pill records that the medication was taken. The system sends a message from the pill’s sensor to a wearable patch, which beams the information to the patient’s app. They can allow caregivers and physician to access the information through an online portal.

Bioethicists and some physicians voiced concerns that the tracking system could be used—Big Brother style—as a sort of digital nanny, or to coerce patients with mental illness to take their meds, especially if incentives like payer discounts are in the offing.

Those fears aside, pharma forfeits an estimated $637 billion per year globally as a result of non-adherence, per Cap Gemini. Schizophrenia is known for having one of the lowest treatment compliance rates of any disease state, and mental health disorders in general are associated with notoriously low adherence.

Particularly in a situation where a patient is dealing with a chronic mental illness and has difficulty recalling whether they took the medication or not, Abilify MyCite could be a useful tool for family and physician (given patient consent) to assist with adherence and, by extension, to prevent hospital readmissions. Raise adherence, the thinking goes, and such downstream medical costs should fall.

Moreover, given the national move to value-based care, plans and providers have an incentive to lower drug spend and thus have an appetite for exploring alliances with pharma. In fact, 65% of IDNs/ACOs are already collaborating with a pharma manufacturer on a medication adherence or side-effect management program, as are 27% of health plans, according to a poll by the firm Precision for Value.

“Payers want a blend of high-tech and high-touch, a customizable menu that they can personalize to their population,” said Maureen Hennessey, an SVP with Precision for Value, last month on an MM&M webcast.

Pharma, for its part, is driven to engage in value-based alliances to demonstrate the real-world value of its products, to collaborate to manage adherence, and to prevent medication-related side effects.

In addition to adherence apps, these alliances often take the form of various kinds of outreach programs, like texts, interactive voice response (IVR), and virtual nurse programs, as well as the use of AI and predictive analytics to identify individuals who are at risk for non-adherence or who aren’t adherent presently. Such collaborations are increasingly springing up to improve outcomes around high-risk populations.

Proteus is reportedly working on embedding sensors into blood pressure and diabetes drugs. As we move into 2018 and beyond, technology like this could expand further to form better collaborations between pharma, payers and organized providers.