Lack of proper adherence to medications has been called a national epidemic. To help address the adherence problem multiple digital health solutions have been proposed with some concerns that there has been limited large-scale evidence to support adoption. A new program focused on oncology patients is attempting to make a difference using a value-based payment structure between a health system and technology company.
Silicon Valley’s Proteus Digital Health has developed a “digital medicine” program for patients with colorectal cancer. The company says it is the first of its kind using sensor-enhanced chemotherapy. The technology provides personalized feedback for drug usage and was previously approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder in collaboration with Otsuka Pharmaceuticals.
The new treatment consists of an oral chemotherapy pill placed within a small gel capsule that contains a tiny ingestible sensor. The product is made of dietary minerals and gets activated when swallowed. It emits a signal to the patient’s smartphone app that can be shared with physicians and caregivers. Proteus is so confident its program will be effective that it has negotiated an arrangement where it only gets paid when patients comply with the treatment plan.
Studies indicate that between one third and one half of patients who are prescribed medications will not stay on treatment. These trends increase disease burden and result in poor outcomes as well as avoidable hospitalizations. Suboptimal medication adherence along with inaccurate prescribing and diagnosis cost about $ 290 billion per year according to the New England Healthcare Institute (NEHI). Insurers must pay for all filled prescriptions and estimates for wasted drugs alone are in the tens of billions of dollars.
The numbers are surprisingly bad for oncology drugs as well. Cancer patients might be considered more motivated to comply with medical plans given the catastrophic consequences of missing treatments. However, adherence to oral chemotherapy drugs has been documented to be as low as 20% in some groups such as adolescents, with others reporting rates between 50 and 100%.
There are multiple reasons for patients to not take medications as prescribed. For example, complexity and frequency of taking pills for serious conditions can be confusing. Some oncology treatment plans require patients to consume 8 to 10 pills per day for cycles of two weeks followed by a week off. Additionally the side effects of these drugs can be quite serious such as pain, hair loss, nausea, vomiting, diarrhea, or even cardiac arrhythmias.
Digital chemotherapy program
Proteus and Fairview Health Services of Minnesota have entered into a value-based program to treat patients with stage 3 and 4 colorectal cancer using a common chemotherapy drug in combination with the digital medicine. Under the arrangement, Fairview only pays if patients take the combination at least 80% of the time. The health system reimburses typical costs for the medication with no additional fees for the digital component.
Health systems often need to resort to cumbersome interventions in order to help patients stay on their chemotherapy schedule. For example, Fairview uses frequent phone calls from pharmacists and other reminders. Therefore, it believes that the digital combination can be cost effective if it delivers better drug adherence as well as improved patient and provider satisfaction.
The ingestible sensor is embedded in a placebo tablet that pharmacists combine with the chemotherapeutic and appear together as a standard drug capsule. The sensor is made of natural food-based materials that release a low-power signal when encountering acidic fluid in the stomach. Patients wear a disposable patch that time-stamps drug ingestion and then transmits a message to their mobile device enabling encrypted transmission to a secure online portal or the electronic medical record. According to Proteus, patients are more engaged with their treatment plans when they are able to receive personalized feedback and behavioral cues that help them keep track of taking mediations.
There have been multiple previous attempts to create electronic interventions that help address drug adherence problems. Mobile apps such as Medisafe, MyMeds and Care4Today were developed to alert patients regarding dosing. Pill packages such as Medminder, AdhereTech, and MyFellow generate text and email reminders and have been called electronic patient assistants. Some solutions focus on specific diseases such as Propeller Health or Cohero Health which are designed for respiratory conditions. There are video digital adherence strategies for infectious diseases such as tuberculosis. Others provide incentives through gift cards such as Mango Health or gamification and rewards such as HealthPrize Technologies. However, there has been skepticism from some payers and health systems that novel high-tech interventions are superior to office visits or scheduling high-touch nurse and pharmacist appointments. Some have expressed concerns about the reliability of data security and patient confidentiality.
Digital medicine early track record
The ingestible sensor technology does have data which suggests adherence benefits in complex medical conditions. A study in hypertensive and diabetic patients who were prescribed multiple drugs showed 80% adherence over a 12 week period with significant improvements in blood pressure and hemoglobin A1c when compared to usual care. There have been studies assessing the performance of the digital medicine in combination with the antipsychotic drug aripiprazole, approved under the name Abilify MyCite. Safety of the digital medicine has been well documented by research trials and FDA approvals.
This new oncology program does not carry additional regulatory costs because both the ingestible sensor and oral chemotherapy have been previously approved by the FDA and are re-packaged together. Typically, new drug applications for combination products need to go through lengthy review processes. However, some state pharmacy boards specifically delineate the safe encapsulation of drug-device combinations and such regulations apply in this case.